chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Suicidal ideation, Weight decreased, X-ray with contrast upper gastrointestinal tract
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old daughter. The patient's medical history included ear infections, when she was a baby and the patient was allergic to nickel. On 11-JAN-2010, the patient was vaccinated with GARDASIL, intramuscularly (dose details, anatomical location, lot number and expiration date were not reported). Concomitant therapies included MENACTRA, DTAP, VARIVAX and 3 other vaccinations. On 31-MAR-2010, the patient experienced unilateral deafness, suicidal thoughts, shortness of breath and rashes. On the same day, the patient was also diagnosed as being bipolar, had Barrett's oesophagus, vomits blood, lost weight, experienced chest pain, back pain and her heart races. The patient vomited her meals up daily. On an unknown date, endoscopy, gastrointestinal (GI) study and many other unspecified tests were performed and results were not reported. The patient sought medical attention and was treated for the adverse events. Therapy with GARDASIL was discontinued on 19-NOV-2010. It was reported that the events reappeared after reintroduction of the vaccine. The outcome of the events was reported as not recovered (reported as did not improve). The causality of the events was not reported. No product quality complaint was reported for GARDASIL. Upon internal review, the events of unilateral deafness, vomits blood, bipolar and Barrett's oesophagus were considered as medically significant. The reporter considered deafness as serious due to disability. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Herpes zoster, Laboratory test normal, Malaise
Clinical narrative: Initial unsolicited report received from a nurse on 09 December 2015. This case involves a 71-years old female patient who was vaccinated with a dose of Influenza Vaccine (batch number: unknown, dose, dose in series, route and administration site was not reported) and with a dose of PREVNAR 13 (Manufactured by: Pfizer; batch number: unknown, dose, dose in series was not reported) intramuscularly in right upper arm both on 16 November 2015. The patient was also vaccinated with Shingles Vaccine (batch number: unknown, dose, dose in series, route and administration site was not reported) in October 2007. The patient's medical history and concomitant medications were not reported. On 23 November 2015, one week following the vaccination, the patient experienced the symptoms of shingles. Laboratory data and corrective treatment was not reported. The patient was not recovered from the event (worsened). The reporter assessed the causal relationship with suspect as might be related. Follow up information received from a nurse on 07 January 2016. The patient was vaccinated with a dose of Fluzone HD (manufacturer: Sanofi Pasteur, batch number- UI475AA, via intramuscular route in the right arm), a first dose of Prevenar 13 vaccine (manufacturer: Wyeth, batch number- I84631) and a first dose of Varicella Zoster vaccine, all at 09:00 am on 16 November 2015. The patient's illness at the time of vaccination was reported as none, medical history included allergy to Penicillin, Sulfa, Lisinopril, Pepcid, Protonix, adhesive tape 2 and seasonal allergy, chronic kidney disease stage 3, hyperlipidemia, hypertension, hyperthyroid, left knee pain. The patient's concomitant medications included Losartan, Atenolol, Benadryl, Citrucel, Vitamin D, Calcium, Simvastatin and thyroid therapy in November and December and annual vaccination with influenza vaccine. The patient felt "minor" lingering illness that lasted all winter following flu shot vaccination. Patient required doctor visit two times. The laboratory tests were within normal limits (physical) on 16 November 2015. The patient had received Famciclovir (500mg, twice a day for 7 days) and Gabapentin (300 mg daily, three times a day as needed) as a corrective treatment. Follow up information received from a nurse on 29 February 2016. No new information was reported. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Injection site pruritus, Rash, Sleep apnoea syndrome
Clinical narrative: Initial unsolicited report received from a consumer on 29 July 2016. This case involves a 60-year-old female patient who was vaccinated with a dose Fluzone HD (batch number: UI478AB, expiration date: 09 May 2016 and dose were not reported) intramuscularly in the left arm on 23 October 2015 and a dose of VARICELLA-ZOSTER VACCINE LIVE in left arm on 09 October 2015. Patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies to nickel Keflex latex. The patient, within four weeks prior vaccinations had "shingles vaccine" in left arm on 09 October 2015. Concomitant medications were not reported. On 24 October 2015 one day following the vaccination patient was diagnosed with cellulitis, experienced episodes of itching upper Left arm but no rash ever since she got the flu shot, which has been on and off three times a day and was diagnosed with autoimmune condition . FLUARIX was charted as being adm but with the HD lot number. "Own physician stated no cellulitis". It was reported that patient required emergency room or doctor visit. Lab data included patch testing, allergies test and TruTest for contact dermatitis all were came back negative. The patient received corrective treatment with antibiotic, suggested light therapy, Claritin Cetaphil dry skin bar soap. The patient's outcome was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event possible autoimmune condition. List of documents held by sender: none. Sender's Comments: Patient had itching over left arm next day following FLUZONE HD, patient was also vaccinated with SHINGLES VACCINE 2 weeks prior and patient was diagnosed with possible autoimmune disease. Time to onset is compatible, but detail medical history, immunological history, any autoimmune disorder in family member, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test negative, Autoimmune disorder, Injection site pruritus, Laboratory test normal, Skin test negative
Clinical narrative: Initial unsolicited report received from a consumer on 29 July 2016. This case involves a 60-year-old female patient who was vaccinated with a dose Fluzone HD (batch number: UI478AB, expiration date: 09 May 2016 and dose were not reported) intramuscularly in the left arm on 23 October 2015 and a dose of VARICELLA-ZOSTER VACCINE LIVE in left arm on 09 October 2015. Patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies to nickel Keflex latex. The patient, within four weeks prior vaccinations had "shingles vaccine" in left arm on 09 October 2015. Concomitant medications were not reported. On 24 October 2015 one day following the vaccination patient was diagnosed with cellulitis, experienced episodes of itching upper Left arm but no rash ever since she got the flu shot, which has been on and off three times a day and was diagnosed with autoimmune condition . FLUARIX was charted as being adm but with the HD lot number. "Own physician stated no cellulitis". It was reported that patient required emergency room or doctor visit. Lab data included patch testing, allergies test and TruTest for contact dermatitis all were came back negative. The patient received corrective treatment with antibiotic, suggested light therapy, Claritin Cetaphil dry skin bar soap. The patient's outcome was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event possible autoimmune condition. List of documents held by sender: none. Sender's Comments: Patient had itching over left arm next day following FLUZONE HD, patient was also vaccinated with SHINGLES VACCINE 2 weeks prior and patient was diagnosed with possible autoimmune disease. Time to onset is compatible, but detail medical history, immunological history, any autoimmune disorder in family member, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information regarding concomitant medication, medical history and drug reaction/allergies was not reported. On 18-JUL-2016, the patient was vaccinated a dose of ZOSTAVAX (lot # 036823 with expiration date 24-DEC-2016; dose unknown; subcutaneous) in the left arm at her primary physician's office. The physician then wrote a script for the patient to receive ZOSTAVAX at local pharmacy (drug prescribing error). On 31-JUL-2016, the pharmacy administered a second dose of ZOSTAVAX (Lot: L046896 with expiration date 23-FEB-2017) in the right arm, not realizing the patient already received a dose (extra dose administered). No adverse effect was reported. Additional information ahs been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information regarding concomitant medication, medical history and drug reaction/allergies was not reported. On 18-JUL-2016, the patient was vaccinated a dose of ZOSTAVAX (lot # 036823 with expiration date 24-DEC-2016; dose unknown; subcutaneous) in the left arm at her primary physician's office. The physician then wrote a script for the patient to receive ZOSTAVAX at local pharmacy (drug prescribing error). On 31-JUL-2016, the pharmacy administered a second dose of ZOSTAVAX (Lot: L046896 with expiration date 23-FEB-2017) in the right arm, not realizing the patient already received a dose (extra dose administered). No adverse effect was reported. Additional information ahs been requested.
Age: 25.0
Sex: F
Vaccine: JEV1, TYP, JEV1, TYP
Symptoms: Blood creatine phosphokinase increased, Neck pain, Pain in extremity
Clinical narrative: LEFT ARM SWELLING AND PAIN, MALAISE, PT DIAGNOSED WITH RHABDOMYALISIS.
Age: 25.0
Sex: F
Vaccine: JEV1, TYP, JEV1, TYP
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Rhabdomyolysis
Clinical narrative: LEFT ARM SWELLING AND PAIN, MALAISE, PT DIAGNOSED WITH RHABDOMYALISIS.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Initial unsolicited report received from a consumer on 08 December 2015. This case involves a 48-years old male patient who was vaccinated with a dose of Flu (batch number, 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 07 December 2015, following the vaccination, the patient had shivers. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event (felling great). List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Pain
Clinical narrative: Initial unsolicited report received from Consumer on 09-Dec-2015. This case involves a 60-year-old female patient who was vaccinated with a dose of Flu Shot (batch number, expiry date, route and site of administration was not reported) on 01-Dec-2015. Medical history and concomitant medications were not reported. On 02-Dec-2015, next day after vaccination, patient was achy, chronic pain which was really bad and her stomach does not do very well. Lab tests were not reported. Patient took Advil Liquid-Gels 200 mg, 80 count bottle (batch number- R21284, Expiration date: Jun-2017) with her other pain medications as the pain was really bad. Outcome of the events were not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a nurse on 21 December 2015. This case is linked to case id: 2015SA176376, 2015SA176377, 2015SA172486. This case involves a (age and gender unknown) patient who was vaccinated with a dose of FLUZONE) (batch number, expiry date was not reported) intramuscularly in left deltoid and also received PNEUMOVAX 23 (batch number L003188, expiry date 06 July 2016, route and site administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced adverse reaction. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via partner company (Pfizer) (Manufacturer Report Number: 2016005924) on 15 January 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, route and site of administration 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 allergy to vaccine. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a healthcare professional via partner company (Pfizer) on 19 January 2016. This case involves 52-year-old female patient who was vaccinated with a dose of Flu vaccine (batch number, route and site of administration not reported) on an unspecified date in 2002. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2002, following the vaccination, the patient had experienced arm and shoulder pain. Laboratory data was not reported. The patient had received physical therapy for 6 weeks as corrective treatment. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a physician in via other company (Pfizer) (Manufacturer Report Number: 2016291804) on 01-Aug-2016. This case involves a patient (sex, onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (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 fever, hives and swelling. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Laboratory test, Nausea, Pregnancy test negative, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 August 2016. This case involves a 17-year-old female patient who was vaccinated with MENACTRA (batch number: U5155AB, expiry date: 15 November 2016) and VARIVAX (batch number: L02507, manufacturer: MSD) (expiry date, dose, dose in series, route of administration were not reported for both vaccines) on 21 July 2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced nausea and vomiting. Patient required ER/doctor visit. Lab test included pregnancy test was negative and other lab tests performed but types and results were unknown. Corrective treatment was not reported. The outcome of the events was unknown. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Patient felt dizzy and passed out. Then started convulsing for a moment. Patient was passed out for less than a minute then woke up.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizness during vaccination.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Back pain, Neck pain, Urticaria
Clinical narrative: Hives ->BENADRYL, temperature ->Unknown, Neck/Back ache.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction, Petit mal epilepsy
Clinical narrative: Immediate post vaccine fell to floor and had approximate 15 second petit mal seizure. When became conscious, stated that before fall left arm felt numb and she felt funny. She also said that she had not eaten that day.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Strabismus
Clinical narrative: Excessive crying, crossing of eyes, began after vaccines administered on 7/28/16.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Received vaccine 8/5. Next day had erythema at injection site and arm his upper arm, placed ice on it and it improved when he was seen 8/9/16.
Age: 65.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test, Biopsy skin, Erythema, Pruritus, Skin lesion
Clinical narrative: Initial unsolicited report received from a consumer on 02 Aug 2016. This case involves a 65 year old female patient who was vaccinated with a first, second and third doses of Imovax (batch number, expiration date, route and site of administration were not reported for all the doses) on 27 Jun 2016, 30 Jun 2016 and 04 Jul 2016 respectively. Patient was also given a fourth dose of RABAVERT (manufacturer: Novartis, batch number: 587011a, expiration date, route of administration were not reported) in right deltoid on 11 Jul 2016 in early afternoon. Illness at time of vaccination was reported as celiac disease, pre-existing physician diagnosed allergies birth defects, medical conditions included gluten allergy and hypertension. Concomitant medications included Amlodipine and amitriptyline. On 11 Jul 2016, by evening, 14 days following the first dose of Imovax vaccination and few hours after RABAVERT, patient developed hives/welts on chest and neck that were very itchy. On 19 Jul 2016, 22 days after Imovax and eight days after RABAVERT, patient noted dark red raised lesions bilaterally on lower legs. Patient required emergency room visit and also saw dermatologist. Serum testing for rabies titers was done, biopsy of leg lesions was performed (results not reported). Patient was treated with prednisone and famotidine and was prescribed a "steroid cream". The outcome of the events was reported as not recovered. The dermatologist believed that the patient had a reaction to RABAVERT. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 02 Aug 2016. This case involves a 65 year old female patient who was vaccinated with a first, second and third doses of Imovax (batch number, expiration date, route and site of administration were not reported for all the doses) on 27 Jun 2016, 30 Jun 2016 and 04 Jul 2016 respectively. Patient was also given a fourth dose of RABAVERT (manufacturer: Novartis, batch number: 587011a, expiration date, route of administration were not reported) in right deltoid on 11 Jul 2016 in early afternoon. Illness at time of vaccination was reported as celiac disease, pre-existing physician diagnosed allergies birth defects, medical conditions included gluten allergy and hypertension. Concomitant medications included Amlodipine and amitriptyline. On 11 Jul 2016, by evening, 14 days following the first dose of Imovax vaccination and few hours after RABAVERT, patient developed hives/welts on chest and neck that were very itchy. On 19 Jul 2016, 22 days after Imovax and eight days after RABAVERT, patient noted dark red raised lesions bilaterally on lower legs. Patient required emergency room visit and also saw dermatologist. Serum testing for rabies titers was done, biopsy of leg lesions was performed (results not reported). Patient was treated with prednisone and famotidine and was prescribed a "steroid cream". The outcome of the events was reported as not recovered. The dermatologist believed that the patient had a reaction to RABAVERT. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Pyrexia, Status epilepticus
Clinical narrative: Child developed fever to 104 four days after getting HIB and Varicella vaccine followed by status epilepticus.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Device function test, Electrocardiogram normal, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: Within 10 minutes of getting TWINRIX Vaccine, I had an extreme headache, nausea and a wave of bad feeling. Around 4:00 my defibrillator went off and I lost consciousness for several seconds; when I woke up on 6/1/2016 had another firing of device but did not lose consciousness.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea
Clinical narrative: Within 10 minutes of getting TWINRIX Vaccine, I had an extreme headache, nausea and a wave of bad feeling. Around 4:00 my defibrillator went off and I lost consciousness for several seconds; when I woke up on 6/1/2016 had another firing of device but did not lose consciousness.
Age: 0.58
Sex: M
Vaccine: DTPIPV
Symptoms: Blister, Crying, Diet refusal, Injection site erythema, Pyrexia
Clinical narrative: 7 mos. High temperature, loud crying, refused food and bottle, blisters. Treatment: Ice cubes in bath water, calamine bath, antihistamine, ginger ale, rice cereal in bottle, banana pudding. 1/2 to 1-1/4 baby aspirin every three hours for red swelling at vaccine site; Minor reaction to vaccine. Time course: Intense three weeks. Lifetime consequence.
Age: 0.58
Sex: M
Vaccine: DTPIPV
Symptoms: Vaccination site swelling
Clinical narrative: 7 mos. High temperature, loud crying, refused food and bottle, blisters. Treatment: Ice cubes in bath water, calamine bath, antihistamine, ginger ale, rice cereal in bottle, banana pudding. 1/2 to 1-1/4 baby aspirin every three hours for red swelling at vaccine site; Minor reaction to vaccine. Time course: Intense three weeks. Lifetime consequence.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Anaemia, Differential white blood cell count, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Immune thrombocytopenic purpura w/ subsequent anemia. IVIG infusions/therapy to prevent ITP.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Computerised tomogram normal, Dizziness, Dyspnoea, Full blood count normal
Clinical narrative: Temp. 102, syncope, headache, dizzy, trouble breathing.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Temp. 102, syncope, headache, dizzy, trouble breathing.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Thyroid function test normal, Vitiligo
Clinical narrative: New onset vitiligo. Exact date of onset unknown. Developed gradually.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Neck pain, Rash
Clinical narrative: Swollen lymph nodes under armpits, sore neck, break out on chest and back.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: MOTHER REPORTED THAT CHILD HAD ABD PAIN AFTER IMMUNIZATION.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Dyspnoea, Ear pain, Headache
Clinical narrative: Symptoms began 4/18/16 in the evening. Pt. reports fever (38.3 degrees Celsius), ear ache, head ache, itchy throat, and shortness of breath. On 4/19/16 the pt. reports redness and purities on the left arm where vaccines where applied lasting a week. Fever lasted 7 days. Pt. did not take analgesics or antipyretics.  Symptoms lasted 9 days. Joint pain began 3 days after vaccines. Stomachache and neck stiffness began 4 days after vaccination. Pt. states she was bed bound for two weeks. Pt. went to see PCP 7/12/16, PCP suggested pt. no longer receive vaccines due to possible adverse reactions.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Injection site erythema, Mobility decreased, Musculoskeletal stiffness, Pyrexia, Throat irritation
Clinical narrative: Symptoms began 4/18/16 in the evening. Pt. reports fever (38.3 degrees Celsius), ear ache, head ache, itchy throat, and shortness of breath. On 4/19/16 the pt. reports redness and purities on the left arm where vaccines where applied lasting a week. Fever lasted 7 days. Pt. did not take analgesics or antipyretics.  Symptoms lasted 9 days. Joint pain began 3 days after vaccines. Stomachache and neck stiffness began 4 days after vaccination. Pt. states she was bed bound for two weeks. Pt. went to see PCP 7/12/16, PCP suggested pt. no longer receive vaccines due to possible adverse reactions.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Patient started experiencing left sided facial weakness on 8/7/2016.  She was seen in office on 8/9/2016 after worsening symptoms and was diagnosed with Bell's Palsy.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted for a few seconds while she was walking several minutes after vaccination.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pain/swelling-localized-left deltoid for approximately 2-3 hours. On 7/14/16-patient noticed decreased range of motion of left shoulder and left arm. Had acupuncture apt on-7/29/16 with doctor-who followed up on Lt shoulder with no obvious findings. Patient had physical therapy on 8/1/16 and saw her orthopedic on 8/2/16-steriod injection.
Age: 1.33
Sex: M
Vaccine: IPV
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Syncope, light headed. Passed out.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope and vomiting with vaccine HPV.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache, Impaired work ability, Malaise
Clinical narrative: Vomiting, Nausea, high fever 102-103, Tingling in legs, severe malaise and fatigue, severe headache. Unable to work, dizziness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Vomiting, Nausea, high fever 102-103, Tingling in legs, severe malaise and fatigue, severe headache. Unable to work, dizziness.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blister
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Gastrointestinal pain
Clinical narrative: Fatigue, chills, no appetite, mild gut pain/upset.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue, Headache, Inflammation, Nausea
Clinical narrative: Inflammation, fatigue, sore throat, headache, abdominal pain, nausea, vomiting.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Inflammation, fatigue, sore throat, headache, abdominal pain, nausea, vomiting.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blister, Erythema, Local swelling, Rash, Rash erythematous
Clinical narrative: Rash - 2d ago noted on trunk a pink bump w/ a central clear blister in center. Noted another one on trunk yesterday and a few other spots developed but those are just tiny skin colored/pink bumps - no clear fluid. No exposures. Did have varicella vaccine 7/28/16.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Infantile spasms, Urine analysis
Clinical narrative: Infantile spasms started at 5pm. Watched her for about an hour before taking to Emergency Room for evaluation.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Dysphonia, Dyspnoea, Lymphadenopathy, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Scratchy throat, swollen lymph nodes around neck, difficulty breathing, hoarseness, sore throat, throat swelling.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Throat irritation
Clinical narrative: Scratchy throat, swollen lymph nodes around neck, difficulty breathing, hoarseness, sore throat, throat swelling.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dementia, Generalised tonic-clonic seizure
Clinical narrative: Generalized Tonic/Clonic Seizures. Major Neurocognitive D/O with executive Deficits. Takes medication daily.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood pressure decreased, Heart rate decreased, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lost consciousness in a 18-year-old female patient who received BEXSERO. Concurrent medical conditions included iron decreased (the patient experienced low iron for 2 years and she takes iron therapy). Concomitant products included ALYACEN and LEXAPRO. On 2nd August 2016, the patient received the 1st dose of BEXSERO 1 ml. On 2nd August 2016, immediately after receiving BEXSERO, the patient experienced lost consciousness (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant), pallor and tremor. On 2nd August 2016, the outcome of the lost consciousness, unresponsive to stimuli, pallor and tremor were recovered/resolved. It was unknown if the reporter considered the lost consciousness, unresponsive to stimuli, pallor and tremor to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient is a long distance runner, so her diastolic pressure tends to run low. Almost immediately after vaccination with BEXSERO, the patient turned white (pale), started shaking and lost her consciousness. The healthcare professional laid the patient down and she was unresponsive for approximately 3 to 4 minutes. Her blood pressure dropped to 58/48 and her pulse rate was decreased. The patient was monitored in the physician's office, then 30 minutes later her blood pressure again dropped and she lost consciousness again for 3 to 4 minutes. The patient was monitored for 2.5 hours following this episode. Her blood pressure then returned to normal and she was discharged. The patient's mother did not have vaccine lot number or expiration date.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lost consciousness in a 18-year-old female patient who received BEXSERO. Concurrent medical conditions included iron decreased (the patient experienced low iron for 2 years and she takes iron therapy). Concomitant products included ALYACEN and LEXAPRO. On 2nd August 2016, the patient received the 1st dose of BEXSERO 1 ml. On 2nd August 2016, immediately after receiving BEXSERO, the patient experienced lost consciousness (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant), pallor and tremor. On 2nd August 2016, the outcome of the lost consciousness, unresponsive to stimuli, pallor and tremor were recovered/resolved. It was unknown if the reporter considered the lost consciousness, unresponsive to stimuli, pallor and tremor to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient is a long distance runner, so her diastolic pressure tends to run low. Almost immediately after vaccination with BEXSERO, the patient turned white (pale), started shaking and lost her consciousness. The healthcare professional laid the patient down and she was unresponsive for approximately 3 to 4 minutes. Her blood pressure dropped to 58/48 and her pulse rate was decreased. The patient was monitored in the physician's office, then 30 minutes later her blood pressure again dropped and she lost consciousness again for 3 to 4 minutes. The patient was monitored for 2.5 hours following this episode. Her blood pressure then returned to normal and she was discharged. The patient's mother did not have vaccine lot number or expiration date.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Nausea, Night sweats, Somnolence
Clinical narrative: Feels sleepy, groggy, describes floating sensation. States started feeling sleepy last night, mild nausea, night sweats.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: Two (2) palpable enlarged lymph nodes in the left submandibular region.
Age: 0.18
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen quad at injection site. Area has swelling, mild erythema, and tenderness. Currently 28 hours post-injection, site is improving with warm compress. No other treatment or investigative imaging/studies done at this time.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash away from injection site for which she sought treatment from her doctor; her doctor diagnosed her with shingles at this time.  This was three days after administration of ZOSTAVAX.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Began with daily Headache, dizziness. Continued to include disrupted sleep, weakness, can't get out of bed, upset stomach. We have spent almost 3 years and lots of money trying to figure out why our daughter's health changed so dramatically. Treatment/tested by ENT, Neurologist, naturopath, chiropractor, Physical Therapist, Psychologist, acupuncture, MRI, MRV, chronic pain clinic, yoga, neurofeedback, mindfulness. Tried the following medications to alleviate migraines - Topomax, amitriptyline, gabapentin, sumatriptan, Maxalt, propranolol.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Sleep disorder, Venogram
Clinical narrative: Began with daily Headache, dizziness. Continued to include disrupted sleep, weakness, can't get out of bed, upset stomach. We have spent almost 3 years and lots of money trying to figure out why our daughter's health changed so dramatically. Treatment/tested by ENT, Neurologist, naturopath, chiropractor, Physical Therapist, Psychologist, acupuncture, MRI, MRV, chronic pain clinic, yoga, neurofeedback, mindfulness. Tried the following medications to alleviate migraines - Topomax, amitriptyline, gabapentin, sumatriptan, Maxalt, propranolol.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Pain, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Very sore arm, low grade fever (99.8-100.8), aching all over, severe pain in armpit, pink blotches where pain is worst (but not at injection site). It's now 2 days later and no change.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS/PAIN/SWELLING/WARMTH AT INJECTION SITE --> PHARMACIST RECOMMENDED ICE PACK & ANTI-INFLAMMATORY (IBU).
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 08/08/2016, patient noticed warmth and redness around injection site. On 08/10/2016, patient came to pharmacy with symptoms.
Age: 4.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Full blood count, Glossodynia, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: This is a 4Y 00M-year-old Female who presents to the ER today after being seen in clinic by Dr at clinic. She was noted to have petechiae and purpura after a bath yesterday. Family decided to take her to the clinic today, where a CBC was noted for platelet count of 4,000. Pediatricians were contacted, and the decision was made to admit her. Mother notes that this morning, the child did wake up at 3:30 with complaints of bleeding on the tongue, and mother notes that she had several sores on her mouth and tongue. No bleeding with urination. Platelet count of 4,000 consistent with Idiopathic thrombocytopenia.  Patient admitted, administered IVIG for Idiopathic thrombocytopenia starting upon admission to the floor.
Age: 4.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Platelet count decreased, Stomatitis, Tongue haemorrhage
Clinical narrative: This is a 4Y 00M-year-old Female who presents to the ER today after being seen in clinic by Dr at clinic. She was noted to have petechiae and purpura after a bath yesterday. Family decided to take her to the clinic today, where a CBC was noted for platelet count of 4,000. Pediatricians were contacted, and the decision was made to admit her. Mother notes that this morning, the child did wake up at 3:30 with complaints of bleeding on the tongue, and mother notes that she had several sores on her mouth and tongue. No bleeding with urination. Platelet count of 4,000 consistent with Idiopathic thrombocytopenia.  Patient admitted, administered IVIG for Idiopathic thrombocytopenia starting upon admission to the floor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site macule, Injection site pain, Injection site swelling
Clinical narrative: Bruise on anterolateral (R) thigh after administration of vaccine. Red and growing bump on 8/9/16.  Denies pain, itching, red streaks, fever. Pt not irritable. Eliminating and sleeping fine. On 8/10: Right anterior thigh- 3.5 cm rround macule, red, warm. Darker and mildly raised in center, lighter towards edges. Appears mildly tender to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Bruise on anterolateral (R) thigh after administration of vaccine. Red and growing bump on 8/9/16.  Denies pain, itching, red streaks, fever. Pt not irritable. Eliminating and sleeping fine. On 8/10: Right anterior thigh- 3.5 cm rround macule, red, warm. Darker and mildly raised in center, lighter towards edges. Appears mildly tender to touch.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Blister, Injection site erythema, Pain, Scratch
Clinical narrative: Pt incurred scratch to leg with administration of vaccine. Upon returning to clinic one week later, pt presents with redness at site of injection as well as red scratch to side of injection site which now has small vesicles lateral to scratch. Both site and scratch appear to be painful to touch. Pt has been afebrile per pt parents report. Pt is being treated with oral KEFLEX and will return to clinic for f/u in one week.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 3 inches width and length severe redness, hard, swollen and hot to touch on the left arm where injection was.
Age: 53.0
Sex: M
Vaccine: MNQ
Symptoms: Heart rate decreased, Hypotension, Syncope
Clinical narrative: Syncopal episode.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Neuralgia, Pain
Clinical narrative: Patient claims that she experienced EXTREME shooting nerve pain when the Immunization was administered. No redness or swelling after, no visible signs of trauma.  Pt has existing Celliac disease and Chronic nerve and muscle pain.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: Hives. Diarrhea. Patient took Benadryl (3 doses yesterday and 1 dose today). Patient reported hives were more numerous and very itchy today. Patient sought medical help from local provider and was prescribed Prednisone 20 mg once daily for 5 days.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Hives. Diarrhea. Patient took Benadryl (3 doses yesterday and 1 dose today). Patient reported hives were more numerous and very itchy today. Patient sought medical help from local provider and was prescribed Prednisone 20 mg once daily for 5 days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling, redness, and warmth to entire left deltoid muscle.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: A week after receiving the vaccine the patient began experiencing an itchy rash on the legs. Upon going to the physician, he was diagnosed with shingles.
Age: 37.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine administered was not needed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Swelling and intense pain with limited range of motion in left shoulder.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a physician, via Novartis (company reference # PUS2016US093951), referring to a 70 year old female patient. The patient's medical history included pneumonia in February 2016. Concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (dose, route and anatomical location were not reported) as indication of asthma and cardiac valve disease. On an unknown date, two days after vaccination, the patient experienced right side pneumonia and required hospitalization. The outcome of the event was unknown. The causality assessment between right side pneumonia and PNEUMOVAX 23 was not given. Upon internal review, right side pneumonia was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in JULY 2016 (reported as "starting on or after 11-JUL-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date 28-SEP-2017; lot # M019706, expiration date 24-OCT-2017, dose not reported) orally. The vaccine was improperly stored in 49.1 degree Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse via Pfizer, referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent polysaccharide vaccine (manufacturer unknown) reported as (PPSV) (concentration, dose, route of administration, lot # and expiry date were not reported). There was no concomitant medication reported. On an unknown date, the patient had a cellulitis after receiving the polyvalent polysaccharide vaccine (manufacturer unknown). Therefore, the patient was hospitalized and given antibiotics. At the time of the reporting, the outcome of cellulitis was unknown. Upon internal review, cellulitis was also considered a medically significant event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an unspecified patient (age and gender were not reported). The patient's pertinent  medical history and concurrent conditions were not provided. It was reported that on an unknown date the patient received the first two doses in the series of three GARDASIL (lot #, expiration date, concentration, dose and therapy route were not reported), on unspecified date, the third dose in the series of three was given of GARDASIL 9 (lot #, expiration date, concentration, dose and therapy route were not reported). Concomitant therapies were not provided. The R.N. stated that on an unknown date another dose of GARDASIL 9 was inadvertently administered on 05-AUG-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Daughter called pharmacy 8/9/16 to report mom was in hospital from flu shot.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on injection site. Pt diagnosed with cellulitis and given Cephalexin.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Pyrexia, Rash, Vomiting
Clinical narrative: Patient was in for a well child check, pt needed 2 month shots. PREVNAR and HIB were administered on right thigh. Which after a couple of hours started getting a bright red streak lateral line. Pts mother stated Pt had a fever and vomit until the following day and went away afterwards. Per PA-C rash is not systemically but locally. Cetirizine 1mg everyday with cold compresses on area were recommended if it does not get any better, patient needs to come back in to see provider.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Dad called approximately 30 h after administration; c/o redness, knot, swelling of leg where vaccines given 48 h after administration fever increased 102, swelling worse. OV recommended tx-ADVIL, BENADRYL, cold compress.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Nightmare
Clinical narrative: Nightmares (like she had when she tried CHANTIX) and sleeplessness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: 8/8/16 Pneumococcal vaccine given 8-8-16. 8-10-16 pt. seen for nausea, patches of erythema, tender to touch left arm, swelling and warmth to touch on left arm.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Pt received vaccine on 5/10/16. Began swelling, tenderness and redness to next day. It is very itchy. She knows to use ice, TYLENOL and topical BENADRYL if needed for itch. The reaction lasted 6 days.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a medical assistant referring to a male adult patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 03-AUG-2016 the patient received two doses of RECOMBIVAX HB (lot # K021581, expired on 24-OCT-2016; lot # L042846, expired on 15-SEP-2017)(dose and route unknown)(product use issue). The reporter was not aware of nay adverse effects or side effects related to the event. Additional information is not expected as there is no consent for follow up.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt was pale and light headed after the shots. He passed out 2 x's that evening but had not ate and he played baseball. (Pt was worked up and afraid of shot prior to getting it).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Fever, rash, arm ache gave CLARITIN and ADVIL.