chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache
Clinical narrative: Achy joints, upset stomach, headache and very fatigue. Sleep, took ADVIL, and stayed hydrated.
Age: 74.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: The day after receiving vaccine, patient developed rash down his back.
Age: 5.0
Sex: F
Vaccine: FLUN4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Skin infection
Clinical narrative: Child was given PROQUAD on 10/21/13. That PM her leg started to get red and swell. Swelling cont. to get worse child came to ER 10/22/13 and clinic 10/23/13 due to swelling spreading. Child was give KEFLEX for skin infection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chest discomfort, Pain, Respiratory tract congestion, Wheezing
Clinical narrative: Per dr - pt had sx - congestion, body aches, wheezing and chest tightness. Tx: KENALOG 40 mg IM, BENADRYL 25 mg PRN. Note to remain out of work until 10-28-13.
Age: 14.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blister, Fungal skin infection, Rash erythematous
Clinical narrative: T/C with mother - states rash (red, blisters) noted 11/3 to trunk, groin area, increase in rash noted over 3 days - contacted health Dept 11/6 - no fever, itching noted.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash, Urticaria
Clinical narrative: Rash developed at school. Sparse hives on trunk and back - no angioedema. Possible hypersensitivity to components of FLUMIST - Rxn 24 hrs later and is isolated hives. No concern of anaphylaxis. Given BENADRYL PRN. Advised to f/u with allergy.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: 0800 - Rapid heart rate and SOB. Lasted about 10 sec. 810-0815 - same as above, this cycle continued until around 11:20. Symptoms became milder.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Inflammation, Injected limb mobility decreased, Lethargy
Clinical narrative: Severity inflamed right arm - unable to lift it, nausea, vomiting x 2 days. diarrhea x 2 days. Symptoms lasted 4 days - dizzy lethargic.
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Severity inflamed right arm - unable to lift it, nausea, vomiting x 2 days. diarrhea x 2 days. Symptoms lasted 4 days - dizzy lethargic.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Patient presented with swelling and redness in back of left arm. Skin area affected has the size of a baseball and warm and stiff to the touch. Patient says symptoms started the evening after receiving the vaccine and have not improved.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Throbbing in injected arm for 2 days which then quit. Reports pain in left arm when lifted over head, shoulder.
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient requested MMR - patient received MENACTRA.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Dysmorphism, Eyelid function disorder
Clinical narrative: On 10/31/13 noted (R) eye not closing completely and (R) side of mouth asymmetry. Referred to physician for evaluation of possible Bell's palsy, MD prescribed VALTREX and Prednisone.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Reports dull throbbing pain in injected arm not red inflamed or swollen.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Employee states left deltoid muscle pain worsening since 9/26/13. PCP recommends PT, NSAIDS.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pt. received FLUMIST 10/19/13. Developed itchy rash on 10/20/13. Parent giving BENADRYL at home. On 10/21/13 -> brought to ER where diagnosed with urticaria, discharged to home on ORAPRED.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient received vaccine (FLUARIX quadrivalent) in left deltoid and in less than 5 minutes, developed hives to forehead, chest and arm. Became itchy and developed swelling and redness at injection site. Treated with 0.3 ml epinephrine which began to resolve symptoms. Pt transported to Urgent Care for MD follow up. Had previously had flu vaccine each year without incident.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient called saying injection site is red and sore and hot to touch. Recommended NEOSPORIN, warm compresses and if gets worse to follow up with MD. Will have a pharmacist follow up with her next day.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema mouth, Oropharyngeal pain
Clinical narrative: Sore throat - 1 hr after shot. 5-15 P.M. Also bottom of mouth was swollen in side around 8 PM, called Dr., told me to call 911 and take me to go to hospital. 920 PM. I was given 4 pills at 1145 P.M. BENADRYL, SINGULAR, PEPCID, Petazone.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Muscle spasms, Paraesthesia
Clinical narrative: Numbness and tingling in arm - muscle cramping in forearm. Cramping in buttocks and lower back - malaise.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Loss of consciousness
Clinical narrative: Felt extremely weak - a bit disoriented. Blacked out for four hours. Did not seek treatment.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Erythema of (L) upper arm.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache
Clinical narrative: 920 H/A feels dizzy, B/P 80/60. No breakfast, 945 B/P 110/80 feeling much better. 10:00 B/P 118/80 - P 84. Mom was called by the school nurse.
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Apnoea, Blood test normal, CSF culture negative, Computerised tomogram head normal, Convulsion
Clinical narrative: Well until 10/23/13 2pm while playing, suddenly became unresponsive w/ eyes deviated to left; he was unresponsive, stiff, focal jerking and apneic. Upon arrival EMS found child still in seizure. Upon arrival to ER was apneic/agonal breathing requiring BMV, several doses of ATIVAN to stop seizure. He was monitored in PICU x 24 hours and on regular floor x 24 hours. Work up in question # 12. He was back to normal activity 10/25/13. Seizure lasted approximately 75 minutes. No fever until at hospital T. 101 degrees after seizure.
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Electroencephalogram normal, Gaze palsy, Intensive care, Musculoskeletal stiffness
Clinical narrative: Well until 10/23/13 2pm while playing, suddenly became unresponsive w/ eyes deviated to left; he was unresponsive, stiff, focal jerking and apneic. Upon arrival EMS found child still in seizure. Upon arrival to ER was apneic/agonal breathing requiring BMV, several doses of ATIVAN to stop seizure. He was monitored in PICU x 24 hours and on regular floor x 24 hours. Work up in question # 12. He was back to normal activity 10/25/13. Seizure lasted approximately 75 minutes. No fever until at hospital T. 101 degrees after seizure.
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiration abnormal, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Well until 10/23/13 2pm while playing, suddenly became unresponsive w/ eyes deviated to left; he was unresponsive, stiff, focal jerking and apneic. Upon arrival EMS found child still in seizure. Upon arrival to ER was apneic/agonal breathing requiring BMV, several doses of ATIVAN to stop seizure. He was monitored in PICU x 24 hours and on regular floor x 24 hours. Work up in question # 12. He was back to normal activity 10/25/13. Seizure lasted approximately 75 minutes. No fever until at hospital T. 101 degrees after seizure.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Aphasia, Headache, Injection site pain, Loss of consciousness, Presyncope
Clinical narrative: Immediate injection site pain - vasovagal reaction. Reported difficulty word finding "passed out". Now having daily headache and tinnitus.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Immediate injection site pain - vasovagal reaction. Reported difficulty word finding "passed out". Now having daily headache and tinnitus.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Dramatic swelling, redness, browny edema of the whole arm from tip of shoulder to elbow and low grade fever. No vomiting or chills. Local area of temperature and warmth. Had significant pain after administration of vaccine.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Dramatic swelling, redness, browny edema of the whole arm from tip of shoulder to elbow and low grade fever. No vomiting or chills. Local area of temperature and warmth. Had significant pain after administration of vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pneumonia
Clinical narrative: Initial report was received from a healthcare professional on 29 October 2013. The reporter for this case is the same as the reporter for cases 2013SA111137 and 2013SA111180. A female patient (aged 65-years plus) received an injection of FLUZONE HIGH-DOSE (lot number, route, site and exact date of administration not reported) in October of 2013 and was hospitalized the day of vaccination with malaise, chills and treatment for pneumonia. The patient had no known allergies (NKA). Outcome was recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Fear of injection, Hyperhidrosis, Nausea
Clinical narrative: Sweaty, nausea, clammy, she does have a fear of needles.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Intensive care, Pyrexia, Tachycardia
Clinical narrative: Initial report was received on 29 October 2013 from a health care professional. A 13 year-old male patient (date of birth not reported) with no known drug allergies had received in October 2013 on an unspecified dated FLUZONE, lot number UH889AA (route and site of administration not reported) and an unspecified amount of time later, developed tachycardia, fever, chills and weakness. The patient was hospitalized for three days and was an ICU patient. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hypersomnia, Pyrexia
Clinical narrative: Shortness of breath, fever, 1st flu shot. Chills, went to bed early 2 PM and slept long time (15 hours).
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza like illness
Clinical narrative: Headache, under the weather, "flu-like" symptoms. Resolved that night, felt normal next morning.
Age: 38.0
Sex: M
Vaccine: FLUC3
Symptoms: Haemorrhage, Local swelling
Clinical narrative: Pt received flu vaccine on 3NOV13 in the left arm. After administering vaccine, pt's left arm became swollen and bleeding. 5 minutes after, I applied pressure to the area and applied an ice pack to lower the swelling.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Insomnia, Nausea
Clinical narrative: Nausea, sick to stomach had to lay on bathroom floor, never vomited, headache trouble sleeping. Soreness at injection site.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, eryth. (L) upper arm.
Age: 70.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Abdominal pain, Fatigue, Gastrointestinal disorder
Clinical narrative: Patient reported GI symptoms after 2nd dose. Fatigue, ongoing abdominal pain.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Headache, Laboratory test, Paraesthesia
Clinical narrative: Initial report received from a consumer on 25 October 2013. A 40-year-old female patient had received an intradermal dose of FLUZONE ID (lot number: UT4722AA, dose number was not reported) in the left deltoid on 17 October 2013. The patient denied for the illness at the time of vaccination, allergy, birth defect and medical history. On 21 October 2013, 4 days post vaccination; the patient experienced a burning sensation in chest, tingling and heaviness in hands and legs, generalized joint pain and headache. On 22 October 2013 at 2:00 hours, the patient went to hospital ER and was administered MSO4 for pain and a GI cocktail and discharged. That same day patient went to another hospital ER and was administered MSO4 for pain, lab work and an ultrasound and was admitted for 24 hrs. On 23 October 2013, the patient was discharged from hospital. Patient was not provided a diagnosis. At the time of this report, the outcome was unknown. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Ultrasound scan
Clinical narrative: Initial report received from a consumer on 25 October 2013. A 40-year-old female patient had received an intradermal dose of FLUZONE ID (lot number: UT4722AA, dose number was not reported) in the left deltoid on 17 October 2013. The patient denied for the illness at the time of vaccination, allergy, birth defect and medical history. On 21 October 2013, 4 days post vaccination; the patient experienced a burning sensation in chest, tingling and heaviness in hands and legs, generalized joint pain and headache. On 22 October 2013 at 2:00 hours, the patient went to hospital ER and was administered MSO4 for pain and a GI cocktail and discharged. That same day patient went to another hospital ER and was administered MSO4 for pain, lab work and an ultrasound and was admitted for 24 hrs. On 23 October 2013, the patient was discharged from hospital. Patient was not provided a diagnosis. At the time of this report, the outcome was unknown. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Paraesthesia, Paraesthesia oral, Swelling
Clinical narrative: Initial case received from a healthcare professional, (nurse) on 23 October 2013. A 46-year-old female patient received a dose of IMOVAX (lot # H1512-3) into the right deltoid on 23 October 2013. It was reported that the patient received a previous dose of IMOVAX, details not reported. On 20 October 2013, the patient had received both RABIVERT, manufacturer Novartis, lot # 532011A into the left deltoid and RIG, manufacturer and lot number unknown into the bite wound into the hand, dose and route not reported. The patient has a history of allergies to PCN, sulfa, Aceti, clinda, DARVOCET, codeine. The patient had an allergy to a vaccine at work, but did not remember the details. The patient had a history of D/C, IBS, Colitis, Bell's palsy, PTSD and anxiety. The patient experienced on day 3, i.e. on 23 October 2013, tightness in her chest, tingling in her throat and tongue and mild swelling on the right side. The patient was hospitalized, duration not reported, on unreported dates. Vital signs were reported as okay at an unspecified time. The patient's temperature was not taken. The patient concomitant medications were not reported. Treatment details were not reported. Laboratory tests were not reported. The patient outcome was not recovered. No further information was available at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hot flush, Malaise, Nausea
Clinical narrative: Hot flashes, nausea, headache did get sick, headache linger x 1 day took TYLENOL - did help with headache.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Fever and body aches 12 hours after vaccine, persistent until 72 hrs later. 72 hrs later has erythema and warmth in 2 patches near but not adjacent to injection site.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia supraventricular, Tachycardia
Clinical narrative: Initial report was received on 29 October 2013 from a health care professional. An 11 year-old male patient with no past medical history had received an intramuscular injection of FLUZONE, lot number UH889AA (site and date of administration not reported) and two to three days later, was evaluated in the emergency department due to tachycardia. The patient was diagnosed with atrial arrhythmia and hospitalized for two to three days. Relevant diagnostic tests/ laboratory data was unknown. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Vaccine received on Friday 10/25/12 over noon hr. Itching began Sunday evening 10/27/13 and by Monday morning rash/hives appeared. Patient was seen by PCP and was told to take benadryl.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Location of shot (left upper arm) begin to swell to approximately 2 inches. The knot was hard and warm to the touch. The 2nd day I started having body aches, chills and ran a fever of 101.2. I took (2) 200 mg of Ibuprofen. Fever and body aches and chills subsided until 3rd day. The knot was larger and red. I went back to the doctor.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Location of shot (left upper arm) begin to swell to approximately 2 inches. The knot was hard and warm to the touch. The 2nd day I started having body aches, chills and ran a fever of 101.2. I took (2) 200 mg of Ibuprofen. Fever and body aches and chills subsided until 3rd day. The knot was larger and red. I went back to the doctor.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Case received from a consumer, who is also the patient on 28-Oct-2013. A 51-year-old female patient, with no known allergies but on thyroid medication, had received her intramuscular dose of FLUZONE (batch number UH906AA) in the left deltoid, at work, on 18-Sep-2013. It was reported that the patient had already received previous doses of FLUZONE in the past. The vaccine provider was unclear but the vaccination was done as a clinic at work. On 18-Sep-2013, immediately post-vaccination, the patient stated left arm began to hurt at injection site, then spread to the shoulder. She saw a physician at Urgent Care two weeks later for pain. The diagnosis was bursitis. She received corrective therapies with NSAID's. The patient stated she was going back "in a week" for cortisone shots. She also stated the pain woke up at night, it hurt to raise arm to dress and weight of clothing hurt arm. No diagnostic tests/lab data were provided. The patient was not recovered at the time of the report.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Case received from a consumer, who is also the patient on 28-Oct-2013. A 51-year-old female patient, with no known allergies but on thyroid medication, had received her intramuscular dose of FLUZONE (batch number UH906AA) in the left deltoid, at work, on 18-Sep-2013. It was reported that the patient had already received previous doses of FLUZONE in the past. The vaccine provider was unclear but the vaccination was done as a clinic at work. On 18-Sep-2013, immediately post-vaccination, the patient stated left arm began to hurt at injection site, then spread to the shoulder. She saw a physician at Urgent Care two weeks later for pain. The diagnosis was bursitis. She received corrective therapies with NSAID's. The patient stated she was going back "in a week" for cortisone shots. She also stated the pain woke up at night, it hurt to raise arm to dress and weight of clothing hurt arm. No diagnostic tests/lab data were provided. The patient was not recovered at the time of the report.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Pt said shoulder where shot given hurt immensely, was sore and she could hardly lift it over her shoulder, after 2 weeks.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Influenza like illness, Lymphadenopathy, Myalgia, Nasal congestion
Clinical narrative: Chronic stuffed nose, muscle aches, flu like symptoms. This has been going on for about 2 months. Also feels at times that glands are swollen. And some breathing difficulty at time along with chest congestion.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Chronic stuffed nose, muscle aches, flu like symptoms. This has been going on for about 2 months. Also feels at times that glands are swollen. And some breathing difficulty at time along with chest congestion.
Sex: U
Vaccine: UNK
Symptoms: Erythema, Injection site warmth, Local swelling, Pain, Skin warm
Clinical narrative: Very swollen, redness, sore, fever in arm, hot to touch in arm and around the site where injection was given, bump in arm (very large).
Sex: U
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Very swollen, redness, sore, fever in arm, hot to touch in arm and around the site where injection was given, bump in arm (very large).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and difficulty moving her left arm (extreme pain) urgent care prescribe antibiotic x 10 days, Ibuprofen, and narcotic 11/12/13 recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Tenderness
Clinical narrative: Painful injection, escalated pain, inability to move arm - tenderness to touch - improves with rest and escalates if attempts to use arm again. Pain meds used, moist heat. MRI planned for future.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity, X-ray limb
Clinical narrative: Aches in arm; escalated to the point that she was unable to move, or use arm. Extreme pain 10/10; started day 3.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Tenderness the following day, along with redness, swelling, warm to touch.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Two days after administration, site was still the size of a baseball, red and puffy, and very warm to touch. Site is sore and I am unable to lay on that arm without extreme pain.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site pruritus, Local swelling, Skin warm
Clinical narrative: Got flu shot 10-7-13 0730. Upon waking 10-8-13 noticed arm was swollen, red, and warm to the touch. On 10-9-13 arm seemed very itchy at the site of injection.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient complained of sore left arm for last two months. Complaint is ongoing, sounds like a muscle ache type pain. Patient has been to doctor but has had no treatment to date.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Upper right arm extremely sore after flu shot. Soreness lasted for two days and interfered with my ability to lift items, perform tasks with right arm.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Notified by office LVN that manager contacted her regarding employee's description of numbness to face following administration of vaccine. No further information is currently available regarding date of onset, severity etc. The employee did indicate she did not see a physician for lack of insurance benefits. She continues to work at this time. The event was not observed in Occupational Health.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Received above vaccines at approximately 2pm on 11-11-13. Mom reported redness from her toes to hips on both legs at about 5pm on 11-11-13, went to urgent care at 9pm on 11-11-13. Resolution of symptoms by following day. Assessment per urgent care = hives.
Age: 1.01
Sex: U
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Rash
Clinical narrative: Employee states he noted rash the evening after receiving the influenza vaccine. He continues to have it to present day. He had been worked up for various other conditions which he indicates have come back as negative. He is currently being referred to a Dermatologist.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Patient had pre-syncope about 5-7 minutes following flu vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information was received from a pharmacist via a company representative regarding a patient (demographics not provided). On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided). On an unknown date, the patient developed itching following vaccination with ZOSTAVAX. The outcome of the itching following vaccination is unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a Medical Assistant via company representative concerning female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on an unknown date, the patient experienced zoster-like rash after vaccination with ZOSTAVAX. The outcome of patient was unknown. Action taken was not applicable. This is one of two reports concerning the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information was received from a pharmacist via a company representative regarding a 61 year old female patient. "Last week," the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided) immediately after the injection, the patient experienced swelling at the injection site. The outcome of swelling at the injection site was reported as recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of GARDASIL (Lot # J008423, expiration date 21-JAN-2016) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 0-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via representative refers to a 17 year old male patient. On 07-AUG-2012 the patient was vaccinated with his first dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). On 29-JUL-2013 the patient was vaccinated with his second dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). Physician reported that patient received his third dose of GARDASIL (injection, strength, lot#, dose and route were unspecified) "too early", on 08-OCT-2013. HCP planned to give the fourth dose of GARDASIL per CDC protocol. This fourth dose has not occurred yet. Patient had not had any side effects from receiving a third dose early. Patient did not seek medical attention as this was paperwork identified event. No lab diagnostics studies were performed and not treatment was given for the event. Therapy was continued and outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Information was received from a physician concerning a 16 year old male patient. On 05-SEP-2013 the patient was vaccinated with GARDASIL (Lot # J006236, expiration 25-FEB-2016), 0.5 ml, intramuscular. The patient experienced left arm pain after administration of GARDASIL on 05-SEP-2013. "A few days later" the patient developed neck pain. "A few days after that", the patient developed pain in the right arm which then progressed to generalized myalgia and fatigue. The patient was evaluated in the office on 08-OCT-2013. The patient was advised to increase hydration. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a pharmacist via a company representative concerning a patient (demographics unknown). The pharmacist reported that 5 or 6 months ago, the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided). One month later, the patient developed shingles. The outcome of shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of VAQTA (Lot # J003719, expiration date 27-SEP-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 10-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Fungal skin infection
Clinical narrative: Information was received from a physician concerning a 13 year old male patient. On an unknown date, the patient was vaccinated with his first dose of GARDASIL. The physician reported that the patient developed a yeast infection underneath an unspecified arm after his first dose of GARDASIL. No further information was provided. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 4 month old male patient. On 07-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, injection via intramuscular route. Lot number was reported as J009833 and expiry date 25-JAn-2015 instead of PREVNAR13. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from healthcare provider refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of M-M-R II (lot # J002502, expired date 28-FEB-2015). The original reporter is unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 19-AUG-2011 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (Lot number not reported) and on 19-OCT-2011, was vaccinated with the second 0.5 ml dose of GARDASIL intramuscularly (Lot number 671463/1359AA, Exp. Date: 23-JUN-2014). There was no concomitant medication. The physician reported that prior to receive the second dose of GARDASIL on 19-OCT-2011, the patient's urine pregnancy test results were negative. The patient came to the office today on 11-NOV-2011, and she told the physician that she had completed a urine pregnancy test on "09-NOV-2011 or 10-NOV-2011" which became positive. On 11-NOV-2011, at the physician's office, a urine pregnancy test and sonogram were performed which confirmed that the patient was pregnant. The physician stated that the patient believed that she conceived on one of the following dates: 20-OCT-2011, 21-OCT-2011 or 22-OCT-2011. No adverse effects were reported. Information has been received for GARDASIL, a Pregnancy Registry product. The estimated date of deliver was reported as an unknown date in July 2012. The pregnancy outcome was live birth (normal infant with no congenital anomaly). Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information was received from a pharmacist regarding a 56 year old male patient with "cholesterol" and a prior history of shingles. On 26-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J003483 (exp. 29-JUN-2014), subcutaneously in the arm. Concomitant therapies included ZOCOR. On 27-OCT-2013, the patient came back to the pharmacy with a 5mm by 1 inch rash next to the ZOSTAVAX injection site. The outcome of the 5 mm by 1 inch rash next to injection site is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, after the vaccination, the patient experienced an unspecified rash. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was given or if any lab tests were performed. The outcome of unspecific rash was unknown. The relatedness for unspecific rash was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Local swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient. Current conditions of the patient included erythromycin allergy and sulfa allergy. The medical history of the patient included atopic dermatitis approximately on an unknown date in 2013 (unspecified if it was in September or October 2013) (reported as about a month ago), resolved on an unknown date in 2013 (reported as now, exact date unspecified). On 28-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date was reported as J006153 and 30-AUG-2014 respectively,  dose unspecified), subcutaneously in the right arm. Concomitant therapies included SIMVASTATIN TABLETS USP, WELLBUTRIN XL, topical estradiol cream and lorazepam. Approximately on an unknown date in October 2013 (reported as shortly after the administration of vaccine), the patient experienced red, itchy rash around the injection site. The patient sought medical attention (pharmacy call). The pharmacist reported that the rash appeared to be resolving with use of some hydrocortisone cream. ON 01-NOV-2013, the patient was presenting with a red, puffy spot on her right elbow that may or may not be related to the ZOSTAVAX. The relatedness for red, itchy rash around the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a 24 year old female consumer. The patient reported that she was vaccinated with her first dose of GARDASIL at age 16 or 17 and since possibly receiving the initial dose she has received two subsequent doses. Because she cannot confirm the initial dose she may be receiving a final dose within the month. At the time of this report it cannot be confirmed that the doses have been given in correct dosing schedule. No adverse event reported. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 23-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously ("physician recommended") (lot # J010447, expiry date: 22-APR-2014). Concomitant therapies included gabapentin, sertraline hydrochloride and lorazepam. The pharmacist reproted that after the patient received ZOSTAVAX, she developed redness and soreness at the injection site. The patient developed these symptoms shortly after administration of the ZOSTAVAX, when she was still in the pharmacy. No lab tests were performed and no treatment was given for the events. The pharmacist reported that all of the patient's symptoms "subsided within a day". No reporter causality was provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Injection site discharge, Injection site dryness, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 61 year old male patient with no drug allergies. Current conditions included asthma and hypertension. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J1007, expiration date April 2014) subcutaneously. Concomitant therapies included amlodipine and benazepril hydrochloride. On 21-OCT-2013 (within 12 hours after vaccination), patient developed significant localized reaction. Patient presented to the urgent care facility on 24-OCT-2013. The physician assistant reported that the patient's arm in which he received ZOSTAVAX was swollen, non-tender with no associated lymphadenitis. She further reported that at the actual injection site, there was roughened non-vesicular, indurated red tissue with dried serous fluid just from the injection site. She reported that around the site, the arm had an angloedematous type of look. Pharmacist reported that the patient stated that the area is mildly pruritic with some pain. Physician assistant had not treated that patient at the time of this report. No laboratory diagnostic studies were performed. The patient sought medical attention for the events. The events were not resolved. Causality was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Local swelling, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 61 year old male patient with no drug allergies. Current conditions included asthma and hypertension. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J1007, expiration date April 2014) subcutaneously. Concomitant therapies included amlodipine and benazepril hydrochloride. On 21-OCT-2013 (within 12 hours after vaccination), patient developed significant localized reaction. Patient presented to the urgent care facility on 24-OCT-2013. The physician assistant reported that the patient's arm in which he received ZOSTAVAX was swollen, non-tender with no associated lymphadenitis. She further reported that at the actual injection site, there was roughened non-vesicular, indurated red tissue with dried serous fluid just from the injection site. She reported that around the site, the arm had an angloedematous type of look. Pharmacist reported that the patient stated that the area is mildly pruritic with some pain. Physician assistant had not treated that patient at the time of this report. No laboratory diagnostic studies were performed. The patient sought medical attention for the events. The events were not resolved. Causality was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 32 year old female. On 07-OCT-2013, a pregnant patient was vaccinated with GARDASIL (Lot# J002641, expiration 10-DEC-2015), 0.5 ml, intramuscular. The patient was mistakenly administered GARDASIL instead of Hepatitis B vaccine. On 09-OCT-2013, the nurse notified the patient and the patient informed the nurse that she is pregnant. The LMP and EDD was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Gaze palsy, Memory impairment, Muscle rigidity, Posture abnormal
Clinical narrative: 30 seconds after vaccine administered, pt's eyes rolled back and pt slumped down in chair. Then pt became rigid and (R) arm drew into her. This all lasted approx. 45 sec. At some point, pt lost bladder control. When pt came to, she said "Where am I"? She didn't remember anything. BP taken when pt opened eyes 110/64.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence
Clinical narrative: 30 seconds after vaccine administered, pt's eyes rolled back and pt slumped down in chair. Then pt became rigid and (R) arm drew into her. This all lasted approx. 45 sec. At some point, pt lost bladder control. When pt came to, she said "Where am I"? She didn't remember anything. BP taken when pt opened eyes 110/64.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Headache, Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report has been received from a 62 year old female consumer reporting on herself. Patients current conditions included diabetic and heart patient, drug reactions/allergies with nitrofurantoin (furadantin), LORABID, and LEVAQUIN. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, lot# and route not reported). Concomitant therapies included carvedilol (manufacturer unknown), hydrochlorothiazide, lisinopril (manufacturer unknown), PLAVIX, LIPITOR, glipizide ER (manufacturer unknown) and venlafaxine hydrochloride (manufacturer unknown). On 12-OCT-2013, the patient experienced redness, itchiness, stinging and burning all over her arm, her arm became extremely swollen, had a red know at the injection site, her arm felt feverish and developed a headache. It was not given a treatment for the adverse events. The patient did not seek medical attention. There was no laboratories diagnostic test performed. The outcome of the adverse events was not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This spontaneous report has been received from a 62 year old female consumer reporting on herself. Patients current conditions included diabetic and heart patient, drug reactions/allergies with nitrofurantoin (furadantin), LORABID, and LEVAQUIN. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, lot# and route not reported). Concomitant therapies included carvedilol (manufacturer unknown), hydrochlorothiazide, lisinopril (manufacturer unknown), PLAVIX, LIPITOR, glipizide ER (manufacturer unknown) and venlafaxine hydrochloride (manufacturer unknown). On 12-OCT-2013, the patient experienced redness, itchiness, stinging and burning all over her arm, her arm became extremely swollen, had a red know at the injection site, her arm felt feverish and developed a headache. It was not given a treatment for the adverse events. The patient did not seek medical attention. There was no laboratories diagnostic test performed. The outcome of the adverse events was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative, refers to unspecified patients. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot number and expiration date were not reported). No concomitant medications were reported. On an unknown dates, the patients experienced approximately four-inch ring or red spot around the injection site that occurred one to two days, after patients received ZOSTAVAX. The pharmacist had told patients to use BENADRYL and to follow-up with physician if no improvement. The patient sought medical attention via calling a pharmacist. Outcome and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 54 years old male patient. The patient medical history included shingles approximately in 1965 (reported as when the patient was 27 years old). On 15-JAN-2013 the patient was vaccinated with ZOSTAVAX subcutaneously, 0.65 ml dose, lot # H018798, expiration date: 15-JAN-2014. Concomitant therapies included NAPROSYN. Two or three days after vaccination in January 2013 the patient developed a rash at the injection site that was noted as red, small, blotchy and raised. He also developed slight itching at the injection site a day later than rash in January 2013. No lab diagnostic studies were performed and there was no treatment given for the patient's adverse events. The patient did not seek medical attention. On an unspecified date in January 2013 (reported as within a week) the patient recovered from his adverse events. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 54 years old male patient. The patient medical history included shingles approximately in 1965 (reported as when the patient was 27 years old). On 15-JAN-2013 the patient was vaccinated with ZOSTAVAX subcutaneously, 0.65 ml dose, lot # H018798, expiration date: 15-JAN-2014. Concomitant therapies included NAPROSYN. Two or three days after vaccination in January 2013 the patient developed a rash at the injection site that was noted as red, small, blotchy and raised. He also developed slight itching at the injection site a day later than rash in January 2013. No lab diagnostic studies were performed and there was no treatment given for the patient's adverse events. The patient did not seek medical attention. On an unspecified date in January 2013 (reported as within a week) the patient recovered from his adverse events. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 25 year old female patient. On an unknown date in April 2013 ("six months ago") the patient was vaccinated with a dose of VARIVAX (Merck), dose, frequency and route unspecified, a month prior to the patient being diagnosed as being pregnant on an unknown date in May 2013. The patient had become pregnant for 5 months (LMP: May 2013, EDD: March 2014). The pregnancy outcome was pending. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Myalgia, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old female patient with no known allergies. On 18-OCT-2013 (ten days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006153, expiration date 30-AUG-2014) intramuscular opposed to the subcutaneous route in the arm (dose unknown). Concomitant therapies included WELLBUTRIN. The physician stated that the patient was experiencing severe pain in the unspecified arm and neck in which the vaccine was administered in October 2013. There was no redness or swelling just pain, "like nerve/muscle ache". The patient visited the physician and was treated for the event with unspecified anti-inflammatory on an unknown date. The patient was not recovered at the time of reporting. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Pt stated.