chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Metabolic function test normal, Pruritus, Pulmonary oedema, Rash
Clinical narrative: On 10/22, corner of right eye was swollen.  !0/24, right eye extremely swollen and fluid pocket below eye.  Left side of lip and left cheek swollen.  These symptoms disappeared towards evening.  On 10/25, bottom of feet and palms were red and itching.  Some spots appeared on torso, legs, and arms.  On 10/26, front and back of upper torso and upper and lower limbs had rash, which appeared as blisters after getting up in the morning, then dissipated throughout the day.  Took 25 mg of Benadryl and this controlled the symptoms.  They then gradually become worse.  Went to clinic on 11/8, with severe rash on body, except for face and head, and pubic area.  Doctor stated it appeared as shingles, but rash covered the whole body, not just one side or in a line.  CBC blood test and metabolic panel results were within normal limits.  Blood pressure elevated to 170/100.  MD unable to make diagnosis or have any suggestions to cause of events.  On 11/9 in evening, lungs began to fill with fluid.  Benadryl taken again.  11/10, went to see an allergist.  He gave cortisone injection and one week of prednisone.  After two days of prednisone, rash disappeared.  Blood pressure now back to normal.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: On 10/22, corner of right eye was swollen.  !0/24, right eye extremely swollen and fluid pocket below eye.  Left side of lip and left cheek swollen.  These symptoms disappeared towards evening.  On 10/25, bottom of feet and palms were red and itching.  Some spots appeared on torso, legs, and arms.  On 10/26, front and back of upper torso and upper and lower limbs had rash, which appeared as blisters after getting up in the morning, then dissipated throughout the day.  Took 25 mg of Benadryl and this controlled the symptoms.  They then gradually become worse.  Went to clinic on 11/8, with severe rash on body, except for face and head, and pubic area.  Doctor stated it appeared as shingles, but rash covered the whole body, not just one side or in a line.  CBC blood test and metabolic panel results were within normal limits.  Blood pressure elevated to 170/100.  MD unable to make diagnosis or have any suggestions to cause of events.  On 11/9 in evening, lungs began to fill with fluid.  Benadryl taken again.  11/10, went to see an allergist.  He gave cortisone injection and one week of prednisone.  After two days of prednisone, rash disappeared.  Blood pressure now back to normal.
Age: 59.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia
Clinical narrative: Tingling in toes.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Lacrimation increased, Myalgia, Ocular hyperaemia
Clinical narrative: Wheezing, tightness in chest, red watery eyes, headache, muscle soreness.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Wheezing, tightness in chest, red watery eyes, headache, muscle soreness.
Age: 0.51
Sex: M
Vaccine: 6VAX-F, FLUX, RVX
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had a high fever following 6 month immunizations. Also had a low grade fever after 2 month shots, a fever around 103 after 4 month shots but after 6 month shots temperature topped out at over 105 and patient ended up going into a febrile seizure and had to be taken to the ER.
Age: 0.27
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Crying, Decreased appetite, Heart rate increased, Pain, Pyrexia
Clinical narrative: High fever 106.3, crying, vomiting, pain, fast heart beats, breathing fast, poor appetite.
Age: 0.27
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Respiratory rate increased, Vomiting
Clinical narrative: High fever 106.3, crying, vomiting, pain, fast heart beats, breathing fast, poor appetite.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Blood test, Computerised tomogram, Convulsion, Gaze palsy, Muscle rigidity
Clinical narrative: 7:30 AM-Patient woke up, ate 6 oz of Similac Advanced formula, and fell asleep on my chest. 8:45 AM- his body went rigid, he started having continuous shaking in his arms and legs, his back arched, and his eyes were open, but pupils were rolled back in his head. 8:47 AM-seizure ended, patient was not able to focus on anything and was very sleepy.  He had four more seizures about two hours apart, and was hospitlized for 3 days.  He is now taking Keppra twice a day.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Nuclear magnetic resonance imaging, Opisthotonus, Somnolence, Tremor, Urine analysis
Clinical narrative: 7:30 AM-Patient woke up, ate 6 oz of Similac Advanced formula, and fell asleep on my chest. 8:45 AM- his body went rigid, he started having continuous shaking in his arms and legs, his back arched, and his eyes were open, but pupils were rolled back in his head. 8:47 AM-seizure ended, patient was not able to focus on anything and was very sleepy.  He had four more seizures about two hours apart, and was hospitlized for 3 days.  He is now taking Keppra twice a day.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Vision blurred
Clinical narrative: 7:30 AM-Patient woke up, ate 6 oz of Similac Advanced formula, and fell asleep on my chest. 8:45 AM- his body went rigid, he started having continuous shaking in his arms and legs, his back arched, and his eyes were open, but pupils were rolled back in his head. 8:47 AM-seizure ended, patient was not able to focus on anything and was very sleepy.  He had four more seizures about two hours apart, and was hospitlized for 3 days.  He is now taking Keppra twice a day.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Approx 48 hrs after vaccines administered child developed hives, swollen lips & tongue also an aching stomach. Episode lasted 72 hrs. Mo had given child BENADRYL, child taken to PMD. Symptoms subsided - more BENADRYL given. Hives off/on.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain in left upper arm where vaccine administered later in evening same day. Pain continues now 3 weeks with decreased range of motion left shoulder.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Pt had local reaction at injection site and below, area approximately 6" x 7" red and warm to touch, slight discomfort to area - started evening 11/14/11 seen by physician - advised to use cold pack to area & TYLENOL and BENADRYL if area becomes itchy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Malaise, Pallor, Syncope
Clinical narrative: 20 minutes after receiving the 3 vaccines & while leaving the office building, patient told her mom, I don't feel good, turned very pale & fainted, once laying down she was conscious, smiling but very pale, mom said that she didn't eat breakfast.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: Within the first 5 hours the patient experienced red eyes, nausea, fever (102 degrees F), chills, headache.
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Received Tdap & Varicella on 8 Nov in (R) arm. On Monday 14 Nov, (R) arm was red and tender and swollen. Wen to doctor. Dx w/ cellulitis Temp 98.4 B/P 100/72 P: 90. Given CLEOCIN 600 mg IM & Tramadol for pain Rx Clindamycin 150 mg x 80 tabs.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Patients developed rash 1 day after getting shot went to emergency room and was advised to take BENADRYL. Came to pharmacy on 11/14/11 - mentioning rash to pharmacist - said rash on trunk. Advised pt to take BENADRYL (he had not taken any yet). Patient's chiropractor called pharmacy 11/15/11 at approximately 14 hrs - said rash had spread & was very severe, over trunk, back and legs.
Age: 1.19
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Intensive care, Rash, Urticaria, Vomiting
Clinical narrative: Rash, hives, vomiting - onset 15 minutes after vaccines administered - given Epinephrine and BENADRYL - admitted to ICU x 1 day.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Gave injection & pt said she felt lightheaded. Said she had not eaten & felt lightheaded & wanted me to call EMS. Her BP dropped but came back up. She laid down on floor & felt better EMS check her out & released her.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Injection site inflammation, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Fever, stomach cramps, nausea at first then got local inflammation at site of administration with swelling & soreness. She said her physician diagnosed it was staph infection.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Staphylococcal infection
Clinical narrative: Fever, stomach cramps, nausea at first then got local inflammation at site of administration with swelling & soreness. She said her physician diagnosed it was staph infection.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient complain about severe pain in arm where she received flu shot, with feeling of hot, tenderness and redness around it. Patient saw Dr and got Ibuprofen, PEPCID & Hydrocortisone and feeling better after couple days of therapy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling started on Sun, 11/13 in the area of the injection. 2-3" diameter of redness, with swelling, itchiness; burning and pain when scratched area.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Fall, Head injury, Headache
Clinical narrative: GARDASIL 0.5ml IM given in LD. Within 2-3 min client became pale then immediately limp, fell to her right, and struck her head on the table on her right, followed by a 5-10 sec seizure as we righted her body to lie her on the floor (head and torso twitching). Within 1 min of twitch ceasing client was layed on the floor and alert. Client then answered appropriately to questions that her step-mother asked her. Ice was applied to quarter size knot on the rt outer forehead x 15 min. Client pale and cool. Client reported at this time that she did not remember hitting her head, but was aware of her head and torso twitching, but could not speak. BP 80/40 with very thready pulse. 10:30 Child sat up and stated that she was lightheaded. BP 70/30 pulse very thready (lying down). 1100 am Child sat up then moved to a chair. C/O lightheadedness and pain where she hit her head. Color - pale. Moved to a cot in the room with HOB elevated. 1115 C/O being cold. Given bottle of cold water. Small individual room heater placed in room. Father present. 1130 Color good, warm/dry, BP 100/60 lying; BP 100/60 after walking around the room. Pulse strong/steady & regular at 806pm. Father left. 1145 Client asking to leave. Ambulated with supervision to step-mother's vehicle. I/S provided to step-mother on signs/symptoms that would require ER care. 11-11-11 3:10 pm At home: Continues to c/o H/A otherwise acting normally as indicated by step-mother per phone.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Muscle twitching, Pallor, Pulse abnormal
Clinical narrative: GARDASIL 0.5ml IM given in LD. Within 2-3 min client became pale then immediately limp, fell to her right, and struck her head on the table on her right, followed by a 5-10 sec seizure as we righted her body to lie her on the floor (head and torso twitching). Within 1 min of twitch ceasing client was layed on the floor and alert. Client then answered appropriately to questions that her step-mother asked her. Ice was applied to quarter size knot on the rt outer forehead x 15 min. Client pale and cool. Client reported at this time that she did not remember hitting her head, but was aware of her head and torso twitching, but could not speak. BP 80/40 with very thready pulse. 10:30 Child sat up and stated that she was lightheaded. BP 70/30 pulse very thready (lying down). 1100 am Child sat up then moved to a chair. C/O lightheadedness and pain where she hit her head. Color - pale. Moved to a cot in the room with HOB elevated. 1115 C/O being cold. Given bottle of cold water. Small individual room heater placed in room. Father present. 1130 Color good, warm/dry, BP 100/60 lying; BP 100/60 after walking around the room. Pulse strong/steady & regular at 806pm. Father left. 1145 Client asking to leave. Ambulated with supervision to step-mother's vehicle. I/S provided to step-mother on signs/symptoms that would require ER care. 11-11-11 3:10 pm At home: Continues to c/o H/A otherwise acting normally as indicated by step-mother per phone.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Pt had a febrile seizure the day after MMR. Has had a febrile sz history, family  h/o of seizures (mom & brother). Pt treated & released from E/R stable.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling & warmth, pain c/o (R) upper arm. No fever or chills TORADOL 60 mg IM given. Patient advised to use warm compresses to area. Call or return to clinic if increase redness, streaking or edema. Advised to not get pneumonia shot again.
Age: 18.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Blood glucose normal, Bundle branch block right, Electrocardiogram abnormal, Sinus bradycardia, Syncope
Clinical narrative: Patient received an intranasal FLUMIST, Tdap IM and MCV4 IM. He had a brief syncope episode (possible vaccine reaction) after receiving IM vaccines, sent to ER via EMS.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Vaccination complication
Clinical narrative: Case number PHEH2011US08392 is an initial spontaneous report received from consumer on 01 Nov 2011: This case refers to 76-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly on 20 Sep 2011. About a week later she experienced pain in the shoulder and general fatigue. On 24 Oct 2011 her knees began to swell until they were approximately a foot across. When her orthopedic specialist examined and drained the fluid from her knee, the fluid was a faint green. Physician also conducted several blood tests for lyme disease and gout and the results were negative. The causality and event outcome were not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Borrelia test negative, Condition aggravated, Fatigue, Joint fluid drainage
Clinical narrative: Case number PHEH2011US08392 is an initial spontaneous report received from consumer on 01 Nov 2011: This case refers to 76-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly on 20 Sep 2011. About a week later she experienced pain in the shoulder and general fatigue. On 24 Oct 2011 her knees began to swell until they were approximately a foot across. When her orthopedic specialist examined and drained the fluid from her knee, the fluid was a faint green. Physician also conducted several blood tests for lyme disease and gout and the results were negative. The causality and event outcome were not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint swelling, Musculoskeletal pain, Synovial fluid analysis
Clinical narrative: Case number PHEH2011US08392 is an initial spontaneous report received from consumer on 01 Nov 2011: This case refers to 76-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly on 20 Sep 2011. About a week later she experienced pain in the shoulder and general fatigue. On 24 Oct 2011 her knees began to swell until they were approximately a foot across. When her orthopedic specialist examined and drained the fluid from her knee, the fluid was a faint green. Physician also conducted several blood tests for lyme disease and gout and the results were negative. The causality and event outcome were not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Headache, Lethargy, Malaise, Nausea, Pain
Clinical narrative: Vomiting occurred 2 days after receiving vaccine.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting occurred 2 days after receiving vaccine.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Electrocardiogram, Hypertension, Influenza like illness, Laboratory test
Clinical narrative: BP was 213/117. Mother received vaccine on 10/19. The next day she was fine. On 10/21 she woke up with aching muscles and joints. She tried to be active all day. I spoke with her around 3:30 PM & said "try to make an appt. with your doctor". She went in to the Dr's at 4:30 PM. She was short of breath, disoriented, weak & joints still sore. The Dr. gave her a breathing treatment & called me to take her to the emergency rm. Full tests given - said she had flu-like symptoms - sent home. Still sick 2 more days. Blood pressure is still dangerously high. Dr. is concerned.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Myalgia, Urine analysis, X-ray
Clinical narrative: BP was 213/117. Mother received vaccine on 10/19. The next day she was fine. On 10/21 she woke up with aching muscles and joints. She tried to be active all day. I spoke with her around 3:30 PM & said "try to make an appt. with your doctor". She went in to the Dr's at 4:30 PM. She was short of breath, disoriented, weak & joints still sore. The Dr. gave her a breathing treatment & called me to take her to the emergency rm. Full tests given - said she had flu-like symptoms - sent home. Still sick 2 more days. Blood pressure is still dangerously high. Dr. is concerned.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Disorientation, Dyspnoea, Hypertension
Clinical narrative: BP was 213/117. Mother received vaccine on 10/19. The next day she was fine. On 10/21 she woke up with aching muscles and joints. She tried to be active all day. I spoke with her around 3:30 PM & said "try to make an appt. with your doctor". She went in to the Dr's at 4:30 PM. She was short of breath, disoriented, weak & joints still sore. The Dr. gave her a breathing treatment & called me to take her to the emergency rm. Full tests given - said she had flu-like symptoms - sent home. Still sick 2 more days. Blood pressure is still dangerously high. Dr. is concerned.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza like illness, Malaise, Myalgia
Clinical narrative: BP was 213/117. Mother received vaccine on 10/19. The next day she was fine. On 10/21 she woke up with aching muscles and joints. She tried to be active all day. I spoke with her around 3:30 PM & said "try to make an appt. with your doctor". She went in to the Dr's at 4:30 PM. She was short of breath, disoriented, weak & joints still sore. The Dr. gave her a breathing treatment & called me to take her to the emergency rm. Full tests given - said she had flu-like symptoms - sent home. Still sick 2 more days. Blood pressure is still dangerously high. Dr. is concerned.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Onset of shingles symptoms. Only previous exposure to varicella virus was from Varivax immunizations given in 1996.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Headache, Impaired driving ability, Metamorphopsia
Clinical narrative: Visual distortion and pain in left temporal area minor at first then became worse distortion at distances over time. Can not drive due to double vision distortion in left eye. Told possible palsy of eye, 6 cranial nerve. Vision corrected when treated with Prism lens by eye doctor.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Decreased appetite, Dysphonia, Nasal congestion
Clinical narrative: Fever & hoarseness 10/27/11 onset x 5 days duration; maximum temperature 101.5 degrees F. Cough, sore throat & nasal congestion 10/28/11 onset x 2-3 day duration. Decreased appetite & "weakness" 10/28/11 onset x 3-4 days.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever & hoarseness 10/27/11 onset x 5 days duration; maximum temperature 101.5 degrees F. Cough, sore throat & nasal congestion 10/28/11 onset x 2-3 day duration. Decreased appetite & "weakness" 10/28/11 onset x 3-4 days.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Pharyngeal oedema
Clinical narrative: Information has been received from a Registered Nurse concerning a 24 year old female with no drug reactions/allergies and no pertinent medical history who on 27-OCT-2011 was vaccinated with a dose of GARDASIL (Lot# 669796/0840AA, expiration date 14-OCT-2013), intramuscularly. There was no concomitant medication. The nurse reported that on 28-OCT-2011 the patient's throat swelled up and her eyes became swollen. The patient went to the emergency room. No lab diagnostics study was performed. BENADRYL, TORADOL and REGLAN were given for the adverse effects. The patient was recovered by 07-NOV-2011. All the adverse effects were considered to be life-threatening by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient had painful swelling at vaccine site for three days.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pharmacist administered flu shot into my shoulder. Pain started next day and increased. Received cortisone shot on Nov. 8. Still having pain and limited movement of arm/shoulder.
Age: 0.96
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: Flu vaccine 10-28-2011, that day f's & that night febrile seizure. Also dx with viral illness 10-28-11 - no fever at the visit.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate decreased, Tachycardia
Clinical narrative: Given vaccine, returned within one hour tachycardia 150 AP. Observation 1.5 hour pulse decreased 106.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Alopecia, Condition aggravated, Epistaxis
Clinical narrative: Mother reports pt had hair loss following vaccination & an increase in freq. of nosebleeds. Pt states she was losing her hair prior to vaccination. Now has two bald patches. P/E N/L in regards to nosebleeds. Has hx of intermittent nosebleeds.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Throat tightness
Clinical narrative: Itchiness, swollen legs, throat tight, felt narrow.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: Information has been received from a Registered Nurse concerning a 58 year old female patient with generalized convulsive epilepsy and no drug reactions/allergies who on 28-SEP-2011, was vaccinated with a second dose of PNEUMOVAX 23 (Lot # 670187/0895AA; Exp. Date: 12-NOV-2012) 0.5 ml, intramuscularly in the right arm. Concomitant therapy included FLUVIRIN. The registered nurse reported that the patient experienced adverse reactions after receiving PNEUMOVAX 23. On 28-SEP-2011, the patient was experiencing right arm pain from the injection site down to her elbow that she rates as an 8-10 on a pain scale of 1-10 (where 10 was the most severe pain). The patient had very limited motion in her right arm, could not drive her car and had missed her work. The nurse stated that this patient had received a dose of PNEUMOVAX 23 at some unspecified time in the past. The patient sought medical attention visiting a urgent care clinic. VICODIN was given for the treatment of the events. It was unspecified if laboratory tests were performed. The registered nurse also reported that the patient stated that the VICODIN was not helping her with the pain. At the time of the report the patient had not recovered. The right arm pain from the injection site down to her elbow and the limited motion in her right arm were considered to be disabling by the registered nurse. A lot check for lot # 670187/0895AA has been initiated. Follow-up information has been received via telephone call from the registered nurse who stated that the patient was still having problems and was currently undergoing therapy (unspecified). Follow-up information has been received from the registered nurse concerning the patient. The patient's concurrent condition also include osteoporosis. She had no known drug allergies. The patient received the first dose of PNEUMOVAX 23 IM in right deltoid (number of prior dose also reported as 1 previously) on 28-SEP-2011. The patient had right shoulder pain. The pain was sharp and aggravated by movement. The pain was relieved by rest and "alier". She had decreased mobility and had difficulty lifting arm. At the time of reporting the patient had not recovered and still complained of pain in arm upon movement. Pain rated 5.6. Upon internal review, right shoulder pain was considered to be disabling. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a Registered Nurse concerning a 58 year old female patient with generalized convulsive epilepsy and no drug reactions/allergies who on 28-SEP-2011, was vaccinated with a second dose of PNEUMOVAX 23 (Lot # 670187/0895AA; Exp. Date: 12-NOV-2012) 0.5 ml, intramuscularly in the right arm. Concomitant therapy included FLUVIRIN. The registered nurse reported that the patient experienced adverse reactions after receiving PNEUMOVAX 23. On 28-SEP-2011, the patient was experiencing right arm pain from the injection site down to her elbow that she rates as an 8-10 on a pain scale of 1-10 (where 10 was the most severe pain). The patient had very limited motion in her right arm, could not drive her car and had missed her work. The nurse stated that this patient had received a dose of PNEUMOVAX 23 at some unspecified time in the past. The patient sought medical attention visiting a urgent care clinic. VICODIN was given for the treatment of the events. It was unspecified if laboratory tests were performed. The registered nurse also reported that the patient stated that the VICODIN was not helping her with the pain. At the time of the report the patient had not recovered. The right arm pain from the injection site down to her elbow and the limited motion in her right arm were considered to be disabling by the registered nurse. A lot check for lot # 670187/0895AA has been initiated. Follow-up information has been received via telephone call from the registered nurse who stated that the patient was still having problems and was currently undergoing therapy (unspecified). Follow-up information has been received from the registered nurse concerning the patient. The patient's concurrent condition also include osteoporosis. She had no known drug allergies. The patient received the first dose of PNEUMOVAX 23 IM in right deltoid (number of prior dose also reported as 1 previously) on 28-SEP-2011. The patient had right shoulder pain. The pain was sharp and aggravated by movement. The pain was relieved by rest and "alier". She had decreased mobility and had difficulty lifting arm. At the time of reporting the patient had not recovered and still complained of pain in arm upon movement. Pain rated 5.6. Upon internal review, right shoulder pain was considered to be disabling. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Rash, Rash erythematous
Clinical narrative: Information has been received from a physician assistant concerning a 61 year old male who on 26-OCT-2011 was vaccinated with 0.5ml PNEUMOVAX 23 (route and lot # not reported). Concomitant therapy included various unspecified medications. On 26-OCT-2011 the patient experienced arm swelled up with a red "infectious looking" rash that went down the whole arm. The patient was working with their healthcare provider to address the situation. The patient was given "RODEPHEN" and other unspecified medication to treat the events. Vaccine with PNEUMOVAX 23 was discontinued. On 29-OCT-2011 the patient recovered from all the events. The reporter considered that red "infectious looking" rash that went down the whole arm and arm swelled up to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who in August 2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # unspecified by reporter) (dose and route not reported). In August 2011, the patient still developed shingles a week after getting ZOSTAVAX (Merck). The patient sought unspecified medical attention. And on an unknown date the patient recovered. The reporter considered the event to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test, Cholecystectomy, Decreased appetite, Gallbladder non-functioning
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history and no drug reaction or allergy who on 22-FEB-2011 and 08-JUL-2011 was vaccinated with the first dose of GARDASIL (lot number: 666595/0096Z; Expiration date: 12-OCT-2014) and the second dose of GARDASIL (lot number: 669308/0636AA; Expiration date: 11-AUG-2013) respectively. There was no concomitant medication. On 09-JUL-2011 the patient complained of abdominal pain, nausea and decreased appetite after receiving the second dose of GARDASIL. The patient did not have any problem with the first dose. The patient saw the physician and was given PRILOSEC for treatment. Gastrointestinal (GI) test and blood work were performed without results. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician concerning the female patient. The patient had no illness at time of vaccination. The patient received the second dose of GARDASIL (lot number: 669308/0636AA) in left arm (route not reported). One day post the second dose, on 09-JUL-2011 the patient had nausea and abdominal pain. She did not improve on PRILOSEC. Cholecystokinin (CCK) test/ Hepatobiliary Imino-Diacetic Acid (HIDA) scan of abdomen showed non-functioning gallbladder. The patient had laparotomy (LAP) and cholecystectomy on 15-SEP-2011 with complete recovery. Upon internal review, non-functioning gallbladder required laparotomy and cholecystectomy was considered to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatobiliary scan, Hepatobiliary scan abnormal, Laparotomy, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history and no drug reaction or allergy who on 22-FEB-2011 and 08-JUL-2011 was vaccinated with the first dose of GARDASIL (lot number: 666595/0096Z; Expiration date: 12-OCT-2014) and the second dose of GARDASIL (lot number: 669308/0636AA; Expiration date: 11-AUG-2013) respectively. There was no concomitant medication. On 09-JUL-2011 the patient complained of abdominal pain, nausea and decreased appetite after receiving the second dose of GARDASIL. The patient did not have any problem with the first dose. The patient saw the physician and was given PRILOSEC for treatment. Gastrointestinal (GI) test and blood work were performed without results. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician concerning the female patient. The patient had no illness at time of vaccination. The patient received the second dose of GARDASIL (lot number: 669308/0636AA) in left arm (route not reported). One day post the second dose, on 09-JUL-2011 the patient had nausea and abdominal pain. She did not improve on PRILOSEC. Cholecystokinin (CCK) test/ Hepatobiliary Imino-Diacetic Acid (HIDA) scan of abdomen showed non-functioning gallbladder. The patient had laparotomy (LAP) and cholecystectomy on 15-SEP-2011 with complete recovery. Upon internal review, non-functioning gallbladder required laparotomy and cholecystectomy was considered to be an other important medical event. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperventilation, Lung infection, Vomiting
Clinical narrative: Symptoms began 3-4 hours after flu shot. Vomiting, chills, hyperventilation. Went to Dr. in the ER, was admitted to hospital with lung infection and treated with LEVAQUIN. Doctor did not think it was related to flu shot.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test, Loss of consciousness
Clinical narrative: Within 1st 24 hours after influenza vaccine, patient had pain, warmth & swelling at site of injection (rt deltoid). Patient then developed fever and passed out 20 hours later. Patient taken to hospital. Tests performed did not attribute patient's condition to flu shot. Patient released after about 24 hrs in normal condition.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Within 1st 24 hours after influenza vaccine, patient had pain, warmth & swelling at site of injection (rt deltoid). Patient then developed fever and passed out 20 hours later. Patient taken to hospital. Tests performed did not attribute patient's condition to flu shot. Patient released after about 24 hrs in normal condition.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest discomfort, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Tightness in chest. 5 mins. heat in chest. Extreme swelling in upper arm radiating below elbow to lower arm. Severe swelling and pain in arm. Extreme heat & redness in arm. Prednisone 10mg, cefadroxil 500mg, PRO-AIR HFA, MUCINEX DM.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Tightness in chest. 5 mins. heat in chest. Extreme swelling in upper arm radiating below elbow to lower arm. Severe swelling and pain in arm. Extreme heat & redness in arm. Prednisone 10mg, cefadroxil 500mg, PRO-AIR HFA, MUCINEX DM.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure increased, Chest pain, Chills, Dyspnoea
Clinical narrative: Pt was having chest pain, itching on injection site, redness, shortness of breath, chills, increased B/P, anxiety.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt was having chest pain, itching on injection site, redness, shortness of breath, chills, increased B/P, anxiety.
Age: 42.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Pt stated she had fever of 102 degrees and achiness.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: The day following immunization, upper arm became red, blistered, edematous, painful and lethargic.  Site observed on 10/27/11, had irregular area 3" X 1" at injection site that appeared crusted over, no longer swollen, red or warm to touch.  States it remains lethargic, told to contact PCP if remains that way.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Lethargy, Scab
Clinical narrative: The day following immunization, upper arm became red, blistered, edematous, painful and lethargic.  Site observed on 10/27/11, had irregular area 3" X 1" at injection site that appeared crusted over, no longer swollen, red or warm to touch.  States it remains lethargic, told to contact PCP if remains that way.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initially it was typical soreness at injection site but the pain has become progressively worse and has impacted range of motion in left shoulder currently 3 weeks post immunization.
Age: 2.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Appeared to be a raised, swollen, red area on the thigh right where the vaccine was injected.  You can still see the "pinhole" where the needle entered the skin.  Area was approximately 2 1/2 inches long and about 1- 1 1/2 inches wide.  Child said it hurt, was sore to the touch.  Very inflamed.  Took child to physician on Monday, 11/14 where she was diagnosed with a skin infection and put on antibiotics.  Now a gland in her groin is also swollen, reported this to physician today, 11/16.
Age: 2.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Skin infection
Clinical narrative: Appeared to be a raised, swollen, red area on the thigh right where the vaccine was injected.  You can still see the "pinhole" where the needle entered the skin.  Area was approximately 2 1/2 inches long and about 1- 1 1/2 inches wide.  Child said it hurt, was sore to the touch.  Very inflamed.  Took child to physician on Monday, 11/14 where she was diagnosed with a skin infection and put on antibiotics.  Now a gland in her groin is also swollen, reported this to physician today, 11/16.
Age: 0.59
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RVX
Symptoms: Intussusception, Respiratory arrest, Ultrasound scan abnormal, Vomiting
Clinical narrative: Child awakened from nap had a few seconds where he stopped breathing, had a bout of emesis. Came to emergency department and had ultrasound confirmation of intussusception.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash erythematous, Rash macular
Clinical narrative: Pruritis and red splotchy rash--treated immediately with Benadryl 25mg IM and resolved by 02:30 PM 11/14/2011.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hyperaesthesia, Joint range of motion decreased, Joint swelling, Maternal exposure during pregnancy
Clinical narrative: Vaccination was the 2011-2012 Fluzone Preservative free vaccine.  Started as what seem to be a sore neck that was attributed the aches and pains that could follow, then because a full on neck spasm and sensitive to the touch. Went to the ER for hours and prescribed pain meds.  Since that time, nerve pain has extended to shoulders (7 days later) wrists, thumbs, and elbows.  All have swelling of nerves and joints.  Inability to move joints.  Tylenol does not work nor does heat/cold.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Neck pain, Neuralgia, Pain, Tenderness
Clinical narrative: Vaccination was the 2011-2012 Fluzone Preservative free vaccine.  Started as what seem to be a sore neck that was attributed the aches and pains that could follow, then because a full on neck spasm and sensitive to the touch. Went to the ER for hours and prescribed pain meds.  Since that time, nerve pain has extended to shoulders (7 days later) wrists, thumbs, and elbows.  All have swelling of nerves and joints.  Inability to move joints.  Tylenol does not work nor does heat/cold.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Vaccination was the 2011-2012 Fluzone Preservative free vaccine.  Started as what seem to be a sore neck that was attributed the aches and pains that could follow, then because a full on neck spasm and sensitive to the touch. Went to the ER for hours and prescribed pain meds.  Since that time, nerve pain has extended to shoulders (7 days later) wrists, thumbs, and elbows.  All have swelling of nerves and joints.  Inability to move joints.  Tylenol does not work nor does heat/cold.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: About 1 hour after injection became dizzy and had severe headache.  This lasted 9 hours.  About 9 hours after injection, had fever of 102.1 and felt nauseous.  Vomited times three.  Fever and vomiting lasted six hours.  Didn't feel well for an additional 12 hours.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: About 1 hour after injection became dizzy and had severe headache.  This lasted 9 hours.  About 9 hours after injection, had fever of 102.1 and felt nauseous.  Vomited times three.  Fever and vomiting lasted six hours.  Didn't feel well for an additional 12 hours.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Muscular weakness, Pain
Clinical narrative: Weakness in the muscle where flu shot was given: could not lift left arm and felt sore while lifting. It took more than 3 weeks to resolve.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site vesicles
Clinical narrative: 3 blisters around inoculation site.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arrhythmia, Body temperature increased, Chills, Headache, Pain
Clinical narrative: Severe body aches, temp of 102, h/a, heart arrythmia, severe shaking chills; episodes repeated every 4-6 wks for 14 months with symptoms less severe and episode shorter; no episodes for 6 months then another severe one on 11/5/11.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Pain, Pain in extremity, Palpitations
Clinical narrative: 24 hours after the vaccine was administered, patient developed a low grade fever and sore arm.  She took Advil.  At 3:30 pm she spiked a fever and had chills.  6:30 pm her heart was racing, temp 103.5.  She called her MD on call.  He recommended Benadryl (patient did not have any) and cold compresses.  8:30 pm Temp 102.  11-11-11 2 Am Had chills and temp 102.  Took Tylenol.  Woke in am with achiness and continued painful right arm.  Temp now gone but arm painful with resistence.  She said the arm does not have redness or swelling but there is a bruise.  She said it does not appear infected.  I recommended she follow up with her provider if the arm does not improve and could try warm compresses or ice (which ever felt better to her to help decrease the pain.  On a scale of 1-10, at it's worst the pain was a 7 and now is a 2.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 24 hours after the vaccine was administered, patient developed a low grade fever and sore arm.  She took Advil.  At 3:30 pm she spiked a fever and had chills.  6:30 pm her heart was racing, temp 103.5.  She called her MD on call.  He recommended Benadryl (patient did not have any) and cold compresses.  8:30 pm Temp 102.  11-11-11 2 Am Had chills and temp 102.  Took Tylenol.  Woke in am with achiness and continued painful right arm.  Temp now gone but arm painful with resistence.  She said the arm does not have redness or swelling but there is a bruise.  She said it does not appear infected.  I recommended she follow up with her provider if the arm does not improve and could try warm compresses or ice (which ever felt better to her to help decrease the pain.  On a scale of 1-10, at it's worst the pain was a 7 and now is a 2.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Malaise
Clinical narrative: Arm where shot administered became red and swollen, and painful to touch. Did not notify employee health at that time, because it seems like a normal local reaction, however didn't feel well at about 12:30 PM and left work.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Administration site rash
Clinical narrative: Rash on thighs at sites of vaccine administration.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blindness cortical, Cardiac arrest, Convulsion, Endotracheal intubation, Hypoglycaemia
Clinical narrative: Presented to ED after 24 hours of minimal po intake and poor responsiveness. Initially asystolic, hypoglycemic (27) with profound metabolic acidosis. Intubated 20 hours after PICU admission when generalized seizures began. Mechanical ventilation x 5 days. Extensive metabolic work up, high glucose/insulin infusion. Discharged on Topiramate & Phenobarb with evidence of hypoxic encephalopathy & suspect cortical blindness.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypophagia, Hyporesponsive to stimuli, Hypoxic-ischaemic encephalopathy, Intensive care, Mechanical ventilation
Clinical narrative: Presented to ED after 24 hours of minimal po intake and poor responsiveness. Initially asystolic, hypoglycemic (27) with profound metabolic acidosis. Intubated 20 hours after PICU admission when generalized seizures began. Mechanical ventilation x 5 days. Extensive metabolic work up, high glucose/insulin infusion. Discharged on Topiramate & Phenobarb with evidence of hypoxic encephalopathy & suspect cortical blindness.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Metabolic acidosis, Metabolic function test
Clinical narrative: Presented to ED after 24 hours of minimal po intake and poor responsiveness. Initially asystolic, hypoglycemic (27) with profound metabolic acidosis. Intubated 20 hours after PICU admission when generalized seizures began. Mechanical ventilation x 5 days. Extensive metabolic work up, high glucose/insulin infusion. Discharged on Topiramate & Phenobarb with evidence of hypoxic encephalopathy & suspect cortical blindness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Axillary nerve injury, Burning sensation, Electromyogram, Hypoaesthesia
Clinical narrative: Pain and burning immediately following vaccine. Fever in area at times. Up until the present time there is pain and burning over my body. X-ray, MRI, EMG, therapy, etc. Pain management is what I am doing now which still does not work. Steroids, cortisone, patches. I have tried them all. The Dr. want to block the nerve (nerve damage). Discussing acupuncture.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injury associated with device, Muscular weakness, Nerve injury, Nuclear magnetic resonance imaging
Clinical narrative: Pain and burning immediately following vaccine. Fever in area at times. Up until the present time there is pain and burning over my body. X-ray, MRI, EMG, therapy, etc. Pain management is what I am doing now which still does not work. Steroids, cortisone, patches. I have tried them all. The Dr. want to block the nerve (nerve damage). Discussing acupuncture.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain, Skin warm, X-ray
Clinical narrative: Pain and burning immediately following vaccine. Fever in area at times. Up until the present time there is pain and burning over my body. X-ray, MRI, EMG, therapy, etc. Pain management is what I am doing now which still does not work. Steroids, cortisone, patches. I have tried them all. The Dr. want to block the nerve (nerve damage). Discussing acupuncture.