chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Viral rash
Clinical narrative: This male subject was enrolled in a study. On 08 February 2013, he received the 1st dose of GSK PRIORIX or Merck's MMR II co-administered with GSK HAVRIX 720 JUNIOR, Merck's VARIVAX and Pfizer's PREVNAR 13. This subject received PRIORIX. On 01 March 2013, 21 days after the 1st dose of Blinded vaccine, 21 days after the 1st dose of HAVRIX 720 JUNIOR, 21 days after the 1st dose of VARIVAX, 21 days after the 1st dose of PREVNAR 13, this 12-month-old subject developed petechiae. The subject was hospitalised. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the petechiae may have been caused by investigational product, HAVRIX 720 JUNIOR, VARIVAX and PREVNAR 13 and that the event was possibly due to a viral infection. Investigator Comments: Received immunizations PREVNAR, HAVRIX, MMR and VARIVAX on 08 February 13. 01 March 2013 subject presented with left otitis media and petechiae under left eye, and nonspecific viral appearing rash on trunk and extremities. OMNICEF prescribed. CBC drawn and results normal except for EOS 4.0%. On 02 April 2013, subject presented with nasal congestion for two days, fever of 100.4, petechiae on extremities and face and bruising on face following a fall. No mucosal involvement. No blood noted in urine or stools. No meningism. Subject was admitted to the hospital for further evaluation on 02 April 2013 and discharged on 03 April 2013. Awaiting records for further information. Has appointment scheduled with primary care provider on 12 April 2013. Causality is listed as related to study vaccine at this time due to the known association of thrombocytopenia with MMR vaccine. We are awaiting for a final diagnosis at the subject's visit with primary care physician on 12 April 2013.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Area red, warm, painful
Age: 55.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Area red, warm, and swollen.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Live birth, No adverse event
Clinical narrative: Information has been received from a 23 year old female patient for GARDASIL, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date in December 2011 the patient was vaccinated with the first dose of GARDASIL (lot number 0626AA) (dose, route and injection site were not reported) to prevent HPV. On 28-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). On 11-APR-2013 the patient was vaccinated with the third dose of GARDASIL (lot number, dose, route and injection site were not reported). There was no concomitant medication. On 23-MAR-2012 the patient found she was pregnant. On 26-NOV-2012 the patient delivered an infant. No side effects have been reported. The outcome was not provided at the time of report. There was no treatment given for adverse event. There was no lab diagnostics studies performed. The patient had seen healthcare professional for medical attention. The baby's information was captured in MARRS # 1304USA006581 (Parent-Child Link). Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: No initial reaction --> 2 weeks after vaccination (3/14/13). Patient had bilateral tingling in hands and feet. Patient wast treated by neurologist, who ruled out Guillain Barre Syndrome but attributed to vaccination.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient is experiencing consistent pain in left arm. She has difficulty moving her arm and limited range of motion.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness / swelling both thighs.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Feeling hot, Injection site rash, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Received vaccines Wed afternoon, felt warm Thursday. Friday morning injection sites had red raised rash it spread to arms and chest in 1 hour. Mom took him to urgent care and was given BENADRYL. Rash has resolved.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pain, swelling - site admin. one inch from bend. Pain and burning on adm. at approximately 4:15p. Swelling and pain upper arm 1-2 hrs later. Severe pain with movement. Iced. Acetaminophen 1000mg.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test normal, Erythema, Hypersensitivity, Inflammation, Pain in extremity
Clinical narrative: Patient had redness, inflammation, and pain in arm after injection. Patient received injection on March 4th. She reported to her MD on March 7th where she received blood work, MD says it appears to be an allergic reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash pruritic
Clinical narrative: Day after receiving vaccine itching mid back to under breast area and eruption of blisters on body in same area as itching rash.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Mom called three days after injection was given to report pt. had "itchy, red area, 6 in long, raised, warm". Denied SOB, itching or swelling around lips or mouth. Pt was given BENADRYL by mom, used ice at site.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Headache, Myalgia
Clinical narrative: Headache, fever, severe joint and muscle pain weakness, diarrhea, poor appetite.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Headache, fever, severe joint and muscle pain weakness, diarrhea, poor appetite.
Age: 1.63
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Developed hives on various body parts within 3 hours, treated with BENADRYL.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Irritability
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old male patient with no pertinent medical history and no drug reactions or allergies. About three months ago (approximately in January 2013) the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified). No concomitant medications were reported. Approximately in 2013, the patient experienced fussiness for two days following the administration. At the time of the report the outcome of fussiness was reported as recovered. Patient did not seek medical attention and did not receive treatment. Laboratory tests were not performed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Pt developed lip and facial swelling after vaccines were given. No respiratory difficulty.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Pt broke out in several raised bumps, approx size and shape of an insect bite on arm, torso, forehead and leg. She states itching and fever, no blister or discharge from bumps.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediate onset of urticaria at site of both injections. No other symptoms or ash or spread of hives.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia, Vomiting
Clinical narrative: 3/31/13 - 11: A.M. Chills, fever. Upset stomach - vomit thru 4/2/13. 2 1/2 days after shingles vaccine.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration
Clinical narrative: MENVEO was injected SQ instead of IM Pt advised to contact Dr if painful and any other symptoms.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site swelling
Clinical narrative: MENVEO was injected SQ instead of IM - caused pain & swelling at site.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Infection, Pain in extremity
Clinical narrative: Symp: Left arm pain. Diag: Left arm infection caused by vaccine.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash maculo-papular, Varicella
Clinical narrative: Presented on 4/5/13 with maculopapular rash, size average 0.5 cm with blistering. Location on scalp, body and upper extremities. Complains of pruritus.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 08-APR-2013 the patient was inadvertently administered GARDASIL that had been improperly stored, 0.5 ml (lot# not reported), intramuscularly. No adverse effects reported. It was not reported if the patient seek medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a nurse (B.S.N.) refers to a 27 year old female patient. On 12-MAR-2013 the patient was vaccinated with her first dose of (merck) VARIVAX (dose and route not reported, lot # H013182, expired date: 05-JUL-2014). On 14-MAR-2013, it was reported that the patient experienced a 20mm by 30mm area of redness and induration at the injection site. The patient was given ice as treatment for the events. At the time of reporting, the outcome of the events was reported as recovered on an unspecified date. The patient sought medical attention by calling the clinic. Additional information has been requested.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abnormal faeces, Culture stool positive, Dehydration, Dermatitis diaper, Diarrhoea
Clinical narrative: Within 1 hr of vaccines infant started fever (99 degrees), diarrhea, vomiting & a pink rash on arms legs, stomach, face started next day. Every day he got worse - by Fri 4/12/13 fever was 102, diarrhea q 15-20 min - projectile, watery, foul-smelling & vomiting. Severe diaper rash - Taken to ER 4/12 - Dx dehydration, rotavirus. Dr. stated he got rotavirus from the shot and may also be having allergic reaction to shot(s). Infant given IV's & foster mom gives PEDIALYTE. Infant continues to have fever, vomiting & severe diarrhea. Two antibiotic ointments for diaper rash.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site rash, Laboratory test abnormal, Pyrexia, Rash erythematous, Rotavirus infection
Clinical narrative: Within 1 hr of vaccines infant started fever (99 degrees), diarrhea, vomiting & a pink rash on arms legs, stomach, face started next day. Every day he got worse - by Fri 4/12/13 fever was 102, diarrhea q 15-20 min - projectile, watery, foul-smelling & vomiting. Severe diaper rash - Taken to ER 4/12 - Dx dehydration, rotavirus. Dr. stated he got rotavirus from the shot and may also be having allergic reaction to shot(s). Infant given IV's & foster mom gives PEDIALYTE. Infant continues to have fever, vomiting & severe diarrhea. Two antibiotic ointments for diaper rash.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Within 1 hr of vaccines infant started fever (99 degrees), diarrhea, vomiting & a pink rash on arms legs, stomach, face started next day. Every day he got worse - by Fri 4/12/13 fever was 102, diarrhea q 15-20 min - projectile, watery, foul-smelling & vomiting. Severe diaper rash - Taken to ER 4/12 - Dx dehydration, rotavirus. Dr. stated he got rotavirus from the shot and may also be having allergic reaction to shot(s). Infant given IV's & foster mom gives PEDIALYTE. Infant continues to have fever, vomiting & severe diarrhea. Two antibiotic ointments for diaper rash.
Age: 53.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 53 year old female patient with no medical history and with no drug reactions/allergies. On 08-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000435, exp date as 10-APR-2014, subcutaneously in the right upper arm, dose unspecified). Other suspect therapies included ENGERIX-B (manufacturer unknown) (in the right upper arm, Lot#, dose/frequency, route and duration were unspecified) on the same day. There was no concomitant medications taken. On 09-APR-2013, patient developed "a red, itchy indurated area around the injection site where ZOSTAVAX was administered in the patient's right upper arm". Patient had sought medical attention via office visit, no lab diagnostics studies were performed. Treatment of CLARITIN was given for the event. The outcome was reported as recovering. Drug relationship was not provided. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site nodule, Injection site swelling
Clinical narrative: On 4/12/13 at 4:31 pm client reported that her arm where she got her varicella vaccine was swollen with a knot at that site. Stated that she noticed it on last night, denies fever. Varicella vaccine was given on 4/10/13. States she had nurse from her job to look at it. States that she was applying ice to area. States was told that the vaccine should have been given IM and not subcutaneous.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 3 year old female patient. On 27-MAR-2013 the patient was vaccinated with the first dose of (merck) VARIVAX in the arm. Other suspect therapies included PREVNAR 13, administered in the same arm on the same date. No concomitant drugs were taken. On 27-MAR-2013, 5 to 10 min after onset of therapy the patient experienced 50 cent piece size hive between the 2 injection site. There was no itching or pain and it resolved within 5 hours. The outcome of 50 cent piece size hive between 2 injection sites was reported as recovered/resolved. Causality was not provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Contusion, Oedema peripheral, Pruritus, Rash
Clinical narrative: Gave Varicella #1 (L) arm on 3/5. Signif swelling, itching, rash of (L) arm x 3w. Took BENADRYL and creams with some relief. Resolved now except for bruising.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Cardiac function test normal, Convulsion, Electroencephalogram normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal
Clinical narrative: Spoke to patient on 3/25/2013.  She stated that on 11/16/12 she was riding bus home from school and fainted and had a seizure.  Taken to hospital for 3 days of tests which were all normal.  States since 11/12 she has been having silent seizures daily and "mini" mild seizures weekly.  Is non-compliant with medications she was prescribed, but states the seizures are "lighter" with medication.  Also complains of sometimes having blurred vision, bilateral edema and numbness and tingling in arms.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Oedema peripheral, Paraesthesia, Syncope, Vision blurred
Clinical narrative: Spoke to patient on 3/25/2013.  She stated that on 11/16/12 she was riding bus home from school and fainted and had a seizure.  Taken to hospital for 3 days of tests which were all normal.  States since 11/12 she has been having silent seizures daily and "mini" mild seizures weekly.  Is non-compliant with medications she was prescribed, but states the seizures are "lighter" with medication.  Also complains of sometimes having blurred vision, bilateral edema and numbness and tingling in arms.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: Pt indicated she didn't have an immunity problems on the screening sheet but after her shot MD noted she was on Plaquenil and Leflunomide--the latter has a warning not to give live vaccines to patients taking this medication.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Low grade fever (he did not take his temperature), chills, aching arm, swelling started on Friday.  Fever and chills gone on Saturday morning.  Arm continued to swell and warm to touch.  Monday called office to report softball size, reddened, warm area to left upper arm.  No fever nor chills since Friday evening.  Client states that everytime he receives a tetanus vaccine the area of injection gets worse each time.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Low grade fever (he did not take his temperature), chills, aching arm, swelling started on Friday.  Fever and chills gone on Saturday morning.  Arm continued to swell and warm to touch.  Monday called office to report softball size, reddened, warm area to left upper arm.  No fever nor chills since Friday evening.  Client states that everytime he receives a tetanus vaccine the area of injection gets worse each time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt called on 4/13/13 complaining of pain at injection site, and returned to store on 4/15/13 with what appeared to be a localized allergic reaction.  At the site of administration, patient has a red, puffy welt that was approximately 2 inches around.  Pt complained of an itch and pain associated with the welt.  She was instructed to take some Benadryl and Naproxen to address the itching and pain. Pt instructed to call pharmacy or physician if condition worsens, will be followed up with in a few days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Pt called on 4/13/13 complaining of pain at injection site, and returned to store on 4/15/13 with what appeared to be a localized allergic reaction.  At the site of administration, patient has a red, puffy welt that was approximately 2 inches around.  Pt complained of an itch and pain associated with the welt.  She was instructed to take some Benadryl and Naproxen to address the itching and pain. Pt instructed to call pharmacy or physician if condition worsens, will be followed up with in a few days.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Crying, Flushing, Somnolence
Clinical narrative: Child cried with flushed face and almost fell in the bathroom. Child was coughing, vitals HR - 123 O2 sats 86/ on RA BP 90 systolic by palpatory method.  Child appeared as though falling asleep, but was responding to questions. Alb Neb rx given; O2 given; Epipen jr. 0.15 ml given. Sats went to 98% after Epipen. 911 was called and child went to ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The SQ site (2"X5") became hard and red the first day.  Then general redness occurred from my upper arm to below my elbow.  My upper arm swelled and was 2 inches bigger in diameter than the right arm.  This stayed hot and swollen unti 4/14/2013.
Age: 29.0
Sex: F
Vaccine: FLU3, IPV
Symptoms: Diarrhoea, Disturbance in attention, Headache, Nausea
Clinical narrative: Headache 8:00 AM ongoing. Two episode of diarrhea 8:30 AM, 9:15 AM. Nausea 8:30 AM ongoing. Inability to concentrate 8:00 AM ongoing.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Oedema peripheral, Pruritus, Rash, Rash generalised
Clinical narrative: Rash all over body and face starting on Friday, April 5th.  Swollen hands, arms and feet.  Itchy and burning.  Took Benadryl.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Extremity contracture, Gaze palsy, Muscle rigidity
Clinical narrative: Wife of patient reports that she "saw him with both upper extremities flexed and rigid and with eyes rolling back, when (she) called 911. She did not observe both lower extremities. He was transported via 1st aid squad to ER.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram, Rotator cuff syndrome
Clinical narrative: Wife of patient reports that she "saw him with both upper extremities flexed and rigid and with eyes rolling back, when (she) called 911. She did not observe both lower extremities. He was transported via 1st aid squad to ER.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan with contrast, Tongue biting
Clinical narrative: Wife of patient reports that she "saw him with both upper extremities flexed and rigid and with eyes rolling back, when (she) called 911. She did not observe both lower extremities. He was transported via 1st aid squad to ER.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Convulsion, Laboratory test
Clinical narrative: Wife of patient reports that she "saw him with both upper extremities flexed and rigid and with eyes rolling back, when (she) called 911. She did not observe both lower extremities. He was transported via 1st aid squad to ER.
Age: 30.0
Sex: F
Vaccine: JEV1, PPV, TDAP, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness & swelling in Rt. deltoid. Went to ER on 4/13/13 due to pain. Given pain meds there. Has been icing and taking Ibuprofen since.
Age: 44.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Lightheadedness, pale, sweating, and nausea immediately after the injection was given with c/o sx when bandaide was being applied to arm w/full recovery within one minute - after legs were elevated. Tx - legs were elevated, ice pack to neck/chest, oral fluids and crackers to eat.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Intensive care, Monoplegia, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Paralysis flaccid
Clinical narrative: Patient started wheezing and collapsed.  She was initially treated for asthma but had never had asthma before.  She spent one night in the ICU and 4 days total in hospital.  Her left arm stopped working after the 5 day.  She was later diagnosed with Transverse Myelitis.  It is now thought that the location of her spnal cord injury caused her respiratory distress.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Respiratory distress, Spinal cord injury cervical, Syncope, Wheezing
Clinical narrative: Patient started wheezing and collapsed.  She was initially treated for asthma but had never had asthma before.  She spent one night in the ICU and 4 days total in hospital.  Her left arm stopped working after the 5 day.  She was later diagnosed with Transverse Myelitis.  It is now thought that the location of her spnal cord injury caused her respiratory distress.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Headache, Pain
Clinical narrative: About 7 days after the smallpox vaccine pt. described chest pain starting at work and progressively getting worse. Fever x 101 degrees & headache. Went to ER and was given shot relieving all pain. Was diagnosed with information in and around heart.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: About 7 days after the smallpox vaccine pt. described chest pain starting at work and progressively getting worse. Fever x 101 degrees & headache. Went to ER and was given shot relieving all pain. Was diagnosed with information in and around heart.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient called pharmacy on 4/3/13. She said shot was given too high on arm, and arm had been hurting since. She said she couldn't raise her arm up for the pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported rapid heart rate and injection site symptoms (swollen, red, hot to touch). Taking OTC BENADRYL and advised pt 4/1/13 to contact MD.
Age: 0.38
Sex: U
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Vaccines admin approx 845 AM. Laid down for nap at 1130 AM. Awakened at 330 PM. Had warm water bath with no relief. Taken to ER at 530 PM because child was covered in hives per Mom. Had slight temp in ER, BENADRYL admin and was released that evening.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt at present time on exchange program. Fever occurred 2 weeks before eruption of rash.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Developed asymptomatic diffuse pink rash of trunk, and left arm (the vaccinated arm) resolved in 72 hrs by 70%.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Vomiting, diarrhea in the evening. Diarrhea and headache the next day.
Age: 1.73
Sex: F
Vaccine: IPV
Symptoms: Antisocial behaviour, Crying, Decreased activity, Eating disorder, Irritability
Clinical narrative: Our daughter went from a very happy and bubbly mood to suddenly very sick within an hour after shot. She displayed persistent non-stop crying and irritability. She wouldn't play, eat, or even interact. She couldn't sleep and kept waking up crying throughout nap time. She would not quit crying for over 4 hours and when we finally calmed her down she only laid down in our lap and wouldn't sleep. She was perfectly ok before shot and only showed symptoms of being sick after shot. The symptoms cleared up after 8 hours.
Age: 1.73
Sex: F
Vaccine: IPV
Symptoms: Malaise
Clinical narrative: Our daughter went from a very happy and bubbly mood to suddenly very sick within an hour after shot. She displayed persistent non-stop crying and irritability. She wouldn't play, eat, or even interact. She couldn't sleep and kept waking up crying throughout nap time. She would not quit crying for over 4 hours and when we finally calmed her down she only laid down in our lap and wouldn't sleep. She was perfectly ok before shot and only showed symptoms of being sick after shot. The symptoms cleared up after 8 hours.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed hives all over body. Diagnosed with hives by pediatrician and allergy doctor. As per mom, started on oral prednisone.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray normal
Clinical narrative: Frozen (limited movement) in left shoulder and pain in shoulder with certain movements.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Periarthritis
Clinical narrative: Frozen (limited movement) in left shoulder and pain in shoulder with certain movements.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb normal
Clinical narrative: Frozen (limited movement) in left shoulder and pain in shoulder with certain movements.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Convulsion
Clinical narrative: Received 6 month vaccines 4/8/12 at 10 AM. At 9 pm had generalized seizure and was admitted to the hospital.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Lipoatrophy, Skin atrophy, Skin discolouration, Skin disorder
Clinical narrative: Severe loss of subcutaneous fat, discoloration and atrophy of surface skin. Continuous bleeding and large area-size of a quarter-of blood colored skin with very fragile surface. Easily broken and very depressed.
Age: 42.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site rash, Rash pruritic
Clinical narrative: Pt reported his left arm developed an itchy rash after the Prevnar. This was observed on L upper arm- red rash on 04/10/13 when pt came to clinic. Pt was recommended to continue Benadryl po.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Essential tremor, Head titubation, Headache, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Impossible to know exact time of start! Silly to ask. Adverse event = headaches for weeks and then head tremors, no treatment until November, diagnosed as essential tremor but nothing showing on brain MRI and no meds are helping. No family history. They continue to this day.
Age: 24.0
Sex: M
Vaccine: HEPAB, JEV1, MNQ, TDAP, YF
Symptoms: Blood glucose normal, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Syncope, LOC, diaphoresis.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Gait disturbance, Injection site reaction, Lethargy, Pyrexia
Clinical narrative: Fever 101, lethargy, limping in leg where injection was administered.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Cardiac monitoring, Computerised tomogram, Dyspnoea, Electromyogram
Clinical narrative: Extreme fatigue 3rd week 9/10. Shortness of breath 1st week in 10/10 followed by muscle aches and cramps by the 2nd week in 10/10 had severe muscle pain arm and leg weakness, dragging right foot, tingling down both arms into fingers, by 4th week extreme all body pain muscles, bones, spasms extreme weakness.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscle spasms, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain
Clinical narrative: Extreme fatigue 3rd week 9/10. Shortness of breath 1st week in 10/10 followed by muscle aches and cramps by the 2nd week in 10/10 had severe muscle pain arm and leg weakness, dragging right foot, tingling down both arms into fingers, by 4th week extreme all body pain muscles, bones, spasms extreme weakness.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain, Paraesthesia, Sleep study
Clinical narrative: Extreme fatigue 3rd week 9/10. Shortness of breath 1st week in 10/10 followed by muscle aches and cramps by the 2nd week in 10/10 had severe muscle pain arm and leg weakness, dragging right foot, tingling down both arms into fingers, by 4th week extreme all body pain muscles, bones, spasms extreme weakness.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Information has been received from an office site manager (healthcare administrator HCA), concerning a 38 year old male patient with diabetes. On 14-MAR-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot #:H020684. Expiration date: 17-APR-2014). On the same date, the patient experienced high fever, and allergic reaction of a rash and redness in the right forearm location, and was admitted to the hospital on 16-MAR-2013. On 25-MAR-2013, the patient was discharged from hospital. On 26-MAR-2013, the patient was fully recovered from all of the events. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Child developed hive type rash approx 1 hour after receiving vaccines, both legs and right hand, referred to local ER given BENADRYL and oral steroid. Rash continued x 11 days. Referred to allergist.
Age: 34.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Arthropathy, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot# unspecified). Other suspect therapies included influenza virus vaccine (manufacturer unknown)(lot# unspecified). On an unknown date "immediately following" concomitant administration of GARDASIL and the unspecified seasonal flu vaccine on an unspecified date, the patient began to experience unspecified "joint issues" all over her body. The outcome of joint issues was reported as not recovered. The patient had sought medical attention via phone call to physician. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no medical history who on 05-APR-2013 was vaccinated with ZOSTAVAX (lot # J000432, exp 10-APR-2014), single dose, subcutaneous in the left arm. Drug reaction/allergies included BENICAR. There were no concomitant therapy. On 06-APR-2013, the patient experienced redness, induration, and warm at the injection site. The patient sought medical attention and she came to pharmacy. The patient self-treated with BENADRYL but the symptoms were "getting worse". The outcome of event was reported as not recovered/not resolved. Additional information is not expected. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular) in the vaccination series and subsequently was possibly administered CERVARIX for her second dose in the vaccination series and on 11-APR-2013, the patient was vaccinated with third dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular) in the vaccination series. No adverse effect reported was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Menorrhagia
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 15 year old female patient with no reported medical history. On 04-APR-2013 the patient was vaccinated with GARDASIL (route, dose and lot number unknown) dose 4. On unknown dates the patient was vaccinated with GARDASIL (route, dose and lot number unknown) dose 1,2 and 3. No other suspect therapies or concomitant medications were reported. The patient erroneously received a 4th dose of GARDASIL on 04-APR-2013. Since then she has had a heavy menstrual period. The outcome of heavy menstrual period is unknown. The reporters relatedness of heavy menstrual period to GARDASIL is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Rash
Clinical narrative: This spontaneous report a received from a female patient who was a nurse of unknown age regarding herself. The patient's medical history included shingles experienced for the first time approximately on an unknown date in 2008 (reported as 5 years ago) unrelated to ZOSTAVAX vaccination, when she was around a patient who has chickenpox. The patient developed shingles after she administering ZOSTAVAX to 3 patients. On an unknown date, she had experienced shingles twice in the past after vaccinating patients with ZOSTAVAX. She did not have names of those 2 patients. Most recently she developed rash on 22-MAR-2013, on her shoulder and neck after administration of ZOSTAVAX (lot number # H021711 and expiry date was 07-MAR-2014). She experienced tingling sensation and pain 2-3 days prior to development of the rash. The outcome of the most recently occurred shingles, rash on her shoulder, tingling sensation and pain was unknown. The two events shingles which had occurred previously was recovered on an unspecified date. Additional information has been occurred.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to the around 13 month old son. On an unknown date the patient was vaccinated with (merck) VARIVAX 1350 U (lot#, dose unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, 5 days later after vaccination, the patient experienced a rash developed on unspecified leg. The patient did not sought medical attention. The outcome was unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a registered pharmacist via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) subcutaneously. No concomitant medications were reported. On an unknown date, the patient developed swelling in his entire arm after receiving the vaccination and was angry about the swelling. The patient sought an unspecified medical attention. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of swelling in his entire arm and was angry about the swelling was unknown. The relatedness for swelling in his entire arm and was angry about the swelling was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Ophthalmological examination normal
Clinical narrative: Starting within 1-2 days after vaccines on 12/10/2012 pt rolls eyes up in head continuously from time morning awakening until nap. Has continued daily until date of report.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Swelling
Clinical narrative: Swelling started day after injection no systemic symptoms. Soreness at site (L) delt). Improving since yesterday.
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abasia, Alanine aminotransferase increased, Aspartate aminotransferase increased, Headache, Lethargy
Clinical narrative: 10:00 AM unable to feel feet or legs, not able to walk because of this. Neck hurt, headache, temp 102.5 degrees, not able to feel arms. Went to ER given IV fluids, monitored over several hours, ate food & improved. Able to walk out of ER. Slept a lot the next 2 days per mom (stepmom).
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Metabolic function test normal, Neck pain, Pyrexia, Sensory loss, White blood cell count increased
Clinical narrative: 10:00 AM unable to feel feet or legs, not able to walk because of this. Neck hurt, headache, temp 102.5 degrees, not able to feel arms. Went to ER given IV fluids, monitored over several hours, ate food & improved. Able to walk out of ER. Slept a lot the next 2 days per mom (stepmom).
Sex: F
Vaccine: VARZOS
Symptoms: Product used for unknown indication, Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a female patient of unknown age who on 08-APR-2013 was vaccinated with a 0.65ml dose of ZOSTAVAX, subcutaneous (Dose and lot # not provided). The pharmacist stated that patient was prescribed prednisone 30 mg, titrating down for approximately a week and half on 30-MAR-2013. Patient was prescribed the prednisone by an unspecified ear, nose and throat physician for unspecified reason. At the time of reporting, the patient's outcome from the event was unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from an adult nurse practitioner concerning a male patient of unknown age with penicillin allergy and with no pertinent medical history. The patient was vaccinated with a dose of M-M-R II (lot numbers, expiry dates, dose and route unspecified) on 12-OCT-1993 and on 07-NOV-1997 by an unspecified pediatrician. There were no concomitant medications. On an unknown date, the patient experienced a negative measles titer. The patient sought medical attention (in office). No treatment was given. The outcome of negative measles titer was reported as not resolved as the patient had the negative measles titer at the time of reporting (reported as currently). The relatedness for negative measles titer was unknown for M-M-R II. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Laboratory test, Loss of consciousness
Clinical narrative: Mom called clinic to report that after receiving HPV vaccine client passed out. After dose #1 passed out 1 1/2 weeks after vaccine; after dose #2 passed out 12 days after. Patient has seen PCP and had lab work done. Mom no longer wishes to complete series.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Culture throat, Erythema, Rash
Clinical narrative: MMR administered on 12/11/12. Following day seen in the office with temp of 100.8 and red cheeks. Rechecked 12/18/12; sx improved. 10 days after vaccine pt went to ER due to rash for 24 hrs. ER notes state patient left ER Against Medical Advice w/o notifying anyone.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to some patient. The nurse was reporting "some patients in the past have had negative antibody titers after receiving 3 doses of RECOMBIVAX HB". The nurse was unable to confirm the exact number or identities of the patients involved. The patients had sought medical attention by unknown type. The outcome of the event was unknown. The relatedness of the event with RECOMBIVAX HB was unknown.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash
Clinical narrative: Rash under injection site, came in to have site looked at by Dr. Pt is ok.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker (certified medical assistant) refers to a patient of unknown age. On 22-FEB-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# and dose unknown). No other co-suspects were reported. No concomitant medications were reported. On 05-APR-2013, the patient received the second dose of RECOMBIVAX HB, no adverse effect reported. Action taken was not provided. It was unknown if the patient had sought medical attention. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant, concerning a 4 month old female patient, with none pertinent medical history. On 15-MAR-2013 the patient received the first dose of PEDVAXHIB (lot number 0419AE, expiration date 17-AUG-2014) (dose, frequency and route were not reported). No other co suspect or concomitant medications were reported. It was reported that in March 2013 the patient developed an injection site reaction which included swelling, redness and a knot at the injection site. The patient sought unspecified medical attention. This was the 3rd of 5 reports from this office. At the time of the report the patient's outcome was recovering for all the adverse events. 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 a patient of unknown age. On an unknown date the patient was vaccinated with one dose of GARDASIL. The dose had been stored in a refrigerator without a thermometer and the healthcare worker did not know the storage temperature. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a third party claims administrator regarding a female. On an unspecified date, the female was vaccinated with a dose of ZOSTAVAX (route, site, lot number, expiration date not reported). On 19-DEC-2012, the female sustained an adverse reaction to Zoster Vaccine Live, more specifically, allergic reaction to vaccine. no further information has been reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. On an unknown date (several years ago), the patient was vaccinated with the first two doses of GARDASIL (lot number, expiry date, dose and route unspecified), intramuscularly as per the labeled vaccination schedule. The patient was not administered the third dose of GARDASIL until recently (09-APR-2013). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an infant patient. On 10-APR-2013 the patient was vaccinated with ROTATEQ (lot # 670513/0543AA) and the vaccine expired on 11-MAR-2013. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician via company representative referring to an unspecified numbers of patients that on an unknown date, were vaccinated with a dose of PNEUMOVAX23 (lot # not reported). The physician mentioned that the patients developed red rash at the injection site after receiving PNEUMOVAX23. At the time of this report all patients outcome were unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram abdomen normal, Diarrhoea, Dizziness
Clinical narrative: Case number PHEH2013US008408 is an initial spontaneous report received froma nurse on 10 Apr 2013. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number not reported) on 09 Apr 2013 at 12:30 pm At approximately 1:30 pm, she experienced vomiting and diarrhea. Between 1:30 pm and 6:30 pm, she called her primary care physician and he recommended her to go to the emergency room due to the symptoms she was experiencing. At 7:30pm, she visited emergency room. She was examined for stomach illness, CT was performed to check any bowel obstruction (if any) and urine sample was collected for testing. No results were provided. She was given 2 bags of saline, ZOFRAN, PROTONIX, ZANTAC, BENADRYL, COMPAZINE, IV contrast, THORAZINE, VALIUM, SOLUMEDROL. It was reported that the doses for the treatment medication was not known. Vomiting stopped after taking VALIUM. At the time of discharge at 12:30pm on 10 Apr 2013, the physician diagnosed with an adverse reaction to meningococcal vaccine. The outcome, seriousness and causality were not reported.