chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Myalgia, Pain
Clinical narrative: I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine. The vaccine was administered high into my left shoulder. My husband and I noted to each other that the injection seemed unusually high on my arm. I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm. I received the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm. I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit. On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was limited. She was alarmed to still see brusing on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine. She was also concerned that this pharmacist was improperly trained on administering injectables and urged mt to contact the pharmacy immediately.
Age: 72.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 04-SEP-2014, the patient was inadvertently vaccinated with pediatric doses of RECOMBIVAX HB 2.5 microgram/0.5 ml (dose and lot# were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 13-APR-2015 from the pharmacist who reported the patient's age (73 years old) and gender (male). The reporter stated that for the first two doses of RECOMBIVAX HB series the patient was given an underdose. The first dose that patient received was on 09-SEP-2015, lot # reported as K005078, via intramuscular in the left arm. The second dose was administered on 07-OCT-2014, lot # K005078, via intramuscular in the left arm. On the third dose, the patient received the correct dose on 11-MAR-2015. On 08-APR-2015, the patient received an extra dose of RECOMBIVAX HB which was described as "a second dose of the correct dose". The reporter also stated that the patient was scheduled to her third dose of the correct adult dose in September 2015. Patient did not die and did not have life-threatening illness. He did not require emergency room/doctor visit or hospitalization. The events did not result in persistent or significant disability or incapacity. He did not require medical or surgical intervention to prevent one of the outcomes listed. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 04-SEP-2014, the patient was inadvertently vaccinated with pediatric doses of RECOMBIVAX HB 2.5 microgram/0.5 ml (dose and lot# were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 13-APR-2015 from the pharmacist who reported the patient's age (73 years old) and gender (male). The reporter stated that for the first two doses of RECOMBIVAX HB series the patient was given an underdose. The first dose that patient received was on 09-SEP-2015, lot # reported as K005078, via intramuscular in the left arm. The second dose was administered on 07-OCT-2014, lot # K005078, via intramuscular in the left arm. On the third dose, the patient received the correct dose on 11-MAR-2015. On 08-APR-2015, the patient received an extra dose of RECOMBIVAX HB which was described as "a second dose of the correct dose". The reporter also stated that the patient was scheduled to her third dose of the correct adult dose in September 2015. Patient did not die and did not have life-threatening illness. He did not require emergency room/doctor visit or hospitalization. The events did not result in persistent or significant disability or incapacity. He did not require medical or surgical intervention to prevent one of the outcomes listed. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 6 year old female patient with no pertinent medical history and no drug allergies. On an unknown date, at 1 year of age, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, route and site of administration were not reported). Other suspect therapies included PROQUAD (Merck) administered on 13-AUG-2013 (lot #, dose, route and site of administration were not reported). There was no concomitant medication. In approximately March 2015 (reported as within last couple days), the patient visited the physician's office with a mild case of chicken pox. There was an appearance of few bumps and spots on his upper trunk and neck area that was diagnosed as chicken pox. No lab diagnostics studies were performed. The patient was treated with BENADRYL and CALAMINE LOTION. The outcome of event was reported as recovering/resolving. The relatedness between chicken pox and VARIVAX (Merck) and PROQUAD (Merck) was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 6 year old female patient with no pertinent medical history and no drug allergies. On an unknown date, at 1 year of age, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, route and site of administration were not reported). Other suspect therapies included PROQUAD (Merck) administered on 13-AUG-2013 (lot #, dose, route and site of administration were not reported). There was no concomitant medication. In approximately March 2015 (reported as within last couple days), the patient visited the physician's office with a mild case of chicken pox. There was an appearance of few bumps and spots on his upper trunk and neck area that was diagnosed as chicken pox. No lab diagnostics studies were performed. The patient was treated with BENADRYL and CALAMINE LOTION. The outcome of event was reported as recovering/resolving. The relatedness between chicken pox and VARIVAX (Merck) and PROQUAD (Merck) was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Diplegia, Plasmapheresis
Clinical narrative: Paralysis bilateral lower extremities 3 weeks after vaccinations. Hospitalized special care unit for 6 days. Underwent plasmapheresis x 5 treatments. Outpatient rehab at a rehab hospital for 6 weeks. Continues rehab 4 days a week at his school.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a store employee refers to an approximately 83 year old male patient. No medical history was reported. On 25-MAR-2015 the patient was vaccinated with ZOSTAVAX, dose: 1 ml (route not provided). Concomitant therapies included VALTREX, omeprazole (manufacturer unknown) and prednisone (manufacturer unknown). On 25-MAR-2015 incorrect dose administered was reported as the patient received 1ml dose of the vaccine. On 29-MAR-2015, the patient experienced loss of hearing in his left ear (medically significant). The reporter was informed that the patient sought medical attention and had an office visit to unspecified physician. The outcome of the event and medication error was unknown. The causality assessment was not provided. No product quality issue was involved. Upon internal review the deafness unilateral was considered as medically significant. Additional information is not expected. The reporter cannot be contacted.
Age: 89.0
Sex: F
Vaccine: PNC
Symptoms: Blood chloride decreased, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased
Clinical narrative: 12x12 cm area of redness and warmth. admitted to hospital with dx acute cellulitis
Age: 89.0
Sex: F
Vaccine: PNC
Symptoms: Blood urea normal, Carbon dioxide normal, Cellulitis, Erythema, Haematocrit decreased
Clinical narrative: 12x12 cm area of redness and warmth. admitted to hospital with dx acute cellulitis
Age: 89.0
Sex: F
Vaccine: PNC
Symptoms: Haemoglobin decreased, Platelet count normal, Skin warm, White blood cell count normal
Clinical narrative: 12x12 cm area of redness and warmth. admitted to hospital with dx acute cellulitis
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin irritation
Clinical narrative: Patient had red skin irritation and arm swelling.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain at injection site as soon as vaccine administered and has not abated. Shoulder pain. Physical therapy ordered.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Swelling, redness, had pain/tender 4 x 7cm area for 4 days.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Local swelling, Pain, Tenderness
Clinical narrative: Swelling, redness, had pain/tender 4 x 7cm area for 4 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness to area. Swollen. Sore. Area grew 3" to 6 1/2-> 5 in height
Age: 80.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: 24 hrs. after injection patient reports; pain in arm, unable to lift arm, swelling and redness at site of injection.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Child began running fever after vaccinations. At approximately 1830 child began having seizure like activity. Parent took to ED immediately, when temp check rectally it was 104.7. Was given MOTRIN. Parents state seizure lasted around 5 mins.
Age: 45.0
Sex: F
Vaccine: FLUN4, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Vaccines given on 3/30/15. Rash started to appear 4/1/15 and 4/2/15 various sizes of batches over entire body, white center surround by red edge c/o very itchy - client went to PMD.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Vaccination complication
Clinical narrative: Colleague had allergic reaction to VARIVAX on 2/23/15 to 1st dose given. (Reported to clinic on 2/23/15). Colleague still wanted 2nd dose to complete series. BENADRYL 25mg 1 tab po given prior to injection. Reaction again, larger, red, warm swollen. Sent to work comp provider for eval and treatment.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and redness of upper arm about 48 hours after vaccine administration. Fever as well.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Malaise, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Could not move my arm, pain in arm for 2 weeks after shots. Pain went from arm up my neck to my head. Did not feel well for at least 4 weeks, Shot was given too high on my arm.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Arm very sore 4 days then very red about 5 inches down towards elbow- slightly itchy- 4-5 days.
Age: 20.0
Sex: M
Vaccine: TYP, YF
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient received Yellow Fever and Typhoid vaccine at 1400 on 3/19/15. Developed SOB and chest tightness while playing basketball at 1630. Taken to hospital at 1740-given BENADRYL 50mg PO x1 and Albuterol Neb tx x1-given Rx for BENADRYL 50mg Q6h prn. Pt states had same reaction after eating eggs in past. F/U in clinic on 3/20/15-stated he felt fine.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen ,warm to touch, sore. Pt. noticed this on 3/24/15. Right arm (Varicella location).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at and surrounding Rt arm injection site. (Approx 5cm). No increased edema, warmth or itching noted. Cool compress applied to site. Instructed to apply cool compress for the next several days. Instructed to give BENADRYL prn if needed for hives, itching. Seek medical attention immediately if breathing difficult occurs. 11 AM spoke with mother who stated redness was resolving.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyskinesia, Headache, Tremor
Clinical narrative: Patient was administered HPV vaccine on 12/2/2014 at approximately 3:40 pm. As per consent form signed by mother of child, patient was not sick and NKDA. Today mother of child returned to our clinic w/complaint of headache that started this morning approximately 10:00 am-she gave her TYLENOL. Patient c/o feeling chills and RN observed tremors of lips and involuntary movements of upper extremities. Oral temp 98.3 BP 106/71 P=105. Transported to be evaluated by dr.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: 4/2/15 pt called to report pain, stiffness noted starting evening after received Tdap 3/25/15. Pain with arm movement into rotator cuff area, shoulder, into neck. Pain has persisted for 8 days. Scale 1-10 pain started at 8, now a 4. Ibuprofen 3 tabs and heat help. Has full range of motion. Denies redness, swelling, numbness. States shot given 1 inch below shoulder joint.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Excessive eye blinking
Clinical narrative: Eye blinking throughout the day. No associated symptoms. From January 15, 2015 and continued currently. Referred to neurology.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Fatigue, Nausea, Pruritus, Rash
Clinical narrative: 5-6 hours later, rash started going down (R) arm. Achy joints. Rash on torso and neck started night of 4-8-15. Itchy, nausea, fatigue.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Malaise, Nausea, Rash, Urticaria
Clinical narrative: 5-6 hours later, rash started going down (R) arm. Achy joints. Rash on torso and neck started night of 4-8-15. Itchy, nausea, fatigue.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness and hot to touch, swelling of arm (given on 4-6-15).
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Dizziness, Feeling cold
Clinical narrative: Tightness in left chest. Tingling in left arm, hand, and left side of body. Pale, felt like fainting and throwing up, cold. Paramedics called, blood pressure elevated, pulse elevated. Oxygen administered and she started to feel a little better. Chest pain and numbness persisted. Recommended medical evaluation.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Heart rate increased, Hypoaesthesia, Pallor, Paraesthesia, Vomiting
Clinical narrative: Tightness in left chest. Tingling in left arm, hand, and left side of body. Pale, felt like fainting and throwing up, cold. Paramedics called, blood pressure elevated, pulse elevated. Oxygen administered and she started to feel a little better. Chest pain and numbness persisted. Recommended medical evaluation.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Muscle pain initially then nerve pain to her left arm which feels like pins and needles that keeps her up at night.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Tonic clonic movements
Clinical narrative: Tonic clonic activity-see ER note for 4/11/2015. PT had same type of problem after receiving vaccines on 2/10/2015.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Erythema, Pain, Skin disorder, Swelling
Clinical narrative: Client came into clinic on 3/18/15 with mother and brother. Clts left arm had some redness and indentation just under the muscle to the inner side of the arm close to the body. Also faint bruising on muscle just above indentation. Clt. states swelled up and became very painful and bruised approximately 4-5 days after administration. Clt was advised to be evaluated by physician.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle aches all over-chills, fatigue, low grade fever 100.1-99.8.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Concurrent or medical conditions were not reported. On 17-MAR-2015, the patient was vaccinated with (Oka-Merck) PROQUAD subcutaneous (dose, strength and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The nurse reported that the patient was supposed to received the second dose of (Oka/Merck) VARIVAX, but the patient inadvertently was administered a dose of (Oka-Merck) PROQUAD. No adverse effects reported. No product quality complain reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Chest X-ray normal, Electrocardiogram normal, Heart rate irregular, Palpitations
Clinical narrative: Heart pounding and irregular rate. No CP/SOB/N.
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. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck), subcutaneous. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) which underwent defrost cycling temperatures (higher than recommended). No adverse effects reported. 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 register nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, strength, route and lot number were not reported) which were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015) (dose and route were not reported). This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of VAQTA (dose, route and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a coordinator Healthcare worker refers to a specific patient of 62 year old of an unknown gender. None concurrent conditions or medical history were reported. On 17-MAR-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, (Lot No. K020802, expiration date: 31-JAN-2016) (route and anatomical location were not reported), which was improperly stored. No adverse effects were reported and no product quality complain (PQC) was filled. Additional information has been requested. This is one of several reports received from the same source.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a coordinator Healthcare worker refers to specific patient of 61 year old of an unknown gender. None concurrent conditions or medical history were reported. On 16-MAR-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot No. K020802, expiration date: 31-JAN-2016), (route and anatomical location were not reported), which was improperly stored. No adverse effects were reported and no product quality complain (PQC) was filled. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (dose and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of PROQUAD (lot # K023364, expiration date was not provided) dose and route were not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Constipation, Herpes simplex, Hypoaesthesia, Urinary retention
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Herpes simplex, Hypoaesthesia, Pain in extremity, Urinary retention
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaginal lesion
Clinical narrative: Information has been received from 66 year old female patient concerning herself. The patient's medical condition included hypertension and allergy to aspirin and penicillin. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (route, dose and strength unknown). Concomitant therapies included Lisinopril (manufacturer unknown), LEVOXYL and CRESTOR. On 10-FEB-2015 (also reported as unspecified dates), the patient experienced internal lesions, numbness in my vaginal area, constipation and pain in the back part of my thigh after receiving the ZOSTAVAX injection. She also said she had to be rushed to Emergency Room on unspecified date because she could not urinate after receiving ZOSTAVAX as well. Unspecified lab work was performed and the result was not provided. It was unknown if the patient had to be admitted. Her physician diagnosed her as having "Herpes Simplex Virus Type II". She was treated with VALTREX and did not currently have an outbreak. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of GARDASIL (dose, route and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Dermatitis contact
Clinical narrative: Reaction to tape (Tegaderm). Received smallpox vaccine and site was covered with Telfa (non-adhesive) and Tegaderm. Developed a reaction 1.5 inches above and below the vaccination site along the edge of the Tegaderm. Reaction were small linear armpit with small blisters.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of PEDVAXHIB (dose, route and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a currently (at the time of the report) 31 year old non pregnant female consumer via a company representative, refers to herself. The patient's relevant medical history was not reported. On 04-JAN-2008 the patient was vaccinated with a third dose of GARDASIL (intramuscular as per prescribing information, dose, lot # and expiration date were not reported). Information about the patient's concomitant medication was not reported. On an unknown date, after the patient's third dose of GARDASIL, the patient tested positive for an unspecified strain of HPV. On an unknown date, the patient underwent a procedure known as loop electrosurgical excision procedure as a treatment for the event. The patient's current status was unspecified regarding the diagnoses of HPV. The patient sought medical attention via visiting a physician (date unspecified). The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (operations manager) referring to unknown number of patients. On unknown dates, the patients were administered improperly stored VAQTA, lot # K012457, expiry date 04-JUN-2017, (route and frequency were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # K025760, expiration date 08-JUN-2016, 0.5 ml, subcutaneously in the right thigh. No adverse effects were reported at this time. 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 nurse refers to a patient of unknown age and gender. On 01-APR-2015 the patient was vaccinated with one dose of VARIVAX (Merck) (dose and route of administration were not reported, lot # K020758 with expiration date: 31-OCT-2016) which was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: HIB given that had expired on 4/10/15. No adverse reaction noted.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Oropharyngeal discomfort, Swelling face, Urticaria
Clinical narrative: Hives, facial swelling, throat discomfort treated with Benadryl 12.5 mg and 0.3 Epi Pen sent to ER.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Induration, Mass, Skin warm
Clinical narrative: Silver dollar sized raised bump, warm to the touch, hard and small blisters within red area.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker state immunization official regarding an unspecified number of patients of an unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, lot number and expiration dates were not provided). Concomitant medication was not provided. No symptoms reported. This is one of two reports from the same (source MARRS #1504USA005150). 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 health care professional from state immunization official regarding an unspecified number of patients of an unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot number and expiration dates were not provided). Concomitant medication was not provided. No symptoms reported. This is one of two reports from the same source (MARRS #1504USA009652). Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an 19 month old child patient of an unknown gender. On 24-FEB-2015, the patient was simultaneously vaccinated with the first dose of PROQUAD lot # K008185 with the expiration date of 05-DEC-2015, 0.5 ml, subcutaneous and with the first dose of VARIVAX (lot# J003704 with the expiration date of 27-MAR-2015, 0.5 ml, first dose, subcutaneous). No adverse effect was reported. No product quality complaint was involved. Follow up has been received from a physician on 09-APR-2015 regarding 19 month old child (also reported as 20 month old child). It was reported that there was no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions. On an unknown date, reported as one week later, the physician followed up with the patient and the child was fine without any adverse event after shots. No adverse effect was reported. Additional information is not expected because there is no follow up required. Reporter tab, product tab, event tab and narrative were updated.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cough, Wheezing
Clinical narrative: Pt had coughing fit on the way home after leaving office and began to wheeze.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram head, Eye pain, VIIth nerve paralysis
Clinical narrative: Bell's palsy symptoms, right eye pain - went to ER 4/11/15 prescriptions given for prednisone po and REFRESH LACRI-LUBE ointment - follow up with primary MD - 4/13/15 who continued prednisone.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram head abnormal, Eye pain, Facial paresis, Ocular hyperaemia, Pain
Clinical narrative: Bell's palsy symptoms, right eye pain - went to ER 4/11/15 prescriptions given for prednisone po and REFRESH LACRI-LUBE ointment - follow up with primary MD - 4/13/15 who continued prednisone.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Seizure, VIIth nerve paralysis
Clinical narrative: Bell's palsy symptoms, right eye pain - went to ER 4/11/15 prescriptions given for prednisone po and REFRESH LACRI-LUBE ointment - follow up with primary MD - 4/13/15 who continued prednisone.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: The patient recently had a TDAP shot at the pharmacy, administered by a pharmacist. Besides soreness at the site of injection on the left arm, the patient claims to have a large lymph node on the right side of his neck. There is visually an enlarge protrusion of the skin the size of a dime in diameter where the patient claims.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: Within 24 hours of receiving the second dose of the GARDASIL vaccination my daughter had the following symptoms: Fever, diarrhea, dizziness, upset stomach.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history and current conditions were not provided. On unknown day in 2008 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route were not reported). On 09-APR-2015, the patient was vaccinated with a second dose of GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse event was reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician referring to a 68 year old male patient with no drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route and lot# were unspecified) at an unspecified pharmacy. There was no concomitant medication reported. The patient called the physician on 06-APR-2015 to report that a rash developed on his right leg on the same day. The physician had not assessed the patient yet, however the patient would be seen by him later on 07-APR-2015. No treatment was given. No lab diagnostic studies was performed. At the time of reporting, the patient had not recovered from rash. The causality between adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # 009482, expiration date 06-MAR-2017, dose and route were unknown) which were exposed to 33F for 0.5 hours. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Fall, Incomplete course of vaccination, Syncope
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a male patient of unknown age. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, in approximtely 2013 (reported as "around two years ago") the patient was vaccinated with GARDASIL, first dose (route of administration, strength, lot number and expiration date were not reported) for prevention of HPV. After receiving his first dose, the patient "fainted and fell straight off the examination table". The patient was send to the "ear nose and throat specialist for unspecified reasons" after the fall. The patient refused to get the two remaining doses recommended for GARDASIL because of his bad experience. The outcome of the events was reported as recovered (date not provided). The relatedness between adverse events and therapy with GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via direct contact, Headache, Product quality issue
Clinical narrative: Information has been received from a nurse via a company representative referring to herself. Medical history of the patient was not reported. On 27-MAR-2015, while withdrawing M-M-R II vaccine (lot# reported as K018990, expiration date unspecified) from the vial, for an unspecified patient, that the needle "exploded" which caused a small amount of the vaccine to splash in the nurse's right eye and on her face. The nurse stated that she was using a Tuberculin syringe, and while withdrawing the vaccine from the vial, that the pressure caused the vacine to squirt out at the point where the needle connected to the syringe. PQC was involved. The nurse stated that she was experiencing a headache, but felt it is not related to the vaccine exposure. Nurse stated that she consulted with an unspeciifed physician was not involved in any topical vaccine exposure due to this event, and that the patient received a dose that was newly drawn up. The outcome of headache was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. On unknown dates from 09-FEB-2015 through 02-APR-2015, the patients were vaccinated with doses of VARIVAX (Merck) (lot # K007783, expiry date: 28-MAY-2016), dose, route, unspecified, which were improperly stored on 09-FEB-2015. No adverse effects reported. No product quality complaint (PQC) involved. The relatedness between the event and therapy with VARIVAX (Merck) was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown gender who was older than 26 years old. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength: 120Y, dose, lot# and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the physician would not like to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. On unknown dates from 09-FEB-2015 through 02-APR-2015, the patients were vaccinated with doses of GARDASIL (lot # K006124, expiry date: 02-FEB-2017), dose, route unspecified, which were improperly stored on 09-FEB-2015. No adverse effects reported. No product quality complaint (PQC) involved. The relatedness between the event and therapy with GARDASIL was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender referring on her/himself. Medical history and concurrent conditions were not reported. On 06-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 07-APR-2015, the patient experienced injection site swelling, injection site pain and injection site erythema, reported as redness, swelling and soreness at injection site. The outcome of injection site swelling, injection site pain and injection site erythema was unknown. The causality was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Musculoskeletal pain
Clinical narrative: At a routine checkup, I got a tetanus shot. It is now almost five months later, and I still have pain in the affected shoulder. It is not as severe or acute, but it is still painful and limiting at times.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. On unknown dates from 09-FEB-2015 through 02-APR-2015, the patients were vaccinated with doses of PEDVAXHIB (lot # reported as K008873, expiry date: 06-FEB-2017), dose route unspecified, which were improperly stored on 09-FEB-2015. No adverse effects reported. No product quality complaint (PQC) involved. The relatedness between the event and therapy with PEDVAXHIB was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Eye swelling, Pain in extremity, Swelling face
Clinical narrative: Pt received PCV-13 vaccine, had adverse rxn. Night of vaccine, pt had leg pain, next morning woke up with swollen eyes, facial swelling, and continued leg pain, without hives on neck. Pt took OTC BENADRYL and APAP, symptoms resolved.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bandaemia, Blood creatine phosphokinase MB increased
Clinical narrative: Initially presented to emergency room with complaints of itching and burning of skin.  Was treated in the Emergency Room and released.  Patient then presented to the Emergency Room again in the early morning hours of 4/9/15 with complaints of malaise, shortness of breath and epigastric pain.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Blood creatine phosphokinase increased, Dyspnoea, Electrocardiogram ST segment elevation, Full blood count abnormal, Leukocytosis
Clinical narrative: Initially presented to emergency room with complaints of itching and burning of skin.  Was treated in the Emergency Room and released.  Patient then presented to the Emergency Room again in the early morning hours of 4/9/15 with complaints of malaise, shortness of breath and epigastric pain.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Malaise, Myocardial infarction, Occult blood positive, Pruritus, Skin burning sensation
Clinical narrative: Initially presented to emergency room with complaints of itching and burning of skin.  Was treated in the Emergency Room and released.  Patient then presented to the Emergency Room again in the early morning hours of 4/9/15 with complaints of malaise, shortness of breath and epigastric pain.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: Initially presented to emergency room with complaints of itching and burning of skin.  Was treated in the Emergency Room and released.  Patient then presented to the Emergency Room again in the early morning hours of 4/9/15 with complaints of malaise, shortness of breath and epigastric pain.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Eyelid oedema, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Since Saturday Mar 28th, patient started developing rash/hives/hot rash/minor swollen mostly on his face, neck & around his ears, scratch his arms/legs.  Until today 4/14/15 the rash get more intense, widen and really bother him even at night.  His pediatrician try switch him to rice milk on 4/9/15, but patient still has series of rash, hive and itch on his face neck n limbs. Symptom developing everyday even eye lids will be puff when itch. Doctor prescribes Desonide cream, started apply on 4/7/15, but had to stop using next day.  Because it got him more red and burn.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Had shot in left bicep muscle. Had cramping in arm, swelling and redness on entire upper arm, and pain stretching from my left ear down to my left hand. Within 5 days the pain, the redness and swelling were so bad that I could not move my arm. I went to the clinic again and they told me I would be fine and that this is common. There is still pain, redness, and itching around the injection site area, and I have not regained full use of my left arm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pain, Peripheral swelling
Clinical narrative: Had shot in left bicep muscle. Had cramping in arm, swelling and redness on entire upper arm, and pain stretching from my left ear down to my left hand. Within 5 days the pain, the redness and swelling were so bad that I could not move my arm. I went to the clinic again and they told me I would be fine and that this is common. There is still pain, redness, and itching around the injection site area, and I have not regained full use of my left arm.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Measles antibody negative
Clinical narrative: RN had second step PPD planted yesterday in left forearm, also received MMR in left upper arm. Overnight her arm in area of the PPD "felt like it was on fire, like I had a bee sting". She had no reaction to TUBERSOL at the first step. Has had only one other PPD she can recall in past which was neg. No travel outside country in past year. Mother has hx of + PPD. The area of skin around MMR site is not bothering her.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Morning after flu vaccine, woke up with terrible pain, Rt upper arm and shoulder - called Dr. - had X-Ray at hospital - took prescription drugs 2 times - had MRI, physical therapy and orthopedic Dr consult.
Age: 2.0
Sex: F
Vaccine: HIBV, IPV
Symptoms: Injection site erythema, Local swelling, Pyrexia
Clinical narrative: Right thigh redness and fever started 7pm that evening swelling localized started the following morning.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient reports (not witnessed) extreme swelling at injection site. Flu like symptoms-stiff neck-sore joints-(shoulders/elbows/back). Duration at 48hrs.