chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.11
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Screaming
Clinical narrative: ABOUT 5 PM ON THE NIGHT THE VACCINE WAS GIVEN THE CHILD BECAME IRRITABLE AND DID NOT SLEEP THROUGH THE NIGHT. THE NEXT DAY HE SCREAMED INCONSOLABLY FOR THE NEXT 24 HOURS AND HAD A LOSE OF APPETITE. THE NEXT DAY ON 1/6 HE WAS EXTREMELY IRRITABLE, RUNNING A FEVER, STILL NOT EATING WELL AND STILL CRYING INCONSOLABLY. THIS WAS NOT LIKE THE CHILDS NORMAL DEMEANOR.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.  Progressed distally.
Age: 24.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a 24 year old patient of unknown gender. Past medical history and concurrent conditions were not reported. The health care worker stated that, the patient was vaccinated with PROQUAD (Merck) (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified) (inappropriate schedule of drug administration). Concomitant medications were not provided. Product quality complaint (PQC) was not reported. No adverse effects were reported. Further information was not provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pain, Swelling
Clinical narrative: Pt developed immediate swelling and induration after Tdap injection which lessened but was still painful and erythematous 1 week after injection. Treated Kw/clindamycin for possible cellulitis - pt reported improvement in swelling and pain 1-2 days after treatment. Clindamycin 300 mg TID, oxycodone 5 mg BID.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Mouth swelling, Urticaria
Clinical narrative: Pt evaluated for mouth swelling and generalized hives 4 days after receiving Tdap and eating ribs w/pink sauce (sauce ingredients unkn). H/O shellfish allergy. Has received tetanus vax before w/o incident. No injection site reaction present. Improved with antihistamines but hives recurring as of 8/10/15 PACT note. Cetirizine 10 mg every day.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 31-DEC-2015, the patient was vaccinated with an expired dose of ROTATEQ lot # K001196, expiration date 22-OCT-2015, oral, (dose was not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, Lot number, expiration date, dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 04-JAN-2016, the patient was vaccinated with improperly stored GARDASIL 120Y, 0.5ml, administered intramuscularly (with lot # K008931 and expiry date of 04-MAR-2017). However, no adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 21-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (strength and dose were not provided) reported lot # L019997 and expiration date 02-DEC-2015, that were improperly storaged. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested. Lot number L019997 has been verified to be a valid number for PROQUAD (Merck).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 30-DEC-2015 the patient was vaccinated an expired dose of ZOSTAVAX (Lot # K012921, expiration date 29-NOV-2015) dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (patient's mother) refers to a male patient of unknown age. Information regarding patient's medical history, concurrent condition and concomitant therapy was not provided. On 30-DEC-2015, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (extra dose administered). Patient's mother stated that the patient was inadvertently vaccinated with 4 doses of GARDASIL. The first dose was administered on 11-JUL-2013, second dose on 05-JUN-2014, third dose on 08-JUL-2015 and fourth dose on 30-DEC-2015. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (patient's mother) refers to a male patient of unknown age. Information regarding patient's medical history, concurrent condition and concomitant therapy was not provided. Patient's mother stated that the patient received 3 doses of GARDASIL, but on the following dates: first dose on 11-JUL-2013, second dose on 05-JUN-2014 and third dose on 30-DEC-2015 (inappropriate schedule of drug administration). No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from licensed practitioner nurse refers to unspecified number of unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, an unspecified number of unspecified patients received improperly stored GARDASIL lot # K009482 and expiration date on 06-MAR-2017, (route, strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a 13 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The nurse reported that on 15-DEC-2015, the patient received a dose of M-M-R II (lot # L024266, expiry date 01-JUL-2017, therapy type unknown) and a dose of VARIVAX (Merck) (lot # L029467; expiry date 06-AUG-2017), dose, route unknown. On 22-DEC-2015, the same patient returned to physician's office and received a dose of M-M-R II (lot # L024266, expiry date 01-JUL-2017) and a dose of VARIVAX (Merck) (lot # L029466; expiry date 06-AUG-2017). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 28 year old patient of unknown gender. No concurrent or historical conditions were reported. On unspecified dates, the patient was vaccinated with 2 doses of GARDASIL Lot number, expiration date, dose, route, and anatomical location were not provided. No concomitant medications were reported. The patient was vaccinated at the age of 28 years old (inappropriate schedule of drug administration). No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Pain, Paraesthesia
Clinical narrative: Muscles on thigh stiff and achy then moved to back and shoulders, neck. Pain significant and continued for 3 weeks. Still have residual pain in muscles, especially shoulder. Numbness and tingling in hand injected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse refers to unspecified number of unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, an unspecified number of unspecified patients received improperly stored M-M-R II lot # K015375 and expiration date on 18-SEP-2015, (route, strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Aphasia, Full blood count normal, Irritability, Laboratory test normal, Social avoidant behaviour
Clinical narrative: Fussy, then withdrawn - significantly less smiling, talking ceased and staring spells.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Staring
Clinical narrative: Fussy, then withdrawn - significantly less smiling, talking ceased and staring spells.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Irritability
Clinical narrative: Mother states child cry a lot and was irritable for 1 week post vaccination.
Age: 1.75
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Cerebellar ataxia, Computerised tomogram head normal, Decreased appetite, Gait disturbance, Laboratory test normal
Clinical narrative: Start of fever of 102 on 11/20/15, shaky movements in arms started on 11/22/15 and mother noticed he was having difficulty walking (looked drunk), was fully alert, worse when he would wake up from sleeping, would get better as day progressed, fever continued Mon-Thurs, decreased appetite. Parents noticed hands were shaking with feeding himself.  Went to ER 11/28/15, CT brain negative, dx with probable acute cerebellar ataxia.
Age: 1.75
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Start of fever of 102 on 11/20/15, shaky movements in arms started on 11/22/15 and mother noticed he was having difficulty walking (looked drunk), was fully alert, worse when he would wake up from sleeping, would get better as day progressed, fever continued Mon-Thurs, decreased appetite. Parents noticed hands were shaking with feeding himself.  Went to ER 11/28/15, CT brain negative, dx with probable acute cerebellar ataxia.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain in right upper arm muscle since vaccine administration. Decreased range of motion secondary to pain. Can't move arm without pain. Decreased strength in right arm.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Antibody test positive, Antinuclear antibody, Antinuclear antibody positive, Arthralgia
Clinical narrative: Generalized joint pain, red pin point rash on legs, swollen glands, sore throat, ongoing low grade fever.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Aspartate aminotransferase increased, Lymphadenopathy, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Generalized joint pain, red pin point rash on legs, swollen glands, sore throat, ongoing low grade fever.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Generalized joint pain, red pin point rash on legs, swollen glands, sore throat, ongoing low grade fever.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Electromyogram normal, Hypoaesthesia, Limb discomfort, Muscular weakness
Clinical narrative: Legs and arms: rapid onset over 5 days numbness, tingling, weakness and heaviness. Dx: Neuropathy.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: Legs and arms: rapid onset over 5 days numbness, tingling, weakness and heaviness. Dx: Neuropathy.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Pt broke out in a itchy, generalized rash. Seen at local ER and treated with antihistamine and oral corticosteroid.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Pt experienced pain, inflammation, erythema, and itching on and around injection site beginning the day after imz administration. Pt came to the pharmacy 1/5/16 and pt was advised to apply ice compress, take Benadryl, and acetaminophen, per protocol. Pt did not follow RPh advice and returned to pharmacy 1/6/16 with same issue.  Pt was advised to go to ERfor further examination.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Fever, vomiting, diarrhea. Subsequently found to be rota positive on testing performed 1/5/16.
Age: 69.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ADMINISTERED MCV4 TO 69 YEAR OLD CLIENT INSTEAD OF PPSV23.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: Positive for severe strain of HPV without being sexually active.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Hypoaesthesia oral, Paraesthesia oral, Pruritus
Clinical narrative: PPSV23 ordered and delivered on 11/06/2015 - then same provider ordered a "booster" on 01/04/2016.  Both were delivered in the left deltoid. Patient states experienced severe erythema and pruritus.  Erythema was localized around the vaccine sight the first night but severe and then spread down the arm and caused slight bruising.  Patient also reports numbness and tingling in the tongue and lips (although there is previous mention of this in patients chart so may not be related, but onset of this incident is suspicious). Patient given oral steroids today and will return in two days for further evaluation.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: PPSV23 ordered and delivered on 11/06/2015 - then same provider ordered a "booster" on 01/04/2016.  Both were delivered in the left deltoid. Patient states experienced severe erythema and pruritus.  Erythema was localized around the vaccine sight the first night but severe and then spread down the arm and caused slight bruising.  Patient also reports numbness and tingling in the tongue and lips (although there is previous mention of this in patients chart so may not be related, but onset of this incident is suspicious). Patient given oral steroids today and will return in two days for further evaluation.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: RN gave Tdap instead of Flu vaccine, two Tdaps were given to patient in the same arm (Left deltoid.)
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: RN gave Tdap instead of Flu vaccine, two Tdaps were given to patient in the same arm (Left deltoid.)
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TD, VARCEL
Symptoms: Asthenia, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Mother called to complain of sore swollen left arm.  Complains of Weakness, and headache.  Denies Fever.  She was told to seek medical attention if she feels her son needs to be seen. She said he is sleeping now but would update me in the morning or take him to the hospital if need be.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Rash pruritic, Skin warm, Vaccination site reaction
Clinical narrative: Patient had reaction to Varicella vaccine at the site of vaccination. Patient was previously given 1 vaccine in 1997, and has previously had chickenpox.  Patient developed a rash that was slightly itchy, warm to touch, with redness, 30mmx20mm induration. No other symptoms.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: SHE HAD SORE ARM FOR SEVERAL DAYS AT THE INJECT SITE (LEFT ARM) WHICH THEN BECAME PAINFUL MIMICKING ROTATOR CUFF TEAR WITH BOUTS OF INABILITY TO USE HER ARM. SHE REGAINED HER RANGE OF MOTION AFTER 2 MONTHS AFTER ORTHOPEDIC AND PT VISITS AND AN MRI WHICH REVEALED THE INJECTION SITE WAS IN TENDON.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse effect in memory of mother, but concern that vaccine was given after window of recommended administration.
Age: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Injection site erythema, Urticaria, Vaccination site swelling
Clinical narrative: Hives, redness, and swelling around vaccination site.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN IN NON-VACCINATED ARM. JOINT PAIN IN KNEES AND ANKLES THAT IS NOT IMPROVING. NO TREATMENT.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Activities of daily living impaired, Agitation, Anxiety, Blood test normal, Coordination abnormal
Clinical narrative: I first began having problems in early 2013. I noticed I was becoming light headed and couldn't focus. Felt like I was going to pass out while working out. Which had never happened before. I then began feeling very fatigued. I remember sitting at work one night and all the sudden my brain felt very weird. It felt like I had a rubber band type of pressure around my head. I felt very uneasy. It lasted for approximately one week. And then my brain went into overdrive. It felt extremely weird. I couldn't breathe and it felt like I was going to pass out. My heart was racing and my brain had a very weird physical sensation to it. I had racing thoughts, and my blood felt like it was very excited. This lasted for a very long time. It never really went away. I felt very ill. All the time as well. It was a state of constant panic. The sensations moved around my body. Sometimes I would have throat symptoms, then stomach, loss of coordination, etc. I was in and out of the hospital constantly. They ran blood test after blood test, MRI, etc and said everything was normal. I had sensitivity to sound and other scary symptoms. It lasted every single day. I remember going to the hospital and could not stop shaking, it was not a seizure but almost felt like it. More like convulsions. I also dealt with severe fatigue and dizziness and at times difficulty breathing. The doctors attributed all of my symptoms to panic disorder. But the reason why I was having anxiety is because of the way I my body was feeling. I felt so extremely sick all of the time. It has been a little over two years now. My symptoms have gotten better but I still deal with stuff every day. I deal with fatigue, dizziness, sense of sickness that comes and goes. Prior to Gardasil I had never felt like this. Not once in my life. I was a happy go lucky guy that had a bright future ahead of myself. But now, my life is destroyed. I am always sick. It's not because of stress or anxiety. Its because my body feels sick all the time. It's physical. No doctor has been able to give me any answers. And its hard for me to believe this has been cause my anxiety. I lost everything because of this, my job, marriage, friends, etc. I sit in my house and deal with my symptoms. I've been on antidepressants and other drugs which never helped. I don't have any solid evidence if Gardasil caused this. But it seems like it did because a few months after I received two Gardasil shots is when my health went down the drain.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: I first began having problems in early 2013. I noticed I was becoming light headed and couldn't focus. Felt like I was going to pass out while working out. Which had never happened before. I then began feeling very fatigued. I remember sitting at work one night and all the sudden my brain felt very weird. It felt like I had a rubber band type of pressure around my head. I felt very uneasy. It lasted for approximately one week. And then my brain went into overdrive. It felt extremely weird. I couldn't breathe and it felt like I was going to pass out. My heart was racing and my brain had a very weird physical sensation to it. I had racing thoughts, and my blood felt like it was very excited. This lasted for a very long time. It never really went away. I felt very ill. All the time as well. It was a state of constant panic. The sensations moved around my body. Sometimes I would have throat symptoms, then stomach, loss of coordination, etc. I was in and out of the hospital constantly. They ran blood test after blood test, MRI, etc and said everything was normal. I had sensitivity to sound and other scary symptoms. It lasted every single day. I remember going to the hospital and could not stop shaking, it was not a seizure but almost felt like it. More like convulsions. I also dealt with severe fatigue and dizziness and at times difficulty breathing. The doctors attributed all of my symptoms to panic disorder. But the reason why I was having anxiety is because of the way I my body was feeling. I felt so extremely sick all of the time. It has been a little over two years now. My symptoms have gotten better but I still deal with stuff every day. I deal with fatigue, dizziness, sense of sickness that comes and goes. Prior to Gardasil I had never felt like this. Not once in my life. I was a happy go lucky guy that had a bright future ahead of myself. But now, my life is destroyed. I am always sick. It's not because of stress or anxiety. Its because my body feels sick all the time. It's physical. No doctor has been able to give me any answers. And its hard for me to believe this has been cause my anxiety. I lost everything because of this, my job, marriage, friends, etc. I sit in my house and deal with my symptoms. I've been on antidepressants and other drugs which never helped. I don't have any solid evidence if Gardasil caused this. But it seems like it did because a few months after I received two Gardasil shots is when my health went down the drain.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Gastric disorder, Head discomfort, Hyperacusis, Impaired work ability, Malaise
Clinical narrative: I first began having problems in early 2013. I noticed I was becoming light headed and couldn't focus. Felt like I was going to pass out while working out. Which had never happened before. I then began feeling very fatigued. I remember sitting at work one night and all the sudden my brain felt very weird. It felt like I had a rubber band type of pressure around my head. I felt very uneasy. It lasted for approximately one week. And then my brain went into overdrive. It felt extremely weird. I couldn't breathe and it felt like I was going to pass out. My heart was racing and my brain had a very weird physical sensation to it. I had racing thoughts, and my blood felt like it was very excited. This lasted for a very long time. It never really went away. I felt very ill. All the time as well. It was a state of constant panic. The sensations moved around my body. Sometimes I would have throat symptoms, then stomach, loss of coordination, etc. I was in and out of the hospital constantly. They ran blood test after blood test, MRI, etc and said everything was normal. I had sensitivity to sound and other scary symptoms. It lasted every single day. I remember going to the hospital and could not stop shaking, it was not a seizure but almost felt like it. More like convulsions. I also dealt with severe fatigue and dizziness and at times difficulty breathing. The doctors attributed all of my symptoms to panic disorder. But the reason why I was having anxiety is because of the way I my body was feeling. I felt so extremely sick all of the time. It has been a little over two years now. My symptoms have gotten better but I still deal with stuff every day. I deal with fatigue, dizziness, sense of sickness that comes and goes. Prior to Gardasil I had never felt like this. Not once in my life. I was a happy go lucky guy that had a bright future ahead of myself. But now, my life is destroyed. I am always sick. It's not because of stress or anxiety. Its because my body feels sick all the time. It's physical. No doctor has been able to give me any answers. And its hard for me to believe this has been cause my anxiety. I lost everything because of this, my job, marriage, friends, etc. I sit in my house and deal with my symptoms. I've been on antidepressants and other drugs which never helped. I don't have any solid evidence if Gardasil caused this. But it seems like it did because a few months after I received two Gardasil shots is when my health went down the drain.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Palpitations, Panic disorder, Seizure, Tachyphrenia
Clinical narrative: I first began having problems in early 2013. I noticed I was becoming light headed and couldn't focus. Felt like I was going to pass out while working out. Which had never happened before. I then began feeling very fatigued. I remember sitting at work one night and all the sudden my brain felt very weird. It felt like I had a rubber band type of pressure around my head. I felt very uneasy. It lasted for approximately one week. And then my brain went into overdrive. It felt extremely weird. I couldn't breathe and it felt like I was going to pass out. My heart was racing and my brain had a very weird physical sensation to it. I had racing thoughts, and my blood felt like it was very excited. This lasted for a very long time. It never really went away. I felt very ill. All the time as well. It was a state of constant panic. The sensations moved around my body. Sometimes I would have throat symptoms, then stomach, loss of coordination, etc. I was in and out of the hospital constantly. They ran blood test after blood test, MRI, etc and said everything was normal. I had sensitivity to sound and other scary symptoms. It lasted every single day. I remember going to the hospital and could not stop shaking, it was not a seizure but almost felt like it. More like convulsions. I also dealt with severe fatigue and dizziness and at times difficulty breathing. The doctors attributed all of my symptoms to panic disorder. But the reason why I was having anxiety is because of the way I my body was feeling. I felt so extremely sick all of the time. It has been a little over two years now. My symptoms have gotten better but I still deal with stuff every day. I deal with fatigue, dizziness, sense of sickness that comes and goes. Prior to Gardasil I had never felt like this. Not once in my life. I was a happy go lucky guy that had a bright future ahead of myself. But now, my life is destroyed. I am always sick. It's not because of stress or anxiety. Its because my body feels sick all the time. It's physical. No doctor has been able to give me any answers. And its hard for me to believe this has been cause my anxiety. I lost everything because of this, my job, marriage, friends, etc. I sit in my house and deal with my symptoms. I've been on antidepressants and other drugs which never helped. I don't have any solid evidence if Gardasil caused this. But it seems like it did because a few months after I received two Gardasil shots is when my health went down the drain.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Tremor
Clinical narrative: I first began having problems in early 2013. I noticed I was becoming light headed and couldn't focus. Felt like I was going to pass out while working out. Which had never happened before. I then began feeling very fatigued. I remember sitting at work one night and all the sudden my brain felt very weird. It felt like I had a rubber band type of pressure around my head. I felt very uneasy. It lasted for approximately one week. And then my brain went into overdrive. It felt extremely weird. I couldn't breathe and it felt like I was going to pass out. My heart was racing and my brain had a very weird physical sensation to it. I had racing thoughts, and my blood felt like it was very excited. This lasted for a very long time. It never really went away. I felt very ill. All the time as well. It was a state of constant panic. The sensations moved around my body. Sometimes I would have throat symptoms, then stomach, loss of coordination, etc. I was in and out of the hospital constantly. They ran blood test after blood test, MRI, etc and said everything was normal. I had sensitivity to sound and other scary symptoms. It lasted every single day. I remember going to the hospital and could not stop shaking, it was not a seizure but almost felt like it. More like convulsions. I also dealt with severe fatigue and dizziness and at times difficulty breathing. The doctors attributed all of my symptoms to panic disorder. But the reason why I was having anxiety is because of the way I my body was feeling. I felt so extremely sick all of the time. It has been a little over two years now. My symptoms have gotten better but I still deal with stuff every day. I deal with fatigue, dizziness, sense of sickness that comes and goes. Prior to Gardasil I had never felt like this. Not once in my life. I was a happy go lucky guy that had a bright future ahead of myself. But now, my life is destroyed. I am always sick. It's not because of stress or anxiety. Its because my body feels sick all the time. It's physical. No doctor has been able to give me any answers. And its hard for me to believe this has been cause my anxiety. I lost everything because of this, my job, marriage, friends, etc. I sit in my house and deal with my symptoms. I've been on antidepressants and other drugs which never helped. I don't have any solid evidence if Gardasil caused this. But it seems like it did because a few months after I received two Gardasil shots is when my health went down the drain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site reaction, Injection site urticaria
Clinical narrative: Patient presented to pharmacy with significant injection site reaction. Pharmacist on duty described it at being a ringlike area about 2x4 inches with a welt in the center like a bee sting.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV, UNK
Symptoms: Drug administered at inappropriate site, Exfoliative rash, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: 1" X 1/2" welt above injection site, which was improperly administered on side/back of thigh instead of front.  Red scaly rash up leg under cheek.  Also shed live virus, resulting in shingles outbreak in myself the day following the injection.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, sore left arm radiating downwards for ~3 days.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: Herpetic rash along dermatome on left upper abdomen and back.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpetic rash along dermatome on left upper abdomen and back.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Heart rate increased, Loss of consciousness
Clinical narrative: This spontaneous report has been received from an oncology nurse via social media referring to her normal healthy 18 year old female daughter. Concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency, route and lot# not reported) by the reporter. The reporter reported that the patient was injured by this vaccine and her life had changed. The patient had a severe adverse reaction to the GARDASIL (like anaphylaxis). The patient had a debilitating illness. Within hours of the vaccine she was gasping for air and had a severe rapid heart rate before going unconscious. The patient had respiratory distress. The patient was rushed to hospital and was treated. The doctors reassured the reporter no issue with her allergies or underlying autoimmune issues. The patient was suffering with hyper postural orthostatic tachycardia syndrome (POTS), severe brain fog and fatigue. Before vaccination, the patient was a great student popular good kid not a partier. The patient had been seriously ill for five months and was unable to leave for college. The reporter said that "it was really devastated my family". At the time of reporting, the outcome of respiratory distress and unconscious was unknown, the outcome of brain fog and POTS was not recovered. The reporter knew POTS was from the vaccine of GARDASIL. The causality between other events with GARDASIL was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Postural orthostatic tachycardia syndrome, Respiratory distress
Clinical narrative: This spontaneous report has been received from an oncology nurse via social media referring to her normal healthy 18 year old female daughter. Concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency, route and lot# not reported) by the reporter. The reporter reported that the patient was injured by this vaccine and her life had changed. The patient had a severe adverse reaction to the GARDASIL (like anaphylaxis). The patient had a debilitating illness. Within hours of the vaccine she was gasping for air and had a severe rapid heart rate before going unconscious. The patient had respiratory distress. The patient was rushed to hospital and was treated. The doctors reassured the reporter no issue with her allergies or underlying autoimmune issues. The patient was suffering with hyper postural orthostatic tachycardia syndrome (POTS), severe brain fog and fatigue. Before vaccination, the patient was a great student popular good kid not a partier. The patient had been seriously ill for five months and was unable to leave for college. The reporter said that "it was really devastated my family". At the time of reporting, the outcome of respiratory distress and unconscious was unknown, the outcome of brain fog and POTS was not recovered. The reporter knew POTS was from the vaccine of GARDASIL. The causality between other events with GARDASIL was not reported. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old male patient with no drug reactions/allergies. The patient's medical history included respiratory syncytial virus infection. On 22-DEC-2015 the patient was vaccinated with a dose of ROTATEQ (oral, lot# L035636, expiration date: 21-MAY-2017, dose was unknown). There was no concomitant medication. On 27-DEC-2015 the patient began to have diarrhea and vomiting. On 28-DEC-2015 the patient was taken to the emergency room at an unspecified hospital and received an unspecified amount of an unspecified type of intravenous fluid and failed an oral challenge with PEDIALYTE. The patient then began to have increased vomiting and bloody diarrhea. The patient was admitted on 28-DEC-2015 to the unspecified hospital and had an ultrasound performed which found intussusception. The intussusception was reduced with an air enema. The patient was currently recovering. The causality was not reported. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old male patient with no drug reactions/allergies. The patient's medical history included respiratory syncytial virus infection. On 22-DEC-2015 the patient was vaccinated with a dose of ROTATEQ (oral, lot# L035636, expiration date: 21-MAY-2017, dose was unknown). There was no concomitant medication. On 27-DEC-2015 the patient began to have diarrhea and vomiting. On 28-DEC-2015 the patient was taken to the emergency room at an unspecified hospital and received an unspecified amount of an unspecified type of intravenous fluid and failed an oral challenge with PEDIALYTE. The patient then began to have increased vomiting and bloody diarrhea. The patient was admitted on 28-DEC-2015 to the unspecified hospital and had an ultrasound performed which found intussusception. The intussusception was reduced with an air enema. The patient was currently recovering. The causality was not reported. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Breath holding, Crying, Screaming, Syncope
Clinical narrative: During/after vaccination patent screamed and cried very loudly triggering, breath-holding spell and subsequent fainting.
Age: 1.09
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Pt has a reaction to the vaccine. Pt had a welt that measured 1 in by 0.5 in.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Developed hives to legs immediately after immunizations given. Monitored for 15 mins; Hives resolved. No other symptoms. Advised to call if hives returned.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test positive, Erythema
Clinical narrative: Information has been received from a pharmacist referring to a 63 years old female patient. The patient had chickenpox as a child, and had a shingles outbreak, 12 years ago. On an unspecified date employer testing showed no varicella immunity and patient received a first dose of VARIVAX (Merck) (dose, route and lot# were not reported) on an unspecified date. The patient developed a "large red reaction" after being administered. Pharmacist reported a titer, obtained on an unspecified date following the first dose of VARIVAX (Merck), showed immunity. Pharmacist reported it was unknown if patient received a second dose of VARIVAX (Merck). The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician referring to his sister. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage, strength, route and lot # unknown). There was no concomitant medication reported. On an unknown date, after receiving ZOSTAVAX the patient developed shingles. At the time of the report (28-DEC-2015), it was unknown if the patient continued to receive ZOSTAVAX and the outcome of the shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with doses of improperly stored ZOSTAVAX (dosage, strength, route and lot # unknown). There was no concomitant medication reported. No adverse effects was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Product container issue
Clinical narrative: Information has been received from a healthcare worker of unknown age referring to herself. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date the patient started ZOSTAVAX vial (Lot# L034726 with expiration date of 09-DEC-2016 dose/frequency/indication was not reported). On 17-DEC-2015, the patient had an intravenous infusion of REMICADE in the top portion of her left hand which might cause her "to be immunocompromised". On 18-DEC-2015 when the patient was opening a box of ZOSTAVAX (Lot# L034726 with expiration date of 09-DEC-2016), one of the vials in the box was broken and she was topically exposed to the ZOSTAVAX powder. Some of the powder leaked out of the broken and got on the palm of both of her hands. No adverse effect was reported. Medical attention was not sought. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 03-DEC-2015, patient was vaccinated with M-M-R II (strength, dose and route were not provided) lot # L011528 and expiration date 03-APR-2017, that were improperly storage. No concomitant medications was reported. Symptoms were reported. No product quality complain was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019336, is an initial spontaneous report received from a nurse on 24 Sep 2015. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 15 Aug 2015 which was stored on incorrect temperature of (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 13 November 2015 from the nurse: Reporter stated that patient did not experience any adverse events and she was doing fine. Follow-up information received on 25 November 2015 from the nurse: Concomitant products included Tdap (batch number: C4730A4). The patient's vaccination status was current. The patient received the 1st dose of MENVEO (intramuscular) .5 ml on the right deltoid. The patient's details (height and weight) were provided.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019371, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 20 Jun 2015 and the vaccine administered was stored in (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 24 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO batch number was changed to M14070; the vaccine was administered intramuscularly on the right deltoid.
Age: 0.37
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.43
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 5 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 09:00 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.