chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. On 20-AUG-2014 the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot # J009827, expiry date 10-AUG-2014 (dose and route not reported). No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a 1 year old female patient (reporter's granddaughter). On 15-AUG-2014 (also reported as today) the patient was inadvertently vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported) instead of VARIVAX. No adverse effects reported at the time of the report. Additional information is not expected as there is no consent to contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was vaccinated with second dose of PROQUAD (0.5 ml, once, subcutaneously; lot # not available), which was improperly stored at 5.7F for 30 minutes. No adverse effects reported. Patient did not seek medical attention. Additional information is not expected. Reported did not wish to be contacted.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Influenza like illness, Rash, Type II hypersensitivity
Clinical narrative: Case number PHEH2014UD016323, is an initial spontaneous report from a physician received on 13 Aug 2014. This report refers to a 37-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with the first dose of RABAVERT (batch number: 52011A) on 01 Aug 2014 and experienced flu-like symptoms (see case: PHHY2014US102563). She was vaccinated with second dose of RABAVERT (batch number: 52011A) on 04 Aug 2014 and third dose of RABAVERT (batch number: 52011A) on 08 Aug 2014 respectively. On 09 Aug 2014, 24 hours after the third dose of RABAVERT was administered, she experienced delayed type II hypersensitivity reactions to RABAVERT in the form of a localized rash, joint, and back pain. The physician insisted the rash was a representative of delayed type II hypersensitivity reaction to RABAVERT. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Case number PHEH2014UD016323, is an initial spontaneous report from a physician received on 13 Aug 2014. This report refers to a 37-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with the first dose of RABAVERT (batch number: 52011A) on 01 Aug 2014 and experienced flu-like symptoms (see case: PHHY2014US102563). She was vaccinated with second dose of RABAVERT (batch number: 52011A) on 04 Aug 2014 and third dose of RABAVERT (batch number: 52011A) on 08 Aug 2014 respectively. On 09 Aug 2014, 24 hours after the third dose of RABAVERT was administered, she experienced delayed type II hypersensitivity reactions to RABAVERT in the form of a localized rash, joint, and back pain. The physician insisted the rash was a representative of delayed type II hypersensitivity reaction to RABAVERT. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Injection site pain, Joint range of motion decreased, Red blood cell sedimentation rate
Clinical narrative: Pt was seen 7/2/14 given ADACEL for preventive care. On 8/7/14 she returned stating she had a "sore arm" at the ADACEL injection site. She has limited extension without pain and abduction. No history of arthritis. She returned 8/13/14 still symptomatic.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Convulsion, Pyrexia, Screaming, Streptococcus test
Clinical narrative: At 11:45PM mother said she was screaming and witnessed a seizure by her mother. Transported to ER with a fever.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 16-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # J012377, expiration date 03-OCT-2015, dose and route not reported) and MMR II (lot # J013315, expiration date 18-OCT-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: Severe swelling and redness around the site of injection. Blister like appearance 3 inches around injection site. Breakout around neck, spottled looking.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Severe swelling and redness around the site of injection. Blister like appearance 3 inches around injection site. Breakout around neck, spottled looking.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Tues Aug 19th pm took bandaids off and it was red, hard and swollen with hard knot of varicella injection site (L) ant. upper arm. Has gotten more red and swollen to present.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's medical history and current condition are not reported. It was reported that on 18-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # and expiry date not reported) of unknown dose and frequency which was stored improperly. No adverse events are reported. Product quality complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: Spread of vaccinia from original site; autoinoculation site of spread = a few inches inferior to original inoculation site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Induration, VIIth nerve paralysis
Clinical narrative: Pt given shingles vaccination at pharmacy on 8/15/14 in (R) arm - developed induration and bruising in the arm locally w/in 24 hours. In 1-2 days developed (R) Bell's palsy.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Pancreatitis
Clinical narrative: A report from a physician concerns a 13 year old male. Generally the patient was healthy and not taking any special medications. During 2009 the patient received an inactivated vaccine and a month later was hospitalized due to pancreatitis. On 23-Nov-2011 the patient was vaccinated with FLUMIST (intranasal). One month later he was hospitalized again due to pancreatitis. At the time of reporting, the patient was improving from pancreatitis. The reporter assessed the event as serious due to hospitalization. Corrected Report on 14-Aug-2014: Initial unit changed to MedImmune case and drug type corrected to vaccine, form completed date and administered by added, vaccine related fields completed for FLUMIST, concomitant vaccine and relevant history added, narrative amended.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Erythema, Injection site induration, Injection site nodule, Local swelling, Pruritus
Clinical narrative: Child had two vaccinations, one in each arm, TDap in left arm, Meningitis in right arm. Left arm started on 08/19/2014 with swelling, bright red circle, hot to touch, itch, hard knot at location of injection. Stated out as size of quarter by 08/20/2014 expanded to size of adult hand. 08/20/2014 right arm started with same symptoms and is currently size of 1/2 dollar, 08/21/2014. Treating with Benadryl ointment on both sites, provided Benadryl oral at bedtime on 08/20/2014. Ice packs and warm compresses on and off throughout the day.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Skin warm
Clinical narrative: Child had two vaccinations, one in each arm, TDap in left arm, Meningitis in right arm. Left arm started on 08/19/2014 with swelling, bright red circle, hot to touch, itch, hard knot at location of injection. Stated out as size of quarter by 08/20/2014 expanded to size of adult hand. 08/20/2014 right arm started with same symptoms and is currently size of 1/2 dollar, 08/21/2014. Treating with Benadryl ointment on both sites, provided Benadryl oral at bedtime on 08/20/2014. Ice packs and warm compresses on and off throughout the day.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AROUND INJECTION SITE ON BACK OF LEFT ARM. COVERING LARGE PORTION OF UPPER ARM.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Pain in extremity, Rash, Skin discolouration, Swelling
Clinical narrative: Sore leg, redness, swelling with dark area in center, rash; becoming more swollen.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
Clinical narrative: VERBALIZED "EVERYTHING IS GOING BLACK". HEAD SLUMPED FORWARD, BODY FELL FORWARD. PLACED IN SUPINE POSITION. ARMS AND LEGS STIFFENED THEN CROSSED. EYES CLOSED. NOT VERBALLY RESONSIVE FOR 10-12 SECONDS THEN RESPONDED AND ASKED "WHAT JUST HAPPENED".
Age: 1.96
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous
Clinical narrative: Solid red raised rash to legs and chest. Mother says it is a mild rash. Encouraged mother to take son to doctor to get rash evaluated and to give him some Benadryl as directed on bottle or by MD.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Nausea
Clinical narrative: Right arm red, raised, and heat to injection site approx. 12cm X 7cm. Mother brought son to health dept on 06/26/14 to have nurse look at arm. Discussed local reaction. Told if arm was worse tomorrow to take him to doctor to have evaluated. Keep cool compress and use motrin to help with swelling. C/o nausea day of injection per mother.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: ITCHING ONSET APPROX 50 MINUTES POST INJECTION ONGOING STILL NO RASH NOTED.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash to face, legs, back, and stomach. c/o itching. No fever. Daycare was wanting to see if child was contagious. Mother has called to report s/s and ask the health department if related to vaccines. Discussed possible SE from MMR vaccine and it should go away, but if not any better in the next 24 hours to see MD.
Age: 1.4
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Dry skin, Rash, Secretion discharge, Skin exfoliation, Skin fissures
Clinical narrative: Rash covering both hands, arms, left knee, both heels and feet with dry cracking/peeling skin on hands and feet with clear drainage noted by mom.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Within 30 mins. of vaccine administration, he passed out and had seizure like symptoms. Called 911, upon their arrival he was alert and oriented. Parent transported him to local hospital.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: DIZZINESS.
Age: 26.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Flushing, Tachycardia, Tremor
Clinical narrative: Tachycardia, flushing, chest pain, shaking.
Age: 26.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Electrocardiogram abnormal, Flushing, Sinus tachycardia, Tachycardia
Clinical narrative: Tachycardia, flushing, chest pain, shaking.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Big 4 inches long 3 inches wide red hot spot on same arm where it was given. Headache. Short of breath, pain on left side of chest. Weak, tired. Muscle hurts.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Big 4 inches long 3 inches wide red hot spot on same arm where it was given. Headache. Short of breath, pain on left side of chest. Weak, tired. Muscle hurts.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Polyarthralgia.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness few mins after vaccine given.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Parents noticed large blister/bulla rash around injection site with redness 2 days after administration.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site pain, Malaise
Clinical narrative: I began to have a stiff neck and pain, immediately after I noticed it I felt pain in the injection site. That evening began 2 days of feeling extremely weak and fatigued. I could barely lift my newborn because my whole body ached and I was struggling to move around. I felt sick like I had the flu, but had no fever.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: I began to have a stiff neck and pain, immediately after I noticed it I felt pain in the injection site. That evening began 2 days of feeling extremely weak and fatigued. I could barely lift my newborn because my whole body ached and I was struggling to move around. I felt sick like I had the flu, but had no fever.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Burning itching red bumps starting on hands, then armpits and inner thigh.  Progressed within 24 hours to whole body except head.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth, pain in right thigh.  Swelling extended down past knee.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: 45-90 second seizure with fever to 103.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash
Clinical narrative: Blister appearing rash on both forearms; rash on right trunk area; family physician contacted; family physician recommended urgent care visit.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: Fever 8 days after vaccine.  Rash starting 9 days after vaccine. Papular rash on torso, face and extremities. Fever to 100.5 degrees.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Fall, Full blood count
Clinical narrative: Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Loss of consciousness, Metabolic function test, Vomiting
Clinical narrative: Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: White blood cell count increased
Clinical narrative: Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Excoriation, Fall, Full blood count
Clinical narrative: Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Haematoma, Head injury, Metabolic function test, Syncope
Clinical narrative: Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, C-reactive protein increased, Dizziness, Flushing, Malaise
Clinical narrative: Vertigo, malaise, tachycardia, faint feeling, flushing, acute joint pain, light-headedness, neuropathy. Acute joint pain, vertigo, neuropathy & light-headedness still continuing.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Neuropathy peripheral, Tachycardia, Vertigo
Clinical narrative: Vertigo, malaise, tachycardia, faint feeling, flushing, acute joint pain, light-headedness, neuropathy. Acute joint pain, vertigo, neuropathy & light-headedness still continuing.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Eye movement disorder, Loss of consciousness, Rash, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt received HiB vaccine at doctors office at approximately 3:45 pm.  While driving home from doctors office approximately 15 minutes after injection patient began vomiting uncontrollably for approximately 30 minutes straight and after 30 minutes appeared to begin to lose consciousness, unable to respond to mother firmly tapping face and yelling babies name, eyes starting to roll back.  Never lost airway.  911 was called, patient began to come around was more alert when ambulance arrived and continued to be more alert.  Rash on cheeks was noted approximately 1 hour after vaccination.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Dizziness, Nausea
Clinical narrative: Felt abdominal pains, nausea, and felt faint. I did not loose consciousness. Only lesser abdominal pains were experienced during following 3 doses.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pruritus
Clinical narrative: Fatigue, pruritus, redness around the injected area.  Advised the patient to take Claritin and contact PCP.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swelling of injection site, redness for 2 plus days.
Age: 1.07
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Rash macular
Clinical narrative: Vaccines given at 3:45 and at 3:52 red blotches, different sizes all over body, note small white pimple bumps in middle of red blotches. At 4:18 most blotches are faded or gone.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 25 year old female patient. On 04-AUG-2014 the patient was vaccinated with a first dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) and then on experienced vaccine induced tremors (in August 2014, exact date unspecified). The outcome of adverse event was not reported. The relatedness between adverse event and GARDASIL 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 Licensed Practical Nurse refers to a patient of unknown age. The patient's medical history and current condition are not reported. It was reported that on 29-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J008443 and expiry date 9-JUL-2015) of dose 0.5 ml, subcutaneously that was improperly stored since an unspecified date. Also reported that no doses of improperly stored (Oka/Merck) VARIVAX were reported as administered on 28-JUL-2014. No adverse events are reported. Product quality complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure increased, Headache, Pyrexia
Clinical narrative: Pt reported fever of 102.0 and increased BP and HA.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Developed hives approx. 5 hours after time of injection. Spread from legs to chest and hands. Given dose of BENADRYL with positive effects. Also 1 bout of diarrhea.
Age: 63.0
Sex: M
Vaccine: FLUC3, VARZOS
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Patient began breaking out in a red itching rash spreading down both arms 8-16-2014.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Burning sensation, Skin exfoliation, Tenderness
Clinical narrative: Patient reported "Burning from inside out". Pain when pressure has put against skin. No rash, but some "pimples" reported on chest, some flaking of skin. Patient prescribed Gabapentin and condition improved (300mg tid).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warming of skin on arm (under administration site), started the day after vaccine.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: Sites where the shot were given were red and swollen. Pt had a mild fever and had body aches. She area of the sites also had itching. Symptoms lasted approx. 24 hours and pt was treated with fever reducers.
Age: 19.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 year old patient. Information regarding concurrent conditions and pertinent medical history was not provided. On 08-AUG-2014 the patient was inadvertently vaccinated with a 0.5ml dose of LIQUID PEDVAXHIB (injection, lot # J016185, expiration date 02-OCT-2016, intramuscular) instead of meningococcal vaccine (unspecified). The healthcare worker stated that writing on bottle had similarities to other vaccine. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reaction or allergies were not reported. On 15-AUG-2014 the patient was inadvertently vaccinated with expired M-M-R II, expiration date 09-AUG-2014 (strength, dose, dose number, route, anatomical location and lot number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. 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 nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history, drug reaction or allergies were reported. On 15-AUG-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 expiration date July 2014, (strength, dose, dose number, route, anatomical location, lot number and exact date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: No fever. Lt vastus lateralis red, swollen, warm, site: 15 x 21 cm induration 4 cm x 4 cm Circum (L) 36 cm (R) 34.5 cm. Follow uo recommendations.
Sex: U
Vaccine: VARZOS
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. The patient's current conditions or medical history were reported. On 08-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml subcutaneous injection (lot number and expiration date not reported) that underwent a temperature excursion. No adverse effect reported. Additional information is not expected as the reporter did not wanted follow up contact.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representatives, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. On 20-JUL-2014, the patient was vaccinated with ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Pharmacist reported that patient developed shingles 30-JUL-2014. Pharmacist that the patient did not had any pain but had minimal vesicles on her back. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 year old female patient. No pertinent medical history, drug reaction or allergies were reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX dose 2 (reported as thinks the patient has received two doses so far on unspecified dates) (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date in 2013 (reported as at least a year ago, the patient developed herpes around the mouth. The patient was seen by physician on unspecified dates and was placed on an unspecified antiviral medication on an  unspecified date for the herpes. The outcome of herpes around the mouth was reported as recovering. The relationship between (Oka/Merck) VARIVAX and the event was not reported. Additional information is not  expected because the reporter refused additional contact.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report was received from a currently 70 year old male nurse who is also the patient with drug reaction/allergies (mild rash) to BACTRIM DS. In 1985, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown). Dose, lot number and expiration date were not reported. In 1995, ten years later, the patient received another dose of hepatitis b vaccine (manufacturer unknown). The patient reported that his titer (first titer) was drawn and result was too low and he received another series of RECOMBIVAX 10mcg/1.0ml (on an unknown date). After completing the series with RECOMBIVAX, second titer was drawn again and at that time, level was adequate and he was told that he was "protected". However, about another 10 years after repeat doses with RECOMBIVAX, another titer (third titer) was drawn for unspecified reason, and the result came back low again (on an unknown date). Nurse did not received any additional hepatitis B series after titer testing. The outcome of his titer was drawn and result was too low/result came back low again was unknown. The patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen and warm to touch from below shoulder to above elbow. Cold compresses, ibubrofen, watch for pain and increase redness.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Activities of daily living impaired, Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Reaction included hives and swelling 10 cm circumference of injection site, fever and extreme tenderness at site. Was seen in Medical Center ER at 10:00PM on 8-20-14. Treated with BENADRYL PO and CELESTONE IM. Patient kept out of school on 8-21-14 per parent.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Erythema, Urticaria
Clinical narrative: Right side face with redness and hives, consistent with coughing.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt has pain and tenderness (L) deltoid area.
Age: 1.62
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling
Clinical narrative: (R) leg swollen 6x 3 1/2 cm (bump).
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness, muscle pain, fever 102.7, nausea symptoms began with an hour of vaccine administration.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram normal, Glucose urine, Orchitis
Clinical narrative: Patient has right orchitis. Received MMR #2 7-23-2014. Had #1 MMR 1 month earlier.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction, large heated erythematous muscular pain at shoulder.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Dizziness, Gastrointestinal pain, Pyrexia, Vomiting
Clinical narrative: Started Typhoid capules first thing in the a.m. Monday afternoon, dizzy, light-headed. Tues. diarrhea started x 5 times, Wed fever 103, severe GI pain, followed by vomiting- went to urgent care.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse event; vaccine was expired on 8/10/14; Merck has in-house data to support potency so didn't re-vaccinate. -This is for the PNEUMOVAX only.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None. PNEUMOVAX expired. Vaccine expired 8/10/14; Merck says that in house data supports potency.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: None. PNEUMOVAX expired. Vaccine expired 8/10/14; Merck says that in house data supports potency.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: Lightheadedness approx 5 minutes after receiving vaccination, patient remained alert, given 1 carton of apple juice and monitored in lying position for 20 minutes prior to discharge in stable condition.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Redness and swelling at injection site treated w/ ice packs, hot flashes, hives all occurred the day after administration.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in on 8/19/2014 and said that she was having a local reaction at injection site. She received the ZOSTAVAX shot on 8/14 and on 8/16 she developed pain and itching at injection site. She said it was also red, swollen and warm. She said it had gotten better since then. Still has a bit of rash.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash
Clinical narrative: Patient came in on 8/19/2014 and said that she was having a local reaction at injection site. She received the ZOSTAVAX shot on 8/14 and on 8/16 she developed pain and itching at injection site. She said it was also red, swollen and warm. She said it had gotten better since then. Still has a bit of rash.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling starting about 6 inches below the injection site. Redness. Severe pain at the arm that was injected (left). Still on going 2 days after administration.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath. Dizziness. Back pain. Patient had to go the ER for treatment. Sx started the evening of 8/15/14.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash vesicular
Clinical narrative: Pt was given MMR and Varicella in thigh on 8/8/14. 8/10/14 pt had a fever T-101 @ 7:30AM and febrile seizure @ 11:30 am. 8/10 pt developed a vesicular, clustered shingle like rash on thighs-resolved after 2 days.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling
Clinical narrative: Pt had swelling the size of soft ball in right leg.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy/lightheaded after HPV, Tdap and MCV4 vaccines. Pt instructed to lie down, given juice and crackers. BP 90/55, heart rate 55. MD assessed patient prior to discharge from clinic.
Age: 0.83
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Rash
Clinical narrative: Pt got a rash about a week after getting her immunizations.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to an approximately 24 year old female patient. The patient's medical history included incompetent cervix. The patient has a history of 2 previous pregnancies, reported as 2 pre-term deliveries (at 33 and 35 weeks from LMP (last menstrual period), no further specified). No birth defects were reported in previous pregnancies. One infant (first child) had a premature birth and was in the NICU (neonatal intensive-care unit) for 1 month. The first child had asthma. On 20-NOV-2013, the patient was vaccinated with GARDASIL (lot # H009746) dose 1. The patient became pregnant with LMP of 01-NOV-2013 and EDD (estimated delivery date) of 08-AUG-2014. The estimated date of conception was reported as 15-NOV-2013. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was pending. Follow up information has been received from a registered nurse. This spontaneous pregnancy report concerns a 24 year old female patient. The was no maternal medical history and no other relevant history (prior to start of GARDASIL). It was reported that the patient was a smoker with a half pack. The patient was an occasionally alcohol user. On 11-SEP-2007 the patient gave a live birth to a male child (weeks from LMP were reported as 33/35, also reported as premature delivery, weight unknown). On 31-AUG-2009 the patient gave a live birth to a male child (weeks from LMP were reported as 33/35, also reported as premature delivery, weight unknown). On 20-NOV-2013 the patient was vaccinated with GARDASIL (first dose, intramuscular, lot# H009746). It was unknown about any products taken prior or during the pregnancy. On 20-NOV-2013 urine pregnancy test showed positive result and the patient was 3 weeks pregnant. On an unknown date (first trimester), the patient experienced spontaneous abortion (below 20th week). The relatedness between events and GARDASIL was unknown. Upon internal review, spontaneous abortion was considered to be medically significant. Additional information is not expected because the reporter provided all information.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Erythema, Papule, Pruritus, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered  nurse refers to a 4 year old male patient. The patient's medical history included subdural hematoma and frenulum tear. No drug reactions or allergies were reported. On 11-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous injection, lot number: K001388, expiration date: 29-JAN-2016 (dose number not reported) indication reported as "needed for school". On 26-JUL-2014, the patient experienced unspecified symptoms and on 27-JUL-2014 sought medical attention at the emergency room and was diagnosed with hives further described as papillary urticaria. On 29-JUL-2014, the patient sought medical attention at the healthcare provider's office and was diagnosed with chickenpox further described as scattered, erythematous papules on his back, buttock, arms and legs. No laboratory diagnostics studies were performed. No treatment was given for the events. The outcome of the events was considered as not recovered/not resolved as it was reported that on 29-JUL-2014, few spots were scabbed over and new spots were appearing on an unspecified areas on the patients body. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Erythema, Papule, Scab, Urticaria, Urticaria papular
Clinical narrative: This spontaneous report as received from a registered  nurse refers to a 4 year old male patient. The patient's medical history included subdural hematoma and frenulum tear. No drug reactions or allergies were reported. On 11-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous injection, lot number: K001388, expiration date: 29-JAN-2016 (dose number not reported) indication reported as "needed for school". On 26-JUL-2014, the patient experienced unspecified symptoms and on 27-JUL-2014 sought medical attention at the emergency room and was diagnosed with hives further described as papillary urticaria. On 29-JUL-2014, the patient sought medical attention at the healthcare provider's office and was diagnosed with chickenpox further described as scattered, erythematous papules on his back, buttock, arms and legs. No laboratory diagnostics studies were performed. No treatment was given for the events. The outcome of the events was considered as not recovered/not resolved as it was reported that on 29-JUL-2014, few spots were scabbed over and new spots were appearing on an unspecified areas on the patients body. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered  nurse refers to a 4 year old male patient. The patient's medical history included subdural hematoma and frenulum tear. No drug reactions or allergies were reported. On 11-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous injection, lot number: K001388, expiration date: 29-JAN-2016 (dose number not reported) indication reported as "needed for school". On 26-JUL-2014, the patient experienced unspecified symptoms and on 27-JUL-2014 sought medical attention at the emergency room and was diagnosed with hives further described as papillary urticaria. On 29-JUL-2014, the patient sought medical attention at the healthcare provider's office and was diagnosed with chickenpox further described as scattered, erythematous papules on his back, buttock, arms and legs. No laboratory diagnostics studies were performed. No treatment was given for the events. The outcome of the events was considered as not recovered/not resolved as it was reported that on 29-JUL-2014, few spots were scabbed over and new spots were appearing on an unspecified areas on the patients body. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a female patient (age unknown) with back issues. The medical history included chickenpox. On an unknown date in 2008 (reported as 6 years ago, patient received ZOSTAVAX, unknown dose and frequency. Relevant concomitant medications were unknown. On an unknown date, the patient experienced rash on her back for which she was hospitalized on an unknown date for an unknown duration where she was diagnosed that the rash she had was because of the shingles (she had since an unknown date) after administration of ZOSTAVAX. Relevant laboratory data was unknown. The outcome of the events was unknown at the time of this report. Therapeutic measures taken in response to the reported events were not provided. The causality assessment was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: (Left arm; varicella) red circle about 1 inch across within hours. It grew to 3 inches across overnight and by 24 hours later, small white blisters formed near injection site. Merged into one 2 inch across blister by evening, when we took her to urgent care with a 100.8 F fever. They said to give her ibuprofen, Zyrtec, cold compresses and to apply neosporin after blister burst. Blister broke that night after growing to half inch thick. Late second morning, more blisters appeared and grew to a one inch size next to burst first one, saw doctor at peds clinic Thursday afternoon about 48 hours after shot; he prescribed prednisone, Zyrtec liquid, and Keflex, which we started last night. Told us to outline the extent of outer red, warm ring (it now covers 90% of upper arm). Have another appt today with same peds doctor to assess if it's still getting worse.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stopped by the pharmacy on 8/21 to have pharmacist look at injection site. Patient complains of soreness, redness, swelling at the injection site; skin is also warm to touch. Advised patient to apply a cold compress and take ibuprofen for pain. Also advised patient if gets worse to contact physician.  Patient came back to pharmacy on 8/21. Pharmacist stated the site has improved since previous day; slightly red and warm. Again pharmacist advised a cold compress and ibuprofen for pain. If reaction gets worse, contact physician
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 27 year old female patient. Patient had no medical history, concurrent conditions. On 04-OCT-2012, the patient was vaccinated with RECOMBIVAX HB dose 1, 1ml, intramuscular. On 06-NOV-2012, the patient was vaccinated with RECOMBIVAX  HB dose 2, 1 ml, intramuscular. On 03-APR-2013 the patient was vaccinated with RECOMBIVAX HB dose 3, 1 ml, intramuscular (lot # not specified for all the doses). Patient was not taking any concomitant medications. The patient was subsequently had negative Hepatitis B antibody titer. The patient sought medical attention by office visit and a Hepatitis B antibody titer was done which was negative. No treatment was given for the event. There was no product quality complaint. The outcome of negative hepatitis B antibody titer is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored dose of ZOSTAVAX Lot # K000994; expiration date06-MAR-2015 (dose and route of administration not reported). The nurse stated that this might have been previously reported but she declined to provide any additional information including name of physician. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age who on 07-AUG-2014 the patient was vaccinated with an improperly stored dose of PROQUAD (lot #, expiration date and dose unspecified). No adverse events were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Transient acantholytic dermatosis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown demographics. No current condition or medical history has been reported. On an unknown date in March 2014, the patient was vaccinated with a dose of ZOSTAVAX vial 0.65 milliliter (ml), subcutaneous injection. No concomitant medication was reported. The physician reported that the patient was recently diagnosed at an unspecified time and date in 2014 with grovers disease which was confirmed on a biopsy by an unspecified dermatologist. There was no product quality complaint involved. The outcome of grovers disease was not reported. Causality between grovers disease and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age who on 08-AUG-2014 the patient was vaccinated with an improperly stored dose of ((Oka/Merck) PROQUAD (lot#, expiration date and dose unspecified). No adverse events were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old female patient with no medical history. Patient's drug reactions or allergies were not reported. On 08-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location not reported, lot#: K001631, expiration date: 06-NOV-2016). There was no concomitant medication. On 08-AUG-2014, the patient fainted following administration of her 1st dose of GARDASIL. There were not laboratory tests performed. There ws no treatment given for the reported event. The outcome of the patient fainted following administration of her 1st dose of GARDASIL was reported as recovered/resolved (date of recovery: 18-AUG-2014). The relatedness between the therapy with GARDASIL and the reported event was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: 8cm x6cm mildly red 2+ swollen area on right arm.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dehydration, Heart rate increased, Injection site pain, Pyrexia
Clinical narrative: Fever to 101 deg F; rapid heart rate to 120 BPM; dehydration.  Took Tylenol (2 x 500 mg) every 6 hours plus copious amount of water plus applied ice pack.  Fever broke approx 1 AM.  Also, unusually painful injection site.