chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Body pains, fever, chills redness/and hardness on the left arm at the injection site and all over the left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Pain, Pyrexia, Rash, Rash vesicular
Clinical narrative: FEVER AND BODY ACHE FOR 3 DAYS. THEN RASH BROKE OUT ON LIPS SPREADING TO FACE.  SIMILAR TO SHINGLES RASH THAT HAPPENED A FEW YEARS AGO.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vaccine administered on Friday 8-17-18 at Pharmacy. Patient started having fever, arm tenderness, swelling and redness which expended around injection site and down arm several inches. Was seen in ER and diagnosed with Cellulitis on 8-18-18 and started on an antibiotic. On 08-21-2018 Patient came to pharmacy - area was marked with marker - to update me on her situation. On 08-23-18 patient called me, stated she seen her normal provider (Dr) on 08-22-2018. The area had worsened and continued further down her arm through 08-22-18. On 08-23-2018 it was starting to lessen and was half as big as it was per patient report.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Myalgia, Pain in extremity
Clinical narrative: Very sore arm, muscles are very sore, bad headache. Flu like symptoms. Don't want to do anything.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Rash
Clinical narrative: Patient experienced Nausea, Fatigue, and soreness to the arm, In 24 hours a rash began and started heading down towards her elbow. She saw her primary physician today and was counseled that she has seen similar reactions with other 2 dose vaccinations. But if the rash does not clear up in a week or if it gets worse she needs to have it rechecked for cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Patient started with fever about 22 hrs after injection was given. Patient's mother then noted that he started having redness around the injection area with rash in area as well. Mother reported that redness continued to get larger in the area of the injection site when mother brought patient into the office redness and rash was about 12 centimeters in radius. Patient was seen in the office for this reaction and was discussed with mother as to what to continue to watch for and to no longer get this injection.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood prolactin, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure like phenomena, Syncope
Clinical narrative: The patient fainted and then had seizure-like activity. He came to, sat up, and then fainted again. The physician is not certain if this event was related to vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Influenza like illness, Mental status changes, Pain
Clinical narrative: Per pt, had body aches and flu like symptoms on the 2nd day and by the 3rd day there was an acute change in the mental status and became oriented by the 5th day at 1 pm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPERIENCED PAIN, SWELLING, REDNESS, AND WARM TO THE TOUCH AROUND THE INJECTION SITE.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain
Clinical narrative: Body aches, headache and some chills; mild stomach ache.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient initially complained of sore arm 3 weeks after the vaccine was given, he was told to put cold compress and take antipyretics to help alleviate the pain. Patient came back a week later on 08/23/18 and still complained of sore arms (specially at the injection site).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient's mom stated that patient's left arm was swollen and red along with a fever the next day after the vaccine was administered. Mom was informed to admin TYLENOL for the fever if there was no drug allergy to medication and have medical provider examine arm. Mom was told to report back to pharmacy with results
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion
Clinical narrative: Bruising in both arms. Bruise in left arm visible when patient reported to the pharmacy. Bruise in right arm was not visible at the time of reporting but the patient stated there was a bruise there.
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Body temperature increased, Lymphadenopathy, Rash
Clinical narrative: Rash in lower arm, 103 F temperature, swollen lymph nodes in both arms, but more pronounced in right arm. Pt's Dr not sure if swollen nodes are due to vaccines or something else. Dr will send pt to get lab work, ultrasound.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Head banging, Malaise, Myalgia
Clinical narrative: Headache, loss of appetite, sore joints and muscles, general malaise.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Induration, Injection site induration, Injection site oedema, Injection site pain, Oedema peripheral
Clinical narrative: Edema and large indurated area (painful) that began around injection site and over a 1-2 week period moved down to elbow/forearm. Resolved with MEDROL dosepak.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Pain in extremity
Clinical narrative: Edema and large indurated area (painful) that began around injection site and over a 1-2 week period moved down to elbow/forearm. Resolved with MEDROL dosepak.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Red and swollen injection site, painful and firm.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Musculoskeletal pain, Swelling
Clinical narrative: Severe pain in shoulder given 8-9-10 pain into joint. Swelling but no erythema. Had to put arm in a sling.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Red welt day after the immunization and progressed to a large red swollen area on the left arm with fever 5 days later resembling cellulitis. Patient is currently going to an urgent clinic right now to have it looked at by a doctor.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Dysphagia, Electrocardiogram, Pain
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palatal swelling, Pharyngeal oedema, Pyrexia, Sensation of foreign body, Swelling
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chest pain, Chills, Diarrhoea, Dysphagia
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Influenza like illness, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Swelling face, Throat tightness
Clinical narrative: Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Low grade fever-2 day. Swelling (L) arm down to elbow and pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Pain, Syncope
Clinical narrative: Sweats, faint, body aches, headache, achy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dermatitis contact
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Hematoma. Upper right extremity. Advised pt to apply ice compress to the affected area, 20 mins at a time, up to 8x daily. Elevate the limb whenever you are lying down, and continue to rest the affected limb and avoid heavy lifting/unnecessary movement. I want to f/u on the resolution of this. Kindly see me back in one week. Injection site pain (from 3 days ago). It does appear that you had a reaction with the SHINGRIX injection at our clinic.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Peripheral swelling, Pyrexia
Clinical narrative: One week of swollen arm - hot, pain, fever, fatigue - 2 days later active outbreak of shingles on left leg.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: One week of swollen arm - hot, pain, fever, fatigue - 2 days later active outbreak of shingles on left leg.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Tenderness, edema, erythema over (L) deltoid.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Complaints of local severe pain on left deltoid and onset of low fevers (less than 100F at home) that began yesterday evening. Treatment: Ice pace provided to left deltoid today, kept in place with ACE wrap. To use 10-15 minutes at a time, several times daily. Continue use of ibuprofen, discussed maximum adult dosage.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at injection site. Burning, itching, stinging and aching at injection site. Fever, weakness, body aches and headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Swelling at injection site. Burning, itching, stinging and aching at injection site. Fever, weakness, body aches and headache.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypersensitivity, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: 6-11-18 administered: BOOSTRIX. Initial reaction: Numbness and tingling within hours of vaccine. Location: Primarily left side. Radiating to head/neck, tops of thighs. Went to ER 6-12-18 patient reports that symptoms have worsened daily since the date of administration. Symptoms since that have warranted medical testing and treatment by multiple providers: Daily neurological symptoms to date include muscle weakness, involuntary twitching of muscles, pressure in head, balance issues, headaches, numbness and tingling in feet, legs, arms, and hands. Pain in hands. Microvascular damage. Nerve pain. Eyelids drooping, nerve tingling and pressure sensations around eyes. EMG showed pinched nerve activity apparent in both arms. I did not have this before the vaccination I was given.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Balance disorder, C-reactive protein normal, Electromyogram abnormal, Eyelid ptosis, Head discomfort
Clinical narrative: 6-11-18 administered: BOOSTRIX. Initial reaction: Numbness and tingling within hours of vaccine. Location: Primarily left side. Radiating to head/neck, tops of thighs. Went to ER 6-12-18 patient reports that symptoms have worsened daily since the date of administration. Symptoms since that have warranted medical testing and treatment by multiple providers: Daily neurological symptoms to date include muscle weakness, involuntary twitching of muscles, pressure in head, balance issues, headaches, numbness and tingling in feet, legs, arms, and hands. Pain in hands. Microvascular damage. Nerve pain. Eyelids drooping, nerve tingling and pressure sensations around eyes. EMG showed pinched nerve activity apparent in both arms. I did not have this before the vaccination I was given.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Muscle twitching, Muscular weakness, Neuralgia
Clinical narrative: 6-11-18 administered: BOOSTRIX. Initial reaction: Numbness and tingling within hours of vaccine. Location: Primarily left side. Radiating to head/neck, tops of thighs. Went to ER 6-12-18 patient reports that symptoms have worsened daily since the date of administration. Symptoms since that have warranted medical testing and treatment by multiple providers: Daily neurological symptoms to date include muscle weakness, involuntary twitching of muscles, pressure in head, balance issues, headaches, numbness and tingling in feet, legs, arms, and hands. Pain in hands. Microvascular damage. Nerve pain. Eyelids drooping, nerve tingling and pressure sensations around eyes. EMG showed pinched nerve activity apparent in both arms. I did not have this before the vaccination I was given.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Ocular discomfort, Pain in extremity, Paraesthesia
Clinical narrative: 6-11-18 administered: BOOSTRIX. Initial reaction: Numbness and tingling within hours of vaccine. Location: Primarily left side. Radiating to head/neck, tops of thighs. Went to ER 6-12-18 patient reports that symptoms have worsened daily since the date of administration. Symptoms since that have warranted medical testing and treatment by multiple providers: Daily neurological symptoms to date include muscle weakness, involuntary twitching of muscles, pressure in head, balance issues, headaches, numbness and tingling in feet, legs, arms, and hands. Pain in hands. Microvascular damage. Nerve pain. Eyelids drooping, nerve tingling and pressure sensations around eyes. EMG showed pinched nerve activity apparent in both arms. I did not have this before the vaccination I was given.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate normal, X-ray limb
Clinical narrative: 6-11-18 administered: BOOSTRIX. Initial reaction: Numbness and tingling within hours of vaccine. Location: Primarily left side. Radiating to head/neck, tops of thighs. Went to ER 6-12-18 patient reports that symptoms have worsened daily since the date of administration. Symptoms since that have warranted medical testing and treatment by multiple providers: Daily neurological symptoms to date include muscle weakness, involuntary twitching of muscles, pressure in head, balance issues, headaches, numbness and tingling in feet, legs, arms, and hands. Pain in hands. Microvascular damage. Nerve pain. Eyelids drooping, nerve tingling and pressure sensations around eyes. EMG showed pinched nerve activity apparent in both arms. I did not have this before the vaccination I was given.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: Developed low grade fever, muscle aches, headache, decreased appetite the day after the vaccination (same symptoms after the 1st dose 2 months ago). Symptoms mainly resolved after 24 hours.
Age: 12.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode after his HPV and Hepatitis B vaccine.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, regarding a 21 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with the first two doses of GARDASIL 9 for prophylaxis (frequency, route, anatomical location, lot # and expiration date were not provided). The patient's last menstrual period was approximately 31-MAY-2018, based on the due date reported. On approximately 14-JUN-2018, the patient became pregnant.  On 06-JUL-2018, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly, lot # R000301 with expiration date 29-AUG-2020 for prophylaxis (frequency and anatomical location were not provided). On 13-JUL-2018, the patient returned for intrauterine device (IUD) placement and the nurse discovered patient was pregnant (exposure during pregnancy). The estimated date of delivery (EDD) was 07-MAR-2019. No information about  prenatal tests performed was provided, no treatment was given for the event and no adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R000301, Expiry date: 29-AUG-2020) for prophylaxis (route and anatomical location were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 20 degrees Farenheit for 5 days.  There was no previous temperature excursion. The call was due to data logger. This is one of the two reports from the same reporter. Sender's Comments:  US-009507513-1808USA008205.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lip erythema, Lip swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 4 month old male patient who did not have concomitant medication, pertinent medical history, drug reactions or allergies.  15-AUG-2018 4 pm, the patient was vaccinated with a dose of ROTATEQ orally, lot # R003111 with expiration date of 12-SEP-2019, for prophylaxis (strength was not reported), with a dose of PEDIARIX lot # 9A2KC with expiration date of 03-JUL-2020), with a dose of PREVNAR 13 lot # T94424, with expiration date of 31-MAR-2020 and a dose of ACTHIB  lot # UI902AAA with expiration date of -14-SEP-2019). The reporter referred that, on the same date at 7 pm, the patient's parents returned to the office with the patient due to his lips being very pink in color (lip erythema) and swollen, the physician evaluated the infant and documented lip swelling had decreased, no respiratory issues and ordered unspecified  diphenhydramine (BENADRYL) 12.5 mg/5 ml, 1/2 teaspoon once every 8 hours, with phone follow up in 48 hours. No lab diagnostics were performed. No intervention to prevent serious criteria, or hospitalization was needed, no life threatening event or disability occurred. The outcome of lip erythema and lip swelling was reported as resolving. The causality assessment between lip erythema and lip swelling with the suspect therapies was not reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to a 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 03-AUG-2018, the patient was vaccinated using public funds at a private doctor's office/hospital with improperly stored vaccines of PROQUAD (lot # R002935, expiry date unknown) subcutaneously in the right arm and KINRIX (lot # 95FR9, expiry date unknown) intramuscularly in the left deltoid. The patient previously received one dose of PROQUAD and "4 doses of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (DTaP) and 3 doses of poliovirus vaccine inactivated (Vero) (IPV)". No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA007644:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to a 12 month old male patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 06-AUG-2018, the patient was vaccinated using public funds at a private doctor's office/hospital with improperly stored vaccines of VARIVAX (lot# R002051 and expiration date unknown) subcutaneously in the left thigh, M-M-R II (lot # N027782, expiry date unknown) subcutaneously in the right thigh, VAQTA (lot # R003739, expiry date unknown) intramuscularly in the left thigh and the fourth dose of PREVNAR 13 (lot # T94425, expiry date unknown) intramuscularly in the right thigh for prophylaxis. No doses of VARIVAX, M-M-R II and VAQTA were administered previously. 3 doses of PREVNAR 13 were administered previously. No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA007644:
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to a 12 year 3 month old female patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On an unknown date, the patient was vaccinated using public funds at a private doctor's office/hospital with improperly stored VARIVAX (lot # R002051, expiry date unknown) subcutaneously in the left arm. The patient previously received one dose of VARIVAX. No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1808USA007644:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs was not provided. On 17-AUG-2018, the patient was vaccinated with a improperly stored VARIVAX subcutaneous, lot # N017395, expiration date 07-JUN-2019 (dose was not reported) for prophylaxis (product storage error). The vaccine was exposed to a range of temperature of -14°C to -10°C during 35 minutes. It was reported that there was not previous temperature excursion. It was reported that data logger was involved and that the vaccine was reconstituted with sterile diluent lot # N006325, expiration date 07-AUG-2019. No adverse effect was reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who received a once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot u58418A via intramuscular route in the left deltoid instead of second dose of MENB not produced by Sanofi Pasteur lot number not reported on 14-Aug-2018 instead of second dose of menb vaccine dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to wrong vaccine administered. It was unknown if patient had any adverse event after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 11 x 3 cm erythema and itchiness at the injection site, noticed last night, improving at the time of the visit per mom, after ice application.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is having pain in arm and shoulder for 14 days, she is having problems lifting her arm.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: 8 pm on day of vaccination started feeling tired, went to bed. Awoke at 11 pm with severe nausea, neck stiffness, and muscle stiffness. Went to ER around midnight. Received medication for nausea.  Was in ER for about 1.5 hours. Returned home and went back to bed. Woke in the morning, nausea was gone. Muscles in back and shoulders were stiff the next day for about 12 hours.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Pt had immediate pain on injection which progressively worsened over the next few days to the point she could not lift her arm.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Itching began within 24 hours, within 3 days there are severe hives all over the body, swelling and itchiness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Extreme exhaustion, day of injection then next day still exhausted plus slight fever 99. Lasted  about 30 hours.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Fatigue, Impaired work ability, Injection site pain
Clinical narrative: Site of injection painful and warm to touch. Extreme fatigue. Slight nausea. Very brief temperature spikes. Aching joints. Needed to take a day and a half off from work. Took ibuprofen at regular intervals as recommended on the bottle. By the morning of August 24, 2018 felt well enough to return to work. The only continuing symptom was the soreness at the injection site which was still warm to the touch.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Site of injection painful and warm to touch. Extreme fatigue. Slight nausea. Very brief temperature spikes. Aching joints. Needed to take a day and a half off from work. Took ibuprofen at regular intervals as recommended on the bottle. By the morning of August 24, 2018 felt well enough to return to work. The only continuing symptom was the soreness at the injection site which was still warm to the touch.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Fever, chills, swelling at site, redness at site, pain at site, nausea. Pain/redness at site began the first afternoon and evening (Tues 8/21). Fever, nausea and chills began the next day (Wed 8/22), worsening to evening. All symptoms remained the next day (Thur 8/23), though lessening gradually throughout the day. Today (Fri 8/24), only remaining is the redness/pain at the site and feels a bit itchy. Could possibly be a little rash, but no blisters or sores are present at this time.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, swelling at site, redness at site, pain at site, nausea. Pain/redness at site began the first afternoon and evening (Tues 8/21). Fever, nausea and chills began the next day (Wed 8/22), worsening to evening. All symptoms remained the next day (Thur 8/23), though lessening gradually throughout the day. Today (Fri 8/24), only remaining is the redness/pain at the site and feels a bit itchy. Could possibly be a little rash, but no blisters or sores are present at this time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Severe pain and swelling at site of shot, headache, low grade fever, SEVERE aches in WHOLE body.....all for 3 days which I spent in bed unable to care for myself. Slept a lot. On 3rd day rash all over my torso and arms....Today feeling almost back to normal.....rash going but itching where it was. I had a similar reaction to the 1st shot, but not as severe...did not put me in bed. The 2nd was VERY unpleasant.....but hopefully I may now avoid Shingles. Thank you
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Severe pain and swelling at site of shot, headache, low grade fever, SEVERE aches in WHOLE body.....all for 3 days which I spent in bed unable to care for myself. Slept a lot. On 3rd day rash all over my torso and arms....Today feeling almost back to normal.....rash going but itching where it was. I had a similar reaction to the 1st shot, but not as severe...did not put me in bed. The 2nd was VERY unpleasant.....but hopefully I may now avoid Shingles. Thank you
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Face injury, Fall, Lip haemorrhage, Tooth fracture
Clinical narrative: Patient was seated on an exam table during vaccinations. She was advised to stay seated after vaccinations. Approximately 2 minutes after vaccinations, patient fell forward off of the table and onto the floor hitting her face. The Medical Assistant and the patient's mom were in the room at this time. The fall resulted in a bloody lip and a broken front tooth. Patient was evaluated by physicians and observed for 30 minutes. We contacted the patient's dentist and mom drove her straight over after she was discharged.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: August 6,2018 area was imflamed, warm, bruised, and knot was present at inject site. Symptoms have improved but lump is present and still hurts and itches.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: August 6,2018 area was imflamed, warm, bruised, and knot was present at inject site. Symptoms have improved but lump is present and still hurts and itches.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Malaise, Nausea, Tremor
Clinical narrative: General feeling of illness beginning at 10 pm. Violent shaking chills lasting for 3 hours, nausea and upset stomach beginning 2 hours after injection and lasting through next day
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: "Reaction appeared 8/14/18. The area of injection was red, warm, and painful sometimes. Then it went away then came back yesterday," (8/18/18) - per patient.
Sex: F
Vaccine: MMR
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were unknown by the reporter. On 13-AUG-2018, the nurse was giving the dose of (wistar ra 27-3) M-M-R II (exact dose, frequency, lot number and expiration date were not reported) to an unspecified patient and she inadvertently got (wistar ra 27-3) M-M-R II squirted into her eye. No adverse effect reported.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Acute disseminated encephalomyelitis, Death, Headache
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Altered state of consciousness, Blood test, Brain herniation, Brain oedema, Computerised tomogram
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Confusional state, Death, Headache, Laboratory test normal, Lumbar puncture
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Viral infection
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Abnormal behaviour, Acute disseminated encephalomyelitis, Acute haemorrhagic leukoencephalitis, Agitation, Ammonia normal
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Autopsy, Bacterial test negative, Blood lactic acid normal, Borrelia test negative, Brain herniation
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Brain oedema, Bronchoscopy, CSF culture negative, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF virus no organisms observed, Computerised tomogram head abnormal, Confusional state
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Craniectomy, Cryptococcus test, Cytomegalovirus test negative, Death, Depressed level of consciousness
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Disorientation, Drug screen negative, Dyskinesia, Dyspnoea, Electrocardiogram normal
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.