chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Needle issue, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical histories, current condition, reactions and allergies were not reported. On 11-AUG-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU (dosage regimen were not reported) (lot # M014310, Expiry date: 26-MAY-2017) subcutaneous, but the "hub of the needle came loose and the ZOSTAVAX 19400 PFU leaked out and ran down the patient's arm". Pharmacist reports that the patient experienced no adverse effects (no adverse event), from the topical exposure from ZOSTAVAX 19400 PFU. Pharmacist reported that "because the first dose was less than the recommended 0.65 ML, the pharmacist administered another 0.65 ML dose of ZOSTAVAX 19400 PFU" (same lot/expiry date and the previous dose). No adverse effects reported. No additional information was provided. No Product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M020926 and expiry date 11-AUG-2018)(dosing regimen unknown). No adverse effects reported. The vaccine was exposed to temperature excursion of 61 F for 39 hours. No previous temperature excursion was reported. No product quality complaint was filed. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 12 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that patient received his first dose of GARDASIL 9 (dosing details were not reported) in August 2015 and a 2nd dose of GARDASIL 9 in August 2016 (inappropriate schedule of drug administration). The patient has come to the physician office for his third dose of GARDASIL 9 on 14-NOV-2016. It is unknown whether the 3rd dose of GARDASIL 9 was administered. The lot and expiration dates for all doses of GARDASIL 9 are unknown. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 7 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-NOV-2010, the patient was vaccinated with VARIVAX, lot number as reported 0437Z, (route, anatomical location and expiration date were not reported). Moreover, on 03-OCT-2014, the patient was vaccinated with PROQUAD lot number K007799 (route, anatomical location and expiration date were not reported). On 05-NOV-2016, the patient experienced the chicken pox. On 07-NOV-2016 the patient went to visit the doctor. On 10-NOV-2016, the patient did recover from the chicken pox. At the time of reporting, the relatedness between the varicella and the therapy with VARIVAX and PROQUAD was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of M-M-R-II (lot# as M007279, expiry date: 09-FEB-2018, lot # M004899, expiry date: 27-JAN-2018) (route: subcutaneous) that was exposed to 52.2F for 3.5 hours. No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of GARDASIL 9 (lot# M023169, expiry date: 13-JUN-2018) that was exposed to 52.2F for 3.5 hours (incorrect product storage). No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician and his medical assistant refers to a 14 year old patient. Pertinent medical histories, current condition, reactions and allergies were not reported. On 21-JUL-2014, the patient was vaccinated with GARDASIL (dosage regiment were not reported) (lot # J006850, expiry date: 31-MAR-2016), intramuscular and a dose of GARDASIL 9 (dosage regiment were not reported) (lot # L014415, Expiry date: 25-JUL-2017) on 20-AUG-2015 (patient experienced inappropriate schedule of drug administration and incorrect drug administration duration). Concomitant medications were not reported. The patient has not experienced an adverse effect. No additional information was provided. No Product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager (other health professional) refers to a patient of unknown age. Pertinent medical histories, current condition, reactions and allergies were not reported. On 31-OCT-2016, the patient was received an improperly dose of ZOSTAVAX (Dosage regimen were not reported) (lot # M028798, expiration date: 18-AUG-2017), intramuscular. Following temperature of 8.1 F for 43 minutes with data logger. Concomitant medications were not reported. No adverse effects were reported (no adverse event). No further details were provided. No Product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 04-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M014301, expiry date: 22-SEP-2017) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of -0.13 degree C for 5.75 hours. The vaccine had a previous temperature excursion of -14.93 degree C for 15 minutes and -14.48 degree C for 15 minutes. Data logger was involved. No known adverse effects. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cough, Feeling abnormal, Pneumonia, Respiratory distress, Respiratory tract congestion
Clinical narrative: This spontaneous report as received from a company representative, reported by nurse refers to a 68 year old female patient. Medical history and current conditions were not reported. Concomitant medications were not reported. On 25-AUG-2016 the patient was vaccinated with PNEUMOVAX 23. On 07-SEP-2016 presented back to the office with cough and congestion that lasted for 6 days. On the 8-SEP-2016 she returned to office, feeling worse and was sent for an x-ray next day. The doctor suspected pneumonia and the patient was diagnosed in the hospital or emergency room, and treated with unspecified antibiotic and the patient progressively got worse. On an unknown date in 2016, just a couple of days after that, the patient presented in the emergency room and ended up staying a week in the hospital, "O2 sat of 84" (as reported). The pneumonia was ruled out and doctor decided that it was a severe reaction, respiratory distress reaction to PNEUMOVAX 23. The patient is alive and was dismissed from the emergency room. The outcome of respiratory distress was unknown. The reporter considered the event respiratory distress to be related to the suspect therapy. The reporter did not provide the causality between the event pneumonia and the suspect therapy. Upon internal review, the events respiratory distress and pneumonia were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a company representative, reported by nurse refers to a 68 year old female patient. Medical history and current conditions were not reported. Concomitant medications were not reported. On 25-AUG-2016 the patient was vaccinated with PNEUMOVAX 23. On 07-SEP-2016 presented back to the office with cough and congestion that lasted for 6 days. On the 8-SEP-2016 she returned to office, feeling worse and was sent for an x-ray next day. The doctor suspected pneumonia and the patient was diagnosed in the hospital or emergency room, and treated with unspecified antibiotic and the patient progressively got worse. On an unknown date in 2016, just a couple of days after that, the patient presented in the emergency room and ended up staying a week in the hospital, "O2 sat of 84" (as reported). The pneumonia was ruled out and doctor decided that it was a severe reaction, respiratory distress reaction to PNEUMOVAX 23. The patient is alive and was dismissed from the emergency room. The outcome of respiratory distress was unknown. The reporter considered the event respiratory distress to be related to the suspect therapy. The reporter did not provide the causality between the event pneumonia and the suspect therapy. Upon internal review, the events respiratory distress and pneumonia were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of PROQUAD (Lot # M022401, expiry date: 01-NOV-2017; Lot # M019233, expiry date: 17-OCT-2017; Lot # M004891, expiry date: 25-JUL-2017) that was exposed to 52.2F for 3.5 hours. No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Muscle tightness
Clinical narrative: Muscle spasm, back tightening within 10 min of administration.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: At 245PM - Zoster vaccine administered on (L) deltoid. Pt. tolerated well. At 125pm - monitored patient; C/O mild itching on nose and arms, denies shortness of breath, no anaphylactic shock, no wheezing, no hives, throat not swollen. Patient able to swallow and speak. Respiration even and non labored. Non diaphoretic. No fever. AAOX4. Notified Provider at 0130 vital signs WNL and BENADRYL/25mg PO STAT ordered. At 210pm evaluated by Dr. At 220pm patient discharged in good condition in no acute distress.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Dizziness & nausea - feeling faint approximately 20 min after vaccination. Several hours later: weakness, fatigue, loss of appetite, severe arm and shoulder muscle pain - swollen. Unable to lift my left arm without severe pain. Moderate fever. fast heartbeat. I did not go to the doctor as I thought symptoms might pass. As of 11/20/2016 most symptoms gone except for fatigue and mild shoulder pain. I can now lift my arm with slight pain. I took Aleve and applied ice pack and then heat to my shoulder. Not much relief from either.  I have never had this kind of reaction from a vaccination. I have not informed my doctor or the pharmacy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Dizziness & nausea - feeling faint approximately 20 min after vaccination. Several hours later: weakness, fatigue, loss of appetite, severe arm and shoulder muscle pain - swollen. Unable to lift my left arm without severe pain. Moderate fever. fast heartbeat. I did not go to the doctor as I thought symptoms might pass. As of 11/20/2016 most symptoms gone except for fatigue and mild shoulder pain. I can now lift my arm with slight pain. I took Aleve and applied ice pack and then heat to my shoulder. Not much relief from either.  I have never had this kind of reaction from a vaccination. I have not informed my doctor or the pharmacy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Dizziness & nausea - feeling faint approximately 20 min after vaccination. Several hours later: weakness, fatigue, loss of appetite, severe arm and shoulder muscle pain - swollen. Unable to lift my left arm without severe pain. Moderate fever. fast heartbeat. I did not go to the doctor as I thought symptoms might pass. As of 11/20/2016 most symptoms gone except for fatigue and mild shoulder pain. I can now lift my arm with slight pain. I took Aleve and applied ice pack and then heat to my shoulder. Not much relief from either.  I have never had this kind of reaction from a vaccination. I have not informed my doctor or the pharmacy.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blister, Erythema, Feeling cold, Malaise, Pain in extremity
Clinical narrative: I woke up to severe pain in my left arm, I felt very ill and very cold. I checked my temperature and it read 100.9. I took my medications which included 1 Lortab 7.5 mg. 1 ibuprofen 800 mg. and 1 OxyContin 20 mg. After a couple of hours my fever started to spike and it went up to 102.9, my fevers continued fluctuating between 102.9 to 100.9 and back up. I took my pain medication as directed along with my ibuprofen but that did not even touch the pain even taking an extra Lortab still it did nothing to alleviate the excruciating pain in my arm. I continued to have fevers and severe excruciating pain in my left arm (where the shots were given), on through until this morning at which time, (so far anyway), I have not yet ran a fever but my arm is still sore  with a blistered type of look, red and swollen. I want to say though that looking at my arm today the redness is worse than in the beginning.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: I woke up to severe pain in my left arm, I felt very ill and very cold. I checked my temperature and it read 100.9. I took my medications which included 1 Lortab 7.5 mg. 1 ibuprofen 800 mg. and 1 OxyContin 20 mg. After a couple of hours my fever started to spike and it went up to 102.9, my fevers continued fluctuating between 102.9 to 100.9 and back up. I took my pain medication as directed along with my ibuprofen but that did not even touch the pain even taking an extra Lortab still it did nothing to alleviate the excruciating pain in my arm. I continued to have fevers and severe excruciating pain in my left arm (where the shots were given), on through until this morning at which time, (so far anyway), I have not yet ran a fever but my arm is still sore  with a blistered type of look, red and swollen. I want to say though that looking at my arm today the redness is worse than in the beginning.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient's daughter stated that on 11/17/16, the patient brought to her attention that the injection site was red, swollen (with a small knot), warm to the touch.  She is not running a fever and she isn't having trouble breathing.  No treatment has been sought at this time.
Age: 74.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Blood urine present, Urine analysis
Clinical narrative: Patient states that he was urinating blood.  It went away for a while, then started back up a week later.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Patient explained that general shoulder muscle soreness started the afternoon after receiving the vaccination. This soreness persisted for a few days and then turned into more of a nerve pain in her shoulder when performing tasks around the house. The pain has persisted for 3 weeks now, but has been getting better. This is the first time patient had received the high dose flu vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: Chills, Aches, Nauseated for 24-36 hours and arm swollen, red, and painful for 7 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Chills, Aches, Nauseated for 24-36 hours and arm swollen, red, and painful for 7 days.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Raised red blanching spreading outward from injection site, some itching. Appearance of a rash. Distinct border.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient called me ~ 10 AM on 11/20/16 and stated she was concerned about her ZOSTAVAX injection she received on 11/18/16.  She was experiencing some redness, slight pain, and itching at the injection site.  I asked her if she had any other symptoms such as hives, breathing issues, large rash, or swollen arm - she stated no - just issue at the site itself, about 1.5 inches in diameter.  She felt fine other than discomfort at the site.  I told her she could use antihistamines oral or topical, and perhaps some pain relievers if needed.  She thanked me for the help and the advice, and I made she was ok to the best of my ability over the phone.  I called her back at ~ 2 pm on 11/20/16 to see how she was, and nothing really had changed - she was ok overall other than just discomfort at the injection site itself.  She thanked me for the follow up call, and all was ok.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Mobility decreased, Muscular weakness
Clinical narrative: Profound weakness both legs, very difficult to mobilize myself to get out of bed. With several minutes, concentration and assistance with my arms I was able to mobilize my legs and bear weight. This lasted approximately 3 days. Continued to have significant fatigue for approximately 2 weeks.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Feeling abnormal, Induration, Nausea
Clinical narrative: First day following vaccine date, pt felt nauseous. Injection site looked normal, and the other side of her arm was swollen by the size of an egg. The swelling was hard and warm at touch. Second day following the vaccine date, swelling went down, but was still ovbious. The whole upper arm became red. Patient felt better, but was still tired and not her normal self. Third day following vaccine date, swelling went down; redness almost went away, and patient felt great and normal again.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: First day following vaccine date, pt felt nauseous. Injection site looked normal, and the other side of her arm was swollen by the size of an egg. The swelling was hard and warm at touch. Second day following the vaccine date, swelling went down, but was still ovbious. The whole upper arm became red. Patient felt better, but was still tired and not her normal self. Third day following vaccine date, swelling went down; redness almost went away, and patient felt great and normal again.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test normal, Myalgia
Clinical narrative: Walking on level surface (concrete sidewalk) for 1 mile total. My knees began to hurt, again. 1st round of knee/joint/muscle pain had begun after 60 days on Pravastatin. June 1, 2016 thru July 31, 2016. Stopped statin on August 22, 2016. Pain in legs began to subside. However, 7 days after receiving High Dose Flu shot, pain began again. Intense. Pain subsided after 880 mg. of naproxen. But stopped naproxen due to possible long term side effects. Pain continues as of this writing, ~ 30 days.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient had bruising after his vaccination and states that his left arm is very sore still. He can not lift anything with it.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient stated 6 days later still running a fever (not as high as previous day after vaccination), and also upper arm swollen, red, and hot.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Sore arm that lasted 10 days, moderate flu-like symptoms that persisted 3 weeks. Pt got PREVNAR and FLUZONE injected the same day. Claims several others he knows who got the same combination on the same day experienced similar symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Breath sounds abnormal, Chest discomfort, Hypersomnia, Injection site erythema, Injection site pruritus
Clinical narrative: Breathing changed, chest seemed heavy and mind seemed cloudy. Slept most of the night. Woke up with a migraine. Approx 1 week later the injection site had approx 1 inch red area at injection site as well as itching and raised bumps. Symptoms lasted approx 7 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Migraine
Clinical narrative: Breathing changed, chest seemed heavy and mind seemed cloudy. Slept most of the night. Woke up with a migraine. Approx 1 week later the injection site had approx 1 inch red area at injection site as well as itching and raised bumps. Symptoms lasted approx 7 days.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Injection site mass, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Lump/bump at injection site and red rash a little larger than the size of a $1 coin at injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Blood test normal, Joint swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Hives, started on child's legs then wend up all the way to face. The next day his face was swollen, joints were swollen, wrists and ankles. Itchy skin, hives were changing shape and location on his body. On Friday 11/18/2016 All his back was read.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Blood gases, Chest X-ray, Dyspnoea, Echocardiogram, Injection site erythema
Clinical narrative: Localized reaction (redness, warmth, rash) at site and up arm, shortness of breath and respiratory distress. Treated in ER and admitted to hospital.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth, Laboratory test, Local reaction, Respiratory distress
Clinical narrative: Localized reaction (redness, warmth, rash) at site and up arm, shortness of breath and respiratory distress. Treated in ER and admitted to hospital.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient passed out after receiving shot. Fell on floor and bumped head. Called 911, patient taken to hospital.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Admin on 9/27/16 in left upper arm. Pt. complains of ongoing pain in joint (shoulder) area. No bruising, no lumps at injection site.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nodule, Pain in extremity
Clinical narrative: (L) arm - pain when stretching or moving sideways, small knot when touched/rubbed. Sore at injection site. Injection date 9/30/2016. Patient called to report this 11/20/2016. He has not seen his PCP yet.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Neck pain
Clinical narrative: Neck pain 3 hours after flu shot. 12 hours later pain subsided.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient got PNEUMOVAX 23 in (R) arm 11/16. He called pharmacy 11/17 reporting severe swelling of (R) arm. Instructed him to go to his mD and follow up w/ VS.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Administration site pain, Dizziness, Injection site erythema, Malaise, Pyrexia
Clinical narrative: Fever reported 101-103 degrees redness/soreness of admin site from shoulder to elbow light head/dizziness - (sick) - OTC ALEVE.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 02-NOV-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose unknown) intramuscularly (Drug use via unapproved administration route). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 07-NOV-2016, the patient was vaccinated with a expired dose of GARDASIL intramuscular, lot # K005083 and expire date 04-NOV-2016 (dose number and area of administration were not reported0. No adverse event were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The information about concurrent condition, medical history and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot#, expiration date, strength, dose, frequency and route were not reported). On unknown dates, the patients felt dizziness after receiving GARDASIL 9. The outcome of dizziness was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Depressed level of consciousness, Erythema, Feeling hot, Headache, Paraesthesia
Clinical narrative: Red, shaky, hot, light headache, felt like going to pass out, tingly all over.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Red, shaky, hot, light headache, felt like going to pass out, tingly all over.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Pt stated it swelled, tenderness, and redness the size of a fist.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Autonomic nervous system imbalance, Death, Fatigue, Gastrointestinal hypomotility
Clinical narrative: Extreme malaise, fatigue, weakness, lethargy, orthostatic hypotension diagnosed with myalgic encephalomyelitis by infectious disease specialist attributing directly to flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Intestinal perforation, Lethargy, Malaise, Orthostatic hypotension, Post viral fatigue syndrome
Clinical narrative: Extreme malaise, fatigue, weakness, lethargy, orthostatic hypotension diagnosed with myalgic encephalomyelitis by infectious disease specialist attributing directly to flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Small intestinal obstruction
Clinical narrative: Extreme malaise, fatigue, weakness, lethargy, orthostatic hypotension diagnosed with myalgic encephalomyelitis by infectious disease specialist attributing directly to flu vaccine.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Electroencephalogram normal, Febrile convulsion
Clinical narrative: Seizure (complex seizure lasted over 40 mins). ATIVAN 0.5mg administer into his muscle by EMTs in ambulance. VALIUM 2.5mg at hospital arrival. VALIUM 5mg at hospital since couldn't control the convulsion. ATIVAN 1mg second dose.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Seizure (complex seizure lasted over 40 mins). ATIVAN 0.5mg administer into his muscle by EMTs in ambulance. VALIUM 2.5mg at hospital arrival. VALIUM 5mg at hospital since couldn't control the convulsion. ATIVAN 1mg second dose.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Blood test, Electroencephalogram, Neurological examination, Nuclear magnetic resonance imaging brain, Seizure
Clinical narrative: Seizure (complex seizure lasted over 40 mins). ATIVAN 0.5mg administer into his muscle by EMTs in ambulance. VALIUM 2.5mg at hospital arrival. VALIUM 5mg at hospital since couldn't control the convulsion. ATIVAN 1mg second dose.
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician via Pfizer (MFR control# 2016504226) referring to a currently 88 year old male patient. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, dose and route unknown). On an unknown date the patient had an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The outcome of the event was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Pyrexia
Clinical narrative: Red, swollen injection site.  Hot to the touch, hard nodule.  Redness continued to spread down the arm.  DX as cellulitis, given cephalexin first then Augmentin.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Red, swollen injection site.  Hot to the touch, hard nodule.  Redness continued to spread down the arm.  DX as cellulitis, given cephalexin first then Augmentin.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Red, swollen injection site.  Hot to the touch, hard nodule.  Redness continued to spread down the arm.  DX as cellulitis, given cephalexin first then Augmentin.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, White blood cell count
Clinical narrative: Red, swollen injection site.  Hot to the touch, hard nodule.  Redness continued to spread down the arm.  DX as cellulitis, given cephalexin first then Augmentin.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Rt upper arm Red swollen and hot to touch. Vaccine given at Walgreens on 11/16/16-Presents to clinic on 11/18 with above c/o-states sx began some time on 11/17/16 and cont to worsen. Placed on Augmentin 875mg every 12hrs.-on 11/18/16.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm Red swollen and hot to touch. Vaccine given at Walgreens on 11/16/16-Presents to clinic on 11/18 with above c/o-states sx began some time on 11/17/16 and cont to worsen. Placed on Augmentin 875mg every 12hrs.-on 11/18/16.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Hot flush, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Nausea and sweats 10:30 PM. Vomiting and diarrhea 11:30 PM. Fever 11:30 PM - 11/18/2026 10:00 AM. On and off Nausea. Currently still having Nausea and heat flashes. Will be going to the doctors 11/21/16.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Nausea and sweats 10:30 PM. Vomiting and diarrhea 11:30 PM. Fever 11:30 PM - 11/18/2026 10:00 AM. On and off Nausea. Currently still having Nausea and heat flashes. Will be going to the doctors 11/21/16.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Coeliac disease, Injection site swelling, Pyrexia
Clinical narrative: Severe swelling of left arm and 103 degree fever.  Treated with antibiotic at ER for swelling.  Next day pediatrician stopped the antibiotic and said that it was a vaccine reaction, not an infection.  1 month later she was diagnosed with celiac disease (autoimmune).
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Rash papular
Clinical narrative: Red bumps around injection site. Large red, raised patches from shoulder to elbow on the affected side. Pain and tenderness to touch of the upper arm.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Pruritus, Rash generalised
Clinical narrative: Started with pain, redness, swelling quite a bit and hard feeling. Progressed to becoming crazy itchy while also painful. From there it became body rash after a couple of days during which I was taking BENADRYL.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Started with pain, redness, swelling quite a bit and hard feeling. Progressed to becoming crazy itchy while also painful. From there it became body rash after a couple of days during which I was taking BENADRYL.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Facial urticaria.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Middle insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: My shoulder/upper arm has been extremely sore since the vaccine.  At first, I figured I would give it a day or two, but almost three weeks later it's just as bad.  I experience pain when lifting or moving my left arm and it sometimes even wakes me up at night.  I will be calling my provider later today to report this and begin seeking treatment.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Medication error, No adverse event
Clinical narrative: No adverse event, reporting med error.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 53-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017. On 7th November 2016, the patient received FLULAVAL QUADIRVALENT .5 ml. On 8th November 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provide as follows: This case was previously reported to a doctor. The reporter was a nurse practitioner at GlaxoSmithKline medical clinic. The patient visited the emergency room. The patient visited doctor for itching at injection site after vaccination with FLUALVAL Quadrivalent.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash on abdomen and arms. Employee started to itch and noted rash.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hyperhidrosis, Injection site discomfort, Injection site pain, Nausea
Clinical narrative: Client received a FLUARIX QUADRIVALENT vaccine from us in her R deltoid on 10-11-2016 for work. She called our office today with complaint that she has had persistent arm pain that developed 2 days after receiving the flu shot. She says she felt fine right after receiving the shot, however 2 days later she developed R arm soreness localized to the injection site. No redness, itching, significant swelling. She says 2 days after she also felt nauseous, sweaty, feverish although this only lasted a few days. She also at that time developed R hip pain that persisted for several weeks up until last week when it finally resolved. She no longer has hip pain. She has never had any radiculopathy of her R extremity. No numbness, tingling or shooting pain. She denies any decrease in function of her arm. Has FROM and full grip strength. No Arm weakness. At this time her only symptom is localized pain to the injection site that is sore to touch. She rates the pain 4/10. She does notice the discomfort at times even without touching the site, but it is mild. She has tried Ibuprofen.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Client received a FLUARIX QUADRIVALENT vaccine from us in her R deltoid on 10-11-2016 for work. She called our office today with complaint that she has had persistent arm pain that developed 2 days after receiving the flu shot. She says she felt fine right after receiving the shot, however 2 days later she developed R arm soreness localized to the injection site. No redness, itching, significant swelling. She says 2 days after she also felt nauseous, sweaty, feverish although this only lasted a few days. She also at that time developed R hip pain that persisted for several weeks up until last week when it finally resolved. She no longer has hip pain. She has never had any radiculopathy of her R extremity. No numbness, tingling or shooting pain. She denies any decrease in function of her arm. Has FROM and full grip strength. No Arm weakness. At this time her only symptom is localized pain to the injection site that is sore to touch. She rates the pain 4/10. She does notice the discomfort at times even without touching the site, but it is mild. She has tried Ibuprofen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The site of injection was red and a bump was present.  The patient complains of pain at the injection site.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Acute kidney injury, Blood creatinine increased, Hypertension, Inflammation, Injection site erythema
Clinical narrative: Patient reported swelling, pruritus, erythema, and warmth at injection site (left deltoid) 2 days after vaccination. For possible cellulitis, she was started on cephalexin. The next day (11/18/16), she returned to clinic due to expansion of erythema, and Bactrim was added to cover for CA-MRSA. Despite these interventions, her erythema seemed to progress, so she came to the ER for evaluation. Exam showed mild progression of erythema distally, but she otherwise looked well and had normal VS with exception of mild hypertension. She was noted to have AKI as her baseline SCr of 0.9 was increased to 1.6 (suspected due to treatment with Bactrim). Labs notable for leukocytosis to 32 from 27 at last check. The etiology of the inflammation seemed likely secondary to a local vaccine reaction; however, a trial of IV Zosyn was started due to possible cellulitis and expansion of erythema despite oral antibiotics (which were both stopped). AKI resolved and she was discharged the following morning on Augmentin x 7 day course.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Leukocytosis, Local reaction
Clinical narrative: Patient reported swelling, pruritus, erythema, and warmth at injection site (left deltoid) 2 days after vaccination. For possible cellulitis, she was started on cephalexin. The next day (11/18/16), she returned to clinic due to expansion of erythema, and Bactrim was added to cover for CA-MRSA. Despite these interventions, her erythema seemed to progress, so she came to the ER for evaluation. Exam showed mild progression of erythema distally, but she otherwise looked well and had normal VS with exception of mild hypertension. She was noted to have AKI as her baseline SCr of 0.9 was increased to 1.6 (suspected due to treatment with Bactrim). Labs notable for leukocytosis to 32 from 27 at last check. The etiology of the inflammation seemed likely secondary to a local vaccine reaction; however, a trial of IV Zosyn was started due to possible cellulitis and expansion of erythema despite oral antibiotics (which were both stopped). AKI resolved and she was discharged the following morning on Augmentin x 7 day course.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count increased
Clinical narrative: Patient reported swelling, pruritus, erythema, and warmth at injection site (left deltoid) 2 days after vaccination. For possible cellulitis, she was started on cephalexin. The next day (11/18/16), she returned to clinic due to expansion of erythema, and Bactrim was added to cover for CA-MRSA. Despite these interventions, her erythema seemed to progress, so she came to the ER for evaluation. Exam showed mild progression of erythema distally, but she otherwise looked well and had normal VS with exception of mild hypertension. She was noted to have AKI as her baseline SCr of 0.9 was increased to 1.6 (suspected due to treatment with Bactrim). Labs notable for leukocytosis to 32 from 27 at last check. The etiology of the inflammation seemed likely secondary to a local vaccine reaction; however, a trial of IV Zosyn was started due to possible cellulitis and expansion of erythema despite oral antibiotics (which were both stopped). AKI resolved and she was discharged the following morning on Augmentin x 7 day course.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Patient was getting ready to leave the office when she fainted and vomited.  No tonic-clonic activity.  No increase in heart rate felt.  She laid down and felt fine 5 minutes later.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Cough, Decreased appetite
Clinical narrative: Case number PHEH2016US029456 is an initial spontaneous report received from consumer on 20 Oct 2016. This report refers to 67 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN at a dose of 0.5 ml intramuscular on 19 Oct 2016. On 20 Oct 2016 the patient experienced flu-like symptoms. The patient states that it was not an anaphylactic reaction and on the same day, the patient had begun feeling warm, dizziness, sweaty, feverish, with a sore throat, cough, pain in upper abdomen, weakness, itchy/watery eyes, runny nose, loss of appetite, joint pain in wrist and fingers. These symptoms lasted one week. The patient cough and achy/feverish feeling left after 1st week. The second week, patient still had a runny nose, itchy eyes, and dizziness. It was reported that the customer states that she had not had any new medications and this was the first flu vaccine she had received in years. The outcome of the events was reported as watery eyes, itchy eyes and dizziness condition unchanged, warmness, weakness, flu-like symptoms were condition improving and sweaty, fever, sore throat, cough, abdominal pain, runny nose, appetite absent and joint pain were reported as complete recovery. The seriousness of the events was reported as serious disability. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye pruritus, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: Case number PHEH2016US029456 is an initial spontaneous report received from consumer on 20 Oct 2016. This report refers to 67 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN at a dose of 0.5 ml intramuscular on 19 Oct 2016. On 20 Oct 2016 the patient experienced flu-like symptoms. The patient states that it was not an anaphylactic reaction and on the same day, the patient had begun feeling warm, dizziness, sweaty, feverish, with a sore throat, cough, pain in upper abdomen, weakness, itchy/watery eyes, runny nose, loss of appetite, joint pain in wrist and fingers. These symptoms lasted one week. The patient cough and achy/feverish feeling left after 1st week. The second week, patient still had a runny nose, itchy eyes, and dizziness. It was reported that the customer states that she had not had any new medications and this was the first flu vaccine she had received in years. The outcome of the events was reported as watery eyes, itchy eyes and dizziness condition unchanged, warmness, weakness, flu-like symptoms were condition improving and sweaty, fever, sore throat, cough, abdominal pain, runny nose, appetite absent and joint pain were reported as complete recovery. The seriousness of the events was reported as serious disability. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Case number PHEH2016US029456 is an initial spontaneous report received from consumer on 20 Oct 2016. This report refers to 67 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN at a dose of 0.5 ml intramuscular on 19 Oct 2016. On 20 Oct 2016 the patient experienced flu-like symptoms. The patient states that it was not an anaphylactic reaction and on the same day, the patient had begun feeling warm, dizziness, sweaty, feverish, with a sore throat, cough, pain in upper abdomen, weakness, itchy/watery eyes, runny nose, loss of appetite, joint pain in wrist and fingers. These symptoms lasted one week. The patient cough and achy/feverish feeling left after 1st week. The second week, patient still had a runny nose, itchy eyes, and dizziness. It was reported that the customer states that she had not had any new medications and this was the first flu vaccine she had received in years. The outcome of the events was reported as watery eyes, itchy eyes and dizziness condition unchanged, warmness, weakness, flu-like symptoms were condition improving and sweaty, fever, sore throat, cough, abdominal pain, runny nose, appetite absent and joint pain were reported as complete recovery. The seriousness of the events was reported as serious disability. The causality of the events was not reported.