chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a phlebotomist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient may had vaccinated (the reporter was not sure) with one of the improperly stored vaccines of PNEUMOVAX23 (which had the lot # L019836, expiration date  24-MAR-2017) or RECOMBIVAX HB (lot # M006708, expiration date 02-JUN-2018, lot # M018625, expiration date 11-AUG-2018) or VAQTA (lot # L015460, expiration date 20-JUL-2017) for prophylaxis (dosage information, route or anatomical site of vaccination were not informed). Information about concomitant medication was not provided. No adverse effect was reported. There was no product quality complaint involved. It was also informed that the vaccines experienced a temperature: >46°F but < 77°F. The time frame was 12 hours and 45 minutes. There was no previous temperature excursion. The call was because of a "data logger". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 20-FEB-2017 from a pharmacist who reported that a dose of expired ZOSTAVAX (lot# L044530, expiration date 09-FEB-2017) was inadvertently administered to an unspecified patient today (age and gender not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 21-FEB-2017 from a medical assistant who reported that an expired dose of ZOSTAVAX vial 19400 PFU (lot# L040443, expiration 15-JAN-2017) was administered subcutaneously to a 60 year old male patient today, 21-FEB-2017. The patient has not experienced an adverse effect. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On 03-FEB-2017 and on 12-FEB-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had a lot # of M011832, an expiration date of 25-JAN-2018, for prophylaxis. Which were exposed to a temperature 0 to 2 C for a  time frame of 3 hours. There were no previous temperature excursion and it was call  because of a data logger. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 26-JAN-2017, the patients were vaccinated with a dose of improperly stored VARIVAX which had a lot # of M025869 with expiration date of 24-MAY-2018 and M005972 with expiration date: 02-FEB-2018, however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions: on 26-JAN-2017 more than -15 degree centigrades (C), but less than 10 degree C (-12.7 degree C) during 1 hour and 4 minutes of; on 14-FEB-2017, more than -15 degree centigrades (C), but less than 10 degree C  (-11.1 degree C) for 6 hours and 4 minutes, and on 15-FEB-2017, more than -15 degree centigrades (C), but less than 8 degree C (-6.2 degree C) for 10 hours and 24 minutes. There had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007294:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23, (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000487: US-009507513-1703USA000488: US-009507513-1702USA008062:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA000487: US-009507513-1702USA008062: US-009507513-1703USA000486:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Left leg had swelling and redness that started 24 hrs. after KINRIX vaccine was given. Symptoms worsened over next two days. No fever on exam left lateral thigh had swelling and warmth with area of redness 10 cm in diameter and is firm. Dr felt it was a localized reaction to immunizations.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Left arm redness.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Lethargy, Mental impairment, Nausea
Clinical narrative: Severe lethargy, nausea, weakness, cloudy thinking.
Age: 52.0
Sex: M
Vaccine: SMALL
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Patient states: -Increased volume of my tinnitus -Mild headaches, but also a feeling that I'm wearing a helmet that's too tight -Pronounced balance problems. Difficulty balancing on one foot, and unable to balance on one foot with eyes closed. -Increased sensitivity to noise and light -Occasional blurred vision in one or both eyes. Having trouble focusing often. Dizzy if I move my gaze too quickly. Headaches when reading -Strange feeling of being on the verge of shivering, tightening muscles, etc. -Having a very difficult time sleeping.
Age: 52.0
Sex: M
Vaccine: SMALL
Symptoms: Hyperacusis, Insomnia, Muscle tightness, Photophobia, Tinnitus
Clinical narrative: Patient states: -Increased volume of my tinnitus -Mild headaches, but also a feeling that I'm wearing a helmet that's too tight -Pronounced balance problems. Difficulty balancing on one foot, and unable to balance on one foot with eyes closed. -Increased sensitivity to noise and light -Occasional blurred vision in one or both eyes. Having trouble focusing often. Dizzy if I move my gaze too quickly. Headaches when reading -Strange feeling of being on the verge of shivering, tightening muscles, etc. -Having a very difficult time sleeping.
Age: 52.0
Sex: M
Vaccine: SMALL
Symptoms: Vision blurred
Clinical narrative: Patient states: -Increased volume of my tinnitus -Mild headaches, but also a feeling that I'm wearing a helmet that's too tight -Pronounced balance problems. Difficulty balancing on one foot, and unable to balance on one foot with eyes closed. -Increased sensitivity to noise and light -Occasional blurred vision in one or both eyes. Having trouble focusing often. Dizzy if I move my gaze too quickly. Headaches when reading -Strange feeling of being on the verge of shivering, tightening muscles, etc. -Having a very difficult time sleeping.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Eye movement disorder, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Patient had an apparent seizure (shaking, eyes rolled back, unresponsive). He did not have a fever when his temp was taken at the ER about an hour later (was 99.2 rectally). They did not think further testing was necessary sent us home to follow up with neurology.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Contusion, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Bruising, petechiae, very low platelet count. Diagnosed with ITP.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Platelet count decreased
Clinical narrative: Bruising, petechiae, very low platelet count. Diagnosed with ITP.
Age: 5.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abnormal behaviour, Attention deficit/hyperactivity disorder, DNA test for fragile X, Laboratory test, Psychiatric evaluation
Clinical narrative: Approximately September 2016 developed worsening behavior difficulties, with uncontrolled outbursts causing severe school problems and home problems and requiring psychiatric evaluation. Symptoms of ADHD.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hallucination, auditory
Clinical narrative: Patient received HPV and had dizziness which progressed to auditory hallucinations and hospitalization.
Age: 54.0
Sex: M
Vaccine: CHOL
Symptoms: Chills, Diarrhoea, Headache, Night sweats
Clinical narrative: Headache began morning of 2/24, lasted until 2/25 AM. Diarrhea began shortly after headache onset on 2/24, lasted until 2/25. Night sweats and chills on 2/27 PM until 2/28 AM.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Large knot that was hard, tender and red around the area the night she received vaccine, arm started swelling up.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Blood test, Computerised tomogram, Condition aggravated, Electroencephalogram
Clinical narrative: Altered mental state. Episodes of amnesia recurring.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Mental status changes, Nuclear magnetic resonance imaging
Clinical narrative: Altered mental state. Episodes of amnesia recurring.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness around vaccine site.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site reaction, Oedema, Pain in extremity
Clinical narrative: Patient received vaccine 2/25/2017. Developed headache (R) arm pain within 12 hours. Over the next 24 hrs pt developed welts at the injection site; developed erythema and edema.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient received vaccine 2/25/2017. Developed headache (R) arm pain within 12 hours. Over the next 24 hrs pt developed welts at the injection site; developed erythema and edema.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Mom noticed when she picked her up from daycare left arm swollen at site of injection down to elbow approx area size 3x6.
Sex: U
Vaccine: FLU4, HEP, HPV4, IPV, MMR, TDAP
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: Parent stated 1 hr. after vaccines client stated son had rash all over body and was s.o.b. Had son take hot shower and breathing improved rash lasted 4 hrs. No medical follow up obtained by client. Recovered at home.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Injection site reaction, Rash papular
Clinical narrative: 48 hours following Tdap patient developed dysphagia and went to Urgent Care. She was given an injection of a steroid and observed, sent home with oral steroid and (2) EPI-PENS. Patient also had a papular rash on (RT) shoulder and arm.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Malaise, Syncope
Clinical narrative: Syncope after MCV4 Pt complained not feeling well, MA had pt lie down and past out briefly. Pt recovered quickly and Pt monitored/Evaluated by provider.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Peripheral swelling
Clinical narrative: Pt came in to office complaining of redness and swelling in right arm noted on 2/14/17 after receiving vaccine on 2/13/17. Pt stated in office visit 2/15/17 that the redness/swelling was better today but wanted it be checked. Dr. advised local reaction take BENADRYL, ice.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin M normal, Diarrhoea, Fatigue, Neutrophil count decreased, Pyrexia
Clinical narrative: C/O diarrhea, vomiting, spreading rash, fatigue, fever of 100.5 6-14 days post #2 MMR, she reports diarrhea, vomiting some rash post #1 MMR. Labs ordered CBC w/Diff MMR Titer, MRI IgM Consult with clinic ID R/O measles.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Vomiting, White blood cell count decreased
Clinical narrative: C/O diarrhea, vomiting, spreading rash, fatigue, fever of 100.5 6-14 days post #2 MMR, she reports diarrhea, vomiting some rash post #1 MMR. Labs ordered CBC w/Diff MMR Titer, MRI IgM Consult with clinic ID R/O measles.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Patient has had a headache since vaccine was given. Patient diagnosed with generalized headache during sick visit 3/1/17 following vaccine admin 2/28/17. Still has headaches.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Rash erythematous, Rash generalised, Rash macular, Skin lesion
Clinical narrative: Symptoms started as red dots on legs with spread to rest of body with raised red lesions, irregular borders and splotches in 24hrs with significant itch. Patient tried BENADRYL and topical cortisone without relief then was prescribed hydroxyzine and 3 day oral steroid burst (prednisone 20 mg PO BID x 3 days). Rash and itching waxed and waned for another 48hrs.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP, YF
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Right upper arm pain at injection site with neuropathic pain radiating to right distal arm and hand.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Appearance of itchy hives superior to injection site at right upper arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen to arms, redness. No pain.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Constipation, Decreased appetite, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: 11/14/2015: 106 degrees F fever, red swollen throat, anorexia, constipation - 11/19/15.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: 11/14/2015: 106 degrees F fever, red swollen throat, anorexia, constipation - 11/19/15.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Analgesic drug level therapeutic, Computerised tomogram head normal, Drug screen negative, Electroencephalogram normal, Full blood count normal
Clinical narrative: Patient experienced seizure like episodes 5 days after vaccination. EEG negative. Diagnosed as pseudoseizures.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal, Psychogenic seizure, Seizure like phenomena
Clinical narrative: Patient experienced seizure like episodes 5 days after vaccination. EEG negative. Diagnosed as pseudoseizures.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a nurse and refers to a 69-year-old female patient with no pertinent medical history,  drug reactions or allergies reported.. The patient's concurrent conditions, and concomitant therapies were not reported. On 25-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number: M041686 (strength, dose, frequency, route, anatomical location and expiration date were not provided), for prophylaxis. On the same date, at night, the patient experienced warmth (feeling hot), redness (Erythema), and mild tenderness (tenderness) in the mid-lateral area of her right upper arm. The patient sought medical attention through to a visit to her physician, on 27-JAN-2017. There, no laboratory tests were performed; however, the patient was prescribed with amoxicillin (+) clavulanate potassium for erythema and feeling hot, and ibuprofen for the pain. At the reporting time, the patient was recovering from the events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse and refers to a 69-year-old female patient with no pertinent medical history,  drug reactions or allergies reported.. The patient's concurrent conditions, and concomitant therapies were not reported. On 25-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number: M041686 (strength, dose, frequency, route, anatomical location and expiration date were not provided), for prophylaxis. On the same date, at night, the patient experienced warmth (feeling hot), redness (Erythema), and mild tenderness (tenderness) in the mid-lateral area of her right upper arm. The patient sought medical attention through to a visit to her physician, on 27-JAN-2017. There, no laboratory tests were performed; however, the patient was prescribed with amoxicillin (+) clavulanate potassium for erythema and feeling hot, and ibuprofen for the pain. At the reporting time, the patient was recovering from the events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a nurse and refers to a 69-year-old female patient with no pertinent medical history,  drug reactions or allergies reported.. The patient's concurrent conditions, and concomitant therapies were not reported. On 25-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number: M041686 (strength, dose, frequency, route, anatomical location and expiration date were not provided), for prophylaxis. On the same date, at night, the patient experienced warmth (feeling hot), redness (Erythema), and mild tenderness (tenderness) in the mid-lateral area of her right upper arm. The patient sought medical attention through to a visit to her physician, on 27-JAN-2017. There, no laboratory tests were performed; however, the patient was prescribed with amoxicillin (+) clavulanate potassium for erythema and feeling hot, and ibuprofen for the pain. At the reporting time, the patient was recovering from the events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist 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 08-FEB-2017, the patient was vaccinated with an expired dose of VARIVAX (dose and route were not reported) (lot # L001326 and expiration date 13-JAN-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site ulcer, Local reaction
Clinical narrative: This spontaneous report was received from healthcare worker (also reported as an office assistant) concerning a 69 years old female patient. The patient had no medical history, concurrent conditions, drug reactions or allergies. On 03-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX23, in the left arm, for prophylaxis, at an unspecified pharmacy (dose number, route of administration, lot number and expiration date were unknown). There were no concomitant medications. On an unspecified date in February 2017, the patient developed burning and pain at the injection site (injection site pain). Then, on 17-FEB-2017, the patient was seen in the office and the evaluation revealed a 2 inch by 3 inch local ulcer at the injection site of the left upper arm (injection site ulcer). The patient was given an unspecified treatment, however no laboratory tests were performed. The patient was referred for treatment at a local wound care center. At the time of reporting, the patient had not recovered from the injection site ulcer and the injection site pain. The causality assessment between the injection site ulcer, the injection site pain and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site ulcer
Clinical narrative: This spontaneous report was received from healthcare worker (also reported as an office assistant) concerning a 69 years old female patient. The patient had no medical history, concurrent conditions, drug reactions or allergies. On 03-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX23, in the left arm, for prophylaxis, at an unspecified pharmacy (dose number, route of administration, lot number and expiration date were unknown). There were no concomitant medications. On an unspecified date in February 2017, the patient developed burning and pain at the injection site (injection site pain). Then, on 17-FEB-2017, the patient was seen in the office and the evaluation revealed a 2 inch by 3 inch local ulcer at the injection site of the left upper arm (injection site ulcer). The patient was given an unspecified treatment, however no laboratory tests were performed. The patient was referred for treatment at a local wound care center. At the time of reporting, the patient had not recovered from the injection site ulcer and the injection site pain. The causality assessment between the injection site ulcer, the injection site pain and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Tingling in bottom of feet; numbness of 2nd small toe on left foot; Turning sensation around ankles and lower leg; burning sensation on hands; hands fallinga asleep at nignt; increased sexual dysfunction; on and off soreness in multiple areas of legs; on and off sensations in eyes - went on 15 day reducing dosage of prednisone that started at 30mg for first 3 days prescribed by different doctor.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abnormal sensation in eye, Burning sensation, Hypoaesthesia, Male sexual dysfunction, Pain in extremity
Clinical narrative: Tingling in bottom of feet; numbness of 2nd small toe on left foot; Turning sensation around ankles and lower leg; burning sensation on hands; hands fallinga asleep at nignt; increased sexual dysfunction; on and off soreness in multiple areas of legs; on and off sensations in eyes - went on 15 day reducing dosage of prednisone that started at 30mg for first 3 days prescribed by different doctor.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: Tingling in bottom of feet; numbness of 2nd small toe on left foot; Turning sensation around ankles and lower leg; burning sensation on hands; hands fallinga asleep at nignt; increased sexual dysfunction; on and off soreness in multiple areas of legs; on and off sensations in eyes - went on 15 day reducing dosage of prednisone that started at 30mg for first 3 days prescribed by different doctor.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: THE PATIENT STATED SHE WAS FEELING SHARP PAIN AROUND THE INJECTION SITE AND SHE COULDN'T MOVE HER ARM OF INJECTION.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Myoclonus
Clinical narrative: Went into ER after what the ER physician determined were myoclonic jerks and ruled out seizures.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to 2 unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unspecified dates, the patients was vaccinated with a GARDASIL 9 (lot number, expiration date, dose, route and frequency were not provided) and experienced syncope. The outcome of syncope is unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an adult patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 27-JAN-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). No adverse events were reported. Additional information is not expected, since there was no consent for further contact with the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 23 years old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of PROQUAD (dose, frequency, route, lot # and expiration date were not reported). No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain, Pruritus, Urine analysis
Clinical narrative: This spontaneous report was received from a  67 year old female consumer with no pertinent medical history and allergy to "Bactirim" reporting on herself. Concomitant therapies included pioglitazone hydrochloride(ACTOSE), metformin," Lavimire" and acetaminophen, hydrocodone bitartrate("RITIDEROLE" VICODIN). On 24-JAN-2015, the patient was vaccinated in the left arm with a dose of  ZOSTAVAX, 1 time vaccine, lot # K012786, expiration date: 28-NOV-2015 to prevent the shingles. On an unspecified day in March 2015 (reported as about a month and a half after getting the vaccine), the patient experienced shingles. She had had continuous shingles since getting the vaccine. They began to clear up on her body but then they came back. The patient stated that she got them in her left shoulder, upper back, and upper chest. She did not get severe pain but the shingles which were really itchy and the pain feelt like someone was sticking a needle on her. Regular lab test such as "CVC", urine analysis, type and cross match lab study were performed  but the results were not provided.  The patient sought medical attention and the physician instructed her to apply capsaicin cream and take diphenhydramine hydrochloride (BENADRYL) tablets for the pain. At the time of reporting the patient's outcome was unknown. Additional information is not expected because reporter refused additional contact.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a nurse practitioner via Pfizer concerning a currently 66 year old female patient. The patient's medical history and concomitant therapy were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, dose and route unknown) for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX23. The outcome of allergy to vaccine was unknown. The reporter considered the event to be related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD (dose and route unknown, lot # M009746, expiration date: 23-AUG-2017) for prophylaxis. The vaccines were stored in -11.2 degrees Celsius for 15 hours 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000601.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, drug reactions/ allergies and concomitant medication were not reported. On 23-FEB-2017, 3 improperly stored doses of LIQUID PEDVAXHIB (lot # M036057 with expiry date 18-MAY-2019, lot#M036612 with expiry date 19-MAY-2019) were administered to these patients for prophylaxis (strength, dosing details, anatomical location and route unknown) (incorrect product storage). The vaccine doses were exposed to the temperature of 0 to 2 degree Celsius for 12 hours. No adverse effects were reported. There was no previous temperature excursion. Data logger was not involved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 month old patient. Pertinent medical histories and concurrent conditions were not reported.  On 24-FEB-2017, the patient was vaccinated with VAQTA (dosage regimen were not reported) for prophylaxis ( product use issue). No adverse effects were reported (no adverse event). All of the data listed were reconfirmed with the reporter. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from administrator (other) refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (lot number and expiration date unspecified) (unspecified dosages) for prophylaxis and then received second unspecified dose of GARDASIL or GARDASIL 9 (lot number and expiration date unspecified) six months later (inappropriate schedule of drug administration). The products could not be clarified, and patient age could not be obtained before the call was disconnected. No additional information is available. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a consumer via company representative regarding a 1-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD and a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines above described) both vaccines for prophylaxis. Additional information has been requested. It has been determined that case US-009507513-1702USA008643 was sent to distribution with an incorrect aware date. Therefore, case # US-009507513-1702USA008643 is being deleted from our files and the cases are consolidated into case # US-009507513- 1703USA000332.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates starting on or after 08-JUL-2016, the patients were vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration and anatomical location were unknown) with lot number M006724 and expiration date 08-FEB-2018 for prophylaxis, which was stored at more than 14 Fahrenheit degrees (°F) to less than 46 °F for 45 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported.     On an unknown date, the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB, (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008062: US-009507513-1703USA000488: US-009507513-1703USA000486:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender.  The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX (dose and route unknown, lot # L017145, expiration date: 13-MAY-2017) for prophylaxis. The vaccines were stored in -11.2 degrees Celsius for 15 hours 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1702USA011265:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 01-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L017265, expiry date: 10-FEB-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site bruising
Clinical narrative: Initial unsolicited report received from a pharmacist on 16-Feb-2017. This case involves an 81 year old female patient who was vaccinated with a dose of FLUZONE HD Batch number: UI731AA, (expiry date, dose, dose in series and route of administration were not reported) in left arm on 12-Feb-2017. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were reported as none. Any other vaccinations within four weeks of vaccinations was none. On 14-Feb-2017, two days following vaccination (on tuesday morning) patient experienced bruising left arm below the deltoid and pain into the elbow for which patient was unable to use the arm (injection site movement impairment) and was with terrible pain. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were none. Corrective treatment were not reported. The outcome of events were reported as not recovered. List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Herpes zoster, Injection site erythema, Injection site rash, Rash papular
Clinical narrative: Initial unsolicited misuse report received from the literature on 20 February 2017. This case involves an 18-month-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose and route of administration was not reported), in the left buttock on an unknown date. It was reported that patient was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. Patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient presented to emergency room with a rash on the left lower extremity, red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. On an unknown date, 1 week; post vaccination on examination patient was afebrile, well-appearing, had multiple discrete clusters of monomorphic pink to violaceous papulovesicles with surrounding erythema scattered across the left buttock, thigh and upper calf, some with central punctate hemorrhagic crust (eruption continued to spread down his left thigh over the next 2 days). On an unknown date, following the vaccination patient was presumed with cutaneous bacterial infection and was diagnosed with Herpes zoster. It was reported that patient did seem uncomfortable when getting dressed. It was also case of vaccine administered at inappropriate site as influenza vaccine was administered one week prior to presentation in the left buttock. Relevant laboratory test included direct fluorescent antibody of a vesicle confirmed the presence of varicella-zoster virus (VZV) and some unspecified test. Patient received corrective treatment with acyclovir(deffered), cephalexin and mupirocin. Outcome of the events was recovering (patient's eruption was asymptomatic and improving by the time that test results were available). Upon internal review the case was considered as serious because of important medical event Herpes zoster. Documents held by sender: none. Sender's Comments: Patient was vaccinated with influenza vaccine and develops herpes zoster and vaccination site erythema. Time to onset is compatible, but additional information regarding patient past medical history, history of herpes infection, immune status, past vaccination history and its tolerance, etiological work up and investigation results to rule out the alternative cause are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 1.5
Sex: M
Vaccine: FLUX
Symptoms: Scab, Skin bacterial infection, Varicella virus test positive
Clinical narrative: Initial unsolicited misuse report received from the literature on 20 February 2017. This case involves an 18-month-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose and route of administration was not reported), in the left buttock on an unknown date. It was reported that patient was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. Patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient presented to emergency room with a rash on the left lower extremity, red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. On an unknown date, 1 week; post vaccination on examination patient was afebrile, well-appearing, had multiple discrete clusters of monomorphic pink to violaceous papulovesicles with surrounding erythema scattered across the left buttock, thigh and upper calf, some with central punctate hemorrhagic crust (eruption continued to spread down his left thigh over the next 2 days). On an unknown date, following the vaccination patient was presumed with cutaneous bacterial infection and was diagnosed with Herpes zoster. It was reported that patient did seem uncomfortable when getting dressed. It was also case of vaccine administered at inappropriate site as influenza vaccine was administered one week prior to presentation in the left buttock. Relevant laboratory test included direct fluorescent antibody of a vesicle confirmed the presence of varicella-zoster virus (VZV) and some unspecified test. Patient received corrective treatment with acyclovir(deffered), cephalexin and mupirocin. Outcome of the events was recovering (patient's eruption was asymptomatic and improving by the time that test results were available). Upon internal review the case was considered as serious because of important medical event Herpes zoster. Documents held by sender: none. Sender's Comments: Patient was vaccinated with influenza vaccine and develops herpes zoster and vaccination site erythema. Time to onset is compatible, but additional information regarding patient past medical history, history of herpes infection, immune status, past vaccination history and its tolerance, etiological work up and investigation results to rule out the alternative cause are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Chest X-ray, Chest pain, Cold sweat, Fatigue
Clinical narrative: Employee complaining of feeling cold and clammy, dull pain mid chest, fatigued and later told ER MD that he had temp 101 over the previous weekend on 2/25/17.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Feeling cold, Influenza virus test, Laboratory test, Viral infection
Clinical narrative: Employee complaining of feeling cold and clammy, dull pain mid chest, fatigued and later told ER MD that he had temp 101 over the previous weekend on 2/25/17.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Rash pruritic, Streptococcus test negative
Clinical narrative: Patient reportedly had non-raised, red, itchy rash start on neck at school that rapidly progressed to face, arms and abdomen.  No difficulty breathing or outward distress.  Patient presented to clinic at 1434.  Tested negative for group A rapid strep. Mother denied any new lotions, soaps or other products that come in contact with skin.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Redness around injection site. Pain. Swelling.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Redness around injection site. Pain. Swelling.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Patient died overnight the night following receiving vaccines.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician and refers to a 16 year old female patient. The patient did not had pertinent medical history and no known drug allergies. Concomitant therapies included ADDERALL XR, ZOLOFT and magnesium hydroxide. On 10-FEB-2017, the patient reported to office for administration of her third series of GARDASIL 9 intramuscularly, lot # M026306, expiration date 30-APR-2018 (dose was not reported) for prevention of cervical cancer as the patient was in childbearing age group. After administration of the vaccine, the patient returned to the office on 13-FEB-2017 and reported redness and minor swelling around the injection site. Additionally, the patient developed small blister slightly anterior to injection site and itchiness related to injection. The physician treated the patient with ibuprofen and BENADRYL. At the time of reporting, the patient was recovering from the events. No lab diagnostics studies were performed and no product quality complain was reported. The causal relationship between GARDASIL 9 and the events was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from an unknown reporter regarding a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed a red raised rash, at the injection site (reported as "insertion site"). The outcome of the events (injection site erythema/Injection site rash) was unknown at the reporting time. The reporter did not provide a causality assessment between the suspect vaccine and the events. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB injection (strength, dose, lot number and expiration date were not provided) for prophylaxis. On 16-FEB-2016 and 03-NOV-2016, the patient was vaccinated with the second and third dose of LIQUID PEDVAXHIB injection (strength, dose, lot number and expiration date were not provided) for prophylaxis, respectively. On 24-FEB-2017, the patient received a fourth dose of LIQUID PEDVAXHIB intramuscular injection (strength and dose were not reported) (lot number: M045207; expiration date: 30-JUN-2019) for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to an elderly (reported as "above the age of 65") male patient. The patient's concurrent conditions and medical history were not reported.  On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, anatomical location, lot number and expiration date were unknown) for prevention of shingles. There were no concomitant therapies reported. It was reported that, on an unknown date, the patient got sick with herpes zoster. At the time of reporting, the outcome of herpes zoster was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as no permission to contact the physician was provided.