chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Blood thyroid stimulating hormone normal, Chest pain, Chills, Dysphagia
Clinical narrative: Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Dyspnoea, Echocardiogram normal, Fatigue, Pharyngeal swelling
Clinical narrative: Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound thyroid normal
Clinical narrative: Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Complement factor C3, Complement factor C4
Clinical narrative: Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Endoscopy, Full blood count, Metabolic function test
Clinical narrative: Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Blood thyroid stimulating hormone normal, Chest pain, Chills, Dysphagia
Clinical narrative: Pt developed Unusual and severe hoarseness after receiving SHINGRIX. She has seen ENT with negative scope and multiple other providers without diagnosis or resolution. Pt is currently being treated with prednisone and colchicine with minimal improvement,
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Dyspnoea, Echocardiogram normal, Fatigue, Pharyngeal swelling
Clinical narrative: Pt developed Unusual and severe hoarseness after receiving SHINGRIX. She has seen ENT with negative scope and multiple other providers without diagnosis or resolution. Pt is currently being treated with prednisone and colchicine with minimal improvement,
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound thyroid normal
Clinical narrative: Pt developed Unusual and severe hoarseness after receiving SHINGRIX. She has seen ENT with negative scope and multiple other providers without diagnosis or resolution. Pt is currently being treated with prednisone and colchicine with minimal improvement,
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Complement factor C3, Complement factor C4
Clinical narrative: Pt developed Unusual and severe hoarseness after receiving SHINGRIX. She has seen ENT with negative scope and multiple other providers without diagnosis or resolution. Pt is currently being treated with prednisone and colchicine with minimal improvement,
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Endoscopy, Full blood count, Metabolic function test
Clinical narrative: Pt developed Unusual and severe hoarseness after receiving SHINGRIX. She has seen ENT with negative scope and multiple other providers without diagnosis or resolution. Pt is currently being treated with prednisone and colchicine with minimal improvement,
Age: 74.0
Sex: F
Vaccine: TYP
Symptoms: Hypotension
Clinical narrative: PATIENT LATER REPORTED THAT SHE FELT EXTREME HYPOTENSION, BUT HAD CHOSE NOT TO GO TO THE HOSPITAL. HAS SINCE RESOLVED.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms, Muscle aches, Chills.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Fatigue, Muscle spasms, Tremor
Clinical narrative: Around 2:45am on 1/25/19, patient began experiencing entire body muscle spasms and shaking, vomiting and diarrhea that has lasted for 6 hours. She has extreme weakness and exhaustion at this time (1:45pm).
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Around 2:45am on 1/25/19, patient began experiencing entire body muscle spasms and shaking, vomiting and diarrhea that has lasted for 6 hours. She has extreme weakness and exhaustion at this time (1:45pm).
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Vomiting, diarrhea, lightheadedness.
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: I don't have this information. MD would.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: ACTHIB diluent only was administered to the patient. Patient's mother was notified and asked to bring the child in to have the vaccination done again.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Moderate swelling, redness, mild tenderness, increased local temperature left upper arm.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Fatigue, Haemorrhage, Headache, Hypertension
Clinical narrative: Pt stated she received the PREVNAR vaccine in her right arm on 10/1/2018 and later that evening "blood leaked into arm, pain radiated up from arm to neck and head." She stated about 7 days after the vaccine she suffered from headaches, high blood pressure, low energy, tired, sick feeling and it has completely changed her life. She said she had to be put on blood pressure medication from this. Her doctor prescribed her blood pressure medication on 12/10/2018.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Laboratory test, Malaise, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt stated she received the PREVNAR vaccine in her right arm on 10/1/2018 and later that evening "blood leaked into arm, pain radiated up from arm to neck and head." She stated about 7 days after the vaccine she suffered from headaches, high blood pressure, low energy, tired, sick feeling and it has completely changed her life. She said she had to be put on blood pressure medication from this. Her doctor prescribed her blood pressure medication on 12/10/2018.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Amenorrhoea, Autoimmune disorder, Autoimmune thyroiditis, Endocrine test
Clinical narrative: Date is approximate but my 15 year old daughter received the GARDASIL vaccine and did not have another period after. I figured it was temporary since she had had very light periods until then. Two years later, my daughter informs me she still hasn't had a period. We went to the pediatrician, who ordered lab work, which led to specialists, more lab work and imaging studies, leading to a diagnosis of autoimmune ovarian failure. At a subsequent visit we were told she has also developed Hashimoto's thyroiditis. She now has no ovaries to speak of and must take hormone replacement (Both reproductive and thyroid). Since she has no eggs, she cannot give birth to her own children.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hormone replacement therapy, Immunology test, Laboratory test, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abdominal abnormal
Clinical narrative: Date is approximate but my 15 year old daughter received the GARDASIL vaccine and did not have another period after. I figured it was temporary since she had had very light periods until then. Two years later, my daughter informs me she still hasn't had a period. We went to the pediatrician, who ordered lab work, which led to specialists, more lab work and imaging studies, leading to a diagnosis of autoimmune ovarian failure. At a subsequent visit we were told she has also developed Hashimoto's thyroiditis. She now has no ovaries to speak of and must take hormone replacement (Both reproductive and thyroid). Since she has no eggs, she cannot give birth to her own children.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure, Ultrasound pelvis, Ultrasound pelvis abnormal
Clinical narrative: Date is approximate but my 15 year old daughter received the GARDASIL vaccine and did not have another period after. I figured it was temporary since she had had very light periods until then. Two years later, my daughter informs me she still hasn't had a period. We went to the pediatrician, who ordered lab work, which led to specialists, more lab work and imaging studies, leading to a diagnosis of autoimmune ovarian failure. At a subsequent visit we were told she has also developed Hashimoto's thyroiditis. She now has no ovaries to speak of and must take hormone replacement (Both reproductive and thyroid). Since she has no eggs, she cannot give birth to her own children.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Antiacetylcholine receptor antibody positive, Computerised tomogram head normal, Computerised tomogram thorax normal, Diplopia, Eyelid ptosis
Clinical narrative: Patient developed diplopia, eyelid ptosis, muscular weakness and fatigability within 24 hours of receiving the SHINGRIX shingles shot. Symptoms have persisted and patient was diagnosed with myasthenia gravis.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Myasthenia gravis, Scan with contrast normal
Clinical narrative: Patient developed diplopia, eyelid ptosis, muscular weakness and fatigability within 24 hours of receiving the SHINGRIX shingles shot. Symptoms have persisted and patient was diagnosed with myasthenia gravis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: Received SHINGRIX 50MCG/0.5ML SUSR - first dose. Within hours felt pain where shot was given. Within 24 hours felt weak, headache, shivers, nausea, diarrhea and belly pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: Received SHINGRIX 50MCG/0.5ML SUSR - first dose. Within hours felt pain where shot was given. Within 24 hours felt weak, headache, shivers, nausea, diarrhea and belly pain.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Abnormal behaviour, Pyrexia, Rash
Clinical narrative: The doctor gave her all the shots at once after I specifically asked him not to because my son and I have had adverse reactions, he went and did them all anyways in "combined vaccinations" and she ended up in the ER the next day with a rash(chicken pox, measles, who knows??) A fever of over 103 and we stayed most of the day. She was given steroids, rested, sent home. The rash took weeks to go away, she wasn't herself for months, it made me genuinely afraid of getting her next shots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bradycardia, Dizziness, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Received first SHINGRIX shot 01/22/2019 about 12:00 noon, administered by PCP. On the morning of 01/23/2019, BP 141/76 P 101, before taking BENICAR 20mg. At 11:40 felt weak, sweating, dizzy, pale - BP 75/44 P51. After consuming 12oz water, 5.5oz V-8 (450mg sodium), half an orange, at 11:50 BP 139/78 P 76. Saw PCP on 01/23/2019 at 1:00pm, BP 124/68 P84, temperature 99, EKG normal. The occurrence of the Bradycardia event is an anomaly, the only variable being the SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor
Clinical narrative: Received first SHINGRIX shot 01/22/2019 about 12:00 noon, administered by PCP. On the morning of 01/23/2019, BP 141/76 P 101, before taking BENICAR 20mg. At 11:40 felt weak, sweating, dizzy, pale - BP 75/44 P51. After consuming 12oz water, 5.5oz V-8 (450mg sodium), half an orange, at 11:50 BP 139/78 P 76. Saw PCP on 01/23/2019 at 1:00pm, BP 124/68 P84, temperature 99, EKG normal. The occurrence of the Bradycardia event is an anomaly, the only variable being the SHINGRIX shot.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient given SHINGRIX vaccine. Documentation in chart that 125 mg of SOLU-MEDROL given due to reaction to vaccine. No documentation of the exact reaction however. Patient transferred to local emergency room; however, the transfer appears to be related to hypertensive emergency. Documented blood pressure prior to vaccine administration was 209/101 with patient also complaining of nausea.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: 10 days after MMR developed measles-like rash, low grade fever. No cough, no coupe, no conjunctivitis, no Koplik spots.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Body temperature, Discomfort, Pruritus, Rash erythematous
Clinical narrative: 10 days after MMR developed measles-like rash, low grade fever. No cough, no coupe, no conjunctivitis, no Koplik spots.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a 4 year old male patient with no illness at time of vaccination. The patient's historical condition include asthma and eczema. Historical vaccines were not reported.Concomitant therapies included hydroxyzine and cetirizine hydrochloride( (ZYRTEC). On 18-SEP-2018, the patient was vaccinated with the second an improperly stored second dose of M-M-R II, subcutaneous in the left thigh, lot # R011802 (expiration date was not provided) and with an improperly stored fourth dose (also reported as 4/3) of QUADRACEL lot # C5325BA (expiration date was not provided), intramuscularly (IM) in the left thigh. Both vaccines were administered for prophylaxis and purchased with public funds. None patient experience was reported. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. No adverse effect was reported. Lot number R011802 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002765:
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 4 month old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 13-SEP-2018, the patient was vaccinated with ROTATEQ orally, lot # R007991, expiration date 18-OCT-2019 (strength, dose and anatomical location were not provided) for prophylaxis; PREVNAR 13 and PENTACEL (strength, dose, route, anatomical location, lot # and expiration date were for both not provided). On 22-NOV-2018, the patient experienced intussusception and was hospitalized due to the event on the same date. The treatment included a barium enema. The patient was discharged from the hospital on 23-NOV-2018. Therapy with ROTATEQ was discontinued, as it was stated that the patient had not and would not receive any additional doses of ROTATEQ due to the adverse event. The outcome of intussusception was reported as recovered. The causality between the event intussusception and the suspect therapies was not provided. Upon internal review the event intussusception was considered to be medical significant.
Age: 5.0
Sex: F
Vaccine: IPV, TD
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product label confusion, Wrong product administered
Clinical narrative: The patient also received a dose of Polio vaccine, manufacturer and lot # unknown, during the same visit. The patient did not experience any adverse reactions after Td administration. The responsible physician (source) reported that the medication error was due to label confusion. The healthcare facility had undergone some recent changes to their vaccine storage locations. At the time of vial verification for this case, the attending healthcare professional indicated that it was difficult to identify the name of the vaccine on the vial which resulted in Td being inadvertently selected and verified instead of DTaP.  The source went on to explain that the healthcare professionals normally use the vaccine abbreviations (e.g., Td, DTaP) and not the full product name on the vial, thereby adding confusion.; Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to a patient that was under the prescribed age for the vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red, hot, and indurated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under the arm pit (same arm as the vaccine was given in).
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Irritability
Clinical narrative: Fussiness; loose heme-positive stools.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Immunoglobulin therapy, Muscular weakness, Neuromyotonia, Tremor
Clinical narrative: Hospitalized on 9/30/18 with diagnosis of neuromyotonia, suspected Issacs' syndrome with leg weakness, tremors and diaphoresis. Treated with SOLU-MEDROL and IV immunoglobulin.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Immunoglobulin therapy
Clinical narrative: Patient should not have received live MMR vaccine within 2 years of stem cell graft. Vaccine was given in error 10 months post graft. IVIG administered prophylactically on 1/19/19. Patient is asymptomatic as of 1/25/19 and is being followed by oncology infectious disease physician until the end of the 21 day incubation period.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Bruising, pain.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Anti-ganglioside antibody positive, Multifocal motor neuropathy, Muscular weakness, Neurological examination abnormal, Ulnar nerve palsy
Clinical narrative: Patient had 2nd dose of vaccine on 12/6/18. On 12/25/18, patient had weakness in left hand. On neurologic exam and  electrodiagnostic testing, he had pure motor nerve palsy of left ulnar and median nerve. Blood work revealed elevated anti-GM1 antibody. There is a working diagnosis of multifocal motor neuropathy. On 1/25/19 pt was re-evaluated and found to have slight improvement in weakness. He has not received any treatment yet, but was offered IVIG which he is considering.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Balance disorder, Barium swallow normal, Blood test, CSF white blood cell count increased, Computerised tomogram head normal
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Coordination abnormal, Encephalitis, Gait inability, General physical condition decreased, Hypotonia
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Lumbar puncture, Nausea, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Posture abnormal, Pyrexia, Scan with contrast abnormal, Speech disorder, Ultrasound abdomen normal
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Vomiting
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Encephalitis, Guillain-Barre syndrome, Lethargy, Pyrexia
Clinical narrative: Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Balance disorder, Barium swallow normal, Blood test, CSF white blood cell count increased, Computerised tomogram head normal
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Coordination abnormal, Encephalitis, Gait inability, General physical condition decreased, Hypotonia
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Lumbar puncture, Nausea, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Posture abnormal, Pyrexia, Scan with contrast abnormal, Speech disorder, Ultrasound abdomen normal
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Vomiting
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4, HEPA
Symptoms: Encephalitis, Guillain-Barre syndrome, Lethargy, Pyrexia
Clinical narrative: Mother reports child with high fever 104, lethargy, approximately 2 weeks after vaccines given. Taken to pediatrician 1/23/19 and admitted to hospital. Mother states: "Diagnosis- inflammation of cerebellum, symptoms similar to Gillian Barre".
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Injection site pain
Clinical narrative: Flu like symptoms began to occur at about six hours after I received the shot. I had a loss of appetite, chills, headache and muscle aches. My left arm at the site of the shot was very sore. I retired and had the symptoms throughout the night. In the morning, I felt better but did not fully recover until about noon. This also occurred when I received the first dose on 08/03/2018.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Vaccine positive rechallenge
Clinical narrative: Flu like symptoms began to occur at about six hours after I received the shot. I had a loss of appetite, chills, headache and muscle aches. My left arm at the site of the shot was very sore. I retired and had the symptoms throughout the night. In the morning, I felt better but did not fully recover until about noon. This also occurred when I received the first dose on 08/03/2018.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Muscle mass, Muscular weakness
Clinical narrative: Patient has ongoing right side arm weakness. Patient can't lift right arm above horizontal to the ground. Patient developed a knot near or on the right trapezius muscle that has waxed and waned since onset of adverse event.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: INJECTION SITE REACTION THAT OCCURRED ABOUT 6 INCHES BELOW THE INJECTION SITE - REDNESS, SWELLING, NODULE UNDER THE SKIN - CLEARING UP EACH DAY. AS OF TODAY 1.25.19 THE SWELLING IS GONE, THE AREA IS LIGHT PINK, & THE NODULE IS ALMOST GONE.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Computerised tomogram head normal, Full blood count normal, Generalised tonic-clonic seizure, Urine analysis normal
Clinical narrative: Generalized tonic clonic seizure. It lasted about 1-2 minutes. The patient was evaluated in the ED and discharged. She has been acting normally since then.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Vomiting
Clinical narrative: Patient had fever of 103 and vomiting within 24 hours of vaccines.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness and swelling on right thigh that has resolved. Small pea sized knot located under the skin on right thigh 19 days later that mother states has decreased in size.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Patient developed a patch of hives that was warm to the touch 1 and 2 inches below the injection site on Wednesday 1/23/19. There was no reaction at the injection site. Then on Thursday, January 24th patient developed swelling from the base of her neck to her shoulder. She went to Urgent Care and was prescribed prednisone 20mg: 2 qd for 5 days.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue. On an unknown date, the outcome of the joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue were unknown. It was unknown if the reporter considered the joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient exercise 3 times per week with no known health problems. At the time of this report, the patient did not receive a 2nd dose of SHINGRIX. The several weeks after the 1st dose of SHINGRIX the patient started to notice some joint and muscle pain in the thighs and pelvic area. As time went on, these symptoms had gotten worse and now the patient had muscle stiffness and pain in the upper arms, shoulders, thighs along with joint pain. The symptoms were bilateral and symmetric and more pronounced when trying to kneel and getting up out of a chair after sitting for a while. The patient was also noticing some fatigue. The patient never had any of these symptoms before taking the SHINGRIX dose. The patient was asking did you (GSK) had reports of any similar side effects.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue. On an unknown date, the outcome of the joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue were unknown. It was unknown if the reporter considered the joint pain, myalgia of lower extremities, muscle stiffness, pain in arm, shoulder pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient exercise 3 times per week with no known health problems. At the time of this report, the patient did not receive a 2nd dose of SHINGRIX. The several weeks after the 1st dose of SHINGRIX the patient started to notice some joint and muscle pain in the thighs and pelvic area. As time went on, these symptoms had gotten worse and now the patient had muscle stiffness and pain in the upper arms, shoulders, thighs along with joint pain. The symptoms were bilateral and symmetric and more pronounced when trying to kneel and getting up out of a chair after sitting for a while. The patient was also noticing some fatigue. The patient never had any of these symptoms before taking the SHINGRIX dose. The patient was asking did you (GSK) had reports of any similar side effects.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 69-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 11th January 2019, the patient received the 1st dose of SHINGRIX. On 11th January 2019, 1 min after receiving SHINGRIX, the patient experienced injection site hemorrhage and injection site pain. On 11th January 2019, the outcome of the injection site hemorrhage was recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX on an unknown arm. The injection site began to bleed as the needle was released from the arm. The pharmacist consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX (batch number 2AH5M, expiry date 21st May 2021) for prophylaxis. On 14th January 2019, the patient received the 1st dose of SHINGRIX. On 15th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, rash and hives. On an unknown date, the outcome of the injection site erythema, injection site swelling, rash and hives were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, rash and hives to be related to SHINGRIX. Additional details were provided as follows: Approximately 24 hours after receiving the vaccine, the patient experienced redness and swelling at the injection site. The patient, also had hives and rash on back of legs, back, and chest. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced feeling unwell, fever and fatigue. On an unknown date, the outcome of the feeling unwell, fever and fatigue were unknown.  It was unknown if the reporter considered the feeling unwell, fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 68 or 69 years old. The day before reporting the patient received a dose of SHINGRIX and she was more concerned about the fever and fatigue. The patient asked about potential side effects. The reporter would not provide any details. The reporter disconnected abruptly.