chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with ZOSTAVAX (dose and route of administration were not provided, lot # M028798 with expiration date 18-AUG-2017), which were improperly stored (temperature excursion 6.8 F for 6 hours on 28-OCT-2016 and 6.44F for 4 hours and 30 minutes on unspecified date). No adverse experiences were reported. Data logger was involved. This is one of several reports received. Additional information has been requested. Sender's Comments: US-009507513-1612USA006421.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 84 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 75 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 71 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 64 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. In December 2015 (reported as on an unspecified date one year ago), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On 07-DEC-2016, the patient was vaccinated with another dose of PNEUMOVAX23 (dose, route, lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with VARIVAX (dose and route of administration were not provided, lot # M028798 with expiration date 18-AUG-2017), which were improperly stored (temperature excursion 6.8 F for 6 hours on 28-OCT-2016 and 6.44F for 4 hours and 30 minutes on unspecified date). No adverse experiences were reported. Data logger was involved. This is one of several reports received. Additional information has been requested. Sender's Comments: US-009507513-1611USA008845.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Injection site cellulitis, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 08Sep2016 at 9:00 am or 10:00 am at 0.5 ml single dose for immunization. Medical history included high cholesterol, Hashimoto's disease, type 2 diabetes, knee replacement (Both knees done 19 years ago), hip replacement (Left hip replaced 7 years ago; Right hip replaced 5 years ago); all on unknown dates. Concomitant medications included ongoing LIPITOR 20 mg daily since 1999, metformin 500 mg, 2x/day ongoing since 2008, and SYNTHROID 137 ug, 1x/day ongoing since 1990. The patient also received aspirin, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide, (PRESERVISION AREDS 2), triamterene / hydrochlorothiazide (75/50mg), KEFLEX 500 mg capsule oral, 1 capsule, three times a day, for 7 days, and prednisone (50 mg tablet) oral, 1 tablet every day, with food, for 5 days. The patient previously received a pneumococcal vaccine for immunisation on an unknown date about 8-9 years ago. She stated that many years ago had a reaction to a product made with duck eggs. On 10Sep2016, the patient reported arm was red and had very warm area on arm, in an area about 6 inches. She was diagnosed an allergic reaction with cellulitis of left upper arm. She received unspecified treatment and recovered.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Initial unsolicited misuse report received from a consumer (patient herself) on 01 December 2016. This case involves a 35-year-old female patient who was vaccinated with a dose of Fluzone NP (Batch number: UI629AA, expiry date: 30 June 2017, dose and dose in series were not reported and route of administration was reported as subcutaneous or intramuscular) in the left deltoid on 12 October 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. The patient stated she experienced low grade fever of 99 degree Fahrenheit and general body aches every year after she had received a flu shot. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 15 October 2016, three days following the vaccination, the patient had developed low grade fever of 99 degree Fahrenheit and general body aches. Patient stated that she did not need to be seen by her physician. It was reported that dose of Fluzone NP might have been administered more subcutaneous than intramuscular. It was a case of inappropriate route of vaccination. Laboratory investigations were not reported. Corrective treatment was not reported. It was reported that she did not need to self-treat her symptoms. The patient was recovered from events on an unknown date. List of the documents held by sender: none
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Bilirubin urine present, Blood urine present, Chromaturia, Protein urine present, White blood cells urine positive
Clinical narrative: Initial unsolicited report received from a nurse via other company (Merck) on 02-Dec-2016. This case involves a four-year-old female patient who was vaccinated with a dose of Fluzone Quadrivalent (Batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of KINRIX (manufacturer: other, batch number, expiration date, dose, dose in series, route and site of administration were not reported), and 0.5 ml single dose of PROQUAD (Batch number: L045676, expiration date: 09-May-2017, dose in series and site of administration were not reported) subcutaneously all on 10-Nov-2016 (reported as given on the same office visit). The patient's pertinent (relevant) medical history and allergies were reported as none. The patient was receiving unspecified pediatric multivitamin with fluoride as concomitant medication. On 18-Nov-2016, eight days following vaccination the patient's mother reported that patient experienced dark urine that was 'sinking to the bottom of the toilet'. The patient was seen in the office by physician assistant on 21-Nov-2016. Laboratory investigations included urinalysis done on 21-Nov-2016 which revealed brown turbid urine with positive results for blood (positive 1), bilirubin (positive 1), protein (positive 3) in urine along with traces of leucocytes. The patient was to return for blood tests and ultrasound on the same day. The patient did not receive any corrective medication. The outcome of the event was not reported. List of documents held by the sender: None.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase normal, Decreased eye contact, Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: On day 1 had sx of diffuse myalgias, feet feel puffy like walking on gel, pt looked tired and had trouble making eye contact. On day 8 patient reported tingling/numbness of feet and 9/10 pain in the rest of his body. Was using TYLENOL 1000mg 3-4 times daily, then tried naproxen 400mg twice daily. Patient went to ER on day 9 and was admitted to the hospital. The Neurologist diagnosed him with Guillain Barre associated with PREVNAR 13 administration. He was treated with IVIG. Discharged on day 13. Post discharge patient is recovering with weakness and aching in legs, which is relieved by hydrocodone. Patient is still recovering. Acetaminophen 1000 mg QID, naproxen 440 mg BID, acetaminophen/hydrocodone 1-2 tab every day.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Immunoglobulin therapy, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: On day 1 had sx of diffuse myalgias, feet feel puffy like walking on gel, pt looked tired and had trouble making eye contact. On day 8 patient reported tingling/numbness of feet and 9/10 pain in the rest of his body. Was using TYLENOL 1000mg 3-4 times daily, then tried naproxen 400mg twice daily. Patient went to ER on day 9 and was admitted to the hospital. The Neurologist diagnosed him with Guillain Barre associated with PREVNAR 13 administration. He was treated with IVIG. Discharged on day 13. Post discharge patient is recovering with weakness and aching in legs, which is relieved by hydrocodone. Patient is still recovering. Acetaminophen 1000 mg QID, naproxen 440 mg BID, acetaminophen/hydrocodone 1-2 tab every day.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia, Peripheral swelling, Red blood cell sedimentation rate normal, Vaccination complication
Clinical narrative: On day 1 had sx of diffuse myalgias, feet feel puffy like walking on gel, pt looked tired and had trouble making eye contact. On day 8 patient reported tingling/numbness of feet and 9/10 pain in the rest of his body. Was using TYLENOL 1000mg 3-4 times daily, then tried naproxen 400mg twice daily. Patient went to ER on day 9 and was admitted to the hospital. The Neurologist diagnosed him with Guillain Barre associated with PREVNAR 13 administration. He was treated with IVIG. Discharged on day 13. Post discharge patient is recovering with weakness and aching in legs, which is relieved by hydrocodone. Patient is still recovering. Acetaminophen 1000 mg QID, naproxen 440 mg BID, acetaminophen/hydrocodone 1-2 tab every day.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Angiogram, Chest pain, Computerised tomogram, Decreased appetite, Decreased interest
Clinical narrative: Started feeling more tired, lethargic, not as hungry, falling asleep at work, lost interest in activities within several days after vaccine. Went to ER with more acute symptoms on 10/29/16 of pain between shoulder blades, chest, down left then right arms, led to paralysis of hands, lower body. Transverse myelitis.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Laboratory test, Lethargy, Musculoskeletal pain, Myelitis transverse
Clinical narrative: Started feeling more tired, lethargic, not as hungry, falling asleep at work, lost interest in activities within several days after vaccine. Went to ER with more acute symptoms on 10/29/16 of pain between shoulder blades, chest, down left then right arms, led to paralysis of hands, lower body. Transverse myelitis.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paralysis, Somnolence
Clinical narrative: Started feeling more tired, lethargic, not as hungry, falling asleep at work, lost interest in activities within several days after vaccine. Went to ER with more acute symptoms on 10/29/16 of pain between shoulder blades, chest, down left then right arms, led to paralysis of hands, lower body. Transverse myelitis.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Erythema, Injection site pain, Malaise, Rash vesicular
Clinical narrative: Pt vaccinated on 9/9/16 on 9/22 pt was seen for pain at injection site, had an area of vesicular rash with surrounding erythema, also runny nose, cough and malaise treated with valacyclovir 500mg 2 tabs TID x 7 days.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Varicella virus test
Clinical narrative: Pt vaccinated on 9/9/16 on 9/22 pt was seen for pain at injection site, had an area of vesicular rash with surrounding erythema, also runny nose, cough and malaise treated with valacyclovir 500mg 2 tabs TID x 7 days.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Lethargy
Clinical narrative: Patient experienced 24 hours of severe lethargy and abdominal pain.
Age: 17.0
Sex: F
Vaccine: DTAP, HEP, HPV4, MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE EVENT, ONLY DTaP WAS GIVEN BY MISTAKE INSTEAD OF TD, PT DIDN'T REPORT ANY ADVERSE SYMPTOM.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bronchospasm, Cough, Immediate post-injection reaction, Incorrect route of drug administration
Clinical narrative: I felt my legs getting weak, felt malaise immediately after, felt weak.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Muscular weakness
Clinical narrative: I felt my legs getting weak, felt malaise immediately after, felt weak.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blood test, Burning sensation, Computerised tomogram, Guillain-Barre syndrome
Clinical narrative: Flu vaccination administered on 11-7-2016. On 11-13-2016, woke up at 3:00 AM and described "left leg on fire". Gradually progressed over next two days to both legs and hands. Could no longer walk. Was hospitalized for approx 11 days, treated for GBS. Now in rehab hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: Flu vaccination administered on 11-7-2016. On 11-13-2016, woke up at 3:00 AM and described "left leg on fire". Gradually progressed over next two days to both legs and hands. Could no longer walk. Was hospitalized for approx 11 days, treated for GBS. Now in rehab hospital.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Patient began to feel faint and nauseous immediately following vaccine. Monitored patient for 30 min. including BP and Glucose. Patients daughter came and picked her up.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Within 24 hrs she experienced swelling, redness, soreness, itching in arm where injection was given, but not at injection site (Right arm). Took 25 mg BENADRYL on Tuesday night. Not much better. Did not see her doctor. Still has symptoms as of 12-7-16. 12-8-16 - Patient states it is "getting better".
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Charted as left deltoid but patient reports was her right. Pain reduced left deltoid ROM, stiffness. Currently only 75% better after 7 weeks.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Pain
Clinical narrative: Pain at injection site, rash, whole tricep swollen, chills, shaking, extreme fatigue, loss of appetite, achiness.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash, Tremor
Clinical narrative: Pain at injection site, rash, whole tricep swollen, chills, shaking, extreme fatigue, loss of appetite, achiness.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Dizziness, Productive cough
Clinical narrative: Severe weakness. Back pain. Progressive and worsening productive coughing. Dizziness.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: SWELLING OF ARMS AND EYES.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Well child visit-pulled immunization from stock-HepA-HAVRIX-Failed to read age on box and gave adult dose which is twice the vaccine amount.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Initially, upper arm was stiff and a bit sore. This has continued since 10/2/16 when shot was administered. When upper arm is still, there is no pain, but I no longer have a full range of motion without pain. This does not disable me but I keep hoping pain will go away.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Pharyngeal oedema, Presyncope
Clinical narrative: Vaccination given appx. 2PM on Tuesday, 11/29. At 2:15 PM, went to ED w/throat swelling, dizziness (to the point of near fainting); clamminess. Symptoms resolved by the time seen in ER-no treatment received.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness, swelling, hot on upper left arm. Pain worsen over 2 days. Sent to urgent care clinic.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: After receiving flu vaccine, experienced moderate to severe aching pain at site, (R) shoulder. Difficulty lifting arm, increased pain when resting on (R) shoulder. Symptoms have been ongoing since time of flu shot.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis to (R) hip/GM.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Computerised tomogram, Episcleritis, Eye pain, Face and mouth X-ray abnormal
Clinical narrative: 2 weeks after flu shot was given, pt had horrible (L) sided eye/forehead pressure and pain. Almost a week later moved to (R) side. Went to MD - XR showed fluid behind sinuses. Took amoxicillin - then had CT - clear. Had to go to eye doctor - he diagnosed episcleritis. Said it could have come from the flu shot.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Headache, Ocular discomfort
Clinical narrative: 2 weeks after flu shot was given, pt had horrible (L) sided eye/forehead pressure and pain. Almost a week later moved to (R) side. Went to MD - XR showed fluid behind sinuses. Took amoxicillin - then had CT - clear. Had to go to eye doctor - he diagnosed episcleritis. Said it could have come from the flu shot.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: This solicited report has been received from the patient's mother referring to her daughter, a female pregnant female of unknown age who was enrolled in a Patient Support Program. The patient's pertinent medical history, drug reaction/allergies or concomitant medication information was not reported. In approximately 2010 (reported as "about six years ago"), while she was pregnant, the patient received a dose of GARDASIL (route, dosage schedule, lot # and expiration date were not reported) for prophylaxis (exposure during pregnancy). The LMP and EDD was unknown at the reporting time. On an unknown date, the patient had a son who is now experiencing an adverse event (case #: 1612USA000539). This is one of two reports received from the same reporter. Additional information is not expected as the reporter refused contact for follow up. Sender's Comments: US-009507513-1612USA000539.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 70 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014127: US-009507513-1611USA014128.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Discomfort, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: I received the flu vaccine at primary's office to my (R) deltoid and within 45 mins-1 hour I started feeling pain to my (R) arm that progressed to my shoulder joint area. I thought it was expected discomfort from injection, but its been almost 2 months and the pain is worse. It's constant pain that affects my sleep and ADL's.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 67 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014128.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a currently 69 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2016, the patient was diagnosed the shingles. The outcome of shingles was unknown. The relatedness between vaccination with ZOSTAVAX and the shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot # K016966 expiry date: 10-MAY-2017, lot # L040460 expiry date: 27-MAY-2017 and lot M018810 expiry date: 28-MAY-2018) for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours (incorrect product storage). The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA006420: US-009507513-1612USA006419.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 expiry date: 11-AUG-2017 and lot L024993 expiry date: 17-OCT-2017) for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours. The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006420: US-009507513-1612USA001439.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot # L035510 expiry date: 13-MAY-2017 and lot # M025565 expiry date: 06-NOV-2017 for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours (incorrect product storage). The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006419: US-009507513-1612USA001439.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A currently 79-year-old female patient of an unspecified ethnicity started to receive levofloxacin (MANUFACTURER UNKNOWN), MOBIC, and CELEXA; all via unspecified routes of administration on unspecified dates at unspecified doses for unspecified indications and received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) via an unspecified route of administration at a single dose for immunization on an unknown date. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced drug allergies to levofloxacin, meloxicam, pneumococcal 13-valent conjugate vaccine, and citalopram hydrochloride. The action taken in response to the events for levofloxacin was unknown, for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine was not applicable, for meloxicam was unknown, and for citalopram hydrobromide was unknown. The clinical outcome of the event, drug allergies to levofloxacin, meloxicam, pneumococcal 13-valent conjugate vaccine, and citalopram hydrobromide, was unknown. Pfizer is Marketing Authorization Holder of levofloxacin and pneumococcal 13-valent conjugate vaccine in the reporter's country. This may be a duplicate report in situations where other Marketing Authorization Holder(s) of levofloxacin and pneumococcal 13-valent conjugate vaccine has/have submitted the same report to the regulatory authorities.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for 71-year-old female patient that received PREVNAR 13 at single dose for immunization duloxetine HCL, LYRICA, PLAVIX, TYLENOL, diazepam, hydrochlorothiazide and codeine sulfate, route of administration, dose date and indication were not reported. Relevant medical history and concomitant medication were not specified. On unknown date the patient experienced an allergic reaction. Pfizer is Marketing Authorization Holder of diazepam in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of diazepam has submitted the same report to the regulatory authorities.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Nasal congestion, Nasal mucosal disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 87-year-old female patient received PREVNAR 13; (NDC number: 0000197102; Lot R45377; Expiry Date: Dec2017), via an unspecified route of administration on 28Nov2016 at 0.5 ml, single on left deltoid  for immunisation. Medical history was none. Concomitant medication included tramadol 50 mg 4x/day, LIPITOR 10 mg daily, omeprazole 20 mg 2x/day, nortriptyline 10 mg 1x/day and buspirone 5 mg daily.  On 29Nov2016 the patient experienced stuffy and mucusy nose; on 05Dec2016 her arm was red around injection site. The outcome of the events was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient in her 2nd decade (a college freshman, either 18 or 19 years old) received TRUMENBA on an unknown date, at single dose, for immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced headache on an unknown date. Event outcome was unknown. No follow-up attempts possible. No further information expected.
Age: 75.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Dizziness, Productive cough
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient received PREVNAR 13, via an unspecified route of administration in the right arm, in Nov2016, at 0.5 ml single, for immunisation and FLUZONE, via an unspecified route of administration in the right arm, in Nov2016, at 0.5 ml single, for antiviral prophylaxis. The patient received the vaccines the same day (17Nov2016 or 18Nov2016) at a pharmacy. Medical history included diabetes mellitus from 1991 and ongoing diagnosed in the summer of 1991, ongoing diabetic nephropathy diagnosed 12 to 13 years before, nephrectomy from 1991 to an unknown date (right kidney), ongoing chronic kidney disease diagnosed 3 to 3 and 1/2 years before, ongoing cardiac disorder, ongoing thyroid disorder, ongoing asthenia (due to thyroid), ongoing sleep disorder, ongoing depression, ongoing anxiety, diabetic neuropathy, history of a lot of pneumonias over the years and ongoing renal disorder. Concomitant medication included glimepiride (unspecified trade name) from an unspecified date in 2016 (started taking about 6 or more months before) and ongoing for renal disorder, AMITRIPTYLINE HCL from an unspecified date (started taking about 20 to 25 years ago) and ongoing for depression and sleep disorder, lorazepam (unspecified trade name) from an unspecified date (started taking at least 7 or 8 years before) and ongoing for anxiety, gabapentin (unspecified trade name) from an unspecified date (started taking about a year and a half before) and ongoing for diabetic neuropathy (when first started taking had to cut the dose due to having a lot of problems with it, since then has been able to go back to the 300 mg dose), levothyroxine (unspecified trade name) from an unspecified date (started taking a couple of years before) and ongoing for thyroid disorder, simvastatin (unspecified trade name) from an unspecified date (started taking  2 to 3 years before) and ongoing for renal disorder and cardiac disorder. The patient experienced Pneumonia like symptoms clarified as weakness, dizziness, coughing up yellow mucus that turned to green mucus and is now green and brown mucus, fluid builds up all on 01Dec2016 with outcome of not recovered. Therapeutic measures were taken as a result of the events and included treatment with rubbing alcohol in mouth to try to keep the mucus down. He was swishing the rubbing alcohol in mouth which he reported that it burn some so he thought this was helping. He planned to go to hospital.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Crying, Moaning, Screaming
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 02 December 2016. This case involves a 2-months-old female patient who was vaccinated with a dose of DAPTACEL (batch number- C5148AA, expiratory date-02 September 2019) via intramuscular route in right site of administration; ACTHIB (batch number- UI549AA, expiration date was not reported) via intramuscular route in right site of administration; ROTAVIRUS other company product (Merck) (batch number- L008997, expiration date was not reported) via oral route of administration and site of administration was not reported (dose in series was not reported for all vaccines) on 26 October 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Concomitant medications were not reported. On 27 October 2016, one day following the vaccination, the patient had experienced moaning, crying and screaming even at rest for 4 days straight. It was reported as unknown if patient was febrile. Relevant laboratory data and corrective treatment was not reported. On an unspecified date the patent was recovered from events. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness near injection site that migrated toward elbow. Pt was seen at a urgent care diagnosed w/possible cellulitis and given doxycycline oral antibiotic.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Chest X-ray, Cough, Injection site bruising, Nasal congestion, Respiratory tract congestion
Clinical narrative: Within 2 days of influenza high dose vaccine I experienced nasal and chest congestion, post nasal drip, severe cough. After 5 days and nights I went to E.R. had x ray to find I had pneumonia. RX Zpack for 5 days Also-severe bruise (L) arm upper.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Within 2 days of influenza high dose vaccine I experienced nasal and chest congestion, post nasal drip, severe cough. After 5 days and nights I went to E.R. had x ray to find I had pneumonia. RX Zpack for 5 days Also-severe bruise (L) arm upper.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood test normal, Dizziness, Gait disturbance, Headache
Clinical narrative: I started seeing stars in my right eye, which continued to blur my vision as I developed a severe headache in my left temple. I felt dizzy and nauseous. I had to have two people help me walk, because I couldn't balance myself. It felt as if someone was controlling my right leg when I walked, and I was concerned I was having a stroke.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vision blurred
Clinical narrative: I started seeing stars in my right eye, which continued to blur my vision as I developed a severe headache in my left temple. I felt dizzy and nauseous. I had to have two people help me walk, because I couldn't balance myself. It felt as if someone was controlling my right leg when I walked, and I was concerned I was having a stroke.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, X-ray
Clinical narrative: Immediately following administration of flu vaccine I experienced severe pain in (L) shoulder and upper arm. Had extreme pain when trying to move shoulder for 3 days. Pain with limited range of motion still has not resolved as of 12/8/16.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Laboratory test normal
Clinical narrative: Pink patches developed on upper right arm; vaccinated on right arm. 2 patches were on the outside of right arm, the size of a small egg, and one large patch, on inner right bicep, about 60% of area. I, his brother/caregiver didn't notice until Sept. 08, 2016, when giving my brother a bath.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, Balance disorder, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a 76-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). The patient's past medical history included stroke (experienced in 1980 and took anticoagulants). Concurrent medical conditions included renal stone (too large to pass and the patient was placed on antibiotics), urinary tract infection (white blood count was very high) and walker user. On 7th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th November 2016, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), weakness (serious criteria hospitalization) and balance disorder (serious criteria hospitalization). On an unknown date, the outcome of the Guillain Barre syndrome, weakness and balance disorder were not recovered/not resolved. The reporter considered the Guillain Barre syndrome, weakness and balance disorder to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the patient's daughter. Concomitant medication included anticoagulants. On 5th November 2016, the patient was admitted to the hospital and was diagnosed with a kidney stone and a urinary tract infection (UTI). She was placed on a large dose of antibiotics and a stent was put in. The patient remained in the hospital until 10th November 2016. When the patient was released from the hospital, she went to a rehab facility. She at first felt off balance and weaker and eventually needed an aid's assistance to walk. As a result of her stroke in 1980, the patient occasionally used a walker in public but was able to drive and walk around in her house. The patient told the aids at the rehab center that she needed to go to the hospital. On 13th November 2016, the patient was admitted to hospital and she stayed until 27th November 2016. While in the hospital for the 2nd time, a number of procedures including a lumbar puncture were performed to try and determine why the patient was unable to walk and becoming weaker. She was diagnosed with Guillain Barre. At the time of reporting, the patient was in a rehab center. The reporter had a form that stated the information was reported on behalf of a nurse but she was not sure this is the same nurse who administered the vaccine. This case might be legally significant as the patient's daughter seemed to be more upset at the facility for administering the vaccine when the patient was already fighting with the infection.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blindness transient, Dizziness, Head injury, Headache, Vision blurred
Clinical narrative: Received vaccine 12/6/16 no adverse symptoms or events until 12/7/16 at 0515 while pt in shower. Pt began to feel lightheaded, dizzy, (+) blurred vision. About 30 sec couldn't see. No LOC. Hit head (right side). Frontal H/A rates 2/10. Negative for N/V.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and severe pain occurred in upper right arm early evening after injection. Called pharmacist who advised using arm, and applying heat. Applied heat as instructed. On 12/09/2016 could not use arm due to severe pain. Continued heat as instructed by pharmacist. On 12/10/2016 awoke to redness and swelling in upper arm from injection site to elbow and around back of arm to elbow. Severe pain continued. Daughter took me to Hospital treatment center where I was diagnosed with cellulitis of the right arm. Heat treatment canceled and antibiotic started. Saw MD on 12/11/16 who continued antibiotic and will see MD on 12/18/16 for continued care.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Upper arm soreness at site of injection.
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted approximately 5 minutes after receiving Varicella and HPV vaccine. Patient unconscious for appx. 10 seconds. Patient slow to recover. EMT called.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received FLUZONE HD and PNEUMOVAX in arm 10/13/16. Contacted pharmacy 11/28/16 to complain of persistent shoulder pain has seen dr. and been to physical therapy, but pain persists.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Symptoms started on 11/17/16 around 2:00pm by patient experiencing pain in arm. She looked at arm around 8:00pm and seen redness and swelling down on (R) antecubital. Patient in on 11/18/16 at 12:00pm and arm antecubital to 3 inches above and across width of arms red, swollen and tender to touch.