chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Urticaria
Clinical narrative: Case number PHHY2014US170654, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547176) website on 29 Dec 2014. This report refers to a 58-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: unknown), along with PNEUMOVAX (batch number: L009105) intramuscularly into the right arm on 17 Sep 2014 at 12:15 PM. On the same day at 07:00 PM, the patient felt chills. On 18 Sep 2014 at 06:30 AM, the patient developed welts and red deltoid. On the same day at 01:00 PM, the patient was referred to emergency room. In the emergency room, the patient was diagnosed with cellulitis. The patient was treated with intravenous pain medications and antibiotics. The final outcome of the events was complete recovery. The events were reported as non-serious. The event cellulitis was internally upgraded as medically significant based on the NVS-IME list. Causality of the events was not reported. The reported FLUVIRIN batch number 1453054 is not a valid batch number. Hence QA investigation will be performed with unknown batch number. Follow-up information received from the Quality Assurance Department (reference number: 344923) on 05 Jan 2015: The reported FLUVIRIN batch number 1453054 is not a valid batch number. Hence QA investigation will be performed with unknown batch number and updated QA reference number.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe pain in shoulder joint. Could not move arm. Pain in shoulder if trying to move. Sharp pain shooting down arm. Visited Urgent care that evening. Followed up with Dr. Sent for Physical Therapy. Shoulder still is better but still hurts.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Alopecia, Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in shoulder joint. Could not move arm. Pain in shoulder if trying to move. Sharp pain shooting down arm. Visited Urgent care that evening. Followed up with Dr. Sent for Physical Therapy. Shoulder still is better but still hurts.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Paraesthesia, Weight increased
Clinical narrative: Severe pain in shoulder joint. Could not move arm. Pain in shoulder if trying to move. Sharp pain shooting down arm. Visited Urgent care that evening. Followed up with Dr. Sent for Physical Therapy. Shoulder still is better but still hurts.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Case number PHEH2014US020679, is an initial spontaneous report from a consumer received on 10 Oct 2014 and a follow up report from a physician received on 10 Nov 2014. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly three weeks ago. On an unknown date after vaccination, her arm was sore and uncomfortable. She developed weakness in arm and pain when she moved the arm in certain positions. It was reported that she will wait little longer and if gets worse or does not get better in certain time she will notify her MD. The final outcome of the events was condition unchanged. Seriousness and causality was not reported. Upon follow up, it was confirmed by the physician that the flu shot was not given at their clinic and the physician did not have the required information and was not aware that the patient had a reaction. Follow up report from the physician received on 10 Nov 2014: Updated physician's comment regarding the patient.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Nervousness, Rash
Clinical narrative: Case number PHEH2014US021911, is an initial spontaneous report from a health care professional received on 29 Oct 2014. This report refers to a 19-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1414201A) intramuscularly on 23 Oct 2014. On the same day, after vaccination, the patient experienced dizziness, flushed face and rash on neck and chest. The patient also felt shaky, The patient went to emergency room (ER) and was given BENADRYL and instructed to not get the flu shot next year without being monitored. It was reported that the patient did not have any respiratory issues and did not need epinephrine. Outcome of the events was reported as unknown. Seriousness and causality of the events was unknown.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: General physical health deterioration, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHEH2014US022022 is an initial spontaneous report received from a pharmacist on 30 Oct 2014 with a follow up information received from the quality assurance department on 11 Nov 2014. This report refers to a 58 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1411301, expiry date: May 2015) on an unknown date (reported as 2 days ago). It was reported that after vaccination, she experienced stiff and sore arm. The arm was stiffer than normal and she was unable to move it. The events were getting worse since she received her vaccine two days ago (condition deteriorated). The seriousness and causality were not reported. The quality assurance department stated that the initially reported batch number 14113-1 was non-valid and the correct batch number was 1411301. Follow up information received from the quality assurance department on 11 Nov 2014: Batch number updated.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Incontinence, Injection site reaction, Migraine, Photophobia
Clinical narrative: Case number PHEH2014US022199, is an initial spontaneous report from a physician received on 31 Oct 2014. This report refers to a 62-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 14622P) intramuscularly on 27 Oct 2014. On the same day, after vaccination, the patient experienced incontinence, migraine, vomiting, photophobia and dizziness. On 28 Oct 2014, the patient experienced diffuse painful rash around the injection site. No treatment was received for incontinence. It was reported that the patient had no history of migraines prior to vaccination. Outcome of the events incontinence, vomiting was reported as recovered on 27 Oct 2014; migraine, photophobia, dizziness as recovered on 29 Oct 2014; painful rash around injection site as improving as of 30 Oct 2014. Seriousness and causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting
Clinical narrative: Case number PHEH2014US022199, is an initial spontaneous report from a physician received on 31 Oct 2014. This report refers to a 62-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 14622P) intramuscularly on 27 Oct 2014. On the same day, after vaccination, the patient experienced incontinence, migraine, vomiting, photophobia and dizziness. On 28 Oct 2014, the patient experienced diffuse painful rash around the injection site. No treatment was received for incontinence. It was reported that the patient had no history of migraines prior to vaccination. Outcome of the events incontinence, vomiting was reported as recovered on 27 Oct 2014; migraine, photophobia, dizziness as recovered on 29 Oct 2014; painful rash around injection site as improving as of 30 Oct 2014. Seriousness and causality of the events was not reported.
Age: 1.34
Sex: M
Vaccine: HEPA
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in a 15-month-old male patient who received HAVRIX. On 24th October 2014, the patient received the 1st dose of HAVRIX. On 24th October 2014, immediately after receiving HAVRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site rash. The patient was treated with TYLENOL and medication unknown, Ice Pack (NOS). On 24th October 2014, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site rash were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site rash to be probably related to HAVRIX. Additional information received: HCP vaccinated a 15 month old pt. that experienced an immediate red, swollen rash down the right leg from where the vaccine was given to the knee after receiving the 1st dose of HAVRIX. They immediately applied ice to the area and gave the child TYLENOL. The redness and swelling went down within 20-25 minutes. They did not give the child anymore vaccinations during this visit due to this reaction. The MA that administered the vaccine used a 5/8-inch needle and the HCP is questioning whether that is the right size needle for a child of this age. The HCP is also questioning whether this could be due to latex in the product. She did not have the lot # and exp. date readily available as she was at a different office today. HCP is considering not giving the 2nd dose of HAVRIX due to this.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Right arm became sore, pain increased over the course of a few days. Could not lift arm above head, lost range of motion. Difficult and painful to lift things. Pain continued for a month so I visited my doctor on 11/14/14 to address my concerns. She took a shoulder X-ray to rule out other injuries. She provided no treatment and assured me the pain would go away in a couple weeks. Pain persisted for another month so I call the doctor and she suggested physical therapy. Since facility denied my appeal to pay for treatment I cannot afford physical therapy. Three months after injection the pain has decreased some. Still painful to lift arm high and am unable to lift certain things or use the arm for throwing. Over the past 3 months the pain has moved up into my neck area. There is tingling and numbness when driving or lifting my arm for long periods of time.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, X-ray limb
Clinical narrative: Right arm became sore, pain increased over the course of a few days. Could not lift arm above head, lost range of motion. Difficult and painful to lift things. Pain continued for a month so I visited my doctor on 11/14/14 to address my concerns. She took a shoulder X-ray to rule out other injuries. She provided no treatment and assured me the pain would go away in a couple weeks. Pain persisted for another month so I call the doctor and she suggested physical therapy. Since facility denied my appeal to pay for treatment I cannot afford physical therapy. Three months after injection the pain has decreased some. Still painful to lift arm high and am unable to lift certain things or use the arm for throwing. Over the past 3 months the pain has moved up into my neck area. There is tingling and numbness when driving or lifting my arm for long periods of time.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Right arm where shot was given is still severely sore where I can't raise it nor lay on it nor touch it.  It has been 4 days and I can hardly move my arm.  It is sore from the top of my arm to the middle of my elbow.  It is very severe.
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Pt states he woke up and noticed his right arm swollen twice in size and that injection site was warm. Pt also reported to be nauseous and has body aches.
Age: 1.77
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia, Respiratory rate increased, Urticaria
Clinical narrative: Extreme fatigue, low grade fever (AM) hives on legs and trunk, rapid breathing, fever of 104.2 (hives, high fever onset approx 8pm).  Contacted doctors office. On-call NP advised administering Advil/Tylenol and monitor. Administered 5ml liquid Tylenol every 4 hours through the night. Fever persisted through approx. 7am. Fever broke and child has returned to normal.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Body temperature increased, Chest X-ray, Choking, Febrile convulsion, Laboratory test
Clinical narrative: Baby went stiff. Eyes fixed.  Mom thought baby was choking.  Tympanic Temp 99.0 at home. Called ambulance. In ER rectal temp 102. Documented febrile seizure.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Musculoskeletal stiffness, Staring, Urine analysis
Clinical narrative: Baby went stiff. Eyes fixed.  Mom thought baby was choking.  Tympanic Temp 99.0 at home. Called ambulance. In ER rectal temp 102. Documented febrile seizure.
Age: 0.79
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. On 06-JAN-2015 the patient was vaccinated with a dose of ROTATEQ (oral, dose, lot number and expiration date were not reported). This was the only dose of ROTATEQ that the patient had ever received. No known adverse effects. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 0.28
Sex: M
Vaccine: HEP, RV5
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception, admitted and reduced with AC/BE.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unspecified dates, the patients were received ROTATEQ (dose/frequency and lot# were unknown), which had been stored improperly. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a adult female patient who received FLULAVAL QUADRIVALENT (batch number 579G3, expiry date 30th April 2015). On 1st October 2014, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, less than a month after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be probably related to FLULAVAL QUADRIVALENT. Additional information: Pharmacy intern reporting adult female patient received vaccination 3 weeks ago. Patient contacted the pharmacy today reporting she is still having pain at the injection site.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received FLUARIX QUADRIVALENT (batch number 7YG4D, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Per HCP, FLUARIX QIV was stored at 13 degrees F and was administered to several patients at facility.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Cerebrovascular accident, Convulsion, Pneumonia, Syncope
Clinical narrative: 10/15/14 - received dose. 10/24/14 - admitted hospital - pneumonia, seizures, stroke. 10/29/14 - discharged - diagnosed stroke, AFib, pneumonia. 12/23/14 - admitted - syncope, seizures, stroke. Presently hospital.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperhidrosis, Pain
Clinical narrative: Patient developed fever 101.4 degrees F, chills, body aches. Abdominal pain and diarrhea started 12-30-14. Fever subsided 12-31-14; increased sweating starting 12-28-14.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient developed fever 101.4 degrees F, chills, body aches. Abdominal pain and diarrhea started 12-30-14. Fever subsided 12-31-14; increased sweating starting 12-28-14.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Child awoke with a high fever of 104 degrees.  Tylenol given and temp continued to increase up to 104.8 degrees.  Parent called the clinic's after hours phone number and was advised to take the child to ER.  Parent took child to the emergency room, temperature was taken and it had come down to 102 degrees.  Parent opted not to be seen and retuned home.  Follow-up call to parent at 2:00pm.  Parent indicated that the child's temperature continue to decrease and that he felt better.  He was eating food and drinking fluids.
Age: 47.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Blister, Burning sensation, Erythema, Full blood count normal, Hypersensitivity
Clinical narrative: On 1-5-15 @ 9:30 PM client developed raised red rash on chest area with burning sensation. She  took 50mg Benadryl PO, went to bed and rash was gone next morning. Approx. 9:30 PM on 1/06/15, client's face became red, swollen, & blistered.  Neck & chest had red rash. Went to ER, was given IV fluids, Solu-medrol, and Benadryl IV. Client discharged with diagnosis of allergic reaction.  Client reports face became red @ 9:30 PM on 1/7/15, took 50 mg Benadryl, went to bed & was gone next morning.
Age: 47.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Metabolic function test normal, Rash papular, Swelling face
Clinical narrative: On 1-5-15 @ 9:30 PM client developed raised red rash on chest area with burning sensation. She  took 50mg Benadryl PO, went to bed and rash was gone next morning. Approx. 9:30 PM on 1/06/15, client's face became red, swollen, & blistered.  Neck & chest had red rash. Went to ER, was given IV fluids, Solu-medrol, and Benadryl IV. Client discharged with diagnosis of allergic reaction.  Client reports face became red @ 9:30 PM on 1/7/15, took 50 mg Benadryl, went to bed & was gone next morning.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Sore arm. Pain is still there after 3 months. Hurts to raise my arm, reach behind me, or to lean on arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Skin exfoliation, Varicella
Clinical narrative: The morning after receiving Zostavax, the patient reported to the pharmacist that he experienced what he described as "chicken pox". Patient further explained that it was on his left side of the chest and shoulder and denied any fever, pain, rash or itchiness with it. The above described condition lasted for approximately 5-6 days and he was shedding dry scaly skin after a couple days. He reports taking no medications to help with it.
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong route of administration in a 9-year-old patient who received FLUARIX. On an unknown date, the patient received FLUARIX (intranasal). On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown. It was unknown if the reporter considered the wrong route of administration to be related to FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vaccine exposure via breast milk in a adult female patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown. Additional information: Nurse reports that she administered a FLUARIX injection to a woman who is breastfeeding.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Extra dose administered, Irritability
Clinical narrative: This case was reported by a nurse and described the occurrence of agitation in a 88-year-old female patient who received FLULAVAL (batch number 3E532, expiry date June 2015). Concurrent medical conditions included dementia. Concomitant products included FLULAVAL, lorazepam, SEROQUEL, calcium carbonate, Calcium CO3 + Minerals + Vitamins and IMMODIUM. On 25th October 2014, the patient received the 2nd dose of FLULAVAL. On 26th October 2014, 1 days after receiving FLULAVAL, the patient experienced agitation and irritability. On an unknown date, the patient experienced extra dose administered. The patient was treated with TYLENOL. On an unknown date, the outcome of the agitation and irritability were not recovered/not resolved and the outcome of the extra dose administered was unknown. The reporter considered the agitation and irritability to be possibly related to FLULAVAL. Additional information received: Nurse stated that on Friday 24 October 2014 she gave a dose to patient, then on Saturday 25 October 2014 another nurse gave a dose. She said this was due to miscommunication. The patient had dementia, so it is hard to determine if they are experiencing AE's from being given 2 doses of flu vaccine. They don't know if the agitation that the patient is experiencing is from this or not.
Age: 1.74
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a female patient who received FLUARIX QUADRIVALENT (batch number 2A2KX, expiry date 15th June 2015). On 2nd October 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of extra dose administered in a 5-year-old male patient who received FLUARIX QUADRIVALENT (batch number 2Y747, expiry date 30th June 2015). Concomitant products included FLUARIX QUADRIVALENT. On an unknown date, the patient received the 2nd dose of FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reports the inadvertent administration of 2 doses of FLUARIX QIV to a 5 years old patient on the same day.
Age: 1.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 1-year-old patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: Nurse reported that a 1 year old patient was inadvertently administered FLUARIX but did not have any further information.
Age: 94.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Case number PHEH2014US021744, is an initial spontaneous report received from health care professional on 27 Oct 2014. This report refers to a 94 year old male patient. He was vaccinated with FLUVIRIN (batch number: 1412801) intramuscular on 13 Oct 2014. On the same day post vaccination he experienced arthralgia, it burned when injection went in, arm was little sore and by the next day it was bad. Reaction continues feels like a rotator cuff injury. Outcome of the event was condition unchanged. Seriousness and causality assessment was not reported.
Sex: U
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of elevated liver enzymes in a patient who received FLUARIX TETRA. Previously administered products included FLUARIX. In 2014, the patient received FLUARIX TETRA. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced elevated liver enzymes, aspartate aminotransferase increase and alanine aminotransferase increased. On an unknown date, the outcome of the elevated liver enzymes, aspartate aminotransferase increased and alanine aminotransferase increased were unknown. It was unknown if the reporter considered the elevated liver enzymes, aspartate aminotransferase increased and alanine aminotransferase increased to be related to FLUARIX TETRA. Additional information received: Post liver transplant patient who has developed elevated liver tests (elevated AST ALT to 5X ULN) after influenza vaccination both in 2013 and 2014.
Sex: U
Vaccine: DTAPIPV, HEPA, RV1, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included ROTARIX, BOOSTRIX and KINRIX. On an unknown date, the patient received HAVRIX at an unknown dose, ROTARIX at an unknown dose, BOOSTRIX at an unknown dose and KINRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, ROTARIX, BOOSTRIX and KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: HAVRIX, ROTARIX, BOOSTRIX and KINRIX were exposed to a low temp. of 31F between 4/2/14 and 4/18/14 for a total of 336 hours. These vaccines were then administered to patients after exposed to this temp. The HCP does know the patient initials, M/F, DOB, lot #, exp. date, etc. for each dose given as he just found out that these doses should be counted as valid (per CDC).
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received FLUARIX QUADRIVALENT (batch number XJ497, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: The reporter informed that approximately 300 patients were vaccinated with FLUARIX QIV that had been exposed to room temperature for about 96 hours. This time at RT is beyond the stability data that we have.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome, X-ray
Clinical narrative: Chronic pain, major limited mobility. Patient visited a doctor as a result. Patient was diagnosed w/Impingement Syndrome by orthopedic.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV on an unknown date. The subject's estimated date of delivery was 27th May 2015. On an unknown date, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Gestational age was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vacine administration in a 13-month-old patient who received FLUARIX QIV. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receivng FLUARIX, the patient experienced inapprorpiate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: FLUARIX QIV was given to a 13 months old.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Lacrimation increased, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site warmth in a 71-year-old female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). Previously administered products included flu (few years ago, patient got really sick). Concurrent medical conditions included house dust allergy and pollen allergy. Concomitant products included aspirin, caffeine, salicylamide. On 27th October 2014 11:00, the patient received FLUARIX. On 27th October 2014, less than a  day after receiving FLUARIX, the patient experienced injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes. The patient was treated with MOTRIN and BENADRYL. On an unknown date, the outcome of the injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes were unknown. It was unknown if the reporter considered the injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes to be related to FLUARIX. Additional information received: ?Per HCP, patient was administered FLUARIX TIV yesterday and reported symptoms of soreness, watery eyes and swollen fingers.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of extra dose administered in a elderly female patient who received FLUARIX. On an unknown date, the patient received .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: Two doses of FLUARIX within one hour of each other.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Developed redness and swelling at the site of the injection.  Redness and warmth continued to spread down the arm, covering a large area of the left arm.  Seen in office, diagnosed with cellulitis and started on oral antibiotics.
Age: 27.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: Rash on bilateral wrists, left elbow, left temple, pruritus lasting for one day until evaluation and treatment with hydroxyzine.  Persistent lesions until evaluation by this provider 48 hours after initial onset of symptoms.
Age: 27.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Allergy test negative, Pruritus, Urticaria
Clinical narrative: Rash on bilateral wrists, left elbow, left temple, pruritus lasting for one day until evaluation and treatment with hydroxyzine.  Persistent lesions until evaluation by this provider 48 hours after initial onset of symptoms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: This is a patient who has previosly had shingles and then received the Zostavax shot (not at the same time or right after). He reported that he experienced an unusual event a few hours after receiving this vaccine. He described it as increased numbness on the left side of his face around his L. eye and nose. He also reported that when he got shingles on his face, the numbness never completely went away and a few hours after receiving zoster shot, he experienced a flare-up in his facial numbness. The patient never treated himself with medications for this increased numbness and the numbness returned to baseline in 4-5 days.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Injection site discolouration, Injection site mass, Injection site vesicles, Pyrexia
Clinical narrative: This case was reported by unknown type of reporter and described the occurrence of fever in a 18-month-old male patient who received INFANRIX (batch number N5339, expiry date 25th March 2016). Concomitant products included Hepatitis A vaccine. On 20th September 2014, the patient received the 4th dose of INFANRIX. On 21st September 2014, 1 days after receiving INFANRIX, the patient experienced fever. On an unknown date, the patient experienced injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar. The patient was treated with BENADRYL, KEFLEX and MOTRIN. On an unknown date, the outcome of the fever and bullous eruption at injection site were recovered/resolved and the outcome of the injection site mass was unknown and the outcome of the injection site discoloration and vaccination site scar were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar to be related to INFANRIX. Additional information received: Parent reports son received 4th KINRIX vaccination in left thigh. Within 24 hours post vaccination, he developed a fever, which lasted 24 hours. She noticed after vaccination that, at the injection site, there was a white spot with a dot in the middle. The white spot continued to spread out and within 48 hours it became approximately the size of a softball. The softball sized area is still there at time of report. The week following the injection, the skin bubbled up around the injection site, taking about 2 weeks to resolve. At the time of the report, there is a permanent scar and skin discoloration in the area around the injection site. Son received a Hepatitis vaccination in right thigh same day, and experienced no reaction. The parent sought medical treatment at a walk in clinic approximately 18 hours after vaccination. Son was given BENADRYL, KEFLEX AND MOTRIN. The bloodwork done at time of clinic visit indicated no infection.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site scar
Clinical narrative: This case was reported by unknown type of reporter and described the occurrence of fever in a 18-month-old male patient who received INFANRIX (batch number N5339, expiry date 25th March 2016). Concomitant products included Hepatitis A vaccine. On 20th September 2014, the patient received the 4th dose of INFANRIX. On 21st September 2014, 1 days after receiving INFANRIX, the patient experienced fever. On an unknown date, the patient experienced injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar. The patient was treated with BENADRYL, KEFLEX and MOTRIN. On an unknown date, the outcome of the fever and bullous eruption at injection site were recovered/resolved and the outcome of the injection site mass was unknown and the outcome of the injection site discoloration and vaccination site scar were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar to be related to INFANRIX. Additional information received: Parent reports son received 4th KINRIX vaccination in left thigh. Within 24 hours post vaccination, he developed a fever, which lasted 24 hours. She noticed after vaccination that, at the injection site, there was a white spot with a dot in the middle. The white spot continued to spread out and within 48 hours it became approximately the size of a softball. The softball sized area is still there at time of report. The week following the injection, the skin bubbled up around the injection site, taking about 2 weeks to resolve. At the time of the report, there is a permanent scar and skin discoloration in the area around the injection site. Son received a Hepatitis vaccination in right thigh same day, and experienced no reaction. The parent sought medical treatment at a walk in clinic approximately 18 hours after vaccination. Son was given BENADRYL, KEFLEX AND MOTRIN. The bloodwork done at time of clinic visit indicated no infection.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Pain, Rash, Swelling
Clinical narrative: 3 by 3 inch circumference rash with swelling, pain and 3, 3 inch long stripes of redness radiating from the rash site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased, Nausea
Clinical narrative: Patient started feeling dizzy, nauseous and increased heart rate. Patients symptoms got a little better before leaving with her husband.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site.
Age: 18.0
Sex: M
Vaccine: TYP, YF
Symptoms: Asthenia, Blood calcium increased, Blood creatine phosphokinase normal, Computerised tomogram head normal, Differential white blood cell count normal
Clinical narrative: Acute onset of weakness, tachycardia, shortness of breath, numbness of peripheral extremities, followed by loss of consciousness. Assessed in the Emergency Department, believed to be a possible generalized seizure.
Age: 18.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dyspnoea, Electrocardiogram normal, Full blood count normal, Hypercalcaemia, Hypoaesthesia
Clinical narrative: Acute onset of weakness, tachycardia, shortness of breath, numbness of peripheral extremities, followed by loss of consciousness. Assessed in the Emergency Department, believed to be a possible generalized seizure.
Age: 18.0
Sex: M
Vaccine: TYP, YF
Symptoms: Loss of consciousness, Tachycardia, Toxicologic test normal
Clinical narrative: Acute onset of weakness, tachycardia, shortness of breath, numbness of peripheral extremities, followed by loss of consciousness. Assessed in the Emergency Department, believed to be a possible generalized seizure.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Induration, Lymphadenopathy, Skin warm, Tenderness
Clinical narrative: Arm was indurated, tender, warm, not red, but he had swollen lymph node in his axilla.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: LOCAL SORENESS WITH ERYTHEMA AND WARMTH 8cm x 12cm.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Drooling, Eye movement disorder, Lethargy, Muscle tightness, Skin warm
Clinical narrative: At 18:45, pt had tactile temp followed by generalized tonic/clonic "shaking" of all 4 extremities, eyes deviated to right, tight facial muscles, drooling. Seemed to be alert off and on during event. Was lethargic, then very clingy. Episode lasted 12-15min. Was taken by private car to ER for eval. Vomited x1 in ER. Was given Ibuprofen prior to discharge.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Tonic clonic movements, Vomiting
Clinical narrative: At 18:45, pt had tactile temp followed by generalized tonic/clonic "shaking" of all 4 extremities, eyes deviated to right, tight facial muscles, drooling. Seemed to be alert off and on during event. Was lethargic, then very clingy. Episode lasted 12-15min. Was taken by private car to ER for eval. Vomited x1 in ER. Was given Ibuprofen prior to discharge.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Cough, Productive cough, Secretion discharge, Sneezing, Wheezing
Clinical narrative: Phlegm, lots of spit, bubbles, sneezing, coughing, wheezing.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Swollen tongue
Clinical narrative: TONGUE SWELLING, RASH, TROUBLE BREATHING.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Injection site reaction, Throat irritation
Clinical narrative: Pt explained having a giant hive on back of left arm (injection site) that reached from elbow to shoulder. Also said had itching of the throat. Pt saw her physician and Dr reported as moderate adverse reaction.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Chest X-ray, Cough, Insomnia, Irritability, Pyrexia
Clinical narrative: Increased coughing, irritability, low grade fever, excessive mucous with vomiting of mucous, some wheezing, difficulty sleeping and nursing.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Respiratory syncytial virus test positive, Secretion discharge, Vomiting, Wheezing
Clinical narrative: Increased coughing, irritability, low grade fever, excessive mucous with vomiting of mucous, some wheezing, difficulty sleeping and nursing.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Pt walked back into pharmacy following day after the shot administered (11: 00 AM on 1/6/15). Left arm was noticeably red, elevated hive, warm to touch. Recommended BENADRYL and to see MD. Contacted physician left message.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong route of administration in a adult patient who received FLUARIX. On an unknown date, the patient received FLUARIX (intranasal). On an unknown date, an unknown time after receiving FLUARIX the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown. It was unknown if the reporter considered the wrong route of administration to be related to FLUARIX.
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 33-month-old female patient who received FLUARIX (batch number 3JE9F, expiry date 30th June 2015. On an unknown date, the patient inadvertently received FLUARIX .5 ml. On an unknown date an unknown time after receiving FLUARIX season, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administered in a 12-month-old male patient who received FLUARIX (batch number DH937, expiry date June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the appropriate age at vaccine administration was unknown. Additional information received: 12 months old given FLUARIX QIV.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 29-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcome sin women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX Quadrivalent or FLULAVAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden on 5th November 2014.  On 5th November 2014, as unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.  Additional details provided: Nurse reported that, she did not know EDD or gestational age. This was 1 of the 2 reports received from the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 27-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALEN or FLULAVAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden on an unknown date. The subject received Flu Seasonal QIV Dresden at week 18 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed vaccine exposure during pregnancy (non serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The patient's estimated due date was unknown. No other AE's were reported.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX Quadrivalent or FLULAVAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden on 5th November 2014. On 5th November 2014, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   Additional details provided: Nurse reported that, she did not know EDD or gestational age. This was 1 of the 2 reports received from the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV in January 2015. In January 2015, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: GSK nurse practitioner administered a Flu vaccine to a pregnant patient today. Lot number/expiration date were unknown. Gestational age/due date are unknown. No other AEs were reported.