chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Borrelia test, Ear swelling, Headache, Local swelling
Clinical narrative: On 2/23/14, patient started to develop swelling behind his ears and neck with a terrible headache. Pt was prescribed prednisone and VALTREX at his doctor's office. Between 3/1 and 3/3 he developed Bell's palsy on his left side of the face. He is not getting any better according to mom but he is on vacation for his spring break.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: On 2/23/14, patient started to develop swelling behind his ears and neck with a terrible headache. Pt was prescribed prednisone and VALTREX at his doctor's office. Between 3/1 and 3/3 he developed Bell's palsy on his left side of the face. He is not getting any better according to mom but he is on vacation for his spring break.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Borrelia test, Ear swelling, Headache, Local swelling, Nuclear magnetic resonance imaging
Clinical narrative: On 2/23/14, patient started to develop swelling behind his ears and neck with a terrible headache. Pt was prescribed prednisone and VALTREX at his doctor's office. Between 3/1 and 3/3 he developed Bell's palsy on his left side of the face. He is not getting any better according to mom but he is on vacation for his spring break.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: On 2/23/14, patient started to develop swelling behind his ears and neck with a terrible headache. Pt was prescribed prednisone and VALTREX at his doctor's office. Between 3/1 and 3/3 he developed Bell's palsy on his left side of the face. He is not getting any better according to mom but he is on vacation for his spring break.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: Significant swelling, and pain to injection site. Followed by erythematous, pruritic rash (localized). (+) fevers (subjective) (+) arthralgias. Symptoms started the following day. 7 days after Tdap adm symptoms still present however inj site slightly improved.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Significant swelling, and pain to injection site. Followed by erythematous, pruritic rash (localized). (+) fevers (subjective) (+) arthralgias. Symptoms started the following day. 7 days after Tdap adm symptoms still present however inj site slightly improved.
Age: 0.42
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Gaze palsy, Tremor
Clinical narrative: Mom described a 10 second episode where hands, wrist, arms, legs and head shaking, also eyes rolled back in his head but after 10 seconds pt was fine.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Post flu vaccines had diarrhea with trip to ER for dehydration and higher fever. 9 days diarrhea starting w/in 1 day of 1st influenza vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Irritability
Clinical narrative: Wed 3/5 decreased appetite; Thurs 3/6 fussy, tired, crying vomiting and diarrhea at NOC no fever. 3/9 final diarrhea; decreased appetite.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Wed 3/5 decreased appetite; Thurs 3/6 fussy, tired, crying vomiting and diarrhea at NOC no fever. 3/9 final diarrhea; decreased appetite.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 1mg dose instead of 0.5 mL dose.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Fall, Gaze palsy, Skin discolouration, Somnolence, Tonic clonic movements
Clinical narrative: On the day following vaccination, the patient was standing at school (well fed and hydrated) when she turned white, eyes rolled back, and she fell to the floor with tonic, clonic movement of upper extremities bilaterally x 1 min. Sleepy following.
Age: 54.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Customer felt fully numbed in the injected arm and need Dr's visit. Dr prescribed naproxen 550mg and TYLENOL #3.
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of bone marrow transplant patients, of unknown age and gender. On an unknown dated the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). Concomitant medications were not reported. Physician reported that patients did not develop full immunity with PNEUMOVAX 23 after they were vaccinated. The outcome of patients did not developed full immunity was unknown. The action taken and the relationship between PNEUMOVAX 23 and the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a female Registered Nurse of unknown age concerning herself. On an unknown date, the patient became pregnant. The LMP and EDD were not known. The patient had no pertinent medical history or drug reactions or allergies. On 07-MAR-2014 the patient was inadvertently administered a dose of GARDASIL (dose and lot # not provided), intramuscular, instead of the intended TDAP vaccine (manufacturer unspecified). Concomitant therapies included NASALCROM, loratadine (manufacturer unknown) and budesonide (manufacturer unknown). No adverse effects were reported. The pregnancy outcome was pending. The patient stated that she was at the physician's office when this occurred. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of RECOMBIVAX HB (dose and lot # not reported). Concomitant therapies included PEDIARIX. The nurse reported that the patient received a dose of PEDIARIX and a dose of RECOMBIVAX HB Pediatric in error. The patient was indicated to receive PEDVAXHIB instead of RECOMBIVAX HB. The nurse stated that the error occurred during the order entry process. She stated that the error did not occur because of the product's labels; it was because the healthcare provider ordered the wrong vaccine. The patient has not demonstrated any adverse effects. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Medical history and drug reactions/allergies were not reported. On approximately 27-FEB-2014 (reported as about a week ago), the patient was vaccinated with GARDASIL (lot, dose and route not reported). Concomitant medication was not reported. On approximately 27-FEB-2014 (reported as since then), the patient had been acting lethargic. The outcome of acting lethargic was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Initially numbness and tingling in (B) hands and feet. Weakness in his upper and lower extremities. Mid July - finished 5 day course of IVIG with clear, marked improvement. Continued IVIG treatments every other month.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Paraesthesia
Clinical narrative: Initially numbness and tingling in (B) hands and feet. Weakness in his upper and lower extremities. Mid July - finished 5 day course of IVIG with clear, marked improvement. Continued IVIG treatments every other month.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old female patient. on 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (subcutaneous, right arm, lot J011651, exp date 22-AUG-2014). Co-suspect therapies included ZOSTAVAX (subcutaneous, right arm, lot J011338 exp date 19-DEC-2014) administered on 17-DEC-2013. On the same date the patient experienced chills and fever (100). The patient recovered on an unknown date in December 2013. The relatedness was not provided. The case is linked to 1312USA010905, 1403USA003215, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251 and 1403USA003253. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Erythema, Influenza like illness
Clinical narrative: This spontaneous report as received from an other health professional refers to a 50 year old female patient with lupus. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the left arm. Other suspect therapies vaccinated on 17-DEC-2013 included ZOSTAVAX lot #J011338, subcutaneous in the left arm and BOOSTRIX lot # T25EG, intramuscular in the left deltoid. No other medications were used. The patient experienced red around entire arm, 2 blisters and flu like symptoms on 17-DEC-2013. The outcome of flu like symptoms, red around entire arm and 2 blisters was reported as recovered/resolved. No causality assessment was provided. Additional information has been requested.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Chills, Erythema, Skin warm, Swelling
Clinical narrative: Initial case received from a health care professional on 06 March 2014. It was reported as part of a cluster of five patients who experienced similar events; the other four cases are non-serious, and are captured in case numbers 2014SA030637, 2014SA030639, 2014SA030640, and 2014SA030641. This case is considered to be a medication error, i.e. wrong route of administration. A female patient received a subcutaneous injection of MENACTRA (lot number reported as U458AB, not a valid lot number) on an unspecified date. Two days post-vaccination, she presented to the emergency department with complaints of a red raised area measuring 8 inches by 5 inches and chills. She was diagnosed with cellulitis. No additional information was reported, and outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Chills, Erythema, Incorrect route of drug administration, Local swelling
Clinical narrative: Initial case received from a health care professional on 06 March 2014. It was reported as part of a cluster of five patients who experienced similar events; the other four cases are non-serious, and are captured in case numbers 2014SA030637, 2014SA030639, 2014SA030640, and 2014SA030641. This case is considered to be a medication error, i.e. wrong route of administration. A female patient received a subcutaneous injection of MENACTRA (lot number reported as U458AB, not a valid lot number) on an unspecified date. Two days post-vaccination, she presented to the emergency department with complaints of a red raised area measuring 8 inches by 5 inches and chills. She was diagnosed with cellulitis. No additional information was reported, and outcome was unknown. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Pyrexia, Tremor
Clinical narrative: Shaking, low fever, disorientation.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: PAIN AT INJECTION SITE, FEVER, MUSCLE ACHES.
Sex: F
Vaccine: FLUX
Symptoms: Neurodegenerative disorder
Clinical narrative: This medically confirmed report (initial receipt 28-Feb-2014) concerns a female patient who had a medical history of cerebral palsy, peripheral neuropathy, an unspecified liver issue and a demyelinating disease. On an unspecified date many years ago, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed an unspecified neurodegenerative disorder after the administration of the influenza vaccine. Outcome was not reported.
Age: 0.3
Sex: F
Vaccine: MMR, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. On unknown date the patient was vaccinated with M-M-R II which is considered an inappropriate age. Route of administration, lot number, expiry date and anatomical location of vaccination were not reported. No adverse effects were reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Grip strength decreased, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 years old female patient with Temporomandibular joint syndrome (TMJ), depression and Gastrooesophageal reflux disease (GERD). His medical history included migraines, interstitial cystitis and exercise induced asthma. The patient had delivered a baby recently. The patient developed nausea and itching (date unspecified) after taking tramadol hydrochloride. On 30-JAN-2014 the patient was vaccinated with a 0.5ml dose of PNEUMOVAX23 (lot# J013345, expiry date: 11-JAN-2015) intramuscular, location unspecified. Concomitant therapies included with Tdap (manufacturer unspecified as reported) and RHOPHYLAC. On 31-JAN-2014 the patient developed "shooting arm pain", could not grip things with her left hand, had a fever of 103.1 F and she also developed injection site redness and swelling 14 hours after receiving PNEUMOVAX23. The patient received the PNEUMOVAX23 shortly after delivered a baby. This reaction occurred while she was already in the hospital because she delivered a baby recently. The pharmacist reported as of 02-FEB-2014 the fever was gone and as of 05-FEB-2014 the patient's pain was almost gone but the pharmacist did not know the status of the patient currently. No product quality complaints (PQC). Pharmacist requested a lot check for this PNEUMOVAX23. Hydrocodone with acetaminophen (manufacturer unknown) and ibuprofen 800mg were given as the treatment. The patient's temperature was taken for measure. The events were considered as disability (temporarily) by reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 years old female patient with Temporomandibular joint syndrome (TMJ), depression and Gastrooesophageal reflux disease (GERD). His medical history included migraines, interstitial cystitis and exercise induced asthma. The patient had delivered a baby recently. The patient developed nausea and itching (date unspecified) after taking tramadol hydrochloride. On 30-JAN-2014 the patient was vaccinated with a 0.5ml dose of PNEUMOVAX23 (lot# J013345, expiry date: 11-JAN-2015) intramuscular, location unspecified. Concomitant therapies included with Tdap (manufacturer unspecified as reported) and RHOPHYLAC. On 31-JAN-2014 the patient developed "shooting arm pain", could not grip things with her left hand, had a fever of 103.1 F and she also developed injection site redness and swelling 14 hours after receiving PNEUMOVAX23. The patient received the PNEUMOVAX23 shortly after delivered a baby. This reaction occurred while she was already in the hospital because she delivered a baby recently. The pharmacist reported as of 02-FEB-2014 the fever was gone and as of 05-FEB-2014 the patient's pain was almost gone but the pharmacist did not know the status of the patient currently. No product quality complaints (PQC). Pharmacist requested a lot check for this PNEUMOVAX23. Hydrocodone with acetaminophen (manufacturer unknown) and ibuprofen 800mg were given as the treatment. The patient's temperature was taken for measure. The events were considered as disability (temporarily) by reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Crying, Loss of control of legs, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient had delivered a baby on an unspecified date. On 30-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# J013345, expiry date: 11-JAN-2015) dose, route and location unspecified. After 14 hours the vaccination the patient developed "excruciating pain, that made the patient cry," unspecified swelling, overall weakness and patient's legs gave out as she was leaving the hospital (on an unspecified date). Pharmacist requested a lot check for this PNEUMOVAX23. At the time of the report, the outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Booster dose missed
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA (dose, frequency and route not specified). Concomitant medications were not reported. The physician reported that on an unknown date the patient has not had the recommended booster dose of VAQTA 6 to 18 months after receiving the first dose. The physician inquired if it had been years since the primary dose, would the recommendation be, to simply give the booster dose anyway or to start all over again. The outcome of not taking the booster dose was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (dose and lot number not reported) were administered by a clinic. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose number, route, lot number and expiry date unknown). On an unknown date the patient developed swelling at the injection site after administration of PNEUMOVAX 23. Patient sought medical attention. The outcome of swelling at the injection site was unknown. No further information provided. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, PPV, TDAP
Symptoms: Blood urine present, Injection site erythema, Injection site pain, Injection site warmth, Urine analysis abnormal
Clinical narrative: Erythematous, tender, warm area on (L) arm lower vaccine (9 x 4.5 cm) (PPV23) site of onset 12 hrs after injection; promptly resolved within 36 hrs upon onset of Prednisone.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male consumer of unknown age who reported on himself. It was reported that in January 2013 the patient was vaccinated with a 1st dose of GARDASIL (lot #, expiration date and dose was not reported) and on 04-MAR-2014 (reported also as today) he was vaccinated with his 2nd dose of GARDASIL (lot #, expiration date and dose was not reported). No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency unspecified). Concomitant medications were not reported. On an unknown date the patient experienced developed rash after receiving ZOSTAVAX. No product quality complaint was involved. The outcome of rash was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site vesicles, Rash vesicular
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via company representative refers to a 1 year old pediatric female patient. ON 13-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # H019521, expiry date 24-OCT-2014) injection (dose, strength and route were unspecified). Other suspect therapies included M-M-R II (lot # H018181, expiry date 10-MAY-2014) (dose, route, strength and indication not reported) and VAQTA (lot # J002347, expiry date 09-APR-2015) (dose, route, strength and indication not reported) both vaccinated on 13-SEP-2013. On approximately 27-SEP-2013 (two weeks later), the patient experienced "a crop of vesicles," at the VARIVAX (Merck) injection site. The patient was prescribed an unspecified anti-viral cream, which was applied to the site. After an unspecified period of time, the rash disappeared. The same patient experienced a second event on 10-FEB-2014. At this time "a shingles-like rash" in the "T2 Dermatome region," appeared. In this instance the patient again applied an unspecified anti-viral cream, along with BENADRYL and unspecified use of CLARITIN. It was reported that the "second" rash was "still present, but improving." The therapy was reported as not reintroduced. The patient requested physician appointment to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient had delivered a baby on an unspecified date. On 30-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# J013345, expiry date: 11-JAN-2015) dose, route and location unspecified. 14 hours after the vaccination (shortly after delivering a baby) the patient developed achiness, weakness and nausea. Pharmacist requested a lot check for this PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, expiration date, dose, route not reported). On an unknown date the patient experienced chickenpox. The reporter was unsure if the patient ever received VARIVAX (Merck) prior to developing the chickenpox. The outcome of chickenpox was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker (pharmacist technician) refers to a patient of unknown age and gender. The patient's medical history included been hospitalized at an unspecified hospital for an unspecified issue. On 27-FEB-2014, upon hospital discharge, the patient was vaccinated with PNEUMOVAX23 (25/0.5) lot # J014399 expiry date 20-NOV-2014 (dose and route not reported. Concomitant medication was not reported. On an unspecified date in 2014, the patient was readmitted to the hospital with cellulitis. The healthcare worker reported that the patient was given an unspecified antibiotic for treatment. The outcome of cellulitis was not reported. The event cellulitis was serious due to hospitalization. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 23 year old female patient with polycystic ovary syndrome, who had not her period in years (dates unspecified) and she was not sexually active. On 07-MAR-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number and expiration date not provided) injection (route, strength and dose not provided) and with the first dose of GARDASIL (route, strength, and dose not provided) (lot number and expiration date not provided). The patient sought unspecified medical attention. The reporter stated that the patient was pregnant. The Last Menstrual Period and Estimated Delivery Date were not known. No adverse effects was reported at that time. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Areflexia, Back pain, Balance disorder, Blepharospasm, CSF test abnormal
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram abdomen, Electrocardiogram, Fall
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Insomnia
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Muscular weakness, Musculoskeletal pain, Neck pain, Nerve conduction studies abnormal
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain, Paraesthesia, Sensation of heaviness, Urine analysis
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ataxia, Back pain, CSF protein increased, Guillain-Barre syndrome, Headache
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Insomnia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: 1/16/14 - Neck pain and shooting pain. 1/17/14 - excruciating back pain and across the shoulder blades. 1/20/14 - went to emergency room for the back pain. Blood work and urine tests were done, along with chest x-ray, CT scan of abdomen, and EKG. Rubbery legs. Instructed to follow up with PCP, which I did on 1/22/14 and was instructed to go to physical therapy. My legs felt rubbery, heavy, and weak. I was very unsteady and began tripping and falling. I had many sleepless nights due to severe pain. 1/27/14 - first physical therapy appointment. 1/30/14 - appointment with neurosurgeon who ordered a cervical MRI which I had done that day. I have been having numbness and tingling in toes. 1/31/14 - appointment with PCP and neurologist. Exam noted Areflexia in the lower extremities and I was admitted to hospital to have many tests done including cervical thoracic MRI, nerve conduction tests, and lumbar puncture. I had rib tightness and headaches. I was treated with IVIG for four days and was hospitalized for seven days. I am diagnosed with Guillain-Barre Syndrome. I was given prescriptions to take. I also had eye twitching and muscle spasms and I still experience numbness and tingling in my fingers and toes, still have back pain, and I currently go to Physical Therapy.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H018987 and expiry date 02-MAR-2014), 0.5 milliliter (ml), intramuscularly. No adverse effect reported. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Husband reports warm, red puffy reaction at injection site. Area measures about 1 x 3 inches.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, Erythema, Hypersensitivity, Injection site erythema, Injection site nodule
Clinical narrative: States after receiving vaccine (L) arm "felt like it was on fire" as walked to car; approximately 30 minutes later noticed (L) arm was red and felt knot near/at injection site. States started taking BENADRYL, by mouth, 3/7/14. By 3/8/14 - A.M. - states had swelling, heat, redness from (L) armpit to below elbow. States 3/8/14 saw MD "who I used to work for" - was told was allergic reaction. 3/11/14 - seen at DOH - has oval red, warm, swollen area on back of (L) upper arm - approximately 8 cm x approximately 6 cm.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Local swelling, Skin warm
Clinical narrative: States after receiving vaccine (L) arm "felt like it was on fire" as walked to car; approximately 30 minutes later noticed (L) arm was red and felt knot near/at injection site. States started taking BENADRYL, by mouth, 3/7/14. By 3/8/14 - A.M. - states had swelling, heat, redness from (L) armpit to below elbow. States 3/8/14 saw MD "who I used to work for" - was told was allergic reaction. 3/11/14 - seen at DOH - has oval red, warm, swollen area on back of (L) upper arm - approximately 8 cm x approximately 6 cm.
Age: 1.48
Sex: M
Vaccine: DTAP
Symptoms: Crying, Emotional distress, Hyperacusis
Clinical narrative: Increased sensitivity to noise, "meltdown" - crying, inconsolable day after immunization.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema
Clinical narrative: Pain, swelling, redness at injection site, noted 1 day after injection. Progressed to approximately 12 cm x 5 cm area of erythema and edema by day 3.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a female physician via a Company Representative, reporting on herself, a patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Patient stated that she received ZOSTAVAX and experienced unspecified an injection site reaction. The outcome of the event was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise
Clinical narrative: Soreness at site of injection, redness at site of injection (2 inches), general malaise. Occurred 2-3 days after administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: Mom states after vaccines she went to sleep. Woke up with rash and "knots" at vaccines. Was given "high dose steroids" at ER per mom.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash
Clinical narrative: Area was itchy, red, developed rash then blisters. Went to Dr's office who prescribed BACTRIM DS to prevent further infection. On 3/8/14 patient came to pharmacy. Area looked clear.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Facial pain, Lip swelling, Paraesthesia, Swelling face
Clinical narrative: Client experienced swollen lower lip and (L) side of face with dull pain and tingling sensation. Client took no treatment.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Skin warm, Swelling, Tenderness, Urticaria
Clinical narrative: Patient had onset of one large (5 cm) raised hive that was warm and tender to touch 1 hour after injection. Raised area grew to 7 cm and remained for 6 days. Patient was treated with Benadryl. On the 6th day, the large hive was replaced by 10 or more smaller hives ranging in size from 3 mm to 1.5 cm in a 7cm×7cm area. The following morning the hives had spread to 12cm×12cm area and were too numerous to count. A call was made to the administering practitioner's office to report reaction.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Local swelling, Malaise
Clinical narrative: On 3/12/14, 16 yo M presented to clinic for well adolescent visit. During visit, pt was ordered second injection of HPV vaccine IM (GARDASIL) [IMM75] (Order 175668570). First dose was administered on 9/9/13 with no documentation of adverse effects. At 0929, after obtaining verbal parental consent, 0.5 mL HPV Quadrivalent vaccine was injected into right deltoid (NDC: 0006-4045-41; Manu: Merck & Co. Inc; lot #J012212; exp: 2/18/2016). Pt was instructed to lay flat for 15 minutes per protocol. After 15 min, NA returned to room to assess pt. At that time, pt reported not feeling well. MD notified & pt exam found some arm swelling. Pt further reported elbow & back pain. Pt was administered diphenhydramine 25 mg PO & held in observation x 30 minutes. After observation, pt was administered a second dose of diphenhydramine 25 mg PO. Pt was then released in the care of his parent. On 3/12, pt's allergy profile was updated to include Gardasil (H Papillomavirus Vac,qval (pf)) (rxn: Swelling). Non-preventable event. Event reported to VAERS.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Local swelling
Clinical narrative: On 3/12/14, 16 yo M presented to clinic for well adolescent visit. During visit, pt was ordered second injection of HPV vaccine IM (GARDASIL) [IMM75] (Order 175668570). First dose was administered on 9/9/13 with no documentation of adverse effects. At 0929, after obtaining verbal parental consent, 0.5 mL HPV Quadrivalent vaccine was injected into right deltoid (NDC: 0006-4045-41; Manu: Merck & Co. Inc; lot #J012212; exp: 2/18/2016). Pt was instructed to lay flat for 15 minutes per protocol. After 15 min, NA returned to room to assess pt. At that time, pt reported not feeling well. MD notified & pt exam found some arm swelling. Pt further reported elbow & back pain. Pt was administered diphenhydramine 25 mg PO & held in observation x 30 minutes. After observation, pt was administered a second dose of diphenhydramine 25 mg PO. Pt was then released in the care of his parent. On 3/12, pt's allergy profile was updated to include Gardasil (H Papillomavirus Vac,qval (pf)) (rxn: Swelling). Non-preventable event. Event reported to VAERS.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Blood glucose normal, Convulsion, Full blood count normal, Metabolic function test normal, Postictal state
Clinical narrative: Short (<1min) generalized seizure followed by a 5 minute postictal state (drowsy, incontinent of urine). Seen in UCC where labs were all normal. No fever. Back to baseline. No treatment given. EEG ordered for future given past hx of ? seizure.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Somnolence, Urinary incontinence
Clinical narrative: Short (<1min) generalized seizure followed by a 5 minute postictal state (drowsy, incontinent of urine). Seen in UCC where labs were all normal. No fever. Back to baseline. No treatment given. EEG ordered for future given past hx of ? seizure.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling.
Age: 1.27
Sex: F
Vaccine: HEP
Symptoms: Blister, Skin exfoliation
Clinical narrative: On her vaginal area one blister popped up and it subsided and then lots of small blisters came and couple grow big and flake and since yesterday it is spreading to the her inner thigh.
Age: 1.19
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Hives immediately following vaccines at the site of injection (right thigh) resolved with Benadryl within 45 minutes.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Acoustic stimulation tests abnormal, Deafness, Headache, Tinnitus, Vertigo
Clinical narrative: Woke up with severe headache and vertigo.  Went back to sleep for a couple of hours, got up with same symptoms.  Called my family doctor at 8:30 a.m. and got appointment for 1:30 p.m.  Around 9:30 a.m. realized that I could not hear very well out of my left ear and a lot of ringing.  Went to see my family doctor and he got me in to see an ENT specialist that same afternoon.  Went thru a battery of hearing tests and found to have 85% hearing loss in my left ear and 25% in my right ear.  Put on high dosage of prednisone.  Went back a week later for more tests.  Hearing was at 65% loss in left ear and 20% in right ear.  Received a shot of prednisone to the ear canal.  Went back again 2 weeks later and the  hearing remains the same.  Tried on a hearing aid but decided to give it a couple more months.  Scheduled to go back to ENT doctor on March 20, 2014 for another test and will probably get the hearing aid as it has not gotten any better.  A lot of ringing in left ear and very hard to understand what is being said when in a room of more than 4 people for meetings, etc.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Heart rate increased, Pyrexia, Retching
Clinical narrative: 03/11/2014 Severe Other. Increased heart rate of 170, retching, and fever with TYLENOL.
Age: 43.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP, YF
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: 3 1/2 days after vaccines pt. noted low grade fever, very tired. Lymph nodes swollen under right side chin and under arm on right side. Dissipated by Sat (3-8-14) afternoon. No problems when I spoke to patient 3-10-14.
Age: 53.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Vomiting, abdominal cramping and loose stools.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Lymphadenopathy, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patient had congenital hearing loss. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. On an unknown date after receiving ZOSTAVAX, the patient lost all hearing abilities (medically significant), developed rash on her face and developed swollen glands. Patient was treated with unspecified steroids. The outcome of lost all hearing abilities and rash on her face was reported as recovering, reporter stated that some of her hearing has come back but not all of it and her rash was little bit better. The outcome of developed swollen glands was unknown. Upon internal review the event of lost all hearing abilities was considered to be medically significant. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Febrile convulsion, Upper respiratory tract infection
Clinical narrative: Simple febrile seizure - patient also had URI sx at the time of seizure.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Dyspnoea, Influenza virus test, Respiratory syncytial virus test, Wheezing
Clinical narrative: Wheezing, difficulty breathing.  Worsened over the night and by March 6 was admitted to the hospital.  Required 3 day hospital stay on oxygen, steroids, and albuterol.
Age: 36.0
Sex: M
Vaccine: FLU4, HEP, MMR, MNQ, TDAP, TYP
Symptoms: Rash erythematous
Clinical narrative: Pt reports he has a rash that started on his abdomen and back. Within 1-2 hours spread to include some of his chest, possibly some on his inner arm bicep area (these later resolved) and also on his feet, ankles and up to his mid-calf area on both feet and legs. He reports he doesn't have any signs of fever, chills, itching, pain, discomfort. He feels "ok". Rash is described as small red dots that look like "hair follicles" but are not raised. I encouraged him to take some Benadryl and monitor closely. If sx worsen or rash spreads more, he should see Dr. ASAP. If he continues to feel okay and sx don't worsen we will monitor closely until Friday when he already has a Dr. apt scheduled.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Endotracheal intubation, Guillain-Barre syndrome, Paraesthesia, Paralysis
Clinical narrative: Onset of progressive tingling in hands and feet progressing to weakness and paralysis. Hospitalized on 05 March, intubated on 07 March. Diagnosed with Guillain-Barre syndrome.