chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: HPV4, PPV, FLU3, HPV4, PPV, FLU3, HPV4, PPV
Symptoms: Abdominal pain upper, Blood test abnormal, C-reactive protein increased, CSF white blood cell count, Headache
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated white blood cells in a 9-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), PNEUMO 23 (non-gsk) and GARDASIL. The subject's medical history included yeast infection. Concurrent medical conditions included asthma, environmental allergy and reflux (nos). Historic medications included DIFLUCAN. Concurrent medications included Loratadine, Albuterol, SINGULAIR and Ranitidine. On 6 November 2012 the subject received 1st dose of FLUARIX (.5 ml, intramuscular, left deltoid), 1st dose of PNEUMO 23 (unknown and 3rd dose of GARDASIL (unknown). On 07 November 2012, within 24 hours of vaccination with FLUARIX, GARDASIL and PNEUMO 23, the subject developed a fever. On 08 November 2012, two days after vaccinations, the subject required visit to an urgent care. The subject was sent to the local emergency department (ED) and admitted that same day. The healthcare professional reported a fever presented within 24 hours of vaccinations. The physician added that the subject also experienced headache, belly pain and muscle aches. The subject has an elevated white blood cell count that has increased from 8 to 22; she has white blood cell counts in her blood and spinal fluid. A spinal tap was performed in the ED. The physician stated "she was placed on intravenous antibiotic of Acyclovir and ROCEPHIN and other than the labs she looks wonderful today. However her labs look questionable for something other than just a typical flu type reaction. The subject's C - reactive protein (CRP) was very high, there were no RBCs. He stated that the labs were questionable for meningitis or encephalitis. The healthcare professional noted Merck has already been contacted and reported. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the fever, muscle pain, cerebrospinal fluid white cell count nos abnormal, 1 possible meningitis and possible encephalitis were unspecified. The elevated white blood cell count was unresolved and headache and abdominal pain had improved. The healthcare professional considered the events of elevated white blood cell count, headache, fever and abdominal pain were possibly related to vaccination with FLUARIX, PNEUMO 23 and GARDASIL.
Age: 9.0
Sex: F
Vaccine: HPV4, PPV, FLU3, HPV4, PPV, FLU3, HPV4, PPV
Symptoms: Influenza like illness, Lumbar puncture abnormal, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated white blood cells in a 9-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), PNEUMO 23 (non-gsk) and GARDASIL. The subject's medical history included yeast infection. Concurrent medical conditions included asthma, environmental allergy and reflux (nos). Historic medications included DIFLUCAN. Concurrent medications included Loratadine, Albuterol, SINGULAIR and Ranitidine. On 6 November 2012 the subject received 1st dose of FLUARIX (.5 ml, intramuscular, left deltoid), 1st dose of PNEUMO 23 (unknown and 3rd dose of GARDASIL (unknown). On 07 November 2012, within 24 hours of vaccination with FLUARIX, GARDASIL and PNEUMO 23, the subject developed a fever. On 08 November 2012, two days after vaccinations, the subject required visit to an urgent care. The subject was sent to the local emergency department (ED) and admitted that same day. The healthcare professional reported a fever presented within 24 hours of vaccinations. The physician added that the subject also experienced headache, belly pain and muscle aches. The subject has an elevated white blood cell count that has increased from 8 to 22; she has white blood cell counts in her blood and spinal fluid. A spinal tap was performed in the ED. The physician stated "she was placed on intravenous antibiotic of Acyclovir and ROCEPHIN and other than the labs she looks wonderful today. However her labs look questionable for something other than just a typical flu type reaction. The subject's C - reactive protein (CRP) was very high, there were no RBCs. He stated that the labs were questionable for meningitis or encephalitis. The healthcare professional noted Merck has already been contacted and reported. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the fever, muscle pain, cerebrospinal fluid white cell count nos abnormal, 1 possible meningitis and possible encephalitis were unspecified. The elevated white blood cell count was unresolved and headache and abdominal pain had improved. The healthcare professional considered the events of elevated white blood cell count, headache, fever and abdominal pain were possibly related to vaccination with FLUARIX, PNEUMO 23 and GARDASIL.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Contusion, Fatigue, Full blood count, Haemorrhage
Clinical narrative: Heavy bleeding & bruising only days after the Gardasil Vaccine. Extreme fatigue, blood platelet count decreased to 20,000 and I was referred to a Hematologist. Diagnosed with ITP after several tests for other causes and biopsy.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Laboratory test, Platelet count decreased
Clinical narrative: Heavy bleeding & bruising only days after the Gardasil Vaccine. Extreme fatigue, blood platelet count decreased to 20,000 and I was referred to a Hematologist. Diagnosed with ITP after several tests for other causes and biopsy.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Cellulitis, Lymph node pain
Clinical narrative: Began with pain under vaccinated arm with pain into lymph nodes across chest and breast bilaterally.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Dizziness, Headache, Incoherent, Lethargy, Vomiting
Clinical narrative: Patient had headache, lethargy, dizziness, vomiting, and incoherence.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Viral infection
Clinical narrative: Fever to 101.8 degrees Rectal temp, likely secondary to immunization, vs viral syndrome, several hours after 9/25/12 influenza vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Abdominal discomfort, Anaphylactic reaction, Eyelid oedema, Lacrimation increased, Lip swelling
Clinical narrative: 5-10 minutes developed anaphylaxis: Eye wateriness, puffiness. Abdominal discomfort. Hives. Swollen lips/tongue. Tachycardia. Given epinephrine and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Swollen tongue, Tachycardia, Urticaria
Clinical narrative: 5-10 minutes developed anaphylaxis: Eye wateriness, puffiness. Abdominal discomfort. Hives. Swollen lips/tongue. Tachycardia. Given epinephrine and BENADRYL.
Age: 89.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site discolouration, International normalised ratio increased
Clinical narrative: Patient's wife reported to the pharmacy that patient had recently had his annual influenza vaccination at his PCP's office. Patient is also on warfarin anticoagulation therapy, as well as undergoing an unknown chemotherapy regimen. Patient's wife reported the patient's entire arm where immunization was given was black and blue, including the underside of the arm. The patient reported the event to his PCP and Oncologist. The patient's INR was taken and found to be elevated, but that information was not provided. Patient normally takes 5-7mg warfarin daily, but was instructed to hold warfarin therapy until his INR was back into therapeutic range. It is unknown what other medications the patient is currently taking including chemotherapy drugs-, or if there were other factors affecting the patient's INR value. The patient was not hospitalized, and has recovered without further incident.
Sex: F
Vaccine: PNC13
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a non-clinical study program. The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow up information on 08Nov2012, this case now contains all required information to be considered valid. A contactable consumer reported that her daughter (age and Ethnicity unknown) received PREVNAR 13 on an unknown date for immunization. Consumer reported that the vaccine was crossed out and then a new one was written in (she stated that a first number was crossed out 4998092 and the other number written next to it 4988715). The reporter later stated that she was not sure what type of the vaccine her child received. The consumer reported that when she brought her child home "she blank out on her".
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy / facial paralysis Left side.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain in extremity, Rash pruritic
Clinical narrative: Extreme headache, pain in upper arm, cold chills, itchy rash.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Scattered red blanching papules to LE.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus generalised, Urticaria
Clinical narrative: Hives, pimples, welts itching primarily on upper back, around waist, upper arms, upper legs.  Back red.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain of skin
Clinical narrative: Note: intradermal flu vaccine given. Pain in injection arm and loss of mobility in at shoulder joint worsening with time up to and including today. Pain is deep in shoulder joint, not just surface/skin pain. I will now seek medical help.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Chest discomfort, Cough, Eye discharge, Face oedema
Clinical narrative: Bilateral Red eyes, eye drainage, facial edema, cough, tightness-pressure in chest, sore throat, head ache, eye pressure, "felt lousy" for 24-36 hours.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Bilateral Red eyes, eye drainage, facial edema, cough, tightness-pressure in chest, sore throat, head ache, eye pressure, "felt lousy" for 24-36 hours.
Age: 50.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast swelling, Breast tenderness, Chills, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Awoke with shivers, fever 101.2' intense left chest wall pain and left breast tenderness, followed by left breast swelling over next 2 days; had MMR and TB tine admin. In left arm; no symptoms to right breast or right chest wall; no redness or bruising to injection sites or elsewhere.
Age: 50.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast swelling, Chills, Pyrexia, Tremor
Clinical narrative: Awoke with shivers, fever 101.2' intense left chest wall pain and left breast tenderness, followed by left breast swelling over next 2 days; had MMR and TB tine admin. In left arm; no symptoms to right breast or right chest wall; no redness or bruising to injection sites or elsewhere.
Age: 1.11
Sex: F
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Mom noticed a small red area where the Prevnar was given.  Mom kept an eye on it, about a week later she noticed that it was redder and had a knot under the it.  She states that it was very red and it grew larger, about an inch.  Used OTC hydrocortisone and it didn't really help that much.  Mom states that it does not hurt patient, she will move her leg without pain.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Foetal death, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Pregnancy loss.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Cold sweat, Headache, Nausea, Somnolence
Clinical narrative: Cold sweats, joint pain, headache, sleepiness, nausea, vomiting.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Cold sweats, joint pain, headache, sleepiness, nausea, vomiting.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Eating disorder, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Hoarseness; Fever 102.4; Runny nose; Not eating; Whiny.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Sensation of pressure
Clinical narrative: Great amount of pressure at time of Pnuemo vaccination. Later in day, Lt arm very sore unable to move away from body.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Fever of 102, redness and sore for 3 days.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, general discomfort.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Haemolytic uraemic syndrome, Intensive care, Plasmapheresis, Thrombotic thrombocytopenic purpura, Transfusion
Clinical narrative: TTP-HUS (Thrombotic Thrombocytopenic Purpura - Hemolytic Uremic Syndrome) treated with plasmapheresis and blood transfusions. 4 days in ICU.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site scar, Laboratory test, Mobility decreased
Clinical narrative: Injection site of upper right arm was very sore later that evening. She rubbed the area and applied cold compress. By the next day she could barely lift up her arm. She then took some ibuprofen and continued stretching and icing the arm. She went to her chiropractic doctor and he said she had a knot of scar tissue at the site of injection. The chiropractor initiated "Star" therapy to break up the area and will do 2 to 3 treatments. The patient stated that this does seem to help.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Oral herpes, Pain, Rash
Clinical narrative: Initial case was retrieved from the scientific literature on 06 November 2012. The following was copied verbatim from the literature case: "A 28-year-old man, with history of varicella as a child, was referred for a painful rash. He was in excellent health until about 2 weeks prior when he received an influenza vaccine. The following day, he noted the development of a cold sore on his lip. He was treated with over the counter medications. About 1 week later, he developed a burning-like pain across the mid-back and then noted a rash. Examination revealed a rash consistent with herpes zoster, just lateral to the midline of the back, at the level of T9. The remainder of the examination was normal. Setting: Outpatient. Results or Clinical Course: The rash had resolved. However, the patient continued to have pain and was started on gabapentin and provided with a TENs unit, which helped to resolve the pain. Discussion: Reactivation of the herpes virus appears to be influenced by age-related immunosenescence, disease-related immunocompromise, or iatrogenic immunosuppression. Studies have shown that the incidence of zoster increases 10-fold with age. It is estimated that approximately 50% of persons who live to age 85 will have an episode of zoster. The virus infects nerve endings in skin and migrates along sensory axons to establish latency in neurons within the regional ganglia. Once reactivation occurs, the virus can spread to other cells within the ganglion and thereby establish infection of the skin. Following viral reactivation, the dorsal spinal ganglion typically exhibits intense inflammation, accompanied by hemorrhagic necrosis of nerve cells. The ganglion undergoes eventual neuronal loss with subsequent fibrosis of afferent nerve fibers, particularly type C nociceptors. One of the goals of antiviral therapy is to reduce the incidence or severity of postherpetic neuralgia (PHN). Antiviral therapy likely reduces neural damage, which may contribute to the development of PHN. Several studies have demonstrated that treatment for herpes zoster reduced the duration and incidence of prolonged pain. Pain management should include use of standardized pain measures and the use of analgesics. If moderate to severe pain continues despite these interventions, steroids can be considered. Conclusions: There is no known case in the literature of the influenza vaccine leading to shingles. In this patient, the influenza vaccine appears to have reactivated the latent HSV-1 & HSV-3 viruses." The patient's outcome was not reported. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Decreased appetite, Erythema, Malaise, Oedema peripheral
Clinical narrative: Left arm swelled significantly red area > 10 cm. Malaise, loss of appetite. Temperature of 101-102 degrees 1-2 days later lump in arm for 3 weeks.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Upper extremity mass
Clinical narrative: Left arm swelled significantly red area > 10 cm. Malaise, loss of appetite. Temperature of 101-102 degrees 1-2 days later lump in arm for 3 weeks.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Had rash & itching on arms & torso.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Laboratory test abnormal, Pyrexia, Vomiting
Clinical narrative: When parents returned with infant for 4 mo. Immunizations, they reported that he & his twin became ill with high fever (103-104 degrees F), vomiting & diarrhea within 24 hrs of 2 mo Immunizations. Both were hospitalized and received IV therapy.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site abscess, Oedema peripheral
Clinical narrative: Upper arm swelling and erythema after second half of flu vaccine (FLUVIRIN).
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Arm tender to the touch, mild swelling, redness of deltoid.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: First flu shot given 11-18-12 approx 110 pm. Patient reported feeling lightheaded, dizzy, no itch, redness, rash or change in breathing reported. Recommended watching in area until sx resolve. 70% better after 15 min. After 40 min still no sign of anaphylaxis S.S. Left store. I checked in 2 1/2 hrs later, husband reported "she was very much better, all time."
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: Public Health Nurse went to local program to administer flu vaccine to children at a flu shot clinic. School nurse gave each parent a IZ consent form and IZ questionnaire to fill out in advance of flu shot clinic visit. Parent of this child wrote down that child did not have asthma on the questionnaire. During flu shot clinic at the program, a child was inadvertently given a single 0.2 ml dose of intranasal MedImmune - lot # AJ 2025 - FLUMIST flu vaccine instead of injectable flu vaccine. This is contraindicated as asthma sufferers are to be given only injectable flu vaccine. PHN contacted parent to request that family watch child for an increased risk of wheezing after the administration of the vaccine. PHN explained that any wheezing or difficulty breathing should be addressed by physician. If severe, child should be taken to the nearest emergency room. Parent said that they would monitor the child closely.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Patient had breakout of rash from neck to ear on (R) side. After injection she felt low grade fever. Her glands were swollen. The rash was blistering. The symptoms resolved after about 4-5 days.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm for nearly one month, worst a couple days after vaccination, getting a little better, but still sore. No rash, itching or lump.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Paraesthesia, Paraesthesia oral, Paralysis
Clinical narrative: The patient had tingling & paralysis in right side of mouth. He also had tingling right arm. These resolved in a few days. The patient has also been exhausted w/ a cough since the Thursday after the shot.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Pain and extreme swelling in (R) arm. Redness pain with mobility to ER 10/13/12 received IM ROCEPHIN and script for PO CLEOCIN. Started vomiting and took only a couple of antibiotics. Later put on BACTRIM.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Pain and extreme swelling in (R) arm. Redness pain with mobility to ER 10/13/12 received IM ROCEPHIN and script for PO CLEOCIN. Started vomiting and took only a couple of antibiotics. Later put on BACTRIM.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Pt received flu vaccine 11/8/12. Pt states he did not notice any symptoms until 2 days later 11/10/12, and at that time his left arm was itching and red. Pt denies any fever, swelling, shortness of breath, or any other symptoms at this time except redness to his left upper arm. Seen by physician today for follow up.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Aura, Vomiting
Clinical narrative: Patient had rainbow visual auras, followed by one episode of vomiting water she drank. Took blood pressure & pulse & they were normal.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, pain at injection site.
Age: 0.24
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: FLUZONE .25 ml given IM.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Erythema, Lip swelling, Oedema peripheral, Swollen tongue
Clinical narrative: Patient experienced swelling and redness of (L) arm beginning about 12 hours after vaccination; she also experienced some lip and tongue swelling within a few days.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Laboratory test abnormal, Pyrexia, Vomiting
Clinical narrative: When parents returned with infant for 4 mo. immunizations, reported that he and his twin became ill with fever, vomiting and diarrhea within 24 hrs of 2 mo immunizations. Fever of 103 progressed to vomiting/diarrhea. Hospitalized with IV fld. therapy.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pyrexia
Clinical narrative: Patient stated had neuropathy fingertips, fever 102, neuropathy involved both hands lasted about 12 hours. Fever about 12 hours. Patient stated took 1000mg TYLENOL. Patient did not contact Health Dept. regarding symptoms until 10/17/12. Patient stated was feeling better patient not sure of time of onset of symptoms on 10/15/12.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Pt left arm warm to touch, hard around and near injection site, pt states she talked to doctor prior nothing was done at doctors office.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Pt states she has burning rash on chest and stomach.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Pruritus, Throat tightness
Clinical narrative: Pt complained of throat-closing, itchy, red eyes, and coughing 5 hours after flu shot admnistered. Took Benadryl and all symptoms went away.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia
Clinical narrative: Patient stated 2 hours after receiving flu vaccine became dizzy, had nausea, fever, felt weak. Patient stated no fever on 10/23/12 still felt weak. Patient wife on phone stated he was still dizzy too no complaint of nausea on 10.23.12.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, CSF protein increased, Culture throat, Gait disturbance, Incontinence
Clinical narrative: URI 1-2 wks before this started. About October 29 started with leg pain, left first. Seen in ER 11-4-12 with leg pain & limping. Xrays normal -> given MOTRIN. Seen in this office 11-5 and unable to walk at school. Xrays, throat culture obtained. Seen ER 11-9-12 with inability to move muscles without pain sent home. Seen here 11-12-12 - pt incontinent as too much pain to sit & urinate.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain, Pain in extremity, Red blood cell sedimentation rate increased, Upper respiratory tract infection
Clinical narrative: URI 1-2 wks before this started. About October 29 started with leg pain, left first. Seen in ER 11-4-12 with leg pain & limping. Xrays normal -> given MOTRIN. Seen in this office 11-5 and unable to walk at school. Xrays, throat culture obtained. Seen ER 11-9-12 with inability to move muscles without pain sent home. Seen here 11-12-12 - pt incontinent as too much pain to sit & urinate.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: URI 1-2 wks before this started. About October 29 started with leg pain, left first. Seen in ER 11-4-12 with leg pain & limping. Xrays normal -> given MOTRIN. Seen in this office 11-5 and unable to walk at school. Xrays, throat culture obtained. Seen ER 11-9-12 with inability to move muscles without pain sent home. Seen here 11-12-12 - pt incontinent as too much pain to sit & urinate.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Injection site rash, Pruritus
Clinical narrative: 10/22/12 Rec'd p/c from pt stating after vaccination developed rash on (L) arm at site of injection. Itching, headache, afebrile, diaphoretic. Per RN 10/23/12 e-mail "had reaction to Flu shot".
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Nodule
Clinical narrative: Patient described as a knot on arm and became bruised, contacted her doctor who said it was an adverse reaction, has doctor appointment today 11/19/12.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain, numbness and tingling extending down into hands and fingers.  Has now persisted for about 5 weeks with no relief.  Still has limited range of motion, weakness in arm, numbness, tingling and pain.  Have seen doctor and received steroid pack which helped for the timeframe she was on the pack.  After it ended all symptoms returned.  She now has been referred to a physical therapist as well.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: X-ray limb normal
Clinical narrative: Extreme pain, numbness and tingling extending down into hands and fingers.  Has now persisted for about 5 weeks with no relief.  Still has limited range of motion, weakness in arm, numbness, tingling and pain.  Have seen doctor and received steroid pack which helped for the timeframe she was on the pack.  After it ended all symptoms returned.  She now has been referred to a physical therapist as well.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Extreme pain, numbness and tingling extending down into hands and fingers.  Has now persisted for about 5 weeks with no relief.  Still has limited range of motion, weakness in arm, numbness, tingling and pain.  Have seen doctor and received steroid pack which helped for the timeframe she was on the pack.  After it ended all symptoms returned.  She now has been referred to a physical therapist as well.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: About 30 min. to an hr, pt reported "tingling" in left arm. Pt stated that her left arm was cold & numb down to her fingers. Pt was instructed to take TYLENOL, ice the area, & to see a physician or nurse practitioner. 10 TENS later, pt reported that she was still having problems and that she saw a physician at a sports medicine clinic. As of 11/19/12 pt. is still having problems.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: X-ray limb normal
Clinical narrative: About 30 min. to an hr, pt reported "tingling" in left arm. Pt stated that her left arm was cold & numb down to her fingers. Pt was instructed to take TYLENOL, ice the area, & to see a physician or nurse practitioner. 10 TENS later, pt reported that she was still having problems and that she saw a physician at a sports medicine clinic. As of 11/19/12 pt. is still having problems.
Age: 21.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: About 30 min. to an hr, pt reported "tingling" in left arm. Pt stated that her left arm was cold & numb down to her fingers. Pt was instructed to take TYLENOL, ice the area, & to see a physician or nurse practitioner. 10 TENS later, pt reported that she was still having problems and that she saw a physician at a sports medicine clinic. As of 11/19/12 pt. is still having problems.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Periorbital oedema
Clinical narrative: Periorbital edema to both eyes that lasted for approximately two days. Child was taken to the emergency room at hospital and the following were administered intramuscularly: Benadryl 25 mg and Decadron 10 mg. In addition, Zyrtec 100 mg was administered orally.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate decreased, Hypotension
Clinical narrative: Dizzy, low pulse, low heart rate, low blood pressure, Light headed. Felt like she was going to pass out.
Age: 20.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Laboratory test normal
Clinical narrative: Seizure.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Fatigue, Heart rate decreased, Myalgia, Pyrexia
Clinical narrative: Decreased Pulse and BP; Extreme Fatigue; Fever; Muscle Ache.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: Client reports having a miscarriage.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema, pruritus.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain in extremity, Rash, Rash vesicular, Skin warm
Clinical narrative: Erythema, pruritus.
Age: 77.0
Sex: M
Vaccine: PPV, TD
Symptoms: Bilirubin conjugated, Blood culture negative, Blood lactate dehydrogenase increased, Blood test normal, Cellulitis
Clinical narrative: Patient presented 10/29/2012 to establish care with and received a pneumococcal vaccine (right arm). On 10/30, the patient experienced fever to 103 degrees along with pain and erythema at injection site on right arm. He presented to the ER 10/31 for further evaluation where he received IV vancomycin for cellulitis; ID was consulted. While in the hospital, the patient received vancomycin, clindamycin and aztreonam. Blood cultures and hemolysis labs were obtained 11/1/12; results were negative. Patient remained afebrile while hospitalized. Patient was discharged 11/2/12 on oral clindamycin 450mg q8h for 7 days to complete a 10 day course. Symptoms: swelling at injection site.
Age: 77.0
Sex: M
Vaccine: PPV, TD
Symptoms: Haematocrit decreased, Haptoglobin normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented 10/29/2012 to establish care with and received a pneumococcal vaccine (right arm). On 10/30, the patient experienced fever to 103 degrees along with pain and erythema at injection site on right arm. He presented to the ER 10/31 for further evaluation where he received IV vancomycin for cellulitis; ID was consulted. While in the hospital, the patient received vancomycin, clindamycin and aztreonam. Blood cultures and hemolysis labs were obtained 11/1/12; results were negative. Patient remained afebrile while hospitalized. Patient was discharged 11/2/12 on oral clindamycin 450mg q8h for 7 days to complete a 10 day course. Symptoms: swelling at injection site.
Age: 77.0
Sex: M
Vaccine: PPV, TD
Symptoms: Pyrexia, Reticulocyte percentage normal, White blood cell count increased
Clinical narrative: Patient presented 10/29/2012 to establish care with and received a pneumococcal vaccine (right arm). On 10/30, the patient experienced fever to 103 degrees along with pain and erythema at injection site on right arm. He presented to the ER 10/31 for further evaluation where he received IV vancomycin for cellulitis; ID was consulted. While in the hospital, the patient received vancomycin, clindamycin and aztreonam. Blood cultures and hemolysis labs were obtained 11/1/12; results were negative. Patient remained afebrile while hospitalized. Patient was discharged 11/2/12 on oral clindamycin 450mg q8h for 7 days to complete a 10 day course. Symptoms: swelling at injection site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound scan normal
Clinical narrative: Received flu shot 11/15/12. Began with (L) arm swelling, erythema & warmth 11/16/12 --> put on KEFLEX. Redness continued to spread 11/17/12 & changed to BACTRIM. Admitted to hospital 11/17/12 for IV antibiotics & SOLUMEDROL. Unclear if infectious or allergic reaction. Allergy felt it was non infectious & just upper extremity swelling secondary to immunization.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: EXCESSIVE INJECTION SITE BRUISING (APPROXIMATELY 4 INCHES IN DIAMETER WITH NOTICEABLE SWELLING).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Immediate post-injection reaction, Insomnia, Pain in extremity
Clinical narrative: Immediate right arm sharp pain down into fingers. Continues with daily pain, which wakes her up. Probable complex regional pain syndrome.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient had 2 months vaccines (Pentacel, PCV 13, Rota at 10/9/12 by PCP, but got another run of the same vaccines + Hep B vc #3 on 10/30/12 in pediatric Clinic brought in by foster care giver when mother was taken away. No reaction noticed since to 11/15/12 when grandmother brought her in (new foster care giver now).
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient with unspecified age, gender, pertinent medical history or drug reactions / allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient received a dose of PNEUMOVAX 23 and was hospitalized (Date and reason were not reported). The patient's outcome was unknown. This is a report of several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Contusion, Erythema, Pain in extremity, Ultrasound scan normal
Clinical narrative: 10-23-12 Flu shot Left delt. Lab draw Left AC (another company). 10-24-12 Arm soreness (L). 10-25-12 Left underarm sore & bruised. 10-26-12 Increased pain & bruising armpit to elbow. 10-27-12 Same as 10-26 now red line from armpit to elbow. 10-28-12 ABX started. 10-29-12 ER visit, US - no clot.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Clumsiness, Electromyogram, Feeling hot, Hypoaesthesia, Muscular weakness
Clinical narrative: At 6 days - numbness, tingling in feet, weakness (L) hip extensor muscle, then clumsy (L) hand, (R) hip weakness, L-1 numbness (saddle numbness) couldn't feel urine stream. Peaked at 7 days. At 21 days noted heat sensation in legs. Sxs slowly resolving.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: At 6 days - numbness, tingling in feet, weakness (L) hip extensor muscle, then clumsy (L) hand, (R) hip weakness, L-1 numbness (saddle numbness) couldn't feel urine stream. Peaked at 7 days. At 21 days noted heat sensation in legs. Sxs slowly resolving.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Urticaria
Clinical narrative: Pt. noticed site injection pain after injection. 8:00 pm teacher noticed hives on pt. face and neck. Pt. had increased pain in left side pt went to private physician next day and was given antihistamines. S & s began resolving.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Headache, Neck pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Reported "horrible headaches" started same day, missed work day two! Itching & rash on arm. Pain in arm to neck & back of head.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Fatigue, Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Reported "horrible headaches" started same day, missed work day two! Itching & rash on arm. Pain in arm to neck & back of head.
Age: 49.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Vomiting
Clinical narrative: Reported "horrible headaches" started same day, missed work day two! Itching & rash on arm. Pain in arm to neck & back of head.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Myalgia, Pain
Clinical narrative: PNEUMOVAX and Influenza vaccines both given in left deltoid on 10/04/12. Within 24-48 she developed fever to 102.1 as well as myalgias and a large hard red welt at injection site. It is worse after showering. The fever and body aches resolved within 24 hours. The red hard area has improved but is still there as of 11/12/12 visit. (Patient believes is due to PNEUMOVAX).
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: PNEUMOVAX and Influenza vaccines both given in left deltoid on 10/04/12. Within 24-48 she developed fever to 102.1 as well as myalgias and a large hard red welt at injection site. It is worse after showering. The fever and body aches resolved within 24 hours. The red hard area has improved but is still there as of 11/12/12 visit. (Patient believes is due to PNEUMOVAX).
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Swelling face
Clinical narrative: Facial redness & swelling.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient was pregnant at the time of vaccination with flu vaccine. State requires pregnant patients receive the preservative free formulation of influenza vaccine.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Inflammation, Local reaction, Pruritus
Clinical narrative: Area is red, inflamed itchy. 17 x 11 cm - local reaction, red and induration. Cephalexin 250/mg/5mL 2 teaspoon three times a day for 10 days. Triamcinolone acetonide 0.1% apply three times a day for seven days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus
Clinical narrative: 30 min after injection pt. c/o facial flushing & itching on legs & arms. Denies SOB, nausea or lightheadedness. BENADRYL 50 mg po given. 1 hour after BENADRYL pt. stated she was feeling better. Pt instructed to go to ER if sx worsen.
Age: 1.35
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: At patient's brother's visit on 11-13-12 his mother reported patient had nausea and vomiting the day of vaccinations after leaving and fevers x 3 days to 104 degrees at 1 time - she refused the booster flu vaccine at that visit.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling, Thrombosis
Clinical narrative: Pt. was vaccinated, a couple days later he noticed a lump/clot in other part of arm. He visited Dr/PCP bump to have it looked at. Dr. told pt to put heat on the bump TID no infection. Pt. still has bump 11/19/12.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase normal, Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Patients arm was extremely sore immediately after vaccination and for a few days after. It seemed to improve somewhat, but recently pain has returned. Pain is so bad he has trouble using and lifting arm. No swelling, just pain.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself with drug hypersensitivity to CELEBREX, AVALOX and lisinopril (manufacturer unknown) (related MARRS # 1211USA007565). The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unspecified date she had symptoms of diarrhea, headache, joint ache and extreme discomfort after receiving the ZOSTAVAX vaccination. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of extreme discomfort, joint ache, headache and diarrhea was unknown. The relatedness for the reported events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Diarrhoea, Discomfort, Headache
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself with drug hypersensitivity to CELEBREX, AVALOX and lisinopril (manufacturer unknown) (related MARRS # 1211USA007565). The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unspecified date she had symptoms of diarrhea, headache, joint ache and extreme discomfort after receiving the ZOSTAVAX vaccination. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of extreme discomfort, joint ache, headache and diarrhea was unknown. The relatedness for the reported events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old male patient with drug allergies to penicillin, cephalosporins, macrolides and sulfa drugs. The patient medical history included a "psychosis type" reaction after taking an unspecified steroid at an unspecified time in the past. The patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously on 31-OCT-2012 for prevention of shingles. Lot # was reported as H012521 with expiry date on 09-OCT-2013. The patient developed a red rash on his arm at the injection site after receiving ZOSTAVAX. No treatment was given. The outcome of red rash at the injection site was reported as not recovered/not resolved. The patient sought medical attention via office visit to physician. This is one of several reports received from the same source (WAES1211USA006599). Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old male patient with drug allergies to penicillin, cephalosporins, macrolides and sulfa drugs. The patient medical history included a "psychosis type" reaction after taking an unspecified steroid at an unspecified time in the past. The patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously on 31-OCT-2012 for prevention of shingles. Lot # was reported as H012521 with expiry date on 09-OCT-2013. The patient developed a red rash on his arm at the injection site after receiving ZOSTAVAX. No treatment was given. The outcome of red rash at the injection site was reported as not recovered/not resolved. The patient sought medical attention via office visit to physician. This is one of several reports received from the same source (WAES1211USA006599). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to an 11 years old male patient. The patient was vaccinated with first dose of GARDASIL (lot number reported as H009746, expired date unknown) on 22-AUG-2012. The patient also received a dose of MENACTRA on the same date. No other co-suspects were reported. The patient experienced malaise, general muscle pain and fatigue after administration of first dose of GARDASIL on 22-AUG-2012. The muscle pain was generalized but especially involved both legs. The symptoms resolved after 2 days without requiring treatment. The patient's parents declined to continue to GARDASIL series. It was unknown if the patient had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of GARDASIL (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports form the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006715 and 1211USA006716. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Painful respiration
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old female patient. The patient had no pertinent medical history and no drug reaction. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number not provided) intramuscularly on 24-OCT-2012. No other co-suspects were reported. There were no concomitant medications. On 25-OCT-2012 the patient experienced substernal, sharp, stabbing chest pain which was worse with inspiration. No treatment was given for adverse event. No laboratory studies were performed. The outcome of adverse event was reported as not recovered. The patient had sought medical attention via office visit. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Pt noted redness, swelling, tenderness in 2 inch diameter a few hours after injection. Pt improving with cool compresses and TYLENOL. No other associated symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Eye swelling, Injection site rash
Clinical narrative: Pt. returned to office approx 1 hour after receiving vaccines. Noted raised area to (R) leg at injection site. Child also with bilateral eye swelling with left more than right. No shortness of breath. Given BENADRYL 12.5mg and sent to Emergency Room for evaluation. Pulse ox 100%.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: Patient reported peripheral neuropathy in feet, toes, hands, arms - starting 10/18/12 the day after receiving Flu shot from pharmacy. She received ZOSTAVAX from pharmacy on 10/7/12.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Burning sensation
Clinical narrative: Pt. had shingles event in 1974 with pain & burning along his left lower back/hip. A few days after his vaccine about 11/8/12 he experienced "residual hot burning and occasional stabbing" in same area. It is improving.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received MENACTRA on 11/9/12 left arm. On 11/10/12 pt. developed "whelps", hives, very itchy, hives on both arms and legs. Pt. used BENADRYL. On 11/11/12 early AM< pt. went to ER. Given BENADRYL 50mg q 8 hours, MEDROL DOSE PACK, PEPCID.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site infection, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Administered site had redness, itchiness, swollen from the next day she got infection.