chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Systemic lupus erythematosus, Weight decreased
Clinical narrative: First signs of lupus started to appear. Rash on my face, loss of appetite, weight loss, fatigue, inflammation, pericarditis.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flucelvax was administered to a 17 years old. No adverse reactions noted.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Type III immune complex mediated reaction
Clinical narrative: Received new intradermal flu vaccine at clinic for the first time. Went to private doctor after the second day.  Red raised and painful patch from mid arm to elbow size of grapefruit. Arthus Reaction. I have had flu shots each year for past 7 years including H1N1 a few years ago.  Never had an intradermal flu vaccine before and never this bad a reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Nausea, Pyrexia
Clinical narrative: Mother describes swollen arm from deltoid to elbow, redness, fever to 101.2, nausea, swollen cheeks. Unable to move left arm for 3-4 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Mother describes swollen arm from deltoid to elbow, redness, fever to 101.2, nausea, swollen cheeks. Unable to move left arm for 3-4 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy bone marrow, Blood test, Differential white blood cell count, Full blood count, Idiopathic thrombocytopenic purpura
Clinical narrative: Thrombocytopenia - platelet count of 30,000. Diagnosis: Idiopathic Thrombocytopenia Purpura
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Ultrasound liver
Clinical narrative: Thrombocytopenia - platelet count of 30,000. Diagnosis: Idiopathic Thrombocytopenia Purpura
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Had a patient that after receiving the Fluvirin vaccine experience a "Funny, weird taste" (as she described). She came back to the pharmacy 30 minutes later and said she feel it two more times but then stopped, no any other symptom. I called Novartis same day and they call back is a side effect not listed but a possible side effect and is being reported before. They reported and told me if happening again they want me to let them know.
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: Pt was given a Kinrix injection instead of Pediarix at 2 month well.
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given a Kinrix injection instead of Pediarix at 2 month well.
Age: 27.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood test normal, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: I always received the flu vaccine.  The first year the H1N1 flu vaccine was included in the seasonal flu shot,  I had a horrible reaction.  I went pharmacy to get the flu vaccine and within 20 minutes of having received the vaccine, I almost fainted, had shortness of breath, dizziness, my legs were incredibly heavy like bricks and I could hardly walk and I was so beyond tired.  I had a headache too.  The following symptoms lasted about 3-4 months: extremely tired, had the horrible heavy legs (walking was hard), and a headache. I was a bit dizzy on and off to.  I went to doctors and urgent care where they checked my thyroid, blood, etc. and nothing was found.  I am too afraid to get another flu vaccine even though my parents want me to since there are young adults dying from the flu.  This is the first time reporting my reaction to the H1N1 seasonal flu vaccine.  I am not allergic to eggs.  I don't recall the specific date I received the vaccine but know it was early in the flu season in September or Oct.
Age: 27.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Presyncope, Sensation of heaviness, Thyroid function test normal
Clinical narrative: I always received the flu vaccine.  The first year the H1N1 flu vaccine was included in the seasonal flu shot,  I had a horrible reaction.  I went pharmacy to get the flu vaccine and within 20 minutes of having received the vaccine, I almost fainted, had shortness of breath, dizziness, my legs were incredibly heavy like bricks and I could hardly walk and I was so beyond tired.  I had a headache too.  The following symptoms lasted about 3-4 months: extremely tired, had the horrible heavy legs (walking was hard), and a headache. I was a bit dizzy on and off to.  I went to doctors and urgent care where they checked my thyroid, blood, etc. and nothing was found.  I am too afraid to get another flu vaccine even though my parents want me to since there are young adults dying from the flu.  This is the first time reporting my reaction to the H1N1 seasonal flu vaccine.  I am not allergic to eggs.  I don't recall the specific date I received the vaccine but know it was early in the flu season in September or Oct.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Dry mouth, Dry skin, Fatigue, Headache
Clinical narrative: Lip swelling, numbness of lips, fevered, hot itching rash when scratched leading to welts. Lower leg pain with swelling and severe cramping. Joint pain, weakness in legs and arms, dry mouth, constant headache, dryness of skin, night sweats and high blood pressure. Extreme fatigue. I went to the doctor and was put on a steroid.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Hypertension, Hypoaesthesia oral, Lip swelling, Local swelling, Muscle spasms
Clinical narrative: Lip swelling, numbness of lips, fevered, hot itching rash when scratched leading to welts. Lower leg pain with swelling and severe cramping. Joint pain, weakness in legs and arms, dry mouth, constant headache, dryness of skin, night sweats and high blood pressure. Extreme fatigue. I went to the doctor and was put on a steroid.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Muscular weakness, Night sweats, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Lip swelling, numbness of lips, fevered, hot itching rash when scratched leading to welts. Lower leg pain with swelling and severe cramping. Joint pain, weakness in legs and arms, dry mouth, constant headache, dryness of skin, night sweats and high blood pressure. Extreme fatigue. I went to the doctor and was put on a steroid.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Skin warm, Urticaria
Clinical narrative: Lip swelling, numbness of lips, fevered, hot itching rash when scratched leading to welts. Lower leg pain with swelling and severe cramping. Joint pain, weakness in legs and arms, dry mouth, constant headache, dryness of skin, night sweats and high blood pressure. Extreme fatigue. I went to the doctor and was put on a steroid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Influenza A virus test negative, Influenza virus test negative, Malaise, Pyrexia, Streptococcus test negative
Clinical narrative: Mother brought child to office this morning stating child woke up not feeling well. Elevated temp noted on triage of 102.7. Strep negative, Rapid Flu negative. Sister ill also with low grade temp. Fever up to 103.6 after Motrin but down to 102.1 after additional Tylenol tx.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Headache, Hypersensitivity, Oesophageal ulcer
Clinical narrative: Swelling in throat, can't breathe, heart racing, etc.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Palpitations, Pharyngeal oedema, Throat tightness
Clinical narrative: Swelling in throat, can't breathe, heart racing, etc.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient's left injection site was swollen and hard.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram normal, Heart rate increased, Oxygen saturation decreased, Scan normal
Clinical narrative: Seizure, increased heart rate, low oxygen levels.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PPV, UNK
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: She broke out in bumps from head to toe. It looked like she had the measles.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Glaucoma, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 13 year old female patient developed uveitis, glaucoma and blindness, following administration of GARDASIL. The patient had as a pre-existing conditions arthralgia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 210 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Endometriosis, Precancerous cells present, Smear cervix
Clinical narrative: This spontaneous report as received from a consumer refers to her currently 24 year old daughter with "seecor" and amoxicillin allergy. On 07-NOV-2006, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided). On 15-JAN-2007, the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route not provided) and on 17-MAY-2007, she received the third dose of GARDASIL (lot#, dose and route not provided). It was reported that the patient received all three doses of GARDASIL, beginning at age 17. The consumer reported that her daughter had experienced "questionable" and "inconclusive" pap smears "for the past several years", she had annual pap smears. She noted that her daughter's physician was planning to begin treating her daughter for "pre-cancer" if the next pap smear came back as "inconclusive". The consumer also added that her daughter also experienced endometriosis, but she had a successful pregnancy and delivery and currently was the mother of a four-year old daughter. The consumer expressed concern regarding the recent recall of GARDASIL and inquired if the recalled lot could had affected her daughter. The patient was not given any treatment for the events. The patient sought medical attention. At the time of the report, the outcome of the pre-cancer and endometriosis was unknown. Upon internal review, pre-cancer was considered as medically significant. This is one of two reports received from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site nodule, Lymphadenopathy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt states her (L) arm began to get sore Fri pm 1/10/14 after receiving her flu shot and since then has moved up to her shoulder and chest. Additional to this soreness, there seems to be a "knot" on the anterior of (L) shoulder. No fever or other sx's. Pt recommended to seek MD care ASAP. Pt went to MD on 1/15. MD said it is just swollen lymph nodes. MD said to take ADVIL and put heat on it. MD said no follow up - I advised her to follow up if remains callus if she needs to go back or has any quest.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Pain in extremity
Clinical narrative: Pt called stating she experience arm and back pain along with a major headache. Recommended her to use ice on the arm and it helped. Dr checking with her on 1/15/14, pt only has headache and recommended to take TYLENOL.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Hypotension, Pallor, Presyncope
Clinical narrative: Pt received flu shot for the 1st time - no Hx of any allergies. After 5 min - pt almost passed out - looked very pale. Both extremities (hands) were red and cold - she felt hot on the skin, but felt dizzy - BP was very low - almost had syncope.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Pt received flu shot for the 1st time - no Hx of any allergies. After 5 min - pt almost passed out - looked very pale. Both extremities (hands) were red and cold - she felt hot on the skin, but felt dizzy - BP was very low - almost had syncope.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain
Clinical narrative: I went to pharmacy late afternoon on the 22nd of November 2013 to get my flu shot. When he put the shot in my arm, I remarked it did not feel right--I could feel something running all the way down to my finger tips. It didn't hurt at the needle site as much as some other shots I have had in previous years, but he kept pushing in much longer than most do. It bothered me some that evening. I woke up in the night and put my arms up to yawn and I noticed the left arm (where I got the shot) did not come up, just the right. I thought I might be dreaming, so later I tried it again and lo and behold, it did not come up. I had to take my right arm and pull my left one up. It hurt to do that, also. I have been taking pain pills (xtra strength TYLENOL and 800 MG ibuprofen). I also put Absorbine Jr liniment to try to help the pain. I keep praying and waiting for this to go away, but it is still there. I called on Monday after I first got the shot and another pharmacist suggested he might have nicked a nerve. He advised me to keep moving it and it would soon go away. I don't even know how to describe the pain I have with it now. It almost makes me cry to try to get my hair pulled up in the morning. From my shoulder to my elbow is the most painful. I can't lift my arm with pain. I would like some suggestions on how to get this problem solved. I don't want to even get anymore flu shots after this bad experience. If you have any ideas on how to help with this, please let me know.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Vaccination complication
Clinical narrative: Shot given 7:45 AM 1-12-14. Reaction to vaccine 10:30 PM 1-12-14. Swelling in throat and difficulty breathing took 25mg BENADRYL, took nebulizer Albuterol treatment every 4 hrs. along with BENADRYL 25mg every 4 hrs. 1-15-14 patient doing better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt developed prodrome symptoms 1 week after receiving the vaccine. Twelve days after receiving the vaccine she broke out with a shingles-type rash on her right torso. Her physician prescribed her 800 mg of acyclovir, which she began on 1/9/14. She followed up with her physician 1/15/14.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea, Hypoaesthesia
Clinical narrative: 2 hours following vaccination, she developed chest tightness, hoarse voice, coughing, SOB, lasted 1.5 hours, partly improved with BENADRYL. In days following she continued to have numbness and weakness of left arm and leg.
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: 2 hours following vaccination, she developed chest tightness, hoarse voice, coughing, SOB, lasted 1.5 hours, partly improved with BENADRYL. In days following she continued to have numbness and weakness of left arm and leg.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Welts, pink colored on bilateral arms, bilateral buttocks, at injection site, and bilateral legs noted on 1-15-14 by mom.
Age: 22.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Raised erythematous welt on left bicep appeared 1 dy ago approx 1 dy after vaccinations. Treatment with CLARITIN 10mg BID and prednisone taper.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Fever - which has passed pain swelling rash - not localized, spreading on left side spreading to neck and face on left side.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site that was 75 mm long 45 mm wide. Slight tenderness at inj site.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
Clinical narrative: Left shoulder pain with injection. 4th day after injection difficulty raising arm. Pain x 3 months. Saw PCP. Dx of rotator cuff tendonitis. Started PT 12/23/13.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Received FLUZONE on 01/09/14. Patient had seizure on 01/10/14. ER visit required.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer of unknown age reporting on himself who 20 years ago, in 1994 was vaccinated with the first dose of pneumococcal vaccine. Since his first vaccination, the patient had received 3 booster doses of PNEUMOVAX 23 (doses, routes and lot numbers not reported) (also reported as unspecified pneumococcal vaccine). No adverse events were reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: This spontaneous report as received from a 70 year old female consumer with no pertinent medical history and no drug reactions or allergies reporting on herself. On 26-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as 00006496341) (dose and route not reported). Concomitant therapies included WELLBUTRIN. The consumer reported that in November 2013, she experienced pain in her left insertion from shoulder to her fingers. She also stated that her fingers were still numb. She stated her neurologist had diagnosed her as having Parsonage Turner syndrome. The patient was treated with anti-inflammatories and VICODIN. There were no Lab diagnosis or studies performed. The patient would follow up with her clinician. The outcome of Parsonage Turner syndrome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Condition aggravated, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with celiac disease. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot were not provided). On an unknown date, the patient had a decrease in control of her celiac disease following vaccination with a dose of GARDASIL. At the time of the report the patient had not recovered from the event. The patient contacted the pharmacist for medical attention. The pharmacist provided that some marker for celiac disease went from 6 to 62 following vaccination. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 12 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 50 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 12 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median ag was 17 (range 12 - 29). The median time from vaccination to onset of ADRs was 30 days (range 0 - 476 days); time to onset was unknown in 1 case; the time to onset in this case was of 49 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional; information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Uterine cancer
Clinical narrative: This spontaneous report as received from a consumer refers to her friends daughter of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot #, dose and route not provided). On an unknown date, the patient experienced uterine cancer. At the time of the report the outcome of the event was unknown. Upon internal review, uterine cancer was considered as medically significant. This is one of two reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 18 year old female patient developed uveitis, following administration of GARDASIL. The patient had as a pre-exising conditions asthenia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 2 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 13 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 476 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 18 year old female patient developed uveitis following administration of GARDASIL. The patient had as a pre-existing conditions hypertension, diabetes mellitus and arthropathy. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 30 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Papillitis, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 27 year old female patient developed uveitis and papillitis, following administration of GARDASIL. The patient had as a pre-existing conditions sarcoidosis and vasculitis. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12 - 29). The median time from vaccination to onset of ADRs was 30 days (range 0 - 476); time to onset was unknown in 1 case; the time to onset in this case was of 9 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 case and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloedema, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 22 year old female patient developed uveitis and papilledema, following administration of GARDASIL. The patient had as a pre-existing conditions elevated free T3. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 36z days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema and papillitis may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Case number PHHY2013US127686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502099) website on 11 Nov 2013 and a follow-up information was received from Quality Assurance Department (reference number: 263701) on 13 Nov 2013 and another follow up received from QA department on 14 Jan 2014. This report refers to a 51-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307901) in the left arm and PNEUMOVAX (batch number: H014196) in the right arm, on 03 Sep 2013. On same day, after vaccinations she had hives, redness and hotness around injection site. She went to doctor and he thought she might have an infection. She received an antibiotic. The outcome of the events reported as condition unchanged as of 06 Sep 2013. The seriousness and causality of the events were not reported. Batch review report (reference number: 263701) received from quality assurance department on 10 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1307901) was manufactured in accordance with approved internal procedures and it is in compliance with the good manufacturing practices (cGMP) requirements. Non-significant follow-up information was received from Quality Assurance Department (reference number: 263701) on 13 Nov 2013. Significant follow up received from Quality Assurance Department on 14 Jan 2014: Updated Batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Cold sweat, Cystitis, Dizziness, Nausea
Clinical narrative: Case number PHHY2013US140173 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503008) website on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 269283) on 14 Jan 2014. This report refers to a 73-year-old female patient. Her concurrent condition included headache. Her concomitant medication included omeprazole and zolpidem. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly into right arm and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly into right arm on 17 Sep 2013. On the same day, she started experiencing chills at 10 pm. On the next day, she proceeded to go to work and complained of dizziness, cold sweats, and nausea. She stated that she felt better after vomiting "green bile". She went to the emergency room and underwent tests. Blood and urine samples revealed low electrolytes in urine and a low grade bladder infection. She received intravenous (IV) fluids. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department concluded that the FLUVIRIN (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 269283) on 14 Jan 2014: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine electrolytes decreased, Vomiting
Clinical narrative: Case number PHHY2013US140173 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503008) website on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 269283) on 14 Jan 2014. This report refers to a 73-year-old female patient. Her concurrent condition included headache. Her concomitant medication included omeprazole and zolpidem. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly into right arm and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly into right arm on 17 Sep 2013. On the same day, she started experiencing chills at 10 pm. On the next day, she proceeded to go to work and complained of dizziness, cold sweats, and nausea. She stated that she felt better after vomiting "green bile". She went to the emergency room and underwent tests. Blood and urine samples revealed low electrolytes in urine and a low grade bladder infection. She received intravenous (IV) fluids. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department concluded that the FLUVIRIN (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 269283) on 14 Jan 2014: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Loss of consciousness
Clinical narrative: Case number PHHY2013US140088 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 504599) web site on 03 Dec 2013 and a follow-up information was received from Quality Assurance Department (reference number: 269001) on 09 Dec 2013 and another follow up received from QA department on 14 Jan 2014. This report refers to a 79-year-old female patient. Her medical history included heart attack three years ago and myasthenia gravis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 25 Sep 2013. On the same day after vaccination, she passed out around 5:30 pm and reported to have experienced headache. She went to emergency room (ER) at midnight and stayed for 12 hours. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported. Batch review report (reference number: 269001) received from quality assurance department on 14 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1307601) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269001) on 09 Dec 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 14 Jan 2014: Updated Batch review report.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back disorder, Dyspnoea
Clinical narrative: Case number PHHY2013US140093 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504608) web site on 03 Dec 2013 and a follow-up was received from Quality Assurance Department (reference number: 269004) on 09 Dec 2013 and another follow up received from QA department on 14 Jan 2014. This report refers to a 36-year-old female patient. Her medical history included hypertension and chronic pain. Her concomitant medications included unspecified anti-hypertension drugs. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly along with second shot of PNEUMOVAX (other manufacturer, batch number: J004141) intramuscularly on an unknown date. On an undetermined date after vaccinations, she complained of shortness of breath and 911 was called immediately. She also complained of terrible back. It was mentioned that the patients was fine after receiving FLUVIRIN and reacted to the PNEUMOVAX shot. Paramedic determined her signs and symptoms were not due to an allergic reaction to the vaccines. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308501) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269004) on 09 Dec 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 14 Jan 2014: Updated Batch review report.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Grand mal convulsion, Skin warm
Clinical narrative: Case number PHHY2013US140214 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 504763) web site on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 269000) on 14 Jan 2014. This report refers to a 64-year-old male patient. He had not known drug allergies. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly in to the right arm on 18 Sep 2013. On 20 Sep 2013 he developed grand mal seizures and felt hot to the touch. He was currently being treated in the emergency room. Final outcome of the events was reported as condition unchanged as on 20 Sep 2013. No further information about causality and seriousness was reported. Based on batch review performed, the QA department concluded that the FLUVIRIN (batch number: 1307901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 269000) on 14 Jan 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2013US140276, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 504895) website on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 268993) on 14 Jan 2014. This report refers to a 51-year-old female patient. Her concurrent conditions included celiac disease, allergy to wheat and previous medications included morphine. Her concomitant medications were not reported. She had celiac disease and experienced this problem when she eat wheat but she did not have any wheat that day to her knowledge. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly on 25 Sep 2013. On the same day evening, she felt that the area between nose and throat was swollen. The injection site was warm to touch, swollen, and very red. The next day all of her joints hurt. She could barely walk or use her hands. The outcome of the events was reported as condition unchanged as of 30 Sep 2013. The events were assessed as serious (life threatening) and the causality was not reported. Based on the investigation performed, the QA department concluded that the FLUVIRIN (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 268993) on 14 Jan 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Oropharyngeal swelling, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US140276, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 504895) website on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 268993) on 14 Jan 2014. This report refers to a 51-year-old female patient. Her concurrent conditions included celiac disease, allergy to wheat and previous medications included morphine. Her concomitant medications were not reported. She had celiac disease and experienced this problem when she eat wheat but she did not have any wheat that day to her knowledge. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly on 25 Sep 2013. On the same day evening, she felt that the area between nose and throat was swollen. The injection site was warm to touch, swollen, and very red. The next day all of her joints hurt. She could barely walk or use her hands. The outcome of the events was reported as condition unchanged as of 30 Sep 2013. The events were assessed as serious (life threatening) and the causality was not reported. Based on the investigation performed, the QA department concluded that the FLUVIRIN (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 268993) on 14 Jan 2014: Updated batch review report.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: Case number PHHY2013US140259, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507602) website on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 268998) on 14 Jan 2014. This report refers to a 43-year-old female patient. She was vaccinated with FLUVIRIN (batch number: L1308501) in the left arm on 30 Sep 2013. On 01 Oct 2013, she experienced shoulder pain and it was diagnosed as tendonitis. The patient visited the emergency room. It was reported that the event persisted since vaccination. The seriousness and causality of the events were not reported. Based on the batch review performed, the QA department concluded that the FLUVIRIN (batch number: 1308501) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 268998) on 14 Jan 2014: Updated batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Tinnitus
Clinical narrative: Case number PHHY2013US147810 is initial report from the vaccine adverse event reporting system (VAERS reference number: 510346) website on 16 Dec 2013 with a follow up information receive from quality assurance department (reference number: 272081) on 13 Jan 2014. This report refers to a 63 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: 31 Mar 2014) intramuscularly in the right arm on 02 Oct 2013. On 03 Oct 2013, she experienced hearing loss and ringing in the ears. It was reported that she was working with the specialist. The event outcome was reported as condition unchanged as of 16 Dec 2013. The seriousness was reported as disability and the causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1308601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up information received from QA department on 13 Jan 2014: Updated batch review report.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Influenza like illness, Pleural effusion, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2014US000946, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510389) website on 06 Jan 2014. This report refers to a 54-year-old male patient. Past medical history included diabetes, stage one pancreatic cancer and Non-Hodgkin's lymphoma. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly into the left arm on 25 Oct 2013. On 26 Oct 2013, he developed rash, itching and hives. On 27 Oct 2013, he experienced flu like symptoms and was hospitalized. On 28 Oct 2013, his blood pressure was 160/120 (units not reported), heart rate was 132 (units not reported) and he had fever with a body temperature of 101 (units not reported). Chest x-ray revealed fluid on lungs. The outcome of the events was reported as condition unchanged as of 30 Oct 2013. The causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHHY2014US000946, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510389) website on 06 Jan 2014. This report refers to a 54-year-old male patient. Past medical history included diabetes, stage one pancreatic cancer and Non-Hodgkin's lymphoma. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly into the left arm on 25 Oct 2013. On 26 Oct 2013, he developed rash, itching and hives. On 27 Oct 2013, he experienced flu like symptoms and was hospitalized. On 28 Oct 2013, his blood pressure was 160/120 (units not reported), heart rate was 132 (units not reported) and he had fever with a body temperature of 101 (units not reported). Chest x-ray revealed fluid on lungs. The outcome of the events was reported as condition unchanged as of 30 Oct 2013. The causality of the events was not reported.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Electromyogram, Local swelling, Muscle disorder, Musculoskeletal pain
Clinical narrative: First severe pain in shoulder, then it radiated down arm, then in a few days tingling in the arm, then limited use of muscles in arm and finger and the arm is swollen.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity, Paraesthesia, X-ray limb
Clinical narrative: First severe pain in shoulder, then it radiated down arm, then in a few days tingling in the arm, then limited use of muscles in arm and finger and the arm is swollen.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneously report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck). Dosing information, route of administration and lot number were not provided. No adverse effect reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Woke to small bumps on back w/welts, and all over body itching.