chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of a year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI)) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Inflammation, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of a year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI)) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of a year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI)) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This spontaneous report was received from a 57 year old non-pregnant female patient with no pertinent medical history and drug reactions or allergies, who was reporting on herself. The patient stated that she had no health issues prior to the vaccine. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU), 1 dose, intramuscularly (lot # H013023, expiration date October 2016). There was no concomitant medication taken. On an unknown date (reported as "2-3 weeks after the injection"), the patient began experiencing numbness and tingling in her feet. It was mild initially, however over the course of a year, it progressively got worse and spread throughout the entire leg. She stated that she sought medical attention from several doctors and specialists and had gotten "every possible test" (including magnetic resonance imaging (MRI)) completed on unknown dates (results were not provided). The patient went to see a rheumatologist that diagnosed her with autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The physician told her that this was caused by the aluminum adjuvant contained in the vaccine. The patient received an unspecified treatment of the adverse event. The outcome of the adverse events was reported as not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided by the reporter. Upon internal review, the adverse event of autoimmune disorder was considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Chills, Eye swelling, Fatigue, Pyrexia
Clinical narrative: Teen visited office on 11/8/16 for well visit. Received flu vaccine and men B (TRUMENBA). Several hours later eyes became swollen esp. RT. eye, high fever, chills, fatigue and throat irritation. Mother gave CLARITIN P.O. for possible allergy. Fever persisted 3 days, fatigue 4 days (TYLENOL). Teen missed 3 days of school.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Activities of daily living impaired, Chills, Eye swelling, Fatigue, Pyrexia
Clinical narrative: Teen visited office on 11/8/16 for well visit. Received flu vaccine and men B (TRUMENBA). Several hours later eyes became swollen esp. RT. eye, high fever, chills, fatigue and throat irritation. Mother gave CLARITIN P.O. for possible allergy. Fever persisted 3 days, fatigue 4 days (TYLENOL). Teen missed 3 days of school.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Throat irritation
Clinical narrative: Teen visited office on 11/8/16 for well visit. Received flu vaccine and men B (TRUMENBA). Several hours later eyes became swollen esp. RT. eye, high fever, chills, fatigue and throat irritation. Mother gave CLARITIN P.O. for possible allergy. Fever persisted 3 days, fatigue 4 days (TYLENOL). Teen missed 3 days of school.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB, FLU4, MENB
Symptoms: Eye swelling, Fatigue, Pyrexia, Throat irritation
Clinical narrative: Teen visited office on 11/8/16 for well visit. Received flu vaccine and men B (TRUMENBA). Several hours later eyes became swollen esp. RT. eye, high fever, chills, fatigue and throat irritation. Mother gave CLARITIN P.O. for possible allergy. Fever persisted 3 days, fatigue 4 days (TYLENOL). Teen missed 3 days of school.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash
Clinical narrative: SHINGLES- SEVERE PAIN IN HIP AND LEG.  FOLLOWED RASH 3-4 WEEKS PREVIOUS.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 18 November 2016. This case involves a 32-years-old of male patient who was vaccinated with a dose of Fluzone QIV intramuscularly (Batch number: UI684AA, expiration date of product: 30-JUN-2017, dose, dose in series were not reported) in right deltoid on 24 October 2016 and with HEP A intramuscularly (Batch number: L02773, expiration date of product, dose, dose in series were not reported) in left deltoid on 04 November 2016. The reporter denied the patient having any illness at time of vaccination. Patient's medical history included asthma and abdominal hernia. Concomitant medications were not reported. On an unknown day, unspecified timeframe following the vaccinations, the patient had developed Guillain-Barre syndrome (GBS) and numbness in both legs. Numbness in both legs occurred sometime after the 4th of November and it progressed for 2 days post onset of symptoms. The patient was hospitalized on an unknown day and discharged after 7 days. The patient required doctor visit for follow up on 18 November 2016. Laboratory investigations were reported as unknown. Corrective treatment included phenergan for nausea and occupational, physical and speech therapy. The outcome of events was reported as unknown. List of documents held by sender: none. Sender's Comments: GBS was suspected in this cases after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and HEPATITIS A VACCINE, however diagnosis was not confirmed. Time to onset (Approximately 11-12 days post INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED) is compatible with a role of the vaccine. To be noted that GBS is often preceded by an gastrointestinal or respiratory infection which was not ruled out in this case. Details regarding infectious work-up and information on infections occurring prior to vaccination are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Age: 52.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Swelling face
Clinical narrative: This is an initial report of an AE, received on 18Nov2016, for Protein Sciences Flublok. A 52 year old female received Flublok Intramuscular on 11Nov2016. On 11Nov2016, the same day after receiving Flublok, the subject began experiencing an adverse reaction which included redness and erythema to the arm and face, as well as redness and swelling to the face. The patient reported these symptoms to the reporter on Monday 14Nov2016, by then, the symptoms were subsiding. The reporter would like to be contacted regarding this case so as to further advise the patient on subsequent use of this vaccination and other influenza vaccine. No further details were available. At the time of the report, the events of redness and erythema to the arm and face, as well as redness and swelling to the face were resolving. Medical or surgical history for the subject included an egg allergy. Concomitant medications were not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Bone pain, Fatigue, Pain
Clinical narrative: This spontaneous report as received via a company representative from a physician's receptionist referring to her 13 year old daughter. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose were unknown) or GARDASIL 9 (lot #, expiration date and dose were unknown) intramuscularly, at the clinic by an unspecified physician. The reporter was unable to confirm which one the vaccine the patient received. On unknown dates, the patient experienced fatigue, bone pain and body aches. On an unknown date, the patient was treated at a hospital by another physician. The outcome of the events was reported as recovered (dates unknown). The reporter did not assess the causality. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as Registered Nurse - R.N.) refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in 2013, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot#, and expiration date were not provided). On an unknown date, after he/she received the ZOSTAVAX, the patient experienced neuropathy or an autoimmune disease. There was no product quality complaint involved. The outcome of neuropathy or an autoimmune disease and the relatedness between the adverse events and ZOSTAVAX were not reported. Upon internal review, the adverse event of autoimmune disease was considered to be medically significant. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Decreased appetite, Fatigue, Myalgia, Nausea
Clinical narrative: Extreme muscle and body aches, fatigue, nausea, loss of appetite, fevers every four hours, coughs, sore throat. Only took TYLENOL for fevers.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Extreme muscle and body aches, fatigue, nausea, loss of appetite, fevers every four hours, coughs, sore throat. Only took TYLENOL for fevers.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever and rash covering torso and neck that is still spreading to other parts of the body.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling at injection site, about 3 inches across and 1/2 inch wide, with rash nearby. Very warm to touch. Pain in arm and neck near site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain
Clinical narrative: Red swelling at injection site, about 3 inches across and 1/2 inch wide, with rash nearby. Very warm to touch. Pain in arm and neck near site.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Blood test, Burning sensation, Hypoaesthesia, Lumbar puncture
Clinical narrative: Burning, tingling, numbness on hands and feet, loss of balance.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Burning, tingling, numbness on hands and feet, loss of balance.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt is having arm pain, can't raise arm fully - still having problem on 11/23/16 per husband.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site reaction. Red, itchy area surrounding injection site.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Loss of consciousness, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Passed out. muscle weakness/numbness left arm, stiff neck .
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Urticaria
Clinical narrative: Nausea started the day of the injection. Hives on the arm that she received the vaccine started the day after the injection.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Rash macular, Skin warm
Clinical narrative: FELT ITCHY, WARM, LARGE CIRCULAR BLOTCHES STARTED ON ARMS AND LEGS AND THEN EXTENDED TO CHEST AND NECK RASH PERSISTED UNTIL 11/22.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Pt said she felt faint, lightheaded. Had her lie down with legs elevated. Stated she felt better and requested a bottle of water which was provided. Pt refused any other treatment.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Mobility decreased, Pyrexia, Vaccination site pain
Clinical narrative: Had difficulty getting up, redness and soreness on vaccination site, slight fevere for 2 days. Given an ice pack today 11/25/16 and advised to take Benadryl.
Age: 11.0
Sex: F
Vaccine: MENB, TDAP, MENB, TDAP
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: Patient received Men B vaccine in her RA and was suppose to received MENVEO.  I adv mom or error on 11/18/2016. I reported error to the manufacturer. Mom said her arm was very sore at the time and I spoke with mom again today 11/25/2016 and she said she is still extremely sore.
Age: 11.0
Sex: F
Vaccine: MENB, TDAP, MENB, TDAP
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: Patient received Men B vaccine in her RA and was suppose to received MENVEO.  I adv mom or error on 11/18/2016. I reported error to the manufacturer. Mom said her arm was very sore at the time and I spoke with mom again today 11/25/2016 and she said she is still extremely sore.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: Pt states bruising starting day after vaccine and still bruised as of this report.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site paraesthesia, Injection site vesicles, Rash
Clinical narrative: Rash on right forearm, small blisters on right shoulder (area the size of a 1/2 dollar), tingling in her right shoulder. Pt reported this to us on 11/25/2016 at 12:13. She then went to urgent care and was diagnosed with having shingles. Pt was given a 7 day course of valacyclovir.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Muscular weakness, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient received a ZOSTAVAX vaccine and is reporting that his entire arm, shoulder and part of his neck is sore and his arm feels week. Patient is contacting his physician.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Fibromyalgia, Imaging procedure, Lethargy, Myalgia
Clinical narrative: Severe muscular pain, body aches, lethargy, tingling in hands and feet. All of these symptoms came on suddenly within one weekend, symptoms have persisted. Rheumatologist diagnosed atypical fibromyalgia from this event. Neurologist suspects flu vaccine adverse reaction. No family history of fibromyalgia.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies, Pain, Paraesthesia, Vaccination complication
Clinical narrative: Severe muscular pain, body aches, lethargy, tingling in hands and feet. All of these symptoms came on suddenly within one weekend, symptoms have persisted. Rheumatologist diagnosed atypical fibromyalgia from this event. Neurologist suspects flu vaccine adverse reaction. No family history of fibromyalgia.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: The patient has described a shooting pain down his arm causing numbness.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient states weakness and slight pain in injection side arm.  Patient states can not lift arm as high as before vaccine.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Day1 moderate redness, soreness, heat at injection site immediately. moderate swelling and hardness in 2-3 inch diameter at injection site within hours. Day 2 continued symptoms, not increasing or decreasing. Day 3 continued symptoms, not increasing or decreasing. Day 4 soreness subsided to mild, hardness subsided to mild.  redness increased to 4 inch diameter and itchy.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Day1 moderate redness, soreness, heat at injection site immediately. moderate swelling and hardness in 2-3 inch diameter at injection site within hours. Day 2 continued symptoms, not increasing or decreasing. Day 3 continued symptoms, not increasing or decreasing. Day 4 soreness subsided to mild, hardness subsided to mild.  redness increased to 4 inch diameter and itchy.
Age: 11.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Localized rash to bilateral upper arms, non infected, non erythematous, did not worsen over the course of 1 month time period. Non systemic.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness around inside of left arm starting just below vaccine administration site and moving inside worsening over previous 24 h.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Sleepy/sore arm/low grade fever/headache/ swelling/redness 2/3 from injection site in shoulder towards elbow.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Somnolence
Clinical narrative: Sleepy/sore arm/low grade fever/headache/ swelling/redness 2/3 from injection site in shoulder towards elbow.
Age: 93.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Mobility decreased
Clinical narrative: Extreme weakness, difficult to get up from couch, difficulty getting up to use bathroom, unable to change clothes on own, very weak. Parents were unable to get through to doctor's office that administered vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site pain, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: Severe pain at injection site, muscle aches and pain, joint pain all over body, Fever, red spots over body.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash generalised
Clinical narrative: Severe pain at injection site, muscle aches and pain, joint pain all over body, Fever, red spots over body.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Myalgia, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, fever, sore throat and muscle aches.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient describes injection site as constantly itching. Was swollen at first but site continues to itch from admin date to today, 11/25/16.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity, X-ray
Clinical narrative: Severe pain and loss of movement in right arm, swelling in shoulder, ongoing since 11/17/2016. Ice and rest, pain medication, not working.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Patient's medical history and current conditions were not reported. Approximately in 2014 (reported as two and half years ago), the patient was vaccinated with subcutaneous ZOSTAVAX 19400 PFU (lot # and expiry date not reported). Concomitant medications were not reported. Approximately in August 2016 (reported as 3 months ago), the patient developed shingles, rash and blisters. The patient received an unspecified treatment for the events. The patient reported that he had a negative reaction to the medicine prescribed for treatment by his physician and was hospitalized (date, brand, manufacturer, and hospital unspecified). On an unspecified date in 2016, the patient recovered. Causality assessment was not provided. No product quality complaint was involved. The patient had called to ask question about re-vaccination, and not to report an AE. Additional information is not expected since no patient demographic and no physician demographic information was provided.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient received shot (flu) on 11-14-2016. His left arm has been extremely sore since that time. He has been unable to lift his arm. He also had some fever for a couple of days after the shot.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Condition aggravated, Pharyngitis streptococcal
Clinical narrative: Pt was seen 2-16-16 for strep throat, returned 2-19-16 because she was feeling it worse. HPV was given 2-16-16, with no fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting post vaccination for 2 weeks.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Urticaria
Clinical narrative: 12cm x 12cm hive on the left arm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood potassium decreased, Blood sodium decreased, Dizziness, Guillain-Barre syndrome
Clinical narrative: Weakness, dizziness, lightheadedness. Na level 127. K level 3.4. Sodium dropped to critical level 111. Treated with IVIG 20 gm, 200 mL IV daily for Guillain-Barre syndrome.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy
Clinical narrative: Weakness, dizziness, lightheadedness. Na level 127. K level 3.4. Sodium dropped to critical level 111. Treated with IVIG 20 gm, 200 mL IV daily for Guillain-Barre syndrome.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pityriasis rosea, Pruritus, Rash, Skin lesion
Clinical narrative: HPI: Mother called last night. She said that child developed Mother reports he has rashes on lower back and legs. She noticed the rash yesterday morning at around 8 am. She reports that BENADRYL (4ml) has helped slightly. ROS: Reports itchiness. Denies fever. Denies swelling or pain at injection site (left deltoid). Denies vomiting, nausea, and diarrhea. No eruption near injection site. PE: Well-appearing well-hydrated patient in NAD. 3 cm x 6 cm ovoid red lesion on posterior lateral left thigh. Partially blanching with slightly raised border but not scaly. Proximal lower extremities and lower trunk have scattered red, ovoid lesions. Lesions are blanching, slightly raised, and 6x9 mm to 1.2 cm in longest dimension. These are not obviously aligned with Blaschko's lines. A/P: Pityriasis rosea (L42): Red ovoid, slightly raised lesions on trunk and lower extremities. Herald lesion on lateral left thigh indicates rash is possibly pityriasis rosea. Adverse reaction caused by viral vaccines. Can't ignore the coincidental timing. But also can't find a report of Pityriasis Rosea associated with flu vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Hypoaesthesia oral, Lip swelling, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Lip swelling, tingling, numbness, tongue throat tightness, hives, within 10 min. Chest tightness over next 12 hours intermittent hives. In evening-fasciculation BLE calves and thighs.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria
Clinical narrative: Lip swelling, tingling, numbness, tongue throat tightness, hives, within 10 min. Chest tightness over next 12 hours intermittent hives. In evening-fasciculation BLE calves and thighs.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody positive, Arthralgia, C-reactive protein increased, Inflammation, Joint swelling
Clinical narrative: Joint pain/swelling, mild fever, the inflammations last 2 days then move to another area. Blood work shows positive ANA, ESR elevated, CRP elevated. ED visit 10/21/16, PMD 10/28/16, PMD 11/1/16, ED visit 11/3/16, 11/1/16 Chiropractor, 12/6/16 Rheumatologist scheduled.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Joint pain/swelling, mild fever, the inflammations last 2 days then move to another area. Blood work shows positive ANA, ESR elevated, CRP elevated. ED visit 10/21/16, PMD 10/28/16, PMD 11/1/16, ED visit 11/3/16, 11/1/16 Chiropractor, 12/6/16 Rheumatologist scheduled.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Laboratory test normal, Rash, Urticaria
Clinical narrative: Grandmother reported SX. after flu vaccine given on 11/18/16. On 11/20 pm - to urgent care facility. Denies pt. being allergic to eggs prior and had vaccine x 3 yr. before. SX reported were "whelps" "rash" to affected arm w/redness to injection site/rash to arms/thighs/ankles and hands. Had cortisone IM at facility plus RX x 5 more days orally given.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Received flu vaccination on 9/23/16 at 4:45 pm. Left arm became sore and unmovable for the next two days. Any movement caused severe pain and was unable to attend work that weekend. Treatment consisted of two rounds of Prednisone and four FLECTOR patches to no avail.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Skin warm, Tenderness, Urticaria
Clinical narrative: 11/14 Meningococcal vaccination given. 11/15 hives, gone that evening, BENADRYL had been given. 11/17 noticed erythema, tenderness and warmth. 11/18 pus expressed, seen and placed on KEFLEX.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Blindness, Nausea, Pain
Clinical narrative: Weakness, nausea, body aches, loss of vision the evening of the vaccine. Took a nap and SX went away.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Fever, hives, myalgias, swelling, pain redness.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Fever, hives, myalgias, swelling, pain redness.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: Fever to 102.7 degrees F and headache overnight after vaccination. By morning she was feeling better and temperature was down to 100.1 degrees F.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site joint pain, Injection site mass, Injection site pain
Clinical narrative: Severe pain at inj. site could not life my arm. Hard lumps, muscle and joint pain - had occupational therapy for two months before the pain began to subside.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called pharmacy to ask about side effects of vaccine. Pt. reports fever, chills, headache; also at site of injection, muscle soreness, swelling, warm to touch. Pt. referred to doctor. Pt. given BENADRYL and prednisone.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient called pharmacy to ask about side effects of vaccine. Pt. reports fever, chills, headache; also at site of injection, muscle soreness, swelling, warm to touch. Pt. referred to doctor. Pt. given BENADRYL and prednisone.
Age: 1.58
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Cardiac monitoring, Chest X-ray, Computerised tomogram head, Laboratory test, Seizure
Clinical narrative: Seizure w/no fever, observation, Neuro referral.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Feeling cold, Tremor
Clinical narrative: After receiving: FLUZONE HIGH DOSE 2016-17 syr; I was fine until 5:00/p; when I got cold, shaking, teeth chattering, and sick at stomach through-out night! Temp. ?
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Dull and achy for the first 2-3 days. Pain with adduction and moving arm overhead since. Icing and light stretching.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Complete shoulder and join pain one month so far.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient receive FLUZONE HD and said her arm was extra sore. She said that it's been going on from 11/1/16 through today,  11/19/16. She spoke to her doctor and he wasn't sure what was causing it. I asked patient if she would like us to contact doctor and she said no.
Age: 22.0
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm was very sore - went to physician one time -> on 11/14/16 - started soreness -> on 10/31/10. She feels was given into tricep muscle.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Flushing
Clinical narrative: After receiving High Dflu vaccine pt had taste in her mouth flushing on face and neck ache down her neck toward her back, within 15 mins felt better by 350PM. BP was 122/62 with SX symptoms. Never had problem with "flu shot" previously. No problem with PNEUMOVAX given 1st.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Vaccine administered at about 6:30. Pt came in store at 10:30 and bought BENADRYL, then went to ER at about 1am.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness tingling in injection arm. Involving fingers - no visible injection site reaction.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Pain
Clinical narrative: For first round of vax in ER, severe hypersensitivity developed 3 hrs after shots. For 2nd booster, no reactions developed. For 3rd booster extreme hypersensitivity developed 9 hrs after vax was given. Over the counter NSAIDs made pain bearable, but did not eliminate it. Last vax scheduled for Dec. 1st.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Eye movement disorder, Seizure
Clinical narrative: Patient had a possible seizure within seconds of receiving the flu vaccine. He started to slump down, eyes rolled back, and convulsed. Seizure lasted approximately 10 seconds and then he came to. We gave him water, a candy bar and told him to rest. He left w/his dad after 30 min.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm swollen and red, itching, and pain at injection site since Inj. 3 days ago.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: Patient presented to pharmacy at 7:00 pm complaining of soreness in left arm. Small (quarter sized) red patch at site of injection. Having difficulty lifting arm. Patient said she was an asthmatic and she need to use Albuterol inhaler today.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Purple bruising at injection site.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Patient was seen at clinic on the morning of 11/17/16 and was ordered a regular flu vaccine and PCV13. However, he received a high dose flu vaccine. Patient and spouse called primary care clinic around 2:30PM to report a reaction to the flu vaccine including bloodshot eyes, sore throat, and other symptoms included above. He confirmed that he had had a reaction two years ago to the high dose vaccine. He was advised to go to the ER, but he stated that he felt okay and did not need to go. Symptoms had subsided in the afternoon.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's medical history included vaccination with a dose of PREVNAR on an unknown date in November 2015 (reported as 1 year ago). Her vaccinated arm got sore an unspecified time after receiving PREVNAR. The patient did not have any other pertinent medical history and drug reactions or allergies. On 09-NOV-2016, the patient was intramuscularly vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection, in an unspecified arm, lot # M022086, expiration date 09-OCT_2017 (frequency reported as "once") (reported as "she needed the second dose of pneumonia vaccine"). The patient's concomitant medications were not reported. On 09-NOV-2016 (also reported "later that afternoon"), the patient called the pharmacy stating that the whole arm where she received PNEUMOVAX 23 hurt and the PNEUMOVAX 23 injection site was sore (no further clarifying information was provided). On 15-NOV-2016 (also reported as today), the patient called the pharmacist and stated that she took oxycodone and ibuprofen "as treatment for the reaction". At the time of reporting, the patient's arm pain improved but the injection site was still sore "to the point where she could not lift her arm to wash her hair or drive a car". The outcome of PNEUMOVAX 23 injection site soreness was considered to be not recovered, while the outcome of arm pain was considered to be recovering/resolving. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's medical history included vaccination with a dose of PREVNAR on an unknown date in November 2015 (reported as 1 year ago). Her vaccinated arm got sore an unspecified time after receiving PREVNAR. The patient did not have any other pertinent medical history and drug reactions or allergies. On 09-NOV-2016, the patient was intramuscularly vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection, in an unspecified arm, lot # M022086, expiration date 09-OCT_2017 (frequency reported as "once") (reported as "she needed the second dose of pneumonia vaccine"). The patient's concomitant medications were not reported. On 09-NOV-2016 (also reported "later that afternoon"), the patient called the pharmacy stating that the whole arm where she received PNEUMOVAX 23 hurt and the PNEUMOVAX 23 injection site was sore (no further clarifying information was provided). On 15-NOV-2016 (also reported as today), the patient called the pharmacist and stated that she took oxycodone and ibuprofen "as treatment for the reaction". At the time of reporting, the patient's arm pain improved but the injection site was still sore "to the point where she could not lift her arm to wash her hair or drive a car". The outcome of PNEUMOVAX 23 injection site soreness was considered to be not recovered, while the outcome of arm pain was considered to be recovering/resolving. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M018767 (expiration date 01-FEB-2017) and lot # M022531 (expiration date 23-FEB-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (route, frequency, batch/lot number, expiration date were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). 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: Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334 and expiration date 05-OCT-2017, (strength, dose and anatomical location were not provided) subcutaneous. No adverse effects were reported. Data logger was involved. It was reported that there were no previous excursions. The temperature of the reported excursion was 24 Celsius (C) for a time frame of 72 hours. 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: Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. Concomitant therapies were not informed. On an unknown dates, from 01-JUL-2016 through 02-OCT-2016, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # L017406, expiration date 26-FEB-2017, (dosages and therapy routes were not provided), using sterile diluent/vaccines (unknown dosage, lot M013638 expiration date: 19-NOV-2018 and M017521 expiration date: 12-OCT-2018). No adverse effects were reported. Not product quality complaint (PQC) was involved. The minimum temperature reported was of 0.09 degrees Celsius. No previous temperature excursions or digital data logger were involved. There was no a previous temperature excursion or call because of a data logger. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site nodule, Injection site warmth
Clinical narrative: Information has been received from a medical assistant via a company employee referring to a 14 years old female patient. The patient's medical history and concurrent condition were not reported. Concomitant therapies included ABILIFY, VYNASE and RETIN A. On 20-JUL-2016, the patient was vaccinated GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route not reported). On 17-AUG-2016, the patient returned to the office and complained about a knot and a bruise at the injection site that was warm to touch beginning on an unspecified date in 2016 after receiving GARDASIL 9. No treatment was given for the events. The knot lasted a couple of weeks. The outcome of the events was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This solicited report refers was received from a patient's relative, as part of a Market Research, and refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose number, dosage, route of administration, lot number and expiry date not reported). On an unknown date, the patient had "serious" side effects from the vaccine (adverse event). The outcome of adverse event was unknown. The reporter considered the adverse event to be related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. Concomitant therapies were not informed. On an unknown dates from 01-JUL-2016 through 02-OCT-2016, the patients were administered improperly stored doses of RECOMBIVAX HB lots # M039201 and M027339 with expiration dates 04-NOV-2018 and 31-MAY-2018 respectively, (dosages and therapy routes were not provided). (unknown dosage, lot # M013638 expiration date: 19-NOV-2018 and M017521 expiration date: 12-OCT-2018). No adverse effects were reported. No product quality complaint (PQC) was involved. The minimum temperature reported was of 0.09 Celsius. No previous temperature excursions or digital data logger. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M033096 (expiration date 31-MAY-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lot # M020103, expiration date 15-FEB-2018, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 48.2F. Time frame: 61.75 hours. There was a call because of a data logger. There was not a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 or GARDASIL (name and lot number were not provided); and 2 years later on an unspecified date, the patient was vaccinated with a second dose of GARDASIL 9 or GARDASIL (lot number were not provided). It was unknown which of the mentioned vaccines was administrated. No adverse event and no product quality complaint (PQC) were reported. Additional information is not expected because the reporter did not access to be contacted.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of soreness to the point she couldn't lift her arm. She did see doctor but they told her that she should put heat on it.