chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse event were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on  30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 29-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029073, expiry date: 19-APR-2017). Nurse stated that VAQTA, RECOMBIVAX HB, GARDASIL, M-M-R II and sterile diluent (Manufacturer unknown) appeared on the product list because temperature stability questions were asked, however, no doses of these improperly stored vaccines were administered to the patient. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029073, expiry date: 19-APR-2017). Nurse stated that VAQTA, RECOMBIVAX HB, GARDASIL, MMR II and sterile diluent (Manufacture unknown) appeared on the product list because temperature stability questions were asked, however, no doses of these improperly stored vaccines were administered to the patient. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Nodule, Oedema, Pruritus
Clinical narrative: Patient experienced erythema, edema, induration, pruritis, mild tenderness documented as 10 cm, and developed a local nodule 1 day after vaccine receipt of PREVNAR 13 lot # M20640.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Patient experienced erythema, edema, induration, pruritis, mild tenderness documented as 10 cm, and developed a local nodule 1 day after vaccine receipt of PREVNAR 13 lot # M20640.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Gastroenteritis viral, Malaise, Nausea, Quality of life decreased, Vomiting
Clinical narrative: This spontaneous report has been received from a consumer via web site, referring to her 16 year old daughter. The patient's historical condition included a perfectly, healthy and an athletic patient, concurrent conditions were not provided. On 2010 the patient was vaccinated with GARDASIL (dose, strength, frequency and indication were not provided). Concomitant therapies were not provided. On an unknown date the reported stated that her daughter developed multiple illness, also experienced nausea, stomach virus that was incurable, and vomit after all solid food, she reported that it was placing in deadly situation, and her quality of life decreased. At the time of the report the outcome of malaise, quality of life decreased, vomiting, gastroenteritis viral and nausea was reported as not recovered. The reporter considered nausea, malaise, quality of life decreased, vomiting and gastroenteritis viral was related to GARDASIL. This is one of several reports from the same source. Additional information is not expected because the consumer did not provide contact details.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Flatulence, Irritability, Pyrexia
Clinical narrative: Mother states pt. cried and was fussy for about two hours off and on, on 01/13/2016 and had a low grade fever. Mother states pt. is fine now and afebrile. Mother states, he seemed to possibly of had gas and he made a mess in his diaper yesterday.' Mother denies pt. having any symptoms currently.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Raised with redness, no pain, no tenderness, no real swelling, but better now than this morning.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Mom reports that child has a red circle on arm where vaccine was given and a hard knot, feels some warmth at the area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Malaise, Neck pain
Clinical narrative: Immediately after the injection my arm started to itch immediately. A red rash started at the injection site at the back of the upper arm. It spread down the arm close to the elbow. Then it started to spread close to the armpit. Then small and big bumps occurred in the area. My neck on the side of the injection hurt, and I did not feel well. The arm continued to itch and be sore. On Tuesday, December 29th I went to urgent care. The doctor said she hadn't seen my type of reaction before. She told me I could do the following: take prednisone, put  Benadryl cream or hydrocortisone ointment on the area, and I could also take Benadryl. She also gave me a prescription for an antibiotic, which I could fill, if my arm became infected. I went back to pharmacy to show the pharmacist. She said she hadn't seen my type of reaction. She told me to take Benadryl. I took Benadryl for a few days.  My arm slowly started to get better. That took a couple of weeks. Also, I had shingles ten years ago.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Immediately after the injection my arm started to itch immediately. A red rash started at the injection site at the back of the upper arm. It spread down the arm close to the elbow. Then it started to spread close to the armpit. Then small and big bumps occurred in the area. My neck on the side of the injection hurt, and I did not feel well. The arm continued to itch and be sore. On Tuesday, December 29th I went to urgent care. The doctor said she hadn't seen my type of reaction before. She told me I could do the following: take prednisone, put  Benadryl cream or hydrocortisone ointment on the area, and I could also take Benadryl. She also gave me a prescription for an antibiotic, which I could fill, if my arm became infected. I went back to pharmacy to show the pharmacist. She said she hadn't seen my type of reaction. She told me to take Benadryl. I took Benadryl for a few days.  My arm slowly started to get better. That took a couple of weeks. Also, I had shingles ten years ago.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's left arm area surrounding the site of Varivax administration is red, raised, and swollen. Her primary care doctor prescribed Cephalexin 500mg 1 capsule by mouth twice daily for 5 days.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Encephalitis, Nuclear magnetic resonance imaging abnormal, Vomiting
Clinical narrative: Progressive constellation of symptoms including abdominal pain, vomiting and MRI findings of cerebellitis.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site swelling, Pain
Clinical narrative: Pt had swelling around injection site and then started having chills and pain. She went to the ER and was given Abx, steroids and EPIPEN.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site discomfort
Clinical narrative: Reports 12 hours post vaccine noted hard to breathe, felt hard to catch breath. Worse when went into cold air. Reports no fever. Also site discomfort redness lt. delt. Went to own Dr. rec'd Albuterol Inhaler w/quick relief within one hour. Arm discomfort improving.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Local swelling, Skin warm
Clinical narrative: Initially swollen this morning, as morning progressed patient had developed erythema, warmth. Area is just below injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 07-JAN-2016, the patient received a dose of improperly stored VAQTA injection (lot # L017757 with expiration date 08-APR-2018; dose and route were not provided). It was exposed to temperature of 48.9F for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itchy at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Diarrhoea, Pruritus, Rash, Urticaria
Clinical narrative: Rash and "some whelps" on legs, arms, back and abdomen and diarrhea. Itching noted by foster mom. She reports rash worse on left arm. Signs and symptom reported by foster mom - not observed by clinic that administered vaccines. Treated with BENADRYL and given prednisone by urgent care MD.
Age: 59.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood test, Feeling abnormal, Injection site pain, Neck pain, Paraesthesia
Clinical narrative: Flu injection hurt left arm badly while being administered.  Have since suffered with intermittent pain at the injection site, all down the arm, and wake up some mornings with pins and needles in arm.  Have had some left shoulder and back of neck pain.  Left leg/foot feels strange at times.  Have visited doctors and talked with a couple of nurses.  In all, I've been prescribed Naproxen 500 mg, told to take B-12 and Magnesium, and prescribed Neurontin.  In addition, I have used ice and heat.  It is my opinion that the health care professionals do not really know what to do about it.  One suggested I may have to get a nerve study done.
Age: 59.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood test, Injection site pain, Limb discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: Flu injection hurt left arm badly while being administered.  Have since suffered with intermittent pain at the injection site, all down the arm, and wake up some mornings with pins and needles in arm.  Have had some left shoulder and back of neck pain.  Left leg/foot feels strange at times.  Have visited doctors and talked with a couple of nurses.  In all, I've been prescribed Naproxen 500 mg, told to take B-12 and Magnesium, and prescribed Neurontin.  In addition, I have used ice and heat.  It is my opinion that the health care professionals do not really know what to do about it.  One suggested I may have to get a nerve study done.
Age: 59.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Flu injection hurt left arm badly while being administered.  Have since suffered with intermittent pain at the injection site, all down the arm, and wake up some mornings with pins and needles in arm.  Have had some left shoulder and back of neck pain.  Left leg/foot feels strange at times.  Have visited doctors and talked with a couple of nurses.  In all, I've been prescribed Naproxen 500 mg, told to take B-12 and Magnesium, and prescribed Neurontin.  In addition, I have used ice and heat.  It is my opinion that the health care professionals do not really know what to do about it.  One suggested I may have to get a nerve study done.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: PAIN IN RIGHT ARM, LOCAL SWELLING AND REDNESS.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular, Skin warm
Clinical narrative: Red, blotchy rash on arm, warm to touch.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Constant Pain at the site of injection, limited Range of Motion in left arm.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Rash generalised, Rash macular
Clinical narrative: SPLOTCHY RASH STARTED ON CHEST AND SPREAD TO ENTIRE BODY WITHIN 2DAYS.  PATIENT ALSO HAD UP TO 102.4 TEMPERATURE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Received MMRV vaccination at 1500. Dad states he had a quarter to half dollar sized knot / redness at injection site only with some itching that same evening. Dad gave Zyrtec then. The knot has decreased in size since onset (seen in office today, 1/14/16).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Flank pain, Skin hyperpigmentation
Clinical narrative: Left abdominal/flank pain, later hyperpigmented rash, appeared like post-herpetic neuralgia though not seen at time of initial rash.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: 3+ edema of the hand, fingers, and lower arm on left side.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy, Blindness, C-reactive protein increased, Migraine, Ocular hyperaemia
Clinical narrative: Cyclic Migraine Headaches that are constant and worsen at bedtime. Hearing a loud whooshing sound in ears. Whites of the eyes are red. Vision problems with intermittent blindness.  Right eye could only see shapes and left eye not as affected but with same symptoms. Possible temporal arteritis, biopsy pending. Body aches.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Red blood cell sedimentation rate increased, Tinnitus, Visual impairment
Clinical narrative: Cyclic Migraine Headaches that are constant and worsen at bedtime. Hearing a loud whooshing sound in ears. Whites of the eyes are red. Vision problems with intermittent blindness.  Right eye could only see shapes and left eye not as affected but with same symptoms. Possible temporal arteritis, biopsy pending. Body aches.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: A few minutes later had runny nose, sore throat, coughing, pain in the arm where vaccination was administered.  At 10:00 PM had chills for a few hours.  Had extreme exhaustion for 3 days and pain in arm for 1 month.
Age: 70.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: A few minutes later had runny nose, sore throat, coughing, pain in the arm where vaccination was administered.  At 10:00 PM had chills for a few hours.  Had extreme exhaustion for 3 days and pain in arm for 1 month.
Age: 66.0
Sex: F
Vaccine: FLUX, HEPA, PPV, TYP, FLUX, HEPA, PPV, TYP
Symptoms: Arthralgia, Axillary pain, Blood test normal, Breast pain, Chest pain
Clinical narrative: Twinges of pain in underarms, breast, chest. Eventually spreading to fingers, knees, shins, ankles and feet.
Age: 66.0
Sex: F
Vaccine: FLUX, HEPA, PPV, TYP, FLUX, HEPA, PPV, TYP
Symptoms: Pain in extremity
Clinical narrative: Twinges of pain in underarms, breast, chest. Eventually spreading to fingers, knees, shins, ankles and feet.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Tinnitus
Clinical narrative: On 1/14/16, pt reported ringing in the ears beginning on 1/13 at about the time he was leaving the store. Reported that went home and went to sleep. In morning, ringing continued and also had a dizzy spell that went away about 30 minutes later.
Age: 0.77
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Wrong drug administered
Clinical narrative: Administration error - wrong vaccines given. Patient was supposed to receive Hepatitis B dose #3 and instead nurse mistakenly repeated 6 month shots (listed on next page).
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Heart rate increased, Hyperhidrosis, Palpitations
Clinical narrative: Rapid, pounding heartbeat; sweating; dizziness and unusual fatigue.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: Loud involuntary vocal tics... they sound like a cross between a cough/sneeze.  The first time we noticed them was immediately following school and they continued for more than an hour.  They now occur off and on daily and can occur as a single tic or multiple tics over the course of an hour.
Age: 0.34
Sex: M
Vaccine: DTAPH, HEP, IPV, PPV, RV5
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Initially a fever 101 degrees, general fussiness and followed by full body rash.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Aggression, Body temperature, Diarrhoea, Dysstasia, Fall
Clinical narrative: 12/23/2015 - Fatigue, longer nap than usual, temperature, vomit that night; 12/24 - 12/29 - total loss of bladder control; 12/24-1/3/2016 - rash on both sides of buttocks up to hip area; rash reappeared in same area but worse from 1/8-1/11/2016; 12/24/2015 - 1/5/2015 - impaired lower extremity and trunk control affecting posture and locomotion; crawling instead of walking, fell off sofas and falling backwards while standing unable to catch herself/prevent fall; could not walk up stairs but instead crawled or dragged self up - right leg worse than left leg; right foot pointed and rotated. 1/5- 1/8 motor skills appeared to be improving but on 1/8-1/10 (same days that rash reappeared and was at its worst) patient crawled and "bear walked" on hands and knees instead of walking especially in the afternoon and had difficulty ascending stairs again. 12/31 loose stools / diarrhea. 12/23-present low grade temperature of approximately 99.4-99.7 in afternoons. 12/28-present - parents note change in behavior of unprovoked aggression towards parents and sisters.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Gait disturbance, Motor dysfunction, Posture abnormal, Pyrexia
Clinical narrative: 12/23/2015 - Fatigue, longer nap than usual, temperature, vomit that night; 12/24 - 12/29 - total loss of bladder control; 12/24-1/3/2016 - rash on both sides of buttocks up to hip area; rash reappeared in same area but worse from 1/8-1/11/2016; 12/24/2015 - 1/5/2015 - impaired lower extremity and trunk control affecting posture and locomotion; crawling instead of walking, fell off sofas and falling backwards while standing unable to catch herself/prevent fall; could not walk up stairs but instead crawled or dragged self up - right leg worse than left leg; right foot pointed and rotated. 1/5- 1/8 motor skills appeared to be improving but on 1/8-1/10 (same days that rash reappeared and was at its worst) patient crawled and "bear walked" on hands and knees instead of walking especially in the afternoon and had difficulty ascending stairs again. 12/31 loose stools / diarrhea. 12/23-present low grade temperature of approximately 99.4-99.7 in afternoons. 12/28-present - parents note change in behavior of unprovoked aggression towards parents and sisters.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urinary incontinence, Vomiting
Clinical narrative: 12/23/2015 - Fatigue, longer nap than usual, temperature, vomit that night; 12/24 - 12/29 - total loss of bladder control; 12/24-1/3/2016 - rash on both sides of buttocks up to hip area; rash reappeared in same area but worse from 1/8-1/11/2016; 12/24/2015 - 1/5/2015 - impaired lower extremity and trunk control affecting posture and locomotion; crawling instead of walking, fell off sofas and falling backwards while standing unable to catch herself/prevent fall; could not walk up stairs but instead crawled or dragged self up - right leg worse than left leg; right foot pointed and rotated. 1/5- 1/8 motor skills appeared to be improving but on 1/8-1/10 (same days that rash reappeared and was at its worst) patient crawled and "bear walked" on hands and knees instead of walking especially in the afternoon and had difficulty ascending stairs again. 12/31 loose stools / diarrhea. 12/23-present low grade temperature of approximately 99.4-99.7 in afternoons. 12/28-present - parents note change in behavior of unprovoked aggression towards parents and sisters.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Abnormal behaviour, Acne, Clumsiness, Crying
Clinical narrative: 1. fatigue - 12/23/2015 through present- child naps 1-2 times a day and complains of fatigue and desire to nap sometimes as early as 12:00 pm.  Child had stopped napping in June 2015 and started again only on 12/23/2015. There was no change in schedule or activities and she does not attend preschool or other events that would tire her out.  Child always has had good sleep habits and continuously sleeps through the night for about 12 hours. 2. Red rash on side of buttocks up to hips/low back with small red pimples that appeared on 12/24 and remained unchanged unti1 1/1/2015 and then began to fade until it was just a few red little bumps on 1/5.  Rash reappeared in same location on 1/8 through 1/10 but seemed worse.  It began to fade 1/11/2016 and at present a few small red bumps remain. 3. Daily low grade fever beginning in afternoon.  12/23/2015 temperature of 100.2 F in afternoon around 1:00 PM and continued through 12/24/2015.  Since then, child has daily low grade fever of 99.4 to 99.7 in afternoons starting around 12PM -2PM sometimes resolving around 5 Pm and other days lasting through bedtime.  Usually coincides with complaint of fatigue and request to nap. 1/4/2016 - blood noted in stool. 1/11 - 2 naps and complaints of stomach pain in evening. 1/13 - complaints of stomach pain in evening and concurrent 99.7 F low grade fever. 4. 12/23/2015 - behavior changes - more weepy and sensitive in general and some difficulty attending to or following simple repeated 1 step commands. 5. Clumsy 12/24/2015-1/11/2015 - appears less coordinated occasionally walking into walls, fell into toilet, fell into pond, etc.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Haematochezia, Pyrexia, Rash, Rash erythematous
Clinical narrative: 1. fatigue - 12/23/2015 through present- child naps 1-2 times a day and complains of fatigue and desire to nap sometimes as early as 12:00 pm.  Child had stopped napping in June 2015 and started again only on 12/23/2015. There was no change in schedule or activities and she does not attend preschool or other events that would tire her out.  Child always has had good sleep habits and continuously sleeps through the night for about 12 hours. 2. Red rash on side of buttocks up to hips/low back with small red pimples that appeared on 12/24 and remained unchanged unti1 1/1/2015 and then began to fade until it was just a few red little bumps on 1/5.  Rash reappeared in same location on 1/8 through 1/10 but seemed worse.  It began to fade 1/11/2016 and at present a few small red bumps remain. 3. Daily low grade fever beginning in afternoon.  12/23/2015 temperature of 100.2 F in afternoon around 1:00 PM and continued through 12/24/2015.  Since then, child has daily low grade fever of 99.4 to 99.7 in afternoons starting around 12PM -2PM sometimes resolving around 5 Pm and other days lasting through bedtime.  Usually coincides with complaint of fatigue and request to nap. 1/4/2016 - blood noted in stool. 1/11 - 2 naps and complaints of stomach pain in evening. 1/13 - complaints of stomach pain in evening and concurrent 99.7 F low grade fever. 4. 12/23/2015 - behavior changes - more weepy and sensitive in general and some difficulty attending to or following simple repeated 1 step commands. 5. Clumsy 12/24/2015-1/11/2015 - appears less coordinated occasionally walking into walls, fell into toilet, fell into pond, etc.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Local redness, firmness, swelling and tender reactive lymph node on (R) arm. Fever of 100.5 at home. BENADRYL, NSAIDS, ice. RN follow up 1/15 by phone. Reassure most reactions resolve 72 hrs. Will report for vaccine manufacturer.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The initial spontaneous report was received from a registered nurse referring to patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 12-JAN-2016, the patient received a dose of improperly stored PNEEUMOVAX 23 injection (lot # K021030 with expiration date 22-JUN-2016; dose and route were not provided). It was exposed to temperature of 48.9F for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several report received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Patient presented 2 days after pneumococcal vaccine with 4 x 9 cm red patch on left arm at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: Red, hot, sore right arm and developed a nodule on the right side of throat pt noticed symptoms 1/14/16 vaccine receive 1/8/16.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states that his arm still hurts from when he received the flu shot on 10/6/15.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Complained of metallic taste in mouth and seemed hard to breathe but not anaphylaxis. Had a large red, raised area where shot administered. She was taking BENADRYL and symptoms are subsiding.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Full blood count, Metabolic function test, Oedema, Pain
Clinical narrative: Edema, pain and itching 48 hours post injection pt. treated for cellulitis with IV ceftriaxone, and oral KEFLEX to (R) deltoid.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Edema, pain and itching 48 hours post injection pt. treated for cellulitis with IV ceftriaxone, and oral KEFLEX to (R) deltoid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pain and red rash on (L) thigh.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a female patient of unknown age with medical history of lupus. Patient's drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not provided). Concomitant medications included unspecified immunosuppressive therapy for her lupus. On an unknown date, after the patient received ZOSTAVAX. The patient received unspecified antiviral and pain medication as treatment for the adverse event. At the time of the report, the patient's outcome and the causality were unknown. Additional information is not expected because the reporter did not want to be contacted.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 21 year old female patient. The patient presented drug allergy to Azithromycin and no pertinent medical history. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route and lot number were not provided). No concomitant medications were reported. On 11-JAN-2016, the patient had abnormal cells on her cervix. No product quality complaint was involved. On an unspecified date, PAP smear was performed. At the time of report, the outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and the vaccination with GARDASIL was not reported. Additional information is not expected since no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (strength, unit, frequency and route not reported, lot # L032749 with Exp. date 04-NOV-2016 and lot # L018499 with Exp. date 25-FEB-2017). Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact the physician.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear tube insertion, Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a 4 year old female patient. The patient's historical drugs included SINGULAIR and an over the counter allergy medicine. The patient's concurrent conditions were not reported. On an unknown date the patient was vaccinated with first dose of PROQUAD (Merck) (lot # L024125, expiry date 30-DEC-2016) 0.5 ml subcutaneously. On 11-DEC-2015, the patient was vaccinated with first dose of VARIVAX (Merck) (lot # L018001, expiry date 19-MAY-2017) 0.5 ml, subcutaneous. Concomitant medications were not reported. On 28-DEC-2015, the patient had tympanic tubes placed in her ears bilaterally. On 30-DEC-2015, the patient went for her well-child 4 years checkup, and the system showed that she was due for M-M-R II and of VARIVAX (Merck). On 30-DEC-2015, the nurse vaccinated the patient with both VARIVAX (Merck) and PROQUAD (Merck) (overdose) (inappropriate schedule of vaccine administered). The nurse did not realize that of VARIVAX (Merck) vaccine was included in PROQUAD (Merck) until the system flagged it as a double dose. On 30-DEC-2015, patient was doing good with the tubes placed in her ears bilaterally (recovering) and she seems fine after the extra dose of varicella vaccine. The nurse stated that, as 30-DEC-2015, the patient no longer takes of VARIVAX (Merck) and it was unknown if she continues to take PROQUAD (Merck). Causality assessment was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test negative, Allergy to vaccine, Cardiac stress test normal, Chest X-ray normal, Ear pruritus
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Enzyme level test, Eye pruritus, Heart rate decreased
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Insomnia, Mouth swelling, Oral pruritus, Palpitations
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Pruritus generalised, Respiratory tract congestion, Sleep disorder
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test, Cough, Fatigue, Lacrimation increased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.