chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain in extremity, Skin warm
Clinical narrative: Complained starting on Monday of arm pit pain....continued saying it bothered him on and off for the next 3-4 days---I did not notice anything apparent when I looked at it, but am suspecting swollen gland.  On March 2, 2014 patient started getting the chills and complained of fatigue.  On March 3 he complained that his legs ached and were sore. He felt warm to the touch and complained of the chills and was not playing as he normally does.  I checked his temperature at 1:00 PM and it was 100.4 F axillary.  At that point I called the doctor to report.
Age: 0.38
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm to touch. Diagnosed with cellulitis from injection site. Prescribed Augmentin 250-62.5/5ml 3ml BID x 7 days.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Discomfort, Fatigue, Nasopharyngitis, Pain
Clinical narrative: Itching, pins and needles, aches, cold like symptoms, seizure like movements during sleep. During first few weeks after flu shot severe fatigue and discomfort and pain due to the symptoms.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Seizure like phenomena, Urine analysis, X-ray
Clinical narrative: Itching, pins and needles, aches, cold like symptoms, seizure like movements during sleep. During first few weeks after flu shot severe fatigue and discomfort and pain due to the symptoms.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthrogram, Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Pain to left shoulder with decreased mobility since receiving vaccine.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain to right shoulder after receiving vaccine.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Coordination abnormal, Headache, Visual field defect
Clinical narrative: Per NP, when he looked back on yesterday, patient thinks he had difficulty with coordination for about one hour later in the day after getting vaccinated.  Patient states today had a black spot in visual field.  NP administered Acetaminophen, 500mg tabs x 2 for c/o mild headache.  Referred patient to Immediate Care for further evaluation and treatment.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Autism, Reaction to preservatives
Clinical narrative: My cousin's granddaughter developed Autism after being given thimerosol early heavy vaccines, she and the mom were working in a doctor's office at the time.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Exposure during pregnancy, Injection site erythema, Injection site swelling
Clinical narrative: The day after receiving the TDAP shot I experienced serve body aches, chills, and fever. The following day I experienced fever, dizziness and nausea. I am 31 weeks pregnant and called my doctor to tell them of my symptoms. They informed me I may have contracted a simple cold and that more than likely the symptoms had nothing to do with the shot.  The symptoms finally decreased by the 4th day. On the 6th day after the shot I was seen by my doctor because the injection site was still large, swollen, hot and beat red. My doctor told me to file this adverse reaction report as they have not seen this type of response to the TDAP before. I have no history of reaction to vaccines. I have no history of allergies to anything. I am not taking any type of medication. I felt 100% fantastic before receiving that shot.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: The day after receiving the TDAP shot I experienced serve body aches, chills, and fever. The following day I experienced fever, dizziness and nausea. I am 31 weeks pregnant and called my doctor to tell them of my symptoms. They informed me I may have contracted a simple cold and that more than likely the symptoms had nothing to do with the shot.  The symptoms finally decreased by the 4th day. On the 6th day after the shot I was seen by my doctor because the injection site was still large, swollen, hot and beat red. My doctor told me to file this adverse reaction report as they have not seen this type of response to the TDAP before. I have no history of reaction to vaccines. I have no history of allergies to anything. I am not taking any type of medication. I felt 100% fantastic before receiving that shot.
Sex: F
Vaccine: HEP
Symptoms: Amino acid level normal, Ammonia increased, Anaemia, Band neutrophil count decreased, Band neutrophil percentage increased
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Blood albumin decreased, Blood alkaline phosphatase, Blood bilirubin increased, Blood culture positive, Blood fibrinogen increased
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Blood lactic acid increased, C-reactive protein increased, CSF red blood cell count positive, CSF test abnormal, Chest X-ray abnormal
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Cyanosis, Dyspnoea, Eosinophil count decreased, Fibrin D dimer increased, Group B streptococcus neonatal sepsis
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Haematocrit decreased, Haemoglobin decreased, Heart rate increased, Hyperbilirubinaemia, Hypochromasia
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Hypoxia, Intensive care, Lymphocyte count abnormal, Metabolic acidosis, Metamyelocyte percentage increased
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Myelocyte percentage increased, Platelet count decreased, Polychromasia, Protein total decreased, Protein urine present
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Prothrombin time prolonged, Red blood cells urine positive, Reticulocyte count decreased, Streptococcus test positive, Tachypnoea
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Sex: F
Vaccine: HEP
Symptoms: Urine abnormality, Wheezing, White blood cell count, White blood cell count decreased
Clinical narrative: Baby was born. We visited with the baby. The baby was then taken to the nursery for hep B shot. Baby was brought back to mother to feed. After feeding, father noticed baby's fast heartbeat and wheezing sound. Nurse took baby away. Doctor informed parents that the baby was having difficulty breathing and an usually fast heart beat. Baby was entered into NICU where they continued to treat baby for "illness." Doctors could not detect what the "illness" was and did not inform parents of possible adverse reaction to the hep B vaccine. Baby was discharged 2 weeks later.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Electromyogram, Muscle twitching, Myalgia, Nerve conduction studies
Clinical narrative: Nerve pain began 4 days after the flu shot. I began to feel prickling in the hands and feet which turned into intense electric like shocking pain that was in my feet, legs, arms in hands. This pain got worse over the course of 8 weeks. I would feel the stabbing pain about once every 10 minutes.  I then began to have muscle pain and involuntary muscle twitching and muscle fluttering. The pain went on for 4 months and is still continuing although it seems to be getting milder and less frequent.  I have never had this before I received the flu shot.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain, Paraesthesia
Clinical narrative: Nerve pain began 4 days after the flu shot. I began to feel prickling in the hands and feet which turned into intense electric like shocking pain that was in my feet, legs, arms in hands. This pain got worse over the course of 8 weeks. I would feel the stabbing pain about once every 10 minutes.  I then began to have muscle pain and involuntary muscle twitching and muscle fluttering. The pain went on for 4 months and is still continuing although it seems to be getting milder and less frequent.  I have never had this before I received the flu shot.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Atrophy, Face oedema, Muscular weakness
Clinical narrative: Face edema.  Right Leg atrophy and weakness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gynaecological examination, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Came down with the illness the vaccine was to protect.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain upper, Abnormal faeces, Diarrhoea, Faecal volume increased, Gastrointestinal pain
Clinical narrative: 2 1/2 mos old male infant in office for 1st vaccination: Pediarix, Hib, Prevnar, Rotateq. Temp max 99. Within 12 hours developed mushy stools with incredibly foul odor, then severe bowel cramping, followed by massive stooling. (he is exclusively breast fed). On day 3 he passed mucous and blood with his stool. The stomach cramping has resolved and the mucous and blood have decreased by today. The foetor has diminished. I suspect he was developing intussusception and is resolving it. His parents are informed to take him immediately to the hospital upon any recurrence of pain or any worsening of any symptoms. Will observe for next 3 weeks. He is not fully recovered yet.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Mucous stools
Clinical narrative: 2 1/2 mos old male infant in office for 1st vaccination: Pediarix, Hib, Prevnar, Rotateq. Temp max 99. Within 12 hours developed mushy stools with incredibly foul odor, then severe bowel cramping, followed by massive stooling. (he is exclusively breast fed). On day 3 he passed mucous and blood with his stool. The stomach cramping has resolved and the mucous and blood have decreased by today. The foetor has diminished. I suspect he was developing intussusception and is resolving it. His parents are informed to take him immediately to the hospital upon any recurrence of pain or any worsening of any symptoms. Will observe for next 3 weeks. He is not fully recovered yet.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Electroencephalogram normal, Muscle twitching, Neurological examination abnormal, Seizure, Staring
Clinical narrative: 3 minute episode of staring and twitching/twirling of right hand - mom caught the last minute of it on video.  Wasn't responding to mom's voice.  Has since been treated as seizure activity by neurologist with oxcarbazepine.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Unresponsive to stimuli
Clinical narrative: 3 minute episode of staring and twitching/twirling of right hand - mom caught the last minute of it on video.  Wasn't responding to mom's voice.  Has since been treated as seizure activity by neurologist with oxcarbazepine.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Joint swelling, Pain in extremity
Clinical narrative: Left arm red and tender, left wrist swollen with limited motion. Also 3 fingers - 3rd, 4th and 5th fingers left hand were tingling at finger tips and were painful.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Left arm red and tender, left wrist swollen with limited motion. Also 3 fingers - 3rd, 4th and 5th fingers left hand were tingling at finger tips and were painful.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling, Warmth about the injection site and regional area.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Formication, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Approximate date and time.  My husband and son who is three received flu shot from the same container.  When leaving the office I felt like there were bugs crawling in my arm where shot was given.  Over next couple of days the spot where shot was given was red hot, swollen and very itchy.  About four days after shot I started having itching and rash on upper abdomen.  It spread to extremities.  I was diagnosed with allergic urticaria.  The reaction lasted about 6 weeks with treatment of oral steroids.  The reaction went away and the an came back the first week of January and lasted again for another 6 weeks.  I was again on the oral steroids for two rounds.  I saw another allergist who diagnosed allergic urticaria.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Pruritus, Rash, Urticaria
Clinical narrative: Approximate date and time.  My husband and son who is three received flu shot from the same container.  When leaving the office I felt like there were bugs crawling in my arm where shot was given.  Over next couple of days the spot where shot was given was red hot, swollen and very itchy.  About four days after shot I started having itching and rash on upper abdomen.  It spread to extremities.  I was diagnosed with allergic urticaria.  The reaction lasted about 6 weeks with treatment of oral steroids.  The reaction went away and the an came back the first week of January and lasted again for another 6 weeks.  I was again on the oral steroids for two rounds.  I saw another allergist who diagnosed allergic urticaria.
Age: 1.37
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Complex febrile convulsions.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Chest X-ray abnormal, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax normal, Intensive care
Clinical narrative: The patient was found on 2/27/15 unresponsive and was resuscitated; admitted to ICU and remains unresponsive on ventilator with a diagnosis of respiratory failure. CT head/neck/chest are all negative. He initially had thrombocytopenia but now stable. Current CXR with BLL infiltrate and hx fever 101.2. Report received from consulting ID MD questions if r/t adenovirus vaccine.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Lung infiltration, Mechanical ventilation, Pyrexia, Respiratory failure, Resuscitation
Clinical narrative: The patient was found on 2/27/15 unresponsive and was resuscitated; admitted to ICU and remains unresponsive on ventilator with a diagnosis of respiratory failure. CT head/neck/chest are all negative. He initially had thrombocytopenia but now stable. Current CXR with BLL infiltrate and hx fever 101.2. Report received from consulting ID MD questions if r/t adenovirus vaccine.
Age: 32.0
Sex: M
Vaccine: ADEN_4_7, FLU3, ADEN_4_7, FLU3
Symptoms: Thrombocytopenia, Unresponsive to stimuli
Clinical narrative: The patient was found on 2/27/15 unresponsive and was resuscitated; admitted to ICU and remains unresponsive on ventilator with a diagnosis of respiratory failure. CT head/neck/chest are all negative. He initially had thrombocytopenia but now stable. Current CXR with BLL infiltrate and hx fever 101.2. Report received from consulting ID MD questions if r/t adenovirus vaccine.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthma, Chest X-ray, Chest discomfort, Electrocardiogram, Laboratory test
Clinical narrative: Experienced chest tightness and heaviness and asthma like symptoms starting about 45-60 minutes after vaccination. Went to the Emergency Room for testing and treatment.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 19-FEB-2015, the patient was vaccinated with the first dose of ROTATEQ orally, outside of the Package Insert (PI) (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Swelling
Clinical narrative: Large red bump, flu like symptoms for a few days.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Fussy. No fever. No site soreness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Developmental delay, Electroencephalogram abnormal, Infantile spasms, Laboratory test, Microcephaly
Clinical narrative: Infantile spasm-corticotropin. Microcephaly. Development delay.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Infantile spasm-corticotropin. Microcephaly. Development delay.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Joint crepitation
Clinical narrative: PT-therapy popping noise in left upper arm where I had flu shot - very very sore - dull ache since Oct. 27 28 2 weeks after flu vaccine. Left upper arm to elbow not normal since flu vac.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Tdap imm 2-19-15. Injection site red, hot, itchy, inflammed 6.5 cm hard  area of induration. Significant malaise.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise
Clinical narrative: Tdap imm 2-19-15. Injection site red, hot, itchy, inflammed 6.5 cm hard  area of induration. Significant malaise.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red itchy swollen -diameter of a golf ball - improved with BENADRYL.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) upper arm redness, warmth. Tx: Hydrpxyzine 25 ml, hydrocortisone cream, ice on/off x 2d.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of pain in a female patient who received BOOSTRIX (batch number 95L3P, expiry date 1st April 2016). In October 2014, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to BOOSTRIX. Additional information: patient experienced pain after vaccination with BOOSTRIX, got vaccinated in October 2014 and still continues to feel pain. No other vaccines given on same day as BOOSTRIX vaccine. patient is not able to exercise due to arm pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of ROTATEQ (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ which was administered orally (dose and lot# were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Patient reported to have developed a skin rash on his left arm around the injection site and on his back.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received PEDIARIX (batch number L9L2K, expiry date 5th June 2016). Previously administered products included DTaP (dose 1), DTaP (dose 2), DTaP (dose 3), Hepatitis B (dose 1), Hepatitis B (dose 2), Hepatitis B (dose 3), IPV (dose 1), IPV (dose 2) and IPV (dose 3). On 11th November 2014, the patient received PEDIARIX. On 11th November 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unkown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate schedule of vaccine administered to be related to PEDIARIX. On 11 November 2014, a new medical assistant to the practice gave 3 patients a dose of PEDIARIX when they were all only due to receive DTaP. All 3 doses of PEDIARIX were from lot number L9L2K (expiration date on 05 June 2016). They were not due for the other components in the vaccine.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history and concurrent condition were not reported. On 02-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot # J004157 expiration date 09-MAY-2014 (dose and route not reported), which was improperly stored and expired. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 24-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot # J002616, expiration date 01-MAR-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinate with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age. On 12-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 27-OCT-2015 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of VAQTA (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age. On 27-JAN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a nurse on 11-FEB-2015 referring to a patient of unknown age. On 30-JAN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, 0.5 ml subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age. On 20-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not reported). No concomitant therapies were reported. The day of vaccination it was discovered that the content of one of the PNEUMOVAX23 syringes was empty. Only condensation was observed in the unit, this problem caused the patient to delay the start of his therapy. No adverse event symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of M-M-R II (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a farther of a patient, Merck employee, pharmacist, concerning the 12 month old male patient. The reporter stated he was calling in from home, to report his son's adverse reaction to vaccinated with M-M-R II and VARIVAX (Merck). On 09-FEB-2015 at 09:15 (also reported as yesterday) the patient was vaccinated with a dose of M-M-R II (dose, lot# and route were unknown) and a dose of VARIVAX (Merck) (dose, lot# and route were unknown), separate vaccines. The reporter stated the day care sent his son home from school on 10-FEB-2015 (also reported as today at 3:30 this afternoon) because he had a fever of 102.1 F. The reporter stated he was calling his son's primary healthcare provider as soon as this call was finished. No treatment was given for the event. The outcome of event was not recovered. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 19 years old patient. On 19-FEB-2015, the patient was inadvertently administered the dialysis formulation of RECOMBIVAX HB (lot number, expiry date, and dose were not reported), instead of the pediatric/adolescent formulation. No adverse effects reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 month old patient. On an unknown date the patient was vaccinated with VAQTA (dose, route and lot# were not reported). The nurse reported VAQTA weren't supposed to get before 12 months of age. No adverse effects reported. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown gender. Concurrent condition and medical history were not reported. On 06-FEB-2015 the 4 month old patient was vaccinated with a dose of GARDASIL (dose 0.5 ml, lot # and expiration date were unknown) intramuscularly. No adverse events were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 66 year old male patient. Medical history and drug reactions or allergies were not reported. On 09-FEB-2015 the patient was vaccinated an expired dose of ZOSTAVAX lot # K000726 expiration date: 09-JAN-2015 (dose and route were not provided). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 02-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection , 0.5 ml, subcutaneously(lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-SEP-2014, the patient was vaccinated with the first dose of PROQUAD, lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. The patient received four doses of GARDASIL (injection, lot#, dose and route were not provided) on the following dates: first dose on 28-JAN-2009, second dose on 28-MAR-2009, third dose on 11-AUG-2009, and fourth dose on 26-FEB-2015. No adverse effect was reported. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-OCT-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Tenderness in shoulder 2/21/15 and 2/22/15. Then woke up in 2/26/15 with redness and baseball size/painful to the touch. Used BENADRYL and cortisone cream to spot. Redness was gone on 2/28/15.
Age: 1.58
Sex: F
Vaccine: MMR, PNC13
Symptoms: Developmental delay, Electroencephalogram, Epilepsy, Neurological examination, Regressive behaviour
Clinical narrative: MMR vaccine administered 5/5/14 -> 5/16/14 presented to MD for staring spells -> now w/ epilepsy dx (Doose syndrome) and developmental regression/delays. Unknown if correlation.
Age: 1.58
Sex: F
Vaccine: MMR, PNC13
Symptoms: Staring
Clinical narrative: MMR vaccine administered 5/5/14 -> 5/16/14 presented to MD for staring spells -> now w/ epilepsy dx (Doose syndrome) and developmental regression/delays. Unknown if correlation.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Nervousness, Pallor, Syncope
Clinical narrative: Patient fainted after Hep A given. Initially quite pale and shaky, but improved within 10 mins. MD had patient lay down on exam table, cool drink of water and cool washcloth for her head. BP 104/70 HR 72 after Hep A prior to Hep A 124/73 HR 72.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 10-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Body temperature increased, Diet refusal, Emotional distress, Irritability
Clinical narrative: Extremely irritable > 36 hrs, temp 102-103 degrees F rectal even with TYLENOL, refusing to eat, inconsolable.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of PNEUMOVAX23, which expired on 09-FEB-2015 (administration route and lot number were not provided). No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood prolactin increased, Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to her daughter of unknown age. Nurse reported that her daughter had allergies to BACTRIM, CECLOR, SUPRAX and azithromycin caused rash; and vancomycin caused rash and swelling of the lips. In December 2014, the patient was vaccinated with an unspecified dose of VARIVAX (Merck) (lot # not reported). No pertinent medical history was reported. There was no concomitant medication. The patient became pregnant with approximately LMP of 16-DEC-2014 and approximately EDD of 22-SEP-2015. The nurse reported that after vaccination it was discovered, by serum pregnancy test and prolactin level, that the patient was at the time of reporting pregnant, 6 to 7 weeks gestation. No adverse effects were reported. No treatment was given for the adverse events. The pregnancy outcome was pending. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 17-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 02-MAR-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (albumin status and lot # were not reported), 0.5 ml, 01-MAR-2015, subcutaneously. No adverse effect was reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema at site and warmth at site. Treated with KEFLEX.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 11-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 65 year or older patient of unknown gender. The patient medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were not provided). Other suspect therapies administered on an unknown date, included PREVNAR 13 (dose, frequency, route, lot # and expiration date were not provided). On an unknown date, the patient experienced interchange of vaccine products as the patient received the dose of PNEUMOVAX 23 and four months later, the patient received one dose of PREVNAR 13. No adverse effects were noted. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and ender. In April 2014, the patients were vaccinated with doses of VAQTA (Lot # H019104 exp date 19-JUL-2015) (doses not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In April 2014, the patients were vaccinated with doses of M-M-R II (Lot # K002528 exp date 18-FEB-2016) (doses not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: (R) anterior thigh redness, tenderness, swelling and clear vesicles. Cellulitis of (R) thigh - today Dx of otitis media.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Otitis media
Clinical narrative: (R) anterior thigh redness, tenderness, swelling and clear vesicles. Cellulitis of (R) thigh - today Dx of otitis media.
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia
Clinical narrative: Developed a fever- mostly moderated but up to 103 for 2-3 days.
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Developed a fever- mostly moderated but up to 103 for 2-3 days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 22-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.