chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Impaired work ability, Injury
Clinical narrative: Information has been received on 01-DEC-2016 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient reported he never had chicken pox or shingles prior to 2010. In 2010, the patient received ZOSTAVAX (lot number not reported) vaccine.  In 2014, the patient began to develop shingles. The patient subsequently began to develop a skin rash on his hands, arm and back. This spread to his entire left hand and developed into nerve damage. As a result of this injury, the patient has lost 60-70 percent of the use of his left hand, and had to retire early from his job. As a direct and proximate result of his use of ZOSTAVAX, the patient continues to experience ongoing symptoms,  including loss of use of his left hand, which is believed to be caused by damage to his nervous system. The patient'  symptoms have resulted in physical limitations not present prior to use of ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of his use of ZOSTAVAX, the patient sustained serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's wife has been the patient's primary caretaker since his illness began in 2014. Shingles, loss  of use of left hand/nerve damage and damage to his nervous system were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Nerve injury, Pain, Physical disability, Quality of life decreased
Clinical narrative: Information has been received on 01-DEC-2016 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient reported he never had chicken pox or shingles prior to 2010. In 2010, the patient received ZOSTAVAX (lot number not reported) vaccine.  In 2014, the patient began to develop shingles. The patient subsequently began to develop a skin rash on his hands, arm and back. This spread to his entire left hand and developed into nerve damage. As a result of this injury, the patient has lost 60-70 percent of the use of his left hand, and had to retire early from his job. As a direct and proximate result of his use of ZOSTAVAX, the patient continues to experience ongoing symptoms,  including loss of use of his left hand, which is believed to be caused by damage to his nervous system. The patient'  symptoms have resulted in physical limitations not present prior to use of ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of his use of ZOSTAVAX, the patient sustained serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's wife has been the patient's primary caretaker since his illness began in 2014. Shingles, loss  of use of left hand/nerve damage and damage to his nervous system were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received on 01-DEC-2016 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient reported he never had chicken pox or shingles prior to 2010. In 2010, the patient received ZOSTAVAX (lot number not reported) vaccine.  In 2014, the patient began to develop shingles. The patient subsequently began to develop a skin rash on his hands, arm and back. This spread to his entire left hand and developed into nerve damage. As a result of this injury, the patient has lost 60-70 percent of the use of his left hand, and had to retire early from his job. As a direct and proximate result of his use of ZOSTAVAX, the patient continues to experience ongoing symptoms,  including loss of use of his left hand, which is believed to be caused by damage to his nervous system. The patient'  symptoms have resulted in physical limitations not present prior to use of ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of his use of ZOSTAVAX, the patient sustained serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's wife has been the patient's primary caretaker since his illness began in 2014. Shingles, loss  of use of left hand/nerve damage and damage to his nervous system were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial unsolicited report received from a patient on 21 November 2016. This case involves a female patient (onset age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose and dose in series were not reported) and one other vaccine both in an unknown route on an unknown date in 2013. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 2013, unspecified timeframe following the vaccination, the patient had developed fever of 103F. The patient's Laboratory investigation and corrective treatment were not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Gastrointestinal disorder, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (manufacturer report number- 2016517225) on 21 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, dose in series, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced fever and Gastro-intestinal disorder. Relevant laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Oxygen saturation decreased, Pyrexia, Seizure
Clinical narrative: Mother reports afternoon fever of 102 in the afternoon before he had an hour long seizure with dropping oxygenation level.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo administered to patient. Only one vial or partial dose used and diluted with a generic diluent. Two vials needed for administration are not attached from the manufacturer.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Information has been received from a female physician assistant via a company representative referring to her father, a 66 year old male patient. The patient's concurrent condition and concomitant therapy were not provided. The historical therapy included PREVNAR 13 in November 2015, "one year ago". On 19-OCT-2016, two weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiration date were unknown; route: injection) at the same time and in the same arm as an unspecified flu vaccine at an unspecified walk-in clinic. On an unknown date in 2016 after PNEUMOVAX 23 was administered, the patient experienced "local and systemic reactions". He experienced "fever, body aches, pains, swelling and chills". He also experienced "redness and warmth" near the injection site. The patient did not see medical attention. The patient present status was reported as "fine". No product quality complain (PQC). The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a female physician assistant via a company representative referring to her father, a 66 year old male patient. The patient's concurrent condition and concomitant therapy were not provided. The historical therapy included PREVNAR 13 in November 2015, "one year ago". On 19-OCT-2016, two weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiration date were unknown; route: injection) at the same time and in the same arm as an unspecified flu vaccine at an unspecified walk-in clinic. On an unknown date in 2016 after PNEUMOVAX 23 was administered, the patient experienced "local and systemic reactions". He experienced "fever, body aches, pains, swelling and chills". He also experienced "redness and warmth" near the injection site. The patient did not see medical attention. The patient present status was reported as "fine". No product quality complain (PQC). The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Expired product administered, Fatigue, Feeling abnormal, Hypertension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 84-year-old female patient who received Influenza vaccine unspecified. Co-suspect products included fluticasone furoate, BREO ELLIPTA inhalation powder (batch number R712207, expiry date October 2016) for difficulty breathing. The patient's past medical history included lung neoplasm (surgically removed 2 years before reporting date). Concomitant products included Z-PAK and medication unknown (Nebulizer (Name Unknown)). On 14th November 2016, the patient received Influenza vaccine unspecified and BREO ELLIPTA (inhaled) 100/25 ug 1 puff(s) once daily (1 puff(s) daily). On 14th November 2016, less than a day after receiving Influenza vaccine unspecified and BREO ELLIPTA and less than a day after starting Influenza vaccine unspecified and BREO ELLIPTA, the patient experienced tiredness, incorrect storage of drug and expired drug used. In November 2016, the patient experienced redness of legs and palmar erythema. On 15th November 2016, the patient experienced feeling bad and blood pressure high. BREO ELLIPTA was discontinued on 15th November 2016 (Dechallenge was unknown). On an unknown date, the outcome of the tiredness, redness of legs, palmar erythema, feeling bad, incorrect storage of drug and expired drug used were unknown and the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to Influenza vaccine unspecified and BREO ELLIPTA. The reporter considered the redness of legs, palmar erythema, feeling bad and blood pressure high to be related to Influenza vaccine unspecified and BREO ELLIPTA. Additional details were provided as follows: The patient reported that she tried BREO ELLIPTA about 8 to 9 months before the reporting date, but discontinued because she could not afford to purchase the medication. The day before reporting date, her doctor told her to start taking BREO ELLIPTA again, so she used a dose from the inhaler she opened several months ago. The inhaler had been opened for more than 6 weeks and was already expired in October 2016. In addition to starting BREO ELLIPTA, she also received a flu shot. She did not know what brand of flu shot she received. Around 8 pm (evening), the patient took the dose of BREO ELLIPTA and afterwards she felt tired, so she went to the bed. Around 4 am she woke up and the palms of her hands and her knees were red. She went back to sleep and when she woke up later in the morning she felt lousy. The patient took another dose of BREO ELLIPTA around 10 am on the date of reporting. She took her blood pressure and it was at 202 by 93. She had taken blood pressure medication to bring it down again and had decided not to continue BREO ELLIPTA.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage, Palmar erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 84-year-old female patient who received Influenza vaccine unspecified. Co-suspect products included fluticasone furoate, BREO ELLIPTA inhalation powder (batch number R712207, expiry date October 2016) for difficulty breathing. The patient's past medical history included lung neoplasm (surgically removed 2 years before reporting date). Concomitant products included Z-PAK and medication unknown (Nebulizer (Name Unknown)). On 14th November 2016, the patient received Influenza vaccine unspecified and BREO ELLIPTA (inhaled) 100/25 ug 1 puff(s) once daily (1 puff(s) daily). On 14th November 2016, less than a day after receiving Influenza vaccine unspecified and BREO ELLIPTA and less than a day after starting Influenza vaccine unspecified and BREO ELLIPTA, the patient experienced tiredness, incorrect storage of drug and expired drug used. In November 2016, the patient experienced redness of legs and palmar erythema. On 15th November 2016, the patient experienced feeling bad and blood pressure high. BREO ELLIPTA was discontinued on 15th November 2016 (Dechallenge was unknown). On an unknown date, the outcome of the tiredness, redness of legs, palmar erythema, feeling bad, incorrect storage of drug and expired drug used were unknown and the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to Influenza vaccine unspecified and BREO ELLIPTA. The reporter considered the redness of legs, palmar erythema, feeling bad and blood pressure high to be related to Influenza vaccine unspecified and BREO ELLIPTA. Additional details were provided as follows: The patient reported that she tried BREO ELLIPTA about 8 to 9 months before the reporting date, but discontinued because she could not afford to purchase the medication. The day before reporting date, her doctor told her to start taking BREO ELLIPTA again, so she used a dose from the inhaler she opened several months ago. The inhaler had been opened for more than 6 weeks and was already expired in October 2016. In addition to starting BREO ELLIPTA, she also received a flu shot. She did not know what brand of flu shot she received. Around 8 pm (evening), the patient took the dose of BREO ELLIPTA and afterwards she felt tired, so she went to the bed. Around 4 am she woke up and the palms of her hands and her knees were red. She went back to sleep and when she woke up later in the morning she felt lousy. The patient took another dose of BREO ELLIPTA around 10 am on the date of reporting. She took her blood pressure and it was at 202 by 93. She had taken blood pressure medication to bring it down again and had decided not to continue BREO ELLIPTA.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Fatigue
Clinical narrative: Began with extreme fatigue at about 4:00 PM and at about 8:00 PM I had a temperature of 103 degrees. By the next morning my temperature was normal and I felt tired but okay.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant reported on behalf of a physician's assistant. A 84-year-old female patient received PREVNAR 13 (NDC number: 0005197102, lot N47827, exp. date 01Nov2017) at 0.5ml single dose via an unspecified route in the right arm on 21Nov2016 for immunization. Concomitant medications included LEVOTHROID 100 mcg, Tablet, Orally, Once a day, MYRBETRIQ 50 mg, Tablet, Once a day, multivitamin, calcium and vitamin D all ongoing. Medical history included Hypothyroidism ongoing. On 26Nov2016 the patient experienced injection site redness, bruising below the injection site and swelling below the injection site. The outcome of the events was reported as recovering. The patient received treatment for the events.
Sex: F
Vaccine: MENB
Symptoms: Impaired work ability, Muscle atrophy
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer reporting for his/her daughter. This female child patient of an unspecified age, race and ethnicity received a single dose of meningococcal group b rlp2086 via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient was injured by the vaccine, she lost muscle mass and her ability to do work was affected. The patient recovered on an unspecified date. Pfizer is a marketing authorization holder of meningococcal b recombinant vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of meningococcal b recombinant vaccine has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.
Age: 0.58
Sex: M
Vaccine: 6VAX-F, FLU4, HIBV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported.
Age: 39.0
Sex: M
Vaccine: JEV1
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Little redness and itchy in the area the shot was administered. This came about with in a minute of when the shot was administered. The patient was looked at by the doctor and was told to take Benadryl.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient stated that her arm started to hurt about a hour after she received the vaccine.  She said it hurts when she exercises with her weights (hurts even when she tried to do 2lbs of weight and she normally does 10lbs for her chest press) Stated she even hurts when she unloads the dishwasher. Stated that taking an aleve (which she doesn't like to take medication) can let her sleep at night. Pt stated that it isn't her shoulder that hurts it is more her tricept. (Stated that if you go down about 1in under your armpit on the outside of her arm is where it hurts.  Said her arm feels weak. Says it feels better if she puts coconut oil and lavender on it and it gets better after she takes a hot shower.  Ask pt if she would like me to call the doctor or wait another week before contacting them.  She stated to wait another week and see if it gets better. Told Patient I would call her back on Monday (12/5/16) and if not better I will contact her doctor.  Pain has lasted her 3 weeks.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Dark circles under eyes, Ear infection, Fatigue, Hypersensitivity, Injection site erythema
Clinical narrative: "Hives" rash and fever appeared within 1-2 hours after the vaccine was administered.  Notified physician's office.  Applied children's skin allergy relief cream to the rash.  Respiratory infection appeared within a week and progressed into an ear infection which is uncommon for my son.  Increased fatigue and dark circles under both eyes noted for 3-4 weeks after the vaccination.  My so also had a large red, hard, and painful area on his leg at the site of the vaccination for several days after the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Pyrexia, Rash, Respiratory tract infection
Clinical narrative: "Hives" rash and fever appeared within 1-2 hours after the vaccine was administered.  Notified physician's office.  Applied children's skin allergy relief cream to the rash.  Respiratory infection appeared within a week and progressed into an ear infection which is uncommon for my son.  Increased fatigue and dark circles under both eyes noted for 3-4 weeks after the vaccination.  My so also had a large red, hard, and painful area on his leg at the site of the vaccination for several days after the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: "Hives" rash and fever appeared within 1-2 hours after the vaccine was administered.  Notified physician's office.  Applied children's skin allergy relief cream to the rash.  Respiratory infection appeared within a week and progressed into an ear infection which is uncommon for my son.  Increased fatigue and dark circles under both eyes noted for 3-4 weeks after the vaccination.  My so also had a large red, hard, and painful area on his leg at the site of the vaccination for several days after the injection.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PAIN FROM SHOULDER TO WRIST ON GOING.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Rash pruritic, Scab
Clinical narrative: Crusting and itching rash.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture negative, Computerised tomogram normal, Hypertension, Pyrexia, Sepsis
Clinical narrative: Initial unsolicited case received from a Physician on 22 Nov 2016. This case involves an 80 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI704AA , Expiry date: 17 May 2017, dose and site of administration was not reported) intramuscularly on 12 Oct 2016. The patient medical history includes cardiac, HTN (hypertension), history of cardiac arrhythmias, overactive bladder, A Fib (atrial fibrillation) and the patient illness at the time of vaccination was reported as unknown as per reporter and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 12 Oct 2016, same day after vaccination the patient developed hypertension, tachycardia, and was febrile with elevated WBC. On an unknown date the patient was evaluated in Emergency department and admitted to hospital overnight for observation. On an unknown date, patient was diagnosed with sepsis. The patient lab test include blood cultures negative, CT scan negative. The patient was treated with antibiotics for diagnosis of sepsis. The outcome of the events were reported as recovered on an unknown date and the patient was discharged from hospital on 13 Oct 2016. It was reported as the Cardiologist determined this was a reaction to the flu shot. List of documents held by sender: none. Sender's Comments: This case concerns 80 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed sepsis, hypertension, tachycardia and was febrile with elevated WBC. Time to onset is compatible with the role of vaccination. Patients medical include hypertension, hypothyroidism, cardiac arrhythmia, overactive bladder and A Fib. Hypertension, tachycardia can be attributed to preexisting condition. Further information regarding etiological work up, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, White blood cell count increased
Clinical narrative: Initial unsolicited case received from a Physician on 22 Nov 2016. This case involves an 80 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI704AA , Expiry date: 17 May 2017, dose and site of administration was not reported) intramuscularly on 12 Oct 2016. The patient medical history includes cardiac, HTN (hypertension), history of cardiac arrhythmias, overactive bladder, A Fib (atrial fibrillation) and the patient illness at the time of vaccination was reported as unknown as per reporter and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 12 Oct 2016, same day after vaccination the patient developed hypertension, tachycardia, and was febrile with elevated WBC. On an unknown date the patient was evaluated in Emergency department and admitted to hospital overnight for observation. On an unknown date, patient was diagnosed with sepsis. The patient lab test include blood cultures negative, CT scan negative. The patient was treated with antibiotics for diagnosis of sepsis. The outcome of the events were reported as recovered on an unknown date and the patient was discharged from hospital on 13 Oct 2016. It was reported as the Cardiologist determined this was a reaction to the flu shot. List of documents held by sender: none. Sender's Comments: This case concerns 80 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed sepsis, hypertension, tachycardia and was febrile with elevated WBC. Time to onset is compatible with the role of vaccination. Patients medical include hypertension, hypothyroidism, cardiac arrhythmia, overactive bladder and A Fib. Hypertension, tachycardia can be attributed to preexisting condition. Further information regarding etiological work up, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 75.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Dysgeusia
Clinical narrative: Very Strong Metallic taste in mouth. Effected taste sensation, made food undesirable, made food taste bad and metallic. Notified Doctor but he did not respond.
Age: 40.0
Sex: M
Vaccine: ANTH, MMR
Symptoms: Feeling hot, Syncope
Clinical narrative: Syncope episode. Patient past out for >1 minute, awoken after using ammonia salt. Patient did not immediately remember where he was or what day of the week it was, but remembered what year it was and his name. Reported feeling hot, and that they felt like they just woke up after a night sleeping. Patient started feeling better after a few minutes and remembered where he was and what had happened up to the syncope episode.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient noticed at midnight after work that her arm was sore.  She looked at it and on the left arm where vaccine was given, noticing redness and swelling.  Today still red, swollen and raised area to back of left arm that I measured to be 3 1/2 inches by 2 1/2 inches.  She states that it does not itch.  Has taken some Ibuprofen.  Will monitor and call doctor or ER if worsens or develops fever, SOB, increase in pain/swelling.  Will call Monday to f/u.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the HPV 9 and flu vaccines, the pt. began to feel dizzy. The pt. lay down for ten min., drank some juice and ate a protein bar. Pt.'s vital signs were checked. Once the pt. was feeling better, he left with his mother.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Headache, Heart rate increased, Nausea, Neck pain
Clinical narrative: Was seen in ER with 102.2 fever, shaking, nausea increase, heart rate head ache and neck pain.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Thyroid function test, Tremor
Clinical narrative: Was seen in ER with 102.2 fever, shaking, nausea increase, heart rate head ache and neck pain.
Age: 56.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hypersensitivity, Inflammation, Nasal congestion
Clinical narrative: INFLAMED FACE, NECK, CHEST AND RIGHT ARM. STUFFY NOSE.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Scar
Clinical narrative: Rash over trunk of body. Took BENADRYL and relief in 3 days. Some scarring remains on abdominal area.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Red rash on both arms, back and abdomen.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neck pain, Tenderness
Clinical narrative: Patient describes a muscular radiating pain in her left arm and extensive tenderness. Says pain has not improved and pain is spreading to neck.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt calling stating that her arm where she received the shingles vaccine is very red and itchy. Pt states that there is no swelling or lumps and is only mildly painful. Pt denies any difficulty breathing/swallowing, fever, dizziness.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site infection
Clinical narrative: Infection at the vaccination site, given doxycycline to treat.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient reported arm being sore and tender. Her upper arm started swelling and turned red on 12/1/16, but then the swelling began to spread past her elbow as time progressed. The swelling was warm to the touch. After a visit with her PCP, it was decided that she see him for assessment. He prescribed a medrol therapy pack for the swelling.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, Chills, Nausea, Vomiting, Fatigue and swelling at site of injection. Pt. took some motrin and put ice on injection site. Felt better by 12/02/2016.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Fever, Chills, Nausea, Vomiting, Fatigue and swelling at site of injection. Pt. took some motrin and put ice on injection site. Felt better by 12/02/2016.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site mass, Injection site swelling
Clinical narrative: 11-17-16 - Parent reports Ct. has baseball size redness with hard lumps at all 3 injection sites. Ct. c/o pain, reports hot to touch, swelling increasing since this a.m. I referred Ct. to M.D. Was seen by M.D. and treated with Sulfametox for infection.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site warmth
Clinical narrative: 11-17-16 - Parent reports Ct. has baseball size redness with hard lumps at all 3 injection sites. Ct. c/o pain, reports hot to touch, swelling increasing since this a.m. I referred Ct. to M.D. Was seen by M.D. and treated with Sulfametox for infection.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash over stomach and back.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 76-year-old male patient received first dose of PREVNAR 13, intramuscular on arm left on 14Sep2016 at 11:45 at single dose for pneumonia prevention. Medical history included seasonal affective disorder, ongoing borderline type 2 diabetes, glaucoma, ongoing cholesterol abnormal, pollen and grass allergies and sinus. He had pneumonia several times in the past and the worst he had was in 1978: "he was taken out of action for 2 weeks, it felt like somebody was sitting on his chest. He has had what is loosely termed "walking pneumonia" about 6 times, but has not had in 20 years". Concomitant medication included simvastatin for more than 10 years and ongoing for Cholesterol control at 40 mg, 1x/day (at night), fluoxetine from 1997 and ongoing for seasonal affective disorder at 20 mg, 1x/day (in the morning), metformin from 2015 and ongoing for borderline type 2 diabetes at 500 mg, 2x/day, timolol maleate began probably 5 years ago and ongoing for glaucoma pressure at 2 Gtt (1 drop each eye) 2x/day ophthalmic, dorzolamide 2% ophthalmic solution, from 2015 and ongoing for glaucoma pressure supplementation at 1 Gtt (one drop in right eye) 2x/day ophthalmic and LUTEIN for his eyes and a multivitamin. In 2015 he received a pneumonia shot (not PREVNAR 13) because of his age and history. In Sep2016 the patient experienced injection site soreness (within a day or two of receiving the vaccine), entire arm was sore and limitation when he moved his arm. On an unknown date he had fatigue/tired feeling, headache and decreased appetite. He had alerted his doctor about these side effects after about a month, and his doctor said it was just a reaction to the shot. The patient's upper left arm was still sore, but it has gotten better very slowly. More than 2 months later, his muscle soreness where the injection occurred and the left arm limitation when he moved his arm still affected him and his daily living. It has been about a 25% improvement. The outcome of injection site soreness and arm limitation was recovering. Fatigue, headache and decreased appetite recovered on an unknown date. Entire arm was sore recovered with sequelae.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 76-year-old male patient received first dose of PREVNAR 13, intramuscular on arm left on 14Sep2016 at 11:45 at single dose for pneumonia prevention. Medical history included seasonal affective disorder, ongoing borderline type 2 diabetes, glaucoma, ongoing cholesterol abnormal, pollen and grass allergies and sinus. He had pneumonia several times in the past and the worst he had was in 1978: "he was taken out of action for 2 weeks, it felt like somebody was sitting on his chest. He has had what is loosely termed "walking pneumonia" about 6 times, but has not had in 20 years". Concomitant medication included simvastatin for more than 10 years and ongoing for Cholesterol control at 40 mg, 1x/day (at night), fluoxetine from 1997 and ongoing for seasonal affective disorder at 20 mg, 1x/day (in the morning), metformin from 2015 and ongoing for borderline type 2 diabetes at 500 mg, 2x/day, timolol maleate began probably 5 years ago and ongoing for glaucoma pressure at 2 Gtt (1 drop each eye) 2x/day ophthalmic, dorzolamide 2% ophthalmic solution, from 2015 and ongoing for glaucoma pressure supplementation at 1 Gtt (one drop in right eye) 2x/day ophthalmic and LUTEIN for his eyes and a multivitamin. In 2015 he received a pneumonia shot (not PREVNAR 13) because of his age and history. In Sep2016 the patient experienced injection site soreness (within a day or two of receiving the vaccine), entire arm was sore and limitation when he moved his arm. On an unknown date he had fatigue/tired feeling, headache and decreased appetite. He had alerted his doctor about these side effects after about a month, and his doctor said it was just a reaction to the shot. The patient's upper left arm was still sore, but it has gotten better very slowly. More than 2 months later, his muscle soreness where the injection occurred and the left arm limitation when he moved his arm still affected him and his daily living. It has been about a 25% improvement. The outcome of injection site soreness and arm limitation was recovering. Fatigue, headache and decreased appetite recovered on an unknown date. Entire arm was sore recovered with sequelae.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Injection site swelling, Injection site warmth, Neck pain, Pain
Clinical narrative: Injection site left upper arm. Area warm to touch swollen site 16cmX15cm. Also had generalized body aches sore neck and upper back.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: Instant metallic taste in mouth after flu vaccine. They very dry mouth.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Low grade (100) fever in early evening of the following day. Was 105F by 6:00 PM intermittently throughout the weekend, was able to bring down with cool bath and compresses and kids Motrin then would drop to below 96, then spike back up to 105.  This happened throughout the weekend. He was lethargic as well, no other symptoms.  Not flu like. No N/V/D or cough during the weekend or in the week following. Monday morning I took him to the DR.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Itching, burning and redness at site with hives all over, No treatment per patient all symptoms self-resolved.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Pallor, Unresponsive to stimuli
Clinical narrative: Patient sitting on exam table. Appeared very pale, leaning to his right side. Writer assisted to lay down. Not responsive for 4 seconds. Observed jerking of arms, legs. Became responsive stating "what just happened?" BP 120 /70  HR 84.  After 5 min sitting up-drinking soda.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Incorrect dose administered, Otitis media, Stridor, Urticaria
Clinical narrative: Hives, stridor. Patient had started Amoxicillin on 11/25 following an ER visit with diagnosis of otitis media. Was seen in clinic for follow-up after having developed the hives. Parents concerned it was the flu shot that caused this even though most likely a penicillin allergy.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Impaired driving ability, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Left shoulder still sore. At first hard to even drive car or sleep without putting arm around head.  Still hurts when raising arm over head. Not excruciating pain but frustrating not knowing when if ever it will go away. Shot was too high on arm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports lower limb pain, numbness, tingling. Reports forearm pain, weakness. Went on for approx. 3 to 4 wks.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Fatigue, Local swelling, Pain
Clinical narrative: Chills, body aches fatigue cough arm swelling up to shoulder and neck felt would have stayed in bed if it had not been Thanksgiving lasted until 11/25/2016 and at that time all symptoms went away.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Chills, body aches fatigue cough arm swelling up to shoulder and neck felt would have stayed in bed if it had not been Thanksgiving lasted until 11/25/2016 and at that time all symptoms went away.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise
Clinical narrative: PT IS NOT FEELING WELL AND HAD 1' BIG ROUND RED SPOT ON LEFT ARM.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Bursitis, Mobility decreased, Pain in extremity
Clinical narrative: Her arm was sore after her flu shot. She stated the pain/soreness worsened over time and she started having trouble moving/raising her arm. She went and saw her physician and was diagnosed with bursitis.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal discomfort, Dizziness, Headache, Neck pain, Pain
Clinical narrative: PATIENT CALLED AND SAID SHE HAS BODY ACHING THAT RADIATED TO HER NECK, HEADACHE, ARM SORENESS, DIZZINESS, UPSET STOMACH EARLY THIS MORNING. I ADVISED HER TO TAKE IBUPROFEN BUT SHE ALREADY TOOK TRAMADOL. TWO HOURS LATER, I CALLED BACK TO CHECK ON HER. SHE FELT LITTLE BIT BETTER AFTER SHE A SHORT NAP, SHE SAID.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: PATIENT CALLED AND SAID SHE HAS BODY ACHING THAT RADIATED TO HER NECK, HEADACHE, ARM SORENESS, DIZZINESS, UPSET STOMACH EARLY THIS MORNING. I ADVISED HER TO TAKE IBUPROFEN BUT SHE ALREADY TOOK TRAMADOL. TWO HOURS LATER, I CALLED BACK TO CHECK ON HER. SHE FELT LITTLE BIT BETTER AFTER SHE A SHORT NAP, SHE SAID.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Mild to moderate body rash on arms and trunk starting 3 days after administration of flu shot.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Pain, Pyrexia
Clinical narrative: Patient's wife called and stated patient had redness of arm, fever of up to 103 degrees, chills and aches from evening of 11/28/2016 until the time she called on 12/02/2016.  She stated they were going to urgent care for further evaluation.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of whole arm at the injection site, bruising and overall hot feeling at the injection site. Symptoms started on 11/27 and were lesser after 2 days.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling
Clinical narrative: I administered FLUARIX QUAD 2016-17 IM, RA. THE INJECTION SITE SWELLS UP AFTER ABOUT 2 TO 3 MINUTES OF INJECTION. I APPLIED COLD PACKS TO THE SITE FOR ABOUT ONE HOUR. SWELLING WENT DOWN TO ABOUT HALF OF WHAT IT HAD STARTED OUT WITH.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test negative, CSF oligoclonal band present, Fatigue, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: 33 year old female with no prior existing conditions began experiencing paresthesia in all 4 extremities a few days following the seasonal flu vaccine. Numbness and extreme fatigue continued to increase over several days. One week after the vaccine when she was unable to function or grasp properly she reported to the emergency room and was admitted with suspected GBS or MS following an enhancing lesion shown on an MRI. Patient was hospitalized for three days and given IV steroids. Patient had a lumbar puncture that revealed oligoclonal bands. Patient was released and referred to neurology to determine guillain-barré or multiple sclerosis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Viral test negative
Clinical narrative: 33 year old female with no prior existing conditions began experiencing paresthesia in all 4 extremities a few days following the seasonal flu vaccine. Numbness and extreme fatigue continued to increase over several days. One week after the vaccine when she was unable to function or grasp properly she reported to the emergency room and was admitted with suspected GBS or MS following an enhancing lesion shown on an MRI. Patient was hospitalized for three days and given IV steroids. Patient had a lumbar puncture that revealed oligoclonal bands. Patient was released and referred to neurology to determine guillain-barré or multiple sclerosis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Redness, pain, tenderness to Right arm.  Tender to touch. 7" x 8" area.  Patient treated with Keflex 500 BID and Medrol Dosepak.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Red, hard welt that itched at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Large, red, welt that was itchy.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: Muscle ache in left upper arm. Warm to touch at times. Difficult to lift with arm due to increased pain.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Erythema, Headache, Lymphadenopathy, Malaise
Clinical narrative: Developed painful, red bump on skin that is warm to touch. Three days later it is still here, along with low-grade fever of 100.3 - 100.6, achy, throat pain, headache, chills, swollen lymph glands.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Developed painful, red bump on skin that is warm to touch. Three days later it is still here, along with low-grade fever of 100.3 - 100.6, achy, throat pain, headache, chills, swollen lymph glands.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Left Upper Brachium Pain, especially when lifting left arm or putting any pressure on it, Tender. So far only taken ADVIL.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site redness in a child male patient who received FLUARIX QUADRIVALENT (batch number MN5CS, expiry date June 2017). On 15th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In November 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness and injection site pain. On an unknown date, the outcome of the injection site redness and injection site pain were not recovered/not resolved. The reporter considered the injection site redness and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose FLUARIX QUADRIVALENT season and a red painful area appeared (11 centimeter) across at the injection site. Till the time of reporting, these reaction had not subsided. The sales representative did not have age or date of birth for the patient, limited information was provided. The healthcare professional would like to be contacted about this adverse event.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Lethargy
Clinical narrative: Lethargy, visual disturbances, dizziness, weakness, cold, clammy, profuse perspiration. Pharmacist called 911/EMS.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Visual impairment
Clinical narrative: Lethargy, visual disturbances, dizziness, weakness, cold, clammy, profuse perspiration. Pharmacist called 911/EMS.
Sex: M
Vaccine: FLU4
Symptoms: Cough, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of cough in a 82-year old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included XTANDI (batch number 1543978PC, expiry date unknown) for prostate cancer. Concurrent medical conditions included prostate cancer. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and XTANDI (oral) 160 mg once daily. On 26th October 2016, less than a year after receiving Influenza vaccine Quadrivalent the patient experienced cough and cold. On an unknown date, the outcome of the cough and cold were unknown. It was unknown if the reporter considered the cough and cold to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. No medical history was provided. No concomitant medication information was provided. In 2016, the patient received a dose of Influenza vaccine Quadrivalent and XTANDI and developed cough and cold. No lab test information was provided. The medical reviewer assessed cough and cold possibly related to XTANDI based on the implied temporal association.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a other health professional and described the occurrence of allergic reaction in a female patient who received Influenza vaccine. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced allergic reaction and documented hypersensitivity to administered product. Influenza vaccine was discontinued. On an unknown date, the outcome of the allergic reaction and documented hypersensitivity to administered product were unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacy student reported that one of their patients (already allergic to eggs) had an allergic reaction to a flu vaccine in the past. Thus, it led to documented hypersensitivity to administered product. The reporter did not know the manufacturer of the vaccine. The reporter did not have any details of the patient.