chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Erythema, Injection site erythema, Injection site streaking
Clinical narrative: This spontaneous report was received from a 75 year old female patient regarding herself. Concurrent conditions include allergy to KEFLEX and unspecified steroids. No medical history reported. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml through an unspecified route. Concomitant therapies included LIPITOR, nifedipine (manufacturer unknown), lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown), baby aspirin, ZOSTAVAX and influenza virus vaccine unspecified. On 08-OCT-2014 the patient experienced her whole upper arm got very red and hot and that she could barely raise her arm because of the pain (disability). On 09-OCT-2014 the patient experienced pain seemed to travel down her chest, under breast and behind her back, she had two red streaks coming out of the injection site and towards her elbow. The patient received treatment with BENADRYL and ibuprofen (manufacturer unknown). It was also reported that on approximately on an unknown date in September 2014 (also reports as a week and a half) prior to receiving her PNEUMOVAX 23 she received both ZOSTAVAX and influenza virus vaccine unspecified. The outcome of the events was reported as recovered on 15-OCT-2014. The causality for the events was unknown. It was reported that the patient did not sought medical attention. No product quality complaint reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a 75 year old female patient regarding herself. Concurrent conditions include allergy to KEFLEX and unspecified steroids. No medical history reported. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml through an unspecified route. Concomitant therapies included LIPITOR, nifedipine (manufacturer unknown), lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown), baby aspirin, ZOSTAVAX and influenza virus vaccine unspecified. On 08-OCT-2014 the patient experienced her whole upper arm got very red and hot and that she could barely raise her arm because of the pain (disability). On 09-OCT-2014 the patient experienced pain seemed to travel down her chest, under breast and behind her back, she had two red streaks coming out of the injection site and towards her elbow. The patient received treatment with BENADRYL and ibuprofen (manufacturer unknown). It was also reported that on approximately on an unknown date in September 2014 (also reports as a week and a half) prior to receiving her PNEUMOVAX 23 she received both ZOSTAVAX and influenza virus vaccine unspecified. The outcome of the events was reported as recovered on 15-OCT-2014. The causality for the events was unknown. It was reported that the patient did not sought medical attention. No product quality complaint reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Headache, Nausea, Rash erythematous
Clinical narrative: Vaccinated at 240PM. Symptoms at 6PM. Red rash 1 inch x 2 inches, very hot, headache, nausea. Put ice on rash, her MD had her take TYLENOL and BENADRYL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pruritus, Lacrimation increased, Ophthalmic herpes zoster, Photophobia
Clinical narrative: Beginning of September, eyes starting bothering. Dr diagnosed herpes of the eye. Was prescribed Zorgan oph in sup  oral acyclovir in Oct. (burning, watering, light sensitivie, itchy eyes).
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a 79 year old male patient regarding himself with penicillin allergy. Medical history was not reported. On 06-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, in the arm, lot number; K006681, expiry date- 21-OCT-2015, (dose, route and frequency was not reported). Concomitant medications were not reported. On 06-OCT-2014, patient experienced pain at injection site and throughout his entire arm. Patient also had fever on 06-OCT-2014. No lab diagnostics studies performed. The patient gave himself ADVIL (also reported treatment given as none) for pain relief and also explained that by 07-OCT-2014 his fever was gone and by 13-OCT-2014 his arm pain had completely recovered. Causality assessment was not reported. Patient did not seek medical attention. Product quality complaint was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Licensed practical nurse) refers to unspecified number of patients of less than 12 months of age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) injection (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, unspecified number of patients received doses of VARIVAX (Merck) prior to the age of 12 months. No adverse experiences reported. Product quality complaint was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. On unspecified date in July 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dose and lot# unknown) injection. On 07-OCT-2014 (also reported as today) the patient was vaccinated with the second dose of GARDASIL (strength, dose and lot# unknown) injection. No adverse effect reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cough, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 53 year old female patient. On 15-OCT-2014 patient received a dose of influenza virus vaccine (unspecified)(manufacturer unknown) (dose, frequency and route unspecified). On 17-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (Lot# was reported as K007826, expired on 03-FEB-2016) injection, 1 dose/once, intramuscular (IM) for chronic risk factors. On 17-OCT-2014, the patient experienced fever, cough, and body aches after receiving PNEUMOVAX23. The reporter stated this patient had missed 2 days of work due to the adverse reactions. The outcome of cough, fever and body aches were reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to an unspecified patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with VAQTA (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient was administered improperly stored VAQTA. No adverse effects reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to at least 2 unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VARIVAX injection (strength, dose and lot# unknown), that were exposed to temperatures outside of the proper storage. No adverse effect reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient came in 10/24 and showed a lot of swelling and bumps at site of injection which she got on 10/11. Patient was instructed to go to urgent care.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The area where vaccine got administered swell  within about 2 inches of injection site was painful 1 day after vaccine was given.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6-7 inches redness inside left arm warm to the touch.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt reported redness and warmth around injection site was reported 2 days after injection. Pt did not report any other symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Zostavax injection burned and it itched immediately. Six hours later site of injection was red. By Thur night (the next day) patient had severe muscle and joint pain and injection site hot. Friday - it was redder and had spread to elbow. Patient had fever, soreness, itching. Sat AM patient went to Dr. Red all the way to elbow with a dark red circle.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Zostavax injection burned and it itched immediately. Six hours later site of injection was red. By Thur night (the next day) patient had severe muscle and joint pain and injection site hot. Friday - it was redder and had spread to elbow. Patient had fever, soreness, itching. Sat AM patient went to Dr. Red all the way to elbow with a dark red circle.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching (mostly). Took BENADRYL (3 times) helping. Is getting better.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Pt felt her throat get scratchy about 4 hours after the shot then she felt a lump in her throat and then it became difficult to breath.  She proceeded to the ER at this time about 4 hours after the shot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Sensation of foreign body, Throat irritation
Clinical narrative: Pt felt her throat get scratchy about 4 hours after the shot then she felt a lump in her throat and then it became difficult to breath.  She proceeded to the ER at this time about 4 hours after the shot.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist (pharmacy intern) refers to an approximately 71 year old male patient. Medical history was not reported and drug allergies were reported as none. On 08-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 injection, lot number K009105, expiry date 21-JAN-2016, 0.5 milliliter, intramuscular. The patient has also received FLUVIRIN (unspecified manufacturer) during his same visit when he had received the PNEUMOVAX 23. Unspecified if the vaccines were administered in the same arm or in separate arms. Concomitant medications were not reported. On 08-OCT-2014, the patient experienced redness around injection site which extended from injection site all the way down to elbow and the injection site became swollen to about size of a soft ball. The affected arm is the arm that had received the PNEUMOVAX 23 injection. Unspecified if the patient has received PNEUMOVAX 23 in the past. The outcome of the injection site became swollen to about size of a soft ball and redness around injection site which extended from injection site all the way down to elbow was reported as not recovered. Causality assessment was not reported. Patient sought medical attention and called the pharmacy on 10-OCT-2014. Product quality complaint was not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist (pharmacy intern) refers to an approximately 71 year old male patient. Medical history was not reported and drug allergies were reported as none. On 08-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 injection, lot number K009105, expiry date 21-JAN-2016, 0.5 milliliter, intramuscular. The patient has also received FLUVIRIN (unspecified manufacturer) during his same visit when he had received the PNEUMOVAX 23. Unspecified if the vaccines were administered in the same arm or in separate arms. Concomitant medications were not reported. On 08-OCT-2014, the patient experienced redness around injection site which extended from injection site all the way down to elbow and the injection site became swollen to about size of a soft ball. The affected arm is the arm that had received the PNEUMOVAX 23 injection. Unspecified if the patient has received PNEUMOVAX 23 in the past. The outcome of the injection site became swollen to about size of a soft ball and redness around injection site which extended from injection site all the way down to elbow was reported as not recovered. Causality assessment was not reported. Patient sought medical attention and called the pharmacy on 10-OCT-2014. Product quality complaint was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Eye pruritus, Headache, Lacrimation increased
Clinical narrative: First 24 hrs included sore throat, itchy runny eyes, and headache.  Day 2 added low energy, achy.  Day 3 and 4 added fever, cough and congestion.  Improvement started on Days 5 and 6.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: First 24 hrs included sore throat, itchy runny eyes, and headache.  Day 2 added low energy, achy.  Day 3 and 4 added fever, cough and congestion.  Improvement started on Days 5 and 6.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Mobility decreased, Pruritus, Pyrexia
Clinical narrative: Red rash all over, dizziness, pain in joints, fever. Felt like I couldn't move. Lasted all of first day, slightly better second day. Rash subsiding gradually but still very itchy. Dr not in to see me.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red rash all over, dizziness, pain in joints, fever. Felt like I couldn't move. Lasted all of first day, slightly better second day. Rash subsiding gradually but still very itchy. Dr not in to see me.
Age: 58.0
Sex: F
Vaccine: DPP
Symptoms: Hypoaesthesia, Lymph node pain, Lymphadenopathy, Pain in extremity, Paraesthesia
Clinical narrative: The lymph glands in my armpit became swollen and painful. Then on 10/25/2014 about 1:00 PM my arm started tingling, hurting and going numb. It is 10:53 PM now, same day, and the symptoms are just now easing up.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Fatigue, Oropharyngeal pain, Sinus congestion
Clinical narrative: Sore throat; hoarseness; mild dizziness; fatigue; sinus congestion.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Somnolence
Clinical narrative: Muscle pain, shivers, initially. Next day headache and need to sleep a lot.  Took naproxen for headache.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever of 101.2 Fahrenheit for the first night, shivering, then for the next two days muscle aches, headaches, weakness, and nausea.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever of 101.2 Fahrenheit for the first night, shivering, then for the next two days muscle aches, headaches, weakness, and nausea.
Age: 65.0
Sex: M
Vaccine: DPP
Symptoms: Headache, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Severe debilitating pain in shoulder. Nausea, headache, body aches.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Diplopia, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Woozy, double-vision, hot, tipsy. Vital signs 162/104, pulse 79,(8:15am), bp 163/104, p 85 (8:20am), bp 135/91, pulse 77 at 08:48. Pt still feels slight wooziness.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and some hives, patient took Benadryl and was fine the next morning.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site pain, Rash
Clinical narrative: Huge red mark about the size of a baseball on backside of arm with bumps. Pains and soreness at injection site.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-ganglioside antibody positive, CSF test normal, Diarrhoea, Electromyogram abnormal, Full blood count normal
Clinical narrative: Fever, myalgias, diarrhea for 36 hours. Muscle weakness in legs which persisted and got worse over a 3 week period.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Nerve conduction studies abnormal, Pyrexia
Clinical narrative: Fever, myalgias, diarrhea for 36 hours. Muscle weakness in legs which persisted and got worse over a 3 week period.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch, from shoulder down past elbow.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain
Clinical narrative: Pain in the left arm from area were flu shot was given into the muscle and part way down to the elbow. Can't move left arm w/o pain. Still very sore and tender on the spot where shot was given.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Hives and itching over most of his body.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Malaise, Pain
Clinical narrative: 3 hrs. after vaccination, started getting bad gravely throat, soon followed by BAD but unproductive cough.  After another hour, got aches from head to toe and headache.  Felt generally ill and fatigued that evening.  These symptoms greatly improved over night.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: 3 hrs. after vaccination, started getting bad gravely throat, soon followed by BAD but unproductive cough.  After another hour, got aches from head to toe and headache.  Felt generally ill and fatigued that evening.  These symptoms greatly improved over night.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: PATIENT REPORTS EXTREME LEFT ARM RADIATING DOWN TO HAND.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: TRIGEMINAL NEURALGIA (TIC DOULOUREAUX) / ATTACKS OF SEVERE FACIAL PAIN LASTING SECONDS TO MINUTES / LEVAQUIN 500MG ONCE DAILY /TYLENOL/COND #3 ONE TO TWO THREE TIMES DAILY.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat but not tachycardic (>90 beats per minute but not over 100). No pain was experienced.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Slight fever that was resolved by acetaminophen.  Redness and swelling around injection site and arm pain.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass
Clinical narrative: Lump found in left armpit, lymph node.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Throat tightness
Clinical narrative: Throat felt like it was closing, headache.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Headache, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, headache, runny nose, sneeze, weakness, muscle aches.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: Fever, headache, runny nose, sneeze, weakness, muscle aches.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swelling that spread to about a 4 inch by 4 inch area, redness, no pain.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Eye discharge, Pruritus
Clinical narrative: Ongoing burning, itching and eye excretion.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Influenza, Paraesthesia
Clinical narrative: Pt. called pharmacy on 10/24 approx 7:00 pm stating she had received vaccination previous day and now complaining of numbness and tingling in both arms. I contacted her on 10/25 in morning and she said upon awakening no longer any symptoms. She however feels like she now has the flu.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Facial pain, Pyrexia, Vomiting
Clinical narrative: Patient started experiencing vomiting, diarrhea, chills and facial soreness. She had a fever of 101 degrees F and symptoms persisted for about 36 hours.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage of one of my twins.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Pain
Clinical narrative: Soreness in deltoid and axilla. Patient reported sleeping on injected arm overnight. Treatment with acetaminophen recommended.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Palpitations, Restlessness
Clinical narrative: Excessive heart racing/restless/major fatigue starting approx 2 hours and lasting about 2 days. Did go to ER. Also very weak.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pharyngeal oedema
Clinical narrative: Throat swelling and excessive tiredness.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Diarrhoea, Vomiting
Clinical narrative: About 4 hours after receiving vaccine, the patient became very weak, had confusion, had loose stools and vomiting. Patient was seen at ER around 8 pm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Tenderness
Clinical narrative: PATIENT STATED THAT EARLY IN EVENING SWELLING AND TENDERNESS BEGAN ON INSIDE OF ARM, ABOVE ELBOW. SAME ARM AS FLU SHOT GIVEN, PERCEIVED AS ALLERGIC REACTION. ADVISED ICE PACK/COLD COMPRESS. PATIENT CAN NOT TAKE NSAIDS. BY TIME REACTION WAS SHOWN TO ME, ABOUT 48HR AFTER INJECTION, SYMPTOMS WERE GETTING BETTER. LESS TENDER.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swelling of left arm; treated with cephalexin.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Heart rate increased, Injection site erythema, Injection site pruritus
Clinical narrative: Headache, dizziness, fast heart rate. All but headache passed within 15 minutes so did not recognize it was related or report it. On Thursday evening developed itch, redness, swelling and warmth to touch at injection site. Called RN who reassured this was a common side effect though delayed.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Headache, dizziness, fast heart rate. All but headache passed within 15 minutes so did not recognize it was related or report it. On Thursday evening developed itch, redness, swelling and warmth to touch at injection site. Called RN who reassured this was a common side effect though delayed.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, Balance disorder, Blood test, Computerised tomogram normal, Electromyogram
Clinical narrative: ON 7/12/14 FELL IN DRIVEWAY WHILE GETTING ON MY BIKE TO GO FOR A RIDE. ON 7/25/14 WOKE UP AT 3:00 AM WITH NUMBNESS AND TINGLING IN MY RIGHT FEET, LEGS ALL THE WAY UP TO MY WAIST. NEXT DAY ON BOTH SIDES. BY 5TH DAY I COULD HARDLY WALK. WENT TO ER ON 7/29/14. HAD A CAT SCAN OF LUMBAR AREA WHICH WAS NEGATIVE. SENT HOME ON IBUPROFEN AND ATIVAN AND BED REST FOR NEXT 3 DAYS. SAW MY DOCTOR ON 8/1/14 SENT UP FOR A CERVICAL, THORACIC AND LUMBAR MRI AND GOING TO BE REFERRED TO A NEUROSURGEON. ON 8/2/14 COULD NOT WALK. WENT TO ER WAS ADMITTED AND HAD ANOTHER MRI OF THORACIC AND LUMBAR WHICH WERE NEGATIVE. SAW A NEUROSURGEON WHO DID SPINAL TAP WHICH WAS ALSO NEGATIVE REFERRED TO A NEUROLOGIST. AFTER BEING EXAMINED NO REFLEXES AND NO BALANCE. HAD AN EMG ON BOTH LEGS AND WAS TO START TREATMENT ME ON NEURONTIN FOR SENSORY AND PERIPHERAL NEUROPATHY. I LAID IN BED FOR A MONTH, ELEVATING MY LEGS ALL DAY AND ALL NIGHT. HOLDING ON TO WALLS AND FURNITURE TO WALK. ASKED FOR PHYSICAL THERAPY WHICH I STARTED ON 8/18/14. STARTED USING A CANE TO HELP ME TO GET AROUND BETTER. NEURONTIN DID GET RID OF THE SENSORY FEELING IN MY LEGS. I WAS THEN REFERRED TO HOSPITAL ON 9/11/14. EXAMINED AND DIAGNOSED WITH WITH GUILLAIN BARRE SYNDROME AND SENT HOME ON SAME TREATMENT PT AND NEURONTIN MEDICATION. TWO DAYS LATER THE NUMBNESS AND TINGLING MOVED UP FROM MY WAIST TO MY CHEST WITH SENSORY FEELING BAD IN STOMACH AND BACK AREAS. AS OF TODAY 10/26/14 STILL HAVE NUMBNESS AND TINGLING IN BOTH FEET, LEGS AND UP TO CHEST NOW.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture normal
Clinical narrative: ON 7/12/14 FELL IN DRIVEWAY WHILE GETTING ON MY BIKE TO GO FOR A RIDE. ON 7/25/14 WOKE UP AT 3:00 AM WITH NUMBNESS AND TINGLING IN MY RIGHT FEET, LEGS ALL THE WAY UP TO MY WAIST. NEXT DAY ON BOTH SIDES. BY 5TH DAY I COULD HARDLY WALK. WENT TO ER ON 7/29/14. HAD A CAT SCAN OF LUMBAR AREA WHICH WAS NEGATIVE. SENT HOME ON IBUPROFEN AND ATIVAN AND BED REST FOR NEXT 3 DAYS. SAW MY DOCTOR ON 8/1/14 SENT UP FOR A CERVICAL, THORACIC AND LUMBAR MRI AND GOING TO BE REFERRED TO A NEUROSURGEON. ON 8/2/14 COULD NOT WALK. WENT TO ER WAS ADMITTED AND HAD ANOTHER MRI OF THORACIC AND LUMBAR WHICH WERE NEGATIVE. SAW A NEUROSURGEON WHO DID SPINAL TAP WHICH WAS ALSO NEGATIVE REFERRED TO A NEUROLOGIST. AFTER BEING EXAMINED NO REFLEXES AND NO BALANCE. HAD AN EMG ON BOTH LEGS AND WAS TO START TREATMENT ME ON NEURONTIN FOR SENSORY AND PERIPHERAL NEUROPATHY. I LAID IN BED FOR A MONTH, ELEVATING MY LEGS ALL DAY AND ALL NIGHT. HOLDING ON TO WALLS AND FURNITURE TO WALK. ASKED FOR PHYSICAL THERAPY WHICH I STARTED ON 8/18/14. STARTED USING A CANE TO HELP ME TO GET AROUND BETTER. NEURONTIN DID GET RID OF THE SENSORY FEELING IN MY LEGS. I WAS THEN REFERRED TO HOSPITAL ON 9/11/14. EXAMINED AND DIAGNOSED WITH WITH GUILLAIN BARRE SYNDROME AND SENT HOME ON SAME TREATMENT PT AND NEURONTIN MEDICATION. TWO DAYS LATER THE NUMBNESS AND TINGLING MOVED UP FROM MY WAIST TO MY CHEST WITH SENSORY FEELING BAD IN STOMACH AND BACK AREAS. AS OF TODAY 10/26/14 STILL HAVE NUMBNESS AND TINGLING IN BOTH FEET, LEGS AND UP TO CHEST NOW.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic normal, Paraesthesia, Peripheral sensory neuropathy, Sensory disturbance
Clinical narrative: ON 7/12/14 FELL IN DRIVEWAY WHILE GETTING ON MY BIKE TO GO FOR A RIDE. ON 7/25/14 WOKE UP AT 3:00 AM WITH NUMBNESS AND TINGLING IN MY RIGHT FEET, LEGS ALL THE WAY UP TO MY WAIST. NEXT DAY ON BOTH SIDES. BY 5TH DAY I COULD HARDLY WALK. WENT TO ER ON 7/29/14. HAD A CAT SCAN OF LUMBAR AREA WHICH WAS NEGATIVE. SENT HOME ON IBUPROFEN AND ATIVAN AND BED REST FOR NEXT 3 DAYS. SAW MY DOCTOR ON 8/1/14 SENT UP FOR A CERVICAL, THORACIC AND LUMBAR MRI AND GOING TO BE REFERRED TO A NEUROSURGEON. ON 8/2/14 COULD NOT WALK. WENT TO ER WAS ADMITTED AND HAD ANOTHER MRI OF THORACIC AND LUMBAR WHICH WERE NEGATIVE. SAW A NEUROSURGEON WHO DID SPINAL TAP WHICH WAS ALSO NEGATIVE REFERRED TO A NEUROLOGIST. AFTER BEING EXAMINED NO REFLEXES AND NO BALANCE. HAD AN EMG ON BOTH LEGS AND WAS TO START TREATMENT ME ON NEURONTIN FOR SENSORY AND PERIPHERAL NEUROPATHY. I LAID IN BED FOR A MONTH, ELEVATING MY LEGS ALL DAY AND ALL NIGHT. HOLDING ON TO WALLS AND FURNITURE TO WALK. ASKED FOR PHYSICAL THERAPY WHICH I STARTED ON 8/18/14. STARTED USING A CANE TO HELP ME TO GET AROUND BETTER. NEURONTIN DID GET RID OF THE SENSORY FEELING IN MY LEGS. I WAS THEN REFERRED TO HOSPITAL ON 9/11/14. EXAMINED AND DIAGNOSED WITH WITH GUILLAIN BARRE SYNDROME AND SENT HOME ON SAME TREATMENT PT AND NEURONTIN MEDICATION. TWO DAYS LATER THE NUMBNESS AND TINGLING MOVED UP FROM MY WAIST TO MY CHEST WITH SENSORY FEELING BAD IN STOMACH AND BACK AREAS. AS OF TODAY 10/26/14 STILL HAVE NUMBNESS AND TINGLING IN BOTH FEET, LEGS AND UP TO CHEST NOW.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Walking aid user
Clinical narrative: ON 7/12/14 FELL IN DRIVEWAY WHILE GETTING ON MY BIKE TO GO FOR A RIDE. ON 7/25/14 WOKE UP AT 3:00 AM WITH NUMBNESS AND TINGLING IN MY RIGHT FEET, LEGS ALL THE WAY UP TO MY WAIST. NEXT DAY ON BOTH SIDES. BY 5TH DAY I COULD HARDLY WALK. WENT TO ER ON 7/29/14. HAD A CAT SCAN OF LUMBAR AREA WHICH WAS NEGATIVE. SENT HOME ON IBUPROFEN AND ATIVAN AND BED REST FOR NEXT 3 DAYS. SAW MY DOCTOR ON 8/1/14 SENT UP FOR A CERVICAL, THORACIC AND LUMBAR MRI AND GOING TO BE REFERRED TO A NEUROSURGEON. ON 8/2/14 COULD NOT WALK. WENT TO ER WAS ADMITTED AND HAD ANOTHER MRI OF THORACIC AND LUMBAR WHICH WERE NEGATIVE. SAW A NEUROSURGEON WHO DID SPINAL TAP WHICH WAS ALSO NEGATIVE REFERRED TO A NEUROLOGIST. AFTER BEING EXAMINED NO REFLEXES AND NO BALANCE. HAD AN EMG ON BOTH LEGS AND WAS TO START TREATMENT ME ON NEURONTIN FOR SENSORY AND PERIPHERAL NEUROPATHY. I LAID IN BED FOR A MONTH, ELEVATING MY LEGS ALL DAY AND ALL NIGHT. HOLDING ON TO WALLS AND FURNITURE TO WALK. ASKED FOR PHYSICAL THERAPY WHICH I STARTED ON 8/18/14. STARTED USING A CANE TO HELP ME TO GET AROUND BETTER. NEURONTIN DID GET RID OF THE SENSORY FEELING IN MY LEGS. I WAS THEN REFERRED TO HOSPITAL ON 9/11/14. EXAMINED AND DIAGNOSED WITH WITH GUILLAIN BARRE SYNDROME AND SENT HOME ON SAME TREATMENT PT AND NEURONTIN MEDICATION. TWO DAYS LATER THE NUMBNESS AND TINGLING MOVED UP FROM MY WAIST TO MY CHEST WITH SENSORY FEELING BAD IN STOMACH AND BACK AREAS. AS OF TODAY 10/26/14 STILL HAVE NUMBNESS AND TINGLING IN BOTH FEET, LEGS AND UP TO CHEST NOW.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased
Clinical narrative: Pt described loss in range of motion in right arm since 10/15/14 after vaccination.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain
Clinical narrative: Left shoulder where the injection was made was extremely painful at time of injection. Pain went away the next day; however, it came back the next week and as of 10/26/2015 is still painful. Worse in the mornings. I have never had a reaction before. Seemed like the injection was done very high up on the shoulder and the injection itself took longer then usual.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Stuffy Nose, Sore Throat, Fatigue.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Palpitations
Clinical narrative: Racing heart actually began around 7pm.  Between 9 and 9:30 pm rapid onset of chills (violently chattering teeth), vomiting, body aches, stomach cramps; fever of 100 taken next morning, headache. Was somewhat better later that day (10/23/2014), and completely better by 10/24/2014.  Treated myself with liquids, hot baths, ocillococinum, naproxen.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Racing heart actually began around 7pm.  Between 9 and 9:30 pm rapid onset of chills (violently chattering teeth), vomiting, body aches, stomach cramps; fever of 100 taken next morning, headache. Was somewhat better later that day (10/23/2014), and completely better by 10/24/2014.  Treated myself with liquids, hot baths, ocillococinum, naproxen.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Shoulder pain, radiating through my arm into my fingers.  It causes sharp pain, that also causes a tingling sensation.  I can't put a shirt on with out horrible pain. I cant rotate my shoulder or reach behind to my back.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Complaint of sore throat on 10/24/2014. Stuffy nose started on 10/25 at 6:00 PM and continues to 10/26, low grade fever of 100.56 F began on 10/26 7:00 PM.  Child is still sick 10/26/2014 at 9:36 PM.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction
Clinical narrative: Persistent immunization site reaction.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Tachycardia
Clinical narrative: Soreness, swelling, redness near injection site, tachycardia.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Diarrhoea, Dizziness, Eye pain, Headache
Clinical narrative: Dizziness, headache, anxiety, eye pain closing eyes and seeing things, Vomiting and diarrhea with nervousness the 1st round of vaccine.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Nervousness, Vomiting
Clinical narrative: Dizziness, headache, anxiety, eye pain closing eyes and seeing things, Vomiting and diarrhea with nervousness the 1st round of vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: REDNESS, SWELLING AND FELT HOT.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Local swelling
Clinical narrative: Swelling under left arm and discomfort in entire arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Headache, Immediate post-injection reaction, Neck pain
Clinical narrative: Immediately after receiving IM AFLURIA pt experienced arm and neck pain; then headache, increased blood pressure, rash, hives and SOB. IM epinephrine administered, then IM BENADRYL. Pt was transported to ER via ambulance.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Immediately after receiving IM AFLURIA pt experienced arm and neck pain; then headache, increased blood pressure, rash, hives and SOB. IM epinephrine administered, then IM BENADRYL. Pt was transported to ER via ambulance.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient received FLUVIRIN vaccine and was fine after administration post 10 min. Pt went home and approx 1 hr later called pharmacy stating she passed out. Pt contacted primary care shortly after.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Had swelling, redness, heat, rash, pain, itching at injection site x3 days. Also developed headache, sinus pressure, cough immediately after shot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Sinus headache
Clinical narrative: Had swelling, redness, heat, rash, pain, itching at injection site x3 days. Also developed headache, sinus pressure, cough immediately after shot.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Palm sized area around injection site of right arm became red and swollen a few days after vaccination. Area was painful at first but symptoms resolved after 4+ days per patient.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 50 year old female patient with drug allergy to erythromycin, drug allergy to penicillin and pulmonary fibrosis. The patient had received PNEUMOVAX 23 on an unspecified date 10 years ago (approximately October 2004) with no ill effect. On 16-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J011799, exp 09-FEB-2015) in the right arm (dose#, dose and route not reported). The patient also received an unspecified flu vaccine on 16-OCT-2014 in her left arm. The patient had soreness at the injection site of the PNEUMOVAX 23 on 16-OCT-2014. The next day, 17-OCT-2014, there was redness and pain at the injection site of the PNEUMOVAX 23. The patient did not seek medical attention and was coming to the unspecified physician's office today for assessment. The patient stated that the arm had a large blister at the site of injection of the PNEUMOVAX 23. The patient stated that there was no more pain however there was a large unspecified blister. No treatment given to these events. The outcome of redness at the injection site of the PNEUMOVAX 23 was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (lot #, dose, dose  number, frequency and route unspecified). Beginning on 22-OCT-2014, the patient experienced injection site reaction in her arm. Site was warm to touch and tender. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of 0.5 ml (Merck) PROQUAD (strength and lot# unknown) injection, which underwent multiple temperature excursions, subcutaneously. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a currently 22 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection, lot # K001504, expiry date 28-MAR-2015, dose and route were not provided).. On an unknown date the patient experienced cellulitis after receiving PNEUMOVAX 23. The patient sought medical attention by office visit on an unspecified date. The outcome of the event was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 10-20-14 swelling red itching at injection site. 10-22-14 rash on both arms. 10-24-14 dizzy and weakness in legs and back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Rash
Clinical narrative: 10-20-14 swelling red itching at injection site. 10-22-14 rash on both arms. 10-24-14 dizzy and weakness in legs and back.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional via field employee refers to unknown number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, unknown number of patients were vaccinated with PNEUMOVAX 23 vial (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, unknown number of patient have been revaccinated with PNEUMOVAX 23 and that an unknown number of patients have received more than 2 immunizations with PNEUMOVAX 23. No adverse effect reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age. Current conditions and medical history was not reported. On an unknown date, unspecified patients were vaccinated with VARIVAX (Merck), 0.5 milliliter, subcutaneously. Concomitant medications were not reported. Nurse reported that unspecified patients received improperly stored VARIVAX (Merck). VARIVAX (Merck) was exposed to -8.4C for 51 hours and -8.4C for 116.5 hours. No adverse effects were reported. Product quality complaint was not reported. This case is linked to 1410USA013136 (same reporter). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age. Current conditions and medical history was not reported. On an unknown date, unspecified patients were vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant medications were not reported. Nurse reported that unspecified patients received improperly stored ZOSTAVAX. ZOSTAVAX was exposed to -8.4C for 229 hours. No adverse effects were reported. This case is linked to 1410USA007717 (same reporter). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Complaint of arm pain at site of injection. Prolonged pain, getting better but still uncomfortable per patient.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (strength, dose, route and lot# unknown) injection, which underwent multiple temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Jaundice, Transaminases increased, Ultrasound abdomen normal
Clinical narrative: Case number PHHY2014US132725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 536228) website on 10 Oct 2014, with the follow-up received from Quality Assurance Department on 15 Oct 2014. This report refers to a 19-year-old female patient. Medical history included developmental delay and depression. Concomitant medications included fluoxetine. She was vaccinated with MENVEO (batch number: unknown) along with GARDASIL (batch number: K001502) into the right arm and BOOSTRIX (batch number: A54AL) into the left arm intramuscularly on 01 Jul 2014. On 03 Jul 2014, she experienced transaminitis (AST/ALT: 200s), abdominal pain and jaundice (total bilirubin: 2.0). Right upper quadrant (RUQ) ultrasound was normal and TYLENOL level was normal. She was sent to emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported. Upon the follow-up, QA department stated that, reported MENVEO vaccine batch number (A13001) is not a valid batch number; hence QA investigation will not be performed. Follow-up received from Quality Assurance Department on 15 Oct 2014: Updated QA comments as reported MENVEO batch number (A13001) is not a valid batch number; hence QA investigation will not be performed.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin, Jaundice
Clinical narrative: Case number PHHY2014US132725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 536228) website on 10 Oct 2014, with the follow-up received from Quality Assurance Department on 15 Oct 2014. This report refers to a 19-year-old female patient. Medical history included developmental delay and depression. Concomitant medications included fluoxetine. She was vaccinated with MENVEO (batch number: unknown) along with GARDASIL (batch number: K001502) into the right arm and BOOSTRIX (batch number: A54AL) into the left arm intramuscularly on 01 Jul 2014. On 03 Jul 2014, she experienced transaminitis (AST/ALT: 200s), abdominal pain and jaundice (total bilirubin: 2.0). Right upper quadrant (RUQ) ultrasound was normal and TYLENOL level was normal. She was sent to emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported. Upon the follow-up, QA department stated that, reported MENVEO vaccine batch number (A13001) is not a valid batch number; hence QA investigation will not be performed. Follow-up received from Quality Assurance Department on 15 Oct 2014: Updated QA comments as reported MENVEO batch number (A13001) is not a valid batch number; hence QA investigation will not be performed.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Transaminases increased, Ultrasound abdomen normal
Clinical narrative: Case number PHHY2014US132725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 536228) website on 10 Oct 2014, with the follow-up received from Quality Assurance Department on 15 Oct 2014. This report refers to a 19-year-old female patient. Medical history included developmental delay and depression. Concomitant medications included fluoxetine. She was vaccinated with MENVEO (batch number: unknown) along with GARDASIL (batch number: K001502) into the right arm and BOOSTRIX (batch number: A54AL) into the left arm intramuscularly on 01 Jul 2014. On 03 Jul 2014, she experienced transaminitis (AST/ALT: 200s), abdominal pain and jaundice (total bilirubin: 2.0). Right upper quadrant (RUQ) ultrasound was normal and TYLENOL level was normal. She was sent to emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported. Upon the follow-up, QA department stated that, reported MENVEO vaccine batch number (A13001) is not a valid batch number; hence QA investigation will not be performed. Follow-up received from Quality Assurance Department on 15 Oct 2014: Updated QA comments as reported MENVEO batch number (A13001) is not a valid batch number; hence QA investigation will not be performed.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: Became short of breath, facial swelling, and difficulty talking one hour after getting flu shot. Treated with Epinephrine IM, BENADRYL, Solumedrol and nebulized ALBUTEROL.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Speech disorder, Swelling face
Clinical narrative: Became short of breath, facial swelling, and difficulty talking one hour after getting flu shot. Treated with Epinephrine IM, BENADRYL, Solumedrol and nebulized ALBUTEROL.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Paraesthesia, Swollen tongue
Clinical narrative: Case number PHEH2014US020855 is a combined initial and follow-up spontaneous report from a pharmacist received on 15 Oct 2014. This report refers to a 21-year-old female patient. Her concurrent condition included allergy to sulfa. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145221) intramuscularly on 11 Oct 2014. On the same day, four hours after vaccination, she developed rash at the injection site, on the face and swollen tongue. She went to emergency room but was told her to go home without any treatment. Outcome of the events was reported as unknown. Seriousness and causality assessment of the events were not reported. Seriousness assessment of swollen tongue was upgraded based on the list.