chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPVX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This literature marketed report as received from the authors of the published article, entitled as stated below, refers to a 15 year old male patient. The authors analyzed the findings of the Vaccine Safety Datalink Guillain Barre Syndrome (GBS) surveillance following quadrivalent human papillomavirus vaccine (manufacturer unknown) from 2006 through 2015. Medical records were reviewed and ajudicated to confirm GBS. Among quadrivalent human papillomavirus vaccine (manufacturer unknown) recipients, the authors identified all potential electronic ICD-9 coded cases of GBS using the following definition: diagnostic ICD-9 code 357.0 within 142 days post-vaccination (whereas day 0 is day of vaccination), in either the inpatient, outpatient, or emergency department settings. An incident case of GBS following quadrivalent human papillomavirus vaccine (manufacturer unknown) was defined as the first diagnosis in the preceding 42 days. Seven cases of GBS were identified using the electronic case definition prior to medical record review. After performing medical record review, the authors confirmed only one case. The patient was a 15 year old male, who received his first dose of quadrivalent human papillomavirus vaccine (manufacturer unknown) on an unknown date (dose, lot#, expiry date, route of administration not reported). 15 days later, he was diagnosed with acute inflammatory demyelinating polyneuropathy, the most common form of GBS. The outcome of the event was not reported. The authors considered the event to be related to the suspect therapy. Upon internal review, GBS was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor, Urticaria
Clinical narrative: This spontaneous report as received from a office a nurse, referring to a female patient of unknown age. The patient's historical drugs, medical history concomitant therapies and concurrent conditions were not reported. On 27-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N019348, expiration date 08-feb-2019, intramuscular, for prevention of pneumonia (strength, dose and frequency were not reported). Later, on the same date, the patient experienced pain in arm that vaccine was administered in that was shooting into fingers (pain in extremity), fever, shaking and hives, so she began taking acetaminophen (TYLENOL) The patient sought medical attention by calling the nurse, but no intervention to prevent serious criteria was performed. No laboratory diagnostic studies were performed..The outcome of pain in extremity, fever, shaking and hives was unknown. The assessment causality between pain in extremity, ever, shaking, and hives with PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1710USA000621: US-009507513-1709USA015022:
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 03-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX vaccine on or about 22-SEP-2009, administered by a physician at a regional medical center, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2011, the patient was treated at a medical center emergency department, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 15-JUN-2011, the patient began a regiment of acupuncture therapy appointments for the treatment of shingles. The patient has been prescribed acyclovir, lidocaine (LIPODERM), gabapentin, and hydrocodone-acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Mouth swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 13Sep2017 at single dose for immunization. Medical history included diabetes and blood pressure. The patient was taking diabetes and blood pressure medicines and everything like others do at her age. The patient received the vaccine in the pharmacy as they give the vaccine to senior citizens. The patient experienced a certain area of her mouth had blown up on 25Sep2017. The patient stated "Let's say a week later, I ended up going to the dentist, so I go to a periodontist and she noticed that a certain area of my mouth had blown up". No treatment was provided for the adverse event. Outcome of the event was unknown.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Redness, sore muscle 2 hours after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Depressed level of consciousness, Injection site erythema, Injection site swelling
Clinical narrative: Patient does have a baseball-sized red area around the vaccination site. It is not warm to the touch but is slightly raised. She also reported on 10/4 that she has been feeling like she could pass out since last night. She also said her blood sugar is running lower than usual. I did contact her PCP on this end and encouraged her to do so as well.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Arthralgia, Contusion, Full blood count, Joint swelling
Clinical narrative: Swelling, bruising, and soreness in left forearm and wrist progressively after injection, unclear if related to injection; seen by primary care provider the following day, followed up again 2 times the following week, referred to and seen by orthopedic hand specialist.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test, Pain in extremity, Peripheral swelling, Prothrombin time
Clinical narrative: Swelling, bruising, and soreness in left forearm and wrist progressively after injection, unclear if related to injection; seen by primary care provider the following day, followed up again 2 times the following week, referred to and seen by orthopedic hand specialist.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast pain, Injection site erythema, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Patient had redness about an inch and a half away from the second injection site which was the flu shot. She also had some swelling in her armpit and lymph nodes along her side. She said her left breast was also sore. She had some nausea and malaise as well. I advised her to take some benadryl and if the redness spread or if her symptoms got any worse to contact her physician.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient had redness about an inch and a half away from the second injection site which was the flu shot. She also had some swelling in her armpit and lymph nodes along her side. She said her left breast was also sore. She had some nausea and malaise as well. I advised her to take some benadryl and if the redness spread or if her symptoms got any worse to contact her physician.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Areflexia, Balance disorder, Blood creatine phosphokinase normal, Bronchiolitis, CSF cell count increased
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: CSF culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased, CSF neutrophil count negative
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: CSF protein increased, CSF white blood cell differential, Cough, Cytomegalovirus test negative, Dyspnoea
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Fall, Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypophagia
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Immunoglobulin therapy, Lethargy, Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rhinorrhoea, Swelling, Ultrasound scan normal, Upper respiratory tract infection, X-ray of pelvis and hip normal
Clinical narrative: MMR and HiB vaccine given 8/31. Mum said to have noticed lethargy, inguinal swelling, fever and decreased oral intake 2 days after receiving the vaccine. No associated vomitting, no diarrhoea, no rash and no cough. No history of GI infection or URI in the weeks preceding administration of vaccines. 5 days after receiving vaccine, mum noticed that her gait was wide based with associated obvious attempt to maintain her balance by holding on to objects to avoid fall. She however does fall a couple of times. No history of associated difficulty in breathing, and no inability to swallow. No change in bowel and bladder function noticed. She had URI (runny nose, cough) with difficulty in breathing 2 weeks after vaccination on account of which mum gave her BENADRYL and 4 courses of breathing treatment for 2 days (2 times per day) because she felt her breathing looks exactly like when she had bronchiolitis in the past. Her symptoms subsequently resolved. CSF was clear in apperance, glu 59, prot 164, differential count- Nucleated cells 1, L 91%, M 9%, cell count 100. Floor Course: Patient arrived to the floor in stable condition. Gait was not reassessed because patient was asleep. Vitals: HR 102, RR 30, BP 128/72, T 36.7C, SpO2 99% RA. Hospital Course: CSF showed Albuminocytological dissociation, which is S/O Guillain Barre Syndrome. CSF Cx was obtained which showed NG 4 days on 10/03. Viral Cx shows CMV shell vial negative at 16 hours. Neuro was consulted: Seconded the possibility of Vaccine associated GBS. IVIG 2gm/kg DIV over 5 days. IVIG doses breakdown per day: 6 g, 6 g, 6 g, 4 g, 0 g. Was started on IVIG, and the improvement in Gait was noted. Gait improved from crawling to having wide based stepping gait, to wobbly to almost back to baseline gait. She started having much more balance in her gait. She finished her IVIG yesterday evening and was monitored overnight for neuro observation and any deterioration/warning sign, if present at all. She continue to have improved MSK status as described above with overall better mood, affect and health. 6 days ago, mum noticed that she started crawling rather than walking. No associated swelling, redness or differential warmth of the legs noticed. No history suggestive of positive Gower sign. Mum presented at pediatrician twice on account of this and blood work was done at the two encounters with no significant findings (BMP, ESR, CPK). She also had X ray and USS of the hips done with no significant findings. She was asked to see a neurologist today for a second opinion during which she was noticed to have absence of reflexes.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient presented with a red rash on her left arm this morning after receiving the influenza vaccine yesterday. Patient is an employee of our office and was receiving the influenza vaccine as part of our annual health fair.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: As a prerequisite to receiving a flu shot, I received a PCV13 (pneumococcal conjugate vaccine) yesterday afternoon. Apart from the usual swelling and associated pain, I have maintained a fever of 100 degrees since last night, and aspirin and ibuprofen have not brought it down.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Antibody test, Borrelia test, Eye movement disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: Patient arrived in our office on 10/3/17 at 3:35 PM complaining of (R) sided facial paralysis. She reports (L) arm/foot weakness and numbness which begin that morning. Vision exam revealed RT 20/13, LT 20/40. Exam show's facial paralysis, no weakness, denies tick exposure. Pt. can blink and move both eyes. No weakness noted of extremities. Ordered Lyme test. Began prednisone 20 mg (3) QD x 5 days, 2 tabs day 6 and 7, 1 tab days 8, 9, 10. Pt was reassesed at 8:00A 10/4/17. No change in facial paralysis. Vision - RT 20/13, LT 20/50. Pt. states it is more difficult to move eyes up and down and left to right. Referral to opthamologist today. Pt. appears stable at this time. Further monitoring ongoing. Pt. had endoscopy/colonoscopy approximately 2 weeks ago. Pt. received sedation.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Laboratory test, Muscular weakness, Visual field tests abnormal
Clinical narrative: Patient arrived in our office on 10/3/17 at 3:35 PM complaining of (R) sided facial paralysis. She reports (L) arm/foot weakness and numbness which begin that morning. Vision exam revealed RT 20/13, LT 20/40. Exam show's facial paralysis, no weakness, denies tick exposure. Pt. can blink and move both eyes. No weakness noted of extremities. Ordered Lyme test. Began prednisone 20 mg (3) QD x 5 days, 2 tabs day 6 and 7, 1 tab days 8, 9, 10. Pt was reassesed at 8:00A 10/4/17. No change in facial paralysis. Vision - RT 20/13, LT 20/50. Pt. states it is more difficult to move eyes up and down and left to right. Referral to opthamologist today. Pt. appears stable at this time. Further monitoring ongoing. Pt. had endoscopy/colonoscopy approximately 2 weeks ago. Pt. received sedation.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: 2 days after flu shot got joint pain in right elbow, fingers, knee and both sides of hip joint. And right toes.
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site, Nervousness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nervous in a adult male patient who received RABAVERT. On 23rd September 2017, the patient received RABAVERT. In September 2017, less than a week after receiving RABAVERT, the patient experienced nervous. On 23rd September 2017, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the nervous and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the nervous to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a molecular biologist who worked at a hospital and called on behalf of the  physician worked with. The health care professional stated that a dose of RABAVERT for pre-exposure was administered to the patient in the front of thigh and not in the deltoid muscle, which led to vaccine administered at inappropriate site. The heath care professional stated that the patient became nervous after administration because the patient read the prescribing information. The reporter did not have lot number or expiration date of the vaccine or further patient information.
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abdominal discomfort, Diplopia, Disturbance in attention, Drug administered at inappropriate site, Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nervous in a adult male patient who received RABAVERT. On 23rd September 2017, the patient received RABAVERT. In September 2017, less than a week after receiving RABAVERT, the patient experienced nervous. On 23rd September 2017, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the nervous and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the nervous to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a molecular biologist who worked at a hospital and called on behalf of the  physician worked with. The health care professional stated that a dose of RABAVERT for pre-exposure was administered to the patient in the front of thigh and not in the deltoid muscle, which led to vaccine administered at inappropriate site. The heath care professional stated that the patient became nervous after administration because the patient read the prescribing information. The reporter did not have lot number or expiration date of the vaccine or further patient information.
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Malaise, Nervousness, Rabies, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nervous in a adult male patient who received RABAVERT. On 23rd September 2017, the patient received RABAVERT. In September 2017, less than a week after receiving RABAVERT, the patient experienced nervous. On 23rd September 2017, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the nervous and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the nervous to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a molecular biologist who worked at a hospital and called on behalf of the  physician worked with. The health care professional stated that a dose of RABAVERT for pre-exposure was administered to the patient in the front of thigh and not in the deltoid muscle, which led to vaccine administered at inappropriate site. The heath care professional stated that the patient became nervous after administration because the patient read the prescribing information. The reporter did not have lot number or expiration date of the vaccine or further patient information.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Received a Flu shot at our workplace Healthy Screening Event and due to the administration of the vaccine being placed too high on arm, the nurse hit my deltoid tendon. I now cannot move my arm and have a lot of pain.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Agitation, Diarrhoea, Morbillivirus test positive, Polymerase chain reaction positive, Pruritus
Clinical narrative: Rash w/ head to toe papules, fever, diarrhea, pruritus, agitation, nasal secretions, ? koplick's spots.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular, Rhinorrhoea
Clinical narrative: Rash w/ head to toe papules, fever, diarrhea, pruritus, agitation, nasal secretions, ? koplick's spots.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized redness, swelling & tenderness to L deltoid at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reporting breaking out in hives on arms and legs the day after vaccination, and has continued for1 week.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient requested as per md instructions and received PREVNAR 13. Called back to inform she received same vaccine 12/16.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complaining of pain upon injection that ran all the way down arm to the fingertips. Pain has persisted until today's date (2 weeks) after vaccination.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain, Tearfulness
Clinical narrative: 9/21/17 receive flu shot, more painful than usual 9/22/17 right arm at site of injection extremely painful, in tears because it hurts to move my arm to remove or put on a shirt 9/23/17 -10/4/17 pain subsides, only hurts when using the muscle in which injection was shot in. 10/3/17 8:15am Went to doctor to have arm looked at. Doctor stated that it was shot too high in arm and it hit deltoid ligament. Must take ibuprofen around the clock, ice compresses, and taught physical therapy stretches to aid in recovery.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Reported a rash with swelling at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt states that within 1hr she experienced a headache and chills. This progressed over the next 48hrs to tremors and fever of 104. That is also when Pt noticed the injection site to be red and swollen. Pt went to see PCP, who prescribed keflex and prednisone 5 dose pack.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Pt states that within 1hr she experienced a headache and chills. This progressed over the next 48hrs to tremors and fever of 104. That is also when Pt noticed the injection site to be red and swollen. Pt went to see PCP, who prescribed keflex and prednisone 5 dose pack.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Nurse administered two Flu vaccines instead of one Flu and one Pneumo.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness radiating to neck and shoulder.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Hypophagia, Pyrexia, Vomiting
Clinical narrative: Pt. received vaccines at 8:39 in clinic. Developed a fever of 101. PO intake decreased by 2000 the night of receiving vaccines. Mom gave TYLENOL. T. max 104.5 w/last dose of TYLENOL given at midnight. Pt. was taken to the ER. Pt. also had 3 loose stools; 4 episodes of emesis.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pt complaint of shoulder pain w/movement or lifting. Says it started the day after administration (9/14/17). Pt has not treated yet. Reported on 10/3/17 to me. Recommended her to f/u w/her MD. Will follow up w/patient. Recommended NSAIDS.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to site. Approximately 12 cm diameter area of erythema to the right upper arm. Seen 48 hours after vaccination. Started on doxycycline on 9/29/17 (78 hours after).
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Peripheral swelling, Vaccination complication
Clinical narrative: Patient received a flu shot on 9/30/17. C/O swelling of upper arm (shoulder to lower forearm). Pt seen in office 10/3/17 -seems to be little better. -loos like localized vaccine reaction.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Neck pain
Clinical narrative: Neck pain, fatigue, headache 48 hours after flu shot, (negative exam for meningitis). Treatment: rest, ice, MOTRIN, massage of neck, monitor Sx, push fluids.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pain in extremity, Seizure, Unresponsive to stimuli
Clinical narrative: Pt. received HPV 1 in (R) arm IM. Pt. C/O (R) arm pain after vaccine administered. Pt. then received FLULAVAL in (L) arm IM. Within 1-2 min after vaccines given pt. reported "not feeling good". Pt. proceeded to lay down in prone position with head, neck, shoulders stiff and elevated off table. Pt. was unresponsive to touch and calling her name. No cyanosis observed. Then pt. had seizure activity lasting 5-7 sec. Pt. BP 132/68 after seizure. Incontinence of urine occurred. Pt. arousable right after seizure. Gave pt. water, rest, PEDIALYTE popsicle. Within 15-20 min after seizure pt. BP 104/62.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Urinary incontinence
Clinical narrative: Pt. received HPV 1 in (R) arm IM. Pt. C/O (R) arm pain after vaccine administered. Pt. then received FLULAVAL in (L) arm IM. Within 1-2 min after vaccines given pt. reported "not feeling good". Pt. proceeded to lay down in prone position with head, neck, shoulders stiff and elevated off table. Pt. was unresponsive to touch and calling her name. No cyanosis observed. Then pt. had seizure activity lasting 5-7 sec. Pt. BP 132/68 after seizure. Incontinence of urine occurred. Pt. arousable right after seizure. Gave pt. water, rest, PEDIALYTE popsicle. Within 15-20 min after seizure pt. BP 104/62.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Local reaction, Tenderness
Clinical narrative: Presented to our office 10/3/17 for follow up from osteomyelitis of left calcaneum. Mom reported a local reaction to flu vaccine, redness to injection site, 4cm in diameter, 1cm high- Tender. Lasted about 3-4 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Deltoid area is red, swollen and warm to touch.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Pt had Flu 2 hrs after getting shot. 3 days symptoms, called us 10/3/17 to report.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Ocular hyperaemia, Urticaria
Clinical narrative: Hives on face and neck, red eyes appox 1 to 1.5 hours post immuz. Pt also reported eating shellfish after immuz. Patient took oral BENADRYL 25mg followed by 50mg 4 hours later. Pt reported next am that symptoms were going away.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, drug reactions or allergies provided. The patient received denosumab (PROLIA) in July 2017 (reported as about 2 months ago). On 07-SEP-2017, the patient was vaccinated with ZOSTAVAX lot # M041669, expiration date: 09-JAN-2018, 0.65 ml, subcutaneously for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effects reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-OCT-2014, the patient was vaccinated at a Medical Care center with ZOSTAVAX (lot number, dosage, and route of administration not provided),  as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about September 4, 2016, was treated at Medical Care Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir and hydrocodone bitartrate and acetaminophen (VICODIN) for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthritis, Cellulitis, Condition aggravated, Erythema, Injection site pain
Clinical narrative: Pain at injection site starting evening of vaccination. Redness, swelling. Likely cellulitis. MD Rx'd prednisone. Believes vaccine aggravated arthritis.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Pain at injection site starting evening of vaccination. Redness, swelling. Likely cellulitis. MD Rx'd prednisone. Believes vaccine aggravated arthritis.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 3 days after receiving influenza vaccine, L deltoid became really sore. It continued to get worse through the weekend and beginning of the next week and felt like a shoulder dislocation. Has been having fevers, some warmth and redness in LUE and L shoulder.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Somnolence
Clinical narrative: Headache, joint pain, feeling tired or weak, feeling sleepy.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient received a GlaxoSmithKline flu vaccine (not specified) and had an anaphylactic reaction. They did not know if it was FLULAVAL or FLUARIX. No other details were known at time of report.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Haemorrhage
Clinical narrative: Excessive bleeding-pressure bandage Right arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had a red and hot patch of skin from immunization (upper deltoid) to her elbow. Lasted 2-3 day. No itching or pain.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient had a headache for a few days. Onset of headache 2 days post immunization. Feels fine 7 days post immunization.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Next day patient called -> chief complaints: soreness/pain injection site, redness/swelling more than 2'" diameter. No other symptoms, localized to injection site.
Age: 39.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: 11 days after receiving vaccines re: flu, MMR, varicella, noticed generalized rashes from head to legs and complain extreme itchiness.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came into the pharmacy on 9/25/17 with swollen, red, hot, puffy left arm. Patient reported that both vaccines were given in the left arm. Pharmacist recommend that patient takes BENADRYL and check with MD. Patient took prednisone and arm was back to normal on 9/27/17.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia, Skin warm
Clinical narrative: 9/22/17 Patient was sweaty "warm to the touch" in the evening. Felt like he had a fever. Went to bed early and it broke by the next morning. Patient is fine otherwise.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Site of inj is tender than usual and appears to be rashy - redness - swelling.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented on 10/04/2017 with redness and swelling on upper left arm, area below shoulder above elbow.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Palpitations, Tenderness
Clinical narrative: Palpation minimal tenderness on deltoid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Skin reaction
Clinical narrative: Large localized reaction on skin, rapidly expanding so treated with antibiotics for possible cellulitis.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: One day after receiving vaccine patient complained of swelling and redness at injection site. Patient went to PCP and was diagnosed with cellulitis and given Cephalexin 500mg #40 1 PO Q 6 H x10 days. Still being treated with antibiotics.
Age: 52.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Expired product administered
Clinical narrative: Pt given expired vaccine. GSK was called and there is no data with any adverse reactions. CDC recommends revaccination.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath that came on after vaccine was given. Patient reported it came on after 20 minutes of getting vaccine but was not exactly sure how long it took.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Rash, red, warm to touch 24 hours after vaccine. Was seen by ARNP who said to report it but did no treat with any medications.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Local redness and swelling.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: PENTACEL  expired on 10/1/2017  given today on 10/4/17, missed read the date backwards, and it was double checked by a provider as well. Will call pt. to come back and have shot again when we get the new order in.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Amniotic membrane rupture test positive, Blood glucose normal, Cervical dilatation, Delivery, Exposure during pregnancy
Clinical narrative: Pt G3P2 at 28.5 weeks with EDD of 12/22/17. Went to OB office on 10/3/17 for routine OB apt at 28.4 weeks. Pt was feeling well, feeling fetal movement, pt's fingerstick blood sugar was 138, Tdap was given per routine office policy. Later that evening, pt began to feel achy and had a low-grade fever of 99 degrees. Pt called MD at approx. 0230 on 10/4/17 to report possible spontaneous rupture of membranes. MD told her it was most likely not her water and to note if it kept coming out. Pt came to triage at hospital at approximately 0830 after feeling certain her water had broken and starting to be in some pain. AmniSure was positive and foul smell noted. Pt was 3cm at this time with no fetal heart tones found. Pt delivered fetal demise 10/4/17 at 1043 am. Baby weighed 1480g, or 3lbs. 4oz.