chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Aggression, Cough, Pruritus, Respiratory tract congestion
Clinical narrative: Broke out in itchy hives all over her body and also developed a very hoarse cough which turned into a congested cough. My daughter STILL has the hives and cough and the date is now 10/15/2015. Her doctor insists this is not from the vaccine. Of course, myself and my husband do not agree. We have also noticed behavioral changes (throwing tantrums which is very out of character for her) and also tactile dysfunction particularly pertaining to her clothing.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Broke out in itchy hives all over her body and also developed a very hoarse cough which turned into a congested cough. My daughter STILL has the hives and cough and the date is now 10/15/2015. Her doctor insists this is not from the vaccine. Of course, myself and my husband do not agree. We have also noticed behavioral changes (throwing tantrums which is very out of character for her) and also tactile dysfunction particularly pertaining to her clothing.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient recieved a flu vaccine and passed out.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus generalised, Rash
Clinical narrative: Itching all over with small bumps on face and hands.  Hands became a little puffy. Continued until about midnight of same day.  Patient had no residual s/s the next day.
Age: 39.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dehydration, Mobility decreased, Pain, Pyrexia, White blood cell count increased
Clinical narrative: Temp spike to 103.8 - Advil given, generalized body aches. Unable to even get out of bed. Fever continued despite Advil, became dehydrated and needed IVF. Antibiotics and steroids started by MD.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid, employee complained of rednesses, swelling and ecchymosis and itching. Denied any difficulty breathing or chest tightness. Personnel health nurse was notified on 10/15/15 regarding reaction to the flu vaccine.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Influenza like illness, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Fever. Tuesday swollen neck glands. Achy, switched between Tylenol and Motrin fever 99.5 - 101.4. Wednesday symptoms continued I believe my wife gave him infant over the counter allergy medication. Thursday fever resided when he woke up. Visited doctor, noticed white spots back of throat, doctor did not feel it was shot related due to white spots although he was fine before the shot. Negative on strep test. Basically mild flu like symptoms with major complaint about neck hurting, swollen glands and loss of appetite in bed. Did not want bandage off arm for 3 days, wife got flu shot earlier and complained her arm was so sore that it was painful to move this did not happen the last two flu shot seasons. Just giving feedback since its better to have too much information than not enough.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pharyngeal disorder, Pyrexia, Streptococcus test negative
Clinical narrative: Fever. Tuesday swollen neck glands. Achy, switched between Tylenol and Motrin fever 99.5 - 101.4. Wednesday symptoms continued I believe my wife gave him infant over the counter allergy medication. Thursday fever resided when he woke up. Visited doctor, noticed white spots back of throat, doctor did not feel it was shot related due to white spots although he was fine before the shot. Negative on strep test. Basically mild flu like symptoms with major complaint about neck hurting, swollen glands and loss of appetite in bed. Did not want bandage off arm for 3 days, wife got flu shot earlier and complained her arm was so sore that it was painful to move this did not happen the last two flu shot seasons. Just giving feedback since its better to have too much information than not enough.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: The Patient is a 4 year old male.  Source of patient information was mother. Afebrile. Patient says his upper arm hurts but does not seem to be in a lot of pain. Bandaid still in place over injection site removed. No erythema or swelling around the injection site but there is an area of mild induration and mild erythema that does not seem tender extending from lower edge of the site of the bandaid almost down the antecubital fossa. There is no erythema or induation around the actual puncture site but a rather large area as described dependent to it. I suspect this might be a reaction to the bandaid, although it is latex free. Possibly the injected serum diffused distally to the injection site and he had an allergic reaction. Child will be prescribed an antibiotic and also Benadryl. Mom advised to apply ice packs 4 times per day and one was applied in the clinic.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: PAIN, REDNESS, WARM TO TOUCH, ITCHY. ICE PACK.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Rash on upper chest and back and itching.  Have not reported reaction to primary care doctor.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: Distal numbness, sensation was diminished, mild associated pinprick sensation. Paraesthesia progressed up her legs and into thighs. Numb feeling in fingertips.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Approx. 5-6 hrs later felt palpatations. Lasted 4 hrs.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient presents for swelling and tenderness at site of flu injection. No fevers, but area has increased in size in the last 2 days. Patient denies fever, vomiting, diarrhea, cough, congestion or sore throat. Normal po/uop. Normal activity.  Skin: tender, swollen left thigh with warmth and erythema--no fluctuance good pulses of left leg
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pharyngeal oedema
Clinical narrative: Pt arm swelled up, throat swelling, went to ER. Benadryl given at hospital. Pt discharged with prednisone RX.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4cm(W)x 5cm(L) reddened elevated area left deltoid injection site - warm/tender to the touch Indurated/erythematous no drainage no SOB no Hives no generalized itching.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Activities of daily living impaired, Angiogram, Asthma, Chest X-ray
Clinical narrative: Immediate rx to arm. Scratchy throat. Second day symptoms  increased, cough, etc. Third say even worse. Stomach distress. Family dr started antibiotic, cough medicine, inhaler. Admitted to the hospital with exacerbation of asthma, rx to flu vaccine, respiratory distress. Hospital x 4 days. IV steroids, antibiotics, resp. therapy. Long story short off work FOUR months. Attempted to return to the Operating Room in Feb 2014 against Pulmonologist Recommendation because out of sick time. Worked several weeks. Relapse. Been off since. Immune system decrease. Continuous SOB. Decreased lung function. Latest Pulmonary fx test lungs 44 %. LOTS of medical records. Now being followed by facility.  Seeing Pulmonologists Endocrinologist. Steroids for almost 90 days. Unable now to do normal activities.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram thorax, Condition aggravated, Cough, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Immediate rx to arm. Scratchy throat. Second day symptoms  increased, cough, etc. Third say even worse. Stomach distress. Family dr started antibiotic, cough medicine, inhaler. Admitted to the hospital with exacerbation of asthma, rx to flu vaccine, respiratory distress. Hospital x 4 days. IV steroids, antibiotics, resp. therapy. Long story short off work FOUR months. Attempted to return to the Operating Room in Feb 2014 against Pulmonologist Recommendation because out of sick time. Worked several weeks. Relapse. Been off since. Immune system decrease. Continuous SOB. Decreased lung function. Latest Pulmonary fx test lungs 44 %. LOTS of medical records. Now being followed by facility.  Seeing Pulmonologists Endocrinologist. Steroids for almost 90 days. Unable now to do normal activities.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immune system disorder, Impaired work ability, Laryngoscopy, Nasal mucosa biopsy, Pulmonary function test decreased
Clinical narrative: Immediate rx to arm. Scratchy throat. Second day symptoms  increased, cough, etc. Third say even worse. Stomach distress. Family dr started antibiotic, cough medicine, inhaler. Admitted to the hospital with exacerbation of asthma, rx to flu vaccine, respiratory distress. Hospital x 4 days. IV steroids, antibiotics, resp. therapy. Long story short off work FOUR months. Attempted to return to the Operating Room in Feb 2014 against Pulmonologist Recommendation because out of sick time. Worked several weeks. Relapse. Been off since. Immune system decrease. Continuous SOB. Decreased lung function. Latest Pulmonary fx test lungs 44 %. LOTS of medical records. Now being followed by facility.  Seeing Pulmonologists Endocrinologist. Steroids for almost 90 days. Unable now to do normal activities.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory distress, Throat irritation, Thyroid function test, Upper respiratory tract endoscopy, Vaccination complication
Clinical narrative: Immediate rx to arm. Scratchy throat. Second day symptoms  increased, cough, etc. Third say even worse. Stomach distress. Family dr started antibiotic, cough medicine, inhaler. Admitted to the hospital with exacerbation of asthma, rx to flu vaccine, respiratory distress. Hospital x 4 days. IV steroids, antibiotics, resp. therapy. Long story short off work FOUR months. Attempted to return to the Operating Room in Feb 2014 against Pulmonologist Recommendation because out of sick time. Worked several weeks. Relapse. Been off since. Immune system decrease. Continuous SOB. Decreased lung function. Latest Pulmonary fx test lungs 44 %. LOTS of medical records. Now being followed by facility.  Seeing Pulmonologists Endocrinologist. Steroids for almost 90 days. Unable now to do normal activities.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Erythema, Local reaction, Peripheral swelling, Pruritus
Clinical narrative: Approximately 1 hour after receiving Flu immunization, site of immunization on arm became largely swollen, red and itchy. Swelling persisted. 45 minutes after that, patient began coughing and within 30 minutes from then began a generalized wheeze. Child was given 2 puffs of inhaled albuterol which helped the wheezing to resolve and it did not reoccur. Today, 10/15/2015, patient continues to have a moderate localized reaction on same arm as he received vaccine, swelling and redness extending from elbow to shoulder.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Approximately 1 hour after receiving Flu immunization, site of immunization on arm became largely swollen, red and itchy. Swelling persisted. 45 minutes after that, patient began coughing and within 30 minutes from then began a generalized wheeze. Child was given 2 puffs of inhaled albuterol which helped the wheezing to resolve and it did not reoccur. Today, 10/15/2015, patient continues to have a moderate localized reaction on same arm as he received vaccine, swelling and redness extending from elbow to shoulder.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Confusional state, Disorientation, Headache
Clinical narrative: Began with chills, increasing in intensity after 2 hours or so, followed by high body temperature, aching joints, nausea (vomiting just prevented by self control around 11 PM) and accompanied by disorientation and confusion toward the end of the reaction (12-2 AM). Symptoms began to recede by 2 or 3 AM, leaving a lingering headache behind the eyes; took 650 mg acetaminophen. By late morning (10/15/2015) was back more or less to normal. Having had flu in past years, I can describe the symptoms here as equivalent to a 2-3 day flu episode compressed into a few hours: chills, high temperature, some aching joints and nausea.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Began with chills, increasing in intensity after 2 hours or so, followed by high body temperature, aching joints, nausea (vomiting just prevented by self control around 11 PM) and accompanied by disorientation and confusion toward the end of the reaction (12-2 AM). Symptoms began to recede by 2 or 3 AM, leaving a lingering headache behind the eyes; took 650 mg acetaminophen. By late morning (10/15/2015) was back more or less to normal. Having had flu in past years, I can describe the symptoms here as equivalent to a 2-3 day flu episode compressed into a few hours: chills, high temperature, some aching joints and nausea.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Vesicle like lesions appeared at the deltoid area 2.5cm around shot location. And 'extension' above left antecubital similar smaller area of erythema base w/slight rise of vesicle like lesions.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up with significant swelling, warmth and redness on arm where vaccine was administered on shoulder. Within 48 hours of vaccine administration, swelling and redness had spread from mid-chest, down arm and extended to child's back almost reaching to spine. Site was itchy. No respiratory issues noted.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Patient woke up with significant swelling, warmth and redness on arm where vaccine was administered on shoulder. Within 48 hours of vaccine administration, swelling and redness had spread from mid-chest, down arm and extended to child's back almost reaching to spine. Site was itchy. No respiratory issues noted.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient administered flu shot.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red non-raised rash below the site of injection.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Started with rash on lower back; by morning it had spread to abdomen, arms and legs - none on head. No breathing probs (+) itch. Has had flu vax for past 15 yrs (12 at DOH). No fever, no swelling, on forearms only had blister-like spots. Saw PCP - given hydroxyzine pills for itch.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Feeling hot, Injection site mass
Clinical narrative: Soon after vaccine, patient complained of feeling lump at injection site and funny taste in mouth. She became light headed and warm. Patient was given cool compress and took a dose of BENADRYL after EMS arrived. Symptoms subsided within 30 minutes.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Right arm pain, numbness up to neck. Right side of facial numbness and headache numbness of hands/fingers. Pain radiated down arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site erythema
Clinical narrative: Patient had 10x10 cm erythema on left upper arm where vaccine was given. No anaphylaxis. Hydroxyzine 10mg tabs given for 3-5 days. Desonide 0.05% BID x 10 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis type reation. ER visit.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: No problem with injection. Injection was given high on arm and may have gone into bursa or tendon. Pt complained of sore arm. Slightly better after 5 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Nausea, diarrhea, HA, fatigue, lightheadedness, general malaise, hives.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urticaria
Clinical narrative: Nausea, diarrhea, HA, fatigue, lightheadedness, general malaise, hives.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Pt started with fever, chills and rash and soreness on the arm where he got the FLUZONE and PNEUMOVAX shot. Pt saw MD for it and MD having ptt watch the area if redness is spreading or not. Pt will follow up w/MD.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Feeling hot, Flushing, Hypoaesthesia, Lip swelling, Pruritus
Clinical narrative: 11:14 am warm, flushing feeling head to toe. Thought it was "hot flash" since menopausal. Returned to work 12:10 swelling lips along with numbness. 12:20 itchy no visible rash. Vital signs stable throughout. No resp or oral difficultty. BENADRYL by mouth and SOLUMEDROL IM given. 12:55 reaction subsided.
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Initial unsolicited report received from a non-health care professional on 2 October 2015. This case involves a (17-year-old) male patient who was vaccinated with a [dose not reported, route of administration and dose series not reported] dose of Flu vaccine (Manufacture: Unknown, frequency once, batch number, expiry date and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had experienced fever and chills. On an unspecified date patient was hospitalized. Patient laboratory investigation was not reported. On an unspecified date patient was discharged from the hospital. Patient had received TYLENOL and BENADRYL as a corrective treatment (proper meds were administered) for the events. The outcome of event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Pain, Rash
Clinical narrative: The initial case was missing the following minimal criteria: no identifiable patient. Upon receipt of follow up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for seven patients. This is the sixth of the seven reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date (between Nov2014-Sep2015). The patient medical history and concomitant medications were not reported. The patient experienced rashes, chills, pain and concern for cellulitis on an unspecified date. The outcome of the events was unknown.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Croup infectious
Clinical narrative: 5 days after FLUMIST he developed croup, necessitating hospitalization.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Bradycardia, Continuous positive airway pressure, Full blood count normal
Clinical narrative: Infant started having multiple events (apnea and bradycardia) requiring vigorous stimulation and PPV and increased oxygen for recovery - 1628-2326. Infant was afebrile, alert, well perfused. Infant was on HFNC at 4L 25% FiO2. Placed on (SiPAP) non invasive ventilation then at 0015 10-14-15. Remains on SiPAP now on 21% FiO2.
Sex: U
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 1 October 2015. This case involves a three patients (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced chills and fever. At least one individual patient was unable to work, unsure of the other 2 patients. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patients were recovered from chills and fever, however the outcome of the event unable to work was not reported. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching on breasts and arms, red splotches on arms.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: PATIENT HAD A STREAM OF BLOOD DOWN HER ARM UPON REMOVING SYRINGE AND SWOLLEN AREA/KNOT APPREARED WITH SLIGHT BRUISING LOOK.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Erythema, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Pain in shoulder, arm and elbow. Swelling and redness.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site haemorrhage
Clinical narrative: The patient bled slightly upon immunization. About an hour later she noticed some bleeding under her skin. She returned to pharmacy approx 5:15 PM. She was instructed to apply pressure and seek medical attention if bleeding got worse. The patient was asked to return to pharmacy the next day. The arm looked better but I still contacted her physician due to her coumadin therapy. The doctor ordered a PT/INR and will adjust coumadin accordingly.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: I received the flu vaccine, working on health care. I developed chills, body aches, Headaches, diarrhea, mild fever. I took Tylenol to alleviate the symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: Patient stated she experienced congestion, hoarse throat and redness of eyes.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Chest X-ray, Dyspnoea, Wheezing
Clinical narrative: Child with c/o shortness of breath treated with Benadryl at home slight improvement noted. 6 am child continued with complaint of shortness of breath which progressed to audible wheezing (around 12pm). Pt taken to emergency room after speaking with MD. Chest xray completed and child given nebulizer treatment. Child improved. Sent home with inhaler for use as needed.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Blood glucose normal, Dyspnoea, Faecal incontinence, Hypersomnia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Pneumonia, Speech disorder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Unresponsive to stimuli, White blood cell disorder, X-ray limb
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Blood glucose normal, Blood test normal, Dyspnoea, Faecal incontinence
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Feeling abnormal, Hypersomnia, Mechanical ventilation, Muscular weakness, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Peripheral swelling, Pneumonia, Speech disorder, Unresponsive to stimuli, White blood cell count abnormal
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: X-ray limb
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). Concurrent medical conditions included multiple allergies. On 30th September 2015, the patient received FLUARIX QUADRIVALENT. On 30th September 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), injection site erythema (serious criteria disability) and injection site itching (serious criteria disability). On 2nd October 2015, the patient experienced sore throat (serious criteria disability) and viral syndrome. On 3rd October 2015, the patient experienced generalized rash (serious criteria disability), fever (serious criteria disability), chills (serious criteria disability), sinus headache (serious criteria disability) and fatigue (serious criteria disability). The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache, fatigue and viral syndrome were unknown. The reporter considered the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache and fatigue to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the viral syndrome to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed injection site pain, redness and itching within 24 hours of receiving the FLUARIX QUADRIVALENT vaccine. Two days later she developed a sore throat. Three days after the vaccine, the patient developed a rash on her arms (antecubital fossa areas), fever, chills, sinus headache and profound fatigue. At the time of this report, the rash had spread to the patient's trunk, back and abdomen, neck and upper chest, buttocks, thighs and arms. It had also spread to her face (forehead and cheeks). The patient was seen by the reporter (physician) and the patient was slated to see an allergist as well. The patient had been off from work because of the fever, chills and fatigue and was not to return to work until afebrile. The reporter stated she felt the symptoms may still be evolving and possibly caused by the FLUARIX vaccine, but she had no ruled out viral syndrome. The patient was treated with antihistamines and a script was provided for Azithromycin in case patient developed sinus infection. The reported batch number for this case was 95251 which does not exist, so as per our sales database it was changed to 9525T.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Oropharyngeal pain, Pyrexia, Rash generalised, Sinus headache
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). Concurrent medical conditions included multiple allergies. On 30th September 2015, the patient received FLUARIX QUADRIVALENT. On 30th September 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), injection site erythema (serious criteria disability) and injection site itching (serious criteria disability). On 2nd October 2015, the patient experienced sore throat (serious criteria disability) and viral syndrome. On 3rd October 2015, the patient experienced generalized rash (serious criteria disability), fever (serious criteria disability), chills (serious criteria disability), sinus headache (serious criteria disability) and fatigue (serious criteria disability). The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache, fatigue and viral syndrome were unknown. The reporter considered the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache and fatigue to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the viral syndrome to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed injection site pain, redness and itching within 24 hours of receiving the FLUARIX QUADRIVALENT vaccine. Two days later she developed a sore throat. Three days after the vaccine, the patient developed a rash on her arms (antecubital fossa areas), fever, chills, sinus headache and profound fatigue. At the time of this report, the rash had spread to the patient's trunk, back and abdomen, neck and upper chest, buttocks, thighs and arms. It had also spread to her face (forehead and cheeks). The patient was seen by the reporter (physician) and the patient was slated to see an allergist as well. The patient had been off from work because of the fever, chills and fatigue and was not to return to work until afebrile. The reporter stated she felt the symptoms may still be evolving and possibly caused by the FLUARIX vaccine, but she had no ruled out viral syndrome. The patient was treated with antihistamines and a script was provided for Azithromycin in case patient developed sinus infection. The reported batch number for this case was 95251 which does not exist, so as per our sales database it was changed to 9525T.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Viral infection
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). Concurrent medical conditions included multiple allergies. On 30th September 2015, the patient received FLUARIX QUADRIVALENT. On 30th September 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), injection site erythema (serious criteria disability) and injection site itching (serious criteria disability). On 2nd October 2015, the patient experienced sore throat (serious criteria disability) and viral syndrome. On 3rd October 2015, the patient experienced generalized rash (serious criteria disability), fever (serious criteria disability), chills (serious criteria disability), sinus headache (serious criteria disability) and fatigue (serious criteria disability). The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache, fatigue and viral syndrome were unknown. The reporter considered the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache and fatigue to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the viral syndrome to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed injection site pain, redness and itching within 24 hours of receiving the FLUARIX QUADRIVALENT vaccine. Two days later she developed a sore throat. Three days after the vaccine, the patient developed a rash on her arms (antecubital fossa areas), fever, chills, sinus headache and profound fatigue. At the time of this report, the rash had spread to the patient's trunk, back and abdomen, neck and upper chest, buttocks, thighs and arms. It had also spread to her face (forehead and cheeks). The patient was seen by the reporter (physician) and the patient was slated to see an allergist as well. The patient had been off from work because of the fever, chills and fatigue and was not to return to work until afebrile. The reporter stated she felt the symptoms may still be evolving and possibly caused by the FLUARIX vaccine, but she had no ruled out viral syndrome. The patient was treated with antihistamines and a script was provided for Azithromycin in case patient developed sinus infection. The reported batch number for this case was 95251 which does not exist, so as per our sales database it was changed to 9525T.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Pain, Rash
Clinical narrative: The initial case was missing the following minimal criteria: no identifiable patient. Upon receipt of follow up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for seven patients. This is the seventh of the seven reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date (between Nov2014-Sep2015). The patient medical history and concomitant medications were not reported. The patient experienced rashes, chills, pain and concern for cellulitis on an unspecified date. The outcome of the events was unknown.
Age: 1.17
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Rash
Clinical narrative: Rash started 1 week after receiving vaccine.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Eyelid function disorder, Hypoaesthesia oral, Hypogeusia, Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Facial (L) side drooping. Sense of taste diminished. Unable to close (L) eye. Numb feeling - tongue.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis, left upper arm.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe Fever. Fever and shivering. Sharp pain in body. Testicular pain. Headache. Weakness.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Testicular pain
Clinical narrative: Severe Fever. Fever and shivering. Sharp pain in body. Testicular pain. Headache. Weakness.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Computerised tomogram head, Electrocardiogram, Full blood count, Lumbar puncture
Clinical narrative: PER PATIENT: AT 1800 PATIENT BEGAN FEELING VERY "ILL". PATIENT STATES SHE CALLED HER DAUGHTER BUT BEGAN REALIZING SHE COULD NOT GET HER WORDS OUT OR MAKE SENSE WHEN TALKING. PATIENT REPORTED CHILLS. PATIENT ADVICED BY DAUGHTER TO CALL AN AMBULANCE. SHE DID SO AND WAS TRANSPORTED TO HOSPITAL.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Malaise, Speech disorder
Clinical narrative: PER PATIENT: AT 1800 PATIENT BEGAN FEELING VERY "ILL". PATIENT STATES SHE CALLED HER DAUGHTER BUT BEGAN REALIZING SHE COULD NOT GET HER WORDS OUT OR MAKE SENSE WHEN TALKING. PATIENT REPORTED CHILLS. PATIENT ADVICED BY DAUGHTER TO CALL AN AMBULANCE. SHE DID SO AND WAS TRANSPORTED TO HOSPITAL.