chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G increased, CD4 lymphocytes normal, CD8 lymphocytes, Differential white blood cell count normal, Extra dose administered
Clinical narrative: Information has been received from the authors as stated above in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficency or recurrent infections in all three cases. This case refers to a male patient of unknown age. The patient had no history of immunodeficency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2013, the patient was vaccinated with sixth dose of MMR II (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in May 2014, MMR titers were measured with the results showed positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on an unspecified date in June 2014. Vaccination failure was reported. On an unspecified date his serum CD3/CD4/CD8/B & T cell counts were normal. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR II (manufacturer unknown). This report is linked to MARRS # 1603USA003154 and #1604USA004010 (same literature link). A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Hepatitis B surface antibody positive, Hepatitis viral test negative, Lymphocyte count normal, Measles antibody negative, Mumps antibody test positive
Clinical narrative: Information has been received from the authors as stated above in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficency or recurrent infections in all three cases. This case refers to a male patient of unknown age. The patient had no history of immunodeficency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2013, the patient was vaccinated with sixth dose of MMR II (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in May 2014, MMR titers were measured with the results showed positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on an unspecified date in June 2014. Vaccination failure was reported. On an unspecified date his serum CD3/CD4/CD8/B & T cell counts were normal. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR II (manufacturer unknown). This report is linked to MARRS # 1603USA003154 and #1604USA004010 (same literature link). A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody positive, Vaccination failure
Clinical narrative: Information has been received from the authors as stated above in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficency or recurrent infections in all three cases. This case refers to a male patient of unknown age. The patient had no history of immunodeficency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2013, the patient was vaccinated with sixth dose of MMR II (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in May 2014, MMR titers were measured with the results showed positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on an unspecified date in June 2014. Vaccination failure was reported. On an unspecified date his serum CD3/CD4/CD8/B & T cell counts were normal. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR II (manufacturer unknown). This report is linked to MARRS # 1603USA003154 and #1604USA004010 (same literature link). A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning to unspecified number of patients (ages and genders not reported) who since 29-FEB-2016, were vaccinated with doses of PROQUAD (Lot No. L002420, exp. 23-JUL-2016) (sites not reported), which were exposed to a temperature of -14.94C, for 6 hours. Vaccines had not been previous to temperature excursion. The reporter was not aware of any adverse effects. No PQC was involved. This report is linked to MARRS 1603USA004021 from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified date in October 2015) ROTATEQ with lot/batch # K016263, expiry date 26-JUN-2016 and lot/batch # L002042, expiry date 28-JUL-2016 (dose, dose number, vaccination site and route of administration not provided. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from same reporter link. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHEH2015US015961 is an initial spontaneous report received from a nurse via GSK employee (sales specialist) on 13 Aug 2015. This report refers to a 26 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) in Jul 2015. He returned the same day with urticaria all over his body. He was sent to emergency room where he received BENADRYL. He recovered and did not stay overnight. The seriousness of the event was not reported, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning to unspecified number of patients (ages and genders not reported) who since 29-FEB-2016, were vaccinated with doses of VARIVAX (Merck) (Lot No. L028276, exp. 28-JUL-2017) (sites not reported), which were exposed to a temperature of -14.94C, for 6 hours. Vaccines had not been previous to temperature excursion. The reporter was not aware of any adverse effects. No PQC was involved. This report is linked to MARRS 1603USA003362 from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 13 year old daughter. There were no pertinent medical history or drug allergies/drug reactions. On 13-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (Lot # and dose not reported). The patient received the second dose of GARDASIL 9 on an unspecified date. It was reported that approximately in March 2016, the patient received the third dose of GARDASIL instead of GARDASIL 9. There were no concomitant therapies. It was reported that on 05-MAR-2016, after receiving GARDASIL the patient experienced tenderness at the injection site. The patient did not receive treatment for the events and there were no laboratory diagnostic tests performed. The patient talked with nurse at physician's office. The outcome of interchange of vaccine products and injection site tenderness was reported as recovered on an unspecified date in March 2016. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to  an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical histories were not provided. On an unspecified date since September 2015, the patients were vaccinated with unspecified doses of improperly stored oral, ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # K0223532, expiration date 21-JUN-2016, then on an unknown date since October 2015, the patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # L008059, expiration date 18-DEC-2016 and then on an unspecified date since December 2015, the patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # L013202, expiration date 27-JAN-2017. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a 13 year old patient. The patient's medical history and concurrent conditions were not reported. The register nurse stated that on 25-FEB-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (inappropriate schedule of drug administration), (strength, dosage, lot# and expiration date were not reported). Concomitant therapy was not reported. No adverse symptoms were reported. Also was informed that the patient was never vaccinated with M-M-R. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Back pain, Dizziness, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received MENVEO. Concomitant products included Multivitamin. On 22nd September 2015, the patient received MENVEO .5 ml. On 22nd September 2015, 30 min after receiving MENVEO, the patient experienced vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain. On an unknown date, the outcome of the vomiting, dizziness, headache, back pain and abdominal pain were recovered/resolved and the outcome of the injection site swelling, injection site pain and injection site warmth were not recovered/not resolved. The reporter considered the vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain to be related to MENVEO. Additional details were received as follows: On 22nd September 2015, 30 to 40 minutes of vaccination, the patient experienced vomiting, dizziness, headache, injection site swelling and soreness. Injection site was also described as warm or hot to touch. The injection site issues were continue at the time reporting. On 22nd September 2015, later in the evening (several hours after vaccination), the patient experienced extreme abdominal and back pain. Due to the events, the patient was taken to the emergency room. The patient underwent a series of tests specific to appendicitis. The appendicitis was ruled out. Vaccine Service Center transferred the caller. The reporter was seeking reimbursement from GlaxoSmithKline, specific to medical bills associated with the event. The reporter has physician notes or records that she would like to submit to GlaxoSmithKline. The reimbursement process was reviewed with reporter, stating that reimbursement is typically only considered for product cost (not medical bills).
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received MENVEO. Concomitant products included Multivitamin. On 22nd September 2015, the patient received MENVEO .5 ml. On 22nd September 2015, 30 min after receiving MENVEO, the patient experienced vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain. On an unknown date, the outcome of the vomiting, dizziness, headache, back pain and abdominal pain were recovered/resolved and the outcome of the injection site swelling, injection site pain and injection site warmth were not recovered/not resolved. The reporter considered the vomiting, dizziness, headache, injection site swelling, injection site pain, injection site warmth, back pain and abdominal pain to be related to MENVEO. Additional details were received as follows: On 22nd September 2015, 30 to 40 minutes of vaccination, the patient experienced vomiting, dizziness, headache, injection site swelling and soreness. Injection site was also described as warm or hot to touch. The injection site issues were continue at the time reporting. On 22nd September 2015, later in the evening (several hours after vaccination), the patient experienced extreme abdominal and back pain. Due to the events, the patient was taken to the emergency room. The patient underwent a series of tests specific to appendicitis. The appendicitis was ruled out. Vaccine Service Center transferred the caller. The reporter was seeking reimbursement from GlaxoSmithKline, specific to medical bills associated with the event. The reporter has physician notes or records that she would like to submit to GlaxoSmithKline. The reimbursement process was reviewed with reporter, stating that reimbursement is typically only considered for product cost (not medical bills).
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced syncope after administration of ADACEL.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Lethargy, Pruritus, Pyrexia
Clinical narrative: Received MMRV, Hepatitis B, PCV, 2-3 days later developed diffuse varicella rash with fever, lethargy, pruritus. Went to ER and on 3/5/16 physician's office on 3/7/16. Placed on acyclovir.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in 2016, reported as since 16-FEB-2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (lot# K015970, expiry date 23-SEP-2016; lot# L029467, expiry date 06-AUG-2017; lot# L035124, expiry date 14-SEP-2017; lot# L027282, expiry date 21-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporting nurse stated that the vaccines were exposed to a temperature excursion of 31.1 degrees Fahrenheit, for a cumulative time of 105 hours since 16-FEB-2016. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of MMR II (lot # L012479, expiration date 10-APR-2017; lot# L019989, expiration date 01-JUN-2017; dose and route were not reported; temperature: 52 F, time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-FEB-2016, the patient was inadvertently vaccinated with a dose of M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. In February 2016 the patient was inadvertently vaccinated with 2nd dose of ZOSTAVAX (dosing regimen and lot # unspecified) (extra dose administered). The pharmacist reported that he inadvertently administered a "2nd dose of ZOSTAVAX in February 2016 (specific date unspecified)" on an anonymous patient. The patient incorrectly stated on pharmacy patient questionnaire that she had never been vaccinated for shingles, however, the patient's husband reminded the patient (when she returned home) that she had already been vaccinated with ZOSTAVAX in November 2015 (specific date unspecified). No adverse effect reported. No additional information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker on behalf of a prescribing physician refers to a 65 year old female patient. No pertinent medial history was reported. On 29-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (INJ 255/0.5 Y) 0.5 ml, intramuscularly for pneumonia prevention. On 29-FEB-2016, the patient experienced injection site redness, itching and swelling (dimensions of effected area- 4-1/2 x 5-1/2). Patient sought medical attention and was prescribed Doxycycline. No lab diagnostic studies were performed. The outcome of events was recovering/resolving. The reporter did not assess the causality between suspect therapy and the adverse events. No Product Quality Complaint (PQC) was involved. Action taken was reported therapy continued. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 13-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, 0.65 ml, lot # L016284, expiration date 07-AUG-2016 (dose number and anatomical location were not reported) (also reported as the vaccination was recommended by physician, prescription written). The patient did not take any concomitant medications. On approximately 17-FEB-2016 (reported as 4 to 5 days after receiving ZOSTAVAX), the patient experienced rash on her legs, which spread to her torso and swelling at the injection site. The patient sought medical attention as she was seen by her physician (on an unknown date) and was prescribed prednisone (manufacturer unknown) (route of administration, dosage, lot number and expiration date were not reported) as treatment for the rash. The patient was additionally prescribed an unspecified antihistamine medication (route of administration, dosage, lot number and expiration date were not reported) for an unspecified reason. No lab diagnostic studies were performed. Product quality complaint was not involved. The outcome of rash and swelling at the injection site was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 13-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, 0.65 ml, lot # L016284, expiration date 07-AUG-2016 (dose number and anatomical location were not reported) (also reported as the vaccination was recommended by physician, prescription written). The patient did not take any concomitant medications. On approximately 17-FEB-2016 (reported as 4 to 5 days after receiving ZOSTAVAX), the patient experienced rash on her legs, which spread to her torso and swelling at the injection site. The patient sought medical attention as she was seen by her physician (on an unknown date) and was prescribed prednisone (manufacturer unknown) (route of administration, dosage, lot number and expiration date were not reported) as treatment for the rash. The patient was additionally prescribed an unspecified antihistamine medication (route of administration, dosage, lot number and expiration date were not reported) for an unspecified reason. No lab diagnostic studies were performed. Product quality complaint was not involved. The outcome of rash and swelling at the injection site was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K021581, expiration date 24-OCT-2016; lot# K026531, expiration date 15-APR-2017; dose and route were not reported; temperature: 52 F, time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-JAN-2013 at 2 years of age, the patient was vaccinated with the first dose and on 01-APR-2013 with the second dose of PROQUAD (Merck), 0.5 ml, subcutaneously, lot # reported as H015637, expiration date: 23-FEB-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013188, expiration date 02-NOV-2016, oral; doses were not reported; temperature: 52 F, time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse referring to a 35 year old female patient with asthma. Patient was not pregnant and had no drug reaction or allergies. On 23-FEB-2016, the patient was intramuscularly vaccinated with dose PNEUMOVAX23 (dose and frequency were not reported, lot # L040178 with expiration date: 18-AUG-2017). Concomitant therapies included CIPRO, PENLAC and DIFLUCAN. On 24-FEB-2016, the patient developed swelling and redness at the site PNEUMOVAX23 injection. The patient was not recovered. No treatment was given for adverse event. Lab diagnostic studies were not performed. The patient sought medical attention. A lot check was requested. Causality assessment was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 22 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient was vaccinated with 3 doses of RECOMBIVAX HB (lot #, expiration date and dose not provided) intramuscularly during childhood as following: the first dose on 18-DEC-1993, the second dose on 10-FEB-1994 (inappropriate schedule of vaccine administered) and the third dose on 14-JUN-1994 (inappropriate schedule of vaccine administered). Recently (date unspecified) the patient had titers drawn which resulted as "less than 5" (hepatitis B antibody negative). No treatment was given for the event. The patient sought unspecified medical attention via office visit. The outcome of hepatitis B antibody negative was not resolved. The patient was requesting a second series to be administered (no doses administered as of yet). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Local reaction, Oedema
Clinical narrative: Developed 15 cm x 9 cm area (oval) of erythema w/minimal edema, no bagginess or tenderness. Brought to ER 1/23/16, and diagnosed w/cellulitis. See in office 1/25/16, diagnosed w/localized reaction to imms, no evidence of further ER visits.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 07-MAR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# K010967, expiration date 06-NOV-2015, dose, anatomical location and route of administration were not reported). The reporter also stated that the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Injection site pain, Pyrexia, Wheezing
Clinical narrative: Fever, cough wheeze and injection site pain. Tramadol 50 mg once, Acetaminophen 650 mg once.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered with doses of improperly stored VARIVAX (Merck) (dose and route not reported, lot # L035124 and exp. date 14-SEP-2017). The vaccines were exposed to 1.6 degree centigrade for 5 hours and 51 minutes, and -8.6 degree centigrade for 4 hours and 46 minutes (two different days in February 2016). There was a previous temperature excursion with 4.1 degree centigrade and 20.1 degree centigrade for a total time frame out of range of 15 minutes in January 2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 13 year old female patient. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The nurse reported that the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L031066, Expiration Date 18-AUG-2017) on 16-FEB-2016. The dose, frequency and route were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a currently 13 year old patient. The patient's medical history and concurrent conditions were not reported. The register nurse stated that on an unknown date, the patient was vaccinated with two doses of VARIVAX (Merck) (extra dose administered), (strength, dosage, frequency, lot # and expiration date were not reported). Concomitant therapy was not reported. No adverse symptoms reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medications was not provided. On 02-MAR-2016 the patient was vaccinated with an expired dose of ROTATEQ (lot # K004795, expiration date 11-FEB-2016, oral, dose and dose # unknown). No adverse effects reported. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm from the elbow to upper arm is bright red, swollen, and warm to touch. Shot given on 3-1-16 and over a week progressed to increased inflammation. On 3-8-16 went to dr. Dr prescribed cephalexin 500 mg TID x 7 days and OTC.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills, Low-grade Fever, Nausea.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Peroneal nerve palsy, Ultrasound Doppler
Clinical narrative: Based on additional information received on 26 February 2016, this case initially considered as non-serious was upgraded to serious due to seriousness criteria: disability. Initial unsolicited report received from a consumer on 18 January 2016. This case involves 72-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number not reported) intramuscularly in the right deltoid on 18 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported and she had no illness at time of vaccination. The patient's concomitant medications were not provided. On 24 October 2015, six days following the vaccination, the patient had experienced numbness, pins and needles feeling, burning type pain in her right leg from the knee to toes and foot drop on the right foot. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received physical therapy as corrective treatment. The outcome of events was reported as not recovered. Follow up information received from a consumer on 26 February 2016 and additional information received on 03 March 2016. Batch number was updated as UI481AA. Pre-existing physician-diagnosed allergies, birth defects, and medical conditions was reported as scleroderma (crest), gastroesophageal reflux disease (GERD), Esophageal Cancer, hypothyroid. The patient did not experience any adverse event prior to vaccination. She did not receive any other vaccinations within 4 weeks prior to date of vaccination. Concomitant medications included Anastrozole 1 mg daily, Calcium 1200 mg daily with "vitamin D", Cyclobenzaprine 5 mg with at bed time, Prolia 60 mg for 6 month "for 6 MO", Furosemide 40 mg daily as needed, Levothyroxine 125 mcg daily, Omeprazole 40 mg daily, Ranitidine 150 mg daily at bed time, Tramadol 5 mg "as needed" pain, Temazepam 15 mg as needed for sleep, sucralfate four times a day. On 29 October 2015, 10 days following the vaccination, the patient had experienced numbness and foot drop. It was reported that, permanent disability resulted on 21 February 2016 and by the time of reporting, patient still had a problem. The patient had a doctor visit on 28 October 2015, she visited a neurologist on 30 Nov 2015, a neurosurgeon on 02 December 2015 and began physiotherapy. Laboratory data included brain MRI (On 02 November 2015), Spine MRI, lower extremity with Doppler, Ultrasound RT. On 10 December 2015, Electromyography was performed. The patient had not recovered from foot drop and numbness. List of documents held by sender: none. Sender's Comments: Foot drop is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE whereas numbness, burning leg and tingling is listed. Time to onset seems to be compatible with a role of the vaccination. Complementary information regarding the patient's condition at the time of the events, medical history and investigations exploring alternative etiologies are needed to further assess the case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Body temperature increased, Cough, Muscle twitching, Respiratory tract congestion, Seizure
Clinical narrative: Patient developed temp of 100.3 and had seizure at home, per ER report mom noted seizure lasted for 2 minutes, with upper extremity shaking, facial twitching, unresponsive. Pt was well prior day but, had developed congestion and minimal cough that morning.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient developed temp of 100.3 and had seizure at home, per ER report mom noted seizure lasted for 2 minutes, with upper extremity shaking, facial twitching, unresponsive. Pt was well prior day but, had developed congestion and minimal cough that morning.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to school nurse for cellulitis like symptoms. School Nurse marked area of 4in x 3in on Left upper arm. Parent brought patient to office for assessment and noted 4in x 3in area of redness and swelling with pain and itching consistent with Cellulitis. Patient given prescription of Bactrim.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Woke up on 3/2 with "incredible nausea" and stomach cramps. Took Zofran with no improvement. 3/3 symptoms still present but milder, so he started taking Truvada for HIV prophylaxis, then nausea and stomach cramps worsened. Stopped Truvada on 3/5. Today on 3/9, nausea persists but mild; stomach cramps fully resolved.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Feeding disorder, Muscle spasms, Nausea
Clinical narrative: Woke up on 3/2 with "incredible nausea" and stomach cramps. Took Zofran with no improvement. 3/3 symptoms still present but milder, so he started taking Truvada for HIV prophylaxis, then nausea and stomach cramps worsened. Stopped Truvada on 3/5. Today on 3/9, nausea persists but mild; stomach cramps fully resolved.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reported symptoms per Aunt (guardian) as of 3/8/16.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Fatigue, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Generalized aches and pains in muscles and very fatigued for around 10 days after high dose flu shot. Lateral aspect of left in arm at site of injection resulted pain similar to tendinitis. Could not lift or pick up anything with left arm. Went for acupuncture but that did not work still have pain. Been taking ALEVE and TYLENOL. Never had reaction to low or single dose prior to this double dose.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Generalized aches and pains in muscles and very fatigued for around 10 days after high dose flu shot. Lateral aspect of left in arm at site of injection resulted pain similar to tendinitis. Could not lift or pick up anything with left arm. Went for acupuncture but that did not work still have pain. Been taking ALEVE and TYLENOL. Never had reaction to low or single dose prior to this double dose.
Age: 62.0
Sex: M
Vaccine: FLUX, TTOX, FLUX, TTOX
Symptoms: Injection site pain
Clinical narrative: After receiving my flu and tetanus shots on 9/21/15 I began to develop tenderness and pain in my muscle under my arm - below where vaccinations were administered. This has continued to hurt since vaccination with no relief. The pain is described as an ache and pinch loaded under my right upper arm, where both vaccinations were administered. The pain is a noticeable pain that has bothersome and unchanged since administration. This in no way prohibits me from performing my job duties or ADL.
Age: 62.0
Sex: M
Vaccine: FLUX, TTOX, FLUX, TTOX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: After receiving my flu and tetanus shots on 9/21/15 I began to develop tenderness and pain in my muscle under my arm - below where vaccinations were administered. This has continued to hurt since vaccination with no relief. The pain is described as an ache and pinch loaded under my right upper arm, where both vaccinations were administered. The pain is a noticeable pain that has bothersome and unchanged since administration. This in no way prohibits me from performing my job duties or ADL.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Abasia, Asthenia, Dizziness, Electroencephalogram, Headache
Clinical narrative: Headaches; Lightheadedness; Vomiting alone; Wheezing; Weak couldn't walk.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test positive, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain, Parainfluenzae virus infection, Viral test positive
Clinical narrative: Headaches; Lightheadedness; Vomiting alone; Wheezing; Weak couldn't walk.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting, West Nile virus test negative, Wheezing
Clinical narrative: Headaches; Lightheadedness; Vomiting alone; Wheezing; Weak couldn't walk.
Age: 18.0
Sex: M
Vaccine: HEP, TD, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, swelling, warmth, itchy, and tenderness.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Swollen injection site at first. Then redness surrounding injection site. Then red blotchy patches on cheek area of face 2 days later. Then increased redness on cheeks the next day and spreading across bilateral arms.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Dermatitis, Erythema, Hypersensitivity, Injection site scab
Clinical narrative: Left side of my face red and an ulcerated scab at the injection site, left upper arm. Today my whole face looks like I am a bit sunburned (both cheeks, across my nose). The left TMJ joint is a bit inflamed (just slightly) and my left cheek gums and sinus is uncomfortable (behind my cheekbone). Both cheeks are hot, left cheek a little inflamed.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site ulcer, Oral discomfort, Paranasal sinus discomfort, Skin discomfort, Skin warm
Clinical narrative: Left side of my face red and an ulcerated scab at the injection site, left upper arm. Today my whole face looks like I am a bit sunburned (both cheeks, across my nose). The left TMJ joint is a bit inflamed (just slightly) and my left cheek gums and sinus is uncomfortable (behind my cheekbone). Both cheeks are hot, left cheek a little inflamed.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Colitis ulcerative, Crohn's disease, Diverticulitis, Fatigue, Irritable bowel syndrome
Clinical narrative: Started having IBS. Fatigued.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Thyroid disorder
Clinical narrative: Started having IBS. Fatigued.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash. Severe itching at times. Thought it due to something else but it continues. Saw Dr in Febuary 29. She said never heard of rash\itching due to this drug, refused to report it and said it was probably due to my BP med and changed that, even though I had been on the BP drug for one and half year prior with NO reaction. She told me to see an allergist if the rash/itching continued. Rash/itching seems to be getting worse. Red welts at itching sites, hands and bottom of feet itch as well as all over body. I don't know what to do at this point. Disappointed with Dr.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, IPV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered second dose of IPV in error. Patient had no immediate reaction to double dose received. Observed in waiting room for 45 minutes at time of this report and no adverse reactions have been noted. Patient is alert & oriented, playing with siblings, no adverse symptoms have been noted.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Patient stated that she had a fever (up to 101.1 F) on day of vaccine but when asked if she was sick on day vaccine was administered, she noted denying being sick. During exam was noted to have rhinosinusitis and was started on AUGMENTIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child developed pain, redness, heat, swelling of left arm 2 days s/p vaccination. Patient was seen at a local urgent care and prescribed KEFLEX x 7D and BENADRYL prn for what was felt to be a possible allergic reaction or possible cellulitis.
Age: 0.68
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Erythema, Eye irritation, Eyelid oedema, Ocular hyperaemia, Pyrexia
Clinical narrative: High fever s/p vaccines: Developed fever of 104.5 degrees F (rectal temp) approximately 14 hrs s/p vaccine administration. Fever somewhat responsive to ibuprofen. Parent also reported red, puffy, irritated looking eyes, red cheeks, rapid breathing w/fever and copious runny nose (spoke w/parent at approximately 22 hrs s/p vaccination). Has been seen twice in the office since then for fever on 2/29 and 3/9. URI symptoms.
Age: 0.68
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Respiratory rate increased, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: High fever s/p vaccines: Developed fever of 104.5 degrees F (rectal temp) approximately 14 hrs s/p vaccine administration. Fever somewhat responsive to ibuprofen. Parent also reported red, puffy, irritated looking eyes, red cheeks, rapid breathing w/fever and copious runny nose (spoke w/parent at approximately 22 hrs s/p vaccination). Has been seen twice in the office since then for fever on 2/29 and 3/9. URI symptoms.
Age: 19.0
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Contusion, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Client rec'd (R) arm - PNEUMOVAX and Hep A #2 (L) arm - MMR #2. C/O of (R) arm, warm, swollen, bruised, slight fever on 2/24/16.
Age: 4.0
Sex: M
Vaccine: DPP, IPV, MMRV
Symptoms: Faeces discoloured, Vomiting
Clinical narrative: Vomiting and Black Tarry Stool for about one hour.