chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2014US023398 is an initial spontaneous report received from a health care professional on 20 Nov 2014. This case refers to a 62 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 13 Oct 2014. On the same day after vaccination, she experienced Guillain Barre Syndrome. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of Guillain Barre Syndrome was upgraded based on the NVS-IME list and NVx key event list.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Feeling hot, Malaise, Throat tightness
Clinical narrative: Case number PHEH2014US023710 is an initial spontaneous report received from a consumer on 24 Nov 2014. This report refers to a 53 years old female patient. She was a tobacco smoker and her current conditions included allergy to Aspirin, ibuprofen and LORTAB. Her concomitant medication included omeprazole. Her vaccination history included administration of ZOSTAVAX (other manufacturer, batch number: not reported) at a dose of 0.65 ml and PNEUMOVAX (other manufacturer, batch number: not reported) at a dose of 0.5 ml; both vaccines given on 06 Oct 2009, Tdap (other manufacturer, batch number: not reported) at a dose of 0.5 ml on 05 May 2013, FLUZONE (other manufacturer, batch number: not reported) at a dose of 0.5 ml in Jul 2014 and an unknown vaccine at a dose of 0.5 ml in the left deltoid at 4:10 pm in Jul 2014. She had no illness at time of vaccination. She was vaccinated with a dose of FLUVIRIN (batch number: 14583P) in the left deltoid on 14 Nov 2014 at 4:10 pm. Within 3 to 4 minutes after the shot, she felt ill with a head rush, dizziness, throat constriction and she was feeling hot. 20 minutes after the flu shot, at 4:30 pm, she said that she was feeling a funny metallic taste her mouth and asked for paramedics. She went to emergency room and received BENADRYL and steroid injection. She refused to leave with paramedics and stated that she would go to hospital with her husband. The event outcome was reported as complete recovery. The seriousness was not reported, but the event throat tightness was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site scab, Injection site swelling
Clinical narrative: She has a grey raised scab looking bump at the injection site that still has not gone away after over a month.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site, with radiation of pain up arm.  Generalized body fatigue.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain, Computerised tomogram abnormal, Gastritis, Headache, Hepatobiliary scan
Clinical narrative: Severe abdominal pain, headache.
Age: 18.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyspnoea, Headache, Pruritus, Urticaria
Clinical narrative: Urticaria, Hives around the neck, both upper and lower extremities, headache, itching, dyspnea.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: SYSTEMIC: MOM STATED THAT PATIENT FELT TIRED AND "NOT FEELING WELL" AND DECREASED APPETITE. HE DEVELOPED A FEVER OF 101F IN THE MIDDLE OF THE NIGHT. FEVER FLUCTUATED FROM MIDNIGHT UNTIL 6AM OF 11/27, WITH THE HIGHEST TEMPERATURE AT 103.5. MOM ADMINISTERED 100 MG OF IBUPROFEN AT 4:30AM. BY THURSDAY MORNING TEMPERATURE STAYED AT 100-101.5F, AND DECREASED TO 99F ON FRIDAY. PATIENT HAD TROUBLE SLEEPING ON THE NIGHT OF 11/26 AND 11/27. ON THE NIGHT OF 11/28, PATIENT SLEPT THROUGH THE NIGHT. LOCAL: MOM NOTICED THAT THE INJECTION SITE WAS "DEEP RED," INFLAMED, AND FELT "HOT TO TOUCH." MOM STATED THE ERYTHEMATOUS AREA WAS 3inX1.5in. MOM STATED PATIENT COMPLAINED OF HIS ARM HURTING WHEN HE MOVED IT.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: SYSTEMIC: MOM STATED THAT PATIENT FELT TIRED AND "NOT FEELING WELL" AND DECREASED APPETITE. HE DEVELOPED A FEVER OF 101F IN THE MIDDLE OF THE NIGHT. FEVER FLUCTUATED FROM MIDNIGHT UNTIL 6AM OF 11/27, WITH THE HIGHEST TEMPERATURE AT 103.5. MOM ADMINISTERED 100 MG OF IBUPROFEN AT 4:30AM. BY THURSDAY MORNING TEMPERATURE STAYED AT 100-101.5F, AND DECREASED TO 99F ON FRIDAY. PATIENT HAD TROUBLE SLEEPING ON THE NIGHT OF 11/26 AND 11/27. ON THE NIGHT OF 11/28, PATIENT SLEPT THROUGH THE NIGHT. LOCAL: MOM NOTICED THAT THE INJECTION SITE WAS "DEEP RED," INFLAMED, AND FELT "HOT TO TOUCH." MOM STATED THE ERYTHEMATOUS AREA WAS 3inX1.5in. MOM STATED PATIENT COMPLAINED OF HIS ARM HURTING WHEN HE MOVED IT.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Extensive shoulder pain starting in the middle of my shoulders and making it difficult to raise my arms which lasted three days.
Age: 61.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Eye pruritus, Rhinorrhoea, Sneezing
Clinical narrative: Strong seasonal allergy symptoms: itchy eyes, sneezing, runny nose.  Ongoing one year later, poorly controlled with daily 10 mg cetirizine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient is experience pain in the arm/shoulder of where injection was given after a Fluzone shot.
Age: 1.47
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Measles-like rash all over body and high fever.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthralgia
Clinical narrative: On Thursday following my shot on Monday I began to experience joint pain in my knees and ankles similar to what I had experienced last year after receiving the flu shot.  It has now been 15 days since I received the shot and the joint pain also now includes my toes, feet, hips, back, fingers, wrists, elbows, and shoulders.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Back and joint pain, stiffness, High temperature, Chills, Headache, Vomits (3).
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Back and joint pain, stiffness, High temperature, Chills, Headache, Vomits (3).
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: (Copied from ED Attending Progress Note). FLU SHOT YESTERDAY. Onset itching/wheal 0630, angioedema of lips onset 0800, no SOB/dysphagia.  Took his meds ate breakfast this am. Wheal and itching propagating across skin.  (Copied from ED Nursing Progress note) 1130 DIPHENHYDRAMINE 50mg IV push given.  1130  RANITIDINE TAB  300MG po given  1130   EPINEPHRINE  250MCG IM gived on left deltoid. 1130  DEXAMETHASONE 12mg IV push given.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Fever of 102.5--gave medicine, he felt lethargic, had chills and had fever for 24 hours--this is following DTAP shot.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle aches, light fever, headache developed after 8 hours.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Heart rate increased, Hyperhidrosis, Hypertension
Clinical narrative: Chills, sweating, rapid heat rate and extremely high blood pressure.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Pt said she had difficulty swallowing about 5 minutes following adminstration, gave patient a dose of Benadryl waited and patient got better. Called in an hour to check up on patient and she said the symptom has resolved.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test, Blood test, Pruritus, Swelling, Urticaria
Clinical narrative: Began as itching, turned into hives under the skin and lumps and bumps under the skin.  I am still being treated for them, they are under control with antihistamines which did keep them under control during the first to third week but are now doing so.  No sign of going away yet.  Working with a Dr.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Decreased appetite, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: My son received the Tdap and Polio vaccine on 11/18/14. Friday 11/21/14 my son was at the babysitters as I was working day shift. Text came to me at 1:24 pm that the babysitter thought he wasn't feeling well, wasn't eating and very cuddly, and that she thought he had a low grade fever. Once I got my son home after work I checked his temperature tympanic and found it to be 102.5. This high temperatures and general malaise lasted from Nov 21st-24th. The highest we let the temp get was 103.7 in the night. We are positive it would have gone higher is not medicated. We gave him infant/child Advil. Eventually the symptoms resolved with no need to go back to the doctor but out son has had a cough and runny nose since it is 12/2/ 2014 today. We are thinking it was due to the Polio vaccine due to the info on the sheet given to us.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: My son received the Tdap and Polio vaccine on 11/18/14. Friday 11/21/14 my son was at the babysitters as I was working day shift. Text came to me at 1:24 pm that the babysitter thought he wasn't feeling well, wasn't eating and very cuddly, and that she thought he had a low grade fever. Once I got my son home after work I checked his temperature tympanic and found it to be 102.5. This high temperatures and general malaise lasted from Nov 21st-24th. The highest we let the temp get was 103.7 in the night. We are positive it would have gone higher is not medicated. We gave him infant/child Advil. Eventually the symptoms resolved with no need to go back to the doctor but out son has had a cough and runny nose since it is 12/2/ 2014 today. We are thinking it was due to the Polio vaccine due to the info on the sheet given to us.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Redness in forearm.  Warm to touch.  Soreness in whole arm, shoulder, and near breast area.  Low grade fever.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Redness in forearm.  Warm to touch.  Soreness in whole arm, shoulder, and near breast area.  Low grade fever.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, X-ray
Clinical narrative: Shoulder pain and limited mobility in left shoulder.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia
Clinical narrative: Started as normal pain just from the needle and continued to get worse. By day 3 my upper left arm was not able to have full movement and the pain wakes me up every night and has for nearly 2 months with no end in sight.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND SORENESS IN INJECTION SITE.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 1 DF. Other suspect therapies included RECOMBIVAX HB, VAQTA and ROTATEQ. No medical history was reported. No concomitant medication was reported. On an unknown date the patient experienced patient received dose of improperly stored vaccine and no adverse event. The outcome of no adverse event is unknown. No further information was provided. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Tenderness
Clinical narrative: Patient complained of muscle pain/soreness. Patient said it felt like she had been hit by a baseball and couldn't put any pressure on arm without it hurting (slept on opposite side).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Local swelling, Pain
Clinical narrative: Left arm red and swollen on left anterior portion of arm. Has erythema, no throbbing-"feels think to touch. Has pain-no open area-no drainage. No hx of reaction from other flu shots.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lip swelling, Ocular hyperaemia, Rhinorrhoea, Swelling face
Clinical narrative: Three hours after flu vaccine, runny nose, itchy throat, cough, eyes red. Next day lips swollen, face swollen.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Three hours after flu vaccine, runny nose, itchy throat, cough, eyes red. Next day lips swollen, face swollen.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Employee received influenza vaccine 10/20/14. On 10/21/14 am left dentoid area red swollen and hot to touch. Area is 7 1/2 cm x 5 cm. Employee took 650 mg of TYLENOL prior to am work.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Confusional state, Febrile convulsion, Laboratory test, Postictal state
Clinical narrative: Febrile seizure - Rectal TYLENOL - Postictal symptoms: confusion
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Local swelling
Clinical narrative: Arm swelling, lip swelling.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Local swelling
Clinical narrative: Patient received influenza vaccine at PCP visit 10/21/14. Patient calls 10/23/14 c/o pain (6/10) in left arm at site of injection for the past 2 days. Patient also states that arm is swollen but denies any redness around the site. Patient was advised to put an ice pack on the arm and take ibuprofen and acetaminophen as needed for pain. Patient also advised to call back in a few days if no improvement. PCP was notified 10/23/14. On 10/24/14 patient was seen by PCP. PCP notes that patient has never received flu vaccines as injection in the past, has only receive nasal administration. It was noted that patient was not allergic to gelatin, antibiotics, eggs or latex. No Guillain Barre's syndrome in the past. Patient advised by PCP to not get flu shot in the future and to continue to take ibuprofen as needed. Patient also advised to go to ED if condition worsens or does not resolve.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Muscle mass, Musculoskeletal stiffness, Pain, Tenderness
Clinical narrative: Tender, stiff muscle right after shot. Within 2 days lifting arm was painful as well as putting arm over the head. A lump developed in the middle of muscle at 3 weeks and patient kneeded it out over 1 week. Pain with moving arm remained for 6-7 months before getting better. It still hurts 1 year later at times when lifting arm and position of arm affects when pain occurs. More use makes it hurt more.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox outbreak.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Paraesthesia, Rash
Clinical narrative: Bilateral shoulder pain. Tingling on left arm for 6 weeks. Rash on front leg both sides-resolved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. 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 licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored M-M-R II (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a 83 year old male patient regarding himself. The patient has high blood pressure and heart condition. On an unknown date in 2013 (reported as two years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported). Concomitant therapies included aspirin, unspecified heart and high blood pressure medications. On 13-NOV-2014 (reported as 1 week ago), the patient noticed that he had some itching and cluster of pimples. On an unknown date in NOV-2014, the patient was in pain. Since the patient was in pain and itching he applied some ointment. There was no lab tests performed. The outcome of the events were unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 9 month old paitent of unknown gender. On 29-OCT-2014 the patient was vaccinated with a dose of M-M- R II (dose, route of administration, lot number and expiration date were not reported). On 06-NOV-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). The nurse stated that the patient received M-M-R II and VARIVAX (Merck) "too close together". No adverse effects reported. Additional information is not expected, because the reporter didn't wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. In an approximately November 2014 (also reported as between 17-NOV-2014 and 26-NOV-2014) the patients were vaccinated with an improperly stored PROQUAD (Merck) (route, dose, frequency and lot # not reported) that was supported with in-house stability data. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. In an approximately November 2014 (also reported as between 17-NOV-2014 and 26-NOV-2014) the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX (route, dose, frequency and lot # not reported) that was supported with in-house stability data. No further information was provided. This is one of several reports 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 as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (Strength, dose, lot numbers and route were not reported). No adverse effects were reported. The patients did not seek medical attention. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Oka/Merck) VARIVAX information (patients identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time.  Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provided and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. The patients did not seek medical attention. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to three unspecified patients of unknown age and gender. The patients' medical histories and concomitant medications were not reported. It was reported that the unspecified doses of GARDASIL (routes of administration, lot numbers and expiry dates were not reported) that were exposed to a supported temperature excursion on 02-OCT-2014 have been administered to three unspecified patients on unspecified dates since 02-OCT-2014. No adverse effects were reported. 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 nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. The patients did not seek medical attention. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range as 6-12, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficulty and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a male patient, age unknown. The patient reported that he participated in the ZOSTAVAX Trial, where he received the placebo. After completion of the clinical trial, he received the ZOSTAVAX (date of vaccination, dosage, and route of administration not provided). The patient reported that he experienced shingles after receiving ZOSTAVAX (onset date not provided). The outcome of the shingles was not reported. The causality was unknown for the event. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 84 years old male patient. Pertinent medical history was unspecified by the reporter. On 16-OCT-2014 at 14:27, the patient was vaccinated with an expired dose of ZOSTAVAX (Strength, dose unknown, lot # J007858, expiry date 28-SEP-2014) dose 1, intramuscular. Patient was not taking any concomitant medications. No relevant lab tests were performed. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patient were vaccinated with improperly stored MMR II (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Blister, Body temperature increased, Papule, Rash, Varicella post vaccine
Clinical narrative: On 12/1/14 pt developed rash on torso. Consistent with varicella - discrete papules and vesicles some open. Patient did have a temp to 101 degrees F. No URI symptom. No known source of infection.
Age: 18.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site reaction, Keloid scar
Clinical narrative: Pt developed keloid st site of MMR and varicella. Pt has no hx of keloid.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain of skin, Paraesthesia, Peripheral coldness
Clinical narrative: Patient c/o arm, chest and stomach becoming cold and tingly and areas hurt to touch. Started 3 days after PNEUMOVAX being administered.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Neuralgia, Paraesthesia
Clinical narrative: Patient c/o arm, chest and stomach becoming cold and tingly and areas hurt to touch. Started 3 days after PNEUMOVAX being administered.
Age: 6.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a female consumer of unknown age reporting on herself. On unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). On unknown date after receiving PNEUMOVAX 23 her arm swelled and she had to carry it on a pillow for 3 days, before she was able to drive. The patient was treated with BENADRYL. The patient sought unspecified medical attention. The outcome of the event was unknown. Additional information is not expected because there is not reporter's contact information.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 1.56
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 18 months old patient of unknown gender. On 03-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 69 year old female patient. No pertinent medical history, drug reaction or allergies were reported. On 16-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K007984, expiration date 20-MAR-2015, 1 shot (dose, dose number and anatomical location were unspecified). No concomitant therapies were reported. On 21-OCT-2014, the patient experienced rash on the abdominal area, hands and injection site. The patient sought medical attention (unspecified) and acyclovir was given for 5 days as treatment for the events. The outcome of the events was reported as recovered on an unknown date in 2014. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old patient of unknown gender. On 01-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 3 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 11-NOV-2014 the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneous injection in the left thigh (strength, dose number, lot number and expiration date were not reported) which was exposed to warmer temperatures. Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 5 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 22-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous injection in the right arm (strength, dose number, lot number and expiration date were not reported) which was exposed to warmer temperatures. Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 01-OCT-2014 the patient received first dose of GARDASIL 0.5 ml (lot # and expiration date not reported), intramuscular. On 21-OCT-2014 patient received second dose of GARDASIL. No concomitant therapy was reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Outcome of the events were not reported. Causality assessment was reported as not related to therapy with GARDASIL. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Client received PNEUMOVAX that had been out of the 2 degree - 8 degree C range for approx 50-60 min. Temperature in the storage cooler ranged from 9-10 degree C. Time frame 9a-10AM.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Painful respiration, Peripheral swelling, Skin warm
Clinical narrative: Patients entire arm swelled-double the size of her normal arm from shoulder to elbow. When breathes in deep-back hurts. Arm is red and warm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 2 days after ZOSAVAX given at local pharmacy.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Severe pain x 3d - redness at injection site.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Contusion, Platelet count decreased
Clinical narrative: Information was received from a consumer who was providing follow-up to her daughter's case (MARRS# 1410USA010376). The consumer reported that her daughter's friend, age and additional demographics were not provided, also received GARDASIL 2 doses with same lot number (K001500 exp 06-NOV-2016) as her daughter. The patient received this at the same physician's office. Her first dose was on 11-JUL-2014. The patient experience bruising with that dose. Dose 2 was given (date not provided) and the patient experienced unspecified problems and then developed low platelets. Treatment and outcome were not provided. The consumer reported that the girl's mother would report the event as well. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to 5 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (strength, dosage schedule and lot # were not reported). On an unknown date the patients experienced unspecified injection site reactions after receiving ZOSTAVAX from the same unspecified lot #. The outcome of the event was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness, Injection site reaction, Nausea, Tremor
Clinical narrative: This spontaneous report was received from a consumer, reporting on her daughter a 14 year old female patient with no pertinent medical history or drug reaction/allergies. Co-suspect and concomitant therapies were not reported. In September 2014 (reported as 3 months ago), the patient was vaccinated with the first dose of GARDASIL (dose, lot number, expiration date and route were not reported). The mother of the patient reported that approximately in 2014, patient experienced an injection site reaction, became nausea, dizzy, shaky, and had uncontrollable crying. The outcome of became nausea, dizzy, shaky and had uncontrollable crying, and injection reaction was reported as recovered. It was also reported that the therapy with GARDASIL was not discontinued. Patient sought medical attention with the physician, but did not received treatment or performed lab diagnostics test. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. On 20-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 1.12
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 month old patient of unknown gender. On 22-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and routed not expected). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unspecified date, the patients were vaccinated with a dose of VAQTA 25/0.5 (dosage form not reported) 0.5 ml intramuscular injection (location, lot number and expiration date not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash macular
Clinical narrative: A spontaneous report was received on 14-NOV-2014 from a female consumer (age not specified) concerning herself. On 08-NOV-2013, the patient received ZOSTAVAX (route not specified). She stated she has never had the chickenpox. Concomitant medications were not specified. Less than a week after she received the ZOSTAVAX, she developed red blotches on her upper body and she experienced burning and itching until January 2014. The patient reported she still has the itching and the burning mainly on her back but some of the red blotches have gone away. She sought medical attention and received unspecified treatment. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer (patient's husband) for (Merck) VARIVAX a Pregnancy Registry Product, refers to a female patient of unknown age. On 22-MAR-2013, the patient was vaccinated with a dose of (Merck) VARIVAX (lot number, expiration date, dose, route were not reported). On 07-APR-2013 the patient learned that she was pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) was not known. The pregnancy outcome was outcome pending. No adverse effects were reported. Follow up information has been received on 24-NOV-2014. On 06-NOV-2014 and on 13-NOV-2014 a phone calls was placed to the physician but the physician was unavailable at this time. On 24-NOV-2014 another phone call was placed to the physician. The receptionist stated that the patient was 19 year old female and had positive pregnancy test on 08-APR-2013. It was the patient's last appointment with this physician's office. The pregnancy outcome was unknown. No further information is available. Patient demographics, laboratory tests and Narrative were updated. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # J003808 and expiry date: 03-JUL-2014 (dose, route were not reported). On 20-NOV-2014 received a dose of ZOSTAVAX that was past expiration date. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, dose number, lot number, expiration date and route were not reported) that was improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test negative, Viral titre
Clinical narrative: This spontaneous report as received from a registered nurse who stated that (on an unknown date in approximately 2014 (also reported as this past summer)) she had about 10 13-17 years old, young patients of unknown age and gender who on an unknown dates were vaccinated with (Merck) VARIVAX 1350 U (dose, route of administration, lot number and expiration date were not reported) and MMR II (dose, route and administration, lot number and expiration date were not reported). On an unknown date the patients had negative titers for varicella, measles and mumps. The reporter stated that some of young people had negative titers for more than one of these illnesses. The outcome of adverse events was unknown. The relatedness between (Merck) VARIVAX, MMR II and adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unknown  number of patients of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of PROQUAD (dose, dose number, lot number, expiration date and route were not reported) that was improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's pertinent medical history was not reported. It was reported that on 28-NOV-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (Lot # reported as H016919 and expiry date reported as 10-SEP-2014) of dose 0.5 ml via subcutaneous route. No adverse experience reported. Product quality complaint was reported as no. the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse practitioner) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 30-APR-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency, lot # and expiration date not reported). In November 2014 (unknown date) patient went to the office to receive a second dose of GARDASIL. No concomitant therapy was reported. No adverse symptoms were reported. No product quality complaint (PQC) was reported. Outcome of the events were not reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via a company representative refers to a patient of unknown age and gender. On 10-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (dose, route of administration and lot # were not reported. No adverse events were reported. It was mentioned that ZOSTAVAX did not have any previous temperature excursions. 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 an unspecified patient of unknown age and gender. On an unknown date the patient received an improperly stored VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effect reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 73 year old male patient with aortic dissection, aortic valvular stenosis, benign prostatic hypertrophy, hypertension, inguinal hernia and degenerative joint disorder. Patient had no drug reactions or allergies. The patient's medical history included old myocardial infarction and transient ischemic accident. On 18-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered once at dose 0.65 ml (lot # K009770 with expiry date: 09-OCT-2015). No concomitant medications were reported. On 19-NOV-2014 (reported as "the next day"), the patient experienced rash. The patient sought medical attention via an office visit on 19-NOV-2014 and was prescribed VALTREX. The outcome of rash was reported as recovering. No laboratory test were performed. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.