chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Inflammation, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint swelling, Injection site mass, Insomnia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Vaccination site pain, Vaccination site swelling, Weight bearing difficulty, X-ray
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration ate 17-SEP-2016, (strength, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On an unknown date, the patient missed a dose of VAQTA because the vial was under filled (product quality issue). No adverse effect was reported. A Product quality complaint (PQC) was reported because the VAQTA vial was under filled. 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 Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of RECOMBIVAX HB (lot # L025738, expiration date: 14-AUG-2017; L029631, expiration date: 14-AUG-2017, L038018, expiration date: 13-SEP-2017) (dose and route were not reported) which were exposed to temperatures outside of the recommended range were administered to the unspecified number of patients. It was unknown if the patients sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaint involved. This is one of several reports from the same source. Lot number L038018 has been verified to be a valid lot number for RECOMBIVAX HB. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLUC3
Symptoms: Angioedema, Eye swelling, Feeling abnormal, Hypersensitivity, Rash
Clinical narrative: 70 year old male who presents to Emergency Dept with c/o; Pt. rec'd immunoglobulin infusion (for Myasthenia Gravis) at neurology today )gets this once every 2 mos.) and then he rec'd a flu shot near the end.....allergic rxn started 20 min. after flu shot...> itchy rash, swelling around eyes, feeling bad. Pt. was then brought to ER for tx. Pt. has had M.G. x 25 yrs. No hoarseness; No difficulty breathing or swallowing; No feeling of throat swelling. No prior allergy to the immunoglobulins or flu shots (has had them both for 25 yrs). Not allergic to eggs. No CP, abd pain, palps, SOB, Etc. Skin: warm and dry. Pt. has a red, urticarial-like rash of lower neck/upper chest region; also some less severe areas of rash on arms. After tx the rashes had faded significantly. ED Course: IV BENADRYL 25 mg. IV SOLU-MEDROL 125 mg. and IV PEPCID 20mg were given..... and the pt's condition improved significantly following the tx. Rash faded; periorbital edema subsided; and pt. felt much better. Later he got another dose of BENADRYL 25 mg IM. Additional prescriptions: Rx: Pred taper; BENADRYL; ZANTAC, Angioedema.
Age: 70.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: 70 year old male who presents to Emergency Dept with c/o; Pt. rec'd immunoglobulin infusion (for Myasthenia Gravis) at neurology today )gets this once every 2 mos.) and then he rec'd a flu shot near the end.....allergic rxn started 20 min. after flu shot...> itchy rash, swelling around eyes, feeling bad. Pt. was then brought to ER for tx. Pt. has had M.G. x 25 yrs. No hoarseness; No difficulty breathing or swallowing; No feeling of throat swelling. No prior allergy to the immunoglobulins or flu shots (has had them both for 25 yrs). Not allergic to eggs. No CP, abd pain, palps, SOB, Etc. Skin: warm and dry. Pt. has a red, urticarial-like rash of lower neck/upper chest region; also some less severe areas of rash on arms. After tx the rashes had faded significantly. ED Course: IV BENADRYL 25 mg. IV SOLU-MEDROL 125 mg. and IV PEPCID 20mg were given..... and the pt's condition improved significantly following the tx. Rash faded; periorbital edema subsided; and pt. felt much better. Later he got another dose of BENADRYL 25 mg IM. Additional prescriptions: Rx: Pred taper; BENADRYL; ZANTAC, Angioedema.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of GARDASIL 9 (Lot #: L013429, exp date 14-FEB-2017 (also reported as 21-JUL-2017); L025737, exp date: 28-JUL-2017; L023230, exp date: 28-JUL-2017) (dose and route were not reported) which were exposed to temperatures outside of the recommended range were administered to the unspecified number of patients. It was unknown if the patients sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaints involved. This is one of several reports from the same reporter. Lot number L025737 has been verified to be a valid lot number for GARDASIL. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and minimal swelling at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and minimal swelling at injection site.
Age: 41.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Body temperature increased, Erythema, Swelling
Clinical narrative: Significant erythema and swelling, temp up to 104.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood count abnormal, Haemoglobin decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received FLUARIX QUADRIVALENT. On 21st October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive. On 23 October 2015, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive were recovering/resolving. The reporter considered the fever, platelet count low, spleen enlarged, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive to be probably related to FLUARIX QUADRIVALENT. It as unknown if the reporter considered the liver enlargement to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a certified medical assistant, who herself was the patient. This case was previously reported to a doctor. On 21st October 2015, at 05:00, the patient received a dose of FLUARIX QUADRIVALENT vaccine in left deltoid. On 23rd October 2015, at 05:00, 2 days after vaccination, the patient developed fever (101.5 degrees F). The patient took TYLENOL. The fever continued for the next 3 days. On 27th October 2015, at 12:00 noon, the fever was (102.5 degrees F). There were no other external symptoms present. On the same day, the patient had blood drawn and underwent laboratory tests, which showed high liver functions and an abnormal blood count. All inflammatory marker tests showed elevations. The patient tested positive for Hepatitis C. On 28th October 2015, the patient underwent an abdominal ultrasound, which revealed an enlarged liver and spleen. The spleen was dangerously enlarged. Over the next week, the patient underwent blood work, which showed liver functions kept rising. The Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and Alkaline Phosphatase tests showed elevations. Two days later test result came back, that the patient did not have Hepatitis C. Her hemoglobin levels decreased from 12.5 to 9.7. The patient stressed that, she was normally a very healthy individual. The patient again underwent a 2nd set of Hepatitis C titers 2 weeks after the initial lab work and results came back negative. The patient added that a month before the vaccination, she had routine blood work done and all levels were good. The patient was scheduled for laboratory work in coming week and said she would have results that she can share when she receives the follow up form.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Hepatitis C virus test positive, Hepatomegaly, Inflammatory marker increased, Liver function test abnormal, Platelet count decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received FLUARIX QUADRIVALENT. On 21st October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive. On 23 October 2015, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive were recovering/resolving. The reporter considered the fever, platelet count low, spleen enlarged, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive to be probably related to FLUARIX QUADRIVALENT. It as unknown if the reporter considered the liver enlargement to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a certified medical assistant, who herself was the patient. This case was previously reported to a doctor. On 21st October 2015, at 05:00, the patient received a dose of FLUARIX QUADRIVALENT vaccine in left deltoid. On 23rd October 2015, at 05:00, 2 days after vaccination, the patient developed fever (101.5 degrees F). The patient took TYLENOL. The fever continued for the next 3 days. On 27th October 2015, at 12:00 noon, the fever was (102.5 degrees F). There were no other external symptoms present. On the same day, the patient had blood drawn and underwent laboratory tests, which showed high liver functions and an abnormal blood count. All inflammatory marker tests showed elevations. The patient tested positive for Hepatitis C. On 28th October 2015, the patient underwent an abdominal ultrasound, which revealed an enlarged liver and spleen. The spleen was dangerously enlarged. Over the next week, the patient underwent blood work, which showed liver functions kept rising. The Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and Alkaline Phosphatase tests showed elevations. Two days later test result came back, that the patient did not have Hepatitis C. Her hemoglobin levels decreased from 12.5 to 9.7. The patient stressed that, she was normally a very healthy individual. The patient again underwent a 2nd set of Hepatitis C titers 2 weeks after the initial lab work and results came back negative. The patient added that a month before the vaccination, she had routine blood work done and all levels were good. The patient was scheduled for laboratory work in coming week and said she would have results that she can share when she receives the follow up form.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Splenomegaly, Ultrasound abdomen abnormal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received FLUARIX QUADRIVALENT. On 21st October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive. On 23 October 2015, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, platelet count low, spleen enlarged, liver enlargement, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive were recovering/resolving. The reporter considered the fever, platelet count low, spleen enlarged, hemoglobin decreased, elevated liver enzymes and hepatitis C test positive to be probably related to FLUARIX QUADRIVALENT. It as unknown if the reporter considered the liver enlargement to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a certified medical assistant, who herself was the patient. This case was previously reported to a doctor. On 21st October 2015, at 05:00, the patient received a dose of FLUARIX QUADRIVALENT vaccine in left deltoid. On 23rd October 2015, at 05:00, 2 days after vaccination, the patient developed fever (101.5 degrees F). The patient took TYLENOL. The fever continued for the next 3 days. On 27th October 2015, at 12:00 noon, the fever was (102.5 degrees F). There were no other external symptoms present. On the same day, the patient had blood drawn and underwent laboratory tests, which showed high liver functions and an abnormal blood count. All inflammatory marker tests showed elevations. The patient tested positive for Hepatitis C. On 28th October 2015, the patient underwent an abdominal ultrasound, which revealed an enlarged liver and spleen. The spleen was dangerously enlarged. Over the next week, the patient underwent blood work, which showed liver functions kept rising. The Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and Alkaline Phosphatase tests showed elevations. Two days later test result came back, that the patient did not have Hepatitis C. Her hemoglobin levels decreased from 12.5 to 9.7. The patient stressed that, she was normally a very healthy individual. The patient again underwent a 2nd set of Hepatitis C titers 2 weeks after the initial lab work and results came back negative. The patient added that a month before the vaccination, she had routine blood work done and all levels were good. The patient was scheduled for laboratory work in coming week and said she would have results that she can share when she receives the follow up form.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Malaise, Pain, Pain in extremity, Periarthritis
Clinical narrative: Painful left arm, fever, soreness, sick feeling, flu like symptoms.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Painful left arm, fever, soreness, sick feeling, flu like symptoms.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had tenderness from the top of the shoulder down to shortly below the injection site.  Moderate to lge amount of swelling generalized around the site and within about 3 inches in diameter firm red swelling around the injection site.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder and loss of mobility of arm.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: Miscarried the morning after I received the vaccine. I have been pregnant prior with no miscarriage and conceived immediately after the miscarriage. Pregnancy is early but with no sign of impending miscarriage.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Immediate post-injection reaction, Pregnancy test urine negative
Clinical narrative: Miscarried the morning after I received the vaccine. I have been pregnant prior with no miscarriage and conceived immediately after the miscarriage. Pregnancy is early but with no sign of impending miscarriage.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Abasia, Eye swelling, Fatigue, Headache, Malaise
Clinical narrative: Pt was given tetanus booster and meningococcal vaccine in the right thigh and polio vaccine in the left thigh. Mom reports pt had severe pain in the right thigh shortly afterwards. Pt had severe malaise and fatigue for 2-3 days. Pt was unable to walk and stayed in bed for several days missing school. Leg pain developed into full body aches. Over the weekend pt developed severe headache and swelling in left eye. Pt started on prednisone 20 mg for 3 days and BENADRYL as well.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt was given tetanus booster and meningococcal vaccine in the right thigh and polio vaccine in the left thigh. Mom reports pt had severe pain in the right thigh shortly afterwards. Pt had severe malaise and fatigue for 2-3 days. Pt was unable to walk and stayed in bed for several days missing school. Leg pain developed into full body aches. Over the weekend pt developed severe headache and swelling in left eye. Pt started on prednisone 20 mg for 3 days and BENADRYL as well.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Rash, Streptococcus test negative, Urine analysis normal
Clinical narrative: Symptoms include skin bumps and skin redness, but do not include pruritus. Located on left side of face, left buttock, left leg, right side of face, (L) buttock and leg. Onset was sudden 12-20-15. Treated with ZYRTEC Children's allergy.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site vesicles, Pruritus, Pyrexia, Rash
Clinical narrative: Vaccine was administered 1-8-16. Patient had redness and swelling. Blister formed at injection site 1/8/16. Patient broke out in rash and had fever on 1/13/16. Came to clinic on 1-15-16 w/rash and itching.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Vaccine was administered 1-8-16. Patient had redness and swelling. Blister formed at injection site 1/8/16. Patient broke out in rash and had fever on 1/13/16. Came to clinic on 1-15-16 w/rash and itching.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a licensed practical nurse referring to an adult patient of unknown age and gender. Information about the patient's concurrent conditions or medical history was not reported. No concomitant therapies were reported. On 29-DEC-2015 the patient was inadvertently administered a pediatric dose of VAQTA 25/0.55 (unit not provided) (dose, route, lot# and expiration date were not reported). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of PROQUAD (lot # L031600, expiration date 18-FEB-2017) were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports (L) arm from shoulder to elbow swollen red hot to touch on 12-11-15 took child to dr and was given antibiotic and antihistamine.
Age: 17.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Full blood count normal, Gait disturbance
Clinical narrative: Started with nausea then GI bleed then severe nausea (lost 8 lbs), severe dizziness and headache accompanied by numbness of left plantar foot. Sxs prompted visits to ER, MDs x2. Debilitating results of dizziness and numbness prevented her from ambulating straight and missing school. Sxs still exist up to this time 1/15.
Age: 17.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Gastrointestinal haemorrhage, Headache, Hypoaesthesia, Liver function test normal, Metabolic function test normal
Clinical narrative: Started with nausea then GI bleed then severe nausea (lost 8 lbs), severe dizziness and headache accompanied by numbness of left plantar foot. Sxs prompted visits to ER, MDs x2. Debilitating results of dizziness and numbness prevented her from ambulating straight and missing school. Sxs still exist up to this time 1/15.
Age: 17.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Nausea, Thyroid function test normal
Clinical narrative: Started with nausea then GI bleed then severe nausea (lost 8 lbs), severe dizziness and headache accompanied by numbness of left plantar foot. Sxs prompted visits to ER, MDs x2. Debilitating results of dizziness and numbness prevented her from ambulating straight and missing school. Sxs still exist up to this time 1/15.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS THEN ONSET OF FEVER.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Swollen tongue
Clinical narrative: During the night woke up tongue felt swollen. Got up at 5:00 AM looked in mirror right side of tongue 3 times larger than left side. Called 911 taken to hospital by ambulance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red, inflamed area at injection site.  Half dollar in size.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Abscess oral, Erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: L Deltoid, inflamed, tender, warm.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: L Deltoid, inflamed, tender, warm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swollen, red, sore and warm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Bedridden, Bronchitis, Cough, Haemoptysis
Clinical narrative: Woke up with whole body aching, arm slightly sore at shot area. Weak and felt like the Flu symptoms. By Day 2 was coughing and day three went to Dr.s and said I had a lung infection, bronchitis. I was subscribed antibiodics and was bedridden for several days, fever and sweats, etc.  Today is 1/15/2016 and still have weakness and coughing. Phlegm  included blood streaks, which is going to be addressed.  It's hard to believe the live virus I was admimistered didn't have anything to do with the shot.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Influenza, Injection site pain, Lung infection, Pain
Clinical narrative: Woke up with whole body aching, arm slightly sore at shot area. Weak and felt like the Flu symptoms. By Day 2 was coughing and day three went to Dr.s and said I had a lung infection, bronchitis. I was subscribed antibiodics and was bedridden for several days, fever and sweats, etc.  Today is 1/15/2016 and still have weakness and coughing. Phlegm  included blood streaks, which is going to be addressed.  It's hard to believe the live virus I was admimistered didn't have anything to do with the shot.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Woke up with whole body aching, arm slightly sore at shot area. Weak and felt like the Flu symptoms. By Day 2 was coughing and day three went to Dr.s and said I had a lung infection, bronchitis. I was subscribed antibiodics and was bedridden for several days, fever and sweats, etc.  Today is 1/15/2016 and still have weakness and coughing. Phlegm  included blood streaks, which is going to be addressed.  It's hard to believe the live virus I was admimistered didn't have anything to do with the shot.
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hib #1 and #2 was given 18 days apart.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Upper right arm twitching and muscle cramping into elbow -- episodic.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Malaise, Tinnitus
Clinical narrative: I felt sick and weak right after shot.  When I got in my car, I knew I was sick.  I had to come home and lay down for the rest of the evening. I felt like I was getting the flu and my ears were ringing, The next day I was about 85% better but still a little weak.  My ears are still ringing and have been ringing every since.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Patient states a blister formed where bandaid was placed on the right deltoid.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Peripheral coldness, Restlessness
Clinical narrative: I started experiencing pain in my back left thigh. I then had pain/tingling in my hands, and some in my feet. The pain in hands became unbearable, as did the pain in my back thighs. I had pain/tingling in my calves, some in my upper arms. The pain was so severe! I have never had such excruciating pain in my life. My hands felt as if they were freezing, but someone touched them, and to the touch, they weren't.  My feel were cold and tingling as well.  I had a little pain in my neck. I couldn't sleep because of the pain and didn't sleep for 5 nights. I was restless and my hands were in so much pain and felt ice cold to me.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: I started experiencing pain in my back left thigh. I then had pain/tingling in my hands, and some in my feet. The pain in hands became unbearable, as did the pain in my back thighs. I had pain/tingling in my calves, some in my upper arms. The pain was so severe! I have never had such excruciating pain in my life. My hands felt as if they were freezing, but someone touched them, and to the touch, they weren't.  My feel were cold and tingling as well.  I had a little pain in my neck. I couldn't sleep because of the pain and didn't sleep for 5 nights. I was restless and my hands were in so much pain and felt ice cold to me.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm swollen a deltoid, red, warm to touch area 14.5cm x 9.5cm.
Age: 25.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain at site of injection. Unable to move/elevate arm due to shoulder pain. With Active ROM, she is only able to elevate arm to 90 degrees. With passive ROM to 160 degrees. Injection site is about 1 cm below head of humerus. Site is clean. no redness, swelling, warmth. Distal pulses strong. No tingling or numbness in arm or shoulder. Patient was given 800mg Motrin and 5mg Flexeril. Was told to f/u if arm not better in 1-2 days.
Age: 25.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Severe pain at site of injection. Unable to move/elevate arm due to shoulder pain. With Active ROM, she is only able to elevate arm to 90 degrees. With passive ROM to 160 degrees. Injection site is about 1 cm below head of humerus. Site is clean. no redness, swelling, warmth. Distal pulses strong. No tingling or numbness in arm or shoulder. Patient was given 800mg Motrin and 5mg Flexeril. Was told to f/u if arm not better in 1-2 days.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Eczema
Clinical narrative: DEVELOPED ECZEMA PER MOTHER.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Body temperature increased, Cytogenetic analysis, Fine motor skill dysfunction, Screaming
Clinical narrative: SCREAMING IN THE MIDDLE OF THE NIGHT, TEMP OF 104, WENT TO ER AFTERWARD LOST SPEECH AND FINE MOTOR SKILLS. WAS REFERRED FOR OT, PT AND ST.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Swallow study
Clinical narrative: SCREAMING IN THE MIDDLE OF THE NIGHT, TEMP OF 104, WENT TO ER AFTERWARD LOST SPEECH AND FINE MOTOR SKILLS. WAS REFERRED FOR OT, PT AND ST.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient called and stated they are having a 2 inch across and 1/4 inch down sized local red spot. Patient states it is slightly raised and itches.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch. Treatment - cool compresses, Ibuprofen.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Dizziness, Dyspnoea, Flushing
Clinical narrative: Immediately after injection felt warmth and pain in arm. Stood up then felt like couldn't breath, "like worst asthma attack of my life" and flushed and dizzy. HR rapid initially to 3P<, O2 sat 98%, BP 130/70 and rash with hives at injection site. Lungs clear, no wheeze.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Immediate post-injection reaction, Injection site rash, Injection site urticaria, Pain in extremity
Clinical narrative: Immediately after injection felt warmth and pain in arm. Stood up then felt like couldn't breath, "like worst asthma attack of my life" and flushed and dizzy. HR rapid initially to 3P<, O2 sat 98%, BP 130/70 and rash with hives at injection site. Lungs clear, no wheeze.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Immediately after injection felt warmth and pain in arm. Stood up then felt like couldn't breath, "like worst asthma attack of my life" and flushed and dizzy. HR rapid initially to 3P<, O2 sat 98%, BP 130/70 and rash with hives at injection site. Lungs clear, no wheeze.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Eye movement disorder, Generalised tonic-clonic seizure, Immediate post-injection reaction, Laboratory test, Loss of consciousness
Clinical narrative: Pt. loss consciousness within 10 sec's after IM injection. Pale, eyes rolled to back of head, tonic-clonic seizure activity x 5-10 secs. Postictal, cleared prior to oxygen. Transferred to hospital in stable condition via ambulance. Labwork drawn there.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Postictal state
Clinical narrative: Pt. loss consciousness within 10 sec's after IM injection. Pale, eyes rolled to back of head, tonic-clonic seizure activity x 5-10 secs. Postictal, cleared prior to oxygen. Transferred to hospital in stable condition via ambulance. Labwork drawn there.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Five days after given the 3 vaccines, his left upper arm became and red and blotchy. It covered about 5-7 inches in length and 3 inches in width. It looked like hives based on his reaction when he was an infant to penicillin.
Age: 1.73
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Rash, Swelling face
Clinical narrative: Facial swelling and rash. Evaluated by onsite pediatrician Dr. Given 3mg BENADRYL and 160mg Acetaminophen.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Pain
Clinical narrative: On 2nd day after shot, pt reports intense neck and head pain on the opposite side of her body from the injection site. Pt was sore the next day and recovered.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Chest X-ray, Dermatitis allergic, Dizziness, Eye swelling
Clinical narrative: Had fever on 12-30-15 - 101 degrees F - mother gave MOTRIN. Went to ER - on 1-2-16 - fever and rash diagnosed as serum sickness, BENADRYL and Ibuprofen was given. 12/30/15 - Received Flu (Influenza vaccine) FLUZONE - UI1515AA Exp - 6/30/16 in her (R) thigh, intramuscular. 12/30/15 - At night got fever, mother gave MOTRIN or Ibuprofen. 12-31-15 - Fever and developed few lesions on her thigh. 1-2-16 - Fever and rash progressed. Went to ER where blood work and chest X Ray was done and sent home - allergic rash. 1-4-16 - Still with fever and swollen eyes - and BENADRYL not working, so steroids - prednisone 15mg/5ml. 5 ml PO BID x 5 days. 1-7-16 - patient was dizzy and not walking right - so was advised to go to ER - went to hospital where blood work was done and diagnosed as serum sickness and advised to continue steroids. 1-8-16 - Doctor called and she said eyes are red but no fever. So thought Kawasaki advised to take to ER (went to ER on 1-10-16) and diagnosed as Kawasaki and IVIG given on 1-11-16 and discharged on 1-12-16. Readmitted on 1-13-16 as fever and aspirin and bld wk.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Immunoglobulin therapy, Kawasaki's disease, Ocular hyperaemia, Pyrexia
Clinical narrative: Had fever on 12-30-15 - 101 degrees F - mother gave MOTRIN. Went to ER - on 1-2-16 - fever and rash diagnosed as serum sickness, BENADRYL and Ibuprofen was given. 12/30/15 - Received Flu (Influenza vaccine) FLUZONE - UI1515AA Exp - 6/30/16 in her (R) thigh, intramuscular. 12/30/15 - At night got fever, mother gave MOTRIN or Ibuprofen. 12-31-15 - Fever and developed few lesions on her thigh. 1-2-16 - Fever and rash progressed. Went to ER where blood work and chest X Ray was done and sent home - allergic rash. 1-4-16 - Still with fever and swollen eyes - and BENADRYL not working, so steroids - prednisone 15mg/5ml. 5 ml PO BID x 5 days. 1-7-16 - patient was dizzy and not walking right - so was advised to go to ER - went to hospital where blood work was done and diagnosed as serum sickness and advised to continue steroids. 1-8-16 - Doctor called and she said eyes are red but no fever. So thought Kawasaki advised to take to ER (went to ER on 1-10-16) and diagnosed as Kawasaki and IVIG given on 1-11-16 and discharged on 1-12-16. Readmitted on 1-13-16 as fever and aspirin and bld wk.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Serum sickness, Skin lesion
Clinical narrative: Had fever on 12-30-15 - 101 degrees F - mother gave MOTRIN. Went to ER - on 1-2-16 - fever and rash diagnosed as serum sickness, BENADRYL and Ibuprofen was given. 12/30/15 - Received Flu (Influenza vaccine) FLUZONE - UI1515AA Exp - 6/30/16 in her (R) thigh, intramuscular. 12/30/15 - At night got fever, mother gave MOTRIN or Ibuprofen. 12-31-15 - Fever and developed few lesions on her thigh. 1-2-16 - Fever and rash progressed. Went to ER where blood work and chest X Ray was done and sent home - allergic rash. 1-4-16 - Still with fever and swollen eyes - and BENADRYL not working, so steroids - prednisone 15mg/5ml. 5 ml PO BID x 5 days. 1-7-16 - patient was dizzy and not walking right - so was advised to go to ER - went to hospital where blood work was done and diagnosed as serum sickness and advised to continue steroids. 1-8-16 - Doctor called and she said eyes are red but no fever. So thought Kawasaki advised to take to ER (went to ER on 1-10-16) and diagnosed as Kawasaki and IVIG given on 1-11-16 and discharged on 1-12-16. Readmitted on 1-13-16 as fever and aspirin and bld wk.
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse regarding a patient (age and gender not reported) who on 29-JAN-2007, was vaccinated with dose 1 of PNEUMOVAX 23 (Lot no. reported as "L008P") (site and route not reported). On 12-AUG-2008, the patient was vaccinated with dose 2 of PNEUMOVAX 23 (lot number, site and route not reported). On 08-OCT-2015, the patient was vaccinated with a dose of PREVNAR 13. No adverse event was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Chest pain, Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. Patient stated he had a case of shingles many years ago, so he got vaccinated with ZOSTAVAX (dosing details not provided) about 6 years ago on an unspecified date and the shingles did subside to the base of his spine. Patient then stated that the shingles virus however "ate the insulation" of his nerves which caused him pain in both his back area and the right side of his chest, to the present time. He mentioned that he went to several unspecified physicians and he was eventually diagnosed with having postherpetic neuralgia but none of the doctors knew how to treat the nerve pain he was experiencing. Patient also stated that he developed some "water blisters" and "stinging" on his back after getting the ZOSTAVAX. He stated that he tried both an unspecified ointment compound solution and "pain patches" to help treat the adverse events but his postherpetic neuralgia has persisted. Outcome of other events were unknown. Causality assessment was not provided. Additional information is not expected. Patient refused to provide his physician name/demographics.
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. Patient stated he had a case of shingles many years ago, so he got vaccinated with ZOSTAVAX (dosing details not provided) about 6 years ago on an unspecified date and the shingles did subside to the base of his spine. Patient then stated that the shingles virus however "ate the insulation" of his nerves which caused him pain in both his back area and the right side of his chest, to the present time. He mentioned that he went to several unspecified physicians and he was eventually diagnosed with having postherpetic neuralgia but none of the doctors knew how to treat the nerve pain he was experiencing. Patient also stated that he developed some "water blisters" and "stinging" on his back after getting the ZOSTAVAX. He stated that he tried both an unspecified ointment compound solution and "pain patches" to help treat the adverse events but his postherpetic neuralgia has persisted. Outcome of other events were unknown. Causality assessment was not provided. Additional information is not expected. Patient refused to provide his physician name/demographics.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 05-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K010215, expiration date 05-MAY-2017 (route was not provided). On 05-JAN-2016, there was an incorrect product storage as the patient was administered a dose of improperly stored GARDASIL. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-JAN-2016, the patient was vaccinated with a dose of oral, ROTATEQ lot # L008996, expiration date 01-DEC-2016 (route was not provided). On 04-JAN-2016, there was an incorrect product storage as the patient was administered a dose of improperly stored oral, ROTATEQ. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K010215, expiration date 05-MAY-2017 (route was not provided). On 04-JAN-2016, there was an incorrect product storage as the patient was administered a dose of improperly stored GARDASIL. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Peripheral swelling, Rash
Clinical narrative: Rash arm swollen and trouble breathing.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Cyst, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: Adhesive capsulitis, pain, range of motion, recent MRI 2 tears with cyst.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Adhesive capsulitis, pain, range of motion, recent MRI 2 tears with cyst.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Electroencephalogram, Excessive eye blinking, Eye movement disorder, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Head tilt back, eyes roll up with eyelid fluttering, not responsive.  Lasting 3-5 seconds.  Re-occurred 2d later.  Admitted for w/u of seizures.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Vertigo
Clinical narrative: Acute, sudden vertigo episode.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Erythema, Edema, and Pain.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Muscle Soreness, Tenderness, Decreased range of motion, Sharp Pain when arm is above 90 Degrees.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin irritation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, soreness at upper arm from elbow to armpit, most severe at location vaccine given. Onset of local irritation started the night receiving vaccine, reported two days later. Suggested to contact prescriber and prescriber instructed to take Benadryl and apply ice.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Fatigue, Groin pain, Irritability, Pruritus, Pyrexia
Clinical narrative: Fever, swelling of crotch, very painful in crotch area, big bump in crotch area, rashes in trunk area, rashes on leg, itchy, irritable, fatigue, bumps along inguinal area (marble like), lasted for 3 weeks.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash, Swelling
Clinical narrative: Fever, swelling of crotch, very painful in crotch area, big bump in crotch area, rashes in trunk area, rashes on leg, itchy, irritable, fatigue, bumps along inguinal area (marble like), lasted for 3 weeks.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Induration, Mass, Swelling
Clinical narrative: Swelling, redness, hard lump.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, sore back, headache.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Back pain, Condition aggravated, Erythema, Eye pain
Clinical narrative: Once I picked up the prescription for the eye issue, I had him one dose which was around 4pm. After that he played like normal. But then he strated showing red rashes on his face. I called children's nurse hotline at 8:50PM. The told me to take him to the urgent care. The doctor on site that night said she believed that he was allergic to the prescribed medication for his eye and/or the flu nasal spray. She told me to stop giving him the medication for his eye issue and to monitor his rash. The rash she believed to be hives that was due to the allergic reaction. Once we got back home his hives had spread to his eyes, the back of his neck, legs, arms, and he complained that his feet hurt and they were red and swollen. I gave him a cool bath and put some Aveeno lotion on him. But then he woke up the next morning (1/16/2016) with his left eyelid swollen shut, although the hives went away. He complained about his eyes hurting, his tummy, and his back hurting. I have him a dose of ibuprofen around 5pm. It is now 10:50pm on 1/16/2016 that my son is covered again in hives.