chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash, Injection site warmth, Pruritus, Skin discolouration
Clinical narrative: Patient reported rash, lump, and warmness at the injection site. ZOSTAVAX was administered on 10/22/12 and the rash appeared on 10/24/12. Itching resolved after 3 days after taking BENADRYL. Rash resolved after almost 7 days. Skin is discolored (grayish in color).
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Dyspnoea, Headache, Syncope
Clinical narrative: Loss of breath. Fainted. Headaches. Dizziness.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot# and dose not reported). On 01-NOV-2012 the patient contacted the pharmacist for medical attention. On 01-NOV-2012 the patient had developed a red 3" welt in diameter at the injection site. There was no pain associated with the event. Patient's status was not reported. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 years old male patient with high blood pressure, arthritis and thyroid replacement medication. On 26-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant medications included MOBIX, omeprazole, diltiazem hydrochloride, levothyroxine sodium, citalopram hydrobromide and amlodipine. On 28-OCT-2012 the patient broke out in a rash at the injection site after having ZOSTAVAX. The patient sought for unspecified medical attention. Patient's status was unknown. The caller would like to know if the patient should be around pregnant women or infants at all. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no known drug allergies. On 23-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as H012579, exp date 28-SEP-2013) subcutaneously in the "back of the arm in the axilla space, the part of the arm that jiggles." No other co-suspects were reported. No concomitant medications were reported. On 25-OCT-2012 the patient developed "a red, raised, itchy area about the size of her palm at the injection site". The patient called the pharmacist to seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of the report, the outcome of a red, raised, itchy area about the size of her palm at the injection site was reported as not recovered. The outcome of "Received ZOSTAVAX subcutaneously in the back of the arm in the axilla space the part of the arm that jiggles" was unknown. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a heath worker refers to a 41 years old female patient with no drug reactions/allergies. The patient's medical history included back pain and anxiety. The patient was subcutaneously vaccinated with a dose of 0.5 ml ZOSTAVAX (lot number reported as H011335, expiry date 08-SEP-2013) on 17-OCT-2012. No other co-suspects were reported. Concomitant medications included FLEXERIL and LEXAPRO. On 19-OCT-2012 the patient developed redness, swelling and itching on her right arm at the injection site after receiving ZOSTAVAX. The patient had sought medical attention via office visit. Ice packs and BENADRYL were given as treatment. The outcome of redness, swelling and itching on her right arm at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient who received ZOSTAVAX 2 weeks after vaccination developed lesions on both her arm and wrist. No treatment was given for adverse event. No laboratory studies were performed. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 year old female patient. The patient was vaccinated with 0.5 ml VARIVAX (merck) (route of administration and lot number unknown) in October 2012. No other co-suspects were reported. No concomitant medications were taken. The patient has no pertinent medical history and no drug reactions/allergies. In October 2012 the patient developed a rash consisting of 13 lesions on her thigh and hips subsequent to the vaccination. The patient sought unspecified medical attention. No treatment was given for the event. No lab/diagnostic studies were performed. The outcome of rash consisting of 13 lesions on the thigh and hips was reported as recovering. The relatedness for rash consisting of 13 lesions on the thigh and hips is unknown for VARIVAX (Merck).
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to patient of unknown age and gender. On 05-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The patient did not recover form the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of several reports from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed Vocational nurse refers to a 77 years old male patient with tetracycline allergy. The patient was vaccinated with ZOSTAVAX (dose, route and frequency not provided) (lot number reported as 0071AE and expiry date reported as 03-APR-2013, also reported as 03-APR-2020) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in September 2012 the patient experienced redness and swelling that became larger than size of a half dollar at the injection site. The patient sought medical attention by office visit. The patient was given BENADRYL. The outcome of redness at the injection site and swelling that became larger than size of a half dollar was reported as recovered on an unknown date in 2012. The relatedness for redness at the injection site and swelling that became larger than size of a half dollar was unknown for ZOSTAVAX. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.04
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Intercepted medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 weeks old male patient who on 12-JUL-2012 was accidentally vaccinated with ROTATEQ (lot number reported as 00418E, Exp. Date: 05-APR-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was not given the full dose, and only a couple of drops got in his mouth. No adverse events were reported. Follow up information has been received from the licensed practical nurse and refers to a 2 weeks old male patient with no pre-existing allergies, birth defects, medical conditions, adverse events following prior vaccination and no illness at the time of vaccination. On 12-JUL-2012 at 15:45, the patient was accidentally vaccinated with ROTATEQ (lot number reported as 0041AE; previously reported as 00418E; exp. date 05-APR-2013). The doctor walked into a room and noticed that a new float medical assistant had been just starting to give oral ROTATEQ to the child as she thought the child was 2 months old. The doctor realized that the child was only 2 weeks old and stopped her. The child only received 2-3 small drops. The reported that they monitored the child for weeks and the child was fine. No symptoms were reported as all. The nurse reported that there was no adverse events. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age. The reporter reported that VAQTA (lot # reported as 1228, exp Jun 2014) which had been exposed to 31 degrees fahrenheit for 62 hours were administered to multiple unspecified patients on 20-OCT-2012. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown age. Two patients were vaccinated with the first two doses of RECOMBIVAX HB (dose and lot # were unknown) intramuscularly on 05-APR-2012 and 12-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if two patients sought medical attention. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This spontaneous report was received from a 58 years old female patient concerning herself. The patient reported that on 24-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot no. not reported0 instead of a first dose of VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. The patient mentioned her titers were low for varicella and she needed the varicella vaccine for entrance to nursing school clinical. The patient mentioned her arm was sore after receiving ZOSTAVAX. The patient did not seek medical attention. At the time of the report, the patient was recovering from her arm swore. The relatedness for the events were unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.68
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, IPV, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 8 months old patient. On 06-SEP-2012, the 8 months old patient was vaccinated with a dose of 0.5 milliliter VAQTA (25 U) (dose, route and lot number unspecified). No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Age: 101.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This registered pharmacist reported that a 101 year old male patient was given on injection of ZOSTAVAX (lot number 670617/0618AA) (dose and route not reported) on 20-OCT-2012. The patient had not relevant medical history or relevant concomitant medications. The patient's relevant past drug history was unknown. The pharmacist discovered that the ZOSTAVAX that was given to the patient had expired on 26-JUl-2012. It was unknown if there was any relevant laboratory data. As of 30-OCT-2012, the patient had not been revaccinated and the outcome of his getting the expired ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age. The reporter reported that RECOMBIVAX HB (lot# reported as 0020AE, exp JUN 2014) which had been exposed to 31 degrees Fahrenheit for 62 hours were administered to multiple unspecified patients on 20-OCT-2012. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Nasopharyngitis, Stool analysis, Vomiting
Clinical narrative: Febrile illness.
Age: 0.15
Sex: M
Vaccine: RV5, RV5
Symptoms: Pyrexia
Clinical narrative: Febrile illness.
Age: 1.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Initial case was received from a consumer on 25 October 2012. A 20-month-old male patient received a right thigh intramuscular injection of PENTACEL, sanofi pasteur Ltd., lot number C4058AA; a lateral right thigh intramuscular (IM) injection of ENGERIX, GSK, lot number AHBVB977CA; a lateral left thigh intramuscular injection of PCV13, Wyeth, lot number F63666; and an anterior lateral left thigh subcutaneous (SC) injection of MMR II, Merck, lot number 1406AA, on 18 October 2012. On 24 October 2012, six days after vaccination, the patient had a febrile seizure and was seen in the emergency room (ER). Diagnostic or laboratory testing was reported as unknown. Treatments were not reported. The patient's past medical history, allergies and illness at time of vaccination were reported as none. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 1.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Initial case was received from a consumer on 25 October 2012. A 20-month-old male patient received a right thigh intramuscular injection of PENTACEL, sanofi pasteur Ltd., lot number C4058AA; a lateral right thigh intramuscular (IM) injection of ENGERIX, GSK, lot number AHBVB977CA; a lateral left thigh intramuscular injection of PCV13, Wyeth, lot number F63666; and an anterior lateral left thigh subcutaneous (SC) injection of MMR II, Merck, lot number 1406AA, on 18 October 2012. On 24 October 2012, six days after vaccination, the patient had a febrile seizure and was seen in the emergency room (ER). Diagnostic or laboratory testing was reported as unknown. Treatments were not reported. The patient's past medical history, allergies and illness at time of vaccination were reported as none. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat closing in a 54-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 2 November 2012 at 11:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left deltoid). On 2 November 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced felt like throat closing off, rash, shortness of breath and swallowing difficult. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Rash, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat closing in a 54-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 2 November 2012 at 11:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left deltoid). On 2 November 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced felt like throat closing off, rash, shortness of breath and swallowing difficult. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Antibody test normal, Antinuclear antibody negative, Ataxia, Biopsy brain abnormal, CSF glucose normal
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: CSF lactate dehydrogenase normal, CSF lactate normal, CSF protein normal, CSF white blood cell count negative, Central nervous system lesion
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Cytokeratin 18, Dysphonia, Epstein-Barr virus test negative
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Flow cytometry, Gait disturbance, Gaze palsy, Gliosis, Herpes simplex serology negative
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Immunohistochemistry, Infrequent bowel movements, Laboratory test normal, Laparoscopic surgery
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Lymphocytic infiltration, Mycobacterium test negative, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Renal cell carcinoma, Saccadic eye movement, Sensory disturbance, Serology normal, T-lymphocyte count increased
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Viral test negative
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Ataxia, Biopsy brain abnormal, Central nervous system inflammation, Dysarthria, Gliosis
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 80.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Lymphocytic infiltration, Macrophages increased
Clinical narrative: Case number PHHY2012US098271, is an initial literature report received from health care professional on 27 Oct 2012. This article reports a case that developed chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids following INFLUENZA vaccination. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with INFLUENZA (batch number and manufacturer unknown) on an unspecified date. On an unknown date two weeks post vaccination the patient presented with numbness of his right hand that ultimately progressed to involved both lower extremities and face and was associated with mild dysarthria and ataxia. The biopsy revealed primarily reactive T-cell lymphocytic infiltrates with macrophages and gliosis. Treatment required long-term immunosuppressive therapy. The patient was diagnosed with a newly described inflammatory process that primarily involves the pons and adjacent structures, which is called chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). The final outcome of the events, seriousness and causal relationship to INFLUENZA vaccine was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort
Clinical narrative: Person noted at time of injection, felt discomfort at site. Localized discomfort continued since and now has increased to where she has discomfort when trying to raise left arm above shoulder height.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Blood test abnormal, Chest pain, Drug administered at inappropriate site, Ear pain
Clinical narrative: Case number PHEH2012US021199 is an initial spontaneous report received from a consumer (who is also a nurse) on 26 Oct 2012. This report refers to a 57-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly in the left arm on 14 Sep 2012. She believed that the vaccine was administered too high in the muscle and immediately she had symptom of injection site pain that caused her to yell out and almost jump out of the chair. Within 20 minutes she could not lift her arm and developed pain which she described as "explosive pain" for the remaining day and evening. She stated that she could not lie on that arm. She woke with armpit pain and nerve like pain that wrapped around to scapula area and bicep with shooting pain to hand, wrist and fingers. The pain had never stopped since administration and it was rated as 10+. She later saw an internist and was given a steroid dose pack which reduced the pain. It was reported that the pain recurred after the dose pack was completed. She saw a neurosurgeon later who also prescribed the steroid dose pack. On an unknown date, she experienced a fever of 101 degree (units not reported). She was scheduled for EMG and MRI. She stated that pain was in neck and jaw. It was reported that her ear was now with shooting pain in ear canal and in the morning she could not open her jaw to chew. She had pain in thoracic and sternal area when she takes deep breath. Currently she was on treatment with VICODIN for pain and ADVIL. She had blood tests on 26 Oct 2012 and was diagnosed with probable brachioneuritis. The outcome of the event was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Neck pain, Neuralgia
Clinical narrative: Case number PHEH2012US021199 is an initial spontaneous report received from a consumer (who is also a nurse) on 26 Oct 2012. This report refers to a 57-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly in the left arm on 14 Sep 2012. She believed that the vaccine was administered too high in the muscle and immediately she had symptom of injection site pain that caused her to yell out and almost jump out of the chair. Within 20 minutes she could not lift her arm and developed pain which she described as "explosive pain" for the remaining day and evening. She stated that she could not lie on that arm. She woke with armpit pain and nerve like pain that wrapped around to scapula area and bicep with shooting pain to hand, wrist and fingers. The pain had never stopped since administration and it was rated as 10+. She later saw an internist and was given a steroid dose pack which reduced the pain. It was reported that the pain recurred after the dose pack was completed. She saw a neurosurgeon later who also prescribed the steroid dose pack. On an unknown date, she experienced a fever of 101 degree (units not reported). She was scheduled for EMG and MRI. She stated that pain was in neck and jaw. It was reported that her ear was now with shooting pain in ear canal and in the morning she could not open her jaw to chew. She had pain in thoracic and sternal area when she takes deep breath. Currently she was on treatment with VICODIN for pain and ADVIL. She had blood tests on 26 Oct 2012 and was diagnosed with probable brachioneuritis. The outcome of the event was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pain in jaw, Painful respiration, Pyrexia
Clinical narrative: Case number PHEH2012US021199 is an initial spontaneous report received from a consumer (who is also a nurse) on 26 Oct 2012. This report refers to a 57-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly in the left arm on 14 Sep 2012. She believed that the vaccine was administered too high in the muscle and immediately she had symptom of injection site pain that caused her to yell out and almost jump out of the chair. Within 20 minutes she could not lift her arm and developed pain which she described as "explosive pain" for the remaining day and evening. She stated that she could not lie on that arm. She woke with armpit pain and nerve like pain that wrapped around to scapula area and bicep with shooting pain to hand, wrist and fingers. The pain had never stopped since administration and it was rated as 10+. She later saw an internist and was given a steroid dose pack which reduced the pain. It was reported that the pain recurred after the dose pack was completed. She saw a neurosurgeon later who also prescribed the steroid dose pack. On an unknown date, she experienced a fever of 101 degree (units not reported). She was scheduled for EMG and MRI. She stated that pain was in neck and jaw. It was reported that her ear was now with shooting pain in ear canal and in the morning she could not open her jaw to chew. She had pain in thoracic and sternal area when she takes deep breath. Currently she was on treatment with VICODIN for pain and ADVIL. She had blood tests on 26 Oct 2012 and was diagnosed with probable brachioneuritis. The outcome of the event was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Radiculitis brachial, Trismus
Clinical narrative: Case number PHEH2012US021199 is an initial spontaneous report received from a consumer (who is also a nurse) on 26 Oct 2012. This report refers to a 57-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly in the left arm on 14 Sep 2012. She believed that the vaccine was administered too high in the muscle and immediately she had symptom of injection site pain that caused her to yell out and almost jump out of the chair. Within 20 minutes she could not lift her arm and developed pain which she described as "explosive pain" for the remaining day and evening. She stated that she could not lie on that arm. She woke with armpit pain and nerve like pain that wrapped around to scapula area and bicep with shooting pain to hand, wrist and fingers. The pain had never stopped since administration and it was rated as 10+. She later saw an internist and was given a steroid dose pack which reduced the pain. It was reported that the pain recurred after the dose pack was completed. She saw a neurosurgeon later who also prescribed the steroid dose pack. On an unknown date, she experienced a fever of 101 degree (units not reported). She was scheduled for EMG and MRI. She stated that pain was in neck and jaw. It was reported that her ear was now with shooting pain in ear canal and in the morning she could not open her jaw to chew. She had pain in thoracic and sternal area when she takes deep breath. Currently she was on treatment with VICODIN for pain and ADVIL. She had blood tests on 26 Oct 2012 and was diagnosed with probable brachioneuritis. The outcome of the event was not reported.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Lipase increased, Pancreatitis, Vomiting
Clinical narrative: Vomited 10/24/12 abdominal pain - epigastric - beginning 10/25/12. Diagnosed with pancreatitis.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Provider reports pt. developed numerous brief seizures after administration.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal X-ray, Abdominal pain upper, Activities of daily living impaired, Blood test normal, Fluid intake reduced
Clinical narrative: Daughter given 3rd shot of GARDASIL on 10/17/2012. Had severe headaches and stomach pain/cramping starting on 10/19/2012. Threw up 4 times that night. Did not eat and limited liquids. Took to Hospital ER early on Saturday 10/20/2012. IV, pain medication for headache and medication for cramping. Pain and discomfort subsided some. Blood and Urine tests came back with no issue. Xray of stomach showed no issues. Discharged in the afternoon with prescription for Mirasol. Sunday late, threw up again after attempting to eat some. Stayed home from school on Monday and Tuesday. Tuesday morning, pain and discomfort spiked again similar to Saturday morning. Took to ER again. Blood work normal again. Ultrasound done with no findings. IV given again. Pain subsided again. Doctors unable to determine cause of issues. Symptoms experienced list as potential side effects.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypophagia, Ultrasound scan normal, Urine analysis normal, Vomiting
Clinical narrative: Daughter given 3rd shot of GARDASIL on 10/17/2012. Had severe headaches and stomach pain/cramping starting on 10/19/2012. Threw up 4 times that night. Did not eat and limited liquids. Took to Hospital ER early on Saturday 10/20/2012. IV, pain medication for headache and medication for cramping. Pain and discomfort subsided some. Blood and Urine tests came back with no issue. Xray of stomach showed no issues. Discharged in the afternoon with prescription for Mirasol. Sunday late, threw up again after attempting to eat some. Stayed home from school on Monday and Tuesday. Tuesday morning, pain and discomfort spiked again similar to Saturday morning. Took to ER again. Blood work normal again. Ultrasound done with no findings. IV given again. Pain subsided again. Doctors unable to determine cause of issues. Symptoms experienced list as potential side effects.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: Daughter given 3rd shot of GARDASIL on 10/17/2012. Had severe headaches and stomach pain/cramping starting on 10/19/2012. Threw up 4 times that night. Did not eat and limited liquids. Took to Hospital ER early on Saturday 10/20/2012. IV, pain medication for headache and medication for cramping. Pain and discomfort subsided some. Blood and Urine tests came back with no issue. Xray of stomach showed no issues. Discharged in the afternoon with prescription for Mirasol. Sunday late, threw up again after attempting to eat some. Stayed home from school on Monday and Tuesday. Tuesday morning, pain and discomfort spiked again similar to Saturday morning. Took to ER again. Blood work normal again. Ultrasound done with no findings. IV given again. Pain subsided again. Doctors unable to determine cause of issues. Symptoms experienced list as potential side effects.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Clinic manager notified me-pharmacist- that they believe that a MENVEO vaccine was diluted with sterile diluent vs. the provided liquid component. Unsure of which pt it happened. There was a report requested of the dates that the vaccine could have been given. After the report was provided it was narrowed down to a 13 yof that the product use error occurred on.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Dizziness, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: Employee developed lightheadedness with tingling & numbness to BUE with palpitations 20 minutes after receiving Flu vaccine. Symptoms did not subside after laying flat for 30 minutes so was taken to ED for monitoring. Given one liter of fluid for dehydration & discharged.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception requiring open surgical reduction 10/16/2012 - 13 days after vaccine administration.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Erythema, Pain, Pharyngeal oedema
Clinical narrative: Developed cough, swollen breasts, redness on chest area, swollen throat, chills, heart rate of 120, body aches, runny nose.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Swelling
Clinical narrative: Developed cough, swollen breasts, redness on chest area, swollen throat, chills, heart rate of 120, body aches, runny nose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dysphonia, Pallor
Clinical narrative: Dizziness, weakness, paleness, hoarseness.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Oral pruritus
Clinical narrative: Developed swollen upper lip and itchy palate approx 30 minutes after receiving vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warmth, and soreness at the injection site.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received shot in left arm.  Developed arm swelling and erythema from upper arm to mid forearm.  Seen by pediatrician.  Started Keflex.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Migratory left upper chest soreness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain
Clinical narrative: Rapid onset pain and muscle weakness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Orange sized redness and swelling at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Pain, Pyrexia, Tinnitus
Clinical narrative: Severe headache stuffiness ringing in ears fever body aches.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Sore arm on day of injection (11/05/12). Woke up next morning (11/06/12) with body aches & headache, neck & shoulder pain, severe pain at injection site. Fatigued and weak all day. Rigors started around 4:30 PM. Fever of 101 degrees at 8:00 PM. On day 3 (11/07/12), significant pain at injection site persists, but fever has subsided.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm on day of injection (11/05/12). Woke up next morning (11/06/12) with body aches & headache, neck & shoulder pain, severe pain at injection site. Fatigued and weak all day. Rigors started around 4:30 PM. Fever of 101 degrees at 8:00 PM. On day 3 (11/07/12), significant pain at injection site persists, but fever has subsided.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms/twitching in left arm/shoulder area where shot was administered. They come and go, but have been a constant, daily nuisance since the day after my flu shot. Only happens in spot on arm where shot was given. Hasn't gotten any better. Haven't treated the symptoms with any medication yet.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature decreased, Body temperature increased, Headache, Rash
Clinical narrative: RASH ON ARMS BACK FACE CHEST  AND LEGS DOWN TO ANKLES. HEAD ACHES. RUNNING A TEMP FROM 95.5 TO 101.1. FEELING WEAK.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Sore in left shoulder area. Left shoulder area achy at rest and severe pain when mobilizing.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Sore in left shoulder area. Left shoulder area achy at rest and severe pain when mobilizing.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Asthenia, Blood glucose normal, Deafness, Hyperhidrosis, Loss of consciousness
Clinical narrative: After receiving 5 vaccines, patient began getting weak. Pt became very pale, sweaty, eyes fixed, weak- leaning forward. Pt was positioned with back/head against wall. He then became nauseous and kept saying "why can't I hear". He kept passing out, then coming to (3 times). Ammonia inhalants and cold wet paper towels were used off and on to try to keep patient from passing out. EMS was called. BP and pulse checks: 10:50 73/34, 47; 10:52 78/47, 66; 10:55 95/33, 63; 11:03 96/58 standing (after feeling better when 911 arrived). Blood sugar 94.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Nausea, Pallor, Pupil fixed
Clinical narrative: After receiving 5 vaccines, patient began getting weak. Pt became very pale, sweaty, eyes fixed, weak- leaning forward. Pt was positioned with back/head against wall. He then became nauseous and kept saying "why can't I hear". He kept passing out, then coming to (3 times). Ammonia inhalants and cold wet paper towels were used off and on to try to keep patient from passing out. EMS was called. BP and pulse checks: 10:50 73/34, 47; 10:52 78/47, 66; 10:55 95/33, 63; 11:03 96/58 standing (after feeling better when 911 arrived). Blood sugar 94.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Pyrexia, Tenderness
Clinical narrative: Reports 100 degree F fever through night, at 7am noticed red area larger than hand underside of right arm.  Area red, hard and extremely tender.  On 11/7/2012 states has seen improvement.