chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that possibly the patient was administered improperly stored GARDASIL on unspecified date. No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient who on 30-JAN-2014 was vaccinated with a dose of M-M-R II lot # J003623, HSA, exp date 22-MAR-2015 (dose and route not provided) and with a dose of VARIVAX (Merck), Lot # J006732, exp date 30-MAY-2015 (dose and route not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unkonwn age. No medical history or concurrent conditions were reported. On 10-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J011882. It was reported that the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion due to delayed shipping from 13-DEC-2013 to 17-DEC-2013. No adverse effects were reported and no further information was provided. This is one of a total of two reports from the same source document. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster
Clinical narrative: This spontaneous report was received from consumer refers to 74 years old male patient with shingles concerning her husband. Approximately in 2011 about 3 years ago, the patient was vaccinated with ZOSTAVAX injection, one time vaccine (dose unit, lot # and expiry date, route unknown) to prevent shingles. On an unknown date, patient started and was undergoing chemotherapy. On 28-JAN-2014 patient has developed shingles. Patient sought medical attention. The outcome of shingles and received shingles vaccine 3 years ago and he was undergoing chemotherapy was unknown. No further information was provided. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Mobility decreased, Pyrexia, Swelling
Clinical narrative: The swelling is associated with decreased mobility, fever and warmth. The patient denies any appetite change, bleeding, blistering, bruising, chest pain, diaphoresis, dyspnea, fatigue, generalized weakness, headache, joint pain, lymph.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported). On an unknown date, a second dose of PNEUMOVAX23 was inadvertently administered to the patient who also received PNEUMOVAX23 one month prior to the second dose. The dose was outside of recommended guidelines. No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: This spontaneous report as received from a physicians assistant via a company representative refers to a 15 year old female patient who was not pregnant. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, and route not provided). On an unknown date, the patient developed hives "all over her body" "immediately" after receiving the dose of GARDASIL. The patient was given BENADRYL, in the physicians assistant office after the hives developed. No laboratory tests were performed. After the BENADRYL was given to the patient, the hives subsided "a little bit". The outcome of hives all over her body was recovered. The physicians assistant was not planning to give the patient a second or third dose of GARDASIL. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of MMR II (lot # and dose not provided) subcutaneous in the anterolateral aspect of the thigh. No adverse effects were reported. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Death
Clinical narrative: None.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Activated partial thromboplastin time normal, Antinuclear antibody negative, Autoimmune thrombocytopenia, Computerised tomogram head normal, Conjunctival haemorrhage
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Ecchymosis, Eye contusion, HIV test negative, Haematuria, Haemoglobin decreased
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Heparin-induced thrombocytopenia test, Hepatitis B test negative, Hepatitis C test negative, Immunoglobulin therapy
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Melaena, Mouth haemorrhage, Platelet aggregation normal, Platelet count decreased, Platelet morphology normal
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Platelet transfusion, Prothrombin time normal, Smear site unspecified normal, Thrombocytopenia, Tongue haemorrhage
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: White blood cell count increased
Clinical narrative: This literature marketed report refers to a 57 year old male patient. Patient's past history included splenectomy at age eleven after a motor vehicle accident. The patient's medical condition included End stage renal disease (ESRD) and the patient was on haemodialysis. On an unknown date the patient was vaccinated with hepatitis B (recombinant) (manufacturer unknown) (strength, dose, dose number, route of administration, indication, lot number and expiration dates were not reported). He had received the vaccine previously with no documented adverse reaction. No concomitant medications were reported. On an unknown date (reported as two days after the vaccination) the patient was transferred from nursing home to a hospital due to an abnormally low platelet count (3000/ mm3) found on a blood test. The patient had noticed bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucosal bleeding in the mouth. A CT head on an unknown date showed no intracranial haemorrhage. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology. On an unknown date prothrombin time and active partial thromboplastin time were normal. Assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies were normal on an unknown date. On an unknown date serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. He was initially transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura (ITP) (life threatening, hospitalization) was made on an unknown date. The patient was started on IV SOLUMEDROL, intravenous immunoglobulin and aminocaproic acid. By the end of the fifth day, the platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow up on an unknown date. The event was considered as recovered. The author stated that the vaccine is usually well tolerated, with few side effects; but several cases of thrombocytopenia after recombinant vaccine have been described. ITP is thought to be caused by the presence of autoantibodies to glycoprotein II b/III a molecules present in the platelet membrane. Repeated doses of vaccine may function as a booster to autoantibody formation. The patient had rapid onset of thrombocytopenia. The author stated that immune thrombocytopenia can be a potential life threatening complication of Hepatitis B vaccination in adults. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Vaccine (Varicella) received 1-30-14 early afternoon. By 6:30 pm on same day client noted "quarter to fifty-cent" sized circles with dark edges on abd, chest, sides of body, and back. Referred to PCP or Urgent Care.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. On 20-JAN-2014 the patient was vaccinated with M-M-R II lot # 0705AA (dose and route not reported). On 20-JAN-2014 the physician administered expired M-M-R II (expiry date 11-MAY-2013). No adverse effects were reported. The outcome of administered expired M-M-R II is unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old post-partum female patient with temporomandibular joint syndrome (TMJ), migraines, sciatica, allergic rhinitis, Gastrooesophageal reflux disease (GERD), endometriosis, exercise induced asthma and TRAMADOL allergy. On 29-JAN-2014 the patient delivery an infant. On 30-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J011345, expiration date 11-JAN-2015, 0.5 ml, intramuscular in the left deltoid. On the same day, the patient was also vaccinated with ADACEL (reported also as a concomitant therapy) in the right deltoid. On 30-JAN-2014, the patient experienced sharp pain, swelling from the injection site to the hand, mildly elevated white blood count, numbness and fevers from 101 to 103 (units not provided). Patient experienced pain, significant, that she could not hold infant to breast feed. As the treatment BENADRYL, hydrocodone, acetaminophen and ibuprofen were administered. The pharmacist was unsure if patient would be discharged to home from hospital on 31-JAN-2014 due to fever. The outcome of sharp pain, swelling from the injection site to the hand, mildly elevated white blood count, numbness and fevers and relatedness between therapy and adverse events were not reported. The pharmacist requested lot check. Sharp pain was considered as significant disability by reporting pharmacist. This is one of several report received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old post-partum female patient with temporomandibular joint syndrome (TMJ), migraines, sciatica, allergic rhinitis, Gastrooesophageal reflux disease (GERD), endometriosis, exercise induced asthma and TRAMADOL allergy. On 29-JAN-2014 the patient delivery an infant. On 30-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J011345, expiration date 11-JAN-2015, 0.5 ml, intramuscular in the left deltoid. On the same day, the patient was also vaccinated with ADACEL (reported also as a concomitant therapy) in the right deltoid. On 30-JAN-2014, the patient experienced sharp pain, swelling from the injection site to the hand, mildly elevated white blood count, numbness and fevers from 101 to 103 (units not provided). Patient experienced pain, significant, that she could not hold infant to breast feed. As the treatment BENADRYL, hydrocodone, acetaminophen and ibuprofen were administered. The pharmacist was unsure if patient would be discharged to home from hospital on 31-JAN-2014 due to fever. The outcome of sharp pain, swelling from the injection site to the hand, mildly elevated white blood count, numbness and fevers and relatedness between therapy and adverse events were not reported. The pharmacist requested lot check. Sharp pain was considered as significant disability by reporting pharmacist. This is one of several report received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had no pertinent medical history. On 03-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml. Concomitant therapies included generic simvastatin (manufacturer unknown) and PREMARIN. On 03-DEC-2013, the patient experienced injection site reaction. The patient stated that the dose was administered on the front of the arm "just above the bend of my elbow". She stated that she was unsure whether it was given in the muscle, or if it was given in the subcutaneous tissue. She stated that 10 minutes after the injection, she began to have itchiness and redness and swelling at injection site. She stated that after 24 hours the itching stopped. She stated that the site was "about the size of a half dollar", and it was red, slightly raised and hard. The patient said that the swelling "felt like there were lumps in it". The injection site reaction had not improved since the injection. The patient stated that she went to the clinic and saw a physician's assistant, who recommended over the counter cortisone cream, did not do any lab work and diagnosed the event as "an allergic reaction". The patient stated that when she received ZOSTAVAX, she was taking generic simvastatin (manufacturer unknown) but that at an unspecified date after the injection she "had to stop taking the generic simvastatin (manufacturer unknown) because it gave me cramps in my legs". The outcome of cramps in legs was not provided. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Muscle spasms
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had no pertinent medical history. On 03-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml. Concomitant therapies included generic simvastatin (manufacturer unknown) and PREMARIN. On 03-DEC-2013, the patient experienced injection site reaction. The patient stated that the dose was administered on the front of the arm "just above the bend of my elbow". She stated that she was unsure whether it was given in the muscle, or if it was given in the subcutaneous tissue. She stated that 10 minutes after the injection, she began to have itchiness and redness and swelling at injection site. She stated that after 24 hours the itching stopped. She stated that the site was "about the size of a half dollar", and it was red, slightly raised and hard. The patient said that the swelling "felt like there were lumps in it". The injection site reaction had not improved since the injection. The patient stated that she went to the clinic and saw a physician's assistant, who recommended over the counter cortisone cream, did not do any lab work and diagnosed the event as "an allergic reaction". The patient stated that when she received ZOSTAVAX, she was taking generic simvastatin (manufacturer unknown) but that at an unspecified date after the injection she "had to stop taking the generic simvastatin (manufacturer unknown) because it gave me cramps in my legs". The outcome of cramps in legs was not provided. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse (RN) refers to a 16 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 08-JAN-2014 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular. There were no concomitant medications. It was reported that the patient was pregnant. The pregnancy was confirmed by urine pregnancy test, for which the patient sought medical attention. The patient became pregnant with Last Menstrual Period (LMP) of 26-DEC-2013 and Estimated Date of Delivery (EDD) of 02-OCT-2014. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was outcome pending. No Product Quality Complaint (PQC) and no adverse effects were reported because of this. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling at injection site, moderate erythema and edema, improved.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash started the evening of 1/31/14. Pt started with rash to the face (forehead, sides of eyes). She had rash on stomach, knees and lower back. The marks directly far apart from one another. Pt. has had 2 Varicella vaccines 1/2008, 6/2011.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Atrial fibrillation, Coma, Dyspnoea, Pain
Clinical narrative: Increased physical weakness, impaired breathing, previously undiagnosed atrial fibrillation, coma, excruciating pain.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Inflammation, Injection site induration, Pain
Clinical narrative: (R) thigh firm area under injection site. Size of lime per mom redness advised cool compress, ibuprofen for pain and inflammation.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Localized itching a few minutes after injection, then red, hot and swollen x 4 days. Question localized response 4 inch diameter.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 30 year old female patient who was asthmatic. The patient was not pregnant. On 25-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # not provided) dose and route as directed recommended due to history of asthma. Concomitant therapies included TDAP vaccine administered on the same day. In 2014, the patient developed a localized reaction on the right side of her arm that included swelling and redness of the size of a golf ball. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Age: 0.88
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, concerning an unspecified number of patients (patient's demographics not provided). Registered nurse first, requested temperature stability data for several vaccines. Then, stated that she believed that an unspecified number of patients may have received improperly stored GARDASIL. No symptoms reported. This is one of two reports from the same source (MARRS; 1402USA001214). Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Subjective fever x 2d.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: Immediately after injection with flu vaccine, pt had episode of hives/urticarial rash, concentrated on thighs and upper arms, some on face.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Sight of shot became hard and very hot area around shot sight became red and itchy.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling on injection area.  Joint pain and fatigue.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Extreme shoulder soreness radiating down arm and up to neck.  Its been 2 1/2 weeks and pain continues and at times is increasing making use of arm very painful.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Dehydration, Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Lethargy, vomiting, fever, crankiness, dehydration.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp 100 the next day.
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus, Pyrexia, Rash
Clinical narrative: Patient presented in office with bumps on arm, back, itching, fever 1 week ago for a few days.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Continued tenderness left deltoid, no swelling or redness.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Diarrhoea, Erythema multiforme, Rash
Clinical narrative: Full exam 1/16/14. Resolving pharyngitis - rapid strep negative. Returned 1/17/14 for vaccines. 1/18/14 Rash began on shoulder, then progressed through trunk and extremities. 1/19/14 Culture positive for strep - began Omnicef. 1/20/14 diarrhea x 1. 1/23/14 Evaluated by MD in another country - Dx E. Multiforme. No response to trial dose of BENADRYL.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Culture positive, Diarrhoea, Erythema multiforme, Rash, Streptococcus test negative
Clinical narrative: Full exam 1/16/14. Resolving pharyngitis - rapid strep negative. Returned 1/17/14 for vaccines. 1/18/14 Rash began on shoulder, then progressed through trunk and extremities. 1/19/14 Culture positive for strep - began Omnicef. 1/20/14 diarrhea x 1. 1/23/14 Evaluated by MD in another country - Dx E. Multiforme. No response to trial dose of BENADRYL.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Activated partial thromboplastin time, Arthralgia, Full blood count, Joint swelling, Prothrombin time
Clinical narrative: Received Hepatitis B vaccination 1/23/14. Began breaking out with red raised bumps from waist down to bottom of feet. 1/25/14 all joints started swelling and severe joint pain. (9.5 on 1-10 scale). Went to hospital ER and received injection of TORADOL, after blood draws and sent home with Naproxen and DAYPRO. Rash and severe joint pain improved 1/27/14.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Received Hepatitis B vaccination 1/23/14. Began breaking out with red raised bumps from waist down to bottom of feet. 1/25/14 all joints started swelling and severe joint pain. (9.5 on 1-10 scale). Went to hospital ER and received injection of TORADOL, after blood draws and sent home with Naproxen and DAYPRO. Rash and severe joint pain improved 1/27/14.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports palm-sized rash on hip after received vaccine on 1/27/14. She reported rash on 2/4/14 to pharmacy and instructed to contact MD.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Patient reports painful arm and difficulty sleeping at night - only reported to us 1/29/2014.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, TYP, YF
Symptoms: Lip swelling, Urticaria, Wheezing
Clinical narrative: Female received yellow fever, Hep B (peds) and HPV approx 09:45. Monitored x 30 minutes before leaving immunization clinic. Approx 12:20-12:22 member back in clinic c/o lips swelling; audible wheezes when attempting to breathe; hives noted on face and neck area. At 12:22 Epi 0.3mg given x1 at 12:45 BENADRYL 50mg IM given vitals at 12:22 137/83; P-78 - R-20 Temp 97.6. Transferred to cardiac room for continuous monitoring by Dr.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Somnolence
Clinical narrative: Patient started to feel very light headed. Did not pass out. Put on 6 liters of O2 and had Doctor come to look at her. Gave her some water and juice. Monitored for 15 minutes. Patient started to feel really sleepy. Called doctor again, left O2 on patient and monitored for 30 more minutes. Released by Dr. at 1354.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Dyspnoea, Dysstasia, Eye irritation
Clinical narrative: Eyes were burning, felt unsettled, then sharp pains in top right rib area under breast, shortness of breath followed by severe pain under breast & back area. Chest was hurting- Continued for 15-20 min, walked, tried to use restroom, continued to hold hand on rib area. Called neighbor (nurse) to come help me. I couldn't sit, lay down, trouble getting on/off toilet. felt like bad gas - daughter took me to ER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Flatulence, Laboratory test normal, Musculoskeletal chest pain, Restlessness
Clinical narrative: Eyes were burning, felt unsettled, then sharp pains in top right rib area under breast, shortness of breath followed by severe pain under breast & back area. Chest was hurting- Continued for 15-20 min, walked, tried to use restroom, continued to hold hand on rib area. Called neighbor (nurse) to come help me. I couldn't sit, lay down, trouble getting on/off toilet. felt like bad gas - daughter took me to ER.
Age: 25.0
Sex: F
Vaccine: DTAP, HPVX
Symptoms: Arthralgia, Chills, Influenza, Influenza virus test negative, Pyrexia
Clinical narrative: I originally started to have sore joints starting in the left arm that shot was administered around 8:00 PM. Around 9:00, my joints were sore all over. Around 10:00, I started to have mild sharp pain in my joints all over. I fell asleep around 10:00 PM and woke up around 12:00 AM 2/04/14 to horrible chill and severe sharp stabbing joint pain. I took my temperature and had a fever of 103.2. This went on throughout the night. When I was finally able to get out of bed at around 11, I called the hospital number and they scheduled me in with my doctor for 2:40 PM on 2/04/14. At first they thought it was the flu, but was confused after that test came back negative. They took my temperature at 102 degrees when I was seen. They don't know if it is an adverse reaction since it was rare. They told me to go back in if it gets worse. I've been taking Ibuprofen and it hasn't helped with reducing my fever. As of today, 2/05/14, I still have a fever of 102 and sore stabbing pain in my joints.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Convulsion, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after administering influenza and meningococcal vaccines patient had a syncopal episode and a generalized seizure for less than 1 minute.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Fall, Gait disturbance
Clinical narrative: According to mother of child, he was falling over and running into things more than usual.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in the left upper deltoid and decreased ROM in left shoulder.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom called office to state injection site was red and swollen. No difficulty breathing and no fever.  Mom advised to apply cold compress and to alternate Motrin and Tylenol for pain/swelling. Mom instructed to monitor the injection site and come to office if s/s worsen.  She came to office today (2/5/14) site was 1 3/4 x 1 3/4 red, raised, warm to touch, no fever, no vomiting, no difficulty breathing. Dr. looked at site and pt was advised to keep up with cold compresses and Motrin/Tylenol and to call the office or go to ER if S/S worsen.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Mom called stating pt was having a reaction to a shot with a big red bump.  No fever, no difficulty breathing.  Mom advised to apply cold compress and use Tylenol/Motrin and all office if symptoms worsened.  Next day, mom came to office with child stating bump was worse.  Red, raised and warm to touch on R thigh, 1 x 1/2 size area.  Dr. looked at area and advised mom that it is local reaction and to watch for worsening s/s.  continue cold compresses and Tylenol/Motrin for pain and swelling.  Please call office or ER if s/s worsen.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Back pain, Blood creatine phosphokinase increased
Clinical narrative: 10/16/2013: body aches, nausea, fatigue, afebrile, back pain. 10/17 - 10/31: weak, poor appetitie, fatigue, able to eat, walk. 11/15: weak, rubber like legs, difficult to stand and walk, aching legs. 11/11 worsening fatigue, weak voice, distal weakness, worse hands/feet. 11/15: pins, needles lower legs bilat. 11/18-11/21: ascending paresthesia to pelvis. 12/10 Begin IV solumedrol for 3 months; dizziness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, Decreased appetite, Dizziness, Dysphonia, Dysstasia
Clinical narrative: 10/16/2013: body aches, nausea, fatigue, afebrile, back pain. 10/17 - 10/31: weak, poor appetitie, fatigue, able to eat, walk. 11/15: weak, rubber like legs, difficult to stand and walk, aching legs. 11/11 worsening fatigue, weak voice, distal weakness, worse hands/feet. 11/15: pins, needles lower legs bilat. 11/18-11/21: ascending paresthesia to pelvis. 12/10 Begin IV solumedrol for 3 months; dizziness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Gait disturbance, Hepatic enzyme increased, Hepatitis C test negative, Muscular weakness
Clinical narrative: 10/16/2013: body aches, nausea, fatigue, afebrile, back pain. 10/17 - 10/31: weak, poor appetitie, fatigue, able to eat, walk. 11/15: weak, rubber like legs, difficult to stand and walk, aching legs. 11/11 worsening fatigue, weak voice, distal weakness, worse hands/feet. 11/15: pins, needles lower legs bilat. 11/18-11/21: ascending paresthesia to pelvis. 12/10 Begin IV solumedrol for 3 months; dizziness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, West Nile virus test negative
Clinical narrative: 10/16/2013: body aches, nausea, fatigue, afebrile, back pain. 10/17 - 10/31: weak, poor appetitie, fatigue, able to eat, walk. 11/15: weak, rubber like legs, difficult to stand and walk, aching legs. 11/11 worsening fatigue, weak voice, distal weakness, worse hands/feet. 11/15: pins, needles lower legs bilat. 11/18-11/21: ascending paresthesia to pelvis. 12/10 Begin IV solumedrol for 3 months; dizziness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching/pain at injection site.
Age: 51.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Pneumonia, Rhabdomyolysis
Clinical narrative: Weakness to lower extremities, seen and treated, diagnosed with Guillain-Barre.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP, ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Arthralgia, C-reactive protein increased, Erythema, Swelling
Clinical narrative: BILATERAL ANKLE PAIN, REDNESS, SWELLING.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP, ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Arthralgia, C-reactive protein increased, Erythema, Joint swelling
Clinical narrative: BILATERAL ANKLE PAIN, REDNESS, SWELLING.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Dizziness, Seizure like phenomena
Clinical narrative: Mother called office reporting taking child to ER due to "small seizure like symptoms" and child feeling light head.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Oral discomfort, Pain in extremity
Clinical narrative: Swollen painful hands, mouth feels strange.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No indication from patient that there were any adverse events.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Decreased appetite, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: 12:00 PM loss of appetite, 2:00 low energy, 3:30 complaining of sore leg and acting lethargic, 4:00 fever, 5:00 PM vomited once, 5:30 gave Ibuprofen, 6:00 fever gone and energy slowly returning, appetite remained low the rest of the night.