chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 year old male patient with no pertinent medical history. The patient's drug reactions or allergies were not reported. On 20-SEP-2012 and 23-SEP-2013, the patient was vaccinated with the first and the second dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported), respectively. On 01-SEP-2016, he was vaccinated intramuscularly with the third 0.5 ml  dose of GARDASIL 9 (lot # M018810, expiry date 28-MAY-2018).  Concomitant therapies included tuberculin purified protein derivative (PPD) and unspecified medication reported as "Mendeo". On 01-SEP-2016, immediately after getting the third dose of GARDASIL 9, the patient fainted, "fell head first from the table" and hit his head. Right after this event, in the office, they tried to wake up the patient by administering him oxygen and ammonia. The patient's blood pressure was measured twice in the office with the first result of 107/58 (unit not provided) and the second result of 117/68 (unit not provided). The office called the emergency number and the patient was sent to hospital on the same day. At the time of report, the patient was still in the hospital and he did not recover. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 26 August 2016. This case involves a 31-year-old female patient who was vaccinated with a first dose of ADACEL (batch number U5458DA, expiration date 28 September 2018, dose, site of administration was not reported) intramuscularly on 26 August 2016 while she was pregnant. Pregnancy information of last menstrual period (LMP) and estimated delivery date was not reported. At the time of vaccination, patient was in third trimester of pregnancy, gestation period- 33 weeks. The patient health during pregnancy and specify risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medication was not reported. On unspecified date, following the vaccination, the patient experienced unknown adverse event. Lab data and corrective treatment was not reported. The outcome of events was not reported. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cataplexy, Fatigue, Insomnia, Narcolepsy, Seizure
Clinical narrative: Developed Narcolepsy with Cataplexy. Started with insomnia, fatigue weight gain. Then seizures from cataplexy triggered by emotion. Began falling sleep driving. Sleep attacks began.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sleep attacks, Sleep study, Somnambulism, Weight increased
Clinical narrative: Developed Narcolepsy with Cataplexy. Started with insomnia, fatigue weight gain. Then seizures from cataplexy triggered by emotion. Began falling sleep driving. Sleep attacks began.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Rash
Clinical narrative: Rash on torso. Sense of hot flash. No fever. Rash doesn't not itch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eczema herpeticum, Herpes simplex test negative, Polymerase chain reaction, Rash vesicular, Varicella virus test negative
Clinical narrative: Pt has eczema. Ten days after he was given PROQUAD vaccine, he developed a vesicular rash, with much worse rash in areas of skin affected by eczema, appearing like eczema herpeticum.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Crying, Full blood count normal, Head discomfort, Headache
Clinical narrative: Crying, pain to right arm and headache on 9/1/16, couldn't get out of bed throughout the night, wet the bed, felt pressure in head and eyes; had dizziness, and blurry vision was taken to school but couldn't get out of the car because of pain and weakness. Patient was taken to hospital ER, had lab work done and labs came back within normal limits (CBC, UA, CMP) Grandmother was told by ER physician that patient could be having possible reaction to HPV vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test normal, Ocular discomfort, Pain, Pain in extremity, Urine analysis normal
Clinical narrative: Crying, pain to right arm and headache on 9/1/16, couldn't get out of bed throughout the night, wet the bed, felt pressure in head and eyes; had dizziness, and blurry vision was taken to school but couldn't get out of the car because of pain and weakness. Patient was taken to hospital ER, had lab work done and labs came back within normal limits (CBC, UA, CMP) Grandmother was told by ER physician that patient could be having possible reaction to HPV vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: Crying, pain to right arm and headache on 9/1/16, couldn't get out of bed throughout the night, wet the bed, felt pressure in head and eyes; had dizziness, and blurry vision was taken to school but couldn't get out of the car because of pain and weakness. Patient was taken to hospital ER, had lab work done and labs came back within normal limits (CBC, UA, CMP) Grandmother was told by ER physician that patient could be having possible reaction to HPV vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Chills, Decreased appetite, Injected limb mobility decreased
Clinical narrative: C/o temp 102 on 9/2/16. C/o severe muscle and joint aches. C/o chills. Loss of appetite. Nausea. Site of injection was reddened and swollen. Unable to move left arm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: C/o temp 102 on 9/2/16. C/o severe muscle and joint aches. C/o chills. Loss of appetite. Nausea. Site of injection was reddened and swollen. Unable to move left arm.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Adenovirus test, Febrile convulsion, Human rhinovirus test, Influenza virus test negative, Respiratory syncytial virus test negative
Clinical narrative: FEBRILE SEIZURE, ADMITTED TO HOSPITAL.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Respirovirus test positive, Viral test negative
Clinical narrative: FEBRILE SEIZURE, ADMITTED TO HOSPITAL.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: PATIENT EXPERIENCED A INJECTION SITE REACTION.  HAD REDNESS THAT EXTENDED FROM INJECTION SITE.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt had redness, burning, and tenderness at injection site.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Gait disturbance, Myalgia
Clinical narrative: Patient described shivering, shaking, cols, hard to talk, and muscle pain like she was getting hit with a stun gun. She covered up with blankets and felt better when she woke up a few hours later.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: Stillbirth of daughter during pregnancy.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Urticaria
Clinical narrative: On 9-4-16 patient develop Hives all over body. Patient took one Benadryl pill.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient received a Tdap, then went for lab work. Patient had been fasting for blood tests, doesn't like needles and fainted when waiting for blood work to be done. Vitals stable, patient was moved to lying position and assessed by provider. No treatment necessary.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 79-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine many years ago. The reporter stated that, the patient was very sick after receiving Flu vaccine. It was reported that, the patient did not elaborate past her being very sick. The reporter did not know the brand of flu vaccine involved.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Pain in extremity
Clinical narrative: Patient had severe soreness of the arm for 2 days, then was experiencing chest pain so went to the hospital on the 3rd day. (patient is on Ranexa so has prior issues with chest pain).  EKG and chest xray was normal and received pain meds from hospital which helped.  Patient saw cardiologist on the 3rd day after and everything was normal.  Patient still has some soreness but is much better.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Eye swelling, Fatigue, Lip swelling
Clinical narrative: 8/24/2016 Within in 15 minutes of vaccine developed fatigue, 2 hours later developed Bronchial burning. 8/25/2016 Woke up with swollen eyes and swollen lips. Took one dose of Claritin and swelling subsided.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Patient states she had fatigue, fever and chills for 3 days following her Zostavax and Prevnar 13 vaccinations.  She states she was "sick as a dog".
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulites at injection site. This was reported by a nurse at ER.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Injection site pain, Pyrexia, Thirst
Clinical narrative: Patient symptoms were chills, fever, loss of appetite, very thirsty and pain and soreness where the vaccine was administered.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: 8/22 - MENACTRA site felt tingly right away and spread to other arm - the same day - during night - had headache, SOB, dizziness and racing heart. 8/23 - legs felt "weird", numb/heavy from pelvis down similar feeling in arms. Paresthesias and generalized weakness persisted x 2d.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Injection site paraesthesia, Limb discomfort, Palpitations, Paraesthesia
Clinical narrative: 8/22 - MENACTRA site felt tingly right away and spread to other arm - the same day - during night - had headache, SOB, dizziness and racing heart. 8/23 - legs felt "weird", numb/heavy from pelvis down similar feeling in arms. Paresthesias and generalized weakness persisted x 2d.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has redness, swelling, and pain at injection site. Dx of cellulitis. Tx with ibuprofen and KEFLEX x 7 days, starting today. Per pt. sx started 9/6.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client was given Proquad instead of individual Varicella and MMR. No problems noted.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Proquad was administered and not individual Varicella and MMR.  No reactions noted.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Feeling of body temperature change, Flushing, Headache, Hypoaesthesia
Clinical narrative: Heart palpitaions and weakness then after 5 days heart palpitations stopped and weakness continued with hot cold flushing. Numbness in toes started atarted about 4 days ago along with light sensitivity and headache and some nausea.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Palpitations, Photophobia
Clinical narrative: Heart palpitaions and weakness then after 5 days heart palpitations stopped and weakness continued with hot cold flushing. Numbness in toes started atarted about 4 days ago along with light sensitivity and headache and some nausea.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Patient presented with arm redness and itchiness. There is no sign of cellulitis currently.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Hypersensitivity, Pruritus generalised, Rash generalised, Rash pruritic
Clinical narrative: Began itching all over during the night.  Woke up the next morning with small bumps all over her body (legs, arms, chest, stomach, back).  Bumps were the same color as her skin, not red.  This child has NO allergies but exhibited what appeared to be an allergic reaction.  These itchy bumps remained for 5 days at which time they subsided and the itchiness stopped.  However, she began to complain about her "heart feels funny, like it feels heavy" on Sept 6, continuing through today.  She has never before complained of heart issues, and no abnormalities have ever been detected. We ruled out all possible allergens such as food and drinks, lotions, shower gel, etc.  There was absolutely nothing we could identify that was out of her ordinary day-to-day consumption and application.  The only "incident" that was not part of her normal ordinary daily activities, ingestion or exposure was a Meningococcal vaccination she received two weeks prior ("Menactra" by Sanofi Pasteur).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Muscle twitching, Nuclear magnetic resonance imaging, Petit mal epilepsy
Clinical narrative: Absence seizure- twitching lasting about 20 minutes, episodes continued for 2 months decreasing in frequency.  No previous history of seizures.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Injection site swelling, Wound
Clinical narrative: PATIENT EXPERIENCED PAIN AND SWELLING IN THE ARM WHERE SHE RECEIVED THE SHOT. PATIENT WAS ALARMED AND CAME BACK TO THE PHARMACY THE FOLLOWING DAY. SHE HAD NO FEVER, NO REDNESS, SLIGHT BRUISING, AND 2 SMALL HOLES.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered a Gardasil 9 vaccine instead of a Pentacel vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury
Clinical narrative: Patient checking out at front desk and fell backwards. Hit head on floor. Cool compresses applied to back of head, given juice, vital signs (BP 139/83 HR 97) and assessed patient mental status.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, WARMTH AND REDNESS LEFT UPPER ARM, REDNESS MAINLY INNER ASPECT LEFT UPPER ARM, REDNESS IS IRREGULAR IN AREA MEASURING 8CMX10CM. LEFT UPPER ARM MEASURES 33CM, RIGHT UPPER ARM MEASURES 30CM CIRCUMFERENCE. APPLY ICE 20MIN 3 TIMES A DAY, TYLENOL OTC.
Age: 30.0
Sex: F
Vaccine: FLU4, HEPAB, PPV
Symptoms: Pyrexia, Seizure
Clinical narrative: Pt had 103 fever and seizure.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction at this time.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives from head to toe four hours after receiving flu vaccination. Patient did not have any change in medications at visit. Patient states eating same diet. Symptoms are present (09/07/2016, 5:30PM). Patient states taking Benedryl. Patient instructed to take Famotidine 150mg twice daily and Allegra 180mg twice daily (09/07/2016).
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Skin ulcer
Clinical narrative: 2 sores on the face appeared. 1 presented itself lateral to the lips & the other was inferior to the lips. 1 centimeter in diameter by 1.5 centimeters in length. Have not disappeared for 7 days now. Child has had no prior medical conditions including but not limited to the skin.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Injection site is warm to touch, knot has formed. This is still present 1 week after injection.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Urticaria
Clinical narrative: Itchy welts, urticaria approx 1''x1''adjacent to injection site.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: Upon completion of the immunization the injection site began bleeding excessively.  I applied pressure to the site with sterile cotton balls until the bleeding slowly subsided and applied new bandages over the site to control any further bleeding.  The patient was an associate here at the store she said she was having no ill effects from the bleeding or the immunization and felt fine to return to work. I advised her to return to the pharmacy before leaving at the end of her shift (which she did approximately 3 hours after the immunization was completed) and I re-cleaned the area following all universal safety procedures and applied a new bandage.  There was no further bleeding at this time nor was the area inflamed or discolored.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, very sore arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysstasia, Guillain-Barre syndrome, Paraesthesia, Posture abnormal
Clinical narrative: Weakness, tingling of hands and feet, inability to stand or sit upright.  Diagnosed with Guillain Barre'.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Abnormal behaviour, Body temperature increased, Chills, Crying, Eye pain
Clinical narrative: She came home from school tired and fell asleep. Not typical behavior. When she woke up had a very bad headache and started chilling. Fell back to sleep. I took her temp at 530pm and it was 103'F. She said her eyes hurt were red and gave her 400mg ibuprofen. At 7 pm checked temp and still at 101.9. She was crying when awake complaining of pain and feeling bad from headache. Very lethargic. 840pm still sleeping.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersomnia, Lethargy
Clinical narrative: She came home from school tired and fell asleep. Not typical behavior. When she woke up had a very bad headache and started chilling. Fell back to sleep. I took her temp at 530pm and it was 103'F. She said her eyes hurt were red and gave her 400mg ibuprofen. At 7 pm checked temp and still at 101.9. She was crying when awake complaining of pain and feeling bad from headache. Very lethargic. 840pm still sleeping.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: She came home from school tired and fell asleep. Not typical behavior. When she woke up had a very bad headache and started chilling. Fell back to sleep. I took her temp at 530pm and it was 103'F. She said her eyes hurt were red and gave her 400mg ibuprofen. At 7 pm checked temp and still at 101.9. She was crying when awake complaining of pain and feeling bad from headache. Very lethargic. 840pm still sleeping.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Patient experienced a raised, 2 inch reddish area not tender to the touch. Injection site felt feverish to the touch.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Guillain-Barre syndrome, Lumbar puncture, Muscle disorder, Nerve conduction studies
Clinical narrative: Diagnosed with Gullian-Barre Syndrome after several weeks of progressive rapid loss of muscle function/peripheral neuropathy of limbs, trunk and head.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging
Clinical narrative: Diagnosed with Gullian-Barre Syndrome after several weeks of progressive rapid loss of muscle function/peripheral neuropathy of limbs, trunk and head.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Vulvovaginal erythema, Vulvovaginal pain, Vulvovaginal rash, Vulvovaginal swelling, Vulvovaginal warts
Clinical narrative: I have never had HPV or genital warts. Prior to this injection, I had a full examination and pap. Everything came back clear. Within 24 hours of taking the first vaccine I had some bumps. By 09/06/2016 my entire vulva/vagina is covered in what I can only assume is warts. It's painful, swollen, bright red and bumps everywhere leading towards the anus. I will be returning to Doctor for a further examination. After this happening, I did some research and there are proven cases where this shot has given the patient warts. I'm devastated. It's uncomfortable to wear panties. And I am not currently sexually active. Can his be fixed?? ????????
Sex: M
Vaccine: MENB
Symptoms: Condition aggravated, Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 18-year-old male patient who received BEXSERO. The patient's past medical history included seizures (the patient was not compliant to seizure medications). On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant and other: as per reporter). BEXSERO was continued with no change. On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: This case was reported by the sales representative. The age at vaccination was not reported. Concomitant medications included seizure medications. The patient experienced a seizure in the evening after vaccination with BEXSERO. The batch number for BEXSERO was not provided. The patient went to a neurologist who recommended the patient to get the 2nd dose of BEXSERO. The patient received a 2nd dose of BEXSERO without reoccurrence of seizures.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Back pain, Computerised tomogram abdomen abnormal, Dysuria, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of ovarian cyst in a 16-year-old female patient who received BEXSERO (batch number 154101A, expiry date 31st May 2017). Co-suspect products included MENVEO (batch number X15144, expiry date 31st July 2017). On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of MENVEO .5 ml. On an unknown date, 1 day after receiving BEXSERO and MENVEO, the patient experienced ovarian cyst (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), nausea (serious criteria other: as per reporter), low back pain (serious criteria other: as per reporter) and urination difficulty (serious criteria other: as per reporter). On an unknown date, the outcome of the ovarian cyst was unknown and the outcome of the abdominal pain, nausea, low back pain and urination difficulty were recovering/resolving. It was unknown if the reporter considered the ovarian cyst, abdominal pain, nausea, low back pain and urination difficulty to be related to BEXSERO and MENVEO. Additional details were reported as follows: The patient received BEXSERO and MENVEO on the same day. The patient was brought into the office for assessment and CT-Scan was performed at which point a large ovarian cyst was found. The patient was then referred to a gynaecologist for further treatment. The patient's symptoms was resolving however nausea and abdominal pain remained. No further information was reported regarding the event. The health care professional was agreed to further contact for follow-up as needed.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Ovarian cyst
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of ovarian cyst in a 16-year-old female patient who received BEXSERO (batch number 154101A, expiry date 31st May 2017). Co-suspect products included MENVEO (batch number X15144, expiry date 31st July 2017). On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of MENVEO .5 ml. On an unknown date, 1 day after receiving BEXSERO and MENVEO, the patient experienced ovarian cyst (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), nausea (serious criteria other: as per reporter), low back pain (serious criteria other: as per reporter) and urination difficulty (serious criteria other: as per reporter). On an unknown date, the outcome of the ovarian cyst was unknown and the outcome of the abdominal pain, nausea, low back pain and urination difficulty were recovering/resolving. It was unknown if the reporter considered the ovarian cyst, abdominal pain, nausea, low back pain and urination difficulty to be related to BEXSERO and MENVEO. Additional details were reported as follows: The patient received BEXSERO and MENVEO on the same day. The patient was brought into the office for assessment and CT-Scan was performed at which point a large ovarian cyst was found. The patient was then referred to a gynaecologist for further treatment. The patient's symptoms was resolving however nausea and abdominal pain remained. No further information was reported regarding the event. The health care professional was agreed to further contact for follow-up as needed.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Respiration abnormal, Respiratory arrest, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 11-year-old male patient who received BOOSTRIX (batch number EC9A9, expiry date unknown). Co-suspect products included ENGERIX B pediatric (batch number 73X43, expiry date unknown) and MENVEO (batch number M16003, expiry date unknown). On 16th August 2016, the patient received BOOSTRIX, the 3rd dose of ENGERIX B pediatric and MENVEO. On an unknown date, the dose was an unknown dose. On an unknown date, several minutes after receiving BOOSTRIX, ENGERIX B pediatric and MENVEO, the patient experienced syncope (serious criteria hospitalization), breathing arrested (serious criteria hospitalization and GSK medically significant) and respiration abnormal (serious criteria hospitalization). On an unknown date, the outcome of the syncope, breathing arrested and respiration abnormal were unknown. It was unknown if the reporter considered the syncope, breathing arrested and respiration abnormal to be related to BOOSTRIX, ENGERIX B pediatric and MENVEO. Additional details were provided as follows: The adverse events were reported by a GSK sales representative. The GSK sales representative did not provide patient's date of birth or expiry dates for vaccines. The healthcare professional would like to be contacted. The reported lot number (EC949) for BOOSTRIX did not exist and was updated to EC9A9, according to sales data sheet.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Viral symptoms onset 24-36 hours after injection, headache, body aches, sore throat, fatigue, cough, fever up to 102 degrees F onset 72 hours later. Treated with OTC Ibuprofen, ALLEGRA, FLONASE and decongestants.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Viral infection
Clinical narrative: Viral symptoms onset 24-36 hours after injection, headache, body aches, sore throat, fatigue, cough, fever up to 102 degrees F onset 72 hours later. Treated with OTC Ibuprofen, ALLEGRA, FLONASE and decongestants.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Ultrasound scan
Clinical narrative: The day after 1st GARDASIL given mother noticed a dime size red spot that steadily increased in size and warmth. Seen in office on day 8 and TX with AUGMENTIN for cellulitis. Returned day 11 with increased pain. Cellulitis improved but increased pain. US of area -> swelling no focal collection of fluids. Severe Pain lasted approximately 12 d.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: According to pt, Dr diagnosed cellulitis at site of injection. Extreme swelling, pain, redness, and warmth at injection site. Pt is given BENADRYL, triamcinolone cream and Bactrim DS.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Patient for flu shot and had allergic reaction like swelling today.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Incoherent, Influenza like illness, Pain
Clinical narrative: Husband stated that she was incoherent, dizziness, body aches, just like flu symptoms 9-7-16.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling, Pain, Tenderness
Clinical narrative: Local swelling, bruising and redness. Also some tenderness and pain.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Local swelling, redness, some pain. Recommended TYLENOL or Ibuprofen.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Eye irritation, Feeling hot, Rhinorrhoea
Clinical narrative: Shaky, burning eyes, nose running, stomach upset, normal temperature but felt hot. Achy joints (had same reaction with the High Dose last year).
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Shaky, burning eyes, nose running, stomach upset, normal temperature but felt hot. Achy joints (had same reaction with the High Dose last year).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: Redness at (R) thigh started 1 day after receiving MMR/V. No fever, no swelling, no warmth to site. Not itching previously, but itchy today in office. 4x6 cm blanching patchy erythema, non tender, #2 MMR/V. T98.5. WT. 36.6 lbs.
Age: 65.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Rash generalised
Clinical narrative: Pt received 3 vaccines, TYPHIM IV, TWINRIX, Yellow Fever and developed rash all over body after 7 days. Received MEDROL DP from Dr. Dr not sure if pt had reaction to vaccines.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 23rd AUGUST 2016, the patient received PEDIARIX .5ml in AUGUST 2016, less than a week after receiving PEDIARIX, the patient experienced fever and irritability. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, irritability and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever and irritability to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced fever and was fussy. They had used PEDIARIX for many years and never experienced this type of problem so they are concerned  that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious  defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with his complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by same reporter.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received BOOXTRIX (batch number KG7E2, expiry date 29th MAY 2018). Concomitant products included irbesartan, Levothyroxine, omeprazole, Wellbutrin XL and Zoloft.  On 9th August 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) .5ml. On 10th AUGUST 2016, 1 days after receiving BOOSTRIX, 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 BOOSTRIX. Additional details were provided as follows: On 9th AUGUST 2016, at 09:21 AM, the patient received a dose of BOOSTRIX in left deltoid.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Hypersensitivity, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 46-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date 5th NOVEMBER 2017). On an unknown date, the patient received BOOSTRIX, .5ml. On an unknown date, an unknown time after receiving BOOSTIRX, the patient experienced nausea/headache, fever, joint pain and allergic reaction. The patient was treated with naproxen. On an unknown date, the outcome of the nausea, headache, fever, joint pain and allergic reaction were unknown. The reporter considered the nausea, headache, fever, joint pain and allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that the patient experienced adverse events (nausea, headache, fever, allergic reaction and joint ache) associated with BOOSTRIX vaccination. The reporter called Center for Disease Control and Prevention and the reporter was told that, the patient was experiencing allergic reaction and asked to treat the patient with Naproxen. It is unknown if the side effects resolved. The reporter would like to be contacted regardless if there were similar reported adverse events associated with this specified lot number or not. The reporter was nervous because she used to buy BOOSTRIX in bulk. This case has been linked with case US201610943, reported by the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about patient's medical history, concurrent conditions and concomitant medication were not reported. On 25-AUG-2016, the patient was vaccinated with PROQUAD dose, (Lot # and expiration date were not provided), subcutaneously, that was reconstituted with an expired Merck sterile diluent (Lot # L010588, expiration date: 18-MAR-2016). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (concentration, route of administration, lot # and expiration date were not reported). The reporter stated that the patient was over the age of 26 years old when vaccinated, it was also reported no adverse events as a result of getting the vaccine out of the age range. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medication  were not reported. On 31-AUG-2016, the patient was vaccination with an expired dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016, subcutaneous, dose not reported). There were no known adverse effects. Additional information is not expected because there is no permission to contact the reporter.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Registered Medical Assistant (R.M.A.) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. No concomitant medications were provided. The R.M.A. reported that on 11-SEP-2015, the patient was vaccinated with the first dose of the 3 dose serious of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided). Subsequently, on 17-AUG-2016, the patient was vaccinated with the second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided) (product use issue). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a 62 year old female office manger via a company representative referring to the manager herself. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2015 (reported as about a year ago) the patient was vaccinated with ZOSTSAVAX (lot # and expiration date unknown, 1 dose, subcutaneous). On an unknown date in 2015 after receiving ZOSTAVAX (reported as about a year ago) the patient experienced a localized injection site reaction that there was a red area which went down and around her arm. The patient did not seek medical attention and no treatment was given for the event. On an unknown date the patient recovered from the event. Causality was not reported. Additional information is not expected as there is no consent to contact the physician.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Hypoaesthesia, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a 71 year old female patient concerning herself. The patient's concurrent conditions included unspecified heart problems, allergy to penicillin and a lot of medicines (captured in MARRS#1609USA003361). Concomitant therapies included ibuprofen. On 13-AUG-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, via intramuscular route (reported as "in the muscle") (strength, dose, lot number and expiration date were not reported). Other suspect medications were not provided. On 15-AUG-2016, the patient experienced low grade fever (pyrexia) she was no able to move her right arm, she could not brush her teeth, comb her hair and was difficult to drive (movement disorder). she had hives on her right arm (urticarial), her right arm was swollen (peripheral swelling) and numb (hypoesthesia). Also, around the injection area her right arm was hot (injection site warmth) and red (injection site erythema). Her skin near the injection area was blotchy, and the blotchy on her right arm was spreading (rash macular). In addition she had no strength (asthenia) and a lots of pain in her right arm (pain in extremity). The patient did  not seek medical attention and no treatment was given for the adverse events. On an unspecified date in August 2016 unspecified blood tests were performed, however, the results were not reported. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the movement disorder, pain in extremity, asthenia, rash macular, injection site erythema, injection site warmth, peripheral swelling, hypoesthesia, urticarial and pyrexia. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from a 71 year old female patient concerning herself. The patient's concurrent conditions included unspecified heart problems, allergy to penicillin and a lot of medicines (captured in MARRS#1609USA003361). Concomitant therapies included ibuprofen. On 13-AUG-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, via intramuscular route (reported as "in the muscle") (strength, dose, lot number and expiration date were not reported). Other suspect medications were not provided. On 15-AUG-2016, the patient experienced low grade fever (pyrexia) she was no able to move her right arm, she could not brush her teeth, comb her hair and was difficult to drive (movement disorder). she had hives on her right arm (urticarial), her right arm was swollen (peripheral swelling) and numb (hypoesthesia). Also, around the injection area her right arm was hot (injection site warmth) and red (injection site erythema). Her skin near the injection area was blotchy, and the blotchy on her right arm was spreading (rash macular). In addition she had no strength (asthenia) and a lots of pain in her right arm (pain in extremity). The patient did  not seek medical attention and no treatment was given for the adverse events. On an unspecified date in August 2016 unspecified blood tests were performed, however, the results were not reported. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the movement disorder, pain in extremity, asthenia, rash macular, injection site erythema, injection site warmth, peripheral swelling, hypoesthesia, urticarial and pyrexia. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Urticaria
Clinical narrative: Information has been received from a 71 year old female patient concerning herself. The patient's concurrent conditions included unspecified heart problems, allergy to penicillin and a lot of medicines (captured in MARRS#1609USA003361). Concomitant therapies included ibuprofen. On 13-AUG-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, via intramuscular route (reported as "in the muscle") (strength, dose, lot number and expiration date were not reported). Other suspect medications were not provided. On 15-AUG-2016, the patient experienced low grade fever (pyrexia) she was no able to move her right arm, she could not brush her teeth, comb her hair and was difficult to drive (movement disorder). she had hives on her right arm (urticarial), her right arm was swollen (peripheral swelling) and numb (hypoesthesia). Also, around the injection area her right arm was hot (injection site warmth) and red (injection site erythema). Her skin near the injection area was blotchy, and the blotchy on her right arm was spreading (rash macular). In addition she had no strength (asthenia) and a lots of pain in her right arm (pain in extremity). The patient did  not seek medical attention and no treatment was given for the adverse events. On an unspecified date in August 2016 unspecified blood tests were performed, however, the results were not reported. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the movement disorder, pain in extremity, asthenia, rash macular, injection site erythema, injection site warmth, peripheral swelling, hypoesthesia, urticarial and pyrexia. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. On 02-FEB-2016, the patient was vaccinated with improperly stored GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration date 21-SEP-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Several days after vaccine was given pt developed redness to left arm. Redness on getting worse. Seen in office dx with cellulitis and tx.
Age: 8.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: Pt received DTAP/IPV combo and MMRV combo vaccines at well child visit on 8/23/16. FOC reported via email that pt had headache, nausea, and decreased appetite since his vaccines the day prior. Pt seen in office for ongoing symptoms 8/31/16. Normal exam.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided.  On 01-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX, injection (lot # K007262, expiry date 25-NOV-2015; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (0.65ml, lot number L016283, expiration date 07-AUG-2016). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender, who was also a physician. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The nurse reported that ZOSTAVAX was received 2 days late in a drop shipment, shipped on 15-AUG-2016 and received on 19-AUG-2016. After the shipment, the vaccine was stored in temperature ranging from 20 degrees Fahrenheit (F) to 30 F up until the administration date. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M005727, expiration date: 03-MAY-2017, 0.65 ml, intramuscular). No adverse effects were reported. No previous excursions were reported. It was unspecified if Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L019836, expiry date 24-MAR-2017, strength, dose, route and site of administration were not reported). NO adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.