chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.07
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: (+) hive like skin lesion noted after administration to injection site-proximal, given BENADRYL-checked site after. Hct and Lead done in lab-site now just erythematous, firm, no other hives noted.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Injection site reaction, Pyrexia, Rash maculo-papular
Clinical narrative: Initial - cough -> low grade fever and maculopapular rash (trunk and extremities). Tx - sxs watched and used APAP.
Age: 50.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Injection site abscess, Staphylococcus test negative
Clinical narrative: Abscess at injection site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with unknown number of doses of GARDASIL, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the GARDASIL lot # reported as J0112752 with expiration date: 21-APR-2016 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of GARDASIL. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash on (L) thigh that started on 4/8/15 and resolved by 4/10/15. Fever (temp 102.4) started on 4/9/15.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot #, dose and route not reported) instead of ZOSTAVAX. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site reaction, Urticaria
Clinical narrative: Pt with immediate wheal and flare at injection of vaccination which spread to 2-3 inches from injection site w/in 1 minute. No resp or GI sx, VSS. BENADRYL given and sx resolved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around site of injection. Tenderness to the touch.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On unspecified dates approximately 2 to 3 years ago, the patient received the first two doses of RECOMBIVAX HB. The patient wanted to receive a third dose on 02-APR-2015 (Inappropriate schedule of drug administration). No adverse symptoms reported. Outcome of the event, inappropriate schedule of drug administration was unknown. Reporting pharmacist considered the event to be not related to RECOMBIVAX HB. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, X-ray
Clinical narrative: Immediately after the immunization, patient had loss of motion in arm and experienced pain. The patient visited the physician once in November and December. Because of the pain and lack of motion, the patient is in physical therapy two to three times a week. The patient also had an X Ray.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, X-ray
Clinical narrative: Immediately after the immunization, patient had loss of motion in arm and experienced pain. The patient visited the physician once in November and December. Because of the pain and lack of motion, the patient is in physical therapy two to three times a week. The patient also had an X Ray.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Joint range of motion decreased, Pain, X-ray
Clinical narrative: The normal pain of injection was present and never stopped. The inflammation continued through February which limited arm motion, raising his hand, reaching back, and across chest. Physical therapy prescribed for 4 weeks, three times a week.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Injection site pain, Mobility decreased, X-ray
Clinical narrative: The normal pain of injection was present and never stopped. The inflammation continued through February which limited arm motion, raising his hand, reaching back, and across chest. Physical therapy prescribed for 4 weeks, three times a week.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: The soreness at the injection site was greater than usual and lasted for several days. The patient still feels the soreness if she presses on it. She began to feel intense pain radiating down the arm within a few days and had limited range of motion for months and could not lift or reach with the arm. Has improved - no medical attention sought.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product label confusion
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified number of patients of unknown age and gender. There was no information or pertinent medical history and drug reactions or allergies. On an unknown date, the patients received less than the recommended dose of VARIVAX (Merck) (dose, route, product lot#, expiry date was not reported). No adverse events were reported. There was no product quality complaint involved. The outcome of the events was unknown. Follow up information has been received from a nurse during a phone call on 07-APR-2015. The nurse provided that vaccination information (dates of vaccination, dose number, lot number) and patient identification information (patient name, date of birth) were not readily available at the time of the call. The nurse provided that there were no adverse events reported following administration of the vaccinations VARIVAX (Merck) and also provided that the patients who received the vaccinations were pediatric patients or "college kids who needed a booster". The nurse stated that the staff "was confused because the product instructions say to draw up 0.5 milliliters but then about 6 paragraphs down, it explained about reconstitution." This is one of the several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Cold sweat, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Tdap vaccine given in LUE, then GARDASIL vaccine given in RUE. Pt walked to chair from table, then had fainting/stiffening episode x approximately 1 minute. Pale, clammy but responsive when I ran in.
Sex: U
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information was received from the territory manager from Pfizer and was assigned manufacturer report number (W2015198854) for PREVNAR. This was originally reported by a consumer or non health professional concerning to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unspecified date approximately in 2013, "two years ago" the patient was vaccinated with PNEUMOVAX 23 (route, anatomical location, lot# and expiration date were not reported). There was no concomitant therapy reported. On an unknown date, the patient experienced swelling and pain. The outcome of swelling and pain were unknown. The territory manager mentioned that an unspecified doctor wanted to know if PREVNAR could be given to the patient or not due to prior adverse events. Additional information is not expected because the reporter details were not provided.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Product contamination physical
Clinical narrative: Prior to administration of Prevnar 13 vaccination, noticed particulate matter floating in solution of pre-filled syringe that did not dissolve with vigorous shaking. Disposed vaccine in appropriate manner. Administered another dosage from same lot without noticeable particulate.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, X-ray normal
Clinical narrative: Limited mobility in shoulder. Severe pain when mobility exceeded.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, WARMTH TO TOUCH WITH BURNING SENSATION.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Headache, Herpes zoster meningitis, Immunology test normal, Neck pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initially started with painful vesicular pustular rash, progressed to headache and neck pain. Diagnosed with VZV meningitis and currently undergoing 14 days of IV acyclovir. MRI brain negative and immune work-up negative to date.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Polymerase chain reaction, Rash, Rash pustular, Varicella virus test positive
Clinical narrative: Initially started with painful vesicular pustular rash, progressed to headache and neck pain. Diagnosed with VZV meningitis and currently undergoing 14 days of IV acyclovir. MRI brain negative and immune work-up negative to date.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash, Swelling
Clinical narrative: Pain, swellig, rash. Pt used ice on the area, itching, and took Benadryl. Pt given Rx for Betamethasone cream on 4/13/2015.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Fever (100.9), headache, chills, muscle aches, fatigue, loss of appetite, drowsiness, limitation of movement on injection site (left upper arm) due to pain.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: Fever (100.9), headache, chills, muscle aches, fatigue, loss of appetite, drowsiness, limitation of movement on injection site (left upper arm) due to pain.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Blepharospasm, Electroencephalogram normal, Muscle spasms, Myoclonus, Posture abnormal
Clinical narrative: Eye twitching, head rolling, body spasms.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pruritus genital, Rash erythematous
Clinical narrative: Raised red rash with itching in the genital and buttock area of the child.  Treated with diaper rash cream, but it keeps coming back.  Pediatrician told mother to phone us.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule
Clinical narrative: PATIENT DEVELOPED A KNOT AT THE INJECTION SITE WHICH SHE CONSULTED A DERMATOLOGIST ABOUT. THE KNOT IS SLOWLY RESOLVING BUT IS STILL PRESENT CURRENTLY.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, itching, swelling, 7 cm area at injection site.
Age: 41.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Paraesthesia, Peripheral swelling
Clinical narrative: 04/13/2015:  Reports to clinic with right arm swelling and tingling. Had Tdap Rt deltoid on 04/06/15. Had some minor soreness for a few days, then on 04/10/15 developed swelling and soreness right deltoid, no redness. Since then has experienced intermittent swelling, tingling and loss of sensation right lower arm and hand. Right hand and lower arm is now mottled with visible swelling; has difficulty with ROM right arm. Radial pulses present bilaterally. Has treated with ice QID, BioFreeze topical and Ibuprofen every 4 hours since 04/10/15. States history of surgery C-6, C-7 with right arm nerve symptoms 2 years ago.
Age: 41.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Sensory loss, Skin discolouration
Clinical narrative: 04/13/2015:  Reports to clinic with right arm swelling and tingling. Had Tdap Rt deltoid on 04/06/15. Had some minor soreness for a few days, then on 04/10/15 developed swelling and soreness right deltoid, no redness. Since then has experienced intermittent swelling, tingling and loss of sensation right lower arm and hand. Right hand and lower arm is now mottled with visible swelling; has difficulty with ROM right arm. Radial pulses present bilaterally. Has treated with ice QID, BioFreeze topical and Ibuprofen every 4 hours since 04/10/15. States history of surgery C-6, C-7 with right arm nerve symptoms 2 years ago.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain, X-ray limb
Clinical narrative: Registered Nurse gave Flu shot in right upper arm, ever since then right upper arm & shoulder are in pain & hurting; can't sleep on it can't lift it without it hurting also when driving it hurts.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Cyanosis
Clinical narrative: Patient with inconsolable crying and 2 cyanotic spells.
Age: 1.19
Sex: M
Vaccine: VARCEL
Symptoms: Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: High fever 106.8; lethargic; zoned out. Fever would come and go for months and months.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever with possible febrile seizure, followed 2 days later by rash.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: About 9 days after smallpox administration patient experienced loss of appetite, muscle aches, sore throat, neck pain, and headache that lasted for a total of 3-4 days. The site had redness and swelling around the site.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: About 9 days after smallpox administration patient experienced loss of appetite, muscle aches, sore throat, neck pain, and headache that lasted for a total of 3-4 days. The site had redness and swelling around the site.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Influenza like illness, Pyrexia, Swelling, Tenderness
Clinical narrative: SWELLING AND REDNESS OVER ENTIRE DELTOID, TENDERNESS, FLU LIKE SYMPTOMS, FEVER.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Arthralgia, Bone pain, Deafness, Dysgraphia
Clinical narrative: Left vaccine center a few minutes after vaccine. Shortly after getting in my car and driving through the parking lot I experienced vision brightness and then tunneled out to almost nothing. I lost my hearing as well. I felt sick and palpitations. I tried to make my way back into the vaccine center but my vision was so diminished I nearly got in a car wreck. I hit a curb and ruined the rim of my car and then left my car parked half way out of a parking stall with my door open to run into the clinic I could barely see before shouting out "something is wrong" I was wobbling and felt like I was going to die. They took me back. No doctor ever came after my episode. I stabilized there with the person who vaccinated me. The vaccine was extremely painful. Later on I started feeling pain shooting down my entire arm. Now my fingers my joints my bones feel in severe pain. I've had the vaccine in both arms but experienced pain in my right almost immediately afterwards. I now am having trouble writing and doing anything. This is difficult because I'm in school. I have to go to a doctor now. Pain is in each one of my phalanges, metacarpals, wrist, and all the way up to almost my shoulder.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Impaired driving ability, Malaise, Pain in extremity, Palpitations
Clinical narrative: Left vaccine center a few minutes after vaccine. Shortly after getting in my car and driving through the parking lot I experienced vision brightness and then tunneled out to almost nothing. I lost my hearing as well. I felt sick and palpitations. I tried to make my way back into the vaccine center but my vision was so diminished I nearly got in a car wreck. I hit a curb and ruined the rim of my car and then left my car parked half way out of a parking stall with my door open to run into the clinic I could barely see before shouting out "something is wrong" I was wobbling and felt like I was going to die. They took me back. No doctor ever came after my episode. I stabilized there with the person who vaccinated me. The vaccine was extremely painful. Later on I started feeling pain shooting down my entire arm. Now my fingers my joints my bones feel in severe pain. I've had the vaccine in both arms but experienced pain in my right almost immediately afterwards. I now am having trouble writing and doing anything. This is difficult because I'm in school. I have to go to a doctor now. Pain is in each one of my phalanges, metacarpals, wrist, and all the way up to almost my shoulder.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Tunnel vision, Visual brightness
Clinical narrative: Left vaccine center a few minutes after vaccine. Shortly after getting in my car and driving through the parking lot I experienced vision brightness and then tunneled out to almost nothing. I lost my hearing as well. I felt sick and palpitations. I tried to make my way back into the vaccine center but my vision was so diminished I nearly got in a car wreck. I hit a curb and ruined the rim of my car and then left my car parked half way out of a parking stall with my door open to run into the clinic I could barely see before shouting out "something is wrong" I was wobbling and felt like I was going to die. They took me back. No doctor ever came after my episode. I stabilized there with the person who vaccinated me. The vaccine was extremely painful. Later on I started feeling pain shooting down my entire arm. Now my fingers my joints my bones feel in severe pain. I've had the vaccine in both arms but experienced pain in my right almost immediately afterwards. I now am having trouble writing and doing anything. This is difficult because I'm in school. I have to go to a doctor now. Pain is in each one of my phalanges, metacarpals, wrist, and all the way up to almost my shoulder.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Systemic lupus erythematosus
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to an approximately 65 year old female patient. Information about patient's current condition or medical history was not reported. On 21-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose not reported) subcutaneously. Concomitant medications were not provided. On 22-MAR-2013 the patient experienced a rash all over her body. The patient was referred to a dermatologist and diagnosed with Lupus in June 2013. The nurse practitioner reported that the patient still saw a Rheumatologist as of April 2015 and outcome of Lupus was reported as not recovered. Upon internal review, Lupus was determined to be medically significant. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Afternoon of injection-pt developed fever (101). Then arm soreness and redness. TX-ice, NSAIDS.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: This spontaneous report as received from a nurse practitioner via Pfizer refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with GARDASIL (route, anatomical location, lot# and expiration date were not reported). There was no concomitant therapy reported. On an unknown date, the patient experienced vaccination complication reported as "the nurse mentioned that her patient had a unusual reaction to GARDASIL. The outcome of vaccination complication was unknown. The nurse queried if GARDASIL could be administered again to the patient again as it is a three dose course and the patient already had an unusual reaction to it. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68 year old male patient. On 09-APR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml administered via subcutaneous with lot # J011826 and expiration date: 26-DEC-2014 in the left arm. No adverse effects reported. Additional information is not expected due to the reporter could not be contacted again.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that on 07-APR-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J003528; expiration date 25-MAR-2015) (dose and route not provided). No adverse effects were noted. Additional information is not expected because the reporter did not provide consent to follow up.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that on 07-APR-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J003528; expiration date 25-MAR-2015) (dose and route not provided). No adverse effects were noted. Additional information is not expected because the reporter did not provide consent to follow up.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 16 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. The physician informed that on an unknown date the patient was inadvertently administered a dose of PROQUAD (strength, dosage, lot# and expiration date were not reported) instead of a dose of VARIVAX. No adverse events were reported. 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 physician refers to an unspecified number of patients of unknown age and gender from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with PROQUAD doses unspecified in series (dose, route and dose number not provided) (lot no. K019102 with expiration date of: 15-APR-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored VARIVAX (please refer to MARRS No. 1504USA005042 and MARRS No. 1503USA012150). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and medical history were not reported. On 02-APR-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # J005067, expiration date: 17-JAN-2015 (expiration date also reported as 07-JAN-2015); 0.5 ml, route of administration unknown. There was no concomitant medication reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no pertinent medical history/rug allergies or drug reactions reported. On 20-MAR-2015, the patient was vaccinated with an expired dose of M-M-R II (expiration date October 2014, exact date of expiry, route, dose and lot# were not reported). Concomitant therapy was not mentioned. No adverse experienced 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 physician refers to an unspecified number of patients of unknown age from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with VARIVAX (Merck) 0.5 ml once subcutaneously doses (unspecified in series) (lot no: K008824 with expiration date: 19-JUN-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored PROQUAD (Merck) and M-M-R II (please refer to MARRS No. 1504USA005042 and MARRS No. 1504USA005043). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. 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 physician refers to an unspecified number of patients of unknown age and gender from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and dose number not provided) (lot no: K004949 with expiration date of: 04-APR-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored VARIVAX (Merck) and PROQUAD (Merck) (please refer to MARRS No. 1503USA012150 and MARRS No. 1504USA005043). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, IPV, MNQ, TD, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Child came to our office/clinic 3/15/15. She claims pregnant between 5-6 months. Vaccine was given 11/05/14. Hep A, HPV, IPV, Td, Varicella, FLUMIST.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Purulent discharge, Swelling
Clinical narrative: Received PCV13 on 4/11 9:30 AM. S/S include swelling of right shoulder and at least 1-2 teaspoons of yellow pus/drainage from injection site. No reports of difficulty breathing.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cardiac monitoring, Oxygen saturation decreased, Rash erythematous
Clinical narrative: 10 mins after the vaccines given to the baby, the mother called us to the room because she had noticed red rash on periorbital areas and left temporal areas. On exam baby was alert, active pulse ox 100% RA, HR 137/min, skin and papules on upper eyelid checked, left temporal and upper back and diaper area. Lungs clear. Abd soft. Oral cavity intact. Continuous pulse ox decreased, heart monitoring were applied, 1 ml of BENADRYL given orally, in next 20 mins the rash faded, pt was D/C'd home stable with appointment to return in 24h and ER precaution.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Asthenia, Body temperature increased, Febrile convulsion
Clinical narrative: Febrile convulsion 4/10/15. Low energy 4/10/15. Temp 102 and at ER. No other s/s of infection.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Pruritus
Clinical narrative: Developed 2 1/2" round, indurated, itchy area 3d after immunization. Symptoms have continued x 7d without resolution.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: (+) erythema (L) tricep region. Raised 3 1/2" x 3". Mild itching x 1-2 days. Tx self with BENADRYL.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Received vaccine 3/27/15 w/well child visit and mom noticed rash on his neck and fever starting 4/6/15-fever 102 at the highest. Responds to TYLENOL, eating and drinking well.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Flushing, Skin warm, Tenderness
Clinical narrative: Patient developed a red, warm to touch arm, slightly tender. He states he was flushed over the weekend, but did not take temp. Dr advised 50mg BENADRYL and cold packs.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abnormal behaviour, Pain in extremity
Clinical narrative: Patient c/o arm pain since given the flu vaccine. Patient states her pain travels from her shoulder down to her wrist. Patient describes it as a nagging pain. Patient states she also experience behavior changes last 24 hours. Patient was accompanying by her daughter.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, HIV test negative, Hepatitis B test negative, Hepatitis C test negative, Injury associated with device
Clinical narrative: While administering vaccine patient moved unexpectedly causing patient to prick her right thumb with needle. She had not had the opportunity to retract the needle. Both patient and immunizer were tested and cleared.
Sex: U
Vaccine: HIBV
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 (exposed to 33F for 0.5 hours) PEDVAXHIB (lot # K015464, expiration date 09-JUL-2017, dose and route were unknown). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were provided. On an unknown date these patients were vaccinated with GARDASIL (lot # K007264, expiration date 02-MAR-2017; dose, frequency and route not reported) which were improperly stored at 32.9F for 22 days. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Feeling abnormal, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Blood test, Burning sensation, Chromaturia
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysgeusia, Erythema, Gait disturbance, Headache
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Hypopnoea, Nausea, Pallor
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor, Urine analysis, Urine odour abnormal, Vomiting
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
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 RECOMBIVAX HB lot # J013394, expiry date: 25-AUG-2016, (route, dose 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.
Sex: U
Vaccine: HEP
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 RECOMBIVAX HB lot # K010535, expiry date: 27-AUG-2016, (route, dose 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.
Sex: U
Vaccine: RV5
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 ROTATEQ, lot # K010323, expiry date: 10-MAY-2016, (route, dose 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.
Sex: U
Vaccine: HPV4
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 GARDASIL, lot # K006960, expiry date: 19-FEB-2017, (route, dose 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.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 15-OCT-2014 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On 26-MAR-2015 the patient was inadvertently vaccinated with a second 0.65ml of ZOSTAVAX (lot# and expiration date not reported), subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Anxiety, Back pain, Borrelia test, Fatigue
Clinical narrative: 1st symptom of lower back pain within 10 days of vaccine. Followed by severe headaches, severe fatigue, muscle aches and pains, fevers, heart palpitations, anxiety, insomnia, abdominal pain, nausea, vomiting. She has been seen by PCP's, Neurologist, Chiropractor, Holistic Health practitioner, has had numerous medications and treatments, MRI's, brain scans, nerve function tests, injections, etc all with no results and this is ongoing still six years later.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Insomnia, Myalgia, Nausea, Nerve conduction studies
Clinical narrative: 1st symptom of lower back pain within 10 days of vaccine. Followed by severe headaches, severe fatigue, muscle aches and pains, fevers, heart palpitations, anxiety, insomnia, abdominal pain, nausea, vomiting. She has been seen by PCP's, Neurologist, Chiropractor, Holistic Health practitioner, has had numerous medications and treatments, MRI's, brain scans, nerve function tests, injections, etc all with no results and this is ongoing still six years later.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Palpitations, Pyrexia, Scan brain
Clinical narrative: 1st symptom of lower back pain within 10 days of vaccine. Followed by severe headaches, severe fatigue, muscle aches and pains, fevers, heart palpitations, anxiety, insomnia, abdominal pain, nausea, vomiting. She has been seen by PCP's, Neurologist, Chiropractor, Holistic Health practitioner, has had numerous medications and treatments, MRI's, brain scans, nerve function tests, injections, etc all with no results and this is ongoing still six years later.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, X-ray
Clinical narrative: 1st symptom of lower back pain within 10 days of vaccine. Followed by severe headaches, severe fatigue, muscle aches and pains, fevers, heart palpitations, anxiety, insomnia, abdominal pain, nausea, vomiting. She has been seen by PCP's, Neurologist, Chiropractor, Holistic Health practitioner, has had numerous medications and treatments, MRI's, brain scans, nerve function tests, injections, etc all with no results and this is ongoing still six years later.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Cough, Eye swelling, Eyelid rash, Lip swelling, Swelling face
Clinical narrative: Swollen tongue-current. Swollen face and lips an eyes. Cough. Rash on eye lids.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue-current. Swollen face and lips an eyes. Cough. Rash on eye lids.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising, Insomnia
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.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray limb
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.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site bruising, Insomnia, Mobility decreased
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.