chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration, Injection site nodule
Clinical narrative: Pt informed on 4/27/15 ADE with flu shot on 10/14/14. Sometime in November noticed a knot with pus at site of injection which grew from the size of quarter to dollar coin. Received AMOXIL and then later AUGMENTIN on 1/26/15. Infx resolved but now left with black indentation size of quarter. Was told by MD that it could be infx due to flu shot but can't confirm.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration, Injection site infection, Injection site nodule, Purulent discharge
Clinical narrative: Pt informed on 4/27/15 ADE with flu shot on 10/14/14. Sometime in November noticed a knot with pus at site of injection which grew from the size of quarter to dollar coin. Received AMOXIL and then later AUGMENTIN on 1/26/15. Infx resolved but now left with black indentation size of quarter. Was told by MD that it could be infx due to flu shot but can't confirm.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervical dysplasia, Colposcopy, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient started therapy with GARDASIL (intramuscularly, dose, frequency, lot/batch # were not provided). The patient was a virgin when she completed the GARDASIL shot series (on unspecified date, in approximately 2007). On an unspecified day, in approximately 2011, abnormal paps started. It was reported that in 2014, the patient had low grade for type 18. The patient was tested positive for HPV for type 18 in 2015 on an unspecified date (she had high grade for type 18), even though the patient completed GARDASIL shot series at age of 16. The test came back with cervical intraepithelial neoplasia (CIN) 2 and 3 on an unspecified date. The patient had a colposcopy on 27-APR-2015, the result was not provided. The patient was scheduled to have loop electrosurgical excision (LEEP) procedure on unspecified date. The outcome of the events was reported as not recovered. The outcome of drug ineffective was unknown. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient started therapy with GARDASIL (intramuscularly, dose, frequency, lot/batch # were not provided). The patient was a virgin when she completed the GARDASIL shot series (on unspecified date, in approximately 2007). On an unspecified day, in approximately 2011, abnormal paps started. It was reported that in 2014, the patient had low grade for type 18. The patient was tested positive for HPV for type 18 in 2015 on an unspecified date (she had high grade for type 18), even though the patient completed GARDASIL shot series at age of 16. The test came back with cervical intraepithelial neoplasia (CIN) 2 and 3 on an unspecified date. The patient had a colposcopy on 27-APR-2015, the result was not provided. The patient was scheduled to have loop electrosurgical excision (LEEP) procedure on unspecified date. The outcome of the events was reported as not recovered. The outcome of drug ineffective was unknown. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervical dysplasia, Colonoscopy, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient started therapy with GARDASIL (intramuscularly, dose, frequency, lot/batch # were not provided). The patient was a virgin when she completed the GARDASIL shot series (on unspecified date, in approximately 2007). On an unspecified day, in approximately 2011, abnormal paps started. It was reported that in 2014, the patient had low grade for type 18. The patient was tested positive for HPV for type 18 in 2015 on an unspecified date (she had high grade for type 18), even though the patient completed GARDASIL shot series at age of 16. The test came back with cervical intraepithelial neoplasia (CIN) 2 and 3 on an unspecified date. The patient had a colposcopy on 27-APR-2015, the result was not provided. The patient was scheduled to have loop electrosurgical excision (LEEP) procedure on unspecified date. The outcome of the events was reported as not recovered. The outcome of drug ineffective was unknown. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Dyspnoea, Fatigue, Heart rate increased, Muscle twitching
Clinical narrative: Initially some fatigue, 24 hours after c/o dif breathing seen in ER -c/o concurrent increased HR, muscle, back aches today 4/23/15 c/o twitching. Currently on ZYRTEC; generic SPRINTEC (BCP); FLONASE ibuprofen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Initially some fatigue, 24 hours after c/o dif breathing seen in ER -c/o concurrent increased HR, muscle, back aches today 4/23/15 c/o twitching. Currently on ZYRTEC; generic SPRINTEC (BCP); FLONASE ibuprofen.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Tdap 4/23 soreness that evening. 4/24-redness at site and below Band-Aid. 4/26-redness-large area-big as hand (hand covered area) warm and hot touch. Chills 4/24 and 4/25; diarrhea 4/24, 4/25 and 4/26. Evaluated-tx ALLEGRA or CLARITIN; warm compresses 3rd day. Return if not improved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Rash erythematous, Skin warm
Clinical narrative: April 15-shot. April 16-50 cent size warm red hard spot. Softball size pink skin around red spots. April 18 Pink skin gone - red spot still warm. April 19 Red spot lighten. April 21 all spot gone.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient stated he needed something to eat about 15 minutes after the vaccine. Then said he felt dizzy and like he was going to faint. We got him to a chair. He said he hadn't eaten all day (6 pm).
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Chills, Erythema, Hypotension, Nausea
Clinical narrative: Got sick to my stomach, got chills, got 101 degree fever, arm was red and hot all the way to my elbow. The next day my sugar was up, and my blood pressure was low, I was still sick to my stomach for 6 days.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Skin warm
Clinical narrative: Got sick to my stomach, got chills, got 101 degree fever, arm was red and hot all the way to my elbow. The next day my sugar was up, and my blood pressure was low, I was still sick to my stomach for 6 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: Large red, hot, itchy and painful 7/10. Began to hurt 30 minutes after injection. has been using ice packs. Today - 47mm induration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccine site: induration and erythema, pain and hot to touch extending 4-5 cm from injection site. Mild cellulitis.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Blister, Infection transmission via personal contact, Oedema peripheral, Orthopoxvirus test positive
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pain, Pain in extremity, Panniculitis lobular, Peripheral swelling, Polymerase chain reaction positive
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Skin exfoliation, Smear site unspecified normal, Staphylococcus test positive
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Blister, Cell death, Culture positive, Infection transmission via personal contact
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oedema peripheral, Orthopoxvirus test positive, Pain, Pain in extremity, Panniculitis lobular
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Peripheral swelling, Polymerase chain reaction positive, Pyrexia, Skin exfoliation, Skin necrosis
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Smear site unspecified normal, Staphylococcus test positive
Clinical narrative: Case of contact transmission - this patient was the contact and not the vaccinee. On 9 Apr 2015, smallpox Vaccinee received his primary smallpox vaccine. Around 10 or 11 Apr 2015, Contact received new tattoo wrapping around his left arm (just below elbow) to his shoulder. On 11 Apr 2015, Vaccinee was in the rain and his shirt became wet. He took off his shirt and threw it in the backseat of his car, where the Contact's LUE (recently tattooed) came into contact with the shirt. (Contact leaned against shirt x approximately 10 minutes). On 15 Apr 2015, contact developed blisters on his left upper arm. On 17 Apr 2015, contact went to Emergency Dept with left axillary swelling. On 18 Apr 2015, contact reports fever, body aches, arm swelling, and pain, as well as new blisters and desquamation over tattoo surface. (In addition to contact transmission, Contact developed secondary infection of LUE affected by tattoo - see cultures).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Chills, Erythema, Headache
Clinical narrative: 4-18-15 10 am pain at site, pain under arm (worsening as day progressed). 4-19-15 2 am woke up with chills, trembling, headache and nausea. Temp 99.9. 4-19-15 2pm Temp 102.2 arm extremely painful at site. Not able to left arm at all.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Nausea, Tenderness, Tremor
Clinical narrative: 4-18-15 10 am pain at site, pain under arm (worsening as day progressed). 4-19-15 2 am woke up with chills, trembling, headache and nausea. Temp 99.9. 4-19-15 2pm Temp 102.2 arm extremely painful at site. Not able to left arm at all.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site started 4-23-15 and symptoms lessening on 4-24-15 when reported.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Heart rate increased
Clinical narrative: Light headed, tight chest, rapid pulse B/P 112/78, HR 84 regular, 99% ox sat. Refused 911 transport to ER. Friend transported her to ER.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Local rx. Erythema/induration approximately 5 x 3 cm. Painful. Treated with MEDROL dose pak/KEFLEX.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A spontaneous report has been received from a field employee who reported on behalf of a pharmacist. The pharmacist reported that an unspecified patient received ZOSTAVAX on an unspecified date. The patient experienced redness, pain and swelling at the injection site on unspecified date. Medical history and concomitant medication were not reported. The outcome of redness, pain and swelling at the injection site was reported as recovered. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye inflammation, Sudden visual loss
Clinical narrative: Inflamed and no vision to left eye sudden presentation.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Blindness unilateral, Immunology test normal, Laboratory test normal, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: Inflamed and no vision to left eye sudden presentation.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Serology test
Clinical narrative: Inflamed and no vision to left eye sudden presentation.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Ataxia, Blood alcohol, Borrelia test, CSF culture negative, Computerised tomogram head
Clinical narrative: Patient developed fever, fatigue 3 days prior to presenting to ER on 4/30/2015 with altered mental status and ataxia.  Admitted to medical center after transfer from emergency room.  CT and MRI brain negative.  LP-traumatic tap, cultures negative including Herpes PCR. Also neg, EBV negative.  Respiratory PCR panel all negative, Lyme, rheumatalogic work up pending, Varicella PCR on CSF pending.  Treated with IV antibiotic, IV acyclovir, IV steroid, IVIG.  Tansferred to another hospital on 5/4/2015 at parents request.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Epstein-Barr virus test negative, Fatigue, Full blood count, Immunoglobulin therapy, Laboratory test
Clinical narrative: Patient developed fever, fatigue 3 days prior to presenting to ER on 4/30/2015 with altered mental status and ataxia.  Admitted to medical center after transfer from emergency room.  CT and MRI brain negative.  LP-traumatic tap, cultures negative including Herpes PCR. Also neg, EBV negative.  Respiratory PCR panel all negative, Lyme, rheumatalogic work up pending, Varicella PCR on CSF pending.  Treated with IV antibiotic, IV acyclovir, IV steroid, IVIG.  Tansferred to another hospital on 5/4/2015 at parents request.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Mental status changes, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Pyrexia, Streptococcus test negative
Clinical narrative: Patient developed fever, fatigue 3 days prior to presenting to ER on 4/30/2015 with altered mental status and ataxia.  Admitted to medical center after transfer from emergency room.  CT and MRI brain negative.  LP-traumatic tap, cultures negative including Herpes PCR. Also neg, EBV negative.  Respiratory PCR panel all negative, Lyme, rheumatalogic work up pending, Varicella PCR on CSF pending.  Treated with IV antibiotic, IV acyclovir, IV steroid, IVIG.  Tansferred to another hospital on 5/4/2015 at parents request.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Traumatic lumbar puncture, Varicella virus test, Viral test
Clinical narrative: Patient developed fever, fatigue 3 days prior to presenting to ER on 4/30/2015 with altered mental status and ataxia.  Admitted to medical center after transfer from emergency room.  CT and MRI brain negative.  LP-traumatic tap, cultures negative including Herpes PCR. Also neg, EBV negative.  Respiratory PCR panel all negative, Lyme, rheumatalogic work up pending, Varicella PCR on CSF pending.  Treated with IV antibiotic, IV acyclovir, IV steroid, IVIG.  Tansferred to another hospital on 5/4/2015 at parents request.
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2015142956 for PREVNAR 13. The originally reported by a pharmacy student concerning to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, route application site were not reported) and she had a local reaction. No concomitant therapies were reported. The outcome of the vaccination site reaction was unknown. The reporter considered vaccination site reaction to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Tenderness, Urticaria
Clinical narrative: Localized tenderness and hives to right thigh.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning two patients of unknown age and gender. The pharmacist reported that on unspecified dates two patients were vaccinated with ZOSTAVAX and on unspecified dates they experienced shingles. The outcome of shingles is unknown. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) arm significant swelling, red streak.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: 4/20/2015: 69-year-old female comes to the emergency department with complaint of a wound on her right lower leg that she received today. Patient reports she was at work, stacking baskets and the stack tipped forward, scraping her lower leg. Denies hitting her head or receiving any other injuries in the incident. Pt reports the area is mildly painful. Sts she is experiencing a 5/10 aching pain in her shin that does not radiate. Pt reports she has been able to walk normally. Patient is unsure when she had her last tetanus and thinks it was many years ago. Patient reports she has diet-controlled diabetes. Patient was administered Tdap on 4/20/15 via intramuscular inj. 4/23/2015: 69 year old female presents today to the ED with complaints of right arm pain at the site of the Tdap injection. Patient states that she was seen on 04/20/2015 after sustaining a laceration and received a tetanus shot. Patient states that since then she has had pain in her arm. Patient rates the pain as a 6/10, constant and aching in nature. Patient has tried ADVIL at home with some relief. Patient denies fever or chills. Right upper arm, lateral aspect with area of erythema, warmth and swelling, no induration or fluctuance, no lymphangitis. Patient was discharged from the ER to home with a prescription of cephalexin 500mg po TID for 21 doses.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: 4/20/2015: 69-year-old female comes to the emergency department with complaint of a wound on her right lower leg that she received today. Patient reports she was at work, stacking baskets and the stack tipped forward, scraping her lower leg. Denies hitting her head or receiving any other injuries in the incident. Pt reports the area is mildly painful. Sts she is experiencing a 5/10 aching pain in her shin that does not radiate. Pt reports she has been able to walk normally. Patient is unsure when she had her last tetanus and thinks it was many years ago. Patient reports she has diet-controlled diabetes. Patient was administered Tdap on 4/20/15 via intramuscular inj. 4/23/2015: 69 year old female presents today to the ED with complaints of right arm pain at the site of the Tdap injection. Patient states that she was seen on 04/20/2015 after sustaining a laceration and received a tetanus shot. Patient states that since then she has had pain in her arm. Patient rates the pain as a 6/10, constant and aching in nature. Patient has tried ADVIL at home with some relief. Patient denies fever or chills. Right upper arm, lateral aspect with area of erythema, warmth and swelling, no induration or fluctuance, no lymphangitis. Patient was discharged from the ER to home with a prescription of cephalexin 500mg po TID for 21 doses.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: 4/23/2015: 69 year old female presents today to the ED with complaints of right arm pain at the site of the Tdap injection.  Patient states that she was seen on 04/20/2015 after sustaining a laceration and received a tetanus shot.  Patient states that since then she has had pain in her arm. Patient rates her pain as a 6/10, constant and aching in nature.  Patient has tried Advil at home with some relief. Patient denies fever or chills. Right upper arm, lateral aspect with area of erythema, warmth and swelling, no induration or fluctuance, no lymphangitis.  Patient was discharged from the ER to home with a prescription for cephalexin 500mg po TID for 21 doses.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: 4/23/2015: 69 year old female presents today to the ED with complaints of right arm pain at the site of the Tdap injection.  Patient states that she was seen on 04/20/2015 after sustaining a laceration and received a tetanus shot.  Patient states that since then she has had pain in her arm. Patient rates her pain as a 6/10, constant and aching in nature.  Patient has tried Advil at home with some relief. Patient denies fever or chills. Right upper arm, lateral aspect with area of erythema, warmth and swelling, no induration or fluctuance, no lymphangitis.  Patient was discharged from the ER to home with a prescription for cephalexin 500mg po TID for 21 doses.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given the Menactra vaccine 2 weeks after receiving the first one.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Fatigue, Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Local and systemic reation. Redness and itching at the injection site. Fver and shakes overnight. Myalgia. Patient continues to have complaint of fatigue.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Local and systemic reation. Redness and itching at the injection site. Fver and shakes overnight. Myalgia. Patient continues to have complaint of fatigue.
Age: 0.59
Sex: M
Vaccine: DTAPH, HEP, IPV, RVX
Symptoms: Dehydration, Emotional distress, Pyrexia, Rash generalised, Screaming
Clinical narrative: Fever, vomiting, unable to keep fluids down, screaming, inconsolable, body rash, slight dehydration.
Age: 0.59
Sex: M
Vaccine: DTAPH, HEP, IPV, RVX
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, unable to keep fluids down, screaming, inconsolable, body rash, slight dehydration.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Dizziness, Injection site cellulitis, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient is a 29-year-old woman who works here at Hospital in the ER area.  She has no significant past medical history except for kidney stones, previous episode of gallstone pancreatitis who apparently was in her usual state of health until this past Friday 04/24/15 while working in the ER she accidentally stuck her left thumb with a needle that she just used to give an IM injection to a patient in the ER.  She said immediately made the needle stick bleed and wash in with soap and water. The source was tested and was negative for HIV and as per protocol she received Tdap shot on her left deltoid area; 24 hours later she started to notice increasing pain and swelling on that area which also was warm she said.  She started to have fever and chills with temperature up to 102 and by the next Monday she went to facility to be checked.  It was thought that she has cellulitis of the left upper arm related to the previous Tdap shot and she was started on Levaquin 750 mg daily.  She was taking Tylenol and Motrin for pain and fevers.  However, by the next day at night she came back to the ER complaining of persistent subjective fever and chills and increasing swelling of that area.  She had a dose of Teflaro 600 mg IV, she got 1 L of normal saline.  Blood cultures were taken and she was put on minocycline 100 mg twice a day plus Percocet as needed (Levaquin was discontinued).  Yesterday she noted that her left arm cellulitis was getting better but by the nighttime it was noted again the swelling was worse, more red, more painful and she was advised to take an extra dose of minocycline (she took 300 mg of minocycline on 04/29/15).  She went this morning to follow up with facility and because of persistent symptoms, feeling nauseous, dizzy (which may be related to the higher dose of minocycline) plus persistent cellulitis (although she said today it looks somewhat better) a decision was made to send her to the ER for further evaluation.  She had already soft tissue ultrasound of the left arm which showed no evidence of abscess or fluid collection.  She received in the Emergency Room 1 g of vancomycin plus Toradol 30 mg IV.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Ultrasound scan normal
Clinical narrative: Patient is a 29-year-old woman who works here at Hospital in the ER area.  She has no significant past medical history except for kidney stones, previous episode of gallstone pancreatitis who apparently was in her usual state of health until this past Friday 04/24/15 while working in the ER she accidentally stuck her left thumb with a needle that she just used to give an IM injection to a patient in the ER.  She said immediately made the needle stick bleed and wash in with soap and water. The source was tested and was negative for HIV and as per protocol she received Tdap shot on her left deltoid area; 24 hours later she started to notice increasing pain and swelling on that area which also was warm she said.  She started to have fever and chills with temperature up to 102 and by the next Monday she went to facility to be checked.  It was thought that she has cellulitis of the left upper arm related to the previous Tdap shot and she was started on Levaquin 750 mg daily.  She was taking Tylenol and Motrin for pain and fevers.  However, by the next day at night she came back to the ER complaining of persistent subjective fever and chills and increasing swelling of that area.  She had a dose of Teflaro 600 mg IV, she got 1 L of normal saline.  Blood cultures were taken and she was put on minocycline 100 mg twice a day plus Percocet as needed (Levaquin was discontinued).  Yesterday she noted that her left arm cellulitis was getting better but by the nighttime it was noted again the swelling was worse, more red, more painful and she was advised to take an extra dose of minocycline (she took 300 mg of minocycline on 04/29/15).  She went this morning to follow up with facility and because of persistent symptoms, feeling nauseous, dizzy (which may be related to the higher dose of minocycline) plus persistent cellulitis (although she said today it looks somewhat better) a decision was made to send her to the ER for further evaluation.  She had already soft tissue ultrasound of the left arm which showed no evidence of abscess or fluid collection.  She received in the Emergency Room 1 g of vancomycin plus Toradol 30 mg IV.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: White blood cell count normal
Clinical narrative: Patient is a 29-year-old woman who works here at Hospital in the ER area.  She has no significant past medical history except for kidney stones, previous episode of gallstone pancreatitis who apparently was in her usual state of health until this past Friday 04/24/15 while working in the ER she accidentally stuck her left thumb with a needle that she just used to give an IM injection to a patient in the ER.  She said immediately made the needle stick bleed and wash in with soap and water. The source was tested and was negative for HIV and as per protocol she received Tdap shot on her left deltoid area; 24 hours later she started to notice increasing pain and swelling on that area which also was warm she said.  She started to have fever and chills with temperature up to 102 and by the next Monday she went to facility to be checked.  It was thought that she has cellulitis of the left upper arm related to the previous Tdap shot and she was started on Levaquin 750 mg daily.  She was taking Tylenol and Motrin for pain and fevers.  However, by the next day at night she came back to the ER complaining of persistent subjective fever and chills and increasing swelling of that area.  She had a dose of Teflaro 600 mg IV, she got 1 L of normal saline.  Blood cultures were taken and she was put on minocycline 100 mg twice a day plus Percocet as needed (Levaquin was discontinued).  Yesterday she noted that her left arm cellulitis was getting better but by the nighttime it was noted again the swelling was worse, more red, more painful and she was advised to take an extra dose of minocycline (she took 300 mg of minocycline on 04/29/15).  She went this morning to follow up with facility and because of persistent symptoms, feeling nauseous, dizzy (which may be related to the higher dose of minocycline) plus persistent cellulitis (although she said today it looks somewhat better) a decision was made to send her to the ER for further evaluation.  She had already soft tissue ultrasound of the left arm which showed no evidence of abscess or fluid collection.  She received in the Emergency Room 1 g of vancomycin plus Toradol 30 mg IV.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Cellulitis staphylococcal, Culture wound
Clinical narrative: Patient is a 29-year-old woman who works here at Hospital in the ER area.  She has no significant past medical history except for kidney stones, previous episode of gallstone pancreatitis who apparently was in her usual state of health until this past Friday 04/24/15 while working in the ER she accidentally stuck her left thumb with a needle that she just used to give an IM injection to a patient in the ER.  She said immediately made the needle stick bleed and wash in with soap and water. The source was tested and was negative for HIV and as per protocol she received Tdap shot on her left deltoid area; 24 hours later she started to notice increasing pain and swelling on that area which also was warm she said.  She started to have fever and chills with temperature up to 102 and by the next Monday she went to facility to be checked.  It was thought that she has cellulitis of the left upper arm related to the previous Tdap shot and she was started on Levaquin 750 mg daily.  She was taking Tylenol and Motrin for pain and fevers.  However, by the next day at night she came back to the ER complaining of persistent subjective fever and chills and increasing swelling of that area.  She had a dose of Teflaro 600 mg IV, she got 1 L of normal saline.  Blood cultures were taken and she was put on minocycline 100 mg twice a day plus Percocet as needed (Levaquin was discontinued).  Yesterday she noted that her left arm cellulitis was getting better but by the nighttime it was noted again the swelling was worse, more red, more painful and she was advised to take an extra dose of minocycline (she took 300 mg of minocycline on 04/29/15).  She went this morning to follow up with facility and because of persistent symptoms, feeling nauseous, dizzy (which may be related to the higher dose of minocycline) plus persistent cellulitis (although she said today it looks somewhat better) a decision was made to send her to the ER for further evaluation.  She had already soft tissue ultrasound of the left arm which showed no evidence of abscess or fluid collection.  She received in the Emergency Room 1 g of vancomycin plus Toradol 30 mg IV.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Developmental delay, Lethargy, Listless, Nystagmus, Pyrexia
Clinical narrative: She developed a high fever lasting several days.  It broke twice during the length of about 6 days.  She was listless, lethargic and unresponsive for 3 days and started being able to look at us with intent on the fourth.  She had stopped making cooing sounds, smiling, reaching for us/things. When she did look at us, she had Nystagmus symptoms. She was unable to track anything or look at anything without having her eyes jerking back and forth for close to a month. She wasn't back on the WHO developmental track until she was 10 months old. Luckily, I exclusively breastfed and only did the one vaccine at the time.  Otherwise, she may have a permanent injury that would potentially impede her ability to read and eventually drive a car.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: She developed a high fever lasting several days.  It broke twice during the length of about 6 days.  She was listless, lethargic and unresponsive for 3 days and started being able to look at us with intent on the fourth.  She had stopped making cooing sounds, smiling, reaching for us/things. When she did look at us, she had Nystagmus symptoms. She was unable to track anything or look at anything without having her eyes jerking back and forth for close to a month. She wasn't back on the WHO developmental track until she was 10 months old. Luckily, I exclusively breastfed and only did the one vaccine at the time.  Otherwise, she may have a permanent injury that would potentially impede her ability to read and eventually drive a car.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Client States she noticed hotness, redness and swelling at the vacination site.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: INJECT SITE REDNESS SPREADING MORE THAN NORMAL TOWARD THE ELBOW.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, HEP, IPV, PPV, RVX
Symptoms: Bacterial test negative, Haematochezia, Irritability, Laboratory test normal
Clinical narrative: Child had red blood in bowel movement.  Child was fussier then usual. Child continues to have red blood in bowel.  Child is breastfed only.  Has never had a reaction to mothers milk other then to citrus foods. Mother was advised to watch diet.  She went on a elimination diet for 8 days and there was no change to bloody bowel.  Bowel may be bloody for a week at a time then no blood for 2 days then it will return.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was used.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Fluid replacement, Injection site erythema, Injection site pain, Injection site swelling, Intensive care
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11 year old male patient with restrictive pulmonary disease and no history of allergies or drug reactions. The patient's medical history included bone marrow transplant. On 21-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot number K020215, expiration date 15-MAY-2016, 0.5 ml, intramuscular. No concomitant therapies were reported. On 21-APR-2015, the patient experienced injection site erythema, injection site swelling and injection site pain. On 22-APR-2015, the patient experienced unspecified "septic-like" symptoms, vomiting and pyrexia. That same date the patient sought medical attention at the emergency room of an unspecified hospital. The patient was then admitted to the pediatric intensive care unit (ICU) of that hospital on 23-APR-2015, where fluid resuscitation, dopamine and unspecified broad spectrum antibiotics were given as treatment. The patient was discharged from the hospital on 28-APR-2015. The outcome of sepsis, vomiting, pyrexia, injection site swelling, injection site pain and injection site erythema was reported as recovered on 28-APR-2015. The reporter considered the events to be life threatening. The reporter considered sepsis to be medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Sepsis, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11 year old male patient with restrictive pulmonary disease and no history of allergies or drug reactions. The patient's medical history included bone marrow transplant. On 21-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot number K020215, expiration date 15-MAY-2016, 0.5 ml, intramuscular. No concomitant therapies were reported. On 21-APR-2015, the patient experienced injection site erythema, injection site swelling and injection site pain. On 22-APR-2015, the patient experienced unspecified "septic-like" symptoms, vomiting and pyrexia. That same date the patient sought medical attention at the emergency room of an unspecified hospital. The patient was then admitted to the pediatric intensive care unit (ICU) of that hospital on 23-APR-2015, where fluid resuscitation, dopamine and unspecified broad spectrum antibiotics were given as treatment. The patient was discharged from the hospital on 28-APR-2015. The outcome of sepsis, vomiting, pyrexia, injection site swelling, injection site pain and injection site erythema was reported as recovered on 28-APR-2015. The reporter considered the events to be life threatening. The reporter considered sepsis to be medically significant. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Abdominal pain lower, Abdominal pain upper, Amylase normal, Chest X-ray normal, Computerised tomogram abdomen normal
Clinical narrative: Patient reported receipt of routine vaccinations while in training with no adverse reactions on 9/10/2014, 10/10/2014 and 11/10/2014. On 3/25/2015 during 9-10am, he received Tdap (BOOSTRIX Lot#5SR2L), injectable influenza (FLUARIX-SK lot #2B472) and Hepatitis B #3 (ENGERIX-B-SK lot #M7JZ4). (Tdap was given as electronic immunization medical records documenting Td being administered 9/2014). Patient recalls onset of right parietal throbbing headache 4-7/10 and then a stabbing like pain to right upper quadrant midline under rib cage <10-15 min after the 3 vaccines that worsened over the next 1-2 hours. He recalls advising immunization staff and was sent to medical. He arrived in medical 3/25/2015 at 11:10 am (1-2 hour after vaccination) where he was diagnosed and treated for headache with NSAIDs and ZOFRAN with some relief (pain at 3-4/10). He described his headache starting as a dull then sharp throbbing pain with nausea. His RUQ pain was sharp (3-6/10) but nondescript with no know aggravating factors (breathing, moving, eating). He denied any visual changes, weakness, facial - neck pain, trauma, recent travel, recent illness/injuries, use of alcohol/drugs, does not smoke, or use of eye glasses or any recent dental care. On 3/27/2015 he returned to medical with persistent headache now lightheaded with nausea and vomiting (x1). He was treated with 1000cc NS, IV ZOFRAN and IM TORADOL and released with prescriptions. He advised while his headache and abdominal pain did decrease. Over the next 3 weeks, he reported neither pain went away. His advised he tolerates both taking medication only when severe while attending school and performing ADL. On 4/20/2015 he returned to medical after "passing out" with worsening headache and expansion of his abdominal pain from RUQ to RLQ. He was transferred to ER for possible appendicitis. An ultrasound and CT of his abdomen/pelvis were normal with no signs of cholecystitis, or appendicitis. He was released with his pain easing with NORCO and ZOFRAN to 3/10. Over the next week he continued to experience both headache (right sided only) and RUQ abdominal pain being able to attend school, eat and exercise. He reported passing out x 2 when head and abdominal pain became severe together. He stated he would stand to leave area which resulted in him "passing out". Witness to these events reported what looked like seizure like activity. His seizures were described as him staring, blacking out, muscles tensing for few seconds and when muscles relaxed he awoke fully aware of where he was. He stated he felt like he just woke up from sleep. There was no report of incontinence during this event or fatigue post event. He did report falling x 1 on 4/27/2015 hitting the right side of head and was again sent to nearby ER for further evaluation and transferred to another hospital for admission.