chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mononucleosis heterophile test negative, Pain in extremity, Reaction to preservatives, Red blood cell sedimentation rate normal, Skin exfoliation
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Mobility decreased, Peripheral swelling, Skin warm, Tremor
Clinical narrative: Severe uncontrollable shaking; temp 102.2f, unable to move arm, deltoid very hot & swollen. This lasted for 72 hrs.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Limb discomfort, Musculoskeletal discomfort, Swelling
Clinical narrative: Redness/ swelling/discomfort in arm/shoulder/neck.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Body temperature increased, Cough, Erythema, Feeling hot
Clinical narrative: At 07:15AM I felt hot and my skin on my chest and neck were red.  I am a nurse and was in a patients room in an isolation gown.  I thought I was hot and the patient noticed I was red and said something to me.  I was in her room for about an hour noticed I was itching but igonored it given I was busy and in the ICU.  Around 08:15 I noticed hives on my chest and neck and developed a dry cough and some wheezing and I took 50 of Benadryl.  By 10am I had 2 hives on left on my neck and chest, skin continued to be red.  11:40 I went to employee health they took my vital signs Blood pressure and pulse ox.  130/80 99% and HR was 110. They told me I did not need a temperature done. (I disagreed took my own temp and it was 100F. did this outside of employee health).  My heart rate is 50-70 normally (I run and do lots of cardio) BP runs low 90-110/60's normally. Employee health told me I could not get any further flu shots without a doctors note.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Pruritus, Urticaria, Wheezing
Clinical narrative: At 07:15AM I felt hot and my skin on my chest and neck were red.  I am a nurse and was in a patients room in an isolation gown.  I thought I was hot and the patient noticed I was red and said something to me.  I was in her room for about an hour noticed I was itching but igonored it given I was busy and in the ICU.  Around 08:15 I noticed hives on my chest and neck and developed a dry cough and some wheezing and I took 50 of Benadryl.  By 10am I had 2 hives on left on my neck and chest, skin continued to be red.  11:40 I went to employee health they took my vital signs Blood pressure and pulse ox.  130/80 99% and HR was 110. They told me I did not need a temperature done. (I disagreed took my own temp and it was 100F. did this outside of employee health).  My heart rate is 50-70 normally (I run and do lots of cardio) BP runs low 90-110/60's normally. Employee health told me I could not get any further flu shots without a doctors note.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 103, muscle aches, headache, dizzy, weakness.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Dysphonia, Productive cough
Clinical narrative: Information has been received from a currently 74 years old female consumer referring to herself. The patient did not have any pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot# and expiration date were not reported) intramuscularly. The patient had been on many unspecified concomitant medications. On an unknown date, the patient developed breast cancer. On 09-NOV-2015 the patient was vaccinated with the second dose of PNEUMOVAX 23 intramuscularly (dose, lot# and expiration date were not reported) and experienced phlegm and hoarseness on the next day, 10-NOV-2015. No lab diagnostics studies had done. The patient did not seek medical attention or received any treatment for the events. The patient did not recover. The causality was not reported. Upon internal review, the event of breast cancer was considered to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: Patient reports bruising after vaccine was administered.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Tenderness
Clinical narrative: Right arm knot that's sore when touching, not itching, pt. is applying hydrocortisone cream. Pt is a little red.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Joint swelling
Clinical narrative: Swelling in both knees, year later diagnose with mild arthritis in both knees.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Inflammation, Injection site erythema, Pain
Clinical narrative: REDNESS AT INJECTION SITE, WHICH CONTINUES TO SPREAD, INFLAMMATION AND HEAT PRESENT, PAINFUL TO MOVE ARM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt noticed a rash that was about 2 inches long from site of injection to her elbow. This began the day after injection. There was no improvement until Friday morning (11/13) after taking BENADEYL for a couple days.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a healthcare worker referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. On an unspecified date in 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dosage, frequency and route unspecified) and would "now" like to continue the vaccine series (exact date unspecified)(inappropriate schedule of vaccine administered). Additional information has ben requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid arm swelling, redness with warmth seen in Peds ED, dx with cellulitis, on abx. Seen by PCP after ED visit. Cellulitis stable.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from the patient's mother referring to a currently 14 years old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. Ona n unspecified date in October 2014 the patient was vaccianted with her first dose of GARDASIL 9strength, dosage, frequency and route unsepcified). The patient was currently on the GARDASIL dosing schedule for a foreign country and based on that schedule, she was not expecting to require her second and final dose until October 2015 (inappropriate schedule of vaccine administration). Because she was now living this country and had missed doses based on its dosing recommendations. No adverse experience was reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Neuralgia, Rash
Clinical narrative: Information has been received from a 79 year old female patient referring to herself. Information about medical history, concurrent condition and concomitant medication was not reported. On 30-AUG-2011 the patient was vaccinated with ZOSTAVAX (once dose/once: strength, dosage and route unspecified). On 15-OCT-2015, the patient experienced a "bad case" of shingles. The shingles rash was primarily on the patient's thigh and there was a burning sensation with "nerve pain underneath". She was officially diagnosed by physician assistant. Physician assistant prescribed the patient valacyclovir as treatment. The patient also visited with her dermatologist and preferred point of contact for shingles treatment. The dermatologist prescribed gabapentin to help with the pain she was experiencing. Lab diagnostic studies were performed (exact information unspecified). The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 14-OCT-2015 the patient was vaccinated with his/her respective second dose in the (Oka/Merck) VARIVAX immunization series that was improperly stored, lot # L019130, expiration date: 27-MAY-2017 (dose, route and application site were not reported). No adverse effects reported. This is one of 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route not reported, lot # L012035, 07-APR-2017; L016126, 06-MAY-2017; L005299, 17-FEB-2017; L019127, 27-MAY-2017; L021210, 10-JUN-2017). Information regarding concomitant medications was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 08-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K005402, expiration date: 07-NOV-2015, (dose, dose #, route and application site were not reported), because she misread the date on the vial to be 07-NOV-2016. The PNEUMOVAX23 in question did not have any previous temperature excursions and was supported with in-house post-expiry data. No adverse symptoms reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # confirmed to be L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6-months old patient of unknown gender. The patient's medical history included chickenpox on an unspecified date. On an unknown date, the patient received the first dose of (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported) at the age of 6 months. On an unspecified date at the age of 1 year, the patient received the second dose of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Adverse event, Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 month old patient of unknown gender. No medical history and drug reactions or allergies were reported. On an unknown day in August 2014, at 13 months of age, the patient was vaccinated with a dose of VARIVAX (dose, lot number and expiration date were not reported) and with MMR II (dose, lot number and expiration date were not reported). No concomitant medications were reported. The nurse stated that the Centers for Disease Control and Prevention (CDC) considered a low dose therapy of corticosteroids. The patient had started and completed a 9 day tapering dose of prednisolone (manufacturer unknown) (dose and frequency were not reported) for an unspecified reason 14 days after receiving VARIVAX and MMR II doses. In March 2015, the patient had a negative titer result for varicella immunity at 20 months of age. The outcome of antibody test negative and adverse event was unknown. The relatedness between antibody test negative and adverse event was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 16 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2000, at the age of 13 months, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (exact dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2008, at the age of 9 years and 2 months, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (exact dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. At the time of the report, the patient had an active case of shingles on her face that started on an unknown date. The outcome of the event was reported as not recovered. The relatedness between the event and the (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Fatigue, Injection site joint pain, Neck pain
Clinical narrative: Initial pain up neck and down arm (still there). Following later with back ache, general joint aching, arm joint where vac. was given. Tiredness lasting for two weeks.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Initial pain up neck and down arm (still there). Following later with back ache, general joint aching, arm joint where vac. was given. Tiredness lasting for two weeks.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction. Red circular area about 3.5 inches in diameter. warm to the touch. No issues breathing.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Headache, Malaise, Pain
Clinical narrative: Uncontrollable shaking shivering lasting an hour; icy cold; body aches; headache.  Took generic ibuprofen to help relieve headache and body aches. As of 11/13 still experiencing body aches and general malaise.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Uncontrollable shaking shivering lasting an hour; icy cold; body aches; headache.  Took generic ibuprofen to help relieve headache and body aches. As of 11/13 still experiencing body aches and general malaise.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Papule
Clinical narrative: Papules over entire body.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Depressed mood, Tearfulness
Clinical narrative: Intense sadness, tearfulness. Lasted about 20-30 mins, resolved. Just mentioning it because it was not listed in the possible side effects - didn't know what effect it might have in a child with depression.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Arm is swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Diagnosed w/cellulitis - treated w/docycycline and Mupirocin.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). On an unspecified date in August 2015, the patient got a very bad case of shingles. On an unspecified date in November 2015, the patient's physician prescribed a second vaccination with ZOSTAVAX, but at the time of report, the patient did not receive it yet. No PQC (product quality complaint) was involved. The outcome of the very bad case of shingles was unknown. The relatedness between this event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative regarding a 2 year old male patient. Concurrent condition and medical history were not provided. Approximately in November 2014 (reported as: one year ago), the patient was vaccinated with first dose of (Oka/Merck) VARIVAX, (route, frequency, dose and lot number were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced shingles. The outcome of herpes zoster was not recovered. The primary reporter did not provide the causality among (Oka/Merck) VARIVAX with shingles. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for (Merck) PROQUAD. On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 14-JUL-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (albumin status HSA), lot # was confirmed to be L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event, product information and narrative were updated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eyelid oedema, Injection site swelling, Pruritus
Clinical narrative: Swelling at injection site. Eyes swollen shut and itchy. Itching.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site. Swelling about 4 inches in diameter.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling about 4-6 inches in diameter, and warmth at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's pertinent medical history was not reported. Patient's concurrent conditions included high cholesterol and high blood pressure. Patient is allergic to sulfa drugs. On 28-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency were not reported) lot # L012609 with an expiry date of 10-SEP-2016, subcutaneously. Concomitant therapies included acetaminophen, hydrocodone/APAP, zolpidem tartrate, simvastatin, furosemide and carvedilol. On 29-OCT-2015, 2 days after vaccination the patient developed bright red, hot, welt at the site of injection. The patient did not receive treatment for the events. The patient sought medical attention by visiting the pharmacists. The outcome of events injection site erythema, injection site warmth and injection site urticaria was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was administered KINRIX vaccine IM without incident. KINRIX is not recommended for children above the age of 6 years.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. The patient's relevant medical history and past drugs were unknown. On 11-JUN-2015 the patient was vaccinated with ZOSTAVAX injection 0.65 ml lot # L028280 with an expiry date of 28-OCT-2016, subcutaneously for prevention of shingles. Concomitant therapies included acetaminophen, polyethylene glycol, ondansetron hydrochloride, metoprolol succinate, atorvastatin, Lisinopril, pantoprazole, calcium 600 plus vitamin D 400, docusate sodium, tramadol hydrochloride, clonazepam, chondroitin sulfate sodium and glucosamine sulfate, minerals (unspecified), CENTRUM SILVER, citalopram, buspirone hydrochloride and diclofenac diethylamine. On 30-OCT-2015, she inadvertently received a second injection of ZOSTAVAX (extra dose administered). It was unknown if there was any relevant lab data. As of 31-OCT-2015, patient did not receive ZOSTAVAX and is not experiencing any problems from receiving doses of ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a male patient of unknown in his 70's-80's with genital warts. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-SEP-2015, the patient was vaccinated with the first dose of GARDASIL series injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. The patient was in the office at the day of the report (i.e. on 10-NOV-2015) in order to receive the 2nd dose in the series as an unspecified dose of GARDASIL 9 injection (strength, dose, route and lot number or batch number unspecified). No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient developed widespread numbness and tingling, legs feeling like rubber approximately 1 week after flu shot. Symptoms lasted 3 days then completely resolved.
Sex: F
Vaccine: HPV9
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a female patient in her 70's- 80's (exact age unspecified) with genital warts. There was no information about patients pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (lot#, expiration dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Audiogram abnormal, Nausea, Neurosensory hypoacusis, Nystagmus, Romberg test positive
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of vestibular neuronitis in a 55-year-old female patient who received FLUARIX TETRA (batch number AFLBA090AB, expiry date 30th June 2016). Concurrent medical conditions included menopause. Concomitant products included melatonina. On 23rd October 2015, the patient received FLUARIX TETRA (intramuscular). On 25th October 2015, 2 days after receiving FLUARIX, the patient experienced vestibular neuronitis (serious criteria hospitalization), vertigo, nausea and vomiting. On an unknown date, the outcome of the vestibular neuronitis, vertigo, nausea and vomiting were recovering/resolving. The reporter considered the vestibular neuronitis, vertigo, nausea and vomiting to be possibly related to FLUARIX TETRA. Additional details were provided as follows: On 28th October 2015, the patient was hospitalized for worsening of vertigo, nausea and vomiting symptoms. On 30th October 2015, the patient was discharged with marked improvement in clinical condition. Follow up was received on 6th November 2015 from a physician via regulatory authority: The patient's date of birth was changed. The patient's medical history included bilateral breast fibroadenoma which was removed surgically, appendicectomy, bilateral saphenectomy and right knee ligament reconstruction. The patient's neurological assessment revealed severe vertiginous symptoms during head movements with nausea and left sided nystagmus. Ear assessment revealed Romberg test with right lateropulsion. Stepping test was done with right deviation, spontaneous horizontal nystagmus to the left inhibited by visual fixation, position nystagmus to the left-in lateral decubitus. Audiometry showed mild bilateral neurosensorial hypoacusia (mainly right side). The patient showed marked improvement after magnesium sulphate administration, steroid and symptomatic therapy. The patient was advised ENT assessment. Home therapy was suggested as Deltacortene 25 mg 1 tablet for 10 days and then 0.5 tablet for 10 days, Lansoprazole 30 mg 1 tablet, Microser 8 mg 3 tablets for 20 days. Arlevertan 20 mg 2 tablets for 10 days and then 1 tablet for 10 days and TORVAST 20 mg 1 tablet. The physician considered a clear causality relationship between events and FLUARIX TETRA administration.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of vestibular neuronitis in a 55-year-old female patient who received FLUARIX TETRA (batch number AFLBA090AB, expiry date 30th June 2016). Concurrent medical conditions included menopause. Concomitant products included melatonina. On 23rd October 2015, the patient received FLUARIX TETRA (intramuscular). On 25th October 2015, 2 days after receiving FLUARIX, the patient experienced vestibular neuronitis (serious criteria hospitalization), vertigo, nausea and vomiting. On an unknown date, the outcome of the vestibular neuronitis, vertigo, nausea and vomiting were recovering/resolving. The reporter considered the vestibular neuronitis, vertigo, nausea and vomiting to be possibly related to FLUARIX TETRA. Additional details were provided as follows: On 28th October 2015, the patient was hospitalized for worsening of vertigo, nausea and vomiting symptoms. On 30th October 2015, the patient was discharged with marked improvement in clinical condition. Follow up was received on 6th November 2015 from a physician via regulatory authority: The patient's date of birth was changed. The patient's medical history included bilateral breast fibroadenoma which was removed surgically, appendicectomy, bilateral saphenectomy and right knee ligament reconstruction. The patient's neurological assessment revealed severe vertiginous symptoms during head movements with nausea and left sided nystagmus. Ear assessment revealed Romberg test with right lateropulsion. Stepping test was done with right deviation, spontaneous horizontal nystagmus to the left inhibited by visual fixation, position nystagmus to the left-in lateral decubitus. Audiometry showed mild bilateral neurosensorial hypoacusia (mainly right side). The patient showed marked improvement after magnesium sulphate administration, steroid and symptomatic therapy. The patient was advised ENT assessment. Home therapy was suggested as Deltacortene 25 mg 1 tablet for 10 days and then 0.5 tablet for 10 days, Lansoprazole 30 mg 1 tablet, Microser 8 mg 3 tablets for 20 days. Arlevertan 20 mg 2 tablets for 10 days and then 1 tablet for 10 days and TORVAST 20 mg 1 tablet. The physician considered a clear causality relationship between events and FLUARIX TETRA administration.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist via Poison Drug Center (RMPDC) (Manufacturer control# US15-053597) and refers to a 87 year old female patient with high blood pressure, macular degeneration, neuropathy and restless legs syndrome. On 02-OCT-2014, the patient was vaccinated with the first dose of ZOSTAVAX injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). The physician wrote her a prescription for ZOSTAVAX, because she thought she received the pneumonia vaccine last year. On the pharmacy questionnaire she had indicated, that she did not previously receive ZOSTAVAX. On 06-NOV-2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX injection (lot# L028279, expiration date 28-OCT-2016, dose, anatomical location and route of administration were not reported). Concomitant therapies included tramadol hydrochloride, gabapentin, hydrochlorothiazide (manufacturer unknown), FOSAMAX, REQUIP, KLONOPIN, acetaminophen, NORCO, DILTIAZEM ER and DIGOXIN. On 06-NOV-2015 reported as "last night", the patient experienced an upset stomach, which could have been caused by her worrying about getting a second dose of vaccine. It was unknown whether the relevant test were done. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. No medical history and concomitant medications were reported. The healthcare worker stated that the packaging of RECOMBIVAX HB and VAQTA were considerable close in appearance and errors may been made in administration. No concomitant medications were reported. The reporter also was requesting to work on changing the packaging of the 2 vaccines and enquired about the age range differences for the vaccines. 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 medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. In approximately 2013 (reported as "about two years ago", the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided). On 09-NOV-2015 (also reported as today), the patient was vaccinated (as the second dose in series) with GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Fever and chills that evening, dizziness all the next day.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to himself as a male patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified) for prevention of shingles. No concomitant medication was reported. On an unknown date in 2015 (reported as 3rd time this year), the patient experienced shingles. On an unknown date, the patient sought unspecified medical attention. The outcome of shingles experienced three times by the patient was unknown. There were no product quality complaints (PQC) involved. The reporter did not provide the causality between the event and the suspect therapy. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown demography. Patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, lot#, expiry date, date of administration was not provided). No information on concomitant medications was provided. The nurse practitioner reported that a patient "waited too long" between the first and second dose of RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint swelling, Pain in extremity
Clinical narrative: Since receiving the Pneumovax vaccine in her right arm, the patient's right arm has been red, swollen, and painful, from her elbow to her shoulder. She states she has edema pooling around her elbow and her arm is in a lot of pain. She had a Fluzone HD in her left arm with no reaction.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: For two or three day after the vaccine, I had pains in my arm where it was given, but they went away. About a week after, I started having more intense pain at the site that radiated to my shoulder, back, and arm. It has been almost a month and my arm still hurts at the spot where it was given when I lift, carry, or move it outside a small ROM.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Very bad vertigo early morning lasting into the next day.  Worse while changing sleep positions at night.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: NOTICED RASH ON LEFT FOREARM ON 11/10/205. NOTICED RASH ON UPPER LEFT THIGH ON 11/11/15. NOTICED RASH ON UPPER RIGHT THIGH 11/12/15. TODAY FACE IS ITCHY AND BEGINNING TO GET A RASH ON MIDDLE BACK.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous/study report was received from a 52 year old female patient with diabetes, referring to herself, as part of marketing research program. On 29-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, route, anatomical location, lot # and expiration date not reported). Concomitant therapies or vaccines were not reported. On 30-OCT-2015, the patient experienced redness, swelling and pain at the injection site. The outcome of these events was reported as recovering. The reporter considered the events to be non-serious and related to ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 17-AUG-2015, the patient was vaccinated with an unknown dose of ZOSTAVAX (route, lot# and expiry date were not reported), but the pharmacist was not sure if she fully reconstituted the vaccine prior to administration it to the patient and was not sure if the patient received a full dose of the vaccine as a result. The pharmacist reported that the issue was caused by use error. No adverse symptoms were reported. Follow up information has been received from the pharmacist on 23-OCT-2015. The patient was a 60 year old female, who was vaccinated with ZOSTAVAX in the left arm (lot# L011533 expiration date unknown) on 17-AUG-2015. Additional information is not expected as all follow up request to complete this report has been received Patient information, product information and narrative were updated.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a healthcare worker referring to a male patient of unknown age. On an unknown date, the patient was vaccinated with two doses of VARIVAX (dose, frequency, route of administration and indication were not reported). On 28-OCT-2015 (reported as "about 2 weeks ago" (from 11-NOV-2015)) the patient developed chickenpox. The outcome of chickenpox was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient current conditions, medical history and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with GARDASIL 9 injection (confirmed lot number 19287 and expiry date 14-SEP-2017, strength, dose, frequency and route were not reported). Other suspect therapies included GARDASIL (formulation, strength, dose, frequency, route, lot number and expiry date were not reported). On an unknown date, the patient completed the vaccination series of GARDASIL. On 29-OCT-2015, the patient inadvertently received a dose of GARDASIL 9. No adverse experiences were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Pt woke up day after vaccine not feeling well, ran fever for several days, then rash showed up 5 days later and they went to ER.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient recieved vaccine, reported on 11/7 area was red, warm and itchy. Area involved was elbow to injection site. Did not recieve medical attention at that time.  Called again 11/8/15 reported that it looked less red but was worried about cellulitis.  Patient was considering visiting urgent care.  Spoke with patient on 11/13/15, symptoms resolved without medical intervention.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Axillary pain, Chest pain, Injection site erythema, Injection site swelling
Clinical narrative: Low grade fever, joint aches and pains, arm very stiff, difficult to move, pain in shoulder/arm/armpit, side of chest.  Redness and swelling extending down arm away from injection site.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, joint aches and pains, arm very stiff, difficult to move, pain in shoulder/arm/armpit, side of chest.  Redness and swelling extending down arm away from injection site.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscle tightness, Pain, Pruritus, Swelling
Clinical narrative: Swelling, mild itching, pretty severe soreness, and muscle tension.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Feeling hot, Swelling, Urticaria
Clinical narrative: Erythema, swelling, warmth, hives almost immediately after vaccine administered.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Death, Malaise, Vomiting
Clinical narrative: Patient received Flu shot on October 20 and became ill the same day. He was vomiting and shivering. He died the day after receiving Flu shot.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Flank pain, Wheezing
Clinical narrative: Pt administered PNEUMOVAX IM in (L) deltoid. Within one minute, pt experienced wheezing, SOB, reddened face, and (L) flank pain. Pt s/s resolved and pt was given IV BENADRYL.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Blood test, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception, admit to Hosp, 11/6/15 - 11/7/15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site mass, Injection site pruritus, Swelling
Clinical narrative: The next day mom noted 1/2 inch lump at site of injection with 2 inches of surrounding "redness and puffiness". Itching of site noted.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: Patient received vaccine 11/6/`5. On 11/7/15 pt. reports rash and some discomfort and (L) rib and back area. Pt. seen on 11/9/15 full shingles breakout. Not treated with antivirals. Infectious disease contacted. 11/13/15 follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Scab, Skin lesion
Clinical narrative: Patient received vaccine 11/6/`5. On 11/7/15 pt. reports rash and some discomfort and (L) rib and back area. Pt. seen on 11/9/15 full shingles breakout. Not treated with antivirals. Infectious disease contacted. 11/13/15 follow up.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Sensation of foreign body
Clinical narrative: Patient received vaccine at 4pm without any adverse rxn. At 9pm she felt like she had a lump in her throat and throat was sore on swallowing. Took a BENADRYL at 10 PM and went to sleep. Upon awakening in morning she felt ok.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Ear pain, Eye discharge, Eye pruritus
Clinical narrative: Aching joints, coughing, listless, sore throat, headache, earache, eyes itching and mucous in eyes stuck closed in AM.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid margin crusting, Headache, Listless, Oropharyngeal pain
Clinical narrative: Aching joints, coughing, listless, sore throat, headache, earache, eyes itching and mucous in eyes stuck closed in AM.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: Chills, aches, nausea evening of vaccination - these symptoms gone next morning but right arm remained sore with pain radiating to right neck and shoulder - difficulty raising arm over head no redness or swelling at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 04-NOV-2015 the patient was vaccinated with his/her respective second dose in the VARIVAX immunization series that was improperly stored, lot # L019130, expiration date: 27-MAY-2017 (dose, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia, Pharyngeal oedema, Pyrexia, Throat tightness
Clinical narrative: Patient reports throat tightening/swelling, red itchy eyes, fever of 101. Reports symptoms are improved.