chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, IPV, UNK
Symptoms: Staring, Tremor
Clinical narrative: No noticeable leg soreness/pain at injection site. Shaky, trembling hands, slight weakness, irritability, more frequent cries. Eating habits changed. Exclusively breastfed baby turned head to and away from breast, over and over (seemed confused/unusual/not seen before). Didn't eat well first night/couldn't/confused? Duration of 02/12/2015, after 4 injections. 02/13/2015: 100.3 temp set in, lasted whole day. Baby cried with more intensity and agitation, eating habits still unusual, didn't/couldn't eat well. Baby always loved looking at herself in the mirror, instant smile at the sight every time from 2 months of age: no longer smiled/blank stare or unnoticed. Getting baby to laugh or smile over the course of the next 7 days following after injections no longer an easy task. Response to stimulation seemed dampened. Sleep pattern changed. Baby seemed mostly back to her old self on 02/21/2015.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reactions noted.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient complaining of swelling and itching at the injection site along with fever and fatigue. Patient was educated that this is not uncommon reactions (with greater risk in low dose methotrexate patients) but insisted the event be reported.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Rash generalised
Clinical narrative: Child started to break out in a rash...over the next few days it spread all over her body.  Also had diarrhea...diarrhea lasted for one month (even after rash went away which was after about 5 days).
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Laboratory test normal, Neuralgia, Pain in extremity
Clinical narrative: Site of injection, moved into arm, then shoulder and continued in nerve on back of shoulder.  Ice and Mobic...did not/has not helped.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Pain
Clinical narrative: Just below left knee and knee joint. Hard to walk. Placed ice pack on to relieve pain. Lasted into next day and then pain was gone.
Age: 13.0
Sex: F
Vaccine: HEP, HPV4, MMR
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Pallor, Seizure
Clinical narrative: One minute after HPV vaccine was shot in my daughters arm by the nurse, she turned white, lost consciousness and had a seizure. Medics arrived, she regained consciousness 60 seconds later and received medical attention until her vitals came back. When the doctor entered during the emergency, she immediately asked the nurse if he gave her the HPV vaccine. Doctor got defensive, said this was "normal" when I requested paramedics and rushed us out of the clinic. Not sure if they reported it. Daughter also received MMR and HepB shots, but the reaction happened after the final HPV shot. Her arm is still swollen and painful on the HPV insertion point, not on the other two.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Fatigue, Pyrexia, Rash generalised
Clinical narrative: Showed signs of fatigue and began running a fever. Fever was 102.3 that evening and the next morning. Rash began showing on face evening of 2/18/15.  Rash spread to torso, arms and legs by end of day 2/19/15. Gave lukewarm bath and Motrin to reduce fever.  Fever was gone by AM Fri 2/20. Rash still present and worsened on face by Sun 2/22.  Mon 2/23, Rash was lighter in color and mostly faded on torso and legs.  Visited Dr to show her the rash.  Still mild rash on face as of 2/24 and very light on torso, arms & legs.  Also during this time experienced decrease in appetite.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Culture, Erythema, Induration, Tenderness
Clinical narrative: Left arm erythema, tenderness, and induration.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient reported that ~24 hours after vaccination she experienced body aches, chills, and fever of 103 degrees. She said this lasted for about 24 hours and then went away.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, joint pain.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever, irritability, rash.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe muscle pain and joint pain in right arm swollen right arm. Severe Pain lasted 3 days and then pain which is still in upper arm in muscle and shoulder and on muscle in back of neck. Took Tylenol and ice packed the area. Went to Instant Care and doctor gave me prescription for pain meds and told me to continue to ice pack, this was on Feb. 18, 2015.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe muscle pain and joint pain in right arm swollen right arm. Severe Pain lasted 3 days and then pain which is still in upper arm in muscle and shoulder and on muscle in back of neck. Took Tylenol and ice packed the area. Went to Instant Care and doctor gave me prescription for pain meds and told me to continue to ice pack, this was on Feb. 18, 2015.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Abasia, Abdominal discomfort, Back pain, Central venous catheterisation, Demyelination
Clinical narrative: On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Dysuria, Gait disturbance, Hypoaesthesia, Incontinence
Clinical narrative: On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture normal, Mobility decreased, Multiple sclerosis, Muscular weakness, Myelitis transverse
Clinical narrative: On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain, Paralysis, Sensory loss, Spinal cord injury
Clinical narrative: On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Wheelchair user
Clinical narrative: On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
Age: 0.2
Sex: M
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 2-month-old male patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was unknown. It was unknown if the reporter considered the blood in stool to be related to ROTARIX. Additional information received: A 2-month-old male experienced bloody stool after receiving ROTARIX. Per sales representative, this event has been reported to VAERS.
Sex: U
Vaccine: HEP, HEPA, HPV4, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. On an unspecified date, patient was inadvertently administered with RECOMBIVAX HB, GARDASIL, VAQTA, ROTATEQ and PNEUMOVAX 23 which were improperly stored at 47 degree Fahrenheit (F). No adverse effects were reported. Outcome of the event was unknown. No product quality complaint (PQC) was reported. The reporter considered event to be not related to RECOMBIVAX HB, GARDASIL, VAQTA, ROTATEQ and PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Ear discomfort, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 69-year-old patient who received FLULAVAL (batch number UNKNOWN, expiry date unknown). The patient's past medical history included diabetic and high cholesterol. Concomitant products included CRESTOR, NOVOLOG, lisinopril and metformin. On 25th October 2014 14:15, the patient received FLULAVAL (intramuscular). On an unknown date, the dose was an unknown dose. On 2nd November 2014, 8 days after receiving FLULAVAL, the patient experienced runny nose, ear noises, sore throat, cough and swollen glands. On an unknown date, the outcome of the runny nose, ear noises, sore throat, cough and swollen glands were not recovered/not resolved. It was unknown if the reporter considered the runny nose, ear noises, sore throat, cough and swollen glands to be related to FLULAVAL. Additional information: A 69 year old male patient received a FLULAVAL vaccine at his physician's office on October 25th, 2014. The patient reports that 8 to 10 days later he began to experience a runny nose and cough. The patient reports that his glands were swollen and that his ears felt full and needed to be popped by yawning. The patient reports that the symptoms have not gone away. At time of report, the patient noted that he saw his physician on January 5, 2015, and the physician prescribed a Z-PAK.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 69-year-old patient who received FLULAVAL (batch number UNKNOWN, expiry date unknown). The patient's past medical history included diabetic and high cholesterol. Concomitant products included CRESTOR, NOVOLOG, lisinopril and metformin. On 25th October 2014 14:15, the patient received FLULAVAL (intramuscular). On an unknown date, the dose was an unknown dose. On 2nd November 2014, 8 days after receiving FLULAVAL, the patient experienced runny nose, ear noises, sore throat, cough and swollen glands. On an unknown date, the outcome of the runny nose, ear noises, sore throat, cough and swollen glands were not recovered/not resolved. It was unknown if the reporter considered the runny nose, ear noises, sore throat, cough and swollen glands to be related to FLULAVAL. Additional information: A 69 year old male patient received a FLULAVAL vaccine at his physician's office on October 25th, 2014. The patient reports that 8 to 10 days later he began to experience a runny nose and cough. The patient reports that his glands were swollen and that his ears felt full and needed to be popped by yawning. The patient reports that the symptoms have not gone away. At time of report, the patient noted that he saw his physician on January 5, 2015, and the physician prescribed a Z-PAK.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Fatigue, Influenza like illness, Malaise, Musculoskeletal chest pain
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling unwell in a 90-year-old female patient who received BOOSTRIX. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included LIPITOR, Blood Pressure Med and SYNTHROID. On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 7th January 2015, 2 days after receiving BOOSTRIX, the patient experienced feeling unwell, dry cough, influenza-like symptoms, fatigue, general body pain and fever. In January 2015, the patient experienced cold symptoms and cold. On an unknown date in January, the patient experienced rib pain and sore throat. On an unknown date, the outcome of the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever were not recovered/not resolved. The reporter considered the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever to be almost certainly related to BOOSTRIX. Additional information: The caller reports that his mother in law received the BOOSTRIX vaccine on Monday, January 5, 2014. She started to experience adverse events on Tuesday. He reports that she is feeling fairly sick, has body aches, dry cough, flu like symptoms, feels like she has a low grade fever, fatigue, her ribs are hurting, has a sore throat, has a cold, and has cold-like symptoms. The caller reports that her side effects are unchanged as of right now.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling unwell in a 90-year-old female patient who received BOOSTRIX. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included LIPITOR, Blood Pressure Med and SYNTHROID. On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 7th January 2015, 2 days after receiving BOOSTRIX, the patient experienced feeling unwell, dry cough, influenza-like symptoms, fatigue, general body pain and fever. In January 2015, the patient experienced cold symptoms and cold. On an unknown date in January, the patient experienced rib pain and sore throat. On an unknown date, the outcome of the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever were not recovered/not resolved. The reporter considered the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever to be almost certainly related to BOOSTRIX. Additional information: The caller reports that his mother in law received the BOOSTRIX vaccine on Monday, January 5, 2014. She started to experience adverse events on Tuesday. He reports that she is feeling fairly sick, has body aches, dry cough, flu like symptoms, feels like she has a low grade fever, fatigue, her ribs are hurting, has a sore throat, has a cold, and has cold-like symptoms. The caller reports that her side effects are unchanged as of right now.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Analgesic drug level increased, Autopsy, Brain oedema, Death, Decreased appetite
Clinical narrative: This case was reported in a literature article and described the occurrence of vomiting in a 7-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced vomiting, appetite lost and influenza A virus infection. On an unknown date, the outcome of the vomiting, appetite lost and influenza A virus infection were unknown. The reported cause of death was Reye's syndrome. An autopsy was performed. The autopsy determined cause of death was hepatic steatosis, kidney tubule disorder, cerebral edema, influenza A virus infection and salicylate intoxication. It was unknown if the reporter considered the vomiting, appetite lost and influenza A virus infection to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of vomiting in a 7-year-old male patient who had received unspecified influenza A vaccination (manufacturer unknown). No information on the patient's medical or family history or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza A vaccine (administration route and site unspecified; dosages unknown; batch numbers not provided). On an unspecified date, 3 days after receiving vaccination the patient developed profound vomiting and loss of appetite. The patient's mother had given him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient was found unresponsive less than 12 hours later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings included diffuse mixed micro and macro vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive for influenza A. Toxicology was positive for salicylate. The outcomes of the events were unspecified. The authors did not comment on causality relationship between the vaccine and the event. The authors concluded that "Reye's syndrome is a rare severe neurologic disorder consisting of a biphasic illness characterized by a viral infection followed by an acute onset of non-inflammatory encephalopathy and hepatic failure, with rapid progression to death if not properly treated. It most commonly affects children younger than 16 years of age who are treated with aspirin during certain viral infections, including varicella and influenza. The exact cause is unknown, but it is thought to result from mitochondrial impairment resulting from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate. This impairment appears to be intensified during viral illnesses".
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Hepatic steatosis, Influenza, Influenza A virus test positive, Renal tubular disorder, Reye's syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of vomiting in a 7-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced vomiting, appetite lost and influenza A virus infection. On an unknown date, the outcome of the vomiting, appetite lost and influenza A virus infection were unknown. The reported cause of death was Reye's syndrome. An autopsy was performed. The autopsy determined cause of death was hepatic steatosis, kidney tubule disorder, cerebral edema, influenza A virus infection and salicylate intoxication. It was unknown if the reporter considered the vomiting, appetite lost and influenza A virus infection to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of vomiting in a 7-year-old male patient who had received unspecified influenza A vaccination (manufacturer unknown). No information on the patient's medical or family history or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza A vaccine (administration route and site unspecified; dosages unknown; batch numbers not provided). On an unspecified date, 3 days after receiving vaccination the patient developed profound vomiting and loss of appetite. The patient's mother had given him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient was found unresponsive less than 12 hours later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings included diffuse mixed micro and macro vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive for influenza A. Toxicology was positive for salicylate. The outcomes of the events were unspecified. The authors did not comment on causality relationship between the vaccine and the event. The authors concluded that "Reye's syndrome is a rare severe neurologic disorder consisting of a biphasic illness characterized by a viral infection followed by an acute onset of non-inflammatory encephalopathy and hepatic failure, with rapid progression to death if not properly treated. It most commonly affects children younger than 16 years of age who are treated with aspirin during certain viral infections, including varicella and influenza. The exact cause is unknown, but it is thought to result from mitochondrial impairment resulting from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate. This impairment appears to be intensified during viral illnesses".
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Toxicity to various agents, Unresponsive to stimuli, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of vomiting in a 7-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced vomiting, appetite lost and influenza A virus infection. On an unknown date, the outcome of the vomiting, appetite lost and influenza A virus infection were unknown. The reported cause of death was Reye's syndrome. An autopsy was performed. The autopsy determined cause of death was hepatic steatosis, kidney tubule disorder, cerebral edema, influenza A virus infection and salicylate intoxication. It was unknown if the reporter considered the vomiting, appetite lost and influenza A virus infection to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of vomiting in a 7-year-old male patient who had received unspecified influenza A vaccination (manufacturer unknown). No information on the patient's medical or family history or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza A vaccine (administration route and site unspecified; dosages unknown; batch numbers not provided). On an unspecified date, 3 days after receiving vaccination the patient developed profound vomiting and loss of appetite. The patient's mother had given him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient was found unresponsive less than 12 hours later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings included diffuse mixed micro and macro vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive for influenza A. Toxicology was positive for salicylate. The outcomes of the events were unspecified. The authors did not comment on causality relationship between the vaccine and the event. The authors concluded that "Reye's syndrome is a rare severe neurologic disorder consisting of a biphasic illness characterized by a viral infection followed by an acute onset of non-inflammatory encephalopathy and hepatic failure, with rapid progression to death if not properly treated. It most commonly affects children younger than 16 years of age who are treated with aspirin during certain viral infections, including varicella and influenza. The exact cause is unknown, but it is thought to result from mitochondrial impairment resulting from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate. This impairment appears to be intensified during viral illnesses".
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ oral (dose, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Monoplegia, Muscular weakness
Clinical narrative: Left arm weakness/paralysis onset 2 hrs following flu vaccine. Seen at hosp ER on 10-9-14 D/T persistent paralysis. Nov 12, 2014 Diagnosed with Guillain Barre Syndrome by neurologist. Partial recovery of strength since that time.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site erythema, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Redness and pain at injection site. Developed pain right arm, neck, back-scapula. Pain improved but still present.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Redness and pain at injection site. Developed pain right arm, neck, back-scapula. Pain improved but still present.
Age: 84.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching-from top of shoulder to elbow-left arm.
Sex: U
Vaccine: MMRV, MMR, MMRV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 12-FEB-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) and a dose of M-M-R II injection, 0.5 ml, subcutaneously (lot# was not reported) (overdose). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 12-FEB-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) and a dose of M-M-R II injection, 0.5 ml, subcutaneously (lot# was not reported) (overdose). No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male physician of unknown age via company representatives refers to himself. In 2008 the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (lot# and strength not reported). On an unknown date the patient experienced a "spot" on the back of his unspecified leg during an unspecified time while on therapy with ZOSTAVAX. The patient had stated that the "spot" was a shingles "spot". he stated that this "spot" appears sporadically on his unspecified leg in the same vicinity. The patient did not seek medical attention. The outcome of the patient's event was not reported. The relatedness between therapy with ZOSTAVAX and the patient's event was not reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Needle issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (subcutaneous). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information: BOOSTRIX admin to a 300lb man with a 1 inch needle instead of 1.5 inch needle. Reporting PharmD thinks it may have gone into fatty tissue and not IM. No lot/exp date available, and no further patient specific details available.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of PROQUAD (lot number, dose and frequency were unknown) that underwent a temperature excursion were administered to an unspecified amount of patients. No adverse effect reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored GARDASIL (route, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was uknown. Additional information received: This product has been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received ENGERIX B adult (batch number UNKNOWN, expiry date unknown). Co-suspect products included TWINRIX adult. Previously administered products included TWINRIX adult (dose 1). On 11th June 2014, the patient received the 2nd doses of ENGERIX B adult. On an unknown date, the dose was an unknown dose. On an unknown date, the patient experienced wrong vaccine administered and underdose. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the wrong vaccine administered, underdose and drug dose administration interval too long were unknown. Additional information: 62 yo female (received TWN 1st dose on 3-28-2014 from a store and then went to another PY and received only the adult 20 mcg ENG-B monovalent vaccine on 6-11-2014. Now she is showing up at this store PY for third dose, which is also delayed just as the 2nd dose was Maladministration.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received TWINRIX. Concurrent medical conditions included hepatitis c. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: A patient received dose 1 on 11/24 and dose 2 on 12/1. She missed dose 3 because she was in the hospital (she is a hep C patient).
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 19-month-old male patient who received HAVRIX 1440 ADULT. On an unknown date, the patient received HAVRIX 1440 ADULT 1440 iu. On an unknown date, an unknown time after receiving HAVRIX 1440 ADULT, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: A 19 month old was inadvertently administered HAVRIX 1440.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a 32 year old male patient, reporting on himself, as part of a market research. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patient experienced pneumonia. The outcome of pneumonia was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 51 year old female nurse practitioner student, with diabetes, hypertension and penicillin allergy, regarding herself. On 21-JAN-2015, the patient was vaccinated with a singles dose of ZOSTAVAX, subcutaneous in the left arm (lot number and expiration date were not reported). Concomitant therapies included VICTOZA, metformin and TRIBENZOR. On 22-JAN-2015, the patient experienced redness, swelling, itching, warmth and pain at the injection site. Subcutaneously the area of the reaction extended from the back of the left arm to her left elbow. The patient contacted an unspecified physician who advised the patient to take ZYRTEC and hydrocortisone cream. The consumer also applied ice packs to the area. The reaction resolved after 1 week, in 29-JAN-2015. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The age and genders of the patients are unknown at this tome. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received KINRIX. Previously administered products included dtap/ipv (1st dose). On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after getting KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from register nurse, concerning an 18 year old patient of unknown gender, who on 20-FEB-2015 was vaccinated with a 0.5 ml dose of PROQUAD (Merck), subcutaneous. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer and described the occurrence of inappropriate age at vaccine administration in a male patient who received HAVRIX. On an unknown date, the patient received HAVRIX an unknown date. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: The reporter reports that her 7 month old accidentally received a HAVRIX vaccine today. The vaccine was intended for his 18 month old sister, however somehow the nurse gave the vaccine to him instead.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever 3 days after administration rash 1 wk, whole body after vaccines.