chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02161 is an initial spontaneous report received from a consumer on 19 Aug 2011. This report refers to a female child. She was given only the MenA lyophilized powder component of MENVEO vaccine (batch number: 10047, 10058 and expiry date: Dec 2012, Jan 2013) without being reconstituted with the MenCWY lyophilized liquid component, intramuscularly on 11 Aug 2011. No other adverse reaction was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02192 is an initial spontaneous report received from a health care professional on 19 Aug 2011. This report refers to a female child. She was given only the MenA lyophilized powder component of MENVEO vaccine (batch number: 10047 and expiry date: Dec 2012) without being reconstituted with the MenCWY lyophilized liquid component, intramuscularly on 11 Aug 2011. No other adverse reaction was reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02107 is an initial spontaneous report received from a consumer on 19 Aug 2011. This report refers to an 18 years old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: X10034) intramuscularly on 11 Aug 2011. No other adverse reaction was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US008665 is an initial spontaneous report received from a physician on 04 Nov 2011: This report refers to an 11-year-old female child. She was given only the CYW-135 liquid component of MENVEO (batch number: M10057) intramuscularly on 20 Oct 2011. No other adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Injection site discolouration
Clinical narrative: Case number PHEH2011US009469 is an initial spontaneous report received from a consumer on 11 Nov 2011: This case refers to unknown age and gender patient. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date in Aug 2011. Few days later patient experienced darker, discolored at injection site that was three to four inches in circumference. At the time of reporting discolored area still persists but faded to some degree. Outcome reported as ongoing.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Case number PHEH2011US009386 is an initial spontaneous report received from a health care professional on 11 Nov 2011. this case refers to a 34-year-old female patient. She was vaccinated with MENVEO vaccine (batch number: M11032) intramuscularly on 08 Nov 2011. On the same day she experienced a rash and slight swelling at the injections site following vaccination. The outcome of the events was not reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable healthcare provider (HCP). A patient (age and gender not specified) received a dose of PREVNAR 13, on an unspecified date for an unspecified indication. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a site reaction to vaccine. The outcome of the event was unknown. Follow-up (26Oct2011): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is the second of the three reports. This is a spontaneous report by a contactable nurse through a Pfizer sales representative. A currently 4-year-old patient (sex unknown) was administered a dose of PREVNAR 13 intramuscularly, in the thigh as catch up dose on 30Sep2010. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 30Sep2010, after vaccination, the patient experienced rash at injection site with a radius greater than 2-5 inches. Relevant lab data was unknown. At the time of the report the patient had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
Age: 1.7
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Decreased appetite, Injection site induration, Injection site mass, Irritability
Clinical narrative: This is a spontaneous report from a contactable consumer (mother) via a Pfizer sales representative. A 20-month-old, female patient received a dose of PREVNAR 13 given in the right thigh along with a dose of HAEMOPHILUS INFLUENZAE B given in the left thigh, both on 15Oct2011 for immunization. Relevant medical history and concomitant medications were unknown. In October of 2011, the patient experienced a hard lump on her right thigh, a low appetite, and felt fussy. Therapeutic measures taken as a result of the events were unknown. The patient has not yet recovered from the vaccination site induration. The outcomes for the other events were unknown.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a company representative on behalf of a contactable physician. A patient (unknown age and gender) received a dose of PREVNAR 13 and a dose of FLUZONE on an unknown date. Relevant medical history, concomitant medication and past product history was not reported. On an unknown date, the patient experienced high fever and was admitted to the emergency room. The outcome of the event is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Streptococcal bacteraemia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-month-old (gender unknown) patient received the fourth dose of PREVNAR 13 on an unknown date at an unknown age. Relevant medical history and concomitant medications were not provided. On an unknown date the patient developed Streptococcus Pneumoniae bacteremia that was not sero-typed and was hospitalized. At the time of the report the outcome of the event was unknown. Follow-up (06Oct2011): No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Sales representative. This nurse reported similar events for three patients. This is the first of three reports. A child (age and gender unknown) received a dose of PREVNAR 13 intramuscularly in the thigh as a catch-up dose on 30Sep2010. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were none. On 30Sep2010, while the patient developed rashes at the injection site with a radius greater than 2 to 5 inches. Relevant lab data was unknown. The event did not require an emergency room or doctor visit. At the time of the report, the patient, currently 3 years old, had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a non-contactable physician. An infant patient (age and gender unknown) received a dose of PREVNAR 13, a dose of PENTACEL, and a dose of ROTATEQ all on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient experienced a rash on the face and neck. The infant was recovering from the event at the time of report. No follow-up attempts is possible. No further information expected.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report initially received by a contactable physician via a Pfizer sales representative with follow-up from medical assistant from a contactable physician's office. A 3-year-old female patient received a supplemental dose of PREVNAR 13 on 22Aug2011 via an intramuscular route of administration in the right thigh. Relevant medical history included jaundice at birth, vesicoureteral reflux (Grade III - II) and was in the Neonatal Intensive Care Unit for 3 days. Concomitant medications were not provided. Past vaccine history included four doses of PREVENAR on unspecified dates (therapy regimen changed). On 22Aug2011, the patient experienced an allergic reaction, redness and swelling at the injection site. Therapeutic measures were not given. The patient recovered on 23Aug2011. On 24Aug2011, the patient was started on BENADRYL, 12.5mg/5ml as needed, for itching and swelling. The reporter stated that there is a reasonable possibility that the events are related to PREVNAR 13. Follow-up (15Nov2011): New information reported from a medical assistant from a contactable physician's office includes: dose details, relevant medical history, past vaccine history, clinical details and causality assessment. Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: No adverse event, Vaccination error
Clinical narrative: This is a spontaneous report from a contactable nurse. An 81-year-old female patient was accidentally administered PREVENAR 13 intramuscularly into the right shoulder at 1400 hrs on 01Nov2011 for immunization along with a dose of FLUZONE intramuscularly, into the left shoulder. Relevant medical history included hyperlipidemia, hypothyroidism, glaucoma, and cardiac dysrhythmia. Relevant concomitant medications included XALATAN eye drops and ALPHAGAN P for glaucoma, ZOCOR 40mg for hyperlipidemia, levothyroxine 100mcg for hypothyroidism, aspirin 325mg, vitamin E, MOTRIN and calcium. No adverse event was reported. The outcome of the event was unknown.
Sex: M
Vaccine: PNC13, UNK
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer (mother) via a project director for a market research study being conducted on behalf of the PREVNAR 13 pediatric brand team. A 12-month-old male patient received a dose of PREVENAR 13 on 16May2011. The patient went to his well visit and received 5 immunization shots, 3 in right leg and 2 in left leg on 16May2011. The mother does not know which vaccines they were, or if one of them was a Pfizer vaccine. The mother reports one was a "pneumococcal vaccine". Relevant medical history, concomitant medications and past product history were not reported. On 16May2011, within hours after vaccination, the child developed painful "bulges" and "tight lumps" on both injection sites. The mother applied warm moist compresses and administered liquid aspirin to relieve mild fever that had developed, following instructions that the doctor had provided. The child was monitored for 2 days while symptoms subsided. The patient is healthy today with no apparent permanent effects. The outcome was recovered.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is an initial spontaneous report by a contactable nurse via a Pfizer Sales representative who reported on three patients. This is the third of three reports. A currently 4 year old patient (age and gender not specified), received a dose of PREVNAR 13 (lot number 916971), administered by intramuscular injection in the thigh as a catch-up dose on 30Sep2010. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day or taken within the last four weeks were none. On 30Sep2010, the patient experienced rashes at injection site with a radius greater than 2-5 inches. The event did not require an emergency room or doctor visit. Relevant laboratory data was unknown. At the time of the report the patient had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Confusional state, Dizziness, Hypoaesthesia, Lumbar puncture
Clinical narrative: Loss of feeling in hands and feet, progressed to arms and legs. Dizziness, forgetfulness, confusion.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Nuclear magnetic resonance imaging
Clinical narrative: Loss of feeling in hands and feet, progressed to arms and legs. Dizziness, forgetfulness, confusion.
Age: 18.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Convulsion, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizure.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Swelling, Tenderness
Clinical narrative: Large area of raised redness and moderate-severe tenderness and warmth.  Area approximately 6 to 8 inches in diameter.  Some edema also present.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised, Rash macular
Clinical narrative: Itching all over, light red blotches all over. Took BENADRYL and put calamine on. Helped a lot. Still has symptoms and continuing BENADRYL.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02101 is an initial spontaneous report received from health care professional on 17 Aug 2011. this report refers to an 18 year old male patient. He was vaccinated with MENVEO (batch number: M10051) intramuscularly on 13 Aug 2011. But, he received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US009064 is an initial spontaneous report received from a nurse on 04 Nov 2011 with the follow-up received on 22 Nov 2011: This report refers to an 11-year-old male patient. Her concomitant medication included ADACEL and GARDASIL. He was given only the MenA powder component of MENVEO (batch number: 024011) reconstituted with another liquid (not sure of liquid) intramuscularly on 14 Sep 2011. No adverse event was reported following this medication error. Follow-up received from nurse on 22 Nov 2011: Patient demographics, concomitant medications and date of vaccination were updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US009176 is an initial spontaneous report received from a nurse on 08 Nov 2011. This case refers to a patient of unknown age and gender. The patient was vaccinated only with the CYW-135 liquid component of MENEVO (batch number: unknown) on an undetermined date. The nurse also stated that she was unsure which of the three possible patients have only received the incomplete dose. No adverse event was being reported at the time of this report.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Case number PHEH2011US009357 is an initial spontaneous report received from nurse on 31 Oct 2011. This report refers to multiple patients (exact number unspecified) who were vaccinated with MENVEO (from batch numbers: M10056, M10057, and M10130) intramuscularly, which were stored at temperature 34 F for 44 hours (wrong temperature).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site injury, Injection site pain, Injection site reaction
Clinical narrative: PATIENT EXPERIENCED FELT FLUID SURGE AT INJECTION SITE AND IMMEDIATE PAIN. PAIN AND STIFFNESS INCREASED OVER NEXT 2 HOURS.  ARM BECAME IMMOBILE; PATIENT WAS UNABLE TO LIFT ARM ABOVE 45 DEGREES. PATIENT SOUGHT MEDICAL ATTENTION ON 8/22/2011, 8/28/2011, 9/1/2011 BUT PHYSICIAN INITIALLY DENIED CONNECTION WITH VACCINE.  FINALLY, ON 11/22/2011, PHYSICIAN DIAGNOSED SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA).  PATIENT RECEIVED CORTISONE INJECTION AND RECOMMENDED PHYSICAL THERAPY.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Joint injury, Musculoskeletal stiffness, Vaccination complication
Clinical narrative: PATIENT EXPERIENCED FELT FLUID SURGE AT INJECTION SITE AND IMMEDIATE PAIN. PAIN AND STIFFNESS INCREASED OVER NEXT 2 HOURS.  ARM BECAME IMMOBILE; PATIENT WAS UNABLE TO LIFT ARM ABOVE 45 DEGREES. PATIENT SOUGHT MEDICAL ATTENTION ON 8/22/2011, 8/28/2011, 9/1/2011 BUT PHYSICIAN INITIALLY DENIED CONNECTION WITH VACCINE.  FINALLY, ON 11/22/2011, PHYSICIAN DIAGNOSED SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA).  PATIENT RECEIVED CORTISONE INJECTION AND RECOMMENDED PHYSICAL THERAPY.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Fatigue, Injected limb mobility decreased
Clinical narrative: Bloodshot eyes, hoarse voice, scratchy throat, extreme fatigue, fever, achy, soreness at injection site, chest tightness, shortness of breath.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Ocular hyperaemia, Pain, Pyrexia, Throat irritation
Clinical narrative: Bloodshot eyes, hoarse voice, scratchy throat, extreme fatigue, fever, achy, soreness at injection site, chest tightness, shortness of breath.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Rash, Swelling
Clinical narrative: Rash (6 inches by 3 inches) severe itching, pain, swelling.  I am still having these symptoms (6:00 PM, Jan. 1).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: Rash (6 inches by 3 inches) severe itching, pain, swelling.  I am still having these symptoms (6:00 PM, Jan. 1).
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Pain, Skin warm
Clinical narrative: Immediately following shot had lots of pain.  Has lots of redness, swelling, warm to touch.  Following day redness has spread to majority of his right thigh.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Immediately following shot had lots of pain.  Has lots of redness, swelling, warm to touch.  Following day redness has spread to majority of his right thigh.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain, Swelling face
Clinical narrative: Facial swelling, headache, body aches, tiredness. Patient self medicated with Advil, Sudafed, Xyzal. Partially resolved by 1/1/2012.
Age: 20.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Injection site pain, Muscle twitching, Urine abnormality, Urine odour abnormal
Clinical narrative: Ongoing, wide spread muscle twitches. Injection sites (muscles) are STILL sore, occasional numbness in hands. My urine has a very strong smell and a cloudy appearance, which is ongoing. I went to Urgent Care concerning this issue and was told I needed to see a Urologist. I am unable to do so financially, as I am a student with no health insurance.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Fever of 105 degrees and unconsolable.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Immediate post-injection reaction, Vomiting projectile
Clinical narrative: Repeated projectile vomiting on administration of vaccine, attempted three times in office with same recurrence of symptoms.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles type sensitivity on left side (lower back and upper leg), continuing for several days, followed by shingles-type pain on third day. Identical to symptoms patient had when shingles was diagnosed several years earlier. Began anti-viral drug treatment upon advice of physician. Extent of shingles outbreak remains to be seen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Red rash at site of injection and surrounding 3-4 inches of arm.  Small amount of swelling at site of injection and surrounding area.  Itching.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, warm posterior left arm, improving by the time she was seen in office (three days after injection), but still red, warm, measuring 18x16cm. Already on fexofenadine, hydroxyzine added.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Blood test normal, Childhood disintegrative disorder, Convulsion, Cytogenetic analysis normal, Electroencephalogram abnormal
Clinical narrative: Eye roll, affect change, stopped smiling, laughing etc. Saw it again the following Thursday in increased amounts all day went to pediatrician. Friday November 19, 2010 went to Hospital. Admitted with seizures.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Gaze palsy, Imaging procedure, Laboratory test normal, Lumbar puncture normal, Mood altered
Clinical narrative: Eye roll, affect change, stopped smiling, laughing etc. Saw it again the following Thursday in increased amounts all day went to pediatrician. Friday November 19, 2010 went to Hospital. Admitted with seizures.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Eye roll, affect change, stopped smiling, laughing etc. Saw it again the following Thursday in increased amounts all day went to pediatrician. Friday November 19, 2010 went to Hospital. Admitted with seizures.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Bright red rash immediately after injection (at site) with burning.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient had VARIVAX (#2) immunization on 12-30-2011 at Right arm. The Mother brought child back to office on 1-2-2012 for rash and redness about 3mm at injection site (R) arm. No fever or shortness of breath reported by the mother.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lactic acid increased, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Patient had low grade fever of 99 degrees on 12/30/11 at 7pm. Temperature increased to 102.5 and went into ER at midnight. Patient's s/sx, dizziness, aching, headache, and some blurry vision. Patient was given IV fluid since admitted to ER.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Patient had low grade fever of 99 degrees on 12/30/11 at 7pm. Temperature increased to 102.5 and went into ER at midnight. Patient's s/sx, dizziness, aching, headache, and some blurry vision. Patient was given IV fluid since admitted to ER.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever 99-101.1. Redness at injection site.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Mobility decreased, Pain
Clinical narrative: Soreness and weakness/pain, difficulty moving arm (left arm) after admin. of flu vac 11-7-11. Doc put pt on anti-inflam & bloodwork.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Nonspecific rash (L) hand on arm of vaccine that should be self-limiting.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Skin discolouration
Clinical narrative: Mother reports that approximately six hours post immunization, patient became limp & grey. Paramedics were called, patient taken to Hospital, received oxygen en route. Discharged from ER, no intervention.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Pericarditis
Clinical narrative: Seen hospital ER on 1/1/12 Dx with pericarditis based on exam, symptoms ECG, had c/o chest pain. Rx SOLUMEDROL. Seen in our office 1/2/12 changed from SOLUMEDROL to ALEVE 2 tabs BID had improved. Rec'd flu vaccine 12/16/11.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema
Clinical narrative: (R) leg -> 6 x 6 cm erythematous reaction on ant/lateral aspect of leg. (L) leg -> 10 x 12 cm erythematous reaction on ant/lateral aspect of leg.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Nodule, Swelling
Clinical narrative: Swelling, nodule immediately. No treatment. Encouraged use of warm compress.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule
Clinical narrative: Patient had nodule noted on left arm after vaccine was administered.
Age: 24.0
Sex: M
Vaccine: ADEN_4_7, HEPA
Symptoms: Asthenia, Electromyogram abnormal, Guillain-Barre syndrome, Hyporeflexia, Muscular weakness
Clinical narrative: 24yo male trainee. On 12/23 he awakened with generalized weakness and soreness and in particular weakness and paresthesias of the feet and hands. Symptoms were progressive until he presented at clinic and was admitted on 12/28 with symmetric weakness/diminished reflexes. He gave a 3 week history of URI with yellow nasal drainage similar to many. EMG confirmed GBS.
Age: 24.0
Sex: M
Vaccine: ADEN_4_7, HEPA
Symptoms: Pain, Pain in extremity, Paraesthesia, White blood cell count increased
Clinical narrative: 24yo male trainee. On 12/23 he awakened with generalized weakness and soreness and in particular weakness and paresthesias of the feet and hands. Symptoms were progressive until he presented at clinic and was admitted on 12/28 with symmetric weakness/diminished reflexes. He gave a 3 week history of URI with yellow nasal drainage similar to many. EMG confirmed GBS.
Age: 20.0
Sex: M
Vaccine: FLU3, IPV, MNQ, TDAP
Symptoms: Dyskinesia, Facial asymmetry, Upper respiratory tract infection, VIIth nerve paralysis
Clinical narrative: 20y male who presents with left facial asymmetry shortly after receiving vaccinations. Over the course of a few days developed progressive left facial droop. He noted the onset between the first round of immunizations during week 1 (Flu, IPV, MENACTRA, Tdap) and the TWINRIX vaccination 5 days later. He initially noticed that when smiling the left side of his mouth did not have the same crease as the right side did. This was apparent when looking at pictures of himself as well as looking in the mirror. He then developed loss of smile lines and nasolabial lines on the left cheek. Symptoms peaked around week 5 and are slightly improved since then. Currently he notices that the left side of his mouth doesn't open as widely as the right, he has asymmetric smile lines, and the skin fold adjacent to his nose is flattened on the left (but not as severely as it was a few weeks ago). He denies facial pain/numbness/tingling, denies difficulty talking, chewing or swallowing, denies lid lag or vision changes. Patient feels that symptoms worsened in the days after TWINRIX vaccination. He denies any illness until week 5 when he developed an URI. He denies rash or oral ulcers in the last 2 months.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Aggression, Aphasia, Autism, Convulsion, Eating disorder
Clinical narrative: Information has been received via letter from the father of a 10 year old female who on an unspecified date in approximately 2000 was vaccinated with MMR II. Subsequently the patient experienced "severe autism, autistic seizures, cannot talk at all, major eating disorder, major temper tantrums, and major brain dysfunction [sic]." The patient's father felt that his daughter's severe autism was due to mercury in the MMR II. The patient's father reported that his daughter will never be able to work a job in her lifetime due to the vaccine. Included in the letter was a pediatric neurology record. On 09-APR-2009, impression included seizures and autism. It was recommended that the patient continue current dose of KEPPRA, 100mg/mL, 1.5 mL in the morning and 1.5 mL in the evening; follow schedule given to begin LAMICTAL; and "MRI today as planned." Diagnosis was noted as epilepsy for which strict seizure safety and precautions were to be followed, "she must be supervised at all times." Autistic seizures, severe autism, and major eating disorder were considered to be disabling. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Epilepsy, Mental impairment, Nervous system disorder
Clinical narrative: Information has been received via letter from the father of a 10 year old female who on an unspecified date in approximately 2000 was vaccinated with MMR II. Subsequently the patient experienced "severe autism, autistic seizures, cannot talk at all, major eating disorder, major temper tantrums, and major brain dysfunction [sic]." The patient's father felt that his daughter's severe autism was due to mercury in the MMR II. The patient's father reported that his daughter will never be able to work a job in her lifetime due to the vaccine. Included in the letter was a pediatric neurology record. On 09-APR-2009, impression included seizures and autism. It was recommended that the patient continue current dose of KEPPRA, 100mg/mL, 1.5 mL in the morning and 1.5 mL in the evening; follow schedule given to begin LAMICTAL; and "MRI today as planned." Diagnosis was noted as epilepsy for which strict seizure safety and precautions were to be followed, "she must be supervised at all times." Autistic seizures, severe autism, and major eating disorder were considered to be disabling. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Mydriasis, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient with no drug reactions/allergies and with no pertinent medical history who on 20-DEC-2011, was vaccinated with the first dose of GARDASIL (0.5 ml, IM, lot number: 668819/0477AA, exp. date: 29-JUN-2013) in the left arm. There was no concomitant medication. It was reported that on 20-DEC-2011, within one minute of administration of his first dose of GARDASIL the patient experienced syncope, seizure- like activity, dilated pupils, pale, stiffness and shaking. The patient sought medical attention via office visit. There was no treatment given for AE. On 20-DEC-2011, the patient recovered from syncope, seizure-like activity, dilated pupils, pale, stiffness and shaking. No lab diagnostic studies were performed. Upon internal review, seizure- like activity was considered to be an other medical event. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient with no drug reactions/allergies and with no pertinent medical history who on 20-DEC-2011, was vaccinated with the first dose of GARDASIL (0.5 ml, IM, lot number: 668819/0477AA, exp. date: 29-JUN-2013) in the left arm. There was no concomitant medication. It was reported that on 20-DEC-2011, within one minute of administration of his first dose of GARDASIL the patient experienced syncope, seizure- like activity, dilated pupils, pale, stiffness and shaking. The patient sought medical attention via office visit. There was no treatment given for AE. On 20-DEC-2011, the patient recovered from syncope, seizure-like activity, dilated pupils, pale, stiffness and shaking. No lab diagnostic studies were performed. Upon internal review, seizure- like activity was considered to be an other medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no medical history and no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number not reported) on 21-JUN-2010, and the third dose (lot number not reported) on 17-DEC-2010. There was no concomitant medication. The patient was subsequently determined to be pregnant on 04-JAN-2011. Urine pregnancy test performed on 04-JAN-2011. The patient sought unspecified medical attention. The patient's outcome was unknown. The follow-up information has been received from a licensed practitioner nurse concerning the patient who was vaccinated with a dose of GARDASIL. The nurse reported that the patient had a spontaneous abortion in January 2011. The patient's outcome for spontaneous abortion was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Cough, Exposure to communicable disease, Headache, Laboratory test abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with drug allergy to amoxicillin, prednisone, CEFTIN, BIAXIN and no pertinent medical history who on 18-NOV-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (dose not reported) (lot number 669794/1285AA). On 22-NOV-2011 the patient developed fever (103 F), cough, body aches, neck pain and nausea after the first dose of GARDASIL was given. The patient sought medical attention by office visit to the nurse practitioner. There was no treatment for the event. No laboratories were performed. At the time of the report the patient had not recovered. Follow-up information has been received from a nurse practitioner who reported that the female patient with no illness at time of vaccination, allergy to amoxicillin, prednisone, CEFTIN, BIAXIN, CECLOR and a medical history of pneumonia as an infant was vaccinated with the first dose of GARDASIL, (dose not reported) (lot number 669794/1285AA) Right Arm at 14:35. The nurse reported that on 22-NOV-2011, the patient experienced neck pain, body temperature measurement of 103 degrees F, headache, cough, starting 24 hours after receiving GARDASIL dose. The nurse mentioned that the patient was on an emergency room and was exposed to meningitis in the past month, subsequently the patient was diagnosed with meningitis and pneumonia and also required hospitalization per 6 days. A diagnostic laboratory test was performed which resulted in meningitis. On unknown day of December 2011 the patient recovered of meningitis and pneumonia. The reporter felt that meningitis and pneumonia were not related to GARDASIL. Additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Meningitis, Nausea, Neck pain, Pain, Pneumonia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with drug allergy to amoxicillin, prednisone, CEFTIN, BIAXIN and no pertinent medical history who on 18-NOV-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (dose not reported) (lot number 669794/1285AA). On 22-NOV-2011 the patient developed fever (103 F), cough, body aches, neck pain and nausea after the first dose of GARDASIL was given. The patient sought medical attention by office visit to the nurse practitioner. There was no treatment for the event. No laboratories were performed. At the time of the report the patient had not recovered. Follow-up information has been received from a nurse practitioner who reported that the female patient with no illness at time of vaccination, allergy to amoxicillin, prednisone, CEFTIN, BIAXIN, CECLOR and a medical history of pneumonia as an infant was vaccinated with the first dose of GARDASIL, (dose not reported) (lot number 669794/1285AA) Right Arm at 14:35. The nurse reported that on 22-NOV-2011, the patient experienced neck pain, body temperature measurement of 103 degrees F, headache, cough, starting 24 hours after receiving GARDASIL dose. The nurse mentioned that the patient was on an emergency room and was exposed to meningitis in the past month, subsequently the patient was diagnosed with meningitis and pneumonia and also required hospitalization per 6 days. A diagnostic laboratory test was performed which resulted in meningitis. On unknown day of December 2011 the patient recovered of meningitis and pneumonia. The reporter felt that meningitis and pneumonia were not related to GARDASIL. Additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with drug allergy to amoxicillin, prednisone, CEFTIN, BIAXIN and no pertinent medical history who on 18-NOV-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (dose not reported) (lot number 669794/1285AA). On 22-NOV-2011 the patient developed fever (103 F), cough, body aches, neck pain and nausea after the first dose of GARDASIL was given. The patient sought medical attention by office visit to the nurse practitioner. There was no treatment for the event. No laboratories were performed. At the time of the report the patient had not recovered. Follow-up information has been received from a nurse practitioner who reported that the female patient with no illness at time of vaccination, allergy to amoxicillin, prednisone, CEFTIN, BIAXIN, CECLOR and a medical history of pneumonia as an infant was vaccinated with the first dose of GARDASIL, (dose not reported) (lot number 669794/1285AA) Right Arm at 14:35. The nurse reported that on 22-NOV-2011, the patient experienced neck pain, body temperature measurement of 103 degrees F, headache, cough, starting 24 hours after receiving GARDASIL dose. The nurse mentioned that the patient was on an emergency room and was exposed to meningitis in the past month, subsequently the patient was diagnosed with meningitis and pneumonia and also required hospitalization per 6 days. A diagnostic laboratory test was performed which resulted in meningitis. On unknown day of December 2011 the patient recovered of meningitis and pneumonia. The reporter felt that meningitis and pneumonia were not related to GARDASIL. Additional information is expected.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse concerning an approximately 29 month old male patient with an allergy to gelatin who in December 2001 (reported as "10 years ago"), was vaccinated with the first dose of MMR II (dose, route and lot number not reported). Subsequently in December 2001 (reported as "10 years ago"), the patient had an anaphylactic reaction and was rushed to the emergency room. At the time of the report the patient's outcome was recovered (date unknown). Upon internal review, anaphylactic reaction was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Contusion, Insomnia, Pruritus, Urticaria
Clinical narrative: Hives with itching started morning 1-2-12 significantly worsened after shower in evening; hives spread from arms to legs, abdomen, back, above eyes, below chin. Itching severe enough to keep awake at night. Bruise also noted to (L) arm 40mm x 35mm on morning 12-30-11.
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Body temperature increased, Chills, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: 12/21/11 son reports patient with temp 101 degrees F, chills, no hives or breathing difficulty. 12/22/11 no increase temp. feeling better. 12/23/11 patient reports pain & swelling on (L) upper arm on site of injection pain also had stiffness on her neck left side. MD consulted and ER visit done rec heat/cold pack and pain reliever and released to home. 1/3/12 patient has swelling on (L) upper arm extending to her elbow and pain, continues heating pad and pain reliever.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient developed arm pain where injection was given one day after receiving. Area continues to be sore in the (L) deltoid, and increased pain with extension.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Hypoaesthesia, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning herself, a 60 year old female patient with high blood pressure, allergy to certain antibiotics and back pain who received her first dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 12 years ago (in approximately December 1999). The nurse reported that she received the second dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 2 years after she received the first dose of PNEUMOVAX 23 (in approximately December 2001). Nurse reported that she experienced pain and swelling at the injection site following the second dose of the vaccine. Nurse reported that she received intramuscularly a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) in her left arm on 13-DEC-2011, and 3 hours later the nurse experienced pain and swelling at the injection site and in the nurse's upper back. Nurse reported that she also developed, "flu like symptoms" on 13-DEC-2011 and the "flu like symptoms" had persisted for the past 7 days. Nurse reported that she was, "deathly sick" for the 24 hours after receiving the PNEUMOVAX 23. Nurse reported that she developed a fever as high as 102 degree Fahrenheit on 14-DEC-2011, and the fever lasted for 1 day. Nurse reported that the injection site swelling "moved" from the injection site after several hours. Nurse reported that she then developed swelling in her arm, wrist, and hand. Nurse reported that with the swelling in her arm, she had also experienced numbness and a sensation described as, "feeling like my circulation was cut of to my arm." Nurse reported that she continued to experience pain and numbness in her left arm. Nurse reported that she took ZITHROMAX (dose and manufacturer unspecified) and the nurse experienced a severe reaction where her "throat closed" and she had to be admitted to a hospital for emergency treatment. There was no laboratory studies performed. The patient sought medical attention by calling the physician and was treated with BENADRYL as needed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Local swelling, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning herself, a 60 year old female patient with high blood pressure, allergy to certain antibiotics and back pain who received her first dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 12 years ago (in approximately December 1999). The nurse reported that she received the second dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 2 years after she received the first dose of PNEUMOVAX 23 (in approximately December 2001). Nurse reported that she experienced pain and swelling at the injection site following the second dose of the vaccine. Nurse reported that she received intramuscularly a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) in her left arm on 13-DEC-2011, and 3 hours later the nurse experienced pain and swelling at the injection site and in the nurse's upper back. Nurse reported that she also developed, "flu like symptoms" on 13-DEC-2011 and the "flu like symptoms" had persisted for the past 7 days. Nurse reported that she was, "deathly sick" for the 24 hours after receiving the PNEUMOVAX 23. Nurse reported that she developed a fever as high as 102 degree Fahrenheit on 14-DEC-2011, and the fever lasted for 1 day. Nurse reported that the injection site swelling "moved" from the injection site after several hours. Nurse reported that she then developed swelling in her arm, wrist, and hand. Nurse reported that with the swelling in her arm, she had also experienced numbness and a sensation described as, "feeling like my circulation was cut of to my arm." Nurse reported that she continued to experience pain and numbness in her left arm. Nurse reported that she took ZITHROMAX (dose and manufacturer unspecified) and the nurse experienced a severe reaction where her "throat closed" and she had to be admitted to a hospital for emergency treatment. There was no laboratory studies performed. The patient sought medical attention by calling the physician and was treated with BENADRYL as needed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sensory disturbance, Throat tightness
Clinical narrative: Information has been received from a registered nurse concerning herself, a 60 year old female patient with high blood pressure, allergy to certain antibiotics and back pain who received her first dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 12 years ago (in approximately December 1999). The nurse reported that she received the second dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 2 years after she received the first dose of PNEUMOVAX 23 (in approximately December 2001). Nurse reported that she experienced pain and swelling at the injection site following the second dose of the vaccine. Nurse reported that she received intramuscularly a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) in her left arm on 13-DEC-2011, and 3 hours later the nurse experienced pain and swelling at the injection site and in the nurse's upper back. Nurse reported that she also developed, "flu like symptoms" on 13-DEC-2011 and the "flu like symptoms" had persisted for the past 7 days. Nurse reported that she was, "deathly sick" for the 24 hours after receiving the PNEUMOVAX 23. Nurse reported that she developed a fever as high as 102 degree Fahrenheit on 14-DEC-2011, and the fever lasted for 1 day. Nurse reported that the injection site swelling "moved" from the injection site after several hours. Nurse reported that she then developed swelling in her arm, wrist, and hand. Nurse reported that with the swelling in her arm, she had also experienced numbness and a sensation described as, "feeling like my circulation was cut of to my arm." Nurse reported that she continued to experience pain and numbness in her left arm. Nurse reported that she took ZITHROMAX (dose and manufacturer unspecified) and the nurse experienced a severe reaction where her "throat closed" and she had to be admitted to a hospital for emergency treatment. There was no laboratory studies performed. The patient sought medical attention by calling the physician and was treated with BENADRYL as needed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a 31 year old female for VARIVAX (Merck), a Pregnancy Registry product, with no drug reaction/allergies and no pertinent medical history, who on 05-NOV-2010 was vaccinated with a first dose of VARIVAX (Merck) (lot # 666850/0714Z). There was no concomitant medication. On 21-NOV-2010 the patient discovered she was pregnant and no adverse effect reported. Annual physical tests were performed. The patient did not seek medical attention. The patient's date of last menstrual period was in the beginning of October 2010. The estimated delivery date would be 09-JUL-2011. Follow up information has been received from a healthcare worker concerning the patient above who delivered her baby in their office. It was reported the patient's LMP (last menstrual period) was 10-OCT-2010, EDD (estimated date of delivery) 19-JUL-2011. The patient delivered a healthy baby girl via C-section (reason unknown) on 28-JUN-2011 at 37 weeks gestation. The neonate had no congenital anomalies. It was reported that the baby weighted 5 lbs, 6 oz, length 19". There were no reported delivery complications. It was unknown if a prenatal varicella titer was done on the patient. Upon internal review, C-section was determined to be an other important medical event. No further information is available.