chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient is a 22 m.o. male who presents with swelling and tenderness on his right thigh. Patient had a DTaP immunization on Tuesday Tuesday night there was some firmness at the site. Seems mildly tender and then Wednesday started to swell up more at the site of injection. With some surrounding erythema there is a firm area in the center. He's been eating well no fever chills or shortness of breath mother tried some hydrocortisone over-the-counter that hasn't made much of a difference. She hasn't given him any medications is a history of an allergy to amoxicillin and a cephalosporin this is both a rash no shortness of breath or systemic symptoms these were for ear infections.
Sex: U
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender, who was the patient of the physician's unspecified colleague. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot #, route and dose not reported). Information regarding concomitant medications was not reported. On an unknown date the patient developed premature ovarian failure following vaccination of GARDASIL. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Condition aggravated, Heart rate decreased, Loss of consciousness, Syncope
Clinical narrative: The spontaneous report was received the office manager via a company representative, referring to a teenage female patient of an unknown age. The patient's concurrent conditions included a cardiac condition, the patient was healthy and involved with a lot of sports. On an unknown date in 2014 (reported as approximately two years ago), the patient was vaccinated with the second dose of GARDASIL (route, anatomical site of vaccination, lot number and expiration date were not informed). Information regarding concomitant medication was unknown for the reporter. The reporter stated that the patient waited 15 minutes after being vaccinated and when she was leaving she passed out (syncope). Apparently, her heart rate was very low and they could not get it back up. The patient was referred to see cardiologist who diagnosed that the shot aggravated the cardiac condition. Additionally, the reporter believed that the patient has aged out of the practice. At the time of reporting, the outcome of syncope, cardiac condition and heart rate was very low was unknown. The causality assessment between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date 31st December 2016). On 21st June 2016, the patient received BEXSERO .5ml. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site induration, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling and injection site warmth to be related to BEXSERO.  Additional details were provided as follows: The patient received a dose of BEXSERO vaccine in her left arm and experienced warmth, firmness, and swelling at the injection site. The healthcare professional stated that, the symptoms had no subsided.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Contusion, Fatigue, Induration, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of bruising of arm in a 16-year-old female patient who received BEXSERO (batch number 151301A, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced bruising of arm, nausea, fatigue and induration. On an unknown date, the outcome of the bruising of arm, nausea, fatigue and induration were not recovered/not resolved. It was unknown if the reporter considered the bruising of arm, nausea, fatigue and induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm bruising, induration, nausea and fatigue. The patient was having difficult in carrying her day to day activities. The expiration date of the vaccine was erroneously reported as same as the patient's birth date. No further information was reported regarding the event.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced injection site pain following the administration of 1st dose of BEXSERO. The reporter stated that she would be able to obtain information related to vaccination dates, lot numbers and expiration dates at a later time, but she wanted to talk to a medical information scientist urgently, as the patient was actively experiencing symptoms at the time of the call. This case has been linked with US2016GSK091341 reported by the same reporter for the same patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 8th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5ml. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the injection site erythema and injection site warmth to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The concomitant medications received by the patients were unknown. The patient experienced redness and warmth around the injection site in her arm. In the morning of the reporting date, the patient had called the office for reporting that the injection site was still red and warm.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: My 11 year old son had severe vomiting 12 hours after getting a first dose of GARDASIL 9. That's not a serious side effect, but vomiting is not listed as a side effect for GARDASIL on its website or the CDC's website. It may be possible that it's a coincidence, but he was not ill prior and seems to be fine the next day.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Registered Nurse Practitioner refers to a patient of unknown age and gender. The medical history and concurrent conditions of the patient were not reported. On 18-JUN-2016 the patient was vaccinated with an expired dose of ROTATEQ lot # K017576, EXP. 12-JUN-2016, 2 ml, oral. No other suspect or concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant), refers to a unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a improperly stored doses of M-M-R II (lot # L024268, expiration date 01-JUL-2017; lot # L012479, expiration date 10-APR-2017; Lot# L030162, expiration date 11-AUG-2017) ( doses not reported). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a 19-year-old male patient who received BEXSERO (batch number 148901B, date 30th September 2016). Previously administered products included BEXSERO (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced arm discomfort and swelling arm. On an unknown date, the outcome of the arm discomfort and swelling arm were recovering/resolving. It was unknown if the reporter considered the arm discomfort and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm discomfort and swelling. No further information was reported regarding the event.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local itching, swelling and redness at the site of PREVNAR injection.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Dermatitis contact, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 2 year old male patient. The patient's medical history included premature birth. Also was reported that the patient had none concomitant therapies or drug reactions/allergies. On 13-OCT-2011, the patient was vaccinated with PROQUAD subcutaneous (which had a lot # reported as 1433Z and an expiration date of 27-APR-2012; however, dose, dosage number and anatomical location were not reported). No other suspect therapies were reported. On an unknown date (reported as "one and a half years later"), the patient developed a rash which lasted for an unspecified duration and recovered on an unspecified date. The patient was seen by an allergist on 13-JUN-2013, who diagnosed him with shingles", however, it was stated that the physician was not completely certain whether this rash was shingles or contact dermatitis. Additionally, it was reported that the patient was treated with acyclovir. Additionally, it was reported that no laboratory diagnostics were performed and that no intervention to prevent serious criteria was necessary, that the adverse events were not was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of "shingles" and "contact dermatitis" was reported as recovered/resolved. The relatedness between the adverse events and PROQUAD was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, myalgia (neck and mid back pain) - onset 24 hours after vaccine. Headache 2 days later. Fever up to 103 degrees. Symptoms lasted 6 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site reaction
Clinical narrative: Patient was at the doctor's office to receive an immunization, and the nurse noticed his red, inflamed arm. Patient states that he had not noticed the reaction until then. Injection site reaction.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Chronic pain in shoulder. Pain 7/10 - worse w/ movement. In PT/TENS unit/improving.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Local reaction, Pertussis
Clinical narrative: Localized rxn to Imm (R) arm probable pertussis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Dizziness, Immediate post-injection reaction, Injection site haemorrhage, Injection site pain
Clinical narrative: Pt. here w/ father for nurse only visit for imm. Tdap and MENCATRA given. Pt was very anxious and immediately c/o pain (L) delt. Site bled but bandaid applied. I advised to wait 15 mins- When left office pt vomited and felt dizzy. Brought back into office and assessed by physician. Pt was stable after 30 mins.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Pt. here w/ father for nurse only visit for imm. Tdap and MENCATRA given. Pt was very anxious and immediately c/o pain (L) delt. Site bled but bandaid applied. I advised to wait 15 mins- When left office pt vomited and felt dizzy. Brought back into office and assessed by physician. Pt was stable after 30 mins.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypoaesthesia, Injection site swelling, Pain, Swelling
Clinical narrative: Severe swelling injection site over few days. Pain, redness. Progressed to swelling upper torso, LUE as well. Some numbness LUE. Nausea. No fever. Symptoms not resolved today at D14.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Cognitive disorder, Fatigue, Headache
Clinical narrative: Received PCV13 and started methotrexate on 16 May and on May 18 went to ED with severe headache, mild cognitive changes and fatigue. She was given meds and occipital nerve block which relieved headache. Much better on discharge.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dizziness, Vomiting
Clinical narrative: Developed chest pain, vomiting, and dizziness after vaccines were administered, 5 minutes after vaccines. Observed for 10 additional minutes. Normal Exam. Walked out of office on his own.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dysphagia, Pyrexia, Rash generalised, Skin exfoliation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received KINRIX (batch number D592C, expiry date 29th September 2017). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced allergic reaction, throat irritation and fever. On an unknown date, the outcome of the allergic reaction, throat irritation and fever were unknown. It was unknown if the reporter considered the allergic reaction, throat irritation and fever to be related to KINRIX. Additional details were provided as follows: The reporter stated that 2 patients received KINRIX and experienced allergic reactions. The patient experienced scratching of throat and fever. The patient was kept in clinic for 3 hours until side effects subsided. The patient was treated with BENADRYL 5 ml. The reporter had minimal information. These were reports from other offices. She believed even though they were indeed KINRIX. She felt as thought there was a mistake and this was not KINRIX. This case was linked to case US2016090309 as reported by the same reporter.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Hypersensitivity, Pyrexia, Throat irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received KINRIX (batch number D592C, expiry date 29th September 2017). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced allergic reaction, throat irritation and fever. On an unknown date, the outcome of the allergic reaction, throat irritation and fever were unknown. It was unknown if the reporter considered the allergic reaction, throat irritation and fever to be related to KINRIX. Additional details were provided as follows: The reporter stated that 2 patients received KINRIX and experienced allergic reactions. The patient experienced scratching of throat and fever. The patient was kept in clinic for 3 hours until side effects subsided. The patient was treated with BENADRYL 5 ml. The reporter had minimal information. These were reports from other offices. She believed even though they were indeed KINRIX. She felt as thought there was a mistake and this was not KINRIX. This case was linked to case US2016090309 as reported by the same reporter.
Age: 0.97
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: The area around the shot was around 2" 24 hrs after the shot, then continued to grow. By the noon of third day it was 9.5cm x 5.5 cm. Patient went back to the administering doctor's office and was told that they are not sure whether it is an allergic reaction or a bacterial infection and that there are no tests at the moment to rule out either one. Was given a prescription for 7 days worth of antibiotic (Sulfamethoxazole - Trimeth 200-40).
Age: 0.97
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Bacterial infection, Injection site hypersensitivity, Injection site reaction
Clinical narrative: The area around the shot was around 2" 24 hrs after the shot, then continued to grow. By the noon of third day it was 9.5cm x 5.5 cm. Patient went back to the administering doctor's office and was told that they are not sure whether it is an allergic reaction or a bacterial infection and that there are no tests at the moment to rule out either one. Was given a prescription for 7 days worth of antibiotic (Sulfamethoxazole - Trimeth 200-40).
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Head discomfort, Heart rate increased, Insomnia, Limb discomfort, Paraesthesia
Clinical narrative: 15 min after shot immediate tension headache pressure on sides of both heads. Tingling in head, and limbs were heavy and tingling fingers. Had trouble sleeping. Heart rate was beating high.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Tension headache
Clinical narrative: 15 min after shot immediate tension headache pressure on sides of both heads. Tingling in head, and limbs were heavy and tingling fingers. Had trouble sleeping. Heart rate was beating high.
Age: 0.8
Sex: M
Vaccine: MEN
Symptoms: Deafness, Lethargy, Meningitis, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's grandmother) on 16 June 2016. This case involves a male patient (age was not reported) who was vaccinated (vaccinated when he was 10 months old)) with a dose of MENINGOCOCCAL VACCINE (Manufacture-unknown, batch number, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient had fever, was looking lethargic, experienced meningitis and became deaf. On an unspecified date, the patient was hospitalized for 14 days. The patient required ER visit. Lab data were not reported. The patient received corrective treatment with Tylenol and Benadryl. The outcome of the events meningitis, fever and looking lethargic was unknown and outcome for deaf was not resolved. The patient also had disability (deaf). List of documents held by sender: none. Sender's Comments: This is a social media case whether manufacturer of the MENINGOCOCCAL VACCINE was not provided. In this case meningitis and deaf was reported after administration of MENINGOCOCCAL VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 1.02
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm painful, swollen. Numb arm and hand.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information was received from a consumer referring to her son, a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was vaccinated with M-M-R II (dose, frequency and route were not reported). On an unknown date the patient developed autism. The outcome was unknown. The causality was not reported. Upon internal review, autism was determined to be medically significant. Additional information is not expected since no contact information is provided.
Sex: U
Vaccine: VARZOS
Symptoms: Transfusion
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On an unknown date, about six months after vaccination with ZOSTAVAX, the patient received two blood transfusions for unspecified reasons. The outcome of the event and the causality assessment between the event and ZOSTAVAX were not provided. Upon internal review, the blood transfusions was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from the healthcare professional via other company (Pfizer) 19 May 2016. Manufacturer control number: 2016248113. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu vaccine (batch number, expiry date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy. Lab data and corrective treatments were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Elongated red rash with pink swelling which goes from injection site to near elbow.  Went to Emergency Center, checked by doctor, and given prescription for Cephalexin (500mg 3 times a day)which I am currently taking.
Age: 50.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: Approx 2 hours after vaccine was received, he complained of fever of 100.3 and chills.  Resolved after taking 2 Tylenol.  No further issues since that time.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal pain
Clinical narrative: Shoulder pain. Headache.
Age: 33.0
Sex: M
Vaccine: HEP, RAB
Symptoms: Electromyogram, Hypoaesthesia, Muscle contractions involuntary, Muscle fatigue, Nerve conduction studies
Clinical narrative: This spontaneous report as received from a physician assistant, an approximately 33-year-old male who refers to himself. There was no information about the patient's concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of rabies vaccine (unspecified) before he was vaccinated with HEPTAVAX-B. After he received rabies vaccine (unspecified) he began to feel Guillain-Barre like symptoms with numbness and tingling that started in his feet, which traveled up to his mid-thighs and then went away. On an unknown date (reported as during the Fall 1988 through March 1989), the patient was vaccinated with a dose of HEPTAVAX-B (dose, route of administration, lot # and expiration date were not reported). On an unknown date in late 1989, after receiving HEPTAVAX-B, the patient developed "neurologic issues", which included hand tremors, fatigue in the muscles of his right forearm during writing,  and leg fasciculations. The patient sought medical attention by office visit.  He had performed an electromyogram and a nerve conduction velocity study (dates and the results were not reported). There was no intervention to prevent serious criteria. The outcome of event was reported as not recovered/not resolved. The relatedness between the event and HEPTAVAX-B and rabies vaccine (unspecified) was not reported. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEP, RAB
Symptoms: Neurological symptom, Paraesthesia, Tremor
Clinical narrative: This spontaneous report as received from a physician assistant, an approximately 33-year-old male who refers to himself. There was no information about the patient's concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of rabies vaccine (unspecified) before he was vaccinated with HEPTAVAX-B. After he received rabies vaccine (unspecified) he began to feel Guillain-Barre like symptoms with numbness and tingling that started in his feet, which traveled up to his mid-thighs and then went away. On an unknown date (reported as during the Fall 1988 through March 1989), the patient was vaccinated with a dose of HEPTAVAX-B (dose, route of administration, lot # and expiration date were not reported). On an unknown date in late 1989, after receiving HEPTAVAX-B, the patient developed "neurologic issues", which included hand tremors, fatigue in the muscles of his right forearm during writing,  and leg fasciculations. The patient sought medical attention by office visit.  He had performed an electromyogram and a nerve conduction velocity study (dates and the results were not reported). There was no intervention to prevent serious criteria. The outcome of event was reported as not recovered/not resolved. The relatedness between the event and HEPTAVAX-B and rabies vaccine (unspecified) was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, nausea.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and Swelling around injection site and a fever of 100.6.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Culture urine negative, Exposure during pregnancy, Fatigue, Full blood count normal
Clinical narrative: 102 degree fever, chills, nausea, body aches, headache, exhaustion. Called OB due to fever and chills at 36 weeks pregnant, and sent me to hospital for Labor & Delivery for monitoring and labs.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: 102 degree fever, chills, nausea, body aches, headache, exhaustion. Called OB due to fever and chills at 36 weeks pregnant, and sent me to hospital for Labor & Delivery for monitoring and labs.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Syncope resulting in head wound, no c/o dizziness, light-headed, or feeling faint. Able to stand and walk without difficulty or gait changes following waiting period. Reaction occurred about 15 minutes after vaccine administration.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Vertigo
Clinical narrative: Vertigo, stiff spine, and bilateral shooting arm pain.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Tachycardia
Clinical narrative: Tachycardia, cellulitis, possible throat issues.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Electrocardiogram, Hepatic enzyme increased
Clinical narrative: Temp 103 degrees, stiff neck, passed out, nausea, chills, muscle aches, joint aches.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Temp 103 degrees, stiff neck, passed out, nausea, chills, muscle aches, joint aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: 2 inch in diameter raised, itchy, red, inflamed injection site.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: This spontaneous report was received from a consumer (patient's daughter in law) refers to a 91 year old female patient. The patient's pertinent medical history included legs swelling and hypertension. Drug reactions or allergies were not reported. On an unknown date in December 2015, the patient was vaccinated with ZOSTAVAX injection (dosage information, lot number and expiry date was not reported). Concomitant medications were not reported. On an unknown date in January 2016, the patient experienced bullous pemphigoid for an unspecified reason. The patient sought the medical attention by visiting a physician and no treatment was provided for the event. The outcome of event was reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, "Bullous pemphigoid" was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Lumbar puncture, Nuclear magnetic resonance imaging whole body
Clinical narrative: This spontaneous report was posted from a consumer and was received via a company representative referring to female patient who was approximately 12 to 13 years at the time of vaccination. In approximately June 2013, the patient was vaccinated with a dose of GARDASIL (dosage, dose number, route of administration, lot number and expiration date were not provided). No other suspect or concomitants therapies were reported. On an unknown date in June 2013 (reported as 3 years ago) shortly after vaccination, the reporter stated that "the GARDASIL almost took her daughters eye sight", it was also stated that the patient went through many possible prognosis such as Leukaemia, migraines, seizures and many other things in the body. Additionally, on unspecified date, the reporter stated that different laboratory diagnostic tests were performed such as 2 Lumbar puncture (spinal taps), 2 full body Nuclear magnetic resonance imaging (MRI), a Computerised tomogram (cat scans), a Electroencephalogram (EEG), numerous X-ray and blood work every 2 hours for day, however, the results were not reported. Furthermore, the reporter referred that the patient was set on a Lyme disease regiment besides, the treatment given included morphine drip. At the time of the report, the outcome of leukaemia, migraine, seizure, unspecified adverse event, Lyme disease and visual impairment was unknown. However, the causality between seizure, migraine, leukemia, adverse event, Lyme disease and GARDASIL was not reported. Upon internal review, the events of seizure, leukaemia and Lyme disease were considered as medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment, X-ray
Clinical narrative: This spontaneous report was posted from a consumer and was received via a company representative referring to female patient who was approximately 12 to 13 years at the time of vaccination. In approximately June 2013, the patient was vaccinated with a dose of GARDASIL (dosage, dose number, route of administration, lot number and expiration date were not provided). No other suspect or concomitants therapies were reported. On an unknown date in June 2013 (reported as 3 years ago) shortly after vaccination, the reporter stated that "the GARDASIL almost took her daughters eye sight", it was also stated that the patient went through many possible prognosis such as Leukaemia, migraines, seizures and many other things in the body. Additionally, on unspecified date, the reporter stated that different laboratory diagnostic tests were performed such as 2 Lumbar puncture (spinal taps), 2 full body Nuclear magnetic resonance imaging (MRI), a Computerised tomogram (cat scans), a Electroencephalogram (EEG), numerous X-ray and blood work every 2 hours for day, however, the results were not reported. Furthermore, the reporter referred that the patient was set on a Lyme disease regiment besides, the treatment given included morphine drip. At the time of the report, the outcome of leukaemia, migraine, seizure, unspecified adverse event, Lyme disease and visual impairment was unknown. However, the causality between seizure, migraine, leukemia, adverse event, Lyme disease and GARDASIL was not reported. Upon internal review, the events of seizure, leukaemia and Lyme disease were considered as medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was posted on the internet from a consumer and was received via a company representative referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dosage, dose number, route of administration, lot number and expiration date were not provided). No other suspect or concomitants therapies were reported. On an unknown date, the reporter stated that "2 of my friends daughters (linked case 1606USA014108) have had serious issues from the GARDASIL". However, it was not reported whether a treatment was given or if laboratory diagnostics were performed. At the time of the report, the outcome of the adverse event was unknown. The reporter stated that the adverse events were related to GARDASIL. Upon internal review, the serious issues were considered as medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bronchospasm, Choking, Cough, Crying, Hypersensitivity
Clinical narrative: Severe bronchospasm/choking with initial administration of ROTATEQ. Heimlich maneuver performed and baby started coughing and crying.  Ater 5 minutes of observation her color was good breathing without difficulty.  PA-C was in to examine respiratory status.  Patient discharged from office. She was seen that night in the ER for cheek swelling and allergic reaction. Discharged with orders to give Benadryl.  Seen in follow up in our office on 06-28-2016 and did not have any respiratory difficulty and cheeks did not appear swollen.
Age: 0.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Swelling face
Clinical narrative: Severe bronchospasm/choking with initial administration of ROTATEQ. Heimlich maneuver performed and baby started coughing and crying.  Ater 5 minutes of observation her color was good breathing without difficulty.  PA-C was in to examine respiratory status.  Patient discharged from office. She was seen that night in the ER for cheek swelling and allergic reaction. Discharged with orders to give Benadryl.  Seen in follow up in our office on 06-28-2016 and did not have any respiratory difficulty and cheeks did not appear swollen.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles - Has recurred about 15 times. Valtrex/Gabapentin.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm (injection site) red, raised, baseball size, hot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Child presented on 07/01/2016 at 12:00 pm with right deltoid swelling, rash, and skin warm to the touch.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Her injection site symptoms are swollen, red and itch and didn't go away after taking allegra, hydrocortisone 1% cr and ice therapy.
Age: 35.0
Sex: M
Vaccine: HEPAB, MNQ, PPV
Symptoms: Injection site rash
Clinical narrative: Patient developed rash originating from injection site.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Extreme swelling at injection site. Raised; Redness all over upper arm; HOT to touch; Hard, Tight skin; Painful. 5pm when I got home from work; took him to a walk-in clinic to be seen; marked the red mark on the upper arm in pen, 8pm. 10pm, the redness had grown outside the marks, Marked again. When he woke at 7am, Wednesday, the redness had grown again and marked again. On Thursday, skin tones in face were blotchy and yellowish. Arm not as red, still HOT to touch and arm was about 3x harder than other arm in comparison. Felt tight. He has been taking Keflex 3 times a day since walk-in on Tuesday. His demeanor is off, did not play outside for a day and a half which is very out of character.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Injection site warmth, Rash macular, Skin tightness, Yellow skin
Clinical narrative: Extreme swelling at injection site. Raised; Redness all over upper arm; HOT to touch; Hard, Tight skin; Painful. 5pm when I got home from work; took him to a walk-in clinic to be seen; marked the red mark on the upper arm in pen, 8pm. 10pm, the redness had grown outside the marks, Marked again. When he woke at 7am, Wednesday, the redness had grown again and marked again. On Thursday, skin tones in face were blotchy and yellowish. Arm not as red, still HOT to touch and arm was about 3x harder than other arm in comparison. Felt tight. He has been taking Keflex 3 times a day since walk-in on Tuesday. His demeanor is off, did not play outside for a day and a half which is very out of character.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Swollen tongue
Clinical narrative: Tongue swelling, Injection site redness with ring.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Albumin globulin ratio, Aldolase normal, Amino acid level normal
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Anion gap normal, Anti-VGCC antibody, Anti-ganglioside antibody, Antibody test negative, Antinuclear antibody
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody positive, Aspartate aminotransferase normal, Attention deficit/hyperactivity disorder, Autoimmune thyroiditis, Autonomic nervous system imbalance
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Bacterial test positive, Basophil count normal, Basophil percentage increased, Beta globulin normal
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Bilirubin urine, Biopsy skin normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate normal
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatine phosphokinase normal
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood immunoglobulin A normal, Blood immunoglobulin G
Clinical narrative: Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.