chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Urine flow decreased
Clinical narrative: Case number PHHY2015US099232 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) web site on 11 Aug 2015. This report refers to a 43 years old male patient. Concurrent condition included seasonal allergies. concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013 and in the Fall of 2013. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099201 and PHHY2015US099231). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014. On 24 Oct 2014 the patient started experiencing gradual restriction in urinary flow. Three days later, urinary flow was fully restricted. Urinary flow did not return to normal until over a month later. Laboratory examinations indicated enlarged prostate and normal prostatic specific antigen (PSA) test. Outcome of the events was recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of enlarged prostate, anuria and urine flow decreased was upgraded based on information in the source document.
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2015US099231 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see case: PHHY2015US099201). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014 and had a full restriction in urinary flow and enlarged prostate (see case: PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099231 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see case: PHHY2015US099201). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014 and had a full restriction in urinary flow and enlarged prostate (see case: PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099231 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see case: PHHY2015US099201). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014 and had a full restriction in urinary flow and enlarged prostate (see case: PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Urine flow decreased
Clinical narrative: Case number PHHY2015US099231 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see case: PHHY2015US099201). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014 and had a full restriction in urinary flow and enlarged prostate (see case: PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2015US099201, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013 and on 22 Oct 2014. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099231 and PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099201, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013 and on 22 Oct 2014. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099231 and PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099201, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013 and on 22 Oct 2014. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099231 and PHHY2015US099232).
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Urine flow decreased
Clinical narrative: Case number PHHY2015US099201, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) website on 11 Aug 2015. This report refers to a 42 years old male patient. Concurrent condition included seasonal allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in early 2013. After vaccination the patient had a gradual restriction in urinary flow. Further on unknown date the patient's urinary flow was fully restricted. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of anuria and urine flow decreased was upgraded based on information in the source document. The patient further vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in the Fall of 2013 and on 22 Oct 2014. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099231 and PHHY2015US099232).
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain
Clinical narrative: 1st of 2 confirmed incidents where Prevnar 13 from Lot L77780 was given and several days later patient presented with signs of infection at injection site and was treated for cellulitis.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site infection
Clinical narrative: 1st of 2 confirmed incidents where Prevnar 13 from Lot L77780 was given and several days later patient presented with signs of infection at injection site and was treated for cellulitis.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Prevnar 13 Lot L77780 inj given on 8/11/15. Pt treated for cellulitis at injection site several days after injection. *second reported case of cellulitis after receiving Prevnar 13 from this lot #
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Prevnar 13 Lot L77780 inj given on 8/11/15. Pt treated for cellulitis at injection site several days after injection. *second reported case of cellulitis after receiving Prevnar 13 from this lot #
Age: 1.05
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Hypophagia, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Symptoms started with the baby not eating At 9PM that night he vomited.  He continued to vomit through the next day.  Red dots showed up all over his torso, neck and legs.  He did not eat any solid food until Sunday night, and very little at that point.  He ran a fever Friday, Saturday and Sunday.  (Today is Monday - still TBD about today.)
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Hyperaesthesia, Peripheral swelling
Clinical narrative: Upper arm is swollen, elevated and red if it is touched or bumped she screams.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, DTAPIPVHIB, HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse events noted, pt. was given 3 vaccines at the wrong time by LPN.  MMRV and Hep A.  It wasn't noted on pt. immunization card here in the office that pt. had, these vaccines.  CIIS may or may not have been checked by LPNs, they are unable to recall if they did or didn't.  So because of this, they weren't able to see that this pt. had received vaccines on 03/12/2015 from another provider.  So the MMRV (ProQuad) was given when it should not have been give, according to the Immunization schedule.  As well as the Hep A given too early.  I only came across this because LPN had a question when entering in one of the vaccines and when looking at the pt. under CIIS, the Hep A the dose was invalid because there wasn't the correct interval between vaccines.  I ask LPN to leave the card out and I would look at it when I was back in that the office on Thursday and review it.  On Thursday, August 20, 2015 I noted that the MMRV and Hep A were given too soon.  I invalidated the Hep A under the CIIS system and spoke in depth with other LPN regarding this incident.  She verbalized an understanding.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, DTAPIPVHIB, HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: No adverse events noted, pt. was given 3 vaccines at the wrong time by LPN.  MMRV and Hep A.  It wasn't noted on pt. immunization card here in the office that pt. had, these vaccines.  CIIS may or may not have been checked by LPNs, they are unable to recall if they did or didn't.  So because of this, they weren't able to see that this pt. had received vaccines on 03/12/2015 from another provider.  So the MMRV (ProQuad) was given when it should not have been give, according to the Immunization schedule.  As well as the Hep A given too early.  I only came across this because LPN had a question when entering in one of the vaccines and when looking at the pt. under CIIS, the Hep A the dose was invalid because there wasn't the correct interval between vaccines.  I ask LPN to leave the card out and I would look at it when I was back in that the office on Thursday and review it.  On Thursday, August 20, 2015 I noted that the MMRV and Hep A were given too soon.  I invalidated the Hep A under the CIIS system and spoke in depth with other LPN regarding this incident.  She verbalized an understanding.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, DTAPIPVHIB, HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NONE.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, DTAPIPVHIB, HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: NONE.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope and vomiting after receiving vaccines.  Cold cloth to head, water, lollipop. Did not require ammonia inhalant. BP 101/65.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Discomfort, Injection site mass, Injection site warmth, Peripheral swelling
Clinical narrative: Arm that received vaccine developed large amount of swelling all the way down to elbow. Lump that developed that was about the size of a grapefruit, and was hot to the touch. Swelling peaked approximately 36-40 hours after shot. We used ice packs, Benadryl and ibuprofen to relieve discomfort. The reaction occurred over a weekend and we did not seek medical consultation.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever to 104.5 and diarrhea.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patients mother called reporting child had rec'd vaccines this Am and was having hives/rash on abdomen and was itching. Wanted to know if she should give him Benadryl. Was instructed by nurse to take child to ER for evaluation by physician. Nurse F/U with mother today (8/24/15) mother states they did not take child to ER but gave him Benadryl and symptoms subsided. No further issue following Benadryl administration. States no further side effects.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth
Clinical narrative: Injection site hot to the touch and large red patches appeared down arm almost to the elbow.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Pharyngeal hypoaesthesia, Urticaria
Clinical narrative: 1/2 hr after injection became nauseated and dizzy. Next day started vomiting, 2 days after developed hives, pt states she took Benadryl at that time. Went to ER when throat and tongue started going numb. They started IV and gave her steroids and more Benadryl, symptoms relieved at that time. States she started with hives again this morning. Will call private physician for medical advice.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: 1/2 hr after injection became nauseated and dizzy. Next day started vomiting, 2 days after developed hives, pt states she took Benadryl at that time. Went to ER when throat and tongue started going numb. They started IV and gave her steroids and more Benadryl, symptoms relieved at that time. States she started with hives again this morning. Will call private physician for medical advice.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The healthcare worker reported that doses of VARIVAX (lot # L000453, expiry date 06-JAN-2017; lot # K015972, expiry date 23-SEP-2016; lot # J013900, expiry date 30-OCT-2015; lot # K002930, expiry date 26-FEB-2016) which were exposed to temperatures outside of the recommended range, have been administered to the unspecified patients on unspecified dates since 20-JUL-2015. At the time of this report, no adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's left arm is swollen and red in an area about 9" long and 5-6" wide starting a little above the injection site and going down her arm. The area is also firm and feverish to the touch. Parents do not want to bring the daughter in to be seen by a physician.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around injection site.
Age: 0.49
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt. was in for catch up on immunizations, given the 4 month series and then in 30 days, he will be given the 6 month series.  Pt. was given Kinrix as he needed DTaP and IPV, when entering this into the CIIS system this was not under the recommended vaccines, and alerted me that this vaccine should have not been given to this age of pt.  When reviewing the package insert it was noted that this should have only been given to pts. >4 years of age.  Emailed the CDC NIPINFO helpdesk and asked what should be done, should the dose be invalidated?  Got an email back stating "the Kinrix dose is off-label, and care should be take to ensure that it doesn't happen again, but both the DTaP and IPV components may be counted as valid doses.  No additional action is needed."
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: 26 hrs - large red, hot area (5X3 inches). 48 hrs - deeper red - tender to touch. 72 hrs - add itching and a 2X1 inch hard painful area. 96 hours - lighter red, but area is now 7X4 inches and still has a hard painful center. 120 hrs - lighter color, even large 7X5 inch area - still with firm and hot center (which is diminishing in size).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 26 hrs - large red, hot area (5X3 inches). 48 hrs - deeper red - tender to touch. 72 hrs - add itching and a 2X1 inch hard painful area. 96 hours - lighter red, but area is now 7X4 inches and still has a hard painful center. 120 hrs - lighter color, even large 7X5 inch area - still with firm and hot center (which is diminishing in size).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 27-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 23-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patent of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 22-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, frequency, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report  as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date in 2012 (reported as 3 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported) to prevent. Approximately in 2012 (reported as next two days after vaccination), the patient was awaken with "1" inch blistering circular appearance spots on her arms and legs that would dissipate within few hours. The patient reported that it was not rash. A complete diagnosis was never able to do determined as the area would dissipate before she could reach her physician's office. The patient sought medical attention. The outcome of the event was reported as recovered/resolved. The causality of the event was not reported. Additional information is not expected as the patient declined to participate in the report.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the physician and refers to an approximately 45 year old female subject enrolled in a study. The subject's concurrent conditions, medical history and concomitant therapies were not reported. On 23-JUN-2015 or about that date, the subject was vaccinated with PNEUMOVAX23 (dose, route of administration and anatomical location were not reported) lot # K018528, which was improperly stored. Action taken with study therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient who in August 2013 was vaccinated with the first dose of GARDASIL 9 0.5 ml, intramuscular. The second dose was administered on 27-MAY-2015 and the third dose was administered on 13-AUG-2015 "a week early". No adverse effects were reported. "Based on date, first dose likely GARDASIL; nurse only referred to GARDASIL 9". It was unable to speak with nurse to confirm the first dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 05-AUG-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 31-DEC-2014, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administratoin unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pneumonia
Clinical narrative: Admitted to hospital with symptoms of pneumonia.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient's right foot went numb and was tingly on his drive home after receiving the vaccination.  He reported this to the pharmacy on 8/18/15.  He saw a doctor at the clinic on 8/20/15 and at that time stated his left foot was also feeling tingly and numb.  Provider ran labs and is ruling out Guillain-Barre syndrome and having patient follow up with neuropathy.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives all over my body and high fever
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blister, Decreased appetite, Irritability, Malaise, Rash
Clinical narrative: Perioral & labial rash, irritability, malaise, decreased appetite, blisters on feet, mild diffused rash on legs.
Age: 55.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Measles antibody negative, Pyrexia, Rash
Clinical narrative: Patient was feeling okay in early morning.  Mid-morning pt developed a rash and a fever and presented at the local emergency room.  ER physician suspects it is a result of the MMR vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports that child had a 4"X3" red swollen area on her arm, and a 2"X2" darker red/purple, hardened area in the middle of the bigger area. This area was warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: High fever, headache, reduced appetite.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: When he woke up the morning after receiving the vaccines, the site of the injection was hard, hot, sore, and had a red circle of approximately 4 inches round. On the second day, the circle had grown to about 6 inches.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Patient noticed tenderness at injection site since 8/18/2015. Patient noted itching and arm more achy on 8/23/205. Patient noted a "quarter" size swollen area at site of injection this morning 8/24/2015. Denies fever.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen, burning L arm distal to injections site.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Sharp pain at the injection site, the pain has continued. I have pain on a scale of 1- 9 as "9". Worse when laying on side, pushing, pulling and moving arm. No longer have full range of motion in the limb. I believe I have SIRVA (Shoulder injury related to vaccine administration).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: A MMRV was given instead of an MMR vaccine. Mother was notified and reported no adverse reaction.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Welt like areas where there had been insect bites.  Treated with a steroid cream.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS, SWELLING 3 X 3 INCHES TO INJECTION SITE.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Breast pain, Chest X-ray normal, Chest pain, Musculoskeletal pain
Clinical narrative: Pain in sterum area that radiated through my right breast and to my shoulder blade, all on the right side, pin so severe at times that had it been on my left side we would have ben off to the hospital. Almost intolerable!!! The pain has lasted, it gets better and then flares up sometimes so bad that I have thought ER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states arm has been sore ever since receiving vaccination 10 months ago. Has discussed with her physician but they can't think of other reason for soreness besides vaccination. I referred her back to PCP.
Age: 0.83
Sex: M
Vaccine: HEP, HEP
Symptoms: Haemophilus test positive, Inability to crawl, Inflammatory marker increased, Injection site erythema, Injection site swelling
Clinical narrative: Fever, redness at site on 8/19/15. 8/20/15 Fever increasing to 103, vomiting, nasal drainage, refusing to crawl or wt bearing, swelling left knee, elevated inflamm markers. To ER admit for IV Abx.
Age: 0.83
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Rhinorrhoea, Staphylococcus test positive, Vomiting, Weight bearing difficulty
Clinical narrative: Fever, redness at site on 8/19/15. 8/20/15 Fever increasing to 103, vomiting, nasal drainage, refusing to crawl or wt bearing, swelling left knee, elevated inflamm markers. To ER admit for IV Abx.
Age: 0.83
Sex: M
Vaccine: HEP, HEP
Symptoms: Fasciitis, Haemophilus test positive, Injection site joint effusion, Injection site oedema, Myositis
Clinical narrative: Fever, redness at site on 8/19/15. 8/20/15 Fever increasing to 103, vomiting, nasal drainage, refusing to crawl or wt bearing, swelling left knee, elevated inflamm markers. To ER admit for IV Abx.
Age: 0.83
Sex: M
Vaccine: HEP, HEP
Symptoms: Nuclear magnetic resonance imaging abnormal, Vaccination site reaction
Clinical narrative: Fever, redness at site on 8/19/15. 8/20/15 Fever increasing to 103, vomiting, nasal drainage, refusing to crawl or wt bearing, swelling left knee, elevated inflamm markers. To ER admit for IV Abx.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became pale and light-headed 3 minutes after vaccination; she sat down and rested about 5 minutes and then went to eat something and was okay.
Age: 42.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Incorrect route of drug administration, Product commingling
Clinical narrative: TDAP mixed in with MMR vaccination and given SQ. A second dose of TDAP was given IM then.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient broke out into hives on her legs and back. Redness and itching occurred. No reaction occurred at the site of injection. Patient had previous tolerance to trivalent flu shot, but had not taken a quadravalent before.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash, Speech disorder developmental
Clinical narrative: High fever and rash.  Mom now thinks that speech may be regressing.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Pallor
Clinical narrative: Patient received the Menactra vaccine and shortly after about 15 minutes felt dizzy and weak.  Patient was pale and almost passed out. No signs or symptoms of allergic reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: PATIENT REPORTS SEVERE SHOULDER PAIN AT INJECTION SITE.  LIMITS RANGE OF MOTION DUE TO PAIN. SEEN AT DR 7/29/2015.  XRAY SHOWED NO SIGNS OF NEEDLE BREAK OFF NOR ANY DAMAGE TO BONE.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Asthenia, Feeling abnormal, Hyperhidrosis
Clinical narrative: Right after getting the vaccine patient felt funny, sweaty and unable to keep her eyes open, patient helped to lie down in the exam table. Patient almost passed out. 7 PM VS taken BP 90/60, Pulse 60, Resp 18, temp 97.3. Medical alert bell pressed, pharmacy manager and store manager came to the clinic. Sent them back patient lying in exam table in no acute ditress. 7:05 PM, patient asking to drink some thing, asked boy friend to bring some drink. Boyfriend brought drink. Patient asked for water, water given to the patient to drink. Boyfriend in the room supporting patient. 7:10 PM,  patient sipping on drink and states feels weak but ok. VS taken BP 90/60, Pulse 56, Resp 18, temp 97.3. 7:15 PM patient still weak, will continue to monitor. Patient requesting her Hep A vaccine; discussed with patient in detail not to take 2 vaccines especially if she had a reaction. MOC called and notified about the incident, NP suggests she come another day to get another vaccine. 7:20 PM patient states ok but wants to sit up. VS taken BP 110/70, Pulse 60, Resp 18, temp 97.3. 7:30 PM VS taken BP 100/60, Pulse 54, Resp 18, temp 97.3. 7:45 PM patient states much better getting out of bed, able to ambulate, boyfriend is driving and discussed with boyfriend not to let her drive, he verbalizes understanding states will watch her.
Age: 0.35
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Giant hard knot in left thigh. Lasted ~4 weeks.
Age: 2.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Agitation, Autism, Crying, Diarrhoea, Hyperacusis
Clinical narrative: Severe diarrhea, autism, development delay, cried for hours, wouldn't sleep, sensory issues - noises and light disturbed/disturb him now, fever and agitation.
Age: 2.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Insomnia, Photophobia, Pyrexia, Sensory disturbance
Clinical narrative: Severe diarrhea, autism, development delay, cried for hours, wouldn't sleep, sensory issues - noises and light disturbed/disturb him now, fever and agitation.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Full blood count normal, Mass, Red blood cell sedimentation rate normal, Ultrasound scan
Clinical narrative: Tdap was given on 8/11/15. Next day morning noticed a 1 inch x 1/2 inch freely moving lump over the left clavicle. Not better in one week. No pain but discomfort while wearing protective gear for sports. Lump has remained unchanged.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (Bachelor of Science in Nursing) refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant therapies, concurrent conditions or medical histories provided. On an unknown dates since 25-JUN-2015, the patients were vaccinated with doses of VARIVAX (lot # L001335, expiration date 13-JAN-2017, dose and route of administration not reported), that were exposed to temperatures outside of the recommended range. There were no adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant (working in a physician's practice) refers to a 12 year old female patient with no concurrent conditions and no medical history. The patient did not take any concomitant medicines. On 16-JUL-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot# and expiry date were not provided) 1 dosage form (DF), intramuscularly (indication reported as vaccination). On 16-JUL-2015 the patient experienced severe injection site pain after receiving GARDASIL 9. Then "about 15 minutes later" she felt hot and light-headed. The physician laid the patient down and placed a cold cloth on her forehead. The patient rested for five minutes, then rose slowly and took long slow deep breaths as the physician instructed. No laboratory diagnostic tests were performed. The patient felt better and was sent home. The outcome of feeling hot, light-headed and injection site pain was described as recovering/resolving (the patient's soreness lessened but was still present at the time of the patient's most recent visit with the physician on 04-AUG-2015). It was unclear if the patient would continue with her GARDASIL 9 series. The relatedness between the all events and suspect therapy was unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: On 8/23/15 pt woke up with swelling in (R) hand. He went to acute care and was given a 7 day course of cephalexin.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction, red, slightly swollen, painful circle approx. 3in in diameter after receiving influenza vaccination. Treated with antihistamine.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: HPV4 was given pt got hot and started to sweat. Laid him down put feet up, and put a wet cool rag on neck. Pt wouldn't let nurse cont to given vaccine. After 5 minutes MCV4 was given again got hot and sweating. Applied ice behind neck gave cool H2O to drink. Wait about 5 minutes then gave Tdap. Ice applied again. Waited for 15 minutes and felt better.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, edema, and warmth surrounding injection site and extending to lower arm.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Within hours of injection-pain at injection site, erythema, sweats, and a low grade fever. Diphenhydramine 25 mg TID, prednisone 40 mg once.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Amnesia, Anxiety, Arthralgia, Asthenia
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Attention deficit/hyperactivity disorder, Back pain, Bipolar disorder, Chest pain, Depression
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Dyspnoea, Emotional distress, Fatigue, Gastroenteritis viral
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.