chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a physician and refers to a 26 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. She did not have any known drug reactions or allergies. She was not pregnant. Approximately in 2008 (reported as "about 9 or 10 years ago), the patient was vaccinated with a dose of GARDASIL injection (exact does, route of administration, lot # and expiry date were not reported) for prophylaxis. In December 2016, upon the physician office visit, the patient was diagnosed with a genital wart. During the same office visit, the patient had a biopsy of the genital wart done and the results showed the genital wart to be human papilloma virus (HPV) positive, with HPV types 6 and 11. The patient received an unspecified treatment for the events. The outcome of the genital wart was reported as recovered on an unknown date. The outcome of HPV infection was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016578021) on 03-Jan-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Virus Vaccines) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced allergy to vaccine (allergies: influenza virus vaccines). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 03 Jan 2017.. Manufacturer control number: 2016457413. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had allergy to tetanus toxoid. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Rash erythematous
Clinical narrative: Raised red rash which grew to 3 in dia. over the next two days.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Patient developed fever of 102F and a headache at 0300.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine error, 19 y.o. got the pediatric dose of Hep A vaccine.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Induration, Limb mass, Pain in extremity
Clinical narrative: (L) upper arm 2 cm, hard lump, painful. Warm compresses 20 min. 3-4 x qd. 800mg MOTRIN TID.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling, Peripheral swelling, Urticaria
Clinical narrative: Pt developed urticaria and swelling of extremities (lower).
Age: 22.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema multiforme, Injection site reaction
Clinical narrative: Erythema multiforme to injection site 2 days post-vaccine. Treated with topical steroid and oral BENADRYL.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Pain, Paraesthesia
Clinical narrative: About day after administration patient had tingling in (L) arm from neck down to fingers. Patient started ibuprofen but has had little relief. Pain still present but slowly resolving.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site rash, Injection site warmth
Clinical narrative: Got shot 1/5/17 came in pharmacy 1/7/17 arm is red at injection site, warm to touch, raised bumpy and she has numbness going down her arm into her fingers-hand feels tight.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Skin tightness
Clinical narrative: Got shot 1/5/17 came in pharmacy 1/7/17 arm is red at injection site, warm to touch, raised bumpy and she has numbness going down her arm into her fingers-hand feels tight.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Presyncope, Slow response to stimuli, Syncope
Clinical narrative: Fainted after vaccines given, dizziness, paleness, slow to respond to name, after receiving vaccines. Received 7 vaccines on 1/6/17 and PPD placement. Recovered after 30 min.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Presyncope, Syncope
Clinical narrative: Fainted after 1st 3 vaccines.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB, MNQ
Symptoms: Underdose
Clinical narrative: 19 y.o. given pediatric dose of Hep A vaccine.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Rash pruritic
Clinical narrative: Raised rash on legs, trunk, arms, feet, forehead that itches.
Age: 11.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 103 that was from 2 am to 10 am.  Tylenol given and fever went away.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Severe pain in left arm, a doctor appointments, a prescript. and now I am in physical therapy.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 10 hours and 49 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016394519) on 03 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed Allergies to Tetanus (speed like response). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus
Clinical narrative: After a couple of days - pt. experienced redness and itching on the right arm - injection site. She went to PCP on 1/5/17 and he said it was infected.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Aphonia, Asthenia, Chest X-ray, Cough
Clinical narrative: Bad cough, lost voice, stomach upset; memory problems, no energy.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Memory impairment
Clinical narrative: Bad cough, lost voice, stomach upset; memory problems, no energy.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Rash covered lower legs, back, arm, abdomen, was itching, patient noticed rash on Thursday night.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Participant noted to have pimple size, red bumps on right forearm, no reaction anywhere else at time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: 01/09/2017 - Redness approx. 4 3/4" wide and warm to touch.
Age: 1.0
Sex: M
Vaccine: RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain since vaccine administered. Pain with raising arm. Uses OTC anti-inflammatory medications.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Joint crepitation, Limb discomfort, Pain
Clinical narrative: Reported to Occupational Health clinic 12/7/2016 c/o left upper arm heaviness, no distal weakness; patient notes click in shoulder with movement, some pain with left shoulder abduction. F/U 1/3/17  with PT consult.
Sex: U
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer, Inc. (2016558927) and refers to an unspecified number of patients of unknown demographics. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (dose, route of administration, lot # and expiry date were not reported) for protection against pneumococcal pneumonia. Subsequently post vaccination, on unknown dates, the patients experienced fatigue. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX23. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 26 year old female patient. The patient's concurrent conditions included mild cervical dysplasia and concomitant therapy included unspecified prenatal vitamins. The patient did not have any known drug reactions or allergies. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 injection intramuscularly in the left arm, once, lot # M013636, expiration date 15-FEB-2018 for abnormal Papanicolaou (PAP) smears. The patient became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The pregnancy outcome was pending. Lab diagnostic studies performed on unknown dates included: biopsy, urine test, which revealed positive result and PAP smear test (abnormal result, positive for human papillomavirus (HPV). No treatment was given for the adverse events. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Renal impairment neonatal, Single functional kidney
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 26 year old female patient. The patient's concurrent conditions included mild cervical dysplasia and concomitant therapy included unspecified prenatal vitamins. The patient did not have any known drug reactions or allergies. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 injection intramuscularly in the left arm, once, lot # M013636, expiration date 15-FEB-2018 for abnormal Papanicolaou (PAP) smears. The patient became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The pregnancy outcome was pending. Lab diagnostic studies performed on unknown dates included: biopsy, urine test, which revealed positive result and PAP smear test (abnormal result, positive for human papillomavirus (HPV). No treatment was given for the adverse events. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Ultrasound kidney abnormal, Ureterocele, Ureterocelectomy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 26 year old female patient. The patient's concurrent conditions included mild cervical dysplasia and concomitant therapy included unspecified prenatal vitamins. The patient did not have any known drug reactions or allergies. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 injection intramuscularly in the left arm, once, lot # M013636, expiration date 15-FEB-2018 for abnormal Papanicolaou (PAP) smears. The patient became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The pregnancy outcome was pending. Lab diagnostic studies performed on unknown dates included: biopsy, urine test, which revealed positive result and PAP smear test (abnormal result, positive for human papillomavirus (HPV). No treatment was given for the adverse events. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical student and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # L035504, expiration date 16-DEC-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  On an unknown dates, the patients were administered improperly stored doses of LIQUID PEDVAXHIB lot # M027884, expiration date 19-APR-2019, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported.  The doses of LIQUID PEDVAXHIB were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003705: US-009507513-1701USA003706:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lot # L038534, expiration date 19-AUG-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002598: US-009507513-1701USA003706:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of VAQTA lot # M036459, expiration date 18-JAN-2018, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of VAQTA were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002598: US-009507513-1701USA003705:
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Grip strength decreased, Injected limb mobility decreased, Mobility decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself.  A 71-year-old female patient received PREVNAR 13, via an unspecified route of administration on 21Dec2016 at 11:00 at a single dose in the left arm for immunisation. Medical history included ongoing borderline diabetes for about 5 years, ongoing high blood pressure for about 10 years ago, ongoing diverticulitis for about 8-9 years for which she had surgery for about 6 years ago; high cholesterol, reflux, and inflammation. Concomitant medications included pravastatin, omeprazole, metformin, hydrochlorothiazide/lisinopril, ergocalciferol, curcuma longa rhizome, and zingiber officinale rhizome. On 21Dec2016, the patient couldn't move her left arm, couldn't lay on her left side because it was painful, and had pain in the left hand. The clinical course was as follows: About 2 hours after receiving the vaccine, she couldn't move her left arm. She took ALEVE and alternated heat and cold to area. The next day, 22Dec2016, it was better but she still couldn't raise her arm. She couldn't lay on her left side because it was so painful. She called her doctor's office about what she was experiencing and was told to continue doing what she was doing as it had improved slightly at that time. After a few days, she called her doctor again and explained she was still having problems. They recommended she go to the urgent care. A physician assistant at the urgent care prescribed prednisone 20mg daily for 4 days. The prednisone immediately helped. She could finally move her left arm and was moving it quite well but couldn't lift it above her head. She reported the pain was relatively gone and she was able to cut back on the naproxen sodium. But still had pain in her left hand and thus she could not use her left hand. She could barely squeeze a ball and couldn't write very well as she was left handed. The clinical outcome of the events, vaccination site joint movement impairment, was recovering. The clinical outcome of the pain in the left hand, was not recovered. The clinical outcome of the event, pain on the left side, was unknown.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself.  A 71-year-old female patient received PREVNAR 13, via an unspecified route of administration on 21Dec2016 at 11:00 at a single dose in the left arm for immunisation. Medical history included ongoing borderline diabetes for about 5 years, ongoing high blood pressure for about 10 years ago, ongoing diverticulitis for about 8-9 years for which she had surgery for about 6 years ago; high cholesterol, reflux, and inflammation. Concomitant medications included pravastatin, omeprazole, metformin, hydrochlorothiazide/lisinopril, ergocalciferol, curcuma longa rhizome, and zingiber officinale rhizome. On 21Dec2016, the patient couldn't move her left arm, couldn't lay on her left side because it was painful, and had pain in the left hand. The clinical course was as follows: About 2 hours after receiving the vaccine, she couldn't move her left arm. She took ALEVE and alternated heat and cold to area. The next day, 22Dec2016, it was better but she still couldn't raise her arm. She couldn't lay on her left side because it was so painful. She called her doctor's office about what she was experiencing and was told to continue doing what she was doing as it had improved slightly at that time. After a few days, she called her doctor again and explained she was still having problems. They recommended she go to the urgent care. A physician assistant at the urgent care prescribed prednisone 20mg daily for 4 days. The prednisone immediately helped. She could finally move her left arm and was moving it quite well but couldn't lift it above her head. She reported the pain was relatively gone and she was able to cut back on the naproxen sodium. But still had pain in her left hand and thus she could not use her left hand. She could barely squeeze a ball and couldn't write very well as she was left handed. The clinical outcome of the events, vaccination site joint movement impairment, was recovering. The clinical outcome of the pain in the left hand, was not recovered. The clinical outcome of the event, pain on the left side, was unknown.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself.  A 71-year-old female patient received PREVNAR 13, via an unspecified route of administration on 21Dec2016 at 11:00 at a single dose in the left arm for immunisation. Medical history included ongoing borderline diabetes for about 5 years, ongoing high blood pressure for about 10 years ago, ongoing diverticulitis for about 8-9 years for which she had surgery for about 6 years ago; high cholesterol, reflux, and inflammation. Concomitant medications included pravastatin, omeprazole, metformin, hydrochlorothiazide/lisinopril, ergocalciferol, curcuma longa rhizome, and zingiber officinale rhizome. On 21Dec2016, the patient couldn't move her left arm, couldn't lay on her left side because it was painful, and had pain in the left hand. The clinical course was as follows: About 2 hours after receiving the vaccine, she couldn't move her left arm. She took ALEVE and alternated heat and cold to area. The next day, 22Dec2016, it was better but she still couldn't raise her arm. She couldn't lay on her left side because it was so painful. She called her doctor's office about what she was experiencing and was told to continue doing what she was doing as it had improved slightly at that time. After a few days, she called her doctor again and explained she was still having problems. They recommended she go to the urgent care. A physician assistant at the urgent care prescribed prednisone 20mg daily for 4 days. The prednisone immediately helped. She could finally move her left arm and was moving it quite well but couldn't lift it above her head. She reported the pain was relatively gone and she was able to cut back on the naproxen sodium. But still had pain in her left hand and thus she could not use her left hand. She could barely squeeze a ball and couldn't write very well as she was left handed. The clinical outcome of the events, vaccination site joint movement impairment, was recovering. The clinical outcome of the pain in the left hand, was not recovered. The clinical outcome of the event, pain on the left side, was unknown.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a  Pfizer sales representative. A 60-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in Apr2015 as single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced deltoid swollen post vaccination in Apr2015; the event was reported as deltoid was swollen for three to four days post vaccination. The outcome of deltoid swollen post vaccination was recovered on an unspecified date in 2015.
Sex: M
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician via Pfizer under reference number 2016346937 on 03 January 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetatnus Vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient had allergies. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Nodule, Peripheral swelling
Clinical narrative: Initial unsolicited misuse report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016451165) on 03 Jan 2017. This case involves 61 year old female patient who was vaccinated with 0.1 ml dose of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE (Batch number: UT5573AA, Expiry date: 30 Jun 2017 and site of administration was not reported) administered intramuscularly on 02 Nov 2016. The patient medical history include hypertension and hyperlipidemia and the patient had no relevant drug history, drug allergies and family history. The patient concomitant medications were Lipitor daily from 31 May 2016 and Coreg daily from 24 Feb 2015. On 03 Nov 2016, one day after vaccination, the patient developed arm swelling and arm nodule. It was a case of inappropriate route of vaccination (influenza vaccine given intramuscular instead of intradermal). No laboratory test was performed. The patient had not received any corrective treatment. On 04 Nov 2016, the patient recovered from arm swelling and the outcome of event arm nodule was not reported. The reporter assessed the causal relationship between the INFLUENZA vaccine and the events arm swelling and arm nodule as reasonable possibility. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site reaction, Skin lesion, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 28-Dec-2016. This case involves a female patient (age not reported), who was vaccinated with ADACEL via intradermal route (batch number, expiry date, dose not reported) instead of TUBERCULIN PPD (batch number, expiry date, route and dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had a lesion. It was also a case of wrong vaccine administration and inappropriate route of vaccination. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site nodule, Injection site pain
Clinical narrative: Px reported painful knot in arm just below injection site. And extreme shivering evening of injection site. No fever lasted 2 1/2 hours.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Throat irritation, Throat tightness
Clinical narrative: Pt received FLUVIRIN MDV. After a few minutes claimed did not feel well. Throat was scratchy-felt like throat closing-called 911. After a few minutes administered EPIPEN in left thigh.
Age: 1.33
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Culture urine negative, Pyrexia, Seizure
Clinical narrative: Sudden onset fever approx. 6 hours after influenza dose #2 given; seizure w/fever-seen and triaged in emergency dept.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: PNEUMOVAX administered 12/16/16 AM in office. Patient developed pain and swelling (L) upper arm/shoulder by same evening. Seen in office 12/20/16 - still having pain, limited ROM (L) arm. Still pain/swelling at recheck, 12/28/16.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Angiogram normal, Chest pain, Dizziness, Headache, Hypertension
Clinical narrative: Shot on Tues-started  with headache on Fri and pain in left arm to neck-chest  pain and light headed started on Sat  to Hosp  on Mon-transferred  to hospital with symptoms of  high B/P  angiogram and ultra  sound  of liver, gall bladder and pancreas was normal. Took 6 wks  till previous health returned.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Neck pain, Pain in extremity, Ultrasound biliary tract, Ultrasound biliary tract normal
Clinical narrative: Shot on Tues-started  with headache on Fri and pain in left arm to neck-chest  pain and light headed started on Sat  to Hosp  on Mon-transferred  to hospital with symptoms of  high B/P  angiogram and ultra  sound  of liver, gall bladder and pancreas was normal. Took 6 wks  till previous health returned.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Ultrasound liver normal, Ultrasound pancreas normal
Clinical narrative: Shot on Tues-started  with headache on Fri and pain in left arm to neck-chest  pain and light headed started on Sat  to Hosp  on Mon-transferred  to hospital with symptoms of  high B/P  angiogram and ultra  sound  of liver, gall bladder and pancreas was normal. Took 6 wks  till previous health returned.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Influenza like illness, Pharyngeal oedema
Clinical narrative: Received vaccine 12-8-16. Throat started swelling night of 12-9-16 and lasted until morning of 12/10/16. Hard time breathing most of Friday night-Took Benadryl. Was seen in urgent care as flu like symptoms occurred - on 12/18/16 and placed on amoxicillin. As of 12-27-16 cough remains. I have taken the flu vaccine every year for many years and the throat swelling was the first bad reaction. I question whether to take the vaccine in 2017.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Headache, painful arms (both) and neck. Dr was contacted-Dr will contact patient.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received FLULAVAL Quadrivalent. On 9th November 2016, the patient received FLULAVAL Quadrivalent .5 ml. On 20th December 2016, 41 days after receiving FLULAVAL Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza A virus infection. On an unknown date, the outcome of the vaccination failure and influenza A  virus infection were unknown. It was unknown if the reporter considered the vaccination failure and influenza A virus infection to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The case was received on the GSK Direct Passive survey. The age at vaccination was not reported. The reporter would like to know why was  not protected from Influenza A and why should continue to purchase this vaccine. This case was considered to be suspected vaccination failure as the confirmatory laboratory result for Influenza A infection was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Right arm became swollen and red, as well as a fever onset on 12/14. Arm was tender to touch. As of 12/17 when patient presented, no necrosis of tissue but still redness. Patient had no fever on 12/17. Patient stated this had happened on previous vaccination years ago.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: 12-9-16 Approx. 4 hs. after receiving PNEUMOVAX 23 - limitation of left arm movement. Excruciating joint and muscle pain from just above elbow to shoulder. It took 5 days for the pain to be completely gone. It took 4 days for me to lift my arm. I took plain TYLENOL for pain which eased pain after the first several days.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Throat tightness
Clinical narrative: 5 minutes after shot patient complained of throat tightening but not distressed; sat patient down administered 10ml BENADRYL and prepared to give EPIPEN pending worsening of symptoms. 10 minutes later sat with patient and companion and was told "all ok" told to wait 10 minutes and then left with no symptoms. Called next A.M. to confirm that all was well and it was.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Hypersomnia, Pyrexia, Skin exfoliation
Clinical narrative: Symptons of VIRUS (long periods sleeping, chills, fever, no appetite) RASH and discoloration at site of vaccination; arm is peeling.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site discolouration, Vaccination site rash, Viral infection
Clinical narrative: Symptons of VIRUS (long periods sleeping, chills, fever, no appetite) RASH and discoloration at site of vaccination; arm is peeling.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: Some discomfort day of injection. Significant pain day 2 & 3 after. Continues to have decreased ROM, pain and intermittent tingling into fingers.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Feeling abnormal, Injection site erythema, Somnolence
Clinical narrative: Injection given on 11/18/16 late afternoon.  Mom called in saying that the evening on 11/18 pt had redness around the injection site.  On 11/19/16 he felt dizzy on and off, felt like he had to sit down, felt sleepy. Temp 99.5.  On 11/20/16, pt felt blah.  Resolved by 11/21 and patient returned to school without symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Dizziness, Dysgeusia, Dyspepsia, Headache
Clinical narrative: Nausea, nasal picking, inflamed,headache, tingling, metallic taste, heart burn, itching all over, migraine, dizziness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Malaise, Migraine, Nausea, Paraesthesia
Clinical narrative: Nausea, nasal picking, inflamed,headache, tingling, metallic taste, heart burn, itching all over, migraine, dizziness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Nausea, nasal picking, inflamed,headache, tingling, metallic taste, heart burn, itching all over, migraine, dizziness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Hives, localized redness-aches.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Two days after vaccine received 45x60mm red, tender area noted to (R) upper posterior arm. Area itchy at thighs. No systemic symptoms noted.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Confusional state, Fall, Hypotonia, Muscle contractions involuntary
Clinical narrative: Pt. became white and weak - stated "I think" the eyes rolled back in head and pt fell limp to floor. Pt. then became rigid and stiff and arms drew up to chest. Lasted app. 1 minute. Pt. then started swinging BUE and opened eyes and appeared to be in confused state.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt. became white and weak - stated "I think" the eyes rolled back in head and pt fell limp to floor. Pt. then became rigid and stiff and arms drew up to chest. Lasted app. 1 minute. Pt. then started swinging BUE and opened eyes and appeared to be in confused state.
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus, Pruritus
Clinical narrative: Itchy area all over left arm, that occurred the day of the shot and the next day. Then he was fine for 2 days, when he experienced more itchiness in the left arm and some chest pain/heaviness.
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Itchy area all over left arm, that occurred the day of the shot and the next day. Then he was fine for 2 days, when he experienced more itchiness in the left arm and some chest pain/heaviness.
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus
Clinical narrative: Itchy area all over left arm, that occurred the day of the shot and the next day. Then he was fine for 2 days, when he experienced more itchiness in the left arm and some chest pain/heaviness.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vac area hot to touch, burning. Worse at night the day of shot. Bad pain at 1 or 2 pm daily . Took Ibup 800 mg take for another condition. Manager gave SOLARCAINE gel 1%, Ibu 200 #20, water.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Injection site painful. Chills and fever first 2 days. Removed Band Aid 3 day and hardness and itching spread over entire upper arm. Itching became extreme and unbearable.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia, Rash, Swelling
Clinical narrative: PAIN, SWELLING, RASH, HEADACHES, FEVER.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Body temperature increased, Endotracheal intubation, Irritability, Respiratory depression, Seizure
Clinical narrative: He was fussy all afternoon and had low grade temp as is common.   At 3 am, he woke to feed and while taking bottle, had a seizure which lasted about 5 minutes. 911 was called, evaluated him and he was fine at that point. They suggested he be taken by family car. As family was getting ready to go, he began with another seizure and this one continued on and off for about an hour or more, requiring midazolam other other medications, and then he had respiratory depression and required intubation.  I know GM well and she called me a little after 5am where he was awaiting transport to hospital. I went to see him there and he was stable and intubated, breathing above vent.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient had syncope in waiting room after checking out at front desk. States felt fine initially after receiving vaccine but then started feeling dizzy and faint after walking around.  Patient was sitting in chair and was diaphoretic and pale when I entered the waiting room after being called to the front for assistance. She was talking to our APRN and stated this has happened to her before. Stated she had not eaten today. Assisted by wheelchair to bed, placed in supine position. BP 103/71 P 79 O2 Sat 97%.  Five minutes sitting BP 105/74. After another five minutes Standing BP 108/79 P 81.  Given orange juice and pretzels to take with her since had not eaten. Stated feeling much better and left with fiancé.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Malaise, Nausea, Pain, Swelling
Clinical narrative: NAUSEA, BODY ACHES, MALAISE, REDNESS, SWELLING  AND PAIN IN SIDE OF REACTION.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain, Swelling
Clinical narrative: NAUSEA, BODY ACHES, MALAISE, REDNESS, SWELLING  AND PAIN IN SIDE OF REACTION.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Low grade fever, followed by a rash all over body over the next 2-3 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. Since 28-NOV-2016, the patients had been administered improperly stored doses of GARDASIL lot # M014929, expiration date 27-MAY-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of GARDASIL were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA003709: US-009507513-1701USA003710: US-009507513-1701USA003711: US-009507513-1701USA003712.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of LIQUID PEDVAXHIB lots # M032148 and M014926 with expiration dates 18-APR-2019 and 17-FEB-2019 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of LIQUID PEDVAXHIB were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003203: US-009507513-1701USA003710: US-009507513-1701USA003711: US-009507513-1701USA003712:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of PNEUMOVAX23 lot # M020521, expiration date 17-NOV-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of PNEUMOVAX23 were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003203: US-009507513-1701USA003709: US-009507513-1701USA003711: US-009507513-1701USA003712:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of VAQTA lot # M015290, expiration date 20-SEP-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of VAQTA were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003203: US-009507513-1701USA003709: US-009507513-1701USA003710: US-009507513-1701USA003712:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of ROTATEQ lots # M011832, M025563 and M019691 with expiration dates 25-JAN-2018, 06-NOV-2017 and 02-NOV-2017 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of ROTATEQ were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003203: US-009507513-1701USA003709: US-009507513-1701USA003710: US -009507513-1701USA003711:
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: (L) shoulder pain that started 1-2 days after vaccine. Treatment, rest, ice, heat. States it is a dull act that flares with excessive use.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLUARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced allergic reaction to FLUARIX. The reporter declined to provide further details on product, patient and the adverse event.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient called 1/9/17 complaining of increased redness and pain around injection site.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to dTpa vaccine. Additional details were provided as follows: The case came in from a pharmacist via click to chat. The age at vaccination was not reported. In the distant past (more than 20 years ago), the patient had an apparent anaphylactic reaction to dTpa vaccine. The pharmacist was enquiring for any information or advice on what to do in those cases where a dTpa vaccine would be indicated in this patient. No further information was provided.