chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.29
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Hypotonia, Intensive care, Pyrexia
Clinical narrative: Fever. Episode of apnea and going limp. Seen in ED and admitted in NICU for 5 days.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Aphthous stomatitis, Pyrexia
Clinical narrative: 8/24/14 pt was seen in Prompt care for fevers after shot. Follow up in office, showed apthous ulcers in mouth, afebrile.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 77 years old female patient reporting on herself. On approximately 18-AUG-2011 (reported as "about 3 years ago") the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included prednisone. On approximately 21-JUN-2014 (reported as "2 months ago this coming Thursday") the patient developed an acute case of shingles. Patient sought medical attention. At the time of the report the outcome of developed an acute case of shingles was reported as recovering. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Hypoacusis
Clinical narrative: Per pt she noted decreased hearing (R) ear 48 hours after 2nd MMR vaccination. She says she was seen by ENT and given oral steroids. She was told that it may be related to the vaccination. She has follow up with ENT.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: Vaccine administered 8/22/14, reports soreness (L) arm. By Saturday reports swelling and redness to elbow and temp of 100 degrees, flu-like symptoms (fatigue, body aches), lightheaded, upset stomach. 8/29/14 into office to report side effects - fever, swelling and redness has gone but continues to feel weak and lightheaded.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Local swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Vaccine administered 8/22/14, reports soreness (L) arm. By Saturday reports swelling and redness to elbow and temp of 100 degrees, flu-like symptoms (fatigue, body aches), lightheaded, upset stomach. 8/29/14 into office to report side effects - fever, swelling and redness has gone but continues to feel weak and lightheaded.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: 1 pm received HD FLUZONE shot. 5:30 pm severe diarrhea. 7:30 pm projectile vomiting. 8:15 pm called/reported issue to pharmacy. No fever temp 98.7 degree F per patient.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Depressed level of consciousness, Fall, Head injury, Hyperhidrosis, Nausea
Clinical narrative: Patient fainted after receiving Tdap and HPV vaccines. She was sitting on exam table while nurse was finishing charting. Patient all of a sudden fell off table onto floor. Unable to arouse for 10-15 seconds. After we got her aroused she was placed on bed. She complained of nausea, sweating, and pale. Also hit on top of head, as shell fell to floor. Doctor notified.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted after receiving Tdap and HPV vaccines. She was sitting on exam table while nurse was finishing charting. Patient all of a sudden fell off table onto floor. Unable to arouse for 10-15 seconds. After we got her aroused she was placed on bed. She complained of nausea, sweating, and pale. Also hit on top of head, as shell fell to floor. Doctor notified.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling in arm where injection was administered, area warm to the touch.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site warmth
Clinical narrative: Within 2 hours of vaccine, developed inconsolable crying, (R) thigh warmth and redness.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Site of PNEUMOVAX became red and swollen and painful, patient went to ER. Either cellulitis or allergic rxn - MD unsure (rxn was definitely around PNEUMOVAX site).
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/27/14 PM - warm, red, swollen at site of injection. 8/28/14 AM - above - worsening. 8/28/14 PM - urgent care visit. Dx - cellulitis. Tx - antibiotic/diphenhydramine.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: Patient received vaccination 8/27/14 (6:54 pm). She began feeling nauseous on 8/28/14 (approx 1 pm) and vomited at around 1:30 pm and again at 4 pm. She ran a low grade temperature. She took TYLENOL 8/29/14 at 10 am and again 2 pm (because low grade temp came back). She is taking ginger ale to replenish fluids (Gator Ade/water/tea).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Pt came to clinic with a reaction to MMR vaccine given at a clinic on Aug 11, 2014. (New pt/no medical or vaccination history)
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site scab, Local reaction
Clinical narrative: Left deltoid area is minimally erythematous and indurated- 7x12cm. Not warm to touch, scabbed entry point of needle (teen says he "pick at it"). Local adverse reaction-topical only.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Allergy to vaccine, Infection, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Patient developed large red whelp at injection site with hard knot. Whelp grew in size over 3 days. 08/29/14 called MD and had patient go to office. Dr. said allergic to medicine and had developed infection. Given KEFLEX and prednisone to treat. Patient should recover.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Patient developed large red whelp at injection site with hard knot. Whelp grew in size over 3 days. 08/29/14 called MD and had patient go to office. Dr. said allergic to medicine and had developed infection. Given KEFLEX and prednisone to treat. Patient should recover.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report ws received from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinated with ROTATEQ (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one os several reports received from the same reporter. Additional information is not expected because no physician details were provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Thiis spontaneous report was received  from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinted with LIQUID PEDVAXHIB (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one of several reports received from the same reporter. Additional informatin is not epxected because no physician details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route and lot # not reported0. The medical Assisi stated that M-M- R II was not improperly stored and (OkaMerck) PROQUAD was not administered to patients. At the time of the report, the patient outcome was unknown. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student to a 66 year old male patient. ON 20-JUN-2014, the patient was vaccinated with a first 0.5 ml dose of PNEUMOVAX23 (lot # reported as K007821, exp 06-JUN-205) IM in the left arm and on 26-AUG-2014, was inadvertently vaccinated with a second 0.5 ml dose of PNEUMOVAX23 (lot # not reported) IM in the left arm. No adverse effects were reported. Additional information is not expected because the reporter did not want the physician to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Current conditions and other relevant medical history were not reported. The nurse reported that on an unspecified date in January 2010, the patient was vaccinated with the first dose of GARDASIL (Intramuscular injection, strength, dose, route, anatomical location, lot # and expiration date not reported). Then, 0n 22-AUG-2014, the patient was in the office to receive the second dose GARDASIL (Intramuscular injection, strength, dose, route, anatomical location, lot # and expiration date not reported). No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 56 year old female patient. On 14-AUG-2014 the patient was vaccinated   with ZOSTAVAX, (subcutaneous, 0.65 ml dose number unknown; lot number reported as K000996 EXP 13-MAR-2014). On 14-AUG-2014, the patient experienced injection site was red, tender and swollen. The injection site reaction continued for 4 days. The patient did not seek medical attention and did not received treatment. The outcome of the events was unknown. Additional information hs been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinated with M-M-R II (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one of several reports received from the same reporter. Additional information is not expected because no physician details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Current conditions and other relevant medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, dose, strength, route, anatomical location, lot # and expiration date not reported). Concomitant therapies were not reported. The reporter stated that on an unknown date, the patient developed shingles after receiving the ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-SEP-2010, the patient was vaccinated with the first dose of VAQTA (lot number and expiration date were not reported), 0.5 ml, intramuscular route. On 22-SEP-2010 patient received a booster dose first dose of VAQTA (lot number and expiration date not reported), 0.5 ml, intramuscular route. The nurse reports that a patient received their first dose of VAQT on 16-APR-2010 and a booster dose of VAQTA at a shorter than recommended interval on 11-SEP-2010. No adverse effect reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: This spontaneous report ws received from a physician via a company representative refers to a 22 year old female patient who was not pregnant. On 18-AUG-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, Lot # reported as K004542, Expiration Date reported as: 19-AUG-2015 (dose and route of administration was not reported). On 18-AUG-2014 the patient developed fever, nausea, redness and pain near the injection site. Patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated   with improperly stored doses of ROTATEQ orally (lot #  not reported) exposed to 32F for 30 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route and lot # not reported) exposed to 8F for 15 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route and lot # not reported) exposed to 32 F for 30 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinated with GARDASIL (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one of several reports received from the same reporter. Additional information is not expected because no physical details were provided.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, CSF culture, Convulsion, Culture urine, Electrocardiogram
Clinical narrative: This spontaneous report was received from a physician via Pfizer refers to a 2 month old baby (gender unspecified). The patient's pertinent medical history and concurrent was not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose not reported). Other suspect therapies included PREVNAR 13, PEDIARIX and ACTHIB. No concomitant therapies reported. On an unknown date the patient had 2 episodes of questionable seizure (hospitalization) witnessed by mother. The second event required mouth to mouth resuscitation by mother. At that point, the patient was taken to emergency room (ER). No further events witnessed. The patient was admitted for full work up including CT head and EEG. The results were reported as negative. It was not sure at that point if events were due to vaccines. It was reported that the child was responding normally at that point in time. The outcome of the events was unknown. The causality of the events was unspecified. Upon internal review, the event of seizure was considered medically significant. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram head normal, Convulsion, Electroencephalogram normal, Laboratory test normal, Resuscitation
Clinical narrative: This spontaneous report was received from a physician via Pfizer refers to a 2 month old baby (gender unspecified). The patient's pertinent medical history and concurrent was not reported. On an unknown date the patient was vaccinated with ROTATEQ (dose not reported). Other suspect therapies included PREVNAR 13, PEDIARIX and ACTHIB. No concomitant therapies reported. On an unknown date the patient had 2 episodes of questionable seizure (hospitalization) witnessed by mother. The second event required mouth to mouth resuscitation by mother. At that point, the patient was taken to emergency room (ER). No further events witnessed. The patient was admitted for full work up including CT head and EEG. The results were reported as negative. It was not sure at that point if events were due to vaccines. It was reported that the child was responding normally at that point in time. The outcome of the events was unknown. The causality of the events was unspecified. Upon internal review, the event of seizure was considered medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site pruritus, Nausea, Rash
Clinical narrative: Swollen rash, itchy at injection site, headache, called pharmacist and told this happened about 1/3; following day headache reoccurred and rash had tripled in size, stopped by pharmacy and was told that "he had never seen a reaction" like this.  Pharmacist told me to keep an eye on it and if it continued, worsened may want to have it looked at by a doctor.  Later that evening, some diarrhea/nausea began.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Crying, Irritability, Pain, Pyrexia, Screaming
Clinical narrative: Slight fever then painful screaming for 6 hours straight. Screaming was non-stop. This was not a normal cry, fussy cry. This was a high pitched screaming.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Uncontrollable chills lasting approximately 2 to 2 1/2 hours accompanied by excessive sweating.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Local swelling, Pain in extremity, Skin discolouration, Skin warm
Clinical narrative: Patient noticed a few hours after getting the shot that her arm was very sore and a little warm to the touch. By the next day, it had become swollen and was purplish in color. She went to see her doctor who thought she should recover within a few days and gave her a prescription for Keflex 500mg, 1 four times a day for 7 days, in case there was a secondary infection. Patient's arm continued to become swollen and fluid built up in the arm, color was purplish/yellowish. The bruise and swelling then moved downwards to the lower part of her upper arm on on the side of her body. It took approximately 7 to 10 days before the problems subsided and she was back to normal.
Age: 54.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Hypersensitivity, Rash
Clinical narrative: Spotty rash on immunization arm.   Patient is taking diphenhydramine to help with the allergic reaction.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Decreased appetite, Dyspnoea, Exposure during pregnancy, Fatigue
Clinical narrative: Exhaustion w sleeplessness, intense muscle pain over entire body, labored breathing, difficulty moving, loss of appetite, achiness, painful joints, muscle cramps.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Mobility decreased, Muscle spasms, Myalgia, Pain
Clinical narrative: Exhaustion w sleeplessness, intense muscle pain over entire body, labored breathing, difficulty moving, loss of appetite, achiness, painful joints, muscle cramps.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Throat irritation
Clinical narrative: Coughing and burning in her throat.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 85 year old female patient of unknown demographics. Patient's current condition and medical history was not reported. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (dose, unit, route not reported). No concomitant medication was reported. On an unknown date in 2014 (four years after receiving ZOSTAVAX), the patient was diagnosed with disseminated zoster (life threatening, hospitalization). The patient was hospitalized for ten days and received unspecified treatments. There was no product quality complaint involved. The outcome of disseminated zoster was reported as recovered. Causality between the event and ZOSTAVAX was not reported. Causality between the event and ZOSTAVAX was not reported. The reporter considered the event to be life threatening. Additional information is not expected as the reporting physician cannot be contacted.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Baseball size swelling around injection site. Redness. Dr. saw pt. two days after and pt. started on antibiotics and VALTREX treatment dose for shingles. Patient claims now has shingles.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt noticed side effects of redness with swelling and pain, itching, warmth and bruising at site of injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt noticed side effects of redness with swelling and pain, itching, warmth and bruising at site of injection.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pruritus generalised
Clinical narrative: Itching all over the body, about to vomit. Patient went to see a doctor. She got prednisone for treatment on 8/28/14.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt describes/reports, allergic rxn and VARIVAX shot- (R) arm itchy redness swelling, above and below the shot injection site prescribed BENADRYL, Medrol Dose Pack, PEPCID, Keflex.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6" red swollen deltoid.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. On an unspecified date in August 2014 (also reported as during this past week) two unspecified patients were administered a re-filled syringe dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not provided). On an unspecified date in August 2014, both patients experienced a moderate local reaction at the injection site of administration described as swelling and erythema. The outcome of the event was unknown. The relatedness between the event and the vaccination with PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 week old (11 year old at 6the time of this report) patient of unknown gender. On 12-FEB-2003, the patient was vaccinated with first dose of RECOBIVAX HB (dose, lot# and route of administration not reported), on 03-APR-2003 the patient received second dose of RECOMBIVAX HB (dose, lot # and route of administration not reported and on 12-JUN-2003 (reported as a bit early) the third dose of RECOMBIVAX HB (dose, lot # and route of administration not reported. The nurse stated that it was unknown if the child had any adverse effects since the child was living outside the reporter's country at that time. It was reported that therapy with RECOMBIVAX HB was continued.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Hyperventilation, Nausea
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 14 year old, non-pregnant female patient. On 04-AUG-2014 the patient was vaccinated with dose of GARDASIL, (intramuscular to prevent HPV; dose and lot # were not reported). Concomitant therapies included ACCUTANE. On 04-AUG-2014 (reported as "later the same evening") the patient experienced hyperventilation, chills, fatigue and nausea. Patient sought medical  attention (she called the physician). None lab diagnostic studies were performed. No treatment was given for adverse events. The outcome of events was unknown. Relatedness between events and vaccination was not reported. 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 nurse practitioner refers to about 10 unspecified patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse practitioner reported that (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (indication, lot# and expiry date unspecified), that underwent a temperature excursion was administered to those patients on 25-AUG-2014. No concomitant medications were reported. No adverse effect was reported. 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 county health nurse/registered nurse and refers to 5 patients of unknown age and gender who, on unspecified date, were vaccinated by the physician with improperly stored VAQTA (route of administration, dose, frequency, lot and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient (also reported as a child). On an unknown dates the patient was vaccinated with complete series of three doses of hepatitis B (manufacturer unknown) 5 mcg/0.5 ml once (doses, lot numbers and route os administration were not noted. The outcome of low antibodies levels were unknown. Relatedness between low antibodies levels and therapy with hepatitis B vaccine (manufacturer unknown) was not 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 pharmacist refers to a patient of unknown age and gender. On 26-AUG-2014 the patient was inadvertently vaccinated with expired (on 22-AUG-2014) PNEUMOVAX23, intramuscularly, dose and lot # were not reported. No adverse effects reported.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Formication, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a 70 year old female patient with diabetes and drug reactions/allergies to sulfa drugs refers to herself. The patient's medical  history included shingles 4 times, but she never ran a fever. On 31-MAY-2012 the patient was vaccinated with ZOSTAVAX (dose, route and lot #  not reported). Concomitant therapies included insulin, pravastatin sodium, VISACOR (EPANOLOL). On unknown date in September 2013 the patient experienced severe pain and a rash on her back. She also developed pain from her ear to  nose described as "felt like little ants" sensation and a lesion on her back. The patient went to emergency room but she was not admitted. Do doctor did not identify the symptoms as shingles. The patient reported that the events were not as severe as prior to receiving ZOSTAVAX. On unknown date blood work was made, but the results were not reported. The patient recovered on unknown date from all adverse events. Causality between the events and ZOSTAVAX was not specified. Additional information is not expected as the patient did not provide doctor's contact details.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 25-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength, route not reported) lot # J0069212 that expired on 09-AUG-2014. The reporter also stated that the patient has not experienced an adverse effect. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 13 year old female patient. The patient pertinent medical history included pregnant. Last Menstrual Period (LMP) was around 29-JUL-2014 and estimated delivery date (EDD) would be 05-MAY-2015. On approximately 05-AUG-2014, (reported as "about two weeks ago"), the patient was vaccinated with first dose of GARDASIL injection (dose, frequency, route and lot# unknown). The patient sought medical attention at physician practice to receive a blood pregnancy test on 17-AUG-2014 to determine pregnancy. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 gender and age. On 18-AUG-2014, the patient was vaccinated with a dose of VAQTA, 0.5ml, intramuscular injection (dose number, lot/batch number, expiration date and indication were not reported) that was improperly stored. No adverse events were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 gender and age. On 18-AUG-2014, the patient was vaccinated with a dose of VAQTA, 0.5 ml, intramuscular injection (dose number, lot/batch number, expiration date and indication were not reported) that was improperly stored. No adverse events were reported.  No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified  number of patients (gender and age unspecified) which reported that the patients received improperly doses of GARDASIL (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. Follow up was received on 19-AUG-2014 from a certified medical assistant. The reporter stated that the 11 years old patient of unknown gender was vaccinated with a dose of improperly stored GARDASIL (dose, route not reported, lot # J009243, exp. date 23-APR-2016) on 24-JUL-2014. This is one of several reports from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 39 year old female patient. On 25-AUG-2014, an adult patient was inadvertently vaccinated with PROQUAD (Merck) dose 0.5ml in left deltoid, Lot # K002999, expiry date 27-AUG-2015. No adverse effects were reported. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history included high blood pressure and high cholesterol. On 22-DEC-2008 the patient was vaccinated with ZOSTAVAX (strength not reported route subcutaneous. Concomitant therapies included LOVAZA and HYZAAR. The reporter stated that on an unknown date blood titer for Varicella Zoster Virus (VZV) antibodies was performed on the patient, and the level of antibodies was  low. The outcome of level of antibodies was low is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of ROTATEQ Orally, dosage and indication were not provided), which were exposed 8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a physician via poison and drug center refers to a 20 month old male patient. The patient had no medical history and his past drug history was unknown. It was reported that patient was healthy. On 25-AUG-2014, the patient was to receive the second pediatric dose of VAQTA, instead he was accidentally given the adult dose of VAQTA lot # H010269 (dose, route of administration and expiration date were not provided). The patient did not take any concomitant medication. The physician reported that the patient was fine. It was unknown if there was any relevant laboratory data. As of 25-AUG-2014, it was unknown if the patient would receive VAQTA again and he was fine after receiving the adult dose. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a county health nurse/registered nurse refers to 3 patients of unknown age and gender, who on unspecified date were vaccinated, by the physician with improperly stored M-M-R II (dates, route of administration, dose, frequency, lot and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a county health nurse/registered nurse refers to 3 patients of unknown age and gender, who on unspecified date were vaccinated by the physician with improperly stored RECOMBIVAX HB (route of administration, dose, frequency, lot # and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of RECOMBIVAX HB (dosage, route of administration and indication were not provided), which were exposed 8.5 C for 15 minutes. No adverse effect were reported. Thi sis one of several reports received from the same reporter. 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 county health nurse/registered nurse refers to 7 patients of unknown age and gender who on unspecified date were vaccinated by the physician with improperly stored GARDASIL (route of administration, dose, frequency, lot # and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 04-DEC-2013, the patient was vaccinated with the first dose of GARDASIL (dose, Lot# and route of administration was not reported). On 14-AUG-2014, the patient was vaccinated with the second dose of GARDASIL (dose, Lot# and route of administration was not reported) which was late according to the reporter. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses VAQTA (dosage, route of administration and indication were not provided), which were exposed  8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of M-M-R II (dosage, route of administration and indication were not provided)   which were exposed 8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse manager via company representative refers to a 60 year old male patient. On 25-AUG-2014 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (dosage and lot number were not provided), instead of ZOSTAVAX. No symptoms reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old male patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, dose number, lot/batch number, expiration date, route and indication were not reported) and at the same time with a dose of hepatitis A vaccine (manufacturer unknown) (dose, dose number, lot/batch number, expiration date, route and indication were not reported). It was reported that the patient was administered GARDASIL and hepatitis A vaccine (manufacturer unknown) at the time and passed out (date unspecified). An unspecified nurse told the reporter that she thought the patient might have been play-acing. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. The outcome of passed out was reported as recovered/resolved on an unknown date. The relatedness between the event and GARDASIL and hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Immediate post-injection reaction, Irritability, Rash, Rash erythematous
Clinical narrative: Immediate reaction within 4-5 hours of vaccination was raised red rash, in clusters, on front and back of legs, and on back. Rash had tiny small clear heads.  Within 24 hours had a low grade temperature of 101 degrees.  The rash continued for 3 days, and the elevated temperature lasted for 2 days.  Son became very irritable. Called nurse and she said not reaction to MMR, but to treat with Benadryl and cool bath.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injection site pain, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: Injection sight pain, spiked a fever after going to bed. Forehead fever 101.7. Fever would go up and down through out the night.  She was experiencing extreme lethargy the next morning and all day, loss of appetite all day on the 30th and continuing to the 31st. Complaining of throat hurting. Extreme lethargy on the 31st. Only treatment is giving fluids and comfort so far.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: AFTER GIVING ZOSTAVAX (SHINGLE VACCINE) SHE WAS HAVING ITCHING AND SHE TOOK BENADRYL TABLET. AFTER THAT ITCHING WAS GONE AND NEXT DAY SHE WENT TO PRIMARY CARE DOCTOR. AND HE TOLD THE SAME THAT SHE IS ALLERGIC TO THAT DRUG. NOW PATIENT IS FINE AND WE UPDATE THE PATIENT PROFILE WITH ALLERGIC TO ZOSTAVAX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Fever + 2 degrees above my normal 98, lasting 48 hours. Site of injection extremely red and swollen, itchy, painful. 6" long by 3" wide, lasting 5 days.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Local swelling
Clinical narrative: PATIENT CALLED PHARMACY COMPLAINING OF "RED ARM", FELT HOT AND SWOLLEN. SHE DID SAY THAT SHE USED HER ARM TO DO HEAVY WORK THE DAY AFTER HER INJECTION.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Bone pain, Central nervous system inflammation, Muscular weakness
Clinical narrative: Painful pelvic bone, inflammation spinal cord, muscular weakness.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: C-reactive protein normal, Full blood count normal, Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: 11 days of low grade fevers since day of vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever, swelling at the point of injection, vomiting.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Pallor, Sensation of heaviness, Tremor
Clinical narrative: Burning during injection, injection arm burning throughout day until reported, vomiting, tremor, pale, heavy but NOT difficult breathing.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Burning during injection, injection arm burning throughout day until reported, vomiting, tremor, pale, heavy but NOT difficult breathing.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: 101.2 F fever, headache, nausea, chills, shivering.
Age: 0.56
Sex: M
Vaccine: DTAP, RVX
Symptoms: Abnormal behaviour, Eczema, Immediate post-injection reaction, Irritability
Clinical narrative: My son was fussy, as to be expected, immediately following his DTAP vaccine. His irritability lasted much longer than what is considered to be typical. He broke out in eczema the night of his vaccine. We noticed the eczema the morning after he was vaccinated. He also stopped babbling. He remained silent for about 4-5 weeks. He continued to be irritable during that time. I was not sure what was causing him to be silent. I thought it was curious it happened immediately after his vaccines. We treated his eczema with a detox of natural vitamin supplements and pro-biotics as directed by our new pediatrician. After treating him with this gentle baby detox for 2 weeks, he excreted out the heavy metals and began talking and babbling again.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day of shot (PNEUMOVAX 23 and FLUZONE HD) 8-28-14 redness, soreness and pain. Progressively got red and swollen from elbow to shoulder of inoculated arm. Pt saw urgent care provider and was given antibiotic which redness and pain decreased significantly.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Laceration, Loss of consciousness, Syncope
Clinical narrative: I administered an ADACEL Tdap shot to a pt, and within 10 mins. The pt experienced syncope (he "blacked out") and fell arms on shelf in the store, which results in a laceration to back of his head.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. showed an injection site reaction; red, swollen, itchy, warm to touch. Pt. has been putting ice on it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient presented with cold sore. She alleges started the day after vaccine administration.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Patient felt dizzy after Tdap brief syncope dropped to knees- Recovered quickly rested in room. Evaluation by MD BPV'd drank juice. Layed down. No injury.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, White blood cell count normal
Clinical narrative: Pt received vaccine on 8/25/14. Reported to another location 8/28/14 with large red, hot area around the injection site. From injection down to elbow. 4.5 inches wide.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Injection site erythema, Injection site induration, Injection site reaction, Injection site streaking
Clinical narrative: Pt received vaccine on 8/25/14. Reported to another location 8/28/14 with large red, hot area around the injection site. From injection down to elbow. 4.5 inches wide.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Pt received vaccine on 8/25/14. Reported to another location 8/28/14 with large red, hot area around the injection site. From injection down to elbow. 4.5 inches wide.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional referred to a patient of unknown age and gender. The call was originally placed by a healthcare worker, but the adverse event information was provided by another healthcare worker   who reported that ZOSTAVAX vial (lot #, dose, route and frequency unspecified) that underwent a temperature excursion was administered to the patient on 15-AUG-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender. The reporting pharmacist reported that on 14-AUG-2014 patient was inadvertently administered an expired dose of PNEUMOVAX23 (lot # J006921, expired on 09-AUG-2014) (dose, route and frequency unspecified). No adverse effect reported. Additional information has been requested.