chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Full blood count, Hypoaesthesia, Joint stiffness, Metabolic function test
Clinical narrative: Pain numbness and tingling in hands, pain stiffness in all joints.  Weakness in hands.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Pain numbness and tingling in hands, pain stiffness in all joints.  Weakness in hands.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cheilitis, Dysphemia, Rash, Rash erythematous
Clinical narrative: Red raised rash on chin and lip area.  2 days later started to stutter when he spoke.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site swelling, Pruritus generalised, Rash
Clinical narrative: Itching all over, swollen at site, rash on back and buttock.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: After 5 minutes some redness next to admin site and some burning. We iced it to see if it will go down but after 5 more minutes it got bigger. Patient given meloxicam, CLARITIN and PEPCID.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Throat irritation
Clinical narrative: Mom reported throat feeling funny four hours after vaccine given.
Age: 0.76
Sex: M
Vaccine: DTAP
Symptoms: Induration, Injection site mass
Clinical narrative: Lump developed at site of injection last year, present all year. 1 month ago another lump developed near initial lump. Hard immobile.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt given ZOSTAVAX vaccine on 3-18-14. Pt developed herpes zoster rash on forehead on 3-21-14.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of LIQUID PEDVAXHIB injections (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of ROTATEQ injection (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Case number PHHY2013US069591 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 478255) web site on 03 Jul 2013, with a follow up received from Quality Assurance Department (QA, reference number: 239144) on 18 Mar 2014. This report refers to a 39-year-old male patient. He had no prior history of fainting or getting dizzy with vaccines. He also did not have any medical conditions. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206301) intramuscularly in the left arm on 15 Dec 2012. On the same day he lost consciousness for seconds after the shot. When he awoke, he said that he had not eaten. Ambulance came and his vitals were measured which were normal. He was later taken to home. The final outcome was however reported as condition unchanged as of 15 Dec 2012. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1206301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 239144) on 18 Mar 2014: Updated batch review report.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pallor, Slow response to stimuli, Tension
Clinical narrative: Case number PHHY2013US032671 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482400) on 04 Apr 2013 with a follow up report received from quality assurance department (QA reference number: 221094) on 18 Mar 2014. This report refers to an 18 year old female patient. Her medical history included allergy to tree nuts. Her concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206301) intramuscularly in to the left arm on 11 Jan 2013. On the same day after vaccination, she was gripping her chair and was tense. A doctor was called to check on her. She was not responding properly. The doctor could not see her face so they moved her hair; she was conscious and breathing and was able to respond. she had slight nausea and was pale. Her responses were abnormal and slow. The reaction was stated to be a 'possible seizure' according to her friend. Emergency was called for further assessment. Final outcome was reported as complete recovery of the patient on an unknown date. FLUVIRIN batch number: 1206301, was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 18 Mar 2014: Updated batch review report and QA reference number.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Central nervous system lesion, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2013US069239 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 489202) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239251) on 18 Mar 2014. This report refers to a 55-year-old female patient. Her medical history included restless legs, neuropathy (unspecified), osteoarthritis and osteopenia. Concomitant medications included NORCO, CELEBREX and ropinirole. She was vaccinated with FLUVIRIN (batch number: 1204521) in the right arm and PNEUMOVAX (batch number: 0895, other manufacturer) at left arm on 31 Aug 2012. It was reported that the patient had severe pain at the time of vaccination and she was unable to move her arm for weeks. She went to her family physician (ER) and took pain medications. On the same date, she also had throbbing and numbness in both arms. On an unknown date, her neurologist performed an MRI of brain, neck, upper and lower back and found lesions on brain and in spinal fluid. The neurologist did not figure it out and the patient was getting a second opinion. The events were reported as serious (permanent disability). The outcome of the events was reported as condition unchanged as of 15 Apr 2013. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204521) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 239251) on 18 Mar 2014: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain, Pain in extremity
Clinical narrative: Case number PHHY2013US069239 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 489202) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239251) on 18 Mar 2014. This report refers to a 55-year-old female patient. Her medical history included restless legs, neuropathy (unspecified), osteoarthritis and osteopenia. Concomitant medications included NORCO, CELEBREX and ropinirole. She was vaccinated with FLUVIRIN (batch number: 1204521) in the right arm and PNEUMOVAX (batch number: 0895, other manufacturer) at left arm on 31 Aug 2012. It was reported that the patient had severe pain at the time of vaccination and she was unable to move her arm for weeks. She went to her family physician (ER) and took pain medications. On the same date, she also had throbbing and numbness in both arms. On an unknown date, her neurologist performed an MRI of brain, neck, upper and lower back and found lesions on brain and in spinal fluid. The neurologist did not figure it out and the patient was getting a second opinion. The events were reported as serious (permanent disability). The outcome of the events was reported as condition unchanged as of 15 Apr 2013. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204521) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 239251) on 18 Mar 2014: Updated batch review report.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 year old female patient. She had no illness at the time of vaccination, and no pre-existing medical conditions. On 17-DEC-2013, the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the left arm and ZOSTAVAX lot # J011338, subcutaneous in the left arm as well. No concomitant medications were reported. On 17-DEC-2013, the patient experienced chills, weakness, flu like symptoms and swelling in nodes. The patient recovered from the flu like symptoms, chills, weakness and swelling in nodes in December 2013. A causality assessment 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, 1403USA003225, 1403USA003248, 1403USA003247, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 59 year old male patient. The patient had no illness at the time of vaccination or pre-existing medical conditions. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous and ZOSTAVAX, also administered subcutaneously (lot number J011338). Concomitantly, the patient took unspecified NSAIDs for an unknown indication. On 17-DEC-2013, the patient experienced chills, redness at (injection) site, fever, headache and nausea. The patient recovered from the adverse event sin December 2013. A causality assessment 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, 1403UAS003246, 1403USA003225, 1403USA003248, 1403USA003247, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information has been requested.
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. Illnesses at the time of vaccination and pre-existing conditions were denied. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm (administered intramuscularly). Other suspect therapies included ZOSTAVAX, administered subcutaneously in the right arm and BOOSTRIX administered in the right deltoid, which were administered on the same dat (17-DEC-2013). Concomitant therapies included prednisone. In December 2013 the patient experienced flu like symptoms. The patient receovered from the flu like symptoms on an unknown date. A causality assessment 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, 1403USA003225, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pain, stinging, bruise, red swollen headache, chickenpox-like rash.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Contusion, Erythema, Headache, Pain, Rash vesicular
Clinical narrative: Pain, stinging, bruise, red swollen headache, chickenpox-like rash.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Swelling
Clinical narrative: Pain, stinging, bruise, red swollen headache, chickenpox-like rash.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Rash on feet, legs and hands - itchy. Parent's applied OTC BENADRYL cream. Provider also stated can take ZYRTEC 10 mg QD until hives resolve.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Rash on feet, legs and hands - itchy. Parent's applied OTC BENADRYL cream. Provider also stated can take ZYRTEC 10 mg QD until hives resolve.
Age: 67.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Engerix-B vaccine Lot 99B32 Exp 6/1/15 in the left deltoid in error.  Patient was given Boostrix Lot 9443E Exp 3/7/16, the correct vaccination, immediately following Engerix B, into the right deltoid.  A follow-up call was placed that evening to make sure the patient was well.  He did not complain of any side-effects from his vaccination.  His physician was contacted and provided with the information of the error.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Bursitis, Insomnia, Musculoskeletal pain, X-ray
Clinical narrative: Shoulder started to hurt. Tried OTC pain relief.  Finally went to doctor on 12/9/13 because pain was becoming severe and needed greater relief.  Was diagnosed as bursitis.  Treatment ineffective.  Saw another doctor on 2/20/14.  Recommended physical therapy.  Symptoms continue to worsen.  Difficulty dressing, showering, sleeping.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Fatigue, Gait disturbance, Immunoglobulin therapy, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. On 30-AUG-2011 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The dose number, the lot number and expiration date of the vaccine, the route of administration and anatomical location of the vaccination were not reported. On 10-SEP-2011, reported as 11 days after the date of vaccination the patient experienced celiac disease (disability, medically significant upon internal review), tripping down the stairs because her legs were so weak (disability), muscle pain (disability), extreme fatigue (disability), myasthenia gravis (disability, medically significant upon internal review) and being so weak that she had issue lifting her arms (disability). Disability was reported as serious criterion, the event(s) to which this referred however were not specified. Treatment for the myasthenia gravis included MESTINON, IVIG and Prednisone. The outcome of celiac disease, tripping down the stairs, muscle pain, extreme fatigue and myasthenia gravis was reported as not recovered/not resolved. The physician reported that all adverse effects were progressing. No causality statement was reported for any of the events in relation to GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Myasthenia gravis
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. On 30-AUG-2011 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The dose number, the lot number and expiration date of the vaccine, the route of administration and anatomical location of the vaccination were not reported. On 10-SEP-2011, reported as 11 days after the date of vaccination the patient experienced celiac disease (disability, medically significant upon internal review), tripping down the stairs because her legs were so weak (disability), muscle pain (disability), extreme fatigue (disability), myasthenia gravis (disability, medically significant upon internal review) and being so weak that she had issue lifting her arms (disability). Disability was reported as serious criterion, the event(s) to which this referred however were not specified. Treatment for the myasthenia gravis included MESTINON, IVIG and Prednisone. The outcome of celiac disease, tripping down the stairs, muscle pain, extreme fatigue and myasthenia gravis was reported as not recovered/not resolved. The physician reported that all adverse effects were progressing. No causality statement was reported for any of the events in relation to GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Local swelling, Pruritus, Rash, Skin warm
Clinical narrative: Pt ok for 2 days after vaccine admin. aft 2 days pt. developed rash/itchy/hot swollen area. Went to ER and had cellulitis. Treated with KEFLEX and getting better.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Acute disseminated encephalomyelitis, Dizziness, Headache, Vertigo
Clinical narrative: Had Flu vaccine on Jan 8 came home with very bad headache next day Jan 9 that day vomiting, dizziness. Took him back to Dr he said it was vertigo. Ended up in hospital weeks later couldn't walk etc. Dr never reported about the flu shot.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Had Flu vaccine on Jan 8 came home with very bad headache next day Jan 9 that day vomiting, dizziness. Took him back to Dr he said it was vertigo. Ended up in hospital weeks later couldn't walk etc. Dr never reported about the flu shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a certificate medical assistant (CMA) refers to a 63 years old female patient with allergy to aspirin and codeine. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX, lot # J006157 (exp. 30-AUG-2014), 0.65 ml, subcutaneous in the left arm. Patient called physician's office on 20-MAR-2014 and stated that the injection site was red and slightly puffy since an unspecified date after the administration of ZOSTAVAX. No treatment was given. No lab test was done. The outcome of injection site was red and slightly puffy was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's cousin refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were unknown). On an unknown date, the patient developed shingles inside her body similar to his wife after receiving ZOSTAVAX and after researching online he found that a multitude of people experienced similar things (called did not want to provide contact information for the cousin and the information he found online). The outcome of shingles inside her body was unknown. Relatedness between shingles and ZOSTAVAX was not reported. This case is linked to MAARS#1403USA008896 and MAARS#1403USA009550 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with MMR II (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with GARDASIL (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse reported. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose and frequency were not reported0 that went through a supported temperature excursion. It was reported that the VARIVAX (Merck) which was administered to the patient were exposed to the temperature of 1.5 degrees C for 22 hours and also was exposed to -1.4 degrees C for 1.5 hours. It was reported that according to prescribing information, the VARIVAX (Merck) should be stored frozen between -58 degree F and +4 degree F(-50 degree C and -15 degree C). Use of dry ice may subject the VARIVAX (Merck) to temperatures colder than -58 degree F (-50 degree C). No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: F
Vaccine: HEPA, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated MMR II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, vaccinated with M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with PNEUMOVAX 23 (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on an unspecified dates were administered with ROTATEQ (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with VAQTA (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: PATIENT'S SISTER CALLED BACK ABOUT 7 HOURS AFTER IMMUNIZATION TO REPORT THE REDNESS AND ITCHINESS OVER A LOT OF THE BODY. NOT EXPERIENCING ANY SWELLING OR BREATHING PROBLEMS AT THIS TIME. SUSPECTED TO BE FROM THE VACCINE. NOT SURE HOW SOON THE REDNESS STARTED AFTER THE VACCINE.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hypoaesthesia, Pain, Paraesthesia, Skin reaction
Clinical narrative: Localized skin reaction, pain, numbness, tingling, headache.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Pt had reaction on right thigh about 5 mm not raised just red, went down the next day. Left thigh just had a small bruise the size of a small fingernail.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Crying, Differential white blood cell count, Dysphonia, Dyspnoea, Irritability
Clinical narrative: Irritability, non stop crying followed by difficulty breathing and hoarseness.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Respiratory syncytial virus test
Clinical narrative: Irritability, non stop crying followed by difficulty breathing and hoarseness.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Blood alkaline phosphatase increased, Blood test, Chest X-ray, Contusion, Electrocardiogram
Clinical narrative: Child presented with rash three days after the vaccinations of MMR shot. Rash diminished within 24 hours. 03/19/2014, child started with swollen ankles and bruising at the ankle area. 03/20/2014, rash returned and progressively got worse by 03/22/2014, the rash turned into huge red patches on her underside of her legs and in groin area. Some spots appeared under chin, under arms and lower legs. 03/22/2014, child was unable to walk properly, presented a fever approximately 1:00 pm of 101.7. Administered Motrin (1.25 mL) at 2:15 PM and two hours later, noticed child was unable to bend at the knees and was walking stiff-legged. Knees were red and swollen and legs began to swell. Child was taken to ER where admitted with 103.3 F fever. Many blood tests were performed, urinalysis, EKG, x-rays of chest and legs. One test ALP was elevated to 5000; two days later this test was repeated and was 7000. The child had a fever fluctuating from 03/22/2014 to 03/23/2014. The last fever presented was on 03/23/2014 at 3 PM. The rash was beginning to diminish by 03/23/2014 evening. The swelling of the knees and ankles went down by 03/24/2014. Child was released on 03/24/2014 to follow up with specialist.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Erythema, Gait disturbance, Joint swelling, Local swelling, Musculoskeletal stiffness
Clinical narrative: Child presented with rash three days after the vaccinations of MMR shot. Rash diminished within 24 hours. 03/19/2014, child started with swollen ankles and bruising at the ankle area. 03/20/2014, rash returned and progressively got worse by 03/22/2014, the rash turned into huge red patches on her underside of her legs and in groin area. Some spots appeared under chin, under arms and lower legs. 03/22/2014, child was unable to walk properly, presented a fever approximately 1:00 pm of 101.7. Administered Motrin (1.25 mL) at 2:15 PM and two hours later, noticed child was unable to bend at the knees and was walking stiff-legged. Knees were red and swollen and legs began to swell. Child was taken to ER where admitted with 103.3 F fever. Many blood tests were performed, urinalysis, EKG, x-rays of chest and legs. One test ALP was elevated to 5000; two days later this test was repeated and was 7000. The child had a fever fluctuating from 03/22/2014 to 03/23/2014. The last fever presented was on 03/23/2014 at 3 PM. The rash was beginning to diminish by 03/23/2014 evening. The swelling of the knees and ankles went down by 03/24/2014. Child was released on 03/24/2014 to follow up with specialist.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Urine analysis, X-ray limb
Clinical narrative: Child presented with rash three days after the vaccinations of MMR shot. Rash diminished within 24 hours. 03/19/2014, child started with swollen ankles and bruising at the ankle area. 03/20/2014, rash returned and progressively got worse by 03/22/2014, the rash turned into huge red patches on her underside of her legs and in groin area. Some spots appeared under chin, under arms and lower legs. 03/22/2014, child was unable to walk properly, presented a fever approximately 1:00 pm of 101.7. Administered Motrin (1.25 mL) at 2:15 PM and two hours later, noticed child was unable to bend at the knees and was walking stiff-legged. Knees were red and swollen and legs began to swell. Child was taken to ER where admitted with 103.3 F fever. Many blood tests were performed, urinalysis, EKG, x-rays of chest and legs. One test ALP was elevated to 5000; two days later this test was repeated and was 7000. The child had a fever fluctuating from 03/22/2014 to 03/23/2014. The last fever presented was on 03/23/2014 at 3 PM. The rash was beginning to diminish by 03/23/2014 evening. The swelling of the knees and ankles went down by 03/24/2014. Child was released on 03/24/2014 to follow up with specialist.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Dry skin, Erythema, Pruritus generalised, Skin irritation
Clinical narrative: "Red, irritated, itchy skin all over". Clarified as "arms and legs". Took Benadryl OTC 1 tablet/allergy... No vaccine reactions prior to this.
Age: 0.76
Sex: M
Vaccine: DTAP
Symptoms: Crying, Irritability, Pain, Screaming
Clinical narrative: Constant screaming/crying, inconsolable, extremely fussy and seemed to be in great pain.  Lasted 2.5 hours.
Age: 0.57
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old male patient. On 26-DEC-2013 the patient was vaccinated with VAQTA 25/0.5 U/ML, lot# CC4735D exp. 15-NOV-2015, 0.5 ml, intramuscular, instead of RECOMBIVAX HB. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with PEDVAXHIB (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patint of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported No product quality complaint involved. The outcome of medication error was unknown. This case is linked to : 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 08-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received a dose of RECOMBIVAX HB on 08-MAR-2014, that was exposed to a supported temperature excursion. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, MMR II and VARIVAX (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, an unspecified patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date not reported). On an unknown date (reported as within a month after vaccination), the patient's spouse, who did not receive ZOSTAVAX, developed shingles. The pharmacist stated the vaccinated spouse may have transmitted the virus to the unvaccinated spouse. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 08-MAR-2014 the patient was vaccinated with VARIVAX (dosing regimen unspecified). Other suspect therapies included on 08-MAR-2014 MMR II (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses of VARIVAX and MMR II on 08-MAR-2014, that were exposed to a supported temperature excursion. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 72 year old male patient. The patient had no known allergies. On 14-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), 0.65 ml, subcutaneously. On an unknown date the patient started experiencing fever blister and then developed doctor diagnosed shingles. The outcome of the events was reported as recovered/resolved on an unknown date. The patient came into pharmacy for medical attention. Additional information is not expected.
Age: 1.57
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a mother refers to her son, an 18 month old patient. The patient had no pertinent medical history. On an unknown date in December 2013 (reported as "about 3 months ago (specific date unknown)") the patient was vaccinated with a dose of VARIVAX (lot#, dose, route unspecified) for the prevention of chickenpox. No concomitant medication reported. On 06-MAR-2014 the patient inadvertently received 2nd shot of VARIVAX (lot#, dose, route unspecified). No treatment was given for the event and no lab diagnostic studies performed. Patient saw the doctor for medical attention. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with GARDASIL and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ orally (dosing regimen unspecified). No concomitant medications were reported. On an unspecified date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality compliant involved. The outcome of medications error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA11268, 1403USA011301, 1403USA011335, 1403USA11343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Local swelling, Rash erythematous
Clinical narrative: Erythematous rash on left deltoid <15 min. after administration. Later, developed erythematous rash and swelling of (R) arm and extension of rash to below her elbow on the (L) arm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with GARDASIL (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.