chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a female patient of unknown age. Concomitant medication and pertinent medical history is not provided. On an unknown date the patient was vaccinated with a third dose of GARDASIL (dose and route were not provided). The reporter stated that the patient "began having seizures and falling down" after having had a third dose of GARDASIL. The patient had sought unspecified medical attention. It is not specified whether patient received treatment or not. The outcome of the adverse event was reported as not recovered/not resolved. The causality relationship between GARDASIL and the adverse event was not provided by the reporter. Upon internal review, seizure was considered to be medical significant. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site vesicles, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female pediatric patient unknown age. On 28-Apr-2014 the patient was administered a dose of (Oka/Merck) PROQUAD (lot reported as J013357, expiry date: 01-MAY-2015). On 29-APR-2014, the patient developed a fever with a "weeping blister that was red and firm" at the injection site. On the same day patient was sent to an unspecified hospital where the patient was treated with intravenous (IV) fluids, and unspecified intravenous (IV) antibiotics. The patient was admitted to hospital for one night and discharged on 30-APR-2014. The event outcome of fever and weeping blister that was red and firm was reported as recovering. the relatedness between event and PROQUAD was not reported. It has been determined that lot # J013357 is an invalid lot for (Oka-Merck) PROQUAD. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Noticed redness 5/17/14, and swelling.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Swollen, tender to touch, painful.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: RASH, DISAPPERED.  Now has pimple w/liquid center.  Bump around waist.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus generalised, Rash
Clinical narrative: FIRE RASH, ITCHY ALL OVER.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: RASH BACK.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Fatigue, Myocarditis, Pericarditis
Clinical narrative: Low grade fever, fatigue and chest pain developed 1 day after meningitis vaccine. Seen at urgent care had ST elev on EKG -> sent to ER. Had high troponin levels, diagnosed w/ pericarditis and myocarditis observed for 4 days in cardiac step down unit d/c on colchicine 0.6mg BID, aspirin 325mg q day, naproxen 500mg BID, PROTONIX 40mg qd.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Low grade fever, fatigue and chest pain developed 1 day after meningitis vaccine. Seen at urgent care had ST elev on EKG -> sent to ER. Had high troponin levels, diagnosed w/ pericarditis and myocarditis observed for 4 days in cardiac step down unit d/c on colchicine 0.6mg BID, aspirin 325mg q day, naproxen 500mg BID, PROTONIX 40mg qd.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Acne, Pruritus, Rash
Clinical narrative: OBLONG RASH, PIMPLES ON SIDE, ITCHY.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Oropharyngeal pain, Otorrhoea, Pyrexia, Respiratory tract congestion
Clinical narrative: Sore throat, ear drainage, low fever chest congestion.  Used inhaler (previously prescribed) and ibuprofen.
Age: 1.03
Sex: M
Vaccine: HEPA, PPV, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Son had red, hardenened spot around injection site. It continued to get larger until middle of the day 05/18/2014. Visited Doctor morning of 05/19/2014 and she confirmed the spot was consistend with bumps from varicella.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site papule, Injection site reaction, Pain, Pyrexia
Clinical narrative: 5yr old patient Imm. given in office 5/14/14. Fever 100-101 began 5/15/14 AM. (+) area redness (6x4cm) to rt deltoid area; 1 cm area circular erythema to rt. Posterior fat pad. (Satellite red papules/welts proximal to this). Tx fever/pain with ibuprofen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: 5yr old patient Imm. given in office 5/14/14. Fever 100-101 began 5/15/14 AM. (+) area redness (6x4cm) to rt deltoid area; 1 cm area circular erythema to rt. Posterior fat pad. (Satellite red papules/welts proximal to this). Tx fever/pain with ibuprofen.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal distension, Computerised tomogram head, Drug screen, Full blood count, Metabolic function test
Clinical narrative: Vomiting and abdominal distention.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urinary system X-ray, Urine analysis, Vomiting
Clinical narrative: Vomiting and abdominal distention.
Age: 20.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Differential white blood cell count normal, Full blood count normal, Infectious mononucleosis, Oropharyngeal pain, Streptococcus test negative
Clinical narrative: Developed sore throat 24 hours after vaccines exudative tonsillitis with neg strep, CBC nl. Past hx mono and rash developed day 6. Day 7 rash -> urticarial, throat clearing.
Age: 20.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Throat irritation, Tonsillitis, Urticaria
Clinical narrative: Developed sore throat 24 hours after vaccines exudative tonsillitis with neg strep, CBC nl. Past hx mono and rash developed day 6. Day 7 rash -> urticarial, throat clearing.
Age: 0.39
Sex: F
Vaccine: DTAPIPV, HIBV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX given to pt. This formulation indicated for 4 yrs or older. No adverse effect noted 2 vaccines where indicated by type.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling
Clinical narrative: Redness, swelling in bicep area. MOTRIN and ice PRN.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at injection site - SEPTRA. R/O Cellulitis.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: ROTARIX given - pt too old (4 months).
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Pt had fine red papular flat rash scattered moderately to trunk and neck. No whelps minimal itching. Treated by mom w/BENADRYL. Advised to monitor for worsening.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Left arm swelling from elbow to shoulder with induration and blistering, tender to touch.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Rash erythematous, Swelling
Clinical narrative: 2 days after receiving vaccine patient had noticed a red rash slightly larger than the size of a quarter. Day 3, the rash is still present but minimal swelling. Patient can feel a lump still.
Age: 54.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Large area of erythema (18cm x 9cm) and pain in area of vaccine site (upper arm). Treated with ice, NSAIDS, antihistamine.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site nodule, Injection site reaction, Pain
Clinical narrative: Site of vaccine administration produced a hard knot in the muscle that continues to cause patient pain. Visible knot measures 4 cm x 3 cm on (R) shoulder.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain, Pyrexia
Clinical narrative: Fever, eyes hurt.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Exaggerated local reaction.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Patient noted large area of redness, erythema (measured at 8 cm x 11 cm on 5/19/14) and intense pruritus with hard knot at injection site. Using Acetaminophen intermittently for past several days.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted large area of redness, erythema (measured at 8 cm x 11 cm on 5/19/14) and intense pruritus with hard knot at injection site. Using Acetaminophen intermittently for past several days.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypersensitivity, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Approximately 12 hours after the Tdap injection of the vaccination I began having extreme pain in my neck, back, arm and hand. It was a deep soreness and inflammation at the injection site. A short time later I acquired a red rash and blotchiness on my entire upper arm. I was then seen by an Urgent Care Doctor as well as a Doctor at the Emergency Room on 05/16/2014 around 8:00 PM.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Approximately 12 hours after the Tdap injection of the vaccination I began having extreme pain in my neck, back, arm and hand. It was a deep soreness and inflammation at the injection site. A short time later I acquired a red rash and blotchiness on my entire upper arm. I was then seen by an Urgent Care Doctor as well as a Doctor at the Emergency Room on 05/16/2014 around 8:00 PM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient got ZOSTAVAX shot on 5/12 and she called on 5/14 that she has 1 x 1 inch swollen red area at injection site. Also, she had headache on 5/12. Her injection site is hot to touch and painful. Pharmacist advised her to contact her Dr. and take BENADRYL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Client phoned health unit to report that she broke out with blisters from the tip of nose to the bridge of her nose after receiving the shingles vaccine. Approx. 10 blisters, some were fluid filled, red, with some itching x 3 weeks. Last spoke to patient still had some blisters.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Patient states became ill with headache, chills, fever, body aches and vomited x 1 about an hour and half after receiving shot. Pt called after hours and reported symptoms. Was advised to report to ER if symptoms persisted or worsened. Pt. reported to ER that evening.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red patch about the size of a quarter. Persistent itching, possibly infected from scratching. Darker area (bruise?) inside area at exact injection site. Counseled to contact primary care doctor.
Age: 0.26
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Decreased activity, Irritability
Clinical narrative: Fussy, clingy, colicky, less babbling.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Injection site became red and had swelling in arm. Treated with KEFLEX and MEDROL pack.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Hypoaesthesia, Local swelling, Pain
Clinical narrative: Stinging, numbness neck to elbow, local redness and swelling, diarrhea.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Adrenocortical insufficiency acute, Condition aggravated, Pyrexia
Clinical narrative: Fever, Addisonian crisis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: 7 hrs after vaccine - felt sick - rash 4 inches x 4 in. developed on site - low grade fever - 2 days.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Pt was immunized on 1-24-14 and at the time she did not know she was pregnant. We were made aware on 5-9-14. Pt is 5 months pregnant with EDC on 9-24-14. Sonograms normal.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Migraine
Clinical narrative: Patient developed headaches after 1st AVA and that they worsened with each dose. Continues with migraines currently 2x/week and daily lesser headaches. No prophylactic tx has been successful thus far.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka-Merck) PROQUAD (dose number, dose, lot # was not reported) which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. This is one of several reports from the same source. 1405USA007382. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Balance disorder, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: Got shots yesterday, several hours later, she took a shower, had a headache and c/o feeling tired, dizzy. Pt went to sleep, slept for several hours. When mom tried to wake her up she was very somnolent, did not awaken, did not move, parents were shaking here, pulling eyelids open, shining a light in her eyes. When pt did began to respond, she said her legs were numb, she couldn't stand, in car ride over, pt head was bobbing from side to side, as if she were drunk or passed out. Had to be transferred to a wheelchair, vitals in ER were ok, maybe sl low blood pressure per mom. Pt was in ER x 3-4 hours before seeing the doctor. But by time she was seen, almost everything had resolved. She was talking, thinking normally, but was still sl unsteady on feet.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Hypotension, Posture abnormal, Somnolence, Wheelchair user
Clinical narrative: Got shots yesterday, several hours later, she took a shower, had a headache and c/o feeling tired, dizzy. Pt went to sleep, slept for several hours. When mom tried to wake her up she was very somnolent, did not awaken, did not move, parents were shaking here, pulling eyelids open, shining a light in her eyes. When pt did began to respond, she said her legs were numb, she couldn't stand, in car ride over, pt head was bobbing from side to side, as if she were drunk or passed out. Had to be transferred to a wheelchair, vitals in ER were ok, maybe sl low blood pressure per mom. Pt was in ER x 3-4 hours before seeing the doctor. But by time she was seen, almost everything had resolved. She was talking, thinking normally, but was still sl unsteady on feet.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA007252 and 1405USA008990 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-MAY-2014 the patient was vaccinated intramuscularly with a 0.5 ml one dose of improperly stored PNEUMOVAX 23 (lot number J004080, expiration date 22-AUG-2014). No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site mass, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Parent reports that child's arm was swollen and rashy at the insertion site. Reports there is a bump the size of a "50 cent piece" at the site. Reports that site is itchy. Instructed to give Benadryl by mouth and apply a cool compress to area.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an health worker. She stated that her refrigerator had two different thermometers and she realized that a temperature of 31F had been recorded for the refrigerator storing PNEUMOVAX 23 (doses, route, indication and lot numbers not reported), (M-M-R II), and GARDASIL, which were exposed to 31F for 96 hours, on 04-NOV-2013, 31F for 48 hours on 18-NOV-213 and 31F for 72 hours on 21-NOV-2013. Improperly stored GARDASIL was administered on unknown dates to unknown number of patients. M-M-R II was supported, as it remained in recommended temperature storage range. PNEUMOVAX 23 was not supported after 21-NOV-2013. No adverse event and no product quality complained (PQC) was identified. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Broke out in rash, itchy.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: Arm sore from shot.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On an unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (Lot # H021346, expiration date 01-OCT-2015) (dose and route not reported) on schedule. The medical assistant reported that the patient missed the third dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to 2 patients of unknown gender and age. On an unspecified date in 2013, "last year", the patients were vaccinated with a ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in 2013, after being administered ZOSTAVAX, the patients experienced injection site rashes. The outcome of injection site rashes was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 63 year old female patient. The patient's medical history included previous history of atrial fibrillation (AFIB). On 31-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml injection once shot (route, lot# and expiration date unspecified). Concomitant therapies included BETAPACE 80 mg, two times a day and aspirin. On 31-DEC-2013, according to the physician, a patient went into "atrial fibrillation (AFIB)" 10 minutes after being administered ZOSTAVAX at a pharmacy. It was stated that this symptom lasted for "about 12 hours." Patient did not seek the medical attention, no laboratory test were performed, no treatment was given. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was not stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA007252 and 1405USA008991 via same reporter link. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old male patient. In approximately February 2014 (reported as "about two months ago") the patient inadvertently received a fourth dose of GARDASIL (lot number and indication were not reported). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified group of patients (demographic data not provided). The patients were vaccinated with ZOSTAVAX on an unknown date, after exposed to 43.1 F for 29 hours on 03-MAR-2014. No adverse event was reported. This report is linked with case MARRS # 1405USA004199 (the same report link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history was not reported. On 12-MAY-2014 the patient was orally vaccinated with a dose of ROTATEQ (dose, lot#, expiration date not reported). Concomitant medications were not reported. It was reported that the patient spit ROTATEQ up and did not vomit the dose but spit some of it out. The reporting nurse stated that when the patient spit some of the dose out, some of the dose got into the patient's mother's eye. There was no treatment given for the event and none laboratory tests were performed. The outcome of the event was reported as recovering/resolving. This is one of several reports from the same source. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 87 year old female patient. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant therapies included gabapentin (manufacturer unknown). On 05-MAY-2014, the patient experienced shingles. The patient sought medical attention on 05-MAY-2014 and visited the physician's office. On 05-MAY-2014, the patient was diagnosed with shingles on her left interior shoulder. The patient was treated with acyclovir (unspecified dose, frequency and manufacturer). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with his first dose of GARDASIL injection, dose (unknown) and route of administration (unknown), for unknown indication. The patients second dose of GARDASIL was administered a year later on an unspecified date. No adverse effect reported. No product quality complaint was involved. The outcome of events was unknown. No further information available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a female patient of unknown age. On an unknown date in July 2013, the patient was vaccinated with GARDASIL (dose, route and frequency were not reported). It was reported that the patient had not received any further doses. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug interaction, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 12-MAY-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously). Other suspect therapies included acyclovir (manufacturer unknown). The patient was failed to discontinue her chronic acyclovir (manufacturer unknown) use before receiving the vaccine. The patient was still using acyclovir (manufacturer unkonwn) with no interruption in therapy. Thus, the pharmacist fears that a drug-vaccine interaction might occur. The patient experienced no known adverse effects. The patient present status was reported as other no known adverse effects. The outcome of failed to discontinue her chronic acyclovir (manufacturer unknown), drug-vaccine interaction might occur and no known adverse effects was unknown. The causality was not reported. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 93 year old female patient. On an unknown date in 2009 (also reported as five years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in April 2014, the patient experienced shingles. The physician stated that a number of dermatomes were affected by the shingles outbreak in the patient. The patient was treated with VALACYCLOVIR (manufacturer unknown). The outcome of shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a other healthcare worker refers to a 9 month old patient of unknown demography. On an unknown, date the 9 month old patient was vaccinated with VAQTA 50/1.0 U/ML (dose, route and frequency were not reported). No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 06-MAY-2014, the patient was vaccinated with expired MMR II lot # 0496E (Expiry: 07-MAR-2014), 0.5 ml, intramuscular. No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, TDAP, YF
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Temporary loss of consciousness during administration of vaccines. Pt. reported dizziness, nausea. Reports loss of consciousness has occurred previously with vaccinations and blood draws. Given juice x2, observed x20 minutes. Reported no s/s left facility.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Redness, swelling, hives, warm to the touch, and pain at injection site and surrounding area.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient received Fluvirin vaccine on 12/13/2014 in the left deltoid muscle. Patient was feeling well at time of vaccination and seemed healthy. On May 19th, patient approached the consulation window and asked to speak with myself, the vaccine administrator. She stated that there is as lump on her arm as a result of the vaccine she received in December. Lump is not visible when arm is relaxed, but when patient flexes muscle, a palpable lump about 2mm can be seen on her left deltoid region. She stated she spoke with her doctor about it and the doctor told her it would go away in time. She stated that the lump is sometimes painful and that it interferes with her range of motion. When I touched the lump she did not show any signs of pain at that time. I told her I had not seen that reaction before and that I would report it to VAERS for her.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Eye movement disorder
Clinical narrative: Injected the shot, patient responded saying "I don't feel so good." His eyes roll back a little bit, Patient slumped over. Jerked his arms and legs once. I called "patient, patient?" and he woke up saying "What's going on?" Dr. came in asked him where he was and he responded "At the doctors." He was fine in a matter of minutes.
Age: 40.0
Sex: M
Vaccine: RAB, TD
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: TINGLING NUMBNESS ON LEFT SIDE OF BODY.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Pruritus, Skin infection, Vaccination complication
Clinical narrative: Swollen red right arm and itchy.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Dizziness
Clinical narrative: Seizure after MCV4 administration, when pt came to senses she stated that right before seizure she felt dizzy. First Aid for seizures rendered.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hypersensitivity, Pruritus, Rash
Clinical narrative: VOLUNTEER FOR DISASTER RELIEF.  C/O RASH ON ARMS, DIZZINESS, AND ITCHING. TRANSPORTED BY AMBULANCE TO EMERGENCY ROOM.  SYMPTOMS RESOLVED BY THE TIME OF HIS ARRIVAL AT ER.  CHART DX:  ALLERGIC REACTION.  B/0 162/80; PULSE 88; RESP 20; OXYGEN SAT 98%.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness in right armpit.  Tdap and MCV4 given in right deltoid.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Back pain, Burning sensation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Burning/pain in right arm after shot. Next two weeks-  Persistent pain continued to develop. Inability to sleep on right side loss of movement and constant pain in shoulder, back, tingling down right arm and into pinky. Loss of range of motion, unable to lift arm completely to reach items above my head. Pain is constant and does is not alleviated except with medication. Pain in sides of hips when driving car and getting out that developed about two weeks after shot was given. Pain in hips when sitting for prolonged period then standing.  This pain was not present prior to vaccine.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Burning/pain in right arm after shot. Next two weeks-  Persistent pain continued to develop. Inability to sleep on right side loss of movement and constant pain in shoulder, back, tingling down right arm and into pinky. Loss of range of motion, unable to lift arm completely to reach items above my head. Pain is constant and does is not alleviated except with medication. Pain in sides of hips when driving car and getting out that developed about two weeks after shot was given. Pain in hips when sitting for prolonged period then standing.  This pain was not present prior to vaccine.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis reactive, Blood test abnormal, Groin pain, Red blood cell sedimentation rate increased
Clinical narrative: Drastic increase in arthritic pain in several joints that previously were never bothersome. This happened within 2-3 days of the shot. Increased levels of pain in multiple joints, specifically the groin and knees. My doctor believed this to be "reactive arthritis" that can be caused by a flu shot. He put me on new NSAIDs and prednisone which were ineffective. The pains in the groin and knee have lasted for over 7 months now and have shown no signs of lessening.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray abnormal
Clinical narrative: Drastic increase in arthritic pain in several joints that previously were never bothersome. This happened within 2-3 days of the shot. Increased levels of pain in multiple joints, specifically the groin and knees. My doctor believed this to be "reactive arthritis" that can be caused by a flu shot. He put me on new NSAIDs and prednisone which were ineffective. The pains in the groin and knee have lasted for over 7 months now and have shown no signs of lessening.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Left arm where DTaP vaccine was given, mom called back and reported swelling, and discomfort. Full range of motion.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: C/o of chicken pox like rash.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Amylase increased, Parotid gland enlargement, Shift to the left
Clinical narrative: Right cheeks (parotidal area) swelling, visited ER where pediatrics diagnosed condition.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Hypotonia, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Infant was alert/awake and suddenly lost consciousness. She became limp and would not respond to my efforts to awake her (picked her up and was loudly talking to her in attempts to keep her conscious). She remained unconscious for about 7 minutes as I drove her to urgent care and then awoke about 2 minutes after we arrived. Temperature, BP and heart rate were all considered normal.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Raised bump at injection site.  Redness in 6" diameter circle around injection site.  Itchy and dark red.
Age: 22.0
Sex: F
Vaccine: FLUX, RAB
Symptoms: Nephrolithiasis
Clinical narrative: Case number PHEH2014US009685 is an initial spontaneous report from the nurse received on 09 May 2014. This report refers to a 22-year-old female patient. On 02 May 2014, she was vaccinated with RABAVERT (batch number: 5400011A) intramuscularly along with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN). On 05 May 2014, the patient went to the emergency room due to kidney stone. The patient was advised to continue with the RABAVERT remaining doses. The patient was doing fine and was unaware if it was related to RABAVERT. No other information was available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history or drug allergies. On 06-MAY-2014, the patient was vaccinated with single dose of ZOSTAVAX lot # J013452, exp# 24-JAN-2015, subcutaneous. No concomitant medications were reported. On 15-MAY-2014, 10 days after onset of therapy the patient was diagnosed with shingles by an unspecified physician. The patient sought medical attention by calling the pharmacy. The patient was treated with unspecified medication. The outcome of shingles was reported as not resolved. The causality was unknown. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No information provided regarding current conditions and medical history. On an unknown date the patient was vaccinated with ZOSTAVAX, PNEUMOVAX 23 and AFLURIA (dose, route, lot# not reported). No concomitant medication reported. The pharmacist reported that some patients felt ill when ZOSTAVAX, PNEUMOVAX 23 and AFLURIA (also reported as possibly AFLURIA) were administered on the same day. The pharmacist added that now she no longer administers ZOSTAVAX, PNEUMOVAX 23 and AFLURIA on the same day. The outcome of the event felt ill was unknown at the time of the report. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a nurse refers to an adult female patient of unknown age, who worked in a nursing home. On approximately 08-MAY-2014 (also reported as last week), the patient was vaccinated with her first dose of M-M-R II injection, dose (unknown) and route of administration (unknown). No concomitant medications were reported. In approximately MAY 2014 (also reported as on an unspecified date), the patient developed cervical lymphadenopathy. Patient sought medical attention (unknown type). Action taken with respect to M-M-R II was not applicable. No product quality complaint was involved. The outcome of cervical lymphadenopathy was not resolved. Causality was not reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 15-MAY-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H014653; expiry date: 19-APR-2014). Dose and route were not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of an unknown ages. The patients medical history was not reported. On an unknown date the unknown number of patients were vaccinated with GARDASIL (lot # J013324, Expiry date: 12-FEB-2016) which was improperly stored. The GARDASIL was exposed to temperature as low as 26.6 Fahrenheit (F) on three separate days. No adverse effects were reported. The outcome of exposed to temperature as low as 26.6 F and no adverse effects reported was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was not stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA008990 and 1405USA008991 via same reporter link. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Rash morbilliform
Clinical narrative: Patient developed a rash resembling measles few hours after vaccination. Seen today for rash/fussiness.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac stress test, Chest pain, Dyspnoea, Immediate post-injection reaction, Muscular weakness
Clinical narrative: In 2013 I got the shingles shot. I have stints for prior coronary event with some heart function loss from prior heart attack. The next day after the shot I got half way around the block and had severe distress. My arms were weak. It was hard to breath. My chest hurt. I felt too weak to continue the walk. Once home I sat down and the symptoms went away but returned and persisted every time I went for a walk. I contacted the clinic and a stress test was conducted which was ambivalent. Slowly ( slowly) the symptoms reduced over time. The distress onset was further and further into the walk and seems to have subsided after six months or more. But the distress was immediate and severe after the shot was given. I was on PLAVIX, CRESTOR and a beta blocker at the time of the vaccine. I also had a nearly singular incident of something like a hot pin being stuck into my lower back but it was only a couple times and only a prick and when I rubbed it it would kind of go away. I did not persist but did happen a few times in the first 10 days after the shot. Thanks
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: In 2013 I got the shingles shot. I have stints for prior coronary event with some heart function loss from prior heart attack. The next day after the shot I got half way around the block and had severe distress. My arms were weak. It was hard to breath. My chest hurt. I felt too weak to continue the walk. Once home I sat down and the symptoms went away but returned and persisted every time I went for a walk. I contacted the clinic and a stress test was conducted which was ambivalent. Slowly ( slowly) the symptoms reduced over time. The distress onset was further and further into the walk and seems to have subsided after six months or more. But the distress was immediate and severe after the shot was given. I was on PLAVIX, CRESTOR and a beta blocker at the time of the vaccine. I also had a nearly singular incident of something like a hot pin being stuck into my lower back but it was only a couple times and only a prick and when I rubbed it it would kind of go away. I did not persist but did happen a few times in the first 10 days after the shot. Thanks
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 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous) (lot# and exp date unknown) which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. This is one of several reports from the same source. 1405USA008131. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site urticaria
Clinical narrative: Cellulitis reaction to R thigh, also urticaria - treated with BENADRYL PO and ice to area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Rec'd KD immunizations in office on 5/12/14. S/S reaction -> app. 2x3" erythema and edema with pruritis to (R) mid-shaft upper arm. Seen in office 05.19.14. Tx with ice packs/Ibuprofen PRN as directed.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 months old male patient. No concomitant medications or relevant medical history were reported. On 13-MAY-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (route, strength, dose, lot# and expiration date not reported). The reporter stated that it was staff error only. No adverse effects were reported at this time. No further relevant medical information was reported. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TYP
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Client experienced redness (8" x 6") tenderness, warmth, swelling on upper (L) arm at the site on her arm where she received her PNEUMOVAX about 1d after receiving the vaccination. 2 days after she had swollen tender lymph nodes in neck, aches, fever (102 degrees)/chills, extreme fatigue. She still has silver dollar size hard tender bump at inj site - most is clearing by today 5/19/14.
Age: 45.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TYP
Symptoms: Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Client experienced redness (8" x 6") tenderness, warmth, swelling on upper (L) arm at the site on her arm where she received her PNEUMOVAX about 1d after receiving the vaccination. 2 days after she had swollen tender lymph nodes in neck, aches, fever (102 degrees)/chills, extreme fatigue. She still has silver dollar size hard tender bump at inj site - most is clearing by today 5/19/14.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pruritus, Tenderness
Clinical narrative: Pt called next day after injection saying her arm was red, swollen and itchy. Unable to lay on the side and her entire upper arm. Said it felt good the next day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Sneezing, Urticaria
Clinical narrative: About 10 minutes after getting KINRIX and MMRV, developed sneezing and generalized hives. Treated with diphenhydramine and prednisone, discharged home.
Age: 74.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Cellulitis, Chills, Decreased appetite, Feeling hot, Injection site erythema
Clinical narrative: Pt had Td and PREVNAR on 4/30/14. Called on 5/5/14 stating she had stiffness in both arms and legs but is feeling much better now. 5/8/14 Patient calls to state she has had stiff neck for 3 days and arms are still sore. OV on 5/8/14 -> (R) arm soreness, right leg weakness and muscle aches 4 days now. Feels warm and having chills, T 98 degrees. Appetite decreased. Aching and swelling over (R) foot last 4 days and using cane. Exam -> (R) upper arm pink, tender, warm to touch, (R) foot warm, tender with non-pitting edema. 5/16/14 - OV - (R) upper extremity full ROM. Able to get out of chair without difficulty.
Age: 74.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Injection site pain, Injection site warmth, Local swelling, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Pt had Td and PREVNAR on 4/30/14. Called on 5/5/14 stating she had stiffness in both arms and legs but is feeling much better now. 5/8/14 Patient calls to state she has had stiff neck for 3 days and arms are still sore. OV on 5/8/14 -> (R) arm soreness, right leg weakness and muscle aches 4 days now. Feels warm and having chills, T 98 degrees. Appetite decreased. Aching and swelling over (R) foot last 4 days and using cane. Exam -> (R) upper arm pink, tender, warm to touch, (R) foot warm, tender with non-pitting edema. 5/16/14 - OV - (R) upper extremity full ROM. Able to get out of chair without difficulty.
Age: 74.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Myalgia, Oedema peripheral, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Pt had Td and PREVNAR on 4/30/14. Called on 5/5/14 stating she had stiffness in both arms and legs but is feeling much better now. 5/8/14 Patient calls to state she has had stiff neck for 3 days and arms are still sore. OV on 5/8/14 -> (R) arm soreness, right leg weakness and muscle aches 4 days now. Feels warm and having chills, T 98 degrees. Appetite decreased. Aching and swelling over (R) foot last 4 days and using cane. Exam -> (R) upper arm pink, tender, warm to touch, (R) foot warm, tender with non-pitting edema. 5/16/14 - OV - (R) upper extremity full ROM. Able to get out of chair without difficulty.
Age: 74.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Walking aid user
Clinical narrative: Pt had Td and PREVNAR on 4/30/14. Called on 5/5/14 stating she had stiffness in both arms and legs but is feeling much better now. 5/8/14 Patient calls to state she has had stiff neck for 3 days and arms are still sore. OV on 5/8/14 -> (R) arm soreness, right leg weakness and muscle aches 4 days now. Feels warm and having chills, T 98 degrees. Appetite decreased. Aching and swelling over (R) foot last 4 days and using cane. Exam -> (R) upper arm pink, tender, warm to touch, (R) foot warm, tender with non-pitting edema. 5/16/14 - OV - (R) upper extremity full ROM. Able to get out of chair without difficulty.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from the consumer's mother refers to a male patient of unknown age. Medical history and current conditions not reported. On 08-MAY-2014 the patient was vaccinated with a dose of GARDASIL dose 5, (strength, lot number and expiration date not reported, route and anatomical location unspecified). No concomitant therapies were reported. On 08-MAY-2014 the reporter stated that on that day the patient received the second extra dose of GARDASIL which would be his 5th dose. No other adverse effects reported. Diagnostic tests and laboratory results not reported. The outcome of 5th dose of GARDASIL was unknown. Additional information has been requested.