chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Arm started out slightly tender as usual after vaccination. Pain slowly progressed and has continued to date 3/9/2014. I talked to pharmacist and he suggested they possibly hit a nerve. I have severe pain when trying to remove my shirt over my head, I also have pain when attempting to reach behind or straight out to the side. The pain seems to move anywhere from my shoulder to my forearm. I cannot sleep on my left side due to pain at night. Pain is worse at night and very severe if I force movement in certain directions. I have not been to my physician. I had hoped it would get better with time.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: POSSIBLE CELLULITIS--ROUND RED AREA 7 INCHES WITH DARKER AREA ABOUT 3 INCHES NEAR INJECTION SITE.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Convulsion, Cyanosis, Gaze palsy, Tonic clonic movements
Clinical narrative: Seizure activity-upward rolling of the eyeballs, tonic-clonic movement of the extremities, perioral cyanosis, altered consciousness lasting for 10 seconds. After the event, she was responsive, cyanosis resolved, able to tolerate PO. Observed in the office for an hour.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bruxism, Computerised tomogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Shaking, jaw clenching, vomiting blurred vision tingling in arms and legs loss of sensation in arms and legs.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Sensory loss, Tremor, Vision blurred, Vomiting
Clinical narrative: Shaking, jaw clenching, vomiting blurred vision tingling in arms and legs loss of sensation in arms and legs.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Malaise, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Sore throat, increased trouble breathing, whites of eyes turned bright red, felt sick. I had similar but less severe reaction to flu vaccine the prior year in 2009. I took Benadryl and breathing difficulty did not get worse.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: Fatigued, nauseous, severe persistent headache for four and a half days (ibuprofen and Excedrin only minimize the headache), dizziness, muscle weakness. Symptoms still strong after 4 days vaccine was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: Erythema, warmth, at injection site. Headache.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Rash
Clinical narrative: Pt. developed rash on both lower legs he states it does not itch, but he feels kind of "queasy".
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Autopsy, Biopsy, Blindness, Death
Clinical narrative: Case number PHHY2014US012738, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514648) website on 03 Feb 2014 and a follow up report from the Quality Assurance department (QA ref: 279084) received on 05 Mar 2014. This report refers to a 35-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with AGRIFLU (batch number: 1309001, expiration date: 30 Apr 2014) on 04 Oct 2013. On 03 Nov 2013, he experienced loss of vision and was admitted to the medical center at 07:00 AM. The outcome of the event was reported as not recovered. On 05 Nov 2013, the patient died (reason unknown). It was reported that the autopsy and biopsy were performed and the results are awaited. The seriousness and causality of the events were not reported. Batch review report (reference number: 279084) received from quality assurance department on 05 Mar 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1309001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 05 Mar 2014: Batch review report was updated. Expiry date of FLUVIRIN was updated.
Age: 59.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a nurse refers to a 59 year old female patient. No information regarding the patient's medical history was provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 with valid lot # J011651, subcutaneously in the left arm, ZOSTAVAX with valid lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the right deltoid. No concomitant medication was reported. On 17-DEC-2013 the patient experienced redness at the elbow. The outcome of redness at the elbow was reported as recovered/resolved. No causality assessment was provided. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 year old female patient. No information regarding the patient's medical history was provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 with lot # J011651, subcutaneously in the left arm, ZOSTAVAX with lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the right deltoid. No concomitant medication was reported. On 17-DEC-2013 the patient experienced redness at the elbow. The outcome of redness at the elbow was reported as recovered/resolved. No causality assessment was provided. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Chills, Cough, Dizziness, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 57 year old female patient. No information regarding the patient's medical history was provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 with lot # J011651, subcutaneously in the left arm, ZOSTAVAX with lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the right deltoid. Concomitant therapy included prednisolone (manufacturer unknown). On 17-DEC-2013 the patient experienced chills, dizziness, cough, fever 102.5 and flu like symptoms. The outcome of flu like symptoms, dizziness, cough, fever 102.5 and chills was reported as recovered/resolved. No causality assessment was provided. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Vaccination site swelling, Viral infection
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 year old female patient. No information regarding the patient's medical history was provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 with lot # J011651, subcutaneously in the left arm, ZOSTAVAX with lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the right deltoid. No concomitant medication was reported. On 17-DEC-2013 the patient experienced a swollen arm at vaccination site and was told that it was a viral infection. The patient received antibiotics. The outcome of viral infections and swollen arm at site was reported as recovered/resolved. No causality assessment was provided. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old female patient. Medical history was not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651 dose 1, subcutaneous in the left arm. Other suspect therapies could included ZOSTAVAX and BOOSTRIX. The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitant, that day. On 17-DEC-2013 the patient experienced flu like symptoms. The outcome of flu like symptoms was reported as recovered/resolved (dates not provided). This case was linked to cases: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 47 year old female patient. Medical history was not provided. On 17-DEC-2013 the patient was vaccinated (doctors order to receive vaccination) with PNEUMOVAX 23 lot # J011651 dose 1, subcutaneous in the left arm. Other suspect therapies could included ZOSTAVAX and BOOSTRIX. The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly, that day. On 17-DEC-2013 the patient experienced fever, achy and pain in arm. The outcome of fever, achy and pain in arm was reported as recovered/resolved (dates not provided). This case was linked to cases: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252, and 1403USA003253 (same reporter). Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Feeling cold
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 year old female patient. The patient denied illness at time of vaccination. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the left arm. The same day the patient was vaccinated with ZOSTAVAX lot # J011338, subcutaneous in the left arm and BOOSTRIX lot # 32S2B, intramuscular in right deltoid. No concomitant medication. On 17-DEC-2013, the patient experienced freezing, chills, tired and hurting under armpit. The outcome of freezing, tired, chills and hurting under arm was reported as recovered/resolved. The causal relationship was not provided. This case is linked to 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. Medical history was not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX23 lot # J011651 dose 1, subcutaneous in the left arm. Other suspect therapies could included ZOSTAVAX and BOOSTRIX. The nurse reported that all patients received PNEUMOVAX 23, but some of the patients may also have received ZOSTAVAX concomitantly, that day. On 17-DEC-2013 the patient experienced flu like symptoms. The outcome of flu like symptoms was reported recovered/resolved (dates not provided). This case was linked to cases: 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 57 year old female patient with no reported medical history. On 17-DEC-2013 (time 8-1) the patient was vaccinated with PNEUMOVAX23 lot # J011651 dose 1, subcutaneous in the left arm. Other suspect therapies included ZOSTAVAX and DTAP-IPV. No concomitant medication was reported. On 17-DEC-2013 the patient experienced headache, achy chills and the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly (medication error). No treatment information was reported. The outcome of achy, headaches and chills was reported as recovered/resolved. The reporters relatedness of achy, headaches and chills to PNEUMOVAX 23 and ZOSTAVAX is unknown. This report is linked (same reporter link) to: 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222,  1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003228, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252, 1403USA003253 (same reporter). Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly. This spontaneous report as received from a registered nurse refers to a 61 year old male patient. The patient denied pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient denied illness at time of vaccination. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the left arm. The same day the patient was vaccinated with ZOSTAVAX lot # J011338, subcutaneous in the left arm and BOOSTRIX lot # 32S2B, intramuscular in right deltoid. No concomitant medication. On 17-DEC-2013 the patient experienced arm red and sore. The outcome arm red and sore was reported as recovered/resolved. Causal relationship was not provided. This case is linked to 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003330, 1403USA032331, 1403USA032332, 1403USA003233, 1403USA003234, 1403USA032335, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA032336, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Dizziness, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 year old female patient with no reported medical history. On 17-DEC-2013 (time 8-1) the patient was vaccinated with PNEUMOVAX23 lot # J011651 dose 1, subcutaneous in the left arm. Other suspect therapies included ZOSTAVAX and DTAP-IPV. No concomitant medication was reported. On 17-DEC-2013 the patient experienced dizzy, achy, no fever and the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly (medication error). No treatment information was reported. The outcome of dizzy, achy and no fever was reported as recovered/resolved. The reporters relatedness of dizzy, achy and no fever to PNEUMOVAX23 and ZOSTAVAX is unknown. This report is linked (same reporter link) to : 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old male patient. No medical history provided. On 17-DEC-2013 at 08:01 the patient was vaccinated with PNEUMOVAX23 (does 1, lot # J011651, exp date: 22-AUG-2015, subcutaneous in the left arm), ZOSTAVAX (dose 1, lot # J011338, exp date: 19-DEC-2014, subcutaneous in the left arm); ZOSTAVAX (dose 1, lot # J011338, exp date: 19-DEC-2014, subcutaneous in the left arm); and BOOSTRIX (dose 1, lot # T25EG, intramuscular in the left deltoid. There were no concomitant medications. On 17-DEC-2013 the patient experienced flu-like symptoms. The outcome of flu-like symptoms was reported as recovered/resolved. No relevant lab diagnostics were provided. No reporter causality was provided. Additional information has been requested. This case is linked to the following cases received from the same reporter: 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Feeling cold, Malaise, Nausea, Pain, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 59 year old female patient. No medical history provided. On 17-DEC-2013 at 08:01 the patient was vaccinated with PNEUMOVAX 23 (dose 1, lot # J011651, exp date: 22-AUG-2015, subcutaneous in the left arm); ZOSTAVAX (dose 1, lot # J011338, exp date: 19-DEC-2014, subcutaneous in the left arm); and BOOSTRIX (dose 1, lot # T25EG, intramuscular in the left deltoid). There were no concomitant medications. On 17-DEC-2013 the patient experienced aching, freezing, vomiting, nausea and was violently ill. The outcome of the events was reported as recovered/resolved. No relevant lab diagnostics were provided. No reporter causality was provided. Additional information has been requested. This case is linked to the following cases received from the same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old female patient. No medical history provided. On 17-DEC-2013 at 08:01 the patient was vaccianted with PNEUMOVAX23 (dose 1, lot # J011651, exp date: 22-AUG-2015, subcutaneous in the right arm); ZOSTAVAX (dose 1, lot # J011338, exp date: 19-DEC-2014, subcutaneous in the right arm); and BOOSTRIX (dose 1, lot # T25EG, intramuscular in the right deltoid. There were no concomitant medications. On 17-DEC-2013 the patient experienced freezing, aching, chills and dizzy. The outcome of freezing, chills, aching and dizzy was reproted as recovered/resolved. No relevant lab diagnostics were provided. No reporter causality was provided. Additional information has been requested. This case is linked to the following cases received from the same reporter: 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a nurse refers to a 58 year old (also reported as 55 years) female patient who is allergic to Sulpha. On 17-DEC-2013 at 08:01 the patient was vaccinated with PNEUMOVAX23 (does 1, lot # J011338, exp date: 19-DEC-2014, subcutaneous in the right arm); BOOSTRIX (dose 1, lot # T25EG, intramuscular in the right deltoid. There were no concomitant medications. On 17-DEC-2013 the patient experienced flu-like symptoms. The outcome of flu-like symptoms was reported as recovered/resolved. No relevant lab diagnostics were provided. No reporter causality was provided. Additional information has been requested. This case is linked to the following cases received form the same reporter: 1312USA010905, 1403USA003215,1403USA003216,1403USA003217, 1403USA003218, 1403USA003219,1403USA003220, 1403USA003221, 1403USA003222, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230,1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253.
Age: 50.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old male patient with asthma. On 17-DEC-2013, the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Other suspect therapies included ZOSTAVAX and BOOSTRIX. On 17-DEC-2013, 1 day after onset of therapy the patient experienced the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly and flu like symptoms. There were no relevant diagnostic tests of laboratory tests performed. The outcome of flu like symptoms was reported as recovered/resolved. The reporter did not assess the relationship between the flu like symptoms and PNEUMOVAX 23 and ZOSTAVAX. This case is related to: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Abasia, Bladder catheterisation, Crying, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Laboratory test, Neck pain, Nuclear magnetic resonance imaging spinal abnormal, Pain, Posture abnormal
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Sensory loss, Spinal cord haemorrhage, Spinal cord injury thoracic, Spinal epidural haematoma, Swelling
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Chest tube insertion, Feeling abnormal, Gastrointestinal tube insertion, Mass, Mechanical ventilation
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Neck pain, Nuclear magnetic resonance imaging spinal abnormal, Paralysis, Posture abnormal, Spinal epidural haematoma
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 4.0
Sex: M
Vaccine: FLUN3, VARCEL, FLUN3, VARCEL
Symptoms: Surgery, Thoracotomy, Tracheostomy
Clinical narrative: Patient started on 10/17/09 with neck pain but it would go away. 10/19/09 patient's neck was tilted to the side after school. Overnight he said his hands and feet felt big. We took him to the hospital in the morning of 10/20/09. That evening (after 9 hrs in the ER) an MRI showed a mass in his spine C3-T5 that needed surgery. He had a spontaneous spinal epidural hematoma. He was hospitalized for 7 mths and came home partially paralyzed with trach, ventilator and feeding tube.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Received 3rd GARDASIL 3/4/14 in (L) arm. Mom noticed (L) arm swelling and redness and itchiness starting 3/6. Came in for MD visit 3/7/14. Dr. reported erythematous, tender and warm area 8 cm x 9 cm LUA.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from CDC (Centers for Disease Control) via company representative refers to 53 patients of unknown age and gender. On an unknown date these patients was vaccinated with GARDASIL (lot#, expiration date, dose, route not reported). These patients died after receipt of the vaccine. The causes of death were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Lymphadenopathy, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with diabetes. On 02-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant therapies included Metformin. On an unknown date in March 2014, the patient developed red rash on her arm near the injection site and swollen lymph node. No treatment was rendered. There was no lab tests performed. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received form a physician via company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, route not reported). On an unknown date after vaccinated with ZOSTAVAX a couple of weeks, the patient developed shingles. The patient sought medical attention via contacting the office. The outcome of the shingles was unknown. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 78 year old female patient. Pertinent medical history and drug allergies were none. On 03-MAR-2014 the patient was vaccinated with single dose of ZOSTAVAX lot # J011337/expiry date: 13-DEC-2014, subcutaneous in the left arm. Concomitant medication was none. On 04-MAR-2014 the patient experienced redness, swelling, soreness, and itching at the injection site. On 05-MAR-2014, 3 days after onset of therapy the patient experienced numbness of both upper arms. The patient sought medical attention since she visited the pharmacy. No lab diagnostic test was performed. No treatment was rendered. It was reported that the patient was referred to her physician for evaluation. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 78 year old female patient. Pertinent medical history and drug allergies were none. On 03-MAR-2014 the patient was vaccinated with single dose of ZOSTAVAX lot # J011337/expiry date: 13-DEC-2014, subcutaneous in the left arm. Concomitant medication was none. On 04-MAR-2014 the patient experienced redness, swelling, soreness, and itching at the injection site. On 05-MAR-2014, 3 days after onset of therapy the patient experienced numbness of both upper arms. The patient sought medical attention since she visited the pharmacy. No lab diagnostic test was performed. No treatment was rendered. It was reported that the patient was referred to her physician for evaluation. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a male patient refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced pain, swelling and redness at the injection site. The outcome of all the events were not recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. VARIVAX doses were exposed to temperature as high as 13 Farenheit. On an unknown date, unspecified number of patients were administered improperly stored VARIVAX (Lot number and expiry date was not reported) and no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, HIBV
Symptoms: Blood test, CSF culture positive, Haemophilus test positive, Meningitis haemophilus
Clinical narrative: Initial report received on 24 February 2014 from a healthcare provider via another manufacturer. A 5 month old patient, date of birth and sex not reported was immunized with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV and /HIB vaccine, manufacturer unknown on an unreported date. Within a few months, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. The patient has a history of being a twin born prematurely at 29 weeks gestation with intraventricular hemorrhage. The patient also has a history of gastroesophageal reflux disease. The patient received a 1st dose of PENTACEL and 2nd dose of Hib vaccine, (dates, route and site of administration) not reported. Concomitant medications include ZANTAC, dose and route not reported. Within a few months of vaccination in 2013, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. Relevant test results included a CSF culture that was HIB positive by latex agglutination and haemophilus test positive in 2013. The patient was hospitalized, dates not reported. The patient outcome was not recovered (events were improved). No further details were available at the time of this report. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza, Laboratory test, Pain, Pyrexia
Clinical narrative: This initial case was received from a healthcare professional on 03 March 2014, and is one of a cluster of three employees at the same facility who experienced similar events after vaccination with FLUZONE ID. The events for the other two patients are captured in cases 2013SA136389 and 2013SA136392. An adult female patient, with no reported concomitant medications or relevant medical history, received an intradermal injection of FLUZONE ID (lot number not reported) in November 2013. On 24 December 2013, the patient developed "suspected flu", described as 103 degree fever, achiness, and weakness. Outcome was not reported. According to the reporter, the patient was no longer an employee of the facility, and was considered lost to follow-up. Additional documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report from a pharmacist refers to a patient of unknown age. On 27-FEB-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscular (lot number was reported as 1417AA expiry date 22-JUN-2013). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On 02-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in March 2014, the patient experienced rash. On an unknown date in March 2014, the patient experienced full blown sh ingles. The patient sought medical attention and called to pharmacy. No treatment was given to the patient. The outcome of full blown shingles and rash was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiry date was not provided). On an unknown date, the patient developed rash on his buttocks. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: (L) arm redness needle mark (grey) evaluated by PCP no diagnosis, no prescribed medication for (L) arm area. Area is still effected.
Age: 0.3
Sex: F
Vaccine: MMR, PNC13, RV5, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 3 month old female patient. On an unknown date, the patient was vaccinated with M-M-R II (dose, route and frequency were not reported) and VARIVAX (merck) (dose, route and frequency were not reported). Concomitant medications included ROTATEQ and PREVNAR 13. No adverse effects were reported. No further information reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient with diabetes. On 17-DEC-2013, the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Other suspect therapies included ZOSTAVAX and BOOSTRIX. On 17-DEC-2013, the patient experienced nausea, redness to back of arm, weak, dizzy, the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly and vomiting. The outcome of dizzy, weak, vomiting, nausea and redness to back of arm was reported as recovered/resolved. The outcome of the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly was unknown. The reporter did not assess the relationship between the events and PNEMOVAX 23 and ZOSTAVAX.  This case is related to case numbers: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252, and 1403USA003253 (same reporter). Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Intensive care, Pain in extremity
Clinical narrative: Approx. 3 days after started with pain in both legs - I went to chiropractor for 3 visits - it got worse. Then I lost strength completely in both legs and both arms totally. I got a friend to bring me to emergency room at hospital where I spent the first 3 days in I.C.U. They administered I.V.'s of medicine for that time - then I spent 6 1/2 days in therapy. Came home and had 9 wks. of home therapy and nursing. 50% to 60% recovery legs are no longer same.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging brain normal, Vomiting
Clinical narrative: Patient received vaccines on 2/19/2014 and subsequently had vomiting once on 2/19, once on 2/20 and once on 2/21. Then on 2/22/14 had 2 afebrile seizures (approximately 2 min each) and then went to the ER. She was admitted to the hospital after the second seizure and then had a 3rd afebrile seizure (2 min 45 sec). Patient is now on TRILEPTAL.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner for GARDASIL concerning a 22 year old female patient with no medical history who on 26-AUG-2011, received her first dose of GARDASIL (Lot # not reported). On 16-SEP-2011, she tested positive for pregnancy. (It was also reported that the laboratory studies performed included pregnancy test on 03-AUG-2011 with no result). Her last menstrual period was on 03-AUG-2011. Estimate delivery date was 09-MAY-2012. The outcome of pregnancy was unknown. The patient sought medical attention by visiting office. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient reported nerve pain in shoulder area that had not gone away. First reported soreness on January 23, 2014 but did not want to file report. Returned on 3-8-14 and said pain still had not gone away. Told her we would submit adverse event report.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: I have a burning sensation on the left side of my body in T1 dermatome with no rash or visible signs of irritation.
Age: 0.77
Sex: M
Vaccine: FLUX
Symptoms: Crying, Irritability, Pain, Pyrexia
Clinical narrative: Began getting fussy and irritable. Developed fever overnight into 3/9/2014 and had a fever off and on through the day with help from Tylenol. Spiked a fever of 104.1 at approx 2:30am on 3/10/2014 and had crying fits that lasted hours and seemed to be in a great deal of pain. Mom remembers a similar chain of events occurring after patient's first dose of the flu vaccine in November 2013. This most recent shot was a booster. Mom questioned the doctor about the initial reaction before patient received the booster shot. The Doctor did not seem to believe that it was an adverse reaction.
Age: 3.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: I gave patient Tdap, which is not licensed for children her age instead of Dtap which I should have given her.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Didn't feel good Friday afternoon, then achy by the evening and by Saturday, noticed swelling and redness to injection site; unable to take temp at time of onset.
Age: 1.29
Sex: M
Vaccine: HEPA, HIBV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: I gave patient a Tdap which is not licensed for children his age instead of a Dtap which is what I should have administered.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Asthenia, Dizziness, Pruritus, Urticaria
Clinical narrative: Flu and Gardasil (1 dose of each) administered at 9:30am.  Between 2-3pm on same day experienced weakness, dizziness and hives with itching.  Hives were on face.  Also on Keflex for UTI.  Took Benadryl at home for hives.  4:45pm states she is still weak but no longer itching.
Age: 27.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. On 23-JAN-2014, the patient was vaccinated with a dose of VAQTA, 1 ml, intramuscular. The nurse reported that the patient received a second dose of VAQTA, too early at 5 weeks after her first dose and no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ROTATEQ 3 days after the expiration date (lot#, expiration date, dose, indication not reported). No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) for GARDASIL, a Pregnancy Registry Product, concerning a 23 year old female patient who on 17-AUG-2011 was vaccinated with her final dose of GARDASIL (dose, route, site and lot number not reported). The CMA said that the patient called the office on 20-AUG-2011 to report that she just found out that she was pregnant. The patient had not yet missed her period. There was no adverse effect reported. Patient's last menstrual period and expected date of delivery were not reported. Follow up information of the prospective pregnancy report as received from the physician refers to the 23 year old female patient. On 17-AUG-2011, the patient was vaccinated with her second dose of (initial reported as final dose) GARDASIL (lot #, expiry date, dose, strength, route and indication not reported). The reporter stated that the patient just found out that she was pregnant. The patient stated that she had not yet missed her period when she called the office on 20-AUG-2011. The patient became pregnant with last menstrual period (LMP) of an unspecified date in 2011. The patient did not seek medical attention. The estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown. Follow up information was received from the MA who reported that the baby was fine. The reporter stated that the baby was born full term and was normal and healthy with no problems and no congenital anomalies. No further information is available. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Contraindication to vaccination
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old female patient with arthritis. The patient had no drug reactions/allergies. On 20-FEB-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# J004268, expiry date: 12-JUL-2014) 0.65ml/once, Subcutaneous for prescriber recommended. Concomitant therapies included with hydroxychloroquine sulfate, warfarin sodium (manufacturer unknown), levothyroxine sodium (manufacturer unknown), verapamil, metoprolol, atorvastatin, MAXZIDE. On 03-MAR-2014 the patient had "blood work" completed and "whatever the blood showed, the patient's rheumatologist now wanted her to go on methotrexate". Additional information has been requested.