chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, redness, itching, hot.
Age: 39.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Large red splotch at injection site (just over 4 inches in diameter).  Splotch is painful and hot to the touch.  Developed during sleep the night after the Flublok was administered.  Was examined by employee health and told that they had seen that reaction before.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Haematemesis, Headache, Retching, Vomiting
Clinical narrative: Violent vomiting and diarrhea and headache lasting several hours. Retched so hard he vomited blood for a while. It eventually resolved and then slow fluid and electrolyte replacement.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Pain in extremity, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Patients arm started hurting evening of administration.  The next morning, patient was starting to have some pain extending down to elbow.  Upon examination, area where vaccination was administered was red, swollen, and starting to flare.  Patient was advised to take diphenhydramine and apply cold to area.  Injection site continued to flare, upon which patient proceded to see physician, where she was diagnosed with cellulitis and prescribed antibiotics for treatment.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Conductive deafness, Deafness neurosensory, Ear discomfort
Clinical narrative: Plugged ear, hearing loss; audiologist 10/15/2014 showed mild/moderate conductive hearing loss from fluid which will require tube placement and bilateral mild sensorineural hearing loss irreversible.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Abdominal pain, Blood glucose normal, Bradycardia, Heart rate irregular, Pallor
Clinical narrative: Sudden onset abdominal pain with sudden pallor, sleepiness, bradycardia to 57 BPM. No LOC, no vomiting. Irregular heart beat. Patient slow to recover and required transport via EMS to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Somnolence
Clinical narrative: Sudden onset abdominal pain with sudden pallor, sleepiness, bradycardia to 57 BPM. No LOC, no vomiting. Irregular heart beat. Patient slow to recover and required transport via EMS to ER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Patient complained of eyes blood red, throat swollen, and chest pain. Sometime after 9:00 pm patient went to ER and was kept overnight for testing and monitoring at Medical Center. Patient states doctor thought it may have been a reaction to a preservative, but not the flu vaccine. The vaccine given patient didn't contain a preservative.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Death, Endotracheal intubation
Clinical narrative: Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Headache, Hypotension, Laboratory test normal, Malaise
Clinical narrative: Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Multi-organ failure, Ocular hyperaemia, Pain, Pyrexia, Septic shock
Clinical narrative: Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Movement disorder, Skin warm
Clinical narrative: Area warm, reddened, difficulty lifting arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Paraesthesia, Skin warm
Clinical narrative: Right arm size of baseball, warm to touch. No fever, tingling to fingers.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site warmth, Pruritus
Clinical narrative: Patient states immediately after receiving vaccine site becae itchy. Today presents with redness, warm t touch, with small nodule at injection site. Informed to let us aware if seeks treatment. 10/8/14 Cc seeking tx tomorrow at either an urgent care or office.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: From injection c/o hurt 4-5days. Today 10/8/14 hard to lift arm-giving her much pain. Referred to one of our offices for evaluation and treatment. Patient has also contacted work partners.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: 60mm by 60mm reddened flattened area at injection site with hard "nodule" in center. Warm to touch and painful. Runny nose, fever of 102, sore throat, and bloody mucus symptoms started early in AM of 10/02/14. Patient seeking treatment at her PCP tomorrow 10/3/14.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: 60mm by 60mm reddened flattened area at injection site with hard "nodule" in center. Warm to touch and painful. Runny nose, fever of 102, sore throat, and bloody mucus symptoms started early in AM of 10/02/14. Patient seeking treatment at her PCP tomorrow 10/3/14.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: 50mm by 50mm flattened reddened area at injection site with hard nodule in center, warm to touch and painful. Has been massaging area and applying warm compresses to site.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Right arm very painful, aching, difficulty moving up.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site urticaria
Clinical narrative: Reddness at site, hives to elbow, numbness to fingers lasted approx 24 hours.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Fever 99 degrees F. Sore shoulder, elbow. Left arm. Took MOTRIN. Next day felt nausea, chills, vomiting, headache.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 99 degrees F. Sore shoulder, elbow. Left arm. Took MOTRIN. Next day felt nausea, chills, vomiting, headache.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site reaction, Limb discomfort, Rash erythematous, Skin warm
Clinical narrative: Presents today with 50 mm by 50 mm flattened red rash at injection site. Warm to touch and c/o numbness and tickling in (L) arm. Referred to facility if seeks treatment. Also informed to let us know if she does seek tx.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse and mother's patient refers to a 27 year old female patient. Concomitant medications, medical history, drug reactions and allergies were not reported. On 23-SEP-2014, the patient accidentally was vaccinated with GARDASIL (lot # J013324 expiry date 12-FEB-2016), 0.5mL, intramuscularly, instead of RHOGAM (dosage and manufacturer unknown). The mother of the patient stated that after the mistake was realized, the patient was then given RHOGAM. No adverse effects were reported. The patient became pregnant with (last menstrual period) LMP of 11-MAR-2014, Date of conception 25-MAR-2014 and Expected Date of Delivery (EDD) of 16-DEC-2014. Initial exposure to GARDASIL was at 28 weeks. The registered nurse reported that it was not know if the woman has received GARDASIL in the past. Unspecified treatment was given. The patient sought unspecified medical attention. No laboratories diagnostic test were performed. The outcome of the pregnancy was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse and mother's patient refers to a 27 year old female patient. Concomitant medications, medical history, drug reactions and allergies were not reported. On 23-SEP-2014, the patient accidentally was vaccinated with GARDASIL (lot # J013324 expiry date 12-FEB-2016), 0.5mL, intramuscularly, instead of RHOGAM (dosage and manufacturer unknown). The mother of the patient stated that after the mistake was realized, the patient was then given RHOGAM. No adverse effects were reported. The patient became pregnant with (last menstrual period) LMP of 11-MAR-2014, Date of conception 25-MAR-2014 and Expected Date of Delivery (EDD) of 16-DEC-2014. Initial exposure to GARDASIL was at 28 weeks. The registered nurse reported that it was not know if the woman has received GARDASIL in the past. Unspecified treatment was given. The patient sought unspecified medical attention. No laboratories diagnostic test were performed. The outcome of the pregnancy was unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Culture negative, Erythema, Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: 10/9/14 3PM RN note. Left arm red and swollen. 10/10/14 - 8:30am - (L) deltoid indurated red with blistering at center (small area). KEFLEX 500mg 1 6hr QID x 7 days - 2 doses taken and refused. BENADRYL 25mg po QID PRN.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: 10/9/14 3PM RN note. Left arm red and swollen. 10/10/14 - 8:30am - (L) deltoid indurated red with blistering at center (small area). KEFLEX 500mg 1 6hr QID x 7 days - 2 doses taken and refused. BENADRYL 25mg po QID PRN.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Myalgia
Clinical narrative: Large (2") red area around injection site, firm to the touch, not tender, arm muscle does ache, deeper red/purple color closer to site. Came to have it checked 10/01 in pharmacy.
Age: 71.0
Sex: F
Vaccine: FLUN4
Symptoms: Wrong drug administered
Clinical narrative: Patient was given FLUMIST (live) vaccine instead of high dose vaccine in our office.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: States "(L) arm was red and warm to touch from shoulder to elbow Monday afternoon (10/13) till this AM 10/15". (L) deltoid swollen area (3 1/2 x 3 1/2 cm) and 2 x 3 1/2 area in inch above elbow red and warm to touch at 18:50 on 10/15. Stated "was painful to raise arm for 2 days, okay now" full range of motion.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Sharp pain from shoulder to elbow when arm is moved in a certain position. Patient has used ibuprofen, heat, and cold to try to help.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Pruritus generalised
Clinical narrative: Developed generalized itching and then sharp chest pain and dyspnea with inspiration approx. 2 hours after vaccination.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Heart rate increased, Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: Seeing white spots, sweats, rapid heartbeat, difficulty breathing, nausea (within one minute).
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness over large area of arm, swelling at injection site. Fever for several days. Seen by MD twice.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration
Clinical narrative: Patient came in 4 days after receiving shot. Whole upper arm was bruised/purple from shoulder to elbow. Pt not on any blood thinners.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: 10-14-14 at 5-6 pm note swelling, pain, redness, fever, nausea, vomiting, diarrhea. She reports reaction on 10-16-14 at 9:30 am. Note redden area (L) delt 7 x 6 1/2 cm warm to touch. She took ibuprofen - area marked BENADRYL given.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: 10-14-14 at 5-6 pm note swelling, pain, redness, fever, nausea, vomiting, diarrhea. She reports reaction on 10-16-14 at 9:30 am. Note redden area (L) delt 7 x 6 1/2 cm warm to touch. She took ibuprofen - area marked BENADRYL given.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vaccination site rash, Vaccination site warmth
Clinical narrative: One hour after vaccine rash and hot at vaccine site 5" x 3" then rash spread to neck and chest.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Erythema that is blanchable on Right upper arm extending 19cm (high) by 13cm width, arm Circ. 23cm vs left arm 19cm warm to touch, painful on palpation, has full ROM at farm, for 24 hours. Treatment: allergy medication. Recovery: unknown.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated, Cough, Peak expiratory flow rate, Vomiting
Clinical narrative: Started w/"wheezing cough" - 10/12/14 vomited x 1-10/13/14- Office visit 10/14/14- dx: acute asthma exacerbation- PEF (160) tx: prednisolone, albuterol MDI- OV to recheck scheduled for 10/17/14.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: Started w/"wheezing cough" - 10/12/14 vomited x 1-10/13/14- Office visit 10/14/14- dx: acute asthma exacerbation- PEF (160) tx: prednisolone, albuterol MDI- OV to recheck scheduled for 10/17/14.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Immediate post-injection reaction, Injection site pain, Lethargy
Clinical narrative: Received vaccine to left deltoid, developed immediate pain at injection site greater than typical for vaccines, then developed sudden blurred vision, lethargy, nausea, abdominal pain, chills, then fever to 100 degrees.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vision blurred
Clinical narrative: Received vaccine to left deltoid, developed immediate pain at injection site greater than typical for vaccines, then developed sudden blurred vision, lethargy, nausea, abdominal pain, chills, then fever to 100 degrees.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: Patient developed bursitis in the arm she received her vaccination in. Dr told patient it was because the injectino was given to high on the arm.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Left upper extremity extreme pain, erythema, induration. Fevers, chills, body aches. Erythema/induration spread distally towards elbow.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Left upper extremity extreme pain, erythema, induration. Fevers, chills, body aches. Erythema/induration spread distally towards elbow.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever 4 days after vaccinations, then again 10 days after vaccination up to 103 degrees rash that is macular 10 days after vaccination.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: "Shingles" (herpes zoster). Breakout occurred 30 hrs after flu vacc. Treated with Acyclovir.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Incoherent, Malaise, Vomiting
Clinical narrative: Patient called 4 days after getting FLUZONE HD saying she was severely sick, 2-3 hrs after getting flu shot on 10/3 - vomiting, severely dehydrated, incoherent; pt. called on 10/7 and was feeling a bit better.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Culture throat, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Influenza vaccine (shot) given on 9/26/14 at pharmacy. Developed fever of 103.5, rash, HA, nausea and diarrhea on 9/29/14.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Influenza vaccine (shot) given on 9/26/14 at pharmacy. Developed fever of 103.5, rash, HA, nausea and diarrhea on 9/29/14.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Joint stiffness, Myalgia, Swelling
Clinical narrative: Redness, swelling, joint stiffness, myalgia, pain in shoulder/wrist/elbow joints.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Phone call from patient - c/o swelling, burning and pain at injection site.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Electroencephalogram normal, Grand mal convulsion, Syncope
Clinical narrative: One min after getting the vaccine (HPV) pt had brief episode of syncope and tonic/clonic sz like activity x 5 sec recovered uneventful.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Visual impairment
Clinical narrative: Vision changes, severe headaches still persisting after 2 days, temperature elevated (normal 92 and running - 98.6) chills.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Ataxia, Chest X-ray normal, Full blood count normal, Insomnia
Clinical narrative: Received High Dose Flu and PREVNAR 13 vaccines October 8th. On October 9th onset difficulty focusing eyes, weakness, insomnia, mild rashes, ataxia. On Oct 10th medic transport to hosp ER. No acute findings, vitals wnl.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Rash, Vision blurred
Clinical narrative: Received High Dose Flu and PREVNAR 13 vaccines October 8th. On October 9th onset difficulty focusing eyes, weakness, insomnia, mild rashes, ataxia. On Oct 10th medic transport to hosp ER. No acute findings, vitals wnl.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: C/o red, slightly raised area at site of flu shot injection. Throbs. Slight warm. Tx. Ice, ibuprofen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills, low grade fever, nausea: -> pt visited ER and got treated with fluids, aspirin and nausea medication on 10/02/2014 per pt.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash generalised
Clinical narrative: Patient received vaccine on 09/28/2014. On 10/05/2014, he stopped by the pharmacy to discuss the rash that appeared all over his arms and body. He bought BENADRYL OTC that day. Recently visited doctor; rec'vd BENADRYL and steroid and is recovering.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red streaks, hot, and arm swelled up.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Large black and blue and purple area on site of injection (about 8 x 4"). Painful. Began evening of injection. Referred to clinic for evaluation.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Discomfort, Lymphadenopathy, Pain, Soft tissue mass, Tenderness
Clinical narrative: Pt noticed tenderness and pain near collarbone before bedtime night of vaccine. The next morning noticed a bump of soft tissue in place where pt had discomfort. Dx as lymph node swelling and pt received ZPAK and Pred taper pack 5mg 6 day.
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt reported to office with possible reaction to vaccine. 9-10 cm red, warm area to upper (R) arm. Pt was given BENADRYL in office, area circled to document change. Pt called in later that day and reported increase in size of redness outside the circle placed in office. KEFLEX called in however for possible infection.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient began having pain, soreness, and limited range of movement severals after administration and has continued until present time.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Cellulitis, Local reaction, Vomiting
Clinical narrative: Temperature, vomiting, local reaction, cellulitis
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Skin pink arm below vaccine site to elbow of (R) arm with red dots - warm, no pain, itching - recommended TYLENOL and ice compress to reduce reaction - RN looked at it and told her the same thing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh redness, swelling, tenderness, warmth measuring 4x6 inches.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Activities of daily living impaired, Body temperature increased, Erythema, Headache, Immediate post-injection reaction
Clinical narrative: Pt received 3 vaccines on 10-14-14. Next AM noted red, swollen RA only. (10 AM). Had headache evening of vaccine date - MOC gave ibuprofen. Site was pink. Next AM went to school -arm noted by pt to be red/swollen. Did not go to nurse at school. Seen here after school. Still red/swollen. See note from nurse earlier. Vaccines yesterday - Tdap (L) deltoid. MENVEO (lower) and influenza (higher) in the (R) arm. Pain and some bleeding from MENVEO site when given. Patient changed Band Aid. Headache last evening and did not participate in her swimming. This am (R) arm with some redness, not tender till 10 am, after running at school. Had temp to 101 per Mom. After school arm red per mother and advised to come for exam. Smiling and joking with mother. (R) upper arm remarkable swollen and red. Upper puncture site (flu) is not center of reaction and is not as swollen as the lower puncture site which is more than an inch lower. Lower site is edematous and swollen. Lightly indurated with borders out 9 x 9 cm, pink but not esp hot. No pustule in center, no fluctuance. Moves arm. Local vaccine reaction to MENVEO. I do not feel that this is an infection. I discussed this with mother and she agrees with watching the site and not treating with antibiotics. It is possible that because there was some bleeding from the site yesterday that there was more opportunity for a reaction. Fever would be more likely due to the Tdap than the MENVEO. Certainly headache can be a vaccine reaction. Observe borders, call with enlargement. (Black dots were marked at the borders for reference). Ibuprofen for fever, headache, inflammation. Cool compresses - one was given here. BENADRYL 25-37.5 mg dosing in case there is local histamine release. We will file VAERS. Call with questions. Especially let me know if you think anything is worsening.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Inflammation, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site oedema
Clinical narrative: Pt received 3 vaccines on 10-14-14. Next AM noted red, swollen RA only. (10 AM). Had headache evening of vaccine date - MOC gave ibuprofen. Site was pink. Next AM went to school -arm noted by pt to be red/swollen. Did not go to nurse at school. Seen here after school. Still red/swollen. See note from nurse earlier. Vaccines yesterday - Tdap (L) deltoid. MENVEO (lower) and influenza (higher) in the (R) arm. Pain and some bleeding from MENVEO site when given. Patient changed Band Aid. Headache last evening and did not participate in her swimming. This am (R) arm with some redness, not tender till 10 am, after running at school. Had temp to 101 per Mom. After school arm red per mother and advised to come for exam. Smiling and joking with mother. (R) upper arm remarkable swollen and red. Upper puncture site (flu) is not center of reaction and is not as swollen as the lower puncture site which is more than an inch lower. Lower site is edematous and swollen. Lightly indurated with borders out 9 x 9 cm, pink but not esp hot. No pustule in center, no fluctuance. Moves arm. Local vaccine reaction to MENVEO. I do not feel that this is an infection. I discussed this with mother and she agrees with watching the site and not treating with antibiotics. It is possible that because there was some bleeding from the site yesterday that there was more opportunity for a reaction. Fever would be more likely due to the Tdap than the MENVEO. Certainly headache can be a vaccine reaction. Observe borders, call with enlargement. (Black dots were marked at the borders for reference). Ibuprofen for fever, headache, inflammation. Cool compresses - one was given here. BENADRYL 25-37.5 mg dosing in case there is local histamine release. We will file VAERS. Call with questions. Especially let me know if you think anything is worsening.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction, Local swelling
Clinical narrative: Pt received 3 vaccines on 10-14-14. Next AM noted red, swollen RA only. (10 AM). Had headache evening of vaccine date - MOC gave ibuprofen. Site was pink. Next AM went to school -arm noted by pt to be red/swollen. Did not go to nurse at school. Seen here after school. Still red/swollen. See note from nurse earlier. Vaccines yesterday - Tdap (L) deltoid. MENVEO (lower) and influenza (higher) in the (R) arm. Pain and some bleeding from MENVEO site when given. Patient changed Band Aid. Headache last evening and did not participate in her swimming. This am (R) arm with some redness, not tender till 10 am, after running at school. Had temp to 101 per Mom. After school arm red per mother and advised to come for exam. Smiling and joking with mother. (R) upper arm remarkable swollen and red. Upper puncture site (flu) is not center of reaction and is not as swollen as the lower puncture site which is more than an inch lower. Lower site is edematous and swollen. Lightly indurated with borders out 9 x 9 cm, pink but not esp hot. No pustule in center, no fluctuance. Moves arm. Local vaccine reaction to MENVEO. I do not feel that this is an infection. I discussed this with mother and she agrees with watching the site and not treating with antibiotics. It is possible that because there was some bleeding from the site yesterday that there was more opportunity for a reaction. Fever would be more likely due to the Tdap than the MENVEO. Certainly headache can be a vaccine reaction. Observe borders, call with enlargement. (Black dots were marked at the borders for reference). Ibuprofen for fever, headache, inflammation. Cool compresses - one was given here. BENADRYL 25-37.5 mg dosing in case there is local histamine release. We will file VAERS. Call with questions. Especially let me know if you think anything is worsening.
Age: 80.0
Sex: U
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Generalized macular rash pink in color non itching, not painful. No systemic symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device
Clinical narrative: I pricked my own thumb after administering the vaccine to patient.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Inflammation, Rash vesicular, Urticaria
Clinical narrative: Red welts developed followed by blistery rash. Was prescribed VALTREX followed by BACTRIM to help with inflammation.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient has bruising on arm where injection was given. Injection on 10/5 - bruising not reported until 10/14 - Patient figures it's from the vaccine.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient was given a flu shot 10/13, 10/15 evening she called reported redness, swelling and warmth in a six inch area on the fatty part of her arm.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness and swelling noted to left deltoid 10/16/14 in AM. C/O itching. Shot flu received 10/15/14.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Migraine, Somnolence
Clinical narrative: Patient reported dizziness, migraine, and somnolence.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site mass, Pruritus
Clinical narrative: Patient reports arm is very itchy, red and that she feels a small lump at the injection site. No fever, area is not hot to the touch.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (.5 ml, unknown batch number, left arm). Within days of vaccination with FLUARIX Quadrivalent, the subject experienced pain and soreness at injection site. At the time of reporting, the outcome of the events were unspecified. Additional information received on 06 October 2014: The patient received 1st dose of FLUARIX Quadrivalent (batch number 2KJ3T, expiry date was unknown). On 4th September 2014, less than a day after receiving FLUARIX Quadrivalent, the patient experienced injection site pain and soreness. On 9th September 2014, the outcome of the events were resolved. The reporter considered the injection site pain and pain to be probably related to FLUARIX Quadrivalent.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt showed redness around the area of injection and reported bumps around injection site.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 45 year old male patient with diabetes. The patient's medical history included cellulitis. There were no other drug reactions/allergies. On 10-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot# reported as J015860), 0.5 ml, intramuscular in the left arm. Concomitant therapies included FLUZONE and insulin. It was reported that the patient developed a fever, redness, swelling, and warmth of the left arm on 11-OCT-2014. The patient was evaluated at an unspecified urgent care facility on 13-OCT-2014. He was diagnosed with cellulitis and was prescribed LEVOQUIN. The outcome of cellulitis was reported as not recovered/not resolved. The patient sought medical attention by urgent care facility. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient had rash that began on leg then spread to neck and all over rest of the body with fevers. The rash lasted about 7-9 days per mom of patient.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: Arm blew up (swollen) and cellulitis.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Varicella post vaccine
Clinical narrative: Low grade fever. "Chicken pox spots" 3 in x 2 in. Redness to injection site. Soft induration and redness blanches.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye swelling, Pain, Rash, Urticaria
Clinical narrative: Had vaccine 10/10/14 - started with hives, pain and upper trunk on Saturday. Rash spread to entire trunk, arms, legs. Eye swelling on Sunday. Took BENADRYL and Hydrocortisone cream. Intermittently hives continued to 10/13/14. Continued with BENADRYL.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 60 year old patient of an unknown gender. On 14-OCT-2014 the patient was vaccinated with an expired vaccine of PNEUMOVAX23, dose 0.5 ml (route, lot number and expiration date not reported). No adverse experiences had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with VAQTA inj 25/0.5 (unspecified units) (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Erythema, muscle pain, swelling at injection site. Acetaminophen 1000 mg BID.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with VARIVAX (Merck) 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 63 year old patient of unknown gender. On 14-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, dose 0.5 ml (route, lot number and expiration date not reported). No adverse experiences had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching, redness around inj site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with MMR II (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 42 year old female patient. The patient's pertinent medical history included respiratory lung disease. The patient's drug allergies were none. On 08-OCT-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (Dose/Frequency: 0.5 ml, lot # H022172 and expiry date: 16-AUG-2014) intramuscular in the left arm. Concomitant medications were none. On the same day (08-OCT-2014), the patient was administered FLUVIRIN in the left arm. On an unspecified date in 2014, the patient experienced soreness and hotness at the left arm injections sites. No treatment was provided for the events. Patient did not sought medical attention. Lab diagnostic tests performed were none. The outcome of soreness and hotness at the left arm injections sites was unknown. The causality of soreness and hotness at the left arm injection sites was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with PEDVAXHIB inj (dose, route, lot# were reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with (Merck) VARIVAX (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Fall, Pneumonia, Wrist fracture
Clinical narrative: This spontaneous report as received from a pharmacist (who was also the patient's husband) refers to a 73 year old female patient. The patient's pertinent medical history was not provided. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23 (Manufacturer unspecified) (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included ALLEGRA. On an unspecified date in June 2014, the patient was diagnosed with pneumonia by an unspecified physician. On an unspecified date in June 2014 a chest x-ray was completed and it had shown 25% of one lobe was affected. The patient was treated with an unspecified medication for 2 weeks following diagnosis and did recover on an unspecified date in approximately 2014. Then, on an unspecified date in September 2014, the patient fell and fractured her right wrist. At the time of the report (also reported as currently), the patient not recovered from the injury. The patient took acetaminophen as a treatment for adverse event. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with RECOMBIVAX HB 5 microgram/0.5 ml  (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a 23 year old female consumer refers to herself. Current condition included drug reactions or allergies to amoxicillin and cetrizine. The patient's medical history included anxiety and traumatic brain injury. The patient reported that on 08-AUG-2011 she received first dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown in upper right arm) and second dose on 11-JUN-2013 and she received third dose on an unknown date in September 2014. Concomitant medications were unspecified by reporter. On an unknown date in 2014, the patient developed anxiety and stomach cramp after third dose of GARDASIL. Patient also stated that "she was trying to get pregnant". The patient also stated that she called nurse (name and contact information were unknown) regarding this and she was advised to take a fourth dose by Nurse. There was no treatment given for the event. The outcome of the events was unknown. The causality for the events anxiety and stomach cramp was unknown. No additional information adverse event information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a female patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On 20-JUN-2012, the patient was vaccinated with first dose of GARDASIL strength reported as 120, units reported as Y (dose, frequency, route, product lot#, expiry date not reported). No concomitant therapy reported. The nurse reported that on an unknown date in OCT-2014 (reported as in office now), the she was in office to receive her second dose of GARDASIL. No adverse symptoms reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old male patient (her husband). On 13-DEC-2012 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and lot # were not provided). On 15-DEC-2012 ("about 2 days after"), the patient experienced a shingles-like rash on his leg the ZOSTAVAX administration. Nurse reported that her husband was treated with acyclovir and prednisone (unspecified dose, frequency, duration) and the rash went away "almost immediately". The lab did not perform. The patient sought medical attention and visit to physician office. The outcome of event was reported as recovered/resolved on unspecified date. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant via field representative refers to a female patient of unknown age. There was no pertinent medical history and no drug reactions/allergies. On 07-OCT-2014 the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). There was no concomitant medication. On an unknown date (approximately in October 2014), the patient developed pain and swelling as well as redness at the ZOSTAVAX injection site. The representative reported this adverse event as soon as they learned of it, and within the 24 hours reporting period. No treatment was given for adverse events. Non lab diagnostics studies were performed. The outcome of adverse events was not reported. The causality between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Computerised tomogram normal, Erythema, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 73 year old nurse refers to herself. The patient current condition included granulomatous changes in right mid lung which was diagnosed in August 2002 and reaction to Computerised axial tomography (CAT) scan dye (unspecified). On 31-DEC-2008 the patient was vaccinated with ZOSTAVAX (strength reported as 19400 PFU, dose, route of administration, anatomical location and lot numbers were unspecified by reporter) because physician told her she needed it. Concomitant medications included cholesterol medication (unspecified product) prescribed for a couple of months in 2012. On 19-JAN-2009, the patient had been experiencing unspecified number of rashes diagnosed as shingles on her perineum, abdomen, waist area, lower legs and right arm. The shingles were described as blisters and redness. The patient sought medical treatment from an unspecified physicians on an unspecified dates. On an unknown date in September 2012 Herpes simplex 1 was 1.51 (units not provided) and Herpes simplex 2 was 5 (units not provided). Treatment included unspecified number of courses of treatment with acyclovir and VALTREX. The patient was also treated with prednisone on 01-JAN2012 and gabapentin on 05-SEP-2013. The patient's shingles was resolved and again returned many times after several treatments with acyclovir and VALTREX and also with prednisone and gabapentin. The patient reported that her last episode of shingles began on 09-SEP-2014. The outcome of shingles was reported as not recovered/resolved. The causality was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Simplex virus test positive
Clinical narrative: This spontaneous report as received from a 73 year old nurse refers to herself. The patient current condition included granulomatous changes in right mid lung which was diagnosed in August 2002 and reaction to Computerised axial tomography (CAT) scan dye (unspecified). On 31-DEC-2008 the patient was vaccinated with ZOSTAVAX (strength reported as 19400 PFU, dose, route of administration, anatomical location and lot numbers were unspecified by reporter) because physician told her she needed it. Concomitant medications included cholesterol medication (unspecified product) prescribed for a couple of months in 2012. On 19-JAN-2009, the patient had been experiencing unspecified number of rashes diagnosed as shingles on her perineum, abdomen, waist area, lower legs and right arm. The shingles were described as blisters and redness. The patient sought medical treatment from an unspecified physicians on an unspecified dates. On an unknown date in September 2012 Herpes simplex 1 was 1.51 (units not provided) and Herpes simplex 2 was 5 (units not provided). Treatment included unspecified number of courses of treatment with acyclovir and VALTREX. The patient was also treated with prednisone on 01-JAN2012 and gabapentin on 05-SEP-2013. The patient's shingles was resolved and again returned many times after several treatments with acyclovir and VALTREX and also with prednisone and gabapentin. The patient reported that her last episode of shingles began on 09-SEP-2014. The outcome of shingles was reported as not recovered/resolved. The causality was unknown. Additional information has been requested.