chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: Moist cough on 12/06.  No elevated temperature.  Moist cough continues today 12/8/11.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Breath sounds abnormal, Cardiac failure congestive, Condition aggravated, Dyspnoea
Clinical narrative: Exacerbated CHF x 6 weeks with multiple changes in medications.  ON continuous O2.  12/2 Extremely dyspnic with anxiety.  Crackles right lung, diminished breath sounds.  Increased peripheral edema.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rales
Clinical narrative: Exacerbated CHF x 6 weeks with multiple changes in medications.  ON continuous O2.  12/2 Extremely dyspnic with anxiety.  Crackles right lung, diminished breath sounds.  Increased peripheral edema.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: 12/6 moist cough, temp 99.3.  Zithromax started.  12/8 continues with loose cough and more responsive.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Nasopharyngitis, Tremor
Clinical narrative: 12/4 Elevated temp 101 F., cold, shaking 12/5 no temp and feeling better
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Ataxia, Body temperature increased, Pneumonia
Clinical narrative: 12/5 sudden ataxia and elevated temp.  To ED and diagnosed with pneumonia and admitted to Acute Care and started on antibiotics.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, General physical condition abnormal, Renal failure, Respiratory failure
Clinical narrative: 12/6 Temp 101.2, moist lungs, non- productive cough, Temp remains elevated in evening. Tylenol Suppository. 12/8 remains in critical condition with renal and respiratory failure.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Bladder catheterisation, Decreased appetite, Heart rate irregular, Respiratory tract congestion, Urinary retention
Clinical narrative: 12/2 feeling congested. 12/3 urinary retention, 12/5 Cipro started, O2 per NC, not eating well, 12/6 Foley inserted, ACCU check's irregular, 12/8 remains in bed.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Dizziness, Headache, Malaise
Clinical narrative: Within a few hours after the shot I started to have itching that progressed to hives all over body. (Hives persisted off and on for several weeks after). Later that night started feeling weak and confused/dizzy- severe headache. Generalized malaise for several days after but the itching and hives was by far the worst symptom.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Within a few hours after the shot I started to have itching that progressed to hives all over body. (Hives persisted off and on for several weeks after). Later that night started feeling weak and confused/dizzy- severe headache. Generalized malaise for several days after but the itching and hives was by far the worst symptom.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ
Symptoms: Conjunctival hyperaemia, Discomfort, Erythema, Feeling hot, Headache
Clinical narrative: Initially patient stated hands and feet both felt hot and itchy, palms were red and warm to touch by HCP. Within a few minutes entire skin red & warm, bulbar conjunctiva also red. No distinguish-able hives (pt is naturaly dark skinned). Pt felt increasingly uncomfortable: itchy, restless and heachachy.  Vital signs were stable with BP 106/72. No signs of respiratory distress was noted at anytime.  Cool compressers were applied, pt. resting on pillow.  Mother noted mild edema behind child's ears.  At 5:45 Benadryl P0 60mg was given (1mg/kg dose, pt= 132lbs).  Within 20 minutes pt was much improved, redness dimished, child happy & talkative.  Advise to go to Hospital for further observation.  An additional dose of Benadryl was given/no other Tx.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ
Symptoms: Oedema, Palmar erythema, Pruritus, Restlessness, Skin warm
Clinical narrative: Initially patient stated hands and feet both felt hot and itchy, palms were red and warm to touch by HCP. Within a few minutes entire skin red & warm, bulbar conjunctiva also red. No distinguish-able hives (pt is naturaly dark skinned). Pt felt increasingly uncomfortable: itchy, restless and heachachy.  Vital signs were stable with BP 106/72. No signs of respiratory distress was noted at anytime.  Cool compressers were applied, pt. resting on pillow.  Mother noted mild edema behind child's ears.  At 5:45 Benadryl P0 60mg was given (1mg/kg dose, pt= 132lbs).  Within 20 minutes pt was much improved, redness dimished, child happy & talkative.  Advise to go to Hospital for further observation.  An additional dose of Benadryl was given/no other Tx.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chest X-ray abnormal, Chills, Cough, Culture negative
Clinical narrative: Chills, fever, back pain, cough.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Endotracheal intubation, Mechanical ventilation, Pneumonia, Pyrexia
Clinical narrative: Chills, fever, back pain, cough.
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site swelling
Clinical narrative: Swollen where injection was given.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Folliculitis, Rash, Rash pustular
Clinical narrative: Rash on abdomen looks more like folliculitis with white pustules. Treated with BACTROBAN.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Pain in extremity, X-ray limb abnormal
Clinical narrative: Pain/numbness in right arm at first then numbness/couldn't use arm.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Oedema peripheral, Rash
Clinical narrative: Swollen (R) arm and leg. Rash on patient's torso.
Age: 60.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itching, redness, soreness at injection site 4-5 inch diameter red area.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury
Clinical narrative: Patient states she believes she has nerve damage in her arm after getting the flu vaccine.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Hypoaesthesia oral, Paraesthesia, Throat irritation
Clinical narrative: HPV #1 & flu shot given (which pt has received & tolerated in past years). Within 2 minutes, she complained of throat "burning" then tingling. Progressed to tongue numbness. 50 mg BENADRYL given PO. Pulse ox remained 100.1, clear lungs, no oral swelling. Transferred to ED & observed. Steroids given, no epinephrine given. Sx resolved.
Sex: U
Vaccine: HPVX, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Injection site redness, irregular raised patches, no vesicles. (+) itching.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Aphasia, Apnoea, Bradyphrenia, Dizziness, Endotracheal intubation
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Extubation, Flushing, Hypoaesthesia facial, Muscle rigidity, Quadriplegia
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Sinus tachycardia, Speech disorder, Staring
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Apnoea, Bradyphrenia, Diplegia, Dizziness, Endotracheal intubation
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Flushing, Hypertension, Hypoaesthesia, Muscle rigidity, Sinus tachycardia
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Slow speech, Staring
Clinical narrative: Case number PHEH2011US00910 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011 and 08 Aug 2011 with combined follow up information received on 28 Nov 2011 and 01 Dec 2011. This report refers to a 61 years old male patient. His medical history included allergy to TRICOR. He received day zero dose of post exposure series of IMOVAX vaccine (other manufacturer, batch number: unknown) with anti-rabies human immunoglobulin (other manufacturer) on 01 Aug 2011. He developed neurological reactions following vaccination. Since he experienced neurological reactions with IMOVAX vaccine, the physician decided to switch him to RABAVERT vaccine. On 04 Aug 2011 at 10:12 hours, he was vaccinated with RABAVERT vaccine (batch number: 467011A) intramuscularly into his left arm. He was administered RABAVERT vaccine in ICU with nurse at bedside. Stacked symptoms began eight minutes after RABAVERT vaccination with facial flushing, slow speech, and slow thoughts. He also experienced facial numbness, lightheadedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling and apneic. He was intubated immediately. He was monitored for sinus tachycardia and his blood pressure was at 193/111. He was extubated on the same day at 15:00 hours. He came back to baseline with no deficits. His post exposure prophylaxis was planned to be discontinued and the serum was obtained for day 14 titer. He had recovered completely from all the events at the time of this report. The reporter considered these events as life threatening and medically significant. Combined follow up information received from a healthcare professional in 28 Nov 2011 and 01 Dec 2011: Updated seriousness, concomitant medications, day zero dose of IMOVAX (previously reported as RABAVERT), reaction to IMOVAX vaccine, day 3 dose of RABAVERT and the adverse events following that.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Blindness unilateral, Headache
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 30-Nov-2011) concerns a 17-year old male patient, who had a concurrent condition of anxiety with persistent worrying and had been prescribed escitalopram. The reporter did not know if the patient was taking escitalopram at the time of the event. On 28-Sep-2011 the patient received a flu shot. On the same day the patient also received his first dose of GARDASIL (batch number: 0840AA) intramuscular injection for HPV (human papillomavirus) prevention. When the patient came in to clinic for his second dose of GARDASIL, he complained about a headache and loss of vision in one eye on 05-Oct-2011, about a week later after his first dose. The patient was on therapy. There was no information as to which eye was affected, how long the event lasted or to what level the vision was lost. Since the physician did not know about the event until later, no testing was done. The reporter did not know if the vision loss was disabling, life-threatening or required hospitalisation. The event outcome was recovered. A second dose of GARDASIL was not administered.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Flushing, Nausea, Skin discolouration
Clinical narrative: None stated.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left upper extremity swelling, warmth, redness spreading from site of vaccination.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm continues 1 month after injection. Recommending anti-inflammatories.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt. states arm pain (sore) when lifting arm. Administered 9/2/11. Today is 12/2/11.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain, Pain
Clinical narrative: High fever, localized swelling/redness, tenderness to site and lymph node, body ache.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: High fever, localized swelling/redness, tenderness to site and lymph node, body ache.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Dyspnoea, Injection site swelling, Pallor
Clinical narrative: Difficulty breathing, wheezing, paleness, weakness swelling where the shot was given, cold chills. Epipen, BENADRYL, XOPENEX, oxygen at office. Transported via ambulance to ER.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Difficulty breathing, wheezing, paleness, weakness swelling where the shot was given, cold chills. Epipen, BENADRYL, XOPENEX, oxygen at office. Transported via ambulance to ER.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Vomiting
Clinical narrative: After 20 min of receiving FluMist, returned to the room.  Two hours later, person brought patient to the office with c/o vomiting.  Person came to pick up patient from facility.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Feeling hot, Hypersensitivity, Inflammation
Clinical narrative: Information has been received from a doctor of pharmacy (pharmacy director) concerning a female patient who "within the last month" in September 2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). The pharmacy director reported that the patient, in September 2011, had an allergic reaction to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from a doctor of pharmacy concerning an 85 year old retired female patient with sulfa allergy, lung cancer and mitral valve disorder and the following illness at time of vaccination: presyncope who in September 2011, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included VALIUM, ANTIVERT, sitagliptin phosphate (MSD), MgSO4, ferrousSO4, XANAX, DUONEB, folic acid, "derm scop", lisinopril (MSD), PLAVIX, heparin, loratadine (MSD), LIPITOR, aspirin, "LALTIB", DUROMINE and montelukast sodium (MSD). On 08-SEP-2011 at 18:00 (also reported as on 09-AUG-2011), the patient experienced shortness of breath, inflammation, heat, was complaining of sore in the upper arm with swelling and redness. The patient sought medical attention and he was treated with DUONEB and BENADRYL and SOLU-MEDROL. On an unknown date, the patient recovered from shortness of breath, inflammation, heat, sore upper arm, swelling and redness. Shortness of breath, inflammation, heat, sore upper arm, swelling and redness required medical/surgical intervention to prevent serious criteria and the events were considered to be other medical events by the pharmacist. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a doctor of pharmacy (pharmacy director) concerning a female patient who "within the last month" in September 2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). The pharmacy director reported that the patient, in September 2011, had an allergic reaction to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from a doctor of pharmacy concerning an 85 year old retired female patient with sulfa allergy, lung cancer and mitral valve disorder and the following illness at time of vaccination: presyncope who in September 2011, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included VALIUM, ANTIVERT, sitagliptin phosphate (MSD), MgSO4, ferrousSO4, XANAX, DUONEB, folic acid, "derm scop", lisinopril (MSD), PLAVIX, heparin, loratadine (MSD), LIPITOR, aspirin, "LALTIB", DUROMINE and montelukast sodium (MSD). On 08-SEP-2011 at 18:00 (also reported as on 09-AUG-2011), the patient experienced shortness of breath, inflammation, heat, was complaining of sore in the upper arm with swelling and redness. The patient sought medical attention and he was treated with DUONEB and BENADRYL and SOLU-MEDROL. On an unknown date, the patient recovered from shortness of breath, inflammation, heat, sore upper arm, swelling and redness. Shortness of breath, inflammation, heat, sore upper arm, swelling and redness required medical/surgical intervention to prevent serious criteria and the events were considered to be other medical events by the pharmacist. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Local reaction
Clinical narrative: Exaggerated local reaction to MENACTRA vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Screaming
Clinical narrative: Screaming after immunization x 7 hours no fever.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, VIIth nerve paralysis
Clinical narrative: Pt reported he went to the doctor because he wasn't feeling well about (7) seven days after immunization and was diagnosed with Bell's Palsy.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy test urine positive, Vaginal haemorrhage
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with stomach cramps and no drug reactions or allergies, who on 28-JUN-2010 received the first dose of GARDASIL and the second dose on 14-OCT-2011. The nurse reported that the patient came to their office because she had her period for 3 weeks. While at the office on 28-JAN-2011 she received her third dose of GARDASIL (Lot # 0787). After receiving the dose a urine pregnancy test was found to be positive. The patient's date of last menstrual period and her estimated date of delivery were unknown. Follow up information has been received from a nurse practitioner via pregnancy questionnaire concerning the patient with Gastrooesophageal reflux disease, tobacco user, anemia and a history of 2 prior spontaneous abortions (date unspecified) who on 28-JAN-2011 experienced a vaginal bleeding spontaneous abortion, 6 weeks from last menstrual period by receiving vaccine. Upon internal review vaginal bleeding SAB by receiving vaccine was determined to be an other important medical event. The products of conception were not examined. It was unknown if the fetus was normal. No further information is available.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt was given pneumococcal vaccine, 3 days later she presented in clinic with cellulitis at injection site, was c/o warmness, redness and itchy at injection site. She was treated with antibiotics.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac pacemaker insertion, Herpes zoster, Pain, Rash, Vascular graft
Clinical narrative: Information has been received from a 78 year old female consumer reporting on herself who about 7 years ago (in approximately 2004), was vaccinated with a dose of ZOSTAVAX (Merck) (route, dose and lot number not reported). The consumer reported that last year and this year over the last 15 months (since approximately August 2010), the patient had been experiencing shingles outbreaks. The consumer said that the episodes had come and go. In December 2010, the patient underwent a bypass surgery. In January 2011, the patient underwent a pacemaker surgery. The patient had been taking acyclovir 800 mg and it had been helping with the pain. The consumer stated that the most recent rash was in the area of her pacemaker. The patient went to an unspecified dermatologist due to the rash who said it was not "shingles". The consumer and her husband no longer resided where they used to and did not give permission to contact the physician. At the time of the report the patient had not recovered from the recurrence of shingles and rash. At the time of the report, the outcome of bypass surgery and pacemaker was unknown. Upon internal review, bypass surgery and pacemaker were determined as other important medical events. No further information is available.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling/aching through the arm, elbow, wrist, shoulder, neck, fingers. Symptoms lasted 7 days. Patient used ibuprofen, warm moist heat to site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Shortness of breath, accelerated heart beat, racing of the heart, stomach cramps the next day.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dysarthria, Guillain-Barre syndrome, Headache
Clinical narrative: Pt. developed bilat numbness tingling hands/feet (digits), then poor focus , HA, 2d later, (L) cheek swollen, (R) facial droop, (R) side of tongue tingling: slurred speech. Seen at ER 11/2/11 & admitted & evaluated also HTN, presumed Guillain-Barre.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia, Laboratory test normal, Paraesthesia, Paraesthesia oral
Clinical narrative: Pt. developed bilat numbness tingling hands/feet (digits), then poor focus , HA, 2d later, (L) cheek swollen, (R) facial droop, (R) side of tongue tingling: slurred speech. Seen at ER 11/2/11 & admitted & evaluated also HTN, presumed Guillain-Barre.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face, Ultrasound Doppler, Ultrasound scan normal, VIIth nerve paralysis, Vision blurred
Clinical narrative: Pt. developed bilat numbness tingling hands/feet (digits), then poor focus , HA, 2d later, (L) cheek swollen, (R) facial droop, (R) side of tongue tingling: slurred speech. Seen at ER 11/2/11 & admitted & evaluated also HTN, presumed Guillain-Barre.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: 12/6/11 - Pt called & said arm where injection very sore & had 2 shots in arm - 1 in injection size & 1 below - very warm & sore. - Pt came into pharmacy tonight & had gone to any ARNP - said she had infection at injection site. Started on antibiotics.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Neuropathy peripheral
Clinical narrative: 1st weakness & numbness. 2nd thought had stroke went to ER ruled out. Worsening neuropathy diagnosed sent home. 3rd back to ER next night in terrible pain. 4th admitted to hospital 11/11/11 - present. Diagnosed with Guillain Barre Syndrome. Advised to never take another flu shot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 1st weakness & numbness. 2nd thought had stroke went to ER ruled out. Worsening neuropathy diagnosed sent home. 3rd back to ER next night in terrible pain. 4th admitted to hospital 11/11/11 - present. Diagnosed with Guillain Barre Syndrome. Advised to never take another flu shot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry mouth, Feeling abnormal, Nasal congestion, Oropharyngeal pain
Clinical narrative: * attached. Two days after the flu shot. I had a terrible sore throat. So bad I had no saliva, that lasted one day. I also had a cough, runny nose and at times a stuffy nose. I had cough syrup w/codeine in it that I took. By Sunday evening I felt so bad, I decided to go to the doctor on Monday. When I got up Monday, I felt like a million dollars. From then on my cough got better and I was myself again. I have taken flu shots before and had no after effects. Could it be because I am over 65 and got a stronger dose?
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: * attached. Two days after the flu shot. I had a terrible sore throat. So bad I had no saliva, that lasted one day. I also had a cough, runny nose and at times a stuffy nose. I had cough syrup w/codeine in it that I took. By Sunday evening I felt so bad, I decided to go to the doctor on Monday. When I got up Monday, I felt like a million dollars. From then on my cough got better and I was myself again. I have taken flu shots before and had no after effects. Could it be because I am over 65 and got a stronger dose?
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt complained of hand & wrist numbness on left side of body, also tingling of fingers (patient reported to pharmacist on 12/9/2011).
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: 11/16/11 Flu & meningococcal vaccine in (L) deltoid - same arm. (L) deltoid 7 x 12 cm induration 11-18-11 erythema. No systemic signs or sxs. Localized - responded to BENADRYL.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/rash on left shoulder around injection site.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pallor, Rash maculo-papular, Skin lesion
Clinical narrative: Development of maculopapular blanching rash centrifugally distributed, confluent lesions on face trunk, extremities palms and soles.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Eyelid oedema
Clinical narrative: Pt called; rt eyelid puffy -> kept getting bigger. Eyelash & lid discomfort. Pt did not call back when 3 attempts were made.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Soreness when moving arm for about 2 weeks now worse at night and when lifting arm to move the muscle.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Induration, Local swelling
Clinical narrative: Local swelling & induration of Rt. upper arm.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Convulsion, Pyrexia
Clinical narrative: Febrile illness; ? apneic event vs seizure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash started at forward, spread to upper, then lower back; hips & buttocks started 4 or 5 days after shot & still have it over 3 months later.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Neck pain, Pain, Salivary gland disorder, Tenderness
Clinical narrative: 13Feb - No fever, had chills & aches after Anthrax vac on 4Feb11. Neck tenderness under ears. 25Feb - No fever, neck pain under ears. 6Mar - No fever, neck pain under ears, submandibular gland irritation.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Decreased appetite, Dehydration, Diagnostic procedure, Gastrointestinal examination, Ileus
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Nov-2011) concerns a male infant, who was preterm and had a medical history of RDS (respiratory distress syndrome) and lower leg amputation. His birth weight was 1.125 pounds and had one sibling (half sibling). On 20-Oct-2011 the patient received flu vaccine. On the same day he also received ROTATEQ, DTAP, HIB, and PREVNAR. Twenty-four to thirty-six hours after vaccinations the patient developed a high temp (temperature) 102 - 103 / vomiting, decreased appetite and dehyd. (dehydration). He was admitted to hospital for 2 days with ileus. Relevant diagnostic tests included obstruction series, KUB (kidneys, ureters and bladder scan) and pedi GI (pediatric gastrointestinal) evaluation. The patient took 4 to 6 days to get better. The event outcome was recovered. The reporter considered events to be serious as the events required emergency room / doctor visit, hospitalisation and medical / surgical intervention.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Pyrexia, Urinary system X-ray, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Nov-2011) concerns a male infant, who was preterm and had a medical history of RDS (respiratory distress syndrome) and lower leg amputation. His birth weight was 1.125 pounds and had one sibling (half sibling). On 20-Oct-2011 the patient received flu vaccine. On the same day he also received ROTATEQ, DTAP, HIB, and PREVNAR. Twenty-four to thirty-six hours after vaccinations the patient developed a high temp (temperature) 102 - 103 / vomiting, decreased appetite and dehyd. (dehydration). He was admitted to hospital for 2 days with ileus. Relevant diagnostic tests included obstruction series, KUB (kidneys, ureters and bladder scan) and pedi GI (pediatric gastrointestinal) evaluation. The patient took 4 to 6 days to get better. The event outcome was recovered. The reporter considered events to be serious as the events required emergency room / doctor visit, hospitalisation and medical / surgical intervention.
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Headache, Injection site pruritus, Pain in extremity
Clinical narrative: Initial report received from a consumer on 30 November 2011. A female patient (age refused to be provided) received a right arm intramuscular injection of FLUZONE, sanofi pasteur Inc. lot number UT440AA, on 25 November 2011. On 25 November 2011, within one hour of receiving the FLUZONE, the patient developed respiratory distress with wheezing and felt like this increased her asthma symptoms. She also complained of headache, fever "104 - 110 degrees Fahrenheit", pain in right arm and itching at the injection site. The patient self medicated with TYLENOL, BENADRYL and asthma inhaler. The outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory distress, Wheezing
Clinical narrative: Initial report received from a consumer on 30 November 2011. A female patient (age refused to be provided) received a right arm intramuscular injection of FLUZONE, sanofi pasteur Inc. lot number UT440AA, on 25 November 2011. On 25 November 2011, within one hour of receiving the FLUZONE, the patient developed respiratory distress with wheezing and felt like this increased her asthma symptoms. She also complained of headache, fever "104 - 110 degrees Fahrenheit", pain in right arm and itching at the injection site. The patient self medicated with TYLENOL, BENADRYL and asthma inhaler. The outcome was reported as not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 29 November 2011. A 31-year-old female patient had received an intramuscular right deltoid injection of FLUZONE, lot number UT499A on 25 October 2011. On an unspecified date, the patient complained of right arm pain for one month after the injection. The patient went to an orthopedic doctor who told her it was bursitis. Medical history and concomitant medications were not reported. No adverse events following prior vaccinations were reported. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: Initial report was received on 28 November 2011 from a health care professional which involved vaccination during pregnancy. A healthy pregnant female patient (date of birth not reported) had received on 02 November 2011 dose one intramuscular injection of ADACEL, lot number C3922AA and one week later after vaccination on 09 November 2011, the patient experienced a miscarriage. The patient was hospitalized (dates not reported). The patient's last menstrual period and estimated date of delivery were not reported. The outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pyrexia
Clinical narrative: Mom reports that patient developed a fever of 104.4 per forehead scanner thermometer 14 hours after given hep A vaccine & INFLUENZA.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu vaccine 11/19/11 - 11/26/11 hives on buttocks - resolved in 2d. History: 11/17/04 flu -> 11/22/05 hives. 10/9/07 flu -> 10/16/07 hives. 10/17/08 flu - 10/24/08 hives.
Age: 26.0
Sex: F
Vaccine: DTAP, HEPA, TYP
Symptoms: Headache, Pyrexia
Clinical narrative: Persistent low grade fever (99.5 degrees F) with headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia, Vaccine positive rechallenge
Clinical narrative: Developed "pink and itchy eyes" shortly after receiving flu shot, duration ~4 hours. States same thing happened last time she received flu shot in 2009.
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Fatigue, Flank pain, Myalgia, Pain
Clinical narrative: I arrived to the gym to workout as usual at 4:20 pm. I normally have the recumbent bike machine set at level 8. I was unable to bike at level 8, 7, 6, 5, 4, or 3 without significant muscle soreness and fatigue so I gave up after 15 minutes. I then walked slowly on the treadmill for 10 minutes. I changed, got in the cold shower, and 45 seconds later I got a severe pain on my left side below my ribcage. About 1 minute after that I became extremely dizzy and felt as though I was about to pass out so I leaned on the shower wall and held on for about 5 minutes before the feeling subsided a bit. Once I could walk I sat down and put my head in between my legs for 5 minutes. Once I stood up I was extremely white and had lost all color in my face. The side pains became less severe after a few minutes and fully sudsided after 30 minutes. As of today (12/9/11) I am feeling very tired despite getting plenty of sleep and my whole body aches. The influenze/H1N1 and TDAP vaccines were both administered yesterday (12/8/11) at the same time.
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pallor
Clinical narrative: I arrived to the gym to workout as usual at 4:20 pm. I normally have the recumbent bike machine set at level 8. I was unable to bike at level 8, 7, 6, 5, 4, or 3 without significant muscle soreness and fatigue so I gave up after 15 minutes. I then walked slowly on the treadmill for 10 minutes. I changed, got in the cold shower, and 45 seconds later I got a severe pain on my left side below my ribcage. About 1 minute after that I became extremely dizzy and felt as though I was about to pass out so I leaned on the shower wall and held on for about 5 minutes before the feeling subsided a bit. Once I could walk I sat down and put my head in between my legs for 5 minutes. Once I stood up I was extremely white and had lost all color in my face. The side pains became less severe after a few minutes and fully sudsided after 30 minutes. As of today (12/9/11) I am feeling very tired despite getting plenty of sleep and my whole body aches. The influenze/H1N1 and TDAP vaccines were both administered yesterday (12/8/11) at the same time.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Developed hard reddened lump at injection site with soreness, size of nickel. Duration 1 week.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Pt went to ED for urticaria rash to chest, back, and face.  Given IV fluids Benadryl 12.5mg, Pepcid 10mh, and solumedrol 30mg IV.  Transferred to Hospital at 5:33 PM via ambulance per ED doctor.
Age: 1.16
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Had approximately 8 pox diagnosed chicken pox from vaccine by pediatrician.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site rash
Clinical narrative: Fatigue, followed by headache, fever, chills, soreness and rash at injection site.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Fatigue, followed by headache, fever, chills, soreness and rash at injection site.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Haematoma, Head injury, Muscle rigidity, Somnolence
Clinical narrative: Pt was reportedly standing with mom and noted to spontaneously drop to the floor (hitting her head with a subsequent forehead hematoma).  Pt was noted to be rigid with extended extremities, a blank stare, and no response for 15 to 30 seconds.  She was drowsy thereafter but returned to her baseline within 1/2 hour.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Pt was reportedly standing with mom and noted to spontaneously drop to the floor (hitting her head with a subsequent forehead hematoma).  Pt was noted to be rigid with extended extremities, a blank stare, and no response for 15 to 30 seconds.  She was drowsy thereafter but returned to her baseline within 1/2 hour.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Mild pain at right superio-lateral deltoid with palpation and abduction to 90 degrees.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Pyrexia
Clinical narrative: does not feel well, has mild fever 37.6C.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Two weeks after getting the shingles vaccine shot I developed the first cold sore of my life on my lips.  The cold sore took three weeks to go away.  I cannot believe this was not a side effect of the vaccine.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Diffuse redness surrounding injection site. No other s+s. Returns to clinic 12/9/11 Large 3"x2" erythema and swelling localized to injection site.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphemia
Clinical narrative: Severe stuttering. No other symptoms. No treatment.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site vesicles, Injection site warmth, Skin lesion
Clinical narrative: Right thigh, raised circular lesion 1.5 cm warm to touch, mildly tender; 3 vesicles of differing sizes within the lesion.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Nausea, Paraesthesia
Clinical narrative: Immediately following the injection, patient experienced soreness at the injection sight, then feeling faint, dizzy and slightly nauseated.  He then had tingling in his left hand (injection was in left arm) and then tingling in right hand, and both arms "felt heavy."  After the tingling subsided somewhat, his legs and then whole body started shaking.  He was given some water to drink.  Symptoms were significantly improved after 20-30 minutes, and we left the pharmacy area where we had been seated during this time, and went home.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of heaviness, Tremor
Clinical narrative: Immediately following the injection, patient experienced soreness at the injection sight, then feeling faint, dizzy and slightly nauseated.  He then had tingling in his left hand (injection was in left arm) and then tingling in right hand, and both arms "felt heavy."  After the tingling subsided somewhat, his legs and then whole body started shaking.  He was given some water to drink.  Symptoms were significantly improved after 20-30 minutes, and we left the pharmacy area where we had been seated during this time, and went home.