chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 25-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an 83 year old patient of unknown gender. The patient was incorrectly vaccinated with two doses of PNEUMOVAX23 (dose, strength, lot #, expiry date and route were not reported) within a 24-hour period respectively on 31-AUG-2015 and 01-SEP-2015 (extra dose administered). This error was identified when a charge was returned from an insurance company, which questioned a double charge. The patient did not experience an adverse effect. Additional information has been requeted.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Swelling
Clinical narrative: Slight swelling with redness, no induration/redness bilateral feet.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dizziness, Erythema, Eye disorder, Hypoaesthesia
Clinical narrative: Pt. called the day after receiving the vaccine, states it started in the morning with erythema on the site of injection, swelling and redness on her shoulder up the side of her neck, numbness of her cheek, and a change in her left eye. She also was dizzy.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Pt. called the day after receiving the vaccine, states it started in the morning with erythema on the site of injection, swelling and redness on her shoulder up the side of her neck, numbness of her cheek, and a change in her left eye. She also was dizzy.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions and allergies were not reported. On 24-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. reports pain in rt. leg from time vaccine was administered to present. Pt. reports feeling a sensation "like lightening" going down her leg when she received her pneumonia vaccine. Pt. states the injection was administered with great speed and pt. suspects nerve involvement. Pt gets relief with ALEVE. Pain increases with activity.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route were unknown) and/or sterile diluent (lot # K0121917, exp date 09-SEP-2017). No adverse effects 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 licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On 09-SEP-2015, the patients were inadvertently vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L010595, expiration date 12-NOV-2016, lot # L001456, expiration date 22-OCT-2016, strength, dose and route unknown). No adverse events had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient received a dose of RECOMBIVAX HB (lot#, dose, strength and route unknown) two days early (inappropriate schedule of vaccine administered). No adverse effect reported. Additional information has been effect.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Vaccination failure
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Patient's medical history, concurrent condition and drug reactions/allergies were not reported. Patient reported that she took the vaccination with ZOSTAVAX back on an unknown date in Septmeber 2014. And according to her, the vaccine caused her to break out all over her body (vaccination failure) on an unknown date. The outcome of vaccination failure was unknown. The patient got called to get a compensation for taking the ZOSTAVAX. She did not wished to reiterate information on what happened. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On 09-SEP-2015, the patients were inadvertently vaccinated with improperly stored doses of VAQTA (lot# L018499, expiration date 25-FEB-2017, strength, dose and route unknown). No adverse events had been reported. This is one of several reports received 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 nurse cnocerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patients were vaccinated wiht doses of oral ROTATEQ (Lot # K019372; expiration date: 16-JUL-2016) which were exposed to temperature outisde of the recommended range. No adverse experience had been reported. This is one of several reports received from the same source. Additional inormation has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, via a company representative, referring to a 16 year old female patient. No pertinent medical history, concurrent conditions or drug reaction/allergies were reported. On an unknown date, the patient was vaccinated with VARIVAX, subcutaneous, (dose, frequency, lot # and expiration date were not provided), and the patient was pregnant (exposure during pregnancy) which is other-than-indicated in the Prescribing Information (contraindicated drug administered).
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient started the GARDASIL 9 (dose, site and route of administration, lot# and expiry date were not reported) administered for the first dose in series and then on an unknown date, the patient was vaccinated for the second and third doses in the series with GARDASIL dose, site and route of administration, lot# and expiry date were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates, the patient was vaccinated with three separate doses of M-M-R II (lot #, expiration dates, doses, route of administration and anatomical location were not reported). On an unknown date, the patient experienced negative titers. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There were no information about patient's concomitant medications and pertinent medical history reported. In August 2012, the patient was vaccinated with the first dose of GARDASIL (dose, site, route of administration, lot# and expiry date were not reported). In August 2013, the patient was vaccinated with the second dose of GARDASIL (dose, site, route of administration, lot# and expiry date were not reported). On 08-SEP-2015, the patient was in the office to receive the third dose of GARDASIL (dose, site, route of administration, lot# and expiry date were not reported) but it was not reported if the patient received this dose. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Pins and needles sensation involving scalp. Intense itching of face, arms, chest and back. Diphenhydramine 50 mg once.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patients were vaccinated with doses of Recombivax HB (Lot # L008660; expiration date: 10-NOV-2016 and Lot# L010595; expiration date: 12-NOV-2015) which were exposed to temperature outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 33-year-old male patient who received BOOSTRIX (batch number X4J7D, expiry date 26th September 2017). On 7th September 2015, the patient received BOOSTRIX .5 ml. In September 2015, less than a week after receiving BOOSTRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unchanged. It was unknown if the reporter considered the enlargement of lymph nodes to be related to BOOSTRIX. Additional details were received as follows: The patient experienced swollen lymph node near the collar bone, on the same side of the injection. The patient was asking if any data regarding this event was available. The batch number for BOOSTRIX was reported as X4J7B, which does not exist per sales data sheet and was updated to be X4J7D.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old female patient who received PEDIARIX (batch number 372DT, expiry date 4th July 2016). On 9th September 2015, the patient received PEDIARIX (intramuscular). On 9th September 2015, immediately after receiving PEDIARIX, the patient experienced extensive swelling of vaccinated limb, injection site redness and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness and injection site warmth were unchanged. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness and injection site warmth to be related to PEDIARIX. Additional details were received as follows: The injection site was right lateral thigh. The patient experienced injection site of 12 X 10 inch pyretic area (warmth) with redness and swelling (ELS). The case was not previously reported.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old female patient who received PEDIARIX (batch number 372DT, expiry date 4th July 2016). On 9th September 2015, the patient received PEDIARIX (intramuscular). On 9th September 2015, immediately after receiving PEDIARIX, the patient experienced extensive swelling of vaccinated limb, injection site redness and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness and injection site warmth were unchanged. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness and injection site warmth to be related to PEDIARIX. Additional details were received as follows: The injection site was right lateral thigh. The patient experienced injection site of 12 X 10 inch pyretic area (warmth) with redness and swelling (ELS). The case was not previously reported.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swollen lymph nodes in a 33-year-old male patient who received BOOSTRIX (batch number X4J7D, expiry date 16th September 2017). On 7th September 2015, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 9th September 2015, 2 days after receiving BOOSTRIX, the patient experienced swollen lymph nodes. On an unknown date, the outcome of the swollen lymph nodes was unchanged. The reporter considered the swollen lymph nodes to be possibly related to BOOSTRIX. Additional detail were received as follows: On 9th September 2015, 2 days after receiving BOOSTRIX, the patient experienced swollen lymph nodes on left collarbone. The patient stated his partner had a baby and so he had been sleeping in funny positions in hospital chairs, the past several days and this might also contributed in the swollen lymph nodes at left collarbone. The pharmacist already had the prescribing information and was transferred to speak with MI about AE.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patients were vaccinated with doses of VAQTA (Lot # L008665; expiration date: 10-FEB-2017, Lot # K008333; expiration date: 10-MAR-2017 and Lot# K011304; expiration date: 28-APR-2017) which were exposed to temperature outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patient were vaccinated with doses of M-M-R II (lot # L004658; expiration date: 11-FEB-2017) which were exposed to temperature outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same source. Aditional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Nausea
Clinical narrative: Pt had PREVNAR 13 injection 9/9/15 Noon. Developed (L) arm redness beneath the site 9/17/15. Some nausea and fatigue (was doing well until 9/17/15 approx 7 AM).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case of shingles after ZOSTAVAX.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a 63 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 09-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot # L012475), 0.65 ml, subcutaneous. The pharmacist reported that the patient experienced an injection site rash on 10-SEP-2015 the day after receiving ZOSTAVAX injection. The rash was treated with BENADRYL and hydrocortisone cream. On 13-SEP-2015, the patient's condition worsened. The patient went to an unspecified urgent care center and was diagnosed with localized shingles (herpes zoster) and cellulitis. At the time of the report, the patient's outcome was unknown. Adidtional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-AUG-2015, the patient was vaccinated with 0.5 ml dose of improperly stored GARDASIL, intramuscularly, lot # K005881, expiry date 14-JAN-2017 (site of administration was not reported). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-SEP-2015, the patient was inadvertently vaccinated with doses of both (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiry date were not reported) and (Oka-Merck) PROQUAD injection (lot# L002213, expiry date 21-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a nurse referring to a 41 year old male patient with HIV infection history. The patient had allergies to AMBIEN, JUSTIVA (unspecified drug). The nurse believed, but was not certain, that the patient received at least one dose of M-M-R II in childhood. Nurse could not provide any details of vaccinations prior to July 2015. The patient had lab work completed once annually. After negative titer results from July 2015, the patient received the first dose of M-M-R II (lot#, dose and route were not provided) at an unspecified time in July 2015. The patient was taking unspecified medications for "HIV regimen". At an unspecified time in July 2015, the patient had titers drawn and showed low titers to MMR. The patient did not seek medical attention. No lab work was completed since titers drawn. No treatment was given for the event. The outcome of the event was unknown. The patient seen in the office on 28-AUG-2015 and received the second dose of M-M-R II (batch# J006136, lot# 0116AE, which had expired 24-MAY-2015) 0.5 ml subcutaneously (expired product administered). The patient was doing fine. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Cold sweat, Depressed level of consciousness
Clinical narrative: By history, 1 day after receiving HPV vaccine he came back to the clinic for blood work, and in the process, he became cold and clammy and felt almost like passing out. Glucose fingerstick done was 100.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Viral test positive
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a female patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot #, expiration date, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. On an unspecified date, the patient experienced blistery  rash and it was mentioned that the patient's unspecified physician took a specimen of the patient's blisters and the results were positive for herpes zoster (date unknown). Additionally, the patient sought medical attention by visiting an unspecified physician. The outcome of herpes zoster was reported as recovered, date unspecified. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of PNEUMOVAX23 (lot# K008410, expiration date: 26-FEB-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of PEDVAX HIB (lot # J000360, expiration date: 25-OCT-2015 (also reported as 23-OCT-2015) (dose,  frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness, Vaccination complication
Clinical narrative: The day after I got a shingles vaccination, a red, swollen area developed. By the next day it was a 3in by 4in, oblong area that was red/hot /tender. I saw an MD 9/16/215 who told me that it was a reaction to the vaccination, and not cellulitis. I was told to apply cold compresses, return if not gone in 2-3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown ages and genders. Concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX injection, lot # L015045, expiration date reported as 29-APR-2017 and L017144, expiration date reported as 13-MAY-2015 (strength, dose, route of administration, anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: Patient stated her arm hurt so bad that she was unable to move it, felt chills and achy all over, fatigued. After 24 hours symptoms began to resolve. Headache initially much better, today.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient stated her arm hurt so bad that she was unable to move it, felt chills and achy all over, fatigued. After 24 hours symptoms began to resolve. Headache initially much better, today.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea, Pain
Clinical narrative: Day of administration = pain at injection site/soreness. Day after administration = soreness/nausea. Approximately 5 to 6 days after administration = site redness/pain/hot to touch.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Hypersensitivity, Localised oedema, Skin irritation
Clinical narrative: Developed cellulitis secondary to allergic reaction to PREVNAR. Localized edema; erythema; skin irritation.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # J007946, expiration date: 24-MAR-2016 (also reported as 26-MAR-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patients received improperly stored dose of (Merck) VARIVAX (dose, frequency and route of administration were not provided) lot # reported as L013066, expiration date 14-APR-2017. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of GARADASIL (lot# reported as K009505, expiration date: 20-FEB-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients for prophylaxis on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to two patients of unknown age and gender. The patients' pertinent medical history or concurrent condition was not reported. On 25-AUG-2015 the two patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L005293, expiration date 17-AUG-2016, strength and frequency were unknown, 0.5 ml) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy student with Pharm D. degree, referring to an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot #, expiration date, dose, route and excursion details unspecified) (incorrect product storage). No adverse effects had been reported post vaccination. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy student with Pharm. D degree, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot #, expiration date, dose, route and excursion details unspecified) (incorrect product storage). No adverse effects had been reported post vaccination. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # L005293 with expiration date of 17-AUG-2016, dose, strength and route unknown). No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to a currently 71 year old female patient. The patient was allergic to codeine. She received an unspecified flu vaccine on an unspecified date 2 years ago (approximately in 2013) and "it  made her very sick". The reporter was unable to provide any additional information about how it made her sick. The patient did recover from the sick on unspecified dates. On an unknown date (reported as "a couple of months ago"), the patient was vaccinated with a dose of unspecified pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose and route not reported) and experienced an injection site reaction, which required unspecified treatment from her physician. The patient recovered from injection site reaction to an unspecified date. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody positive
Clinical narrative: Information has been received from a healthcare worker via a company representative referring to a male patient of unknown age. The patient's concurrent condition and medical history were not reported. On unknown dates the patient was vaccinated with an unspecified number of doses of Hepatitis B vaccine (manufacturer unknown) (lot#, expiration date, dose and route were unknown). On an unknown date the patient had titers drawn which were negative. As a result, the patient was then administered another dose of an unspecified Hepatitis B vaccine (manufacturer unknown) (lot#, expiration date, dose and route were unknown) on an unspecified date. The patient then had titers drawn again on an unspecified date which were positive. Additional information is not expected as there was no consent for contacting the physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 71 year old male pharmacist via company representative referring to himself. In approximately 2012, about three years ago, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). On an unknown date the patient experienced a "mild" rash while on therapy with ZOSTAVAX. The rash resolved itself within a few days. The patient did not seek medical attention. Additional information is not expected because the reporter refused additional contact.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Hyperhidrosis, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2015US110720, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559561) received on 10 Sep 2015. This report refers to a 31-year-old male patient. Historical conditions and current illness were none. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1411601) intramuscular into the left arm on 28 Oct 2014. On the same day after vaccination at 15:00 PM the patient became diaphoretic and pale in color. Further, the patient began to lose consciousness; at this point the patient feet were elevated as the patient had decreased level of consciousness and difficulty responding to his name for approximately two minutes. The patient became more diaphoretic, blood pressure was 102/54 and heart rate was 42. After two minutes the patient was able to respond to his name. The patient was given a glass of water to drink. At 15:09 PM, blood pressure was 104/42. At 15:29, blood pressure was 110/62 and heart rate was 48. The patient stood and reported no dizziness. The patient stated he would have a snack once returned to his desk and was pink in color and started feeling good enough to return to desk. The patient was allowed to leave at 15:37. Final outcome of the events was unknown. The events were reported as non-serious and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Slow response to stimuli
Clinical narrative: Case number PHHY2015US110720, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559561) received on 10 Sep 2015. This report refers to a 31-year-old male patient. Historical conditions and current illness were none. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1411601) intramuscular into the left arm on 28 Oct 2014. On the same day after vaccination at 15:00 PM the patient became diaphoretic and pale in color. Further, the patient began to lose consciousness; at this point the patient feet were elevated as the patient had decreased level of consciousness and difficulty responding to his name for approximately two minutes. The patient became more diaphoretic, blood pressure was 102/54 and heart rate was 42. After two minutes the patient was able to respond to his name. The patient was given a glass of water to drink. At 15:09 PM, blood pressure was 104/42. At 15:29, blood pressure was 110/62 and heart rate was 48. The patient stood and reported no dizziness. The patient stated he would have a snack once returned to his desk and was pink in color and started feeling good enough to return to desk. The patient was allowed to leave at 15:37. Final outcome of the events was unknown. The events were reported as non-serious and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a physician on 08 September 2015. This case involves a three months old female patient who was vaccinated with a second dose of PENTACEL (batch number: C4855AA/C4772AA, expiry date: 18 July 2016) via intramuscular route in right upper limb on 12 May 2015. The patient had also received a second dose of PREVNAR (manufacturer: Wyeth, batch number: L62072, expiry date, dose were not reported) via intramuscular route in left thigh and a second dose of ROTATEQ (manufacturer: Merck, batch number: K020183, expiry date, dose were not reported) orally both on 12 May 2015. The patient was found well on check up. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. The patient had previously received a first dose of PENTACEL, PREVNAR and ROTATEQ vaccines. The patient had medical history of benign macro cranium (Incidental finding during investigations for the events). Concomitant medications were not reported. On 12 May 2015, three hours following the vaccination, the patient had fussiness which was consolable and the baby had to be held by mother for six days. Along with fussiness the patient also had right sixth nerve palsy, distended anterior fontanelle that started after an unspecified time on the day of vaccination. The patient required ER/doctor visit and was examined by ophthalmologist. On 02 June 2015, ultrasound of head was performed which had normal ventricle size with benign macro cranium. Corrective treatment was not reported. On an unknown date, the patient had fully recovered from the events. Upon medical review, the case was considered as serious due to important medical event: right sixth nerve palsy. List of documents held by sender: none.