chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 25-MAR-2015 the patient was accidentally administered a dose of VARIVAX (Merck) (dose and lot number was unknown), which was improperly stored. The outcome of the event was unknown. This case is linked to MARRS# 1504USA000709 with the same patient link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 25-MAR-2015 the patient was vaccinated with PROQUAD (Merck) (dose and lot number was unknown), which was improperly stored. The outcome of the event was unknown. This case is linked to MARRS# 1504USA001857 with the same patient link. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Hyperkeratosis, Lichenoid keratosis, Lymphocytic infiltration, Papule
Clinical narrative: Information was received from published article. This literature marketed report refers to a 10 year old female patient. The patient denied any systemic symptoms and had no family history of skin disorders. The patient took no medicines, no known drug allergies and was up to date on all vaccines. On an unknown date the patient was vaccinated with first dose of GARDASIL. Concomitant medications were not reported. A few days after receiving her first dose, the patient developed pruritic eruption of the arms, legs, trunk and neck diagnosed as lichenoid drug eruption. The patient initially sought treatment in the emergency department, where she received hydroxyzine, diphenhydramine and triamcinolone cream, but none of these agents improved her symptoms after 1 month of treatment. Physical examination revealed violaceous planar papules and plaques on the chest, lumbar back, extensor and flexural extremities, dorsal hands, palms and soles. Mucous membranes and nails appeared normal. A punch biopsy of a representative plaque on the left hip was performed. Histopathology demonstrated compact hyperkeratosis with parakeratosis, a saw tooth rete ridge pattern with a lymphocytic infiltrate and rare eosinophils. These findings were consistent with a diagnosis of lichenoid drug eruption (LDE). A 4-week prednisone taper improved the eruption dramatically. The action taken with GARDASIL was withdrawn (reported as advised to refrain from receiving subsequent vaccines). The outcome of lichenoid drug eruption was reported as recovered (reported as at her 6-week follow-up visit, the patient had only significant postinflammatory hyperpigmentation). The reporter considered the event lichenoid drug eruption to be related to GARDASIL. The GARDASIL contains relatively inert additives. It contains aluminum, which has been associated with cutaneous reactions. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Parakeratosis, Skin plaque
Clinical narrative: Information was received from published article. This literature marketed report refers to a 10 year old female patient. The patient denied any systemic symptoms and had no family history of skin disorders. The patient took no medicines, no known drug allergies and was up to date on all vaccines. On an unknown date the patient was vaccinated with first dose of GARDASIL. Concomitant medications were not reported. A few days after receiving her first dose, the patient developed pruritic eruption of the arms, legs, trunk and neck diagnosed as lichenoid drug eruption. The patient initially sought treatment in the emergency department, where she received hydroxyzine, diphenhydramine and triamcinolone cream, but none of these agents improved her symptoms after 1 month of treatment. Physical examination revealed violaceous planar papules and plaques on the chest, lumbar back, extensor and flexural extremities, dorsal hands, palms and soles. Mucous membranes and nails appeared normal. A punch biopsy of a representative plaque on the left hip was performed. Histopathology demonstrated compact hyperkeratosis with parakeratosis, a saw tooth rete ridge pattern with a lymphocytic infiltrate and rare eosinophils. These findings were consistent with a diagnosis of lichenoid drug eruption (LDE). A 4-week prednisone taper improved the eruption dramatically. The action taken with GARDASIL was withdrawn (reported as advised to refrain from receiving subsequent vaccines). The outcome of lichenoid drug eruption was reported as recovered (reported as at her 6-week follow-up visit, the patient had only significant postinflammatory hyperpigmentation). The reporter considered the event lichenoid drug eruption to be related to GARDASIL. The GARDASIL contains relatively inert additives. It contains aluminum, which has been associated with cutaneous reactions. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Pain under left ear followed by swelling and fever 102-103 very painful to touch running behind ear and down neck turned to sore throat on same side went to PCP on 4/2/2015 was given amox-clav 875mg tablets. 10 day prescription.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Pain under left ear followed by swelling and fever 102-103 very painful to touch running behind ear and down neck turned to sore throat on same side went to PCP on 4/2/2015 was given amox-clav 875mg tablets. 10 day prescription.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Shot was painful, pain in arm increased over next 2 weeks, and lost range of motion /flexibility in arm. Pain severe. Saw MD. Pain continues even more now, patient going to physical therapy trying to get range of motion back in arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, Crying, Culture urine negative
Clinical narrative: Mom placed pt in bed and dad noticed that her eyes were rolling back into her head and she was moving her eyes side to side.  Nose was twitching, lip smacking, strange cry.  Arms extended and legs flexed.  Lasted about a minute and then she fell asleep.  Mom fed her, burped her.  Mom changed diaper and she had another spell which was similar in nature.  Took her to the ER by family car and on the way she looked up a few times.  No known FH seizures.  Boodwork and LP were reassuring except for increased CRP to 17mg/L.  Monitored in the ER for a few hours then sent home.  Seen next day.  Had another similar spell when mom played her down on the changing table which lasted for 10 seconds.  Otherwise well.  Blood, urine and CSF cultures negative.  EEG unremarkable.  Head U/S showed slight asymmetry of the lateral ventricles with left greater than right, otherwise normal.  Has done fine since.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram normal, Eye movement disorder, Muscle twitching, Tardive dyskinesia, Ultrasound skull abnormal
Clinical narrative: Mom placed pt in bed and dad noticed that her eyes were rolling back into her head and she was moving her eyes side to side.  Nose was twitching, lip smacking, strange cry.  Arms extended and legs flexed.  Lasted about a minute and then she fell asleep.  Mom fed her, burped her.  Mom changed diaper and she had another spell which was similar in nature.  Took her to the ER by family car and on the way she looked up a few times.  No known FH seizures.  Boodwork and LP were reassuring except for increased CRP to 17mg/L.  Monitored in the ER for a few hours then sent home.  Seen next day.  Had another similar spell when mom played her down on the changing table which lasted for 10 seconds.  Otherwise well.  Blood, urine and CSF cultures negative.  EEG unremarkable.  Head U/S showed slight asymmetry of the lateral ventricles with left greater than right, otherwise normal.  Has done fine since.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Acidosis hyperchloraemic, Dehydration, Diarrhoea, Feeding disorder of infancy or early childhood, Fluid replacement
Clinical narrative: Vomiting and Diarrhea, poor feeding, feeding intolerance, dehydration, worsening over the course of 4 days, admitted to hospital for fluid resuscitation for 24 hours. Vomiting stopped after 4 days, diarrhea reduced after 5 days.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Poor feeding infant, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Vomiting and Diarrhea, poor feeding, feeding intolerance, dehydration, worsening over the course of 4 days, admitted to hospital for fluid resuscitation for 24 hours. Vomiting stopped after 4 days, diarrhea reduced after 5 days.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report was received from a former Merck field employee via company representative regarding a patient of unknown age and gender. The patient was diagnosed with unspecified cancer. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, strength, dose, frequency and route of administration) (medication error). On an unknown date the patient died. The exact cause of the death was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Streptococcus test negative
Clinical narrative: This spontaneous report was received from physician assistant regarding a 23 year old female patient. The patient's concurrent condition included asthma, allergic rhinitis and attention deficit disorder. The patient has a medical history of dysmenorrhea. On 20-MAR-2015, the patient was vaccinated with PROQUAD (Merck) lot # K005883, expiry date 24-OCT-2015, 0.5 ml, once, subcutaneously. Concomitant therapies included PROAIR, SPRINTEC, tramadol hydrochloride and MOBIC. On 23-MAR-2015, the patient experienced fever 104.8 F, sore throat, congestion and general malaise. The patient sought medical attention (visited office). The patient was treated with amoxicillin. On an unknown date in March 2015, the patient underwent strep culture which showed negative result. The physician assistant considered the events to be significant disability/incapacity to the patient since she received PROQUAD (Merck) as a required vaccination in order to become a camp counselor, but due to the reaction, she had to return home and miss a week of camp. The outcome of the events was reported as recovering. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approx 2 1/2" x 5" area of redness with centralized swelling near injection site. Required "quick care" visit for abx an steroid ointment.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from health care worker refers to a child female patient of unknown age. The patient pertinent medical history was not reported. On 14-JAN-2010, the patient was vaccinated with VAQTA (dose and route were unknown). On 08-APR-2010 and 06-AUG-2014, the patient was vaccinated with HAVRIX. No adverse effects were reported. No product quality complaint (PQC) was reported for hepatitis a vaccine, inactivated. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Ear infection, Metabolic function test, Nausea, Rotavirus test positive
Clinical narrative: Information has been received from a certified medical assistant referring to a 23 month old female patient with gastric esophageal reflux disease and no drug allergies. On 17-MAY-2013 the patient was vaccinated with a dose of ROTATEQ (lot # J000035, expiration date 24-APR-2014), 2 ml, orally for the prevention of retrovirus. On unspecified dates, the patient was vaccinated with the rest two doses of ROTATEQ, 2 ml, orally. The lot numbers of these two doses were lot# H012252 with expiration date 29-JAN-2014, and lot#H016250 with expiration date 27-MAR-2014. On 05-MAR-2015 the patient who had received ROTATEQ series, experienced diarrhea, nausea, vomiting and ear infection. On 09-MAR-2015, after experiencing four days of the above events, the patient was seen in the physician's office. A stool sample was collected and did test positive for Rotavirus. A basic metabolic panel was performed on the patient as well. The patient was treated with oral fluids and an unspecified antibiotic. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant referring to a 23 month old female patient with gastric esophageal reflux disease and no drug allergies. On 17-MAY-2013 the patient was vaccinated with a dose of ROTATEQ (lot # J000035, expiration date 24-APR-2014), 2 ml, orally for the prevention of retrovirus. On unspecified dates, the patient was vaccinated with the rest two doses of ROTATEQ, 2 ml, orally. The lot numbers of these two doses were lot# H012252 with expiration date 29-JAN-2014, and lot#H016250 with expiration date 27-MAR-2014. On 05-MAR-2015 the patient who had received ROTATEQ series, experienced diarrhea, nausea, vomiting and ear infection. On 09-MAR-2015, after experiencing four days of the above events, the patient was seen in the physician's office. A stool sample was collected and did test positive for Rotavirus. A basic metabolic panel was performed on the patient as well. The patient was treated with oral fluids and an unspecified antibiotic. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 14 year old male patient. The patient pertinent medical history was unspecified. On an unknown date in August 2014, the patient was vaccinated with PROQUAD (Merck) subcutaneously. No adverse effects were reported. The patient sought medical attention with the physician. No product quality complaint (PQC) was reported for PROQUAD (Merck). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Fever, swollen glands, sore throat, muscle pain.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, swollen glands, sore throat, muscle pain.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Influenza like illness, Lobar pneumonia, Pyrexia, Respiratory disorder
Clinical narrative: Flu like symptoms with fever and respiratory illness within 48 hours of vaccine administration; previously without symptoms.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Middle insomnia, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in upper left arm that has never subsided after the vaccination.  Inability to raise arm above shoulder height.  Intermittent pain severe enough to wake me up at night, with intermittent pain in to neck and lower arm. Requested medical massage treatment which is now being carried out, although pain is still present three and a half months after shot.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Pain in upper left arm that has never subsided after the vaccination.  Inability to raise arm above shoulder height.  Intermittent pain severe enough to wake me up at night, with intermittent pain in to neck and lower arm. Requested medical massage treatment which is now being carried out, although pain is still present three and a half months after shot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No current or historical conditions were reported. Between late DEC-2014 and early JAN-2015, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, Lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Cognitive disorder, Coordination abnormal
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Depressed level of consciousness, Disorientation, Disturbance in attention, Dizziness, Erectile dysfunction
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Hypoaesthesia, Impaired reasoning
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Lethargy, Malaise, Memory impairment, Nausea
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Sensory disturbance, Sensory loss, Slow response to stimuli, Speech disorder
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Visual acuity reduced
Clinical narrative: Overnight and upon waking extreme fatigue and disorientation.  Symptoms similar to being sick with very severe virus or flu.  I experienced numbness my senses were deadened.  I could not feel lung discomfort I had been experiencing lately.  Also I had runners knee for several months which I could not feel.  Also I had sore shoulder for at least a year which I could not feel. There were altered perception and sensory changes.  Walking coordination was difficult.  My legs felt different.  I had cognitive issues my mind was unable to focus or think clearly.  My reasoning and reactions were very slow. Also had behavioral changes, felt very subdued not my usual upbeat self.  Basically felt sedated.  This was very acute for the first week.  Very slight improvement after first week.  Still my senses, perception balance etc were all extremely diminished. Still felt numb.  Several days later discovered I was impotent, a problem which I never had in my life which I now continue to experience since my vaccination.  I am unable to be stimulated due to the deadening numbness I experienced since the vaccination.  12 days after my vaccination I started to experience joint pain. Noticeable diminishment of my vision as well. Tingling and bubbling sensation and leg and foot fall "asleep". 3 weeks later still feel dizzy weak and at times almost to ill to work.   I felt nauseous.  I was also experiencing joint pain in some of my fingers and toes. This went on several months. About one month later coordination and concentration a little better. Still have numbness.  Not speaking completely normal yet still jumbling words mixing up order and misspeaking works.  Loss of sensation and lethargy still big problems...My damage was great but my improvements were limited and incremental.  3 month after felt knee and shoulder pain a little but didn't continue.  Went back to numb. 4 months later don't feel ill any more.  Very numb.  Very lethargic.  Still lowered state of consciousness especially walking spatial coordination and perception. Focus and concentration a little better. Now I am still experiencing lethargy and diminished focus and memory issues and numbness and subsequent impotence. I am still experiencing an altered perception. I am again dealing with joint pain since July 2014. I am experiencing a diminished degraded state of consciousness compared to my pre vaccination condition.
Age: 71.0
Sex: M
Vaccine: FLUC3
Symptoms: Infective tenosynovitis
Clinical narrative: Case number PHHY2015US033249, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556265) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 359040) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359040) on 01 Apr 2015. This report refers to a 71-year-old male patient. Medical history and concomitant medications were not reported. On 19 Sep 2014, he was vaccinated with FLUCELVAX (batch number: 015021A) into left arm. On an unspecified date, his tendon became infected resulting in cortisone injections. Outcome of the event was unknown. The event was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of tendon infection was upgraded based on NVS-IME list. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 015021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 359040) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359040) on 01 Apr 2015: Updated FLUCELVAX vaccine batch review report.
Age: 77.0
Sex: F
Vaccine: FLUC3
Symptoms: Death, Diarrhoea
Clinical narrative: Case number PHHY2015US031962 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 557396) on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 358470) on 19 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358470) on 01 Apr 2015. This report refers to a 77 years old female patient. Her current conditions were diabetes, chronic obstructive pulmonary disease (COPD), arthritis and depression. Other than the pre-existing conditions, no other illnesses were evident at the time of vaccination. Her concomitant medications were LANTUS, metformin, citalopram, lisinopril, IMODIUM, gabapentin and acetaminophen. She was vaccinated with FLUCELVAX (batch number: 014011A) intramuscularly in the left arm on 10 Oct 2014. On 11 Oct 2014, she had diarrhea during nap. IMODIUM dose was increased and there was no other complaints following it. She was normal with no problems till 21 Oct 2014 5:00 pm. She was found deceased on 22 Oct 2014 at 9:30 am. The causality of the events was not reported. No further information was provided. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 014011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 358470) on 19 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358470) on 01 Apr 2015: Updated FLUCELVAX vaccine batch review report.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling jittery, Palpitations
Clinical narrative: Case number PHHY2015US037696, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 560568) website on 30 Mar 2015, with the follow-up information received from Quality Assurance Department on 02 Apr 2015. This report refers to a 32-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) in to her left arm on 12 Dec 2014. On the same date after vaccination, she felt light headed, jittery and felt her heart was racing. She was treated with EPIPEN. Following the events she visited emergency room. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness assessment of felt her heart was racing was upgraded based on available information in the source document. Upon the follow-up from the QA department, it stated that the reported FLUVIRIN batch number 1414107 is not valid batch number and no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 02 Apr 2015: Updated QA comments (no QA investigation would be performed).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Pain
Clinical narrative: Information has been received from a consumer referring to her mother, a 74 year old female patient with no medical history or drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a single shot of ZOSTAVAX (dose, route and lot# were not reported). Concomitant medication included multiple unspecified medications. On 12-MAR-2015 the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention via speaking with physician. VALTREX, prednisone and other unspecified medications were given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as no contact details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to her mother, a 74 year old female patient with no medical history or drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a single shot of ZOSTAVAX (dose, route and lot# were not reported). Concomitant medication included multiple unspecified medications. On 12-MAR-2015 the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention via speaking with physician. VALTREX, prednisone and other unspecified medications were given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as no contact details were provided.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Rash, Scar
Clinical narrative: 2-3 day after flu shot recognized small bumps on neck and face said maybe heat rash maybe worsen over a week outbreak 3 weeks later small size on neck spread rapid.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Rash, Skin cancer
Clinical narrative: 2-3 day after flu shot recognized small bumps on neck and face said maybe heat rash maybe worsen over a week outbreak 3 weeks later small size on neck spread rapid.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Rash
Clinical narrative: Patient almost immediately began to itch in the injection site (R deltoid). Within minutes, a rash had developed on the patients arm and it had spread to her abdomen and left arm.  The injection site "knotted" up and became very red. Treatment: patient was told to take Benadryl and was given a steroid shot in the doctor's office.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Encephalopathy, Organ failure, Pneumonia, Sepsis, Vaccination complication
Clinical narrative: Only detail patient provided was that he was hospitalized potentially due to a reaction from Prevnar13.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Blood test, Brain oedema, Chest X-ray abnormal, Encephalopathy, Nuclear magnetic resonance imaging brain
Clinical narrative: Only detail patient provided was that he was hospitalized potentially due to a reaction from Prevnar13.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Organ failure, Pneumococcal sepsis, Pneumonia, Pneumonia streptococcal
Clinical narrative: Only detail patient provided was that he was hospitalized potentially due to a reaction from Prevnar13.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Encephalopathy, Organ failure, Pneumonia, Sepsis, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer that reported for himself. A 69-years-old male patient received PREVNAR 13 (Lot: KZ394 exp: Jun15) single dose on 19Jan2015. Concomitant medications included CYMBALTA 90mg once a day for depression, LAMICTAL 200mg daily for depression, SYNTHROID 75mcg daily for thyroid, NEXIUM 40mg daily for acid reflux, lisinopril 20mg for blood pressure, BUSPAR 45mg daily for anxiety, LIPITOR 80mg daily for cholesterol. The patient's medical history included depression for 15 or 20 years, acid reflux for 15 or 20 years, thyroid disorder for 15 or 20 years, blood pressure for 10 years, anxiety 15 or 20 years, cholesterol high 15 or 20 years. The patient experienced pneumonia on 20Jan2015, sepsis pneumonia on 27Jan2015, organ failure on unknown date in Jan2015, brain swelling on unknown date, pneumonia streptococcal on unknown date in Jan2015, encephalopathy on unknown date in Jan2015. The patient was hospitalized for the events from 27Jan2015 to 18Feb2015. The outcome of the events was unknown. The patient done chest x-rays that showed streptococcal pneumonia, blood test and MRI of brain.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Blood test, Brain oedema, Chest X-ray abnormal, Encephalopathy, Nuclear magnetic resonance imaging brain
Clinical narrative: This is a spontaneous report from a contactable consumer that reported for himself. A 69-years-old male patient received PREVNAR 13 (Lot: KZ394 exp: Jun15) single dose on 19Jan2015. Concomitant medications included CYMBALTA 90mg once a day for depression, LAMICTAL 200mg daily for depression, SYNTHROID 75mcg daily for thyroid, NEXIUM 40mg daily for acid reflux, lisinopril 20mg for blood pressure, BUSPAR 45mg daily for anxiety, LIPITOR 80mg daily for cholesterol. The patient's medical history included depression for 15 or 20 years, acid reflux for 15 or 20 years, thyroid disorder for 15 or 20 years, blood pressure for 10 years, anxiety 15 or 20 years, cholesterol high 15 or 20 years. The patient experienced pneumonia on 20Jan2015, sepsis pneumonia on 27Jan2015, organ failure on unknown date in Jan2015, brain swelling on unknown date, pneumonia streptococcal on unknown date in Jan2015, encephalopathy on unknown date in Jan2015. The patient was hospitalized for the events from 27Jan2015 to 18Feb2015. The outcome of the events was unknown. The patient done chest x-rays that showed streptococcal pneumonia, blood test and MRI of brain.
Age: 69.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Organ failure, Pneumococcal sepsis, Pneumonia, Pneumonia streptococcal
Clinical narrative: This is a spontaneous report from a contactable consumer that reported for himself. A 69-years-old male patient received PREVNAR 13 (Lot: KZ394 exp: Jun15) single dose on 19Jan2015. Concomitant medications included CYMBALTA 90mg once a day for depression, LAMICTAL 200mg daily for depression, SYNTHROID 75mcg daily for thyroid, NEXIUM 40mg daily for acid reflux, lisinopril 20mg for blood pressure, BUSPAR 45mg daily for anxiety, LIPITOR 80mg daily for cholesterol. The patient's medical history included depression for 15 or 20 years, acid reflux for 15 or 20 years, thyroid disorder for 15 or 20 years, blood pressure for 10 years, anxiety 15 or 20 years, cholesterol high 15 or 20 years. The patient experienced pneumonia on 20Jan2015, sepsis pneumonia on 27Jan2015, organ failure on unknown date in Jan2015, brain swelling on unknown date, pneumonia streptococcal on unknown date in Jan2015, encephalopathy on unknown date in Jan2015. The patient was hospitalized for the events from 27Jan2015 to 18Feb2015. The outcome of the events was unknown. The patient done chest x-rays that showed streptococcal pneumonia, blood test and MRI of brain.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Axillary pain, Brachial plexopathy, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: Initial unsolicited case received from a physician's assistant on 30 March 2015. A 57-year-old male patient, with a history of HIV and Hepatitis C, received a right arm injection of MENOMUNE (lot number UH537AA) and a left arm injection of PREVNAR (lot number J67646, Pfizer) on 30 January 2015. Multiple allergies were also reported, including latex, acetaminophen, ciprofloxacin, other unspecified antibiotics, meperidine derivatives, and lactose. An unspecified amount of time following vaccination, the patient reported right arm pain to the armpit, right scapula pain, and right hand weakness. The patient, who was himself a neurologist, was seen by a neurologist on 06 March 2015 and diagnosed with brachial plexitis from vaccination. Treatments and laboratory tests were not reported. The symptoms were reported as improving, although some pain in the right scapula and arm, in addition to weakness, still continued at the time of the report. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited case received from a physician's assistant on 30 March 2015. A 57-year-old male patient, with a history of HIV and Hepatitis C, received a right arm injection of MENOMUNE (lot number UH537AA) and a left arm injection of PREVNAR (lot number J67646, Pfizer) on 30 January 2015. Multiple allergies were also reported, including latex, acetaminophen, ciprofloxacin, other unspecified antibiotics, meperidine derivatives, and lactose. An unspecified amount of time following vaccination, the patient reported right arm pain to the armpit, right scapula pain, and right hand weakness. The patient, who was himself a neurologist, was seen by a neurologist on 06 March 2015 and diagnosed with brachial plexitis from vaccination. Treatments and laboratory tests were not reported. The symptoms were reported as improving, although some pain in the right scapula and arm, in addition to weakness, still continued at the time of the report. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Axillary pain, Brachial plexopathy, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Initial unsolicited case received from a physician's assistant on 30 March 2015. A 57-year-old male patient, with a history of HIV and Hepatitis C, received a right arm injection of MENOMUNE (lot number UH537AA) and a left arm injection of PREVNAR (lot number J67646, Pfizer) on 30 January 2015. Multiple allergies were also reported, including latex, acetaminophen, ciprofloxacin, other unspecified antibiotics, meperidine derivatives, and lactose. An unspecified amount of time following vaccination, the patient reported right arm pain to the armpit, right scapula pain, and right hand weakness. The patient, who was himself a neurologist, was seen by a neurologist on 06 March 2015 and diagnosed with brachial plexitis from vaccination. Treatments and laboratory tests were not reported. The symptoms were reported as improving, although some pain in the right scapula and arm, in addition to weakness, still continued at the time of the report. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Musculoskeletal pain, Pain in extremity, Treponema test positive
Clinical narrative: Initial unsolicited case received from a physician's assistant on 30 March 2015. A 57-year-old male patient, with a history of HIV and Hepatitis C, received a right arm injection of MENOMUNE (lot number UH537AA) and a left arm injection of PREVNAR (lot number J67646, Pfizer) on 30 January 2015. Multiple allergies were also reported, including latex, acetaminophen, ciprofloxacin, other unspecified antibiotics, meperidine derivatives, and lactose. An unspecified amount of time following vaccination, the patient reported right arm pain to the armpit, right scapula pain, and right hand weakness. The patient, who was himself a neurologist, was seen by a neurologist on 06 March 2015 and diagnosed with brachial plexitis from vaccination. Treatments and laboratory tests were not reported. The symptoms were reported as improving, although some pain in the right scapula and arm, in addition to weakness, still continued at the time of the report. Documents held by sender: None.