chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Injury, Neuralgia
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 06-SEP-2012, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 08-JUL-2015, the patient was treated by a health care professional for symptoms of an itchy painful rash that had persisted for 5 days and was worsening in severity. The patient was then diagnosed with herpes zoster, also known as a shingles outbreak. On or about 08-JUL-2015 the patient was prescribed valacyclovir (manufacturer unknown) for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered,  is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain  and emotional distress were considered disabling. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Physical disability, Rash, Rash pruritic
Clinical narrative: Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 06-SEP-2012, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 08-JUL-2015, the patient was treated by a health care professional for symptoms of an itchy painful rash that had persisted for 5 days and was worsening in severity. The patient was then diagnosed with herpes zoster, also known as a shingles outbreak. On or about 08-JUL-2015 the patient was prescribed valacyclovir (manufacturer unknown) for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered,  is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain  and emotional distress were considered disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with an expired VARIVAX (lot # L004651, expiration date 11-FEB-2017) for prophylaxis (dose, frequency and route of administration were not reported). No adverse symptoms were reported and it was stated that the expired VARIVAX administered did not have any previous temperature excursions. No product quality complaint was involved. Additional information is not expected since the reporter had no further information to provide.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M023892, expiration date: 15-SEP-2017 (dose and route of administration were not reported). Temperature excursion ranged from 32 to 35 degrees Fahrenheit (from 0 to 1 degrees Celsius) for 2 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA010600: US-009507513-1703USA005103.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 injection, lot # M040804, expiration date: 20-MAY-2018 (dose and route of administration were not reported). Temperature excursion ranged from 32 to 35 degrees Fahrenheit (from 0 to 1 degrees Celsius) for 2 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005103: US-009507513-1703USA010599:
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria. Pruritus.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: On 9 February he was given a PREVNAR 13 injection. Within several days he developed a rash which is about 4 cm in diameter at the injection site which was the right deltoid area. Several days thereafter he developed a diffuse rash which was symmetrical in nature and pruritic. Skin. Rash.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after vaccines were given arm became red and swollen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient developed a generalized rash on 12/23, nine days after receiving a varicella vaccine. No complications, parent reported patient having a fever. No additional cases reported among contacts. No laboratory testing was performed for diagnostic purposes. Rash lasted about 14 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/o erythema and swelling to left upper arm after Dtap-IPV and MMR-V were administered. Advised to apply cool compresses to the affected area and if needed, may take tylenol.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: None. No adverse reaction, patient was given ROTATEQ immunization after 12 weeks of age.  Plan is to complete series now.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Mother reported that the child got a single welt at administration site and few hours later it expanded as hives through the whole body.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra FLUZONE QUADRIVALENT dose.
Age: 12.0
Sex: F
Vaccine: HIBV, HPV9
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 25.0
Sex: F
Vaccine: JEV1, PPV, TYP
Symptoms: Anaemia, Blood lactate dehydrogenase normal, Chills, Coombs direct test negative, Fatigue
Clinical narrative: Pt received travel vaccinations 3/16 in preparation for a trip at the end of the month. Typhoid IM (prior 2011), PNEUMOVAX (1st), JEV (Ixiaro, first). The following day she developed fever to 102.4, chills, fatigue, diaprhoresis,  and at the site of the pneumovax vaccine in the left upper arm she also developed redness with swelling and tenderness. No arthralgias or systemic rash of any sort. Seen in ER for these sx 3/18, photo taken of left arm showing reaction with large area of erythema and edema c/w a local reaction. She shows me several additional photos today showing various stages of the immunization reaction.  She had no other systemic sx to include cough, dysuria, abdominal pain or diarrhea. She did have some shoulder and midback soreness, but on 3/14 she had been shoveling a lot of snow and ice and she is not sure this was related to the other symptoms. Screening bloodwork at ER showed anemia with leukocytosis and left shift with ANC as high as 18.7K. ER team spoke with ID, hematology, and AI - AI Dr  recommended that this patient see me as outpatient for vaccine concerns. Got 4L IVF, benadryl IV that reduced degree of local redness, treated with 2 doses of vanc in ER per ID reccs, d/c with Keflex to r/o cellulitis, zyrtec, triamcinolone. H/H 9.9/30.6 at intake 3/18 PM and decreased to 8.7/27.0 overnight with hydration. Concern raised over possible vaccine associated hemolytic anemia. Patient denied history of any excessive bleeding, has only mild flow with periods since IUD placed last year, no obvious GI source. She is medical student and gives blood routinely, usually every 7 weeks - she reports fingerstick pre-donation Hgb is regularly 14 - however in Nov it was as low as 12.5, and in Jan it was as low as 11.5, to the point where they almost did not let her donate blood. Has seen hematology in the interim, and peripheral blood workup revealed an iron saturation of 6, ferritin was 39 on 3/19/2017. LDH was 134, haptoglobin was 86, and DAT was negative which seemed to argue against hemolytic cause of the anemia.  Oncology recommends GI workup with EGD/colonscopy - pending for tomorrow. Plan for repeat bloodwork next week as well.
Age: 25.0
Sex: F
Vaccine: JEV1, PPV, TYP
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haptoglobin normal, Hyperhidrosis, Injection site erythema
Clinical narrative: Pt received travel vaccinations 3/16 in preparation for a trip at the end of the month. Typhoid IM (prior 2011), PNEUMOVAX (1st), JEV (Ixiaro, first). The following day she developed fever to 102.4, chills, fatigue, diaprhoresis,  and at the site of the pneumovax vaccine in the left upper arm she also developed redness with swelling and tenderness. No arthralgias or systemic rash of any sort. Seen in ER for these sx 3/18, photo taken of left arm showing reaction with large area of erythema and edema c/w a local reaction. She shows me several additional photos today showing various stages of the immunization reaction.  She had no other systemic sx to include cough, dysuria, abdominal pain or diarrhea. She did have some shoulder and midback soreness, but on 3/14 she had been shoveling a lot of snow and ice and she is not sure this was related to the other symptoms. Screening bloodwork at ER showed anemia with leukocytosis and left shift with ANC as high as 18.7K. ER team spoke with ID, hematology, and AI - AI Dr  recommended that this patient see me as outpatient for vaccine concerns. Got 4L IVF, benadryl IV that reduced degree of local redness, treated with 2 doses of vanc in ER per ID reccs, d/c with Keflex to r/o cellulitis, zyrtec, triamcinolone. H/H 9.9/30.6 at intake 3/18 PM and decreased to 8.7/27.0 overnight with hydration. Concern raised over possible vaccine associated hemolytic anemia. Patient denied history of any excessive bleeding, has only mild flow with periods since IUD placed last year, no obvious GI source. She is medical student and gives blood routinely, usually every 7 weeks - she reports fingerstick pre-donation Hgb is regularly 14 - however in Nov it was as low as 12.5, and in Jan it was as low as 11.5, to the point where they almost did not let her donate blood. Has seen hematology in the interim, and peripheral blood workup revealed an iron saturation of 6, ferritin was 39 on 3/19/2017. LDH was 134, haptoglobin was 86, and DAT was negative which seemed to argue against hemolytic cause of the anemia.  Oncology recommends GI workup with EGD/colonscopy - pending for tomorrow. Plan for repeat bloodwork next week as well.
Age: 25.0
Sex: F
Vaccine: JEV1, PPV, TYP
Symptoms: Injection site oedema, Injection site pain, Injection site swelling, Leukocytosis, Local reaction
Clinical narrative: Pt received travel vaccinations 3/16 in preparation for a trip at the end of the month. Typhoid IM (prior 2011), PNEUMOVAX (1st), JEV (Ixiaro, first). The following day she developed fever to 102.4, chills, fatigue, diaprhoresis,  and at the site of the pneumovax vaccine in the left upper arm she also developed redness with swelling and tenderness. No arthralgias or systemic rash of any sort. Seen in ER for these sx 3/18, photo taken of left arm showing reaction with large area of erythema and edema c/w a local reaction. She shows me several additional photos today showing various stages of the immunization reaction.  She had no other systemic sx to include cough, dysuria, abdominal pain or diarrhea. She did have some shoulder and midback soreness, but on 3/14 she had been shoveling a lot of snow and ice and she is not sure this was related to the other symptoms. Screening bloodwork at ER showed anemia with leukocytosis and left shift with ANC as high as 18.7K. ER team spoke with ID, hematology, and AI - AI Dr  recommended that this patient see me as outpatient for vaccine concerns. Got 4L IVF, benadryl IV that reduced degree of local redness, treated with 2 doses of vanc in ER per ID reccs, d/c with Keflex to r/o cellulitis, zyrtec, triamcinolone. H/H 9.9/30.6 at intake 3/18 PM and decreased to 8.7/27.0 overnight with hydration. Concern raised over possible vaccine associated hemolytic anemia. Patient denied history of any excessive bleeding, has only mild flow with periods since IUD placed last year, no obvious GI source. She is medical student and gives blood routinely, usually every 7 weeks - she reports fingerstick pre-donation Hgb is regularly 14 - however in Nov it was as low as 12.5, and in Jan it was as low as 11.5, to the point where they almost did not let her donate blood. Has seen hematology in the interim, and peripheral blood workup revealed an iron saturation of 6, ferritin was 39 on 3/19/2017. LDH was 134, haptoglobin was 86, and DAT was negative which seemed to argue against hemolytic cause of the anemia.  Oncology recommends GI workup with EGD/colonscopy - pending for tomorrow. Plan for repeat bloodwork next week as well.
Age: 25.0
Sex: F
Vaccine: JEV1, PPV, TYP
Symptoms: Neutrophil count increased, Pyrexia, Serum ferritin normal, Shift to the left, Transferrin saturation decreased
Clinical narrative: Pt received travel vaccinations 3/16 in preparation for a trip at the end of the month. Typhoid IM (prior 2011), PNEUMOVAX (1st), JEV (Ixiaro, first). The following day she developed fever to 102.4, chills, fatigue, diaprhoresis,  and at the site of the pneumovax vaccine in the left upper arm she also developed redness with swelling and tenderness. No arthralgias or systemic rash of any sort. Seen in ER for these sx 3/18, photo taken of left arm showing reaction with large area of erythema and edema c/w a local reaction. She shows me several additional photos today showing various stages of the immunization reaction.  She had no other systemic sx to include cough, dysuria, abdominal pain or diarrhea. She did have some shoulder and midback soreness, but on 3/14 she had been shoveling a lot of snow and ice and she is not sure this was related to the other symptoms. Screening bloodwork at ER showed anemia with leukocytosis and left shift with ANC as high as 18.7K. ER team spoke with ID, hematology, and AI - AI Dr  recommended that this patient see me as outpatient for vaccine concerns. Got 4L IVF, benadryl IV that reduced degree of local redness, treated with 2 doses of vanc in ER per ID reccs, d/c with Keflex to r/o cellulitis, zyrtec, triamcinolone. H/H 9.9/30.6 at intake 3/18 PM and decreased to 8.7/27.0 overnight with hydration. Concern raised over possible vaccine associated hemolytic anemia. Patient denied history of any excessive bleeding, has only mild flow with periods since IUD placed last year, no obvious GI source. She is medical student and gives blood routinely, usually every 7 weeks - she reports fingerstick pre-donation Hgb is regularly 14 - however in Nov it was as low as 12.5, and in Jan it was as low as 11.5, to the point where they almost did not let her donate blood. Has seen hematology in the interim, and peripheral blood workup revealed an iron saturation of 6, ferritin was 39 on 3/19/2017. LDH was 134, haptoglobin was 86, and DAT was negative which seemed to argue against hemolytic cause of the anemia.  Oncology recommends GI workup with EGD/colonscopy - pending for tomorrow. Plan for repeat bloodwork next week as well.
Age: 25.0
Sex: F
Vaccine: JEV1, PPV, TYP
Symptoms: White blood cell count increased
Clinical narrative: Pt received travel vaccinations 3/16 in preparation for a trip at the end of the month. Typhoid IM (prior 2011), PNEUMOVAX (1st), JEV (Ixiaro, first). The following day she developed fever to 102.4, chills, fatigue, diaprhoresis,  and at the site of the pneumovax vaccine in the left upper arm she also developed redness with swelling and tenderness. No arthralgias or systemic rash of any sort. Seen in ER for these sx 3/18, photo taken of left arm showing reaction with large area of erythema and edema c/w a local reaction. She shows me several additional photos today showing various stages of the immunization reaction.  She had no other systemic sx to include cough, dysuria, abdominal pain or diarrhea. She did have some shoulder and midback soreness, but on 3/14 she had been shoveling a lot of snow and ice and she is not sure this was related to the other symptoms. Screening bloodwork at ER showed anemia with leukocytosis and left shift with ANC as high as 18.7K. ER team spoke with ID, hematology, and AI - AI Dr  recommended that this patient see me as outpatient for vaccine concerns. Got 4L IVF, benadryl IV that reduced degree of local redness, treated with 2 doses of vanc in ER per ID reccs, d/c with Keflex to r/o cellulitis, zyrtec, triamcinolone. H/H 9.9/30.6 at intake 3/18 PM and decreased to 8.7/27.0 overnight with hydration. Concern raised over possible vaccine associated hemolytic anemia. Patient denied history of any excessive bleeding, has only mild flow with periods since IUD placed last year, no obvious GI source. She is medical student and gives blood routinely, usually every 7 weeks - she reports fingerstick pre-donation Hgb is regularly 14 - however in Nov it was as low as 12.5, and in Jan it was as low as 11.5, to the point where they almost did not let her donate blood. Has seen hematology in the interim, and peripheral blood workup revealed an iron saturation of 6, ferritin was 39 on 3/19/2017. LDH was 134, haptoglobin was 86, and DAT was negative which seemed to argue against hemolytic cause of the anemia.  Oncology recommends GI workup with EGD/colonscopy - pending for tomorrow. Plan for repeat bloodwork next week as well.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot number M036059 and expiration date 03-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with GARDASIL 9 was 30 minutes between 9 to 25 Celsius degrees. No previous temperature excursion was performed and the temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009373: US-009507513-1703USA009374: US-009507513-1703USA009372:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M009378, expiration date: 23-APR-2018; lot # M009378;  expiration date: 07-APR-2019). The vaccines were exposed to 32 degrees F to 35 degrees F for 8 hours. No previous excursions. A data logger was used. No adverse effects were reported.  This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007389: US-009507513-1703USA007409: US-009507513-1703USA007408:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a laboratory technician concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot #: M005972 with expiration date: 02-FEB-2017) (dose, strenght, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 6°F but less than 14°F for 15 minutes (no digital data logger involved) without any previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006906:
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 66-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced red and sore arm, with outcome of unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: PT DEVELOPED A 2-3 INCH CIRCULAR RASH WITH A BLISTER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Crying, Petechiae, Rash, Retching, Vomiting
Clinical narrative: Patient received his immunizations and within 5 minutes had a petechial, sandpapery feeling rash at the base of his neck circumferentially. He continued to cry and gagged several times beginning to vomit. He had normal respirations and no swelling of mouth, tongue or lips. He recieved 12.5 mg diphenhydramine.  He settled down and was able to tolerate water and rested for 45 minutes.  He was sent home with his mother with return precautions.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash - red bumps on face then chest, arms.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Blood test normal, Concussion, Contusion, Disorientation, Electrocardiogram normal
Clinical narrative: My daughter received her 2nd inoculations of GARDASIL 9 and BEXSERO PFS and went to bed within 3 1/2 hrs of the vaccinations. She got up for school at 5:25 AM, precisely 12 hours after the inoculation. She felt nauseated and disoriented, turned to go back to bed and fainted. I heard something hit the floor and a minute later, heard noises. I listened for about 10 seconds to ascertain whether it was laughing or crying. It was 5:27 AM when I entered her room and found her on the floor. She had hit her head and elbow and had an extreme headache. She sustained a concussion, her third in 2 1/2 years. I sent her back to bed. Upon arising at 9 AM, she started seeing black and rushed to lie down. She felt nauseated, had a low-grade fever, headache, slight swelling and soreness at the site of the inoculations. We called the doctor. She advised rest, ADVIL and to watch the symptoms. My daughter's nausea subsided once she had eaten, but she's had headaches on and off ever since (most likely from the concussion). Three days later, she fell and bumped her chin on the floor hard enough to cause a bruise and hear her neck crack with the impact. Again, she had a severe headache, so we thought it best to visit the ER.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Fall, Head injury, Headache, Injection site pain, Injection site swelling
Clinical narrative: My daughter received her 2nd inoculations of GARDASIL 9 and BEXSERO PFS and went to bed within 3 1/2 hrs of the vaccinations. She got up for school at 5:25 AM, precisely 12 hours after the inoculation. She felt nauseated and disoriented, turned to go back to bed and fainted. I heard something hit the floor and a minute later, heard noises. I listened for about 10 seconds to ascertain whether it was laughing or crying. It was 5:27 AM when I entered her room and found her on the floor. She had hit her head and elbow and had an extreme headache. She sustained a concussion, her third in 2 1/2 years. I sent her back to bed. Upon arising at 9 AM, she started seeing black and rushed to lie down. She felt nauseated, had a low-grade fever, headache, slight swelling and soreness at the site of the inoculations. We called the doctor. She advised rest, ADVIL and to watch the symptoms. My daughter's nausea subsided once she had eaten, but she's had headaches on and off ever since (most likely from the concussion). Three days later, she fell and bumped her chin on the floor hard enough to cause a bruise and hear her neck crack with the impact. Again, she had a severe headache, so we thought it best to visit the ER.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Joint injury, Nausea, Pyrexia, Syncope, Visual impairment
Clinical narrative: My daughter received her 2nd inoculations of GARDASIL 9 and BEXSERO PFS and went to bed within 3 1/2 hrs of the vaccinations. She got up for school at 5:25 AM, precisely 12 hours after the inoculation. She felt nauseated and disoriented, turned to go back to bed and fainted. I heard something hit the floor and a minute later, heard noises. I listened for about 10 seconds to ascertain whether it was laughing or crying. It was 5:27 AM when I entered her room and found her on the floor. She had hit her head and elbow and had an extreme headache. She sustained a concussion, her third in 2 1/2 years. I sent her back to bed. Upon arising at 9 AM, she started seeing black and rushed to lie down. She felt nauseated, had a low-grade fever, headache, slight swelling and soreness at the site of the inoculations. We called the doctor. She advised rest, ADVIL and to watch the symptoms. My daughter's nausea subsided once she had eaten, but she's had headaches on and off ever since (most likely from the concussion). Three days later, she fell and bumped her chin on the floor hard enough to cause a bruise and hear her neck crack with the impact. Again, she had a severe headache, so we thought it best to visit the ER.
Age: 4.0
Sex: F
Vaccine: MMRV, TDAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm red swelling in Left upper arm.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Dyspnoea, Presyncope
Clinical narrative: Pt given Hep A Vaccine - Adverse reaction of near syncopal episode upon leaving the exam room 10min later. Pt sat down to steady himself. Vitals taken and wnl. Assisted pt back to exam room to lie down and take deep breaths. Pt with increased WOB, stated "my body feels like its burning on the inside." Afebrile, O2 sat 100%, no rash or hives, no change in vitals. Waited 10min with continued monitoring and crash cart outside. Pt able to drink water, juice. Ambulated to restroom with assistance. Pt still felt burning pain inside lying down when returned to exam room, vitals continued to be wnl. CDC Hep A adverse reactions include soreness, HA, low grade fever, syncope. No other reported SE that coincide with pt sx. Given pt extreme burning discomfort, 911 called. EMT arrived, report given, progress note and vaccine information papers provided to take to ED. Mom and brother went with pt in ambulance. Discussed f/u after ED visit. Pt and mom in agreement with plan.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: Sore right arm at injection site....with rash/hives.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: On the first day, she had more pain than usual with an immunization.  By that night, she had pain with abduction of her left shoulder and the area where the injection was given was red and tender. The next day, the arm ached. She would get some relief with extending her elbow or moving her shoulder. Pain radiated into her left upper back. A couple of days later the pain in the left upper back eased, and pain started radiating into the left arm and forearm. By the third or fourth day, she was experiencing some tingling in her dorsal hand which has persisted for two weeks.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: On the first day, she had more pain than usual with an immunization.  By that night, she had pain with abduction of her left shoulder and the area where the injection was given was red and tender. The next day, the arm ached. She would get some relief with extending her elbow or moving her shoulder. Pain radiated into her left upper back. A couple of days later the pain in the left upper back eased, and pain started radiating into the left arm and forearm. By the third or fourth day, she was experiencing some tingling in her dorsal hand which has persisted for two weeks.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Per store manager, patient felt dizzy and mother had to grab her. Mother disclosed that patient has recently been having problems with fainting. Patient is being monitored by per pcp.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia oral
Clinical narrative: PATIENT HAD NUMBNESS OF LIPS WHICH IS ONGOING.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on arm.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, PNC13
Symptoms: Diet refusal, Eczema, Fatigue, Irritability, Rash generalised
Clinical narrative: Rash covering body flared up eczema irratibilty fatigue refusal to eat.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, PNC13
Symptoms: Dermatitis atopic, Rash
Clinical narrative: Rash covering body flared up eczema irratibilty fatigue refusal to eat.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Case number PHEH2017US008343, is an initial spontaneous report received from a consumer on 20 Mar 2017. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unknown date in Oct 2016. On 18 Mar 2017, the patient got the flu, symptoms of flu and high fever. The patient had a flu test that was an A strain flu (positive test) on 18 Mar 2017. Patient received TAMIFLU. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of influenza, vaccination failure and pyrexia was upgraded to serious (medically significant) based on the information available in the source document.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Unevaluable event, X-ray
Clinical narrative: See attached ER visit notes and SF 600 note. Labs, xray, CT results, EKG.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, limited range of motion unable to raise left hand above head Treatment: ADVIL with food, ice.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Developed red mosquito like rash to neck, bilateral arms, chest, thighs. Only itching noted to neck area. Rash onset 3/10/17 and has been taking BENADRYL with no improvement. Encouraged to cont. taking BENADRYL and notify PCP or urgent care. 3/21/17 - Call to patient, left msg to return call for follow up on reaction. 3/23/17 - Call to patient. States she did not go to PCP/urgent care but kept taking BENADRYL and rash resolved 3/18/17. She reports no further problems or questions at this time.
Age: 1.67
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 20 minutes post vaccination swelling and redness developed at site.
Age: 31.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect dose administered
Clinical narrative: Dose of YF vaccine was not verified by administration 5 dose dial was diluted with 0.6 ML's of sodium chloride and administered to the patient. Patient was taken to the Hosp for evaluation and released.
Age: 34.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect dose administered
Clinical narrative: Dosage of YF vaccine was not verified by administrator. 5 dose vial was diluted with 0.6mL's of sodium chloride and administered to the patient. Patient was taken to the Hosp for evaluation and released.
Age: 20.0
Sex: F
Vaccine: TYP, YF
Symptoms: Incorrect dose administered
Clinical narrative: Dosage of YF vaccine was not verified by administration 5 dose vial was dilated with 0.6 ml's sodium chloride and administered to the patient. Patient was taken to the Hosp for evaluation and released.
Age: 29.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect dose administered
Clinical narrative: Dosage of YF vaccine was verified by administrator. 5 dose vial was diluted with 0.6 ml's of sodium chloride and administrated to the patient. Patient was taken to the hospital for evaluation and released.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Seen by provider 12/10/2015 - ibuprofen ice/heat stretch. 12/17/2015 seen by another provider - declined imaging same area. 1/11/2016 0 physical - shoulder much better. 2/18/2016 secure message still having shoulder pain. 2/23/16 - Dr apt - referred to ortho.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Asthenia, Blood test, Burning sensation, Cold sweat
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax, Demyelinating polyneuropathy, Electromyogram
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Head discomfort, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Muscle atrophy, Muscular weakness, Nerve root compression, Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, Peroneal nerve palsy, Pyrexia
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Sarcopenia, Weight decreased
Clinical narrative: 10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule
Clinical narrative: Pt has a knot that is palpable. About 1 inch in diameter. Pt denies pain, but was concerned about the reaction.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines given 3/8. 3/10 parent called stated leg red sl. swollen in for appt. Apparent reaction to vaccines given (L) leg Dtap/HIB. Ice area, called next day, doing better. CT 3/13/17.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular, Urticaria
Clinical narrative: FLUZONE/PREVNAR given. After vaccine (R) leg red splotchy hive like rash. Ice applied observed x30 min clear Dr aware.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened area approx. 4 1/2 cm wide and 2 cm long, warm to the touch surrounding injection of the upper left arm.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Heart rate irregular, Injection site induration, Injection site swelling, Musculoskeletal discomfort, Palpitations
Clinical narrative: 3 years ago received PNEUMOVAX 23 with no problems. 1 year ago received PREVNAR 13 with no problems. Vaccination felt like flooded shoulder. Discomfort in shoulder started that night, lasted for 2 days and gradually subsided. 12 days later still there is discomfort in muscle. After vaccination area got swollen and hard. Next morning irregular heart beat started to this day still has palpitations. Reported to doctor via call on 3/20 and today to pharmacist.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching at injection site, pain at injection site.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper sore arm with 12 x 12 cm red warm swollen. Tender to touch area.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Patient called pharmacy with concerns about side effects of immunization. She woke up with swollen lips. BENADRYL was recommended.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Seen 3/22/17 - given Tdap, HPV-9 #1, MCV4 #1 and RX for EPIDUO for acne before 12 noon. Late afternoon per child face a little puffy. Used EPIDUO for 1st time later that day.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Influenza B virus test positive, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythematous, warmth, tenderness (L) deltoid region PPSV 23 site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Lump and redness at site, like a whitehead or zit. Pt was given an antibiotic BACTRIM.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, White blood cell count normal
Clinical narrative: Redness (more than usual) not at injection site but below deltoid area and surrounding arm. Pain (soreness) reported by patient more severe evening of/after vaccination.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Body temperature increased, Differential white blood cell count, Eye movement disorder, Febrile convulsion, Full blood count normal
Clinical narrative: Mom reports temp at 9:00pm on 12/8/16 was 99.9 and she gave TYLENOL by wt. At 4:00am eyes rolled back and began shaking. Called 911. When paramedics arrived temp. was 105 degrees and cold clothes applied. In ER temp was 103.9 degrees rectally and Ibuprofen given. Discharged on cefdinir. Dx febrile seizure.