chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursions of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. 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 regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route dose of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, multiple unspecified patients were inadvertently vaccinated with PROQUAD (dosing details, lot# and expiry date were not reported). It was reported that the vaccines were exposed (excursion 1) to the temperature of -4.3C during a time frame of 1 hour and 6 minutes. It was reported that the vaccines were exposed (excursion 2) to the temperature of -2C during a time frame of 2 hours and 20 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is second of the two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Wrong drug administered
Clinical narrative: This spontaneous report as received from the patient's mother refers to a 6 year old female patient. The patient's medical history and drug reactions or allergies were not reported. On 02-AUG-2016, the patient was taken to the physician for vaccination with VAQTA, but was given GARDASIL instead (dose, route, lot # and expiry date were not reported) by the nurse practitioner. Concomitant medications were not reported. On 02-AUG-2016, the patient experienced injection site redness and pain. The patient did not have any other reactions, but the reporter felt that it was too coon to say whether any other affects would appear. The patient did not seek medical attention. No treatment was provided. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (-0.2C for 116 hours, 24 minutes, and data logger was involved) doses of PNEUMOVAX 23 (dose, frequency and route were unknown, lot # L048265, expiration date 10-JUN-2017, another lot # M013156, expiration date 15-OCT-2017). The PNEUMOVAX 23 didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one several reports received from the same reporter.
Sex: F
Vaccine: HEP, HPV9
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient did not have any concomitant therapies, pertinent medical history or known drug reactions or allergies. In approximately July 2016 (reported as "sometime last week"), the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, intramuscularly, lot # M003659 with expiration date 20-SEP-2017. On the same day, she was also vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L001456 with expiration date 22-OCT-2016 (dose and route of administration were not reported). Administered doses of vaccines experienced a temperature excursion of 25 degrees Fahrenheit for 7 days. There were no previous temperature excursions. Data logger was involved. In approximately 2016, the patient experienced sore arm. The patient did not seek medical attention and did not receive any treatment. There were no lab diagnostic studies performed. The outcome of the sore arm and the relatedness between the event and the suspect drugs were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse referring to a 19 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a pediatric dose of VAQTA which had lot # M022531, expiry date: 23-FEB-2018 (dose and route not reported), which was outside the recommendations per VAQTA prescribing information. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist referring to a 80 years old female patient. The patient's medical history was not reported. The patient was allergic to tetracycline. Concomitant therapies included blood pressure medicines (names unspecified). On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # M001745, expiration date 07-APR-2017, dose not reported) subcutaneously in right arm. In 2016 (reported as "after receiving ZOSTAVAX"), the patient experienced sore arm. The soreness was not just around injection site but her entire arm was sore. The patient had been experiencing soreness in her arm for more than a week. The patient did not seek medical attention and no treatment was given for the event. No laboratory test was performed. The outcome of the events was reported as not recovered. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and frequency unknown, lot # M006722, expiration date: 08-FEB-2018; lot # M002064, expiration date: 12-JAN-2018; lot # M010484, expiration date: 01-MAR-2018). The vaccines were stored under 11.0 Fahrenheit degree for 30 minutes. There was no previous temperature excursion. The call was due to a "data logger". No adverse effects were reported. This is one of two reports received from the same reporter. Lot verification has been received on 23-AUG-2016, lot number M010484 is valid for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. The patient's medical history was not reported. On 15-AUG-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L017138, expiration date 13-AUG-2016 (dose, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) and on an unknown date, with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from the authors in a published literature article as stated below concerning 29 adult (42 +/- 13 years)patients of unknown age and gender with frequent or severe bacterial respiratory tract infections and selective subnormal lgG3 levels. It was sought to extend characterization of adults with selective IgG3 deficiency. Thus, it was retrospectively compiled clinical and laboratory features in 121 consecutive adult index patients referred to single practice because they had frequent or severe bacterial respiratory tract infections and were subsequently found to have subnormal serum IgG3 in the absence of subnormal levels of other Ig isotypes. It was recommended that all patients accept vaccination with PNEUMOVAX 23. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route, and lot # not reported). On an unknown date, the IgG levels in 29 patients did not increase after PNEUMOVAX 23. At the time of the report, the patients' outcome was unknown. A copy of the published article is attached as further documentation of the patients' experience. Additional information has been requested. Literature report:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: 2 weeks after vaccine given, developed rash on face that looked like chickenpox.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy bone marrow, Blood test, Computerised tomogram, Contusion, Platelet count decreased
Clinical narrative: Had bruising since late October which continued to get worse. It was Nov 15 that my tongue turned purple and I went to the hospital for diagnosis and found out my platelets were at 7,000.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Scan spleen, Tongue discolouration, Ultrasound liver
Clinical narrative: Had bruising since late October which continued to get worse. It was Nov 15 that my tongue turned purple and I went to the hospital for diagnosis and found out my platelets were at 7,000.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient c/o onset of upper left arm redness, itching and heat on 8/16/16 that spread slowly from injection site to elbow and shoulder. Initially treated symptoms with BENADRYL but no significant relief. Pt sought further evaluation from PHP on 8/20/2016. Patient given Rx Prednisone 10mg daily PO and Cephalexin 500 mg PO. Patient presented to our HD on 8/22/16 with only slight appearance of redness to reported area. Swelling was absent.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: Chills. Stomach pain. Fevers. Headaches.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Syringe issue
Clinical narrative: Patient was given the flu vaccine. Upon administration into her arm, the plunger was stuck and pharmacist was unable to push the vaccine into the patient. The patient reported tingling down her arm right away and for a few hours after. We have left a message with her PCP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Initially C/O pain at injection site, redness at site, and dizziness. Within 24 hrs patient progressed to arm pain and pain with movement. Determined incorrection injection site, given above deltoid close to shoulder. patient's symptoms relieved with cool compress and Ibuprofen. As of 8/1/16 symptoms relieved.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Hot, itchy, and redness spread from injection site to top of arm.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, approximately in 2014 (reported as 2 years ago), the patient had received two doses of GARDASIL 9 (dosing details not reported). Subsequently, on an unknown date, the patient became sick and never returned for the third dose. The outcome of the event and causality assessment was unknown. No product quality complaint (PQC) involved. Additional information is not expected as the reporter did not wish to be contacted.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: Right arm developed weakness and movement restriction within 24 hours of vaccination; has not changed.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Induration, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Red oblonged indurated patch with swelling in right arm (asymmetrical to left arm) swelling spread down arm toward elbow. Tender to palpation and warm to touch. Prescription for KEFLEX to treat cellulitis 8/11th-15th.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old male patient. The patient's concurrent conditions and medical history were not reported. On 18-AUG-2016,reported as yesterday, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration were unknown). There were no concomitant therapies reported. The reporter stated that then, the patient experienced joint pain and tingling in his fingers. The patient did not seek medical attention nor treatment was given for the adverse events. No product quality complaint was involved. The outcome of parasthesia and arthralgia was unknown. The causality between parasthesia and arthralgia and ZOSTAVAX was not provided. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Echocardiogram, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Small red bump at site of injection, a little soreness.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan
Clinical narrative: Small red bump at site of injection, a little soreness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot# L024993, 14-OCT-2017. No adverse effects were reported. Data logger was yes, vaccines went to 35F for 30 hours. Vaccines were back in range. This is one of the two reports received from the same reporter. 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 referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of -13 degree Celsius for 5 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. 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 pharmacist referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU, which had lot # L046896, expiry date: 28-FEB-2017 (dose and route not reported). No adverse effects reported. No further information provided. 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 medical assistant and refers to 3 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were each administered a dose of improperly stored (Oka/Merck) VARIVAX injection, lot # M006722, expiration date 08-FEB-2018 (dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Headache, Lymphadenopathy, Paraesthesia
Clinical narrative: Seen in ER with complaint of dizziness, lightheadedness, tingling sensation of her skin, blurred vision, and headache approximately eight hours after receiving immunization. Seen again in ER 8/14/16 with same symptoms and weakness, swollen lymph nodes.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Seen in ER with complaint of dizziness, lightheadedness, tingling sensation of her skin, blurred vision, and headache approximately eight hours after receiving immunization. Seen again in ER 8/14/16 with same symptoms and weakness, swollen lymph nodes.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Bradycardia, Electrocardiogram, Electrocardiogram abnormal, Hypotension
Clinical narrative: Pt lost consciousness within 5 min of vaccine administration, then bradycardia to 42 persisted with hypotension to 66/23 for approx 30 minutes.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt lost consciousness within 5 min of vaccine administration, then bradycardia to 42 persisted with hypotension to 66/23 for approx 30 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased eye contact, Electroencephalogram, Myoclonus
Clinical narrative: Parent reported the baby became less animated, no smiling or cooing, less eye contact the day of vaccine administration. Mother then reports infant developed some myoclonic movement (head turning, eyes now looking directly at parent) Seen in ED x 2 no interventions except exam and counseling seen by pedi neuro 8/2/2016 EEG reported normal. Baby has returned to baseline.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local redness at LVL post vaccination KINRIX. Noted at baseball sixe w/(+) redness and hot to touch. Seen 3 days post vaccine. Home tx: ice; TYLENOL and BENADRYL as needed.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Bad headache, arm/neck soreness no fever. Recommended po BENADRYL, ibuprofen and cool compresses.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: C-reactive protein increased, Disturbance in attention, Dizziness, Full blood count normal, Headache
Clinical narrative: Patient developed cellulitis at the site of the BEXSERO shot 5 days later. On the same day of shot developed tactile fever, severe headache, dizziness and poor concentration. Treatment was AUGMENTIN. Improving slowly.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Patient developed cellulitis at the site of the BEXSERO shot 5 days later. On the same day of shot developed tactile fever, severe headache, dizziness and poor concentration. Treatment was AUGMENTIN. Improving slowly.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles like rash.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash
Clinical narrative: GARDASIL 9 given on 01-20-16. Pt. states there was a rash to the right arm. GARDASIL 9 given on 4-18-16. Pt. states there was a rash with drainage to the left arm. Pt. reported on 8-18-16 at providers office.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified nurse, who on 05-AUG-2016, was attempting to administer a dose of GARDASIL 9 injection (lot # L024993, expiry dose 17-OCT-2017) to an unspecified patient. She did not attaché the needle to the syringe properly, and when she attempted to depress the plunger, the vaccine squirted out of the syringe hub and went into the nurse's eye. This resulted in a possible partial dose of GARDASIL 9 administered to the patient (captured in MARRS#1608USA004229). No adverse effect was reported. No additional information was provided. This is one of two reports received from the same reporter. 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 registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ of lots M025565 with expiry date 06-NOV-2017, M019708 with expiry date 25-OCT-2017, L048854 with expiry date 31-AUG-2017, L033694 with expiry date 16-JUN-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC)) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 of lots L037554 with expiry date 25-DEC-2017, M011117 with expiry date 07-DEC-2017, M018810 with expiry date 28-MAY-2018 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were unknown by the reporter. Concomitant therapies were unknown by the reporter. Approximately on 03-AUG-2016 (reported as about two weeks ago) the patient was vaccinated with PNEUMOVAX 23 (# lot number and Expiry date was unknown by the reporter) in the right arm. Approximately on 03-AUG-2016, the patient experienced an injection site reaction about 3 hours after receiving the vaccine and the patient developed cellulitis in the arm. The outcome of cellulitis was unknown. Causality was not reported. Upon internal review the event cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, once, lot # L015460, expiration date: 20-JUL-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to 2 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). On unknown dates (reported as in the last few years), the patients were diagnosed with shingles, after the receipt of ZOSTAVAX. The outcome of shingles was reported as recovered on unknown dates. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, albumin status as recombinant human albumin (rHA), lot # M006107, expiry date 01-AUG-2017 and lot # M017337, expiry date 05-OCT-2017 (strength, dose, route and site of administration were not reported). No adverse effect was reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA of lots L015460 with expiry date 20-JUL-2017, M011116 with expiry date 17-JUN-2017, M018644 with expiry date 20-SEP-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. 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 registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L019124, expiry date 27-MAY-2017 (strength, dose, route and site of administration were not reported). No adverse effect was reported. This is one of two cases received from the same reporter. Additional information ha been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: On 8/17/16 patient was seen in MD office for bump and bruise on right upper arm at injection site. States it appeared 2 weeks after HPV-9 vaccine and is still there.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site nodule, Injection site warmth
Clinical narrative: On 8/17/16 patient was seen in MD office for bump and bruise on right upper arm at injection site. States it appeared 2 weeks after HPV-9 vaccine and is still there.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: On office visit 8/17/16, patient stated thee was a knot that appeared "a couple weeks" after injection at site. There was a bruise at site and warm to the touch.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site nodule, Injection site warmth
Clinical narrative: On office visit 8/17/16, patient stated thee was a knot that appeared "a couple weeks" after injection at site. There was a bruise at site and warm to the touch.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MMRV
Symptoms: Urticaria
Clinical narrative: Hives all over body - 24 hours - BENADRYL 50mg tablet - three times a day until rash is gone.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness spreading approximately 4 inches across arm, pain everywhere it is red, hot to the touch.
Age: 10.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Back pain, Loss of consciousness, Pallor, Respiratory rate increased, Skin discolouration
Clinical narrative: Child lost consciousness in clinic room after receiving three vaccines. She turned pale/green. Her hands were cool to touch and after regaining consciousness she had rapid breathing, tremulous legs and arms, and reported back pain. Water and juice provided. EMS called.
Age: 10.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Tremor
Clinical narrative: Child lost consciousness in clinic room after receiving three vaccines. She turned pale/green. Her hands were cool to touch and after regaining consciousness she had rapid breathing, tremulous legs and arms, and reported back pain. Water and juice provided. EMS called.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Erythema, Rash
Clinical narrative: 24 hours after the patient received ZOSTAVAX at our pharmacy, the patient experience redness across her chest, some disorientation, and a small, closed-rash under her breast. Patient was seen by her PCPA on 8/17 and it was unable to determine if this reaction was associated with the immunization received.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Gaze palsy, Syncope
Clinical narrative: After receiving immunizations syncopal episode occurred. She stood up, eyes rolled to the back off her head and fainted.  She fell backwards hitting right arm and possibly her head. Laid on floor.  Pillow under head, juice given, ice applied to right arm.  20 minutes observed.  Waited 10 more minutes in waiting room.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Feeling cold, Headache, Malaise, Pyrexia
Clinical narrative: Headache, chills, fever of 101.7, weakness, malaise.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Blood test, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: Abnormal involuntary movements- being referred to neurology; chest pain, shortness of breath (possible anxiety
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: Abnormal involuntary movements- being referred to neurology; chest pain, shortness of breath (possible anxiety
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Tremor
Clinical narrative: Abnormal involuntary movements- being referred to neurology; chest pain, shortness of breath (possible anxiety
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: Abnormal involuntary movements- being referred to neurology; chest pain, shortness of breath (possible anxiety
Age: 20.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Presented to ED with fever, not feeling well and swollen lymph nodes in left arm. Received MMR and Tdap on 8/8/2016 in left arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT CALLED TO REPORT A RASH UNDER HER ARM AFTER THE ZOSTAVAX VACCINE.  PATIENT TOLD TO TAKE BENADRYL.  IF REACTION WORSENS OR DOESN'T IMPROVE, CALL MD.  PATIENT ALSO CALLED MD AND WAS TOLD THE SAME THING.
Age: 1.0
Sex: F
Vaccine: DTP, MNQHIB, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site nodule, Injection site rash, Injection site reaction
Clinical narrative: Localized reaction to the chicken pox (varicella) vaccine. Localized reaction at injection site; right upper thigh; redness, low grade fever (99 degrees for 5 consecutive days with 2.5 mg of baby TYLENOL every 4 hours), swelling, 2 inch knot under skin, bumps at injection site, pain and irritability, swelling caused bumps to burst and bleed which caused more pain to our daughter. Bruising appeared after bumps ruptured. Daughter now has a scar on her right thigh.
Age: 1.0
Sex: F
Vaccine: DTP, MNQHIB, VARCEL
Symptoms: Injection site scar, Injection site swelling, Irritability, Local reaction, Pain
Clinical narrative: Localized reaction to the chicken pox (varicella) vaccine. Localized reaction at injection site; right upper thigh; redness, low grade fever (99 degrees for 5 consecutive days with 2.5 mg of baby TYLENOL every 4 hours), swelling, 2 inch knot under skin, bumps at injection site, pain and irritability, swelling caused bumps to burst and bleed which caused more pain to our daughter. Bruising appeared after bumps ruptured. Daughter now has a scar on her right thigh.
Age: 1.0
Sex: F
Vaccine: DTP, MNQHIB, VARCEL
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Localized reaction to the chicken pox (varicella) vaccine. Localized reaction at injection site; right upper thigh; redness, low grade fever (99 degrees for 5 consecutive days with 2.5 mg of baby TYLENOL every 4 hours), swelling, 2 inch knot under skin, bumps at injection site, pain and irritability, swelling caused bumps to burst and bleed which caused more pain to our daughter. Bruising appeared after bumps ruptured. Daughter now has a scar on her right thigh.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Varicella
Clinical narrative: Chicken Pox.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Full blood count normal, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache, temp of 102.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Fever, body aches, headache, temp of 102.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Localized painful cluster of blisters proximal and posterior left arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Mobility decreased, Vision blurred
Clinical narrative: The patient states she felt dizzy after 45 minutes of getting the vaccine to the extent she could not move, it got better the following day and that's when she came to report it. She stated she had a little blurry vision but she could drive and work. I called to check on her today (Tuesday) and she states she is still a little dizzy.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling on left thigh and soreness. Swelling was 9cm in diameter.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT. DEVELOPED INCREASED REDNESS, SWELLING, AND SOME PAIN AT INJECTION SITE THAT IS GETTING WORSE AND SPREADING DOWN ARM. WHEN PT. PRESENTED TO OFFICE SHE WAS RX'D ANTIBIOTIC AND STEROID.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approx 1.5 inch diameter bruising around injection site, located under inject-safe barrier bandage used.  Redness, itching, around and below injection site and significant swelling below injection site.  Patient has been icing the area.  Also recommended the patient to continue with ice, take Benadryl and pain therapy.  Patient said she could not take Ibuprofen or Aleve, recommended Tylenol for pain.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Cough, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Immediately felt very faint after the vaccination. When my daughter arrived back home she immediately began to feel very nauseous and dizzy. She started vomiting during the night. Her arm became very red, sore and swollen. She experienced severe pain and aching at the back of her neck. She developed a very bad headache, sore throat and started coughing. The next day her whole body was sore and aching as if she had the flu. She felt exhausted and spent almost the whole weekend in bed resting. She has had these symptoms since last Thursday (8/18/2016) until today (08/23/2016) so I phoned her doctor today who recommended she get this, the Pharmacy that administered it and also called the CDC and FDA because I am so worried. She is due to start college on Friday (8/26/2016) and I don't think she will be well enough to attend. We were never warned about these possible side effects and would never have allowed this vaccination to have been administered if we had known it would make her this sick. Now I am worried about the potential future side effects and what this has or might do to her body and her overall health. This drug should never have been approved - it is dangerous to give this to teens who have no idea what they are letting themselves in for. Doctors should NOT be recommending this. I am now trying to get information on how to get her better and get this out of her system. There is NO ADVICE OR HELP AVAILABLE and I am really scared for her.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Immediate post-injection reaction, Influenza like illness, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Immediately felt very faint after the vaccination. When my daughter arrived back home she immediately began to feel very nauseous and dizzy. She started vomiting during the night. Her arm became very red, sore and swollen. She experienced severe pain and aching at the back of her neck. She developed a very bad headache, sore throat and started coughing. The next day her whole body was sore and aching as if she had the flu. She felt exhausted and spent almost the whole weekend in bed resting. She has had these symptoms since last Thursday (8/18/2016) until today (08/23/2016) so I phoned her doctor today who recommended she get this, the Pharmacy that administered it and also called the CDC and FDA because I am so worried. She is due to start college on Friday (8/26/2016) and I don't think she will be well enough to attend. We were never warned about these possible side effects and would never have allowed this vaccination to have been administered if we had known it would make her this sick. Now I am worried about the potential future side effects and what this has or might do to her body and her overall health. This drug should never have been approved - it is dangerous to give this to teens who have no idea what they are letting themselves in for. Doctors should NOT be recommending this. I am now trying to get information on how to get her better and get this out of her system. There is NO ADVICE OR HELP AVAILABLE and I am really scared for her.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Immediately felt very faint after the vaccination. When my daughter arrived back home she immediately began to feel very nauseous and dizzy. She started vomiting during the night. Her arm became very red, sore and swollen. She experienced severe pain and aching at the back of her neck. She developed a very bad headache, sore throat and started coughing. The next day her whole body was sore and aching as if she had the flu. She felt exhausted and spent almost the whole weekend in bed resting. She has had these symptoms since last Thursday (8/18/2016) until today (08/23/2016) so I phoned her doctor today who recommended she get this, the Pharmacy that administered it and also called the CDC and FDA because I am so worried. She is due to start college on Friday (8/26/2016) and I don't think she will be well enough to attend. We were never warned about these possible side effects and would never have allowed this vaccination to have been administered if we had known it would make her this sick. Now I am worried about the potential future side effects and what this has or might do to her body and her overall health. This drug should never have been approved - it is dangerous to give this to teens who have no idea what they are letting themselves in for. Doctors should NOT be recommending this. I am now trying to get information on how to get her better and get this out of her system. There is NO ADVICE OR HELP AVAILABLE and I am really scared for her.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted after vaccination, remained seated in chair with assistance of mom and nurse using wet paper towels and cold packs.  Regained consciousness after about 45 seconds, slowly regained color.  Remained seated for 10 minutes, mom refused assistance when nurse offered to call 9-1-1. Insisted on walking to car, nurse followed to car to make sure patient was o.k. Mom assured nurse that patient was ok and that this always happens when he receives injections.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal, White blood cell count increased
Clinical narrative: Mom reports took child to ER and PMD due to elevated fever, leg pain and back pain, white blood count was 38,000 and sed rate was normal, PMD reports maybe a viral response to Tdap.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: C/o feeling fatigue, headache, and nausea. No treatment, Advised her to return to clinic Monday (this is Friday) if symptoms persist.  She agrees to this plan.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site swelling, Insomnia, Muscle twitching
Clinical narrative: Fever/chills, severe headache, nausea, muscle twitching, insomnia, swollen injection site.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever/chills, severe headache, nausea, muscle twitching, insomnia, swollen injection site.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: RIGHT ARM WAS TENDER, ITCHY, BURNING SENSATION, REDNESS, SWELLING THROUGHOUT UPPER ARM. WORSENED AS DAY PROGRESSED. DID NOT SLOWLY IMPROVE UNTIL 8/21/16. HYDROCORTISONE CREAM 1%, COLD WATER, ICE WAS USED TO ALLEVIATE THE PAIN AND REACTION ABOUT 3-4 TIMES DAILY. AT TIME OF REPORTING (8/23/16), HAS NOT COMPLETELY RESOLVED.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Sleep talking
Clinical narrative: REDNESS/SWELLING OF UPPER RIGHT ARM. POSSIBLE FEVER (DID NOT TAKE ACTUAL TEMP). MALAISE. TALKING IN SLEEP.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Hepatic enzyme increased, Pruritus, Urticaria
Clinical narrative: Itchy at 7:00 PM 07/22/2016 hours after GARDASIL 9 injection. Hives followed mainly in back, buttocks, and arms. Hives spread to neck, trunk, neck and face over the next 4 weeks. Visited doctor twice, 8/8 and 8/18. Took Antihistamin, which helps a little but hives keep coming back. Doctor gave blood test on 8/18. Results coming back with very elevated liver enzyme levels.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Patient developed a case of shingles. Rash on shoulders. Treated by physician with antivirals. Patient continuing to recover.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Low grade temp 99.4 no treatment. Then two days later developed a red rash all over face and body.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Pt received HPV, TdaP, Hep A, & varicella. Pt received 4 IM injections, tolerated them well. Approx. 4-5 minutes afterwards pt. became dizzy and almost lost consciousness. Pt was in altered state of consciousness for 20+ minutes before his condition improved.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, PPV
Symptoms: Injection site erythema, Injection site warmth, Skin sensitisation
Clinical narrative: Began as two small red dots at injection site and grew into a new extremely red, sensitive, hot patch the size of a fist. It looked as though her leg had been scalded.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain where shot was given, especially if touched there. Tiredness. Severe pain in bicep of the arm shot given. Great difficulty moving arm. Could not move arm without pain. Could not dress or lift arm without severe pain.
Age: 0.17
Sex: M
Vaccine: DTAP, RVX
Symptoms: Constipation
Clinical narrative: Ongoing chronic constipation. Has not been able to poop unassisted for weeks after vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A) referring to an unknown number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2016, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # M013636, expiration date 15-FEB-2018, intramuscularly. Anatomical location was not reported. No adverse events were reported. It was not a product quality complaint involved. Additional information is not expected due there is not consent for follow-up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010212, expiry date 21-JAN-2019) concentration, dose and route of administration were not reported. Concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.