chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Balance disorder, C-reactive protein normal, CSF glucose normal, CSF oligoclonal band absent
Clinical narrative: Patient told me that his legs were numb and that he was having difficulty balancing and walking. I took him that afternoon to his pediatrician, who said that his symptoms could be Guillain Barre caused by the flu shot or could just be a normal reaction from the flu shot. His doctor also advised that the symptoms could last a few days but if they worsened to take him to the ER.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein normal, CSF white blood cell count increased, Gait disturbance, Hypoaesthesia, Inflammatory marker test
Clinical narrative: Patient told me that his legs were numb and that he was having difficulty balancing and walking. I took him that afternoon to his pediatrician, who said that his symptoms could be Guillain Barre caused by the flu shot or could just be a normal reaction from the flu shot. His doctor also advised that the symptoms could last a few days but if they worsened to take him to the ER.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient told me that his legs were numb and that he was having difficulty balancing and walking. I took him that afternoon to his pediatrician, who said that his symptoms could be Guillain Barre caused by the flu shot or could just be a normal reaction from the flu shot. His doctor also advised that the symptoms could last a few days but if they worsened to take him to the ER.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysgeusia, Heart rate increased, Hypertension, Skin warm
Clinical narrative: Happened seconds after shot, metallic taste in mouth, high pulse, high blood pressure, hot feet and hot vaginal area, started to panic each episode lasted several mins 11 in total getting weaker as each one happened.
Age: 89.0
Sex: F
Vaccine: FLUC3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complaining of redness, swelling, tenderness, and itching around injection site of Prevnar 13 (right arm). Advised patient to take Benadryl as directed and to contact us if the condition worsened or persisted longer than 7 days.
Age: 46.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states injection given too high on the shoulder. Result was inhibited range of motion with shoulder pain. States he has had other immunizations without this type of pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Sneezing, Wheezing
Clinical narrative: Started with itching at injection site, approximately 5 cm swelling around injection site, then with in 90 minutes of injection had sneezing and wheezing.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles like rash appearing on forehead.
Age: 10.0
Sex: M
Vaccine: FLUN4, JEV1
Symptoms: Abdominal pain upper, Malaise, Pruritus, Rash, Syncope
Clinical narrative: Pts mother came back and informed technician that child fainted in the parking lot/had a rash/complained of itchy scalp/not feeling well/stomach cramps.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Some swelling, redness, warm to the touch, soreness, by next morning swelling spread, redness spread, hot to touch, pain, low grade fever, by Wednesday morning arm had gotten 3 inches larger, redness from shoulder to elbow and almost completely around arm, very painful to touch, unable to use arm much at all. Went to Dr. Was given a shot of steroids and follow up tomorrow 10/22/2015 at 11:00 AM CST.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Some swelling, redness, warm to the touch, soreness, by next morning swelling spread, redness spread, hot to touch, pain, low grade fever, by Wednesday morning arm had gotten 3 inches larger, redness from shoulder to elbow and almost completely around arm, very painful to touch, unable to use arm much at all. Went to Dr. Was given a shot of steroids and follow up tomorrow 10/22/2015 at 11:00 AM CST.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Patient awoke during the night with nausea; pain and chills in calves, ankles, and feet; general chills; and arm soreness. These subsided by the next morning, though her arm remained very sore when touched for several days, and she has experienced thin, loose bowel movements for the subsequent week.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Patient awoke during the night with nausea; pain and chills in calves, ankles, and feet; general chills; and arm soreness. These subsided by the next morning, though her arm remained very sore when touched for several days, and she has experienced thin, loose bowel movements for the subsequent week.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Pain
Clinical narrative: PAINFUL RAISED HARD KNOT STARTED TUESDAY 10/13/15 STOPPED SUNDAY 10/18/15.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Chills, fever (101-102F), muscle aches, extreme fatigue, headache. Ie, flu-like symptoms but this was not a mild reaction. It felt like full blown flu for 24 hours (symptoms were as severe as the actual active flu virus I had last year).   Onset was 10 hours after flu shot (Sanofi Fluzone QIV MDV). Fever lasted about 12 hours, headache lasted 24 hours.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills, fever (101-102F), muscle aches, extreme fatigue, headache. Ie, flu-like symptoms but this was not a mild reaction. It felt like full blown flu for 24 hours (symptoms were as severe as the actual active flu virus I had last year).   Onset was 10 hours after flu shot (Sanofi Fluzone QIV MDV). Fever lasted about 12 hours, headache lasted 24 hours.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Caused me to itch all over.
Age: 6.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient injected with HPV vaccine when not indicated/ordered for age. No significant difficulty after being injected with HPV vaccine.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Painful at injection and aching pain has continued down my whole arm since then.  Very painful and wakes me up at night.  Reduction in mobility in that arm.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Painful at injection and aching pain has continued down my whole arm since then.  Very painful and wakes me up at night.  Reduction in mobility in that arm.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Started as sore arm, then muscle aches, then headache, then chills and fever 100.4 started at 6:00 PM.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Influenza like illness, Muscle spasms, Rash
Clinical narrative: Flu like symptoms, rash, and muscle spasms.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Influenza like illness, Muscle spasms, Myalgia, Rash
Clinical narrative: Flu like symptoms, rash, and muscle spasms.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: At 1400 I began to feel tightness in my chest. Tried to rest and woke up at 1430 with worsening symptoms. My throat was scratchy, very hoarse voice, felt like I had to try really hard to talk. Breathing was difficult, felt like I had something in my throat, but j did not feel my airway was compromised. I was able to talk it was just difficult and I sounded hoarse. Began to cough. Very dizzy. Took 25mg Benadryl. Did not improve, but did not get worse. Decided to go to the doctor and get some steroids. Got an IM injection of dexamethasone and methylprednisone. My voice was less hoarse and easier to breath within 3 hours.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: At 1400 I began to feel tightness in my chest. Tried to rest and woke up at 1430 with worsening symptoms. My throat was scratchy, very hoarse voice, felt like I had to try really hard to talk. Breathing was difficult, felt like I had something in my throat, but j did not feel my airway was compromised. I was able to talk it was just difficult and I sounded hoarse. Began to cough. Very dizzy. Took 25mg Benadryl. Did not improve, but did not get worse. Decided to go to the doctor and get some steroids. Got an IM injection of dexamethasone and methylprednisone. My voice was less hoarse and easier to breath within 3 hours.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient contacted the pharmacy on October 21, 2015 complaining of increased swelling, tenderness and itching at the injection site of the left arm.  Pharmacist recommended using ice and an antihistamine.  If no relief, contact physician.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Cough, Pyrexia, Wheezing
Clinical narrative: Back pain, joint pain, fever, cough, wheezing. NSAIDS and Theraflu.
Age: 28.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever of about 100 degrees Fahrenheit, sore throat and red spots on hands and feet until 9/18/2015.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient received influenza vaccination 10/16 around 7:38PM. She states that the following morning of Saturday, she woke up with the injection site being very stiff all the way up to her collarbone to the point she could not move her arm. On Sunday, 10/18, the injection site/arm was still stiff, however, not as severe at the day before.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Left arm pain, fever, body aches and headaches. 10 x 12 cm red, tender area over left deltoid. T. 102, No flu shot test available to rule out flu.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Left arm pain, fever, body aches and headaches. 10 x 12 cm red, tender area over left deltoid. T. 102, No flu shot test available to rule out flu.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Macule, Rash generalised, Rash pruritic
Clinical narrative: Generalized itchy rash/macule upper chest/neck/upper back. No hives, SOB or chest pain. No wheezing.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain immediately and later persistently in (L) shoulder, particularly with ant flexion and flexion with internal rotation.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction - zoster vaccine (R) deltoid. Recommended Topical hydrocortisone.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, 2/2 reaction, redness, swelling, warmth to left upper arm. PREVNAR 13 given on 10/12/15-came to clinic on 10/15/15. TX cool compress. BENADRYL PRN, TYLENOL PRN. Instructed pt to go to ER for chest pain, SOB, anaphylaxis, tongue swelling, wheezing.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt came to pharmacy on 10/21/15 reporting pain in left arm where flu shot was administered on 9/17/15.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site scab, Injection site ulcer, Limb discomfort, Pruritus
Clinical narrative: 10-15-2015 my left arm itchy - took off band aid on 10/15/15 and noticed small ulcer that has scabbed over never had rxn like this before - (L) deltoid heavy and sore for couple days.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX was administered to this 17 yr old. Appropriate age is > 18 yrs.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on chest, moving to arms.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt stated he had red, enlarged injection site as well as fever, chills, nausea, etc. - Said he could not get out of bed.
Age: 76.0
Sex: U
Vaccine: FLU3, FLU3, PPV
Symptoms: Rash
Clinical narrative: Vaccine given 10/18/15 presented on 10/21/15 w/rash under arms on both sides.
Age: 76.0
Sex: U
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site pain, Rash
Clinical narrative: Vaccine given 10/18/15 presented on 10/21/15 w/rash under arms on both sides.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Redness and swelling from injection site to bend in elbow. Area feels warm and itchy. Started 24 hours after shot but resolving now after 4 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Soreness, aching and decreased range of motion post vaccine administration on 9/28/15.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient called to report that she was experiencing widespread itching after receiving the vaccine. She has never had a reaction to a flu shot in the past. Pt was told to take diphenhydramine and contact MD if symptoms worsen.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm-feeling to the touch swelling, round, red patch on area the size of a half-dollar around injection site.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: Patient passed out after vaccination for about 5 seconds. Patient was checked by paramedic and was fine.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at injection site (L-deltoid).
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itching on extremities, severe redness with bumps. Patient was issued a script by phone 10/21/15 for steroid cream.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt presented to triage nurse with complaints of injection site: pain, redness, swelling, stiffness and abdominal nausea. For 7 days after PREVNAR's injection.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm sore, red and warm to the touch. Patient came into pharmacy on 10/21/15 and reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient reported all over hives within 24 hrs of receiving FLUVIRIN shot, took BENADRYL. Resolved approximately 24 later, never any past problems with flu shots.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea vomiting symptoms getting better.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site exfoliation, Injection site haemorrhage, Injection site pain, Injection site scab, Injection site ulcer
Clinical narrative: When the vaccine was administer it bleed. The lady giving me the vaccine clean the area and cover it with a bandage. Two/three days later the skin had peel back in the area where I got the shot a small sore had formed. It was painful in the area then a scab had formed over it.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ear swelling, Eye swelling, Eyelids pruritus, Mouth swelling, Nasal inflammation
Clinical narrative: Oculorespiratory Syndrome. Swollen/red eyes/eyelids itchy. Swollen ear canal itchy. Inflamed nasal passage. Abnormal breathing. Swollen mouth. Swollen tongue. BENADRY, OPCON A, FLONASE, Dr. exam. Hydrocortisone.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Oculorespiratory syndrome, Pruritus, Respiration abnormal, Swollen tongue
Clinical narrative: Oculorespiratory Syndrome. Swollen/red eyes/eyelids itchy. Swollen ear canal itchy. Inflamed nasal passage. Abnormal breathing. Swollen mouth. Swollen tongue. BENADRY, OPCON A, FLONASE, Dr. exam. Hydrocortisone.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eye disorder, Eye pruritus, Ocular hyperaemia, Respiratory disorder
Clinical narrative: Oculorespiratory Syndrome. Swollen/red eyes/eyelids itchy. Swollen ear canal itchy. Inflamed nasal passage. Abnormal breathing. Swollen mouth. Swollen tongue. BENADRY, OPCON A, FLONASE, Dr. exam. Hydrocortisone.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Upper extremity mass
Clinical narrative: Injection was placed too high and too far to the front of arm, into a tendon. I have been to 2 doctors, one recommended ice - it did not work. The other says heat. Certain arm movements are terribly painful. There is still a lump in my arm, after 1 month.
Age: 34.0
Sex: U
Vaccine: FLUR3
Symptoms: Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: Warm to touch. Pain. Swelling. Unable to lift arm.
Age: 2.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to a 2 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017, 0.5 ml, intramuscularly). The patient's parents has not reported that their sone had experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L013827, expiration date 21-APR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, hot feeling to arm that was injected - elbow to shoulder. Resolved after 7 days. No medical treatment or advice sought. Event reported to pharmacy on 10-21-15.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Rash over entire body, took BENADRYL q6h for 2 days. Rash resolved after 48 hrs.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Flushing, Generalised erythema, Wheezing
Clinical narrative: Immunizations given at 11:30- by 21:00 that evening (10/15/15) pt. was "flushed". Woke up and had redness on neck. Came home from school that afternoon and had generalized redness with wheezing/SOB. In ED pt - given steroids. *DC home.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient injected with expired ZOSTAVAX (2014). Patient informed. Will re-vaccinate in 30 days.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: 10-14-15 2 hrs after immunization of Hep AB, numbness of (R) thumb. Painful if cold weather. Referred to dr. 10/14. Sometimes tip of (R) Thumb aches "like a toothache" all day. Continued to be numb some days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm swollen from injection site to almost elbow. Itchy, hot to touch, arm sore.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to three patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (strength, dose and lot # were not reported) 1 shot in the arm. No concomitant medications were reported. On an unknown date the patients experienced a cellulitis reaction in the arm at the injection site while using PNEUMOVAX 23. The outcome of the event was not reported. The reporter did not provide the causality between the event and the suspect therapy. There was not product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 5 year old male patient. No concurrent conditions or medical history were reported. On 27-APR-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-OCT-2015 these patients were inadvertently vaccinated with improperly store GARDASIL (lot # K014191, expiration date 10-MAY-2017; dose, frequency and route not reported). No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown date, the patients were vaccinated with unspecified number of improperly stored MMR II, (dose and route not provided) (lot number # K024035, expiration date: 26-NOV-2016 or lot number # K022284, expired date 12-JUL-2016). No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates since 23-JUN-2015, the patients were vaccinated with doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016; K008931, expiration date 04-MAR-2017) (strength, dose and route of administration were not provided) that were exposed to temperatures outside of recommended range. No adverse experience had been reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown date since 01-JUL-2015, the patients were vaccinated with doses of VARIVAX (Merck) (lot # K007979, expiration date 30-JUN-2016; L000454, expiration date 06-JAN-2016) (strength, dose and route of administration were not provided) that were exposed to temperatures out of range from 01-JUL-2015 to 30-JUL-2015. No adverse experience had been reported. This is one of two reports received from the same source. Additional information as been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored PROQUAD (Merck) (lot#K006117, expiry date 14-JAN-2017, lot # L007230, expiry date 03-SEP-2016, lot # K025761, expiry date 08-JUN-2016). No adverse effect was reported. This is one of the several reports received from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD injection, lot # L021599 with expiration date 10-DEC-2016, L009210 with expiration date 17-SEP-2016 (dose and route of administration were not reported). No information on patients' concomitant medication was provided. The reporter could not determine which of the reported lot numbers were administered to the patients and which were not. No adverse effects were reported. This is one of the two reports from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # L017146 with expiration date 13-MAY-2017, L019124 with expiration date 27-MAY-2017, L012036 with expiration date 07-APR-2017 and L015047 with expiration date 29-APR-2017 (dose and route of administration were not reported). No information on patient's concomitant medications was provided. The reporter could not determine which of the reported lot numbers were administered to the patients and which were not. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 92.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a consumer refers to her father a 92 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In approximately September 2015 (date estimated based on "about a month earlier"), the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route of administration, injection site, lot number and expiration date were not reported). On 20-OCT-2015, the patient received a second injection of PNEUMOVAX 23, 0.5 ml, intramuscularly, (injection site, lot number and expiration date were not reported), which was other that indicated in the prescribing information. The patient did not seek medical attention. No treatment was given for the event. Additional information is not expected as insufficient contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23, RECOMBIVAX HB (MARRS # 1501USA003586), M-M-R II (MARRS # 1510USA010025) or ROTATEQ. (MARRS # 1510USA010026). No adverse effects were reported. No further information was provided. 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 Registered Nurse concerning multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, PNEUMOVAX 23 (MARRS# 1510USA010024), M-M-R II (MARRS# 1510USA010025) or ROTATEQ (MARRS # 1510USA010026). No adverse effects were reported. No further information was provided. 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 registered nurse refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K006135, expiration date 29-APR-2015 or lot # L003777, expiration date 04-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored M-M-R II, RECOMBIVAX HB, (1510USA003586), PNEUMOVAX 23 (MARRS # 1510USA010024), or ROTATEQ (MARRS # 1510USA010026). No adverse effects were reported. No further information was provided. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # J008423 with expiration date 21-JAN-2016, J009243 with expiration date 23-APR-2016 and K011562 with expiration date 08-APR-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 5 year old male patient. No concurrent conditions or medical history were reported. On 12-MAR-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored of VAQTA injection, lot # K009506, expiration date 22-SEP-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the two reports from the same reporter. Addtional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Experienced polymyalgia condition: Described stiff muscle of neck and shoulder the night of vaccination date. Fully symptom free 10/10/15.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: 5 days after shot noticed red circle at the site - it became larger and hard underneath. Exam - Red, hot circle 4 cm x 3.5 cm, hard lump under and surrounding circle 7 cm x 5 cm. 10-12-15 redness and hardness have reduced by 50% and continues daily.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Nodule
Clinical narrative: Patient received PREVNAR13 and 24 hours post vaccination, patients arm had a knot and was warm at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: A single hive approx 2cm x 3cm appeared distal to PROQUAD injection site within approx 1 minute of injection. Denies trouble breathing or a "tickle" in her throat. Denies itching. Went away approx 2 hours.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Hypoaesthesia, Injection site erythema
Clinical narrative: Red rash at administration site. Numbness and tingling in arm. Stomach cramps, joint pain, dizziness.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Paraesthesia
Clinical narrative: Red rash at administration site. Numbness and tingling in arm. Stomach cramps, joint pain, dizziness.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Oral mucosal blistering, Peripheral swelling
Clinical narrative: Arm swelled up, (double size) was very red, redness as far as wrist. Has blisters inside mouth (roof of mouth) 3 separate times over 2 weeks. Seeing doctor for this.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: There was redness, swelling, and itching on the arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Patient complained that arm was sore for 5 days. Called pharmacy on 10/13/15 and spoke w/pharmacist and told us that rph that gave the injection thru IM route not SQ. Arm feels fine now.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Immediately after vaccine -> lightheadedness with 23 hours -> fatigue, HA, abd ache, loose stool 9/25/15 - persistent HA, nausea, neck pain advised hydration, rest 10/1/15 - "hand and finger swelling" reported, difficulties with concentration.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Immediate post-injection reaction, Nausea, Neck pain, Peripheral swelling
Clinical narrative: Immediately after vaccine -> lightheadedness with 23 hours -> fatigue, HA, abd ache, loose stool 9/25/15 - persistent HA, nausea, neck pain advised hydration, rest 10/1/15 - "hand and finger swelling" reported, difficulties with concentration.
Age: 84.0
Sex: U
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Chills, Cough, Fatigue
Clinical narrative: Fever, chills, muscle pain, fatigue, cough - lasted over 2 1/2 months!
Age: 84.0
Sex: U
Vaccine: PNC13
Symptoms: Laboratory test, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle pain, fatigue, cough - lasted over 2 1/2 months!
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: 10/11/15 - insomnia - 10/12/15 - pain at injection site, redness and swelling at site, fever (101.4 degrees at MD)) - went to MD - started AUGMENTIN - 10/13/15 - went to ER - cultures taken, DECADRON given, improving but not yet resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 10/11/15 - insomnia - 10/12/15 - pain at injection site, redness and swelling at site, fever (101.4 degrees at MD)) - went to MD - started AUGMENTIN - 10/13/15 - went to ER - cultures taken, DECADRON given, improving but not yet resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 25-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L012475 exp. July 2016, dose of 0.65 ml, subcutaneous, in the left arm. The pharmacist stated that the patient had a circular spot, quarter size, at the injection site of left arm since unspecified date after vaccination in 2015. Pharmacist states the spot was not hot, not raised, and was not itchy. No rash. The patient sought medical attention as she visited the pharmacy. At the time of this report, the outcome of injections site erythema was reported as not recovered. Additional information is not expected as the reporter refused additional contact.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient was allergic to azithromycin and sulfa drugs. On 09-OCT-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml) (lot # L020482 with an expiry date of 02-SEP-2016) subcutaneously. No concomitant medications were reported. On 12-OCT-2015, after vaccination the patient experienced very bad itching on her back. The itching became painful and the on 15-OCT-2015, patient visited her physician. The patient was diagnosed with shingles. Patient received treatment with VALTREX on 15-OCT-2015. The outcome of the event herpes zoster was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX (Merck) (lot # L017142, expiration date 13-MAY-2017; dose, route not provided. They were improperly stored. No adverse effects were reported. This was one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 08-SEP-2015 the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L017144, expiration date 13-MAY-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 08-SEP-2015 the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L013068, expiration date 14-APR-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatoin has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 08-SEP-2015 the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L010145, expiration date 24-MAR-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 06-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L017997, expiration date 19-MAY-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 02-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L017997, expiration date 19-MAY-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medication, drug reactions or allergies provided. From 20-SEP-2015 to 30-SEP-215, the patients were vaccinate with improperly stored doses of ROTATEQ (lot # J015689, expiration date 11-NOV-2015, dose was not reported; orally). No adverse events were reported. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: PPV
Symptoms: Cough, Decreased appetite, Fatigue, Nausea, Wheezing
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 45 year old patient of unknown gender with asthma. The patient had no drug reaction/allergies. On 23-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K008927 with expired date 17-MAR-2016; dose and route were unknown). No concomitant medication was taken. The reporter stated that the patient started with cough on an unspecified date following administration of the vaccine, then began to experience fatigue, decreased appetite, some wheezing and some nausea on an unspecified date in 2015. On 05-OCT-2015, the patient presented to the office for medical attention. The patient was given an unspecified nebulizer treatment while in the office and was started on unspecified antibiotics. No lab tests were performed. At the time of the report, the outcome of the events was unknown. The reporter indicated that the patient's unspecified physician believed that the reaction was in relation to PNEUMOVAX 23. Ths is one of two reports received from the same reporter (1510USA008310). Additional information has bene requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored PEDVAXHIB, (dose and route not provided) (lot number # L014428, expiration date: 12-MAR-2018, lot number # L006545, expired date 16-NOV-2017, lot number # L014427, expired date 09-MAR-2017 or lot number # L002867, expired date 11-NOV-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-OCT-2015 these patients were inadvertently vaccinated with improperly stored VARIVAX (Merck) (lot # L001335, expiration date 13-JAN-2017; dose, frequency and route not reported). No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to an unspecified number of patients of unknown age and gender. The primary reporter stated that 90 improperly stored doses of ROTATEQ (lot number# K024700, expiration date 30-JUL-2016, dose, route not provided) were given to an unspecified number of unspecified patients after July of 2014. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Dry eye, Sinus disorder
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age reporting on herself. The patient reported that on 21-SEP-2015, as she was administering a dose of ZOSTAVAX injection to unknown patient. The patient pulled away from the syringe. The pharmacist reported, that this may have caused some of the ZOSTAVAX to squirt into her eye. She stated, that she removed her contact lenses and washed her eyes and after that she did not use her contact lenses. The patient stated, that since this her eyes had been very dry and her sinuses were also dry. The outcome of the events was unknown. Relatedness between the events and ZOSTAVAX was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Oka-Merck) PROQUAD (lot # K011311, expiration date 14-FEB-2016; Lot# L024122, Expiration date 30-DEC-2016; dose, route not provided). They were improperly stored. No adverse effects were reported. This was one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 16-OCT-2015 the patient was vaccinated with a dose of M-M-R II (lot # J008154, dose and frequency were unknown) subcutaneously, which was expired on 08-JUL-2015. No adverse effect was reported. Additional information has been requested.