chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Headache, Injection site pain, Sinusitis
Clinical narrative: Severe head pain, sinus infection, throbbing of the injection site, and arm pit throbbing and pain.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute respiratory failure, Biopsy skin abnormal, Death, Herpes zoster disseminated, Mental status changes
Clinical narrative: Disseminated zoster infection, MRSA infection--sepsis and pneumonia, acute respiratory failure, altered mental status.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia staphylococcal, Staphylococcal sepsis, Staphylococcus test positive
Clinical narrative: Disseminated zoster infection, MRSA infection--sepsis and pneumonia, acute respiratory failure, altered mental status.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Rash
Clinical narrative: Hours after administration of vaccine: large patches over body of erythema/induration/itching waxing and waning, changing location. Very uncomfortable for 2 days.
Age: 0.53
Sex: M
Vaccine: DTPIPV
Symptoms: Acne, Erythema, Skin mass
Clinical narrative: Hard knot under skin. Red pimple looking bump on top of skin.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Tongue oedema
Clinical narrative: Tongue edema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Injection site pain, Lethargy, Pyrexia, Respiratory tract congestion
Clinical narrative: Lethargy, mild fever (101-102*), soreness at injection site, congestion and more labored breathing while sleeping.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, Swelling, warm to touch, and painful to touch.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Axonal neuropathy, Electromyogram abnormal, Nerve conduction studies abnormal, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anion gap decreased, Ballismus, Blood alkaline phosphatase increased, Blood magnesium decreased, Cyanosis
Clinical narrative: Dystonic Reaction:  Hyperthermia, Tachypnea, Tachycardia, Distal muscular rigidity, Distal cyanosis, Hemiballismus, and Altered mentation.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dystonia, Hyperthermia, Hypomagnesaemia, Leukocytosis, Mental status changes
Clinical narrative: Dystonic Reaction:  Hyperthermia, Tachypnea, Tachycardia, Distal muscular rigidity, Distal cyanosis, Hemiballismus, and Altered mentation.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic acidosis, Muscle rigidity, Tachycardia, Tachypnoea, White blood cell count increased
Clinical narrative: Dystonic Reaction:  Hyperthermia, Tachypnea, Tachycardia, Distal muscular rigidity, Distal cyanosis, Hemiballismus, and Altered mentation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema 60 mm x 60 mm around injection site.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Aggression, Bacterial infection, Bacterial test positive, Body temperature increased, Diarrhoea
Clinical narrative: Pt had violent reaction 24 hours after vaccine had to go to ER extremely low Blood Pressure, shallow breathing. Pt hospitalized on 7-6-15 with diarrhea for 4 days, increased temp 103.5 degrees goes back up after wares off. On oxygen, IV antibiotics, put in ICU. Seeing infectious disease MD due to infection resistance to (-) gram rod infection.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Hypopnoea, Hypotension, Intensive care
Clinical narrative: Pt had violent reaction 24 hours after vaccine had to go to ER extremely low Blood Pressure, shallow breathing. Pt hospitalized on 7-6-15 with diarrhea for 4 days, increased temp 103.5 degrees goes back up after wares off. On oxygen, IV antibiotics, put in ICU. Seeing infectious disease MD due to infection resistance to (-) gram rod infection.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Adverse reaction
Clinical narrative: Pt had violent reaction 24 hours after vaccine had to go to ER extremely low Blood Pressure, shallow breathing. Pt hospitalized on 7-6-15 with diarrhea for 4 days, increased temp 103.5 degrees goes back up after wares off. On oxygen, IV antibiotics, put in ICU. Seeing infectious disease MD due to infection resistance to (-) gram rod infection.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt arrives from Dr's. office and asks to receive her Prevnar. State shots and chart checked.  Order in chart.  VIS provided and reviewed with pt and she signed VIS without further questions.  Vaccine administered and nurse went to enter in computer and order had been completed.  Call to Dr.s office and discovered pt had received Prevnar in that office before arriving at clinic. Pt therefore had duplicate dose. Pt retained in office and informed of above.  Pt insists she just has TDAP in office.  VS assessed and stable. Reviewed again possible side effects and when to call MD.  MD notified and pt discharged home.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Student was given Tdap, Menactra and HPV. The HPV was the last to be administered. His whole body became stiff/clamped and lost consciousness for less than a minute (about 40 seconds). A little diaphoretic after the episode.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Slight raised skin at site of injection upon administration. No other adverse events at that time.  As of 07/24/15, red rash surrounding site of injection, no other adverse reactions.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Redness approx 2 1/2 cm circumference along with itching.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chills, Irritability, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, fussiness.
Age: 2.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient developed high fever and pain in her legs at the site of the injections.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Crying, Electrocardiogram normal
Clinical narrative: At 11:00 am, patient received meningitis vaccine.  At 4:30 pm child had been napping approximately 2 hrs.  Unable to fully wake child, extremely lethargic, unable to open eyes, crying, left leg tremor uncontrollable and hyperventalation. Called and spoke to nurse at Dr's office.  Nurse stated that they had not heard of this reaction to a vaccine and to take patient to ER. Took child to ER shortly after 5 pm.  Facility treated for allergic reaction.  IV fluids, Benadryl and steroid.  Within 45-60 minutes of treatment, symptoms subsided. Facility performed CT Head, EKG, CXR, Blood work and urinalysis which were all normal.  The ER then had her transferred to another Hospital for observation.  At this time, all symptoms had subsided and child was hungry.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Hyperventilation, Lethargy, Somnolence, Tremor
Clinical narrative: At 11:00 am, patient received meningitis vaccine.  At 4:30 pm child had been napping approximately 2 hrs.  Unable to fully wake child, extremely lethargic, unable to open eyes, crying, left leg tremor uncontrollable and hyperventalation. Called and spoke to nurse at Dr's office.  Nurse stated that they had not heard of this reaction to a vaccine and to take patient to ER. Took child to ER shortly after 5 pm.  Facility treated for allergic reaction.  IV fluids, Benadryl and steroid.  Within 45-60 minutes of treatment, symptoms subsided. Facility performed CT Head, EKG, CXR, Blood work and urinalysis which were all normal.  The ER then had her transferred to another Hospital for observation.  At this time, all symptoms had subsided and child was hungry.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: At 11:00 am, patient received meningitis vaccine.  At 4:30 pm child had been napping approximately 2 hrs.  Unable to fully wake child, extremely lethargic, unable to open eyes, crying, left leg tremor uncontrollable and hyperventalation. Called and spoke to nurse at Dr's office.  Nurse stated that they had not heard of this reaction to a vaccine and to take patient to ER. Took child to ER shortly after 5 pm.  Facility treated for allergic reaction.  IV fluids, Benadryl and steroid.  Within 45-60 minutes of treatment, symptoms subsided. Facility performed CT Head, EKG, CXR, Blood work and urinalysis which were all normal.  The ER then had her transferred to another Hospital for observation.  At this time, all symptoms had subsided and child was hungry.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Patient did not experience an adverse event. The vaccine vial had previously thawed and been refrozen four months prior, and was inadvertantly used for the immunization.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Father states pt has redness and swelling on the left arm one week after vaccination.  Next day, swelling gone and redness decreased.  Cool compress to affected site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother states L upper deltoid swelling, redness and sore to the touch at site of DTaP vaccination. Swelling noted adverse reaction the day following vaccination.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Clostridium test, Toxicologic test normal
Clinical narrative: Generalized progressive weakness, treated with supportive care.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Mother report pt upper L deltoid bruising on 7/22/15, post administration of DTaP vaccine at site. Redness, swelling noted in office (7/23/15). Pt treated for dx: cellulitis. tx: Septra oral antibiotic x 7 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, pain and swelling at injection site, fever, loss of appetite.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, pain and swelling at injection site, fever, loss of appetite.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Dizziness, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, dizziness, weakness, pain at injection site; Tylenol provides relief.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, fever, dizziness, mild nausea; Tylenol.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Pt called and said she had a "blue circle" at the administration site as well as a "red mark" underneath the area.  She gave no history of when this started.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Syncope, Tremor
Clinical narrative: Syncope with tremors and 15 secs of loss of consciousness.
Age: 66.0
Sex: M
Vaccine: OPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Aches in shoulder joints & muscles.  Pain will not stop.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, General physical health deterioration, Lethargy, Pain, Pain in extremity
Clinical narrative: Chills, low grade fever, body ache, entire body, shooting pains in toes and fingers. Lethargic, over decline in health.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Chills, low grade fever, body ache, entire body, shooting pains in toes and fingers. Lethargic, over decline in health.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Patient felt dizzy, then threw up and sweating. She rested for 20 minutes then requested some water. I gave her a bottle water. She got better then left.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Acupuncture, Arthritis, Ear pain, Injected limb mobility decreased, Injection site pain
Clinical narrative: Started off slowly with tenderness at injection site, progressed to severe pain when arm was placed in certian positions, especially behind center line of body. Pain raising left arm, putting it behind the back, trouble relaxing arm especially at night. Two months later I wasn't using left arm for normal tasks like taking off or putting on clothes.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Pain in jaw, X-ray
Clinical narrative: Started off slowly with tenderness at injection site, progressed to severe pain when arm was placed in certian positions, especially behind center line of body. Pain raising left arm, putting it behind the back, trouble relaxing arm especially at night. Two months later I wasn't using left arm for normal tasks like taking off or putting on clothes.
Sex: F
Vaccine: HPV4
Symptoms: Skull fracture, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown dates, several years ago, the patient was vaccinated with a dose of GARDASIL (4) (dose, route of administration and anatomical location was not reported). Concomitant medications were unspecified by reporter. On an unspecified dates, after administration of the GARDASIL, the patient left the physician's office and fainted in the parking lot and fractured her skull. It was unspecified if the patient was required any medical attention or not. The reporting physician stated that the patient was not his patient. The outcome of the events was unknown. The causal relationship between the events and GARDASIL was not provide. No further information was reported. Upon internal review, fractured her skull was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram abnormal, Seizure
Clinical narrative: This spontaneous report was received from a female consumer of unknown age, referring to herself. Neither medical history nor concurrent conditions were reported. On 14-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (lot number and expiration date not reported) at an unspecified pharmacy. No concomitant therapies were reported. On 21-MAR-2015, 128 days after onset of therapy, the patient experienced a seizure (medically significant) and was admitted overnight at an unspecified hospital. Next day, on 22-MAR-2015, she had another seizure (medically significant) at the hospital and an electroencephalogram (EEG) was performed, which detected seizure activity. At the time of the report, the outcome of the first seizure was considered as recovered, but for the second seizure event was unknown. The reporter's causality was not provided for the reported events. No fatal consequences nor product quality complaints were reported, nonetheless, the patient declined to participate in answering questions related to the present report. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant referring to a 29 year old male patient. The patient's medical history included born premature. The patient's relevant past drug history included receiving the initial "Hep B" injection when he was born. On 22-JUL-2015, the patient was accidentally given one injection of PEDVAXHIB (dose and route unknown, lot number K019700, expiration date 16-JUL-2017). He had no relevant concomitant medications. On 22-Jul-2015, the medical assistant stated that she meant to give the patient a "Hep B" injection but grabbed the wrong vial. She might maybe they looked similar but when she went back to look, they didn't. No adverse reactions had been noted in the patient. It was unknown if any relevant lab work had been done. As of 22-JUL-2015, it was unknown if the patient would continue on the PEDVAXHIB and the outcome of receiving the PEDVAXHIB injection was unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a male patient of unknown age. No concurrent conditions or medical history were reported. On 14-MAY-2015, the patient was vaccinated with the first dose of VAQTA injection 25/0.5 and on 13-JUL-2015, the patient received the second dose of VAQTA injection 25/0.5 (units not reported) (lot. No., dose, route and anatomical location of administration of both vaccines were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. There was no concurrent condition and medical history reported. On an unknown date the patient was inadvertently administered a dose of improperly stored LIQUID PEDVAXHIB (lot # K026533, Expiration Date 07-AUG-2015, strength, dose and route not provided). There was no concomitant medication reported. No adverse effect was reported. 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 healthcare worker concerning multiple patients of unknown demographics. On unknown dates, multiple different unspecified patients received a dose of PROQUAD (Merck) (unspecified lot # and expiry date) that was improperly stored. No adverse effects reported, No product quality complaint was involved. The case is also relate to 1506USA002056, 1507USA010860 and 1507USA010861 (same reporter link). Additional information has been requested,
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. There was no concurrent condition and medical history reported. On an unknown date was inadvertently administered a dose of improperly stored ROTATEQ (lot # K023534, Expiration Date 22-MAY-2016, strength and dose not provided, oral). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Myalgia, Ocular hyperaemia, Pyrexia
Clinical narrative: On an unknown date, the patient was vaccinated with a third dose of GARDASIL (Lot No., dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, afterward of vaccination, the patient experienced fever (pyrexia), aching muscles (myalgia) and his left eye was "blood shot" (ocular hyperaemia). The outcome of ocular hyperaemia, myalgia and pyrexia was unknown. Additional information is not expected due to no contact details for perform follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The nurse reported that between 13-JUL-2015 to the 17-JUL-2015, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneously, once, (strength, anatomical location, lot number and expiration date were not reported), which were improperly storage. Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot # L000454; expiry date: 06-JAN-2017) (dose, route and frequency unspecified). Concomitant therapy was not reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route and dose number were unspecified), J007304/exp 16-DEC-2015, L001456/exp 22-OCT-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 21-JUL-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K003604, expiration date: 20-MAR-2015, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders. Concurrent conditions and medical histories were not provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ, oral (dose, strength and lot# not provided). There was no concomitant medication. No adverse events reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 02-JUL-2015, the patient was vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported) (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of three reports 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 was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with MMR II (lot # K016154; expiry date: 24-SEP-2016) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # K026246; expiry date: 28-JAN-2017) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patient were vaccinated with ROTATEQ suspension 2 (lot # K012432; expiry date: 28-MAY-2016) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, lo#, expiration date and indication were not reported). No concomitant medications were reported. There was no adverse effects reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous medically confirmed report concerns a 76 year old male patient. On 25-SEP-2014, the patient received one time dose of intravenous influenza virus vaccine (manufacturer and batch number not reported) at 0.5 ml (inappropriate route of vaccine administration). The outcome was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-MAR-2015) concerns an unknown demographics patient. ON an unspecified date, the patient received unspecified flu vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced a bad severe reaction to an unspecified flu vaccine a few years ago. The outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This non-serious consumer report (initial receipt 03-Apr-2015) concerns a female patient who had a medical history of a sore arm and redness at the injection site after an unspecified bacterial meningitis shot. On the 04-Mar-2015, the patient developed a sore arm and redness at the injection site after VARIVAX. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a sore arm. Outcome was reported as recovered.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous medically confirmed report (initial receipt 17-Jul-2014) concerns a 53 year old female patient. On 18-Jan-2013, the patient received one time dose of intravenous influenza virus vaccine (manufacturer and batch number not reported) at 0.5 ml. The outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: On an unspecified date, the patient received unspecified flu vaccine (lot number not reported). On an unspecified date, the patient developed sore arm after receiving the flu vaccine. The outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased
Clinical narrative: This medically confirmed spontaneous report (initial receipt 05-Mar-2015) concerns a female patient who had a medical history of chronic headaches and gluten intolerance. On 05-Mar-2015, the patient received AFLURIA injection (batch number not reported) for the prevention of influenza. On 05-Mar-2015, following AFLURIA administration, the patient felt that her heart was beating much faster than normal and had a headache. The outcome was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Feb-2015) concerns a 36-year-old male patient. The patient received TB vaccine in the past four weeks. On 27-Jan-2015 at 17:06, the patient received intramuscular AFLURIA pre-filled syringe, (batch number: T51808), that was kept at 21.2 degree C on for 1-2 days (administration of temperature excursion vaccine). It was reported the patient was fine and there was no adverse event. Outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as unrelated.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Emotional distress, Pain in extremity, Weight bearing difficulty
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Feb-2015) concerns a 53 year-old female patient who was taking many cancer medications, including rituximab, for an unspecified cancer. She received FLUZONE on 24-Sep-2013 without any reports of patient harm. On 12-Jan-2015 at 11:00 AM, the patient received intramuscular AFLURIA, (batch number T51808) 0.5 mL. AFLURIA was stored correctly. On 12-Jan-2015 at 11:00 AM, the patient received intramuscular AFLURIA, (batch number T51808) 0.5 mL. AFLURIA was stored correctly. On 12-Jan-2015, the patient experienced pain int he arm since the date of AFLURIA administration. Her arm was sore after the injection and was advised that it was normal. Three weeks following the AFLURIA administration, the patient complained of persisting pain in the arm and discussed with her doctor who advised her to discuss with her pharmacist to determine if AFLURIA was administered improperly or with a "bad batch" of vaccine. Pain in the arm was described as excruciating and had lessened since AFLURIA administration but has not healed. She had difficulty in lifting everyday items like plates. The more she moved her arm, the more it gets lubricated and felt better. However, there was still some associated pain. She was upset with the pain. The outcome was not recovered for the pain in the arm, and unknown for other AEs. Reporter's comments: The patient believed the pain was a direct result of AFLURIA administration.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a male patient who had no medical history and no current illness and no medications at the time of vaccination. In 2013, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed left axilla lymph node tenderness, redness and swelling (two or three marble-sized nodes). Outcome was recovered. Linked to case 2015048755.
Sex: M
Vaccine: FLU3
Symptoms: Myositis
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 19 year old male patient. On an unspeicifed date, the patient received AFLURIA (batch number not reported). On an unspecified date in 2013, the patient developed myositis in the left arm at the time of injection. It was not evaluated medically. Outcome was not reported. Linked to 2015018753.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This medically confirmed spontaneous report (initial receipt 08-NOV-2014) concerns a female patient. On an unspecified date, the patient received trivalent inactivated influenza vaccine (manufacturer and batch number not reported).  ON an unspecified date after receiving the vaccination, the patient developed hives. Outcome was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This non serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a female patient. On an unspecified date, the patient received the influenza seasonal vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed fever. Linked to 2014046402. Outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 11-NOV-2014) concerns a female patient. On 24-OCT-2014, the patient received intramuscular AFLURIA (batch number 10149221A) at 0.5 ml one.  On 24-OCT-2014, within one hour after receiving the vaccine, the patient developed hives around the injection site. By 26-OCT-2014, the patient had hives all over the body. The nurse was notified of the adverse reactions on 27-OCT-2014. The outcome was reported not recovered.
Age: 66.0
Sex: M
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: This consumer spontaneous report (an uinitial receipt 06-NOV-2014) concerns a 66 year-old male patient. On unknown date, the patient received influenza vaccine (manufacturer and batch number not provided), TDAP (manufacturer and batch not provided), pneumococcal vaccine (manufacturer and batch not provided), and ZOSTAVAX (batch number not provided). On an unknown date, following the administration of ZOSTAVAX, the patient experienced chest pain and felt like he was going to die. Outcome was reported as recovered.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-NOV-2014) concerns a 62 year-old female patient with no known allergies. On an unknown date in October 2014, the patient received flu vaccine (manufacturer and batch number not provided) and subcutaneous ZOSTAVAX (batch number not provided) 0.65 ml both vaccines were given in the left arm. On an unknown date in 2014, the patient experienced swelling, itching and redness at the injection site. There was no rash. The swelling at the injection site somewhat had decreased. The patient's husband contacted their health care provider who advised them to keep monitoring these events. Outcome was reported as not recovered.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 29-Jan-2015) concerns an 85 year old male patient. On the 15-Jan-2015, the patient received AFLURIA (batch number 09649211A) 0.5mL annually via the intramuscular route. After administration it was realised that the multi-dose vial was two weeks expired (an opened AFLURIA vial was administered after 28 days of being punctured). The vial was discarded therefore the expiration date on the vial or the date the vial was punctured could not be provided. The patient was fine with no adverse events to report. Outcome was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 13-Nov-2014) concerns a 36 year-old female patient who received the flu shot last year without any issues. On 11-Nov-2014, the patient received intramuscular AFLURIA (batch number: T51208) 0.5 mL annually in the left arm. On 12-Nov-2014, the patient began to experience stiffness and pain at the injection site. On 13-Nov-2014, the patient intensified and she also experienced numbness which was very concerning to the patient. The outcome was not recovered
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This medically confirmed spontaneous report (initial receipt 22-Jan-2015) concerns an adult patient. On an unspecified date, the patient received intramuscular influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed hives after receiving an unspecified flu vaccine many years ago. The patient had since recovered. The outcome was recovered on an unknown date.
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This consumer spontaneous report (initial receipt 13-Nov-2014) concerns a female patient who was in her early 60 year-old. On 12-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) 0.5 mL once. On 12-Nov-2014, 1 hour after the vaccine she noticed that her upper lip began to quiver intermittently which persisted at the time of reporting. The outcome was not recovered. Reporter's comments: The reporter assessed the event as non-serious.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Penile discharge, Penile swelling, Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Nov-2014) concerns a 40 year-old male patient who had an allergy to haloperidol and sulfonamides. He received flu vaccines in 2010, 2012 and 2013 without any issues. Concomitant medications included carbamazepine, citalopram, simvastatin and omeprazole. On 08-Nov-2014, the patient received AFLURIA vaccine (batch number T53509). On 08-Nov-2014, sometime in the morning following the administration of the AFLURIA vaccine, the patient experienced swelling and some leakage of the penis. He also had small rash-like eruptions on the cheeks and forehead. The patient took diphenhydramine 50mg once. The patient's doctor was aware of these events and prescribed diphenhydramine 25mg three times daily. The symptoms resolved over two days. Outcome was recovered on 10-Nov-2014. Reporter comments: The reporter was not aware that the patient had any other skin issues.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 17-Nov-2014) concerns a female patient who had a right shoulder surgery about 8 years ago. She had received flu vaccines in the past one of which was a quadrivalent vaccine last year. On 02-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T52108) 0.5mL in her left arm. On 02-Nov-2014, approximately 3 hours following the vaccination, the patient experienced extreme pain in the injected arm. The pain was described as "knife grinding into her arm" and felt like the pain she had when she was recovering from the surgery. The pain was constantly there but was worse when she moved her arm side to side or when lifting it up, and felt "really weird". She had limited range of motion. On the night of the administration, she called the 24-hour hotline number which was provided by her insurance company. During this phone call, she spoke to the nurse who stated it may be related to the AFLURIA administration. She went grocery shopping and did not do anything strenuous after the administration. She had not notified her primary care physician because she hoped it would go away soon. She was self-treated with ibuprofen 600mg two or three times daily, which seemed to somewhat helped. Outcome was reported as not yet recovered.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 19-Nov-2014) concerns a 7 year-old female patient who had no known allergies or sensitivities to latex or eggs. On 16-Nov-2014 at 17:00 hours, the patient received intramuscular AFLURIA (batch number T52908) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014 in the morning, the patient started to have a fever which was 99 Fahrenheit and caused her to miss her school. On 18-Nov-2014, she developed warmth and pinkness at the injection site, which widened to an area of the size of a golf ball. The injection site was not painful, it was only warm to touch. The patient recovered from the fever on 19-Nov-2014 and went to school, but the injection site reaction remains. Patient's mother did not seek medical attention or administer any medications to her daughter. Outcome was reported recovered for fever and not yet recovered for injection site reactions.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Fatigue, Pain
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a 70 year-old female patient who previously received flu vaccine (unknown if AFLURIA was administered) and experienced high temperatures, chills, fatigue, severe joint aches and generalized body pain (see case 2014046773). On 15-Oct-2014 at 14:50 hours, the patient received intramuscular AFLURIA vaccine (batch number 10149211A) 0.5mL. On the same day as the AFLURIA vaccine, 15-Oct-2014, some hours later, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain for 24-36 hours. She stayed in bed for the entire evening. On 16-Oct-2014, she went to work where it was confirmed that her temperature was 101.7 degrees Fahrenheit. She was sent home where she remained in bed to rest. Her primary care provider was aware and she was advised to take acetaminophen or ibuprofen for the achiness. On 17-Oct-2014, she felt better. All the signs and symptoms resolved. Outcome was recovered on 17-Oct-2014.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a 70 year-old female patient who previously received flu vaccine (unknown if AFLURIA was administered) and experienced high temperatures, chills, fatigue, severe joint aches and generalized body pain (see case 2014046773). On 15-Oct-2014 at 14:50 hours, the patient received intramuscular AFLURIA vaccine (batch number 10149211A) 0.5mL. On the same day as the AFLURIA vaccine, 15-Oct-2014, some hours later, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain for 24-36 hours. She stayed in bed for the entire evening. On 16-Oct-2014, she went to work where it was confirmed that her temperature was 101.7 degrees Fahrenheit. She was sent home where she remained in bed to rest. Her primary care provider was aware and she was advised to take acetaminophen or ibuprofen for the achiness. On 17-Oct-2014, she felt better. All the signs and symptoms resolved. Outcome was recovered on 17-Oct-2014.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a 70 year-old female patient who previously received flu vaccine (unknown if AFLURIA was administered) and experienced high temperatures, chills, fatigue, severe joint aches and generalized body pain (see case 2014046773). On 15-Oct-2014 at 14:50 hours, the patient received intramuscular AFLURIA vaccine (batch number 10149211A) 0.5mL. On the same day as the AFLURIA vaccine, 15-Oct-2014, some hours later, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain for 24-36 hours. She stayed in bed for the entire evening. On 16-Oct-2014, she went to work where it was confirmed that her temperature was 101.7 degrees Fahrenheit. She was sent home where she remained in bed to rest. Her primary care provider was aware and she was advised to take acetaminophen or ibuprofen for the achiness. On 17-Oct-2014, she felt better. All the signs and symptoms resolved. Outcome was recovered on 17-Oct-2014.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Fatigue, Pain
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a female patient. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain. Outcome was unknown. Linked to 2014046770.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a female patient. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain. Outcome was unknown. Linked to 2014046770.
Age: 70.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a female patient. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain. Outcome was unknown. Linked to 2014046770.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a 65 year-old female patient who previously received influenza vaccine without any issues. On 17-Oct-2014 at 09:00 hours, the patient received intramuscular AFLURIA vaccine (batch number 10149211A) 0.5mL. On the same day as the AFLURIA vaccine, 17-Oct-2014, the patient experienced chills and felt like she had an elevated temperature for 24 hours (however her temperature was not taken). On 18-Oct-2014, after bed rest, she felt better. All her signs and symptoms resolved. Outcome was recovered on 18-Oct-2014. Reporter Comments: Reporter stated that the patient's primary care provider was not made aware.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-Nov-2014) concerns a 70 year-old female patient who previously received flu vaccine (unknown if AFLURIA was administered) and experienced high temperatures, chills, fatigue, severe joint aches and generalized body pain (see case 2014046773). On 15-Oct-2014 at 14:50 hours, the patient received intramuscular AFLURIA vaccine (batch number 10149211A) 0.5mL. On the same day as the AFLURIA vaccine, 15-Oct-2014, some hours later, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain for 24-36 hours. She stayed in bed for the entire evening. On 16-Oct-2014, she went to work where it was confirmed that her temperature was 101.7 degrees Fahrenheit. She was sent home where she remained in bed to rest. Her primary care provider was aware and she was advised to take acetaminophen or ibuprofen for the achiness. On 17-Oct-2014, she felt better. All the signs and symptoms resolved. Outcome was recovered on 17-Oct-2014. Reporter Comments: Reporter stated that she did not if the patient's concomitant medications, medical history, height and weight.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous medically confirmed report (initial receipt 24-Nov-2014) concerns a 40-year-old patient. On 24-Nov-2014, the patient received intramuscular AFLURIA (batch number not reported) at a dose of 1 ml. No adverse reactions occurred since administration. Outcome was reported as recovered. Reporter's comments: The reporter assessed the event as non-serious.