chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash
Clinical narrative: Patient received an MMR vaccine on 6/27/16. On 7/7/16 patient started to develop a fever, and the next day a rash. Patient also develop sore throat, rash and eye irritation. Physician diagnosed as Measles. Product was MMR vaccine from Merck Lot # L041457.
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood test, Eye irritation, Measles, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient received an MMR vaccine on 6/27/16. On 7/7/16 patient started to develop a fever, and the next day a rash. Patient also develop sore throat, rash and eye irritation. Physician diagnosed as Measles. Product was MMR vaccine from Merck Lot # L041457.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product label confusion
Clinical narrative: According to the manufacturer's product label, the recommended dose is 0.5 ml. Per label "The dose for any age is 0.5 ml administered subcutaneously, preferably into the outer aspect of the upper arm." Also in the label the "Each 0.5 ml dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus; 12,500 TCID50 of mumps virus; and 1,000 TCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (?0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin." The diluent contains an overfill of up to 0.7 ml total volume, which later in the label the entire content of the vial should be administered. However, the label identifies the dose is 0.5 ml and there is remaining volume that is not being administered to patients. The manufacturer is considering if the entire content of the vial is NOT administered then it's considered partial dose. The label is misleading because it states the dose is 0.5 ml and 0.5 ml contains a specific amount of product. However, the entire content of the vial, which may be up to 0.7 ml is considered the actual dose.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes virus infection, Viral test positive
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a female patient of unknown age. Medical history and concurrent condition were not reported. The patient stated that "she received VARIVAX at birth and at 10 years old". Dose, route, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. Recently, the patient developed a "herpes outbreak". For this Herpes outbreak the patient was prescribed Valacyclovir, 500 mg daily, by her physician. The patient stated that she was entering to nursing school and received serologic testing (date unspecified) that included varicella titers; results came back as "low" (viral test positive). The outcome of herpes virus infection and a "low" results for serologic testing was reported as unknown ("I am working through it"). The causality between the events and the therapy with VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unknown number of patients of unknown ages and genders. The patient's medical histories and concurrent conditions were not reported. Since February 2016 the patients were administered improperly stored LIQUID PEDVAXHIB (lot# L0303871, expiration date 10-JUN-2018, dose and route not reported). The vaccine was improperly stored in 27.1 degree Fahrenheit for 10 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot #L006380, expired on 25-MAY-2016) subcutaneously. No adverse effect was 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 medical assistant referring to unknown number of patients of unknown ages and genders. The patient's medical histories and concurrent conditions were not reported. Since February 2016 the patients were administered improperly stored oral ROTATEQ (lot# L027719, expiration date 28-APR-2017, dose not reported) orally. Concomitant therapy was not reported. The vaccine was improperly stored in 27.1 degree Fahrenheit for 10 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unknown number of patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. Since February 2016 the patients were administered improperly stored GARDASIL 9 (lot# L020015, expiration date 16-AUG-2017, dose and route not reported). Concomitant therapy was not reported. The vaccine was improperly stored in 27.1 degree Fahrenheit for 10 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were unknown). There were no concomitant therapies reported. The reporter stated that, on an unknown date, the patient experienced rash, itchiness, eye issues and other side effects. When reviewing the product information (PI), it was suggested to contact the physician about any further concerns. The outcome of the aforementioned events was unknown. The causality between ZOSTAVAX and all the events was not provided. This case is one of two from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Local swelling, Skin warm
Clinical narrative: Patient had a severe local reaction according to walk-in dr. 2 by 3 inch red area, hot and swollen. No rash.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Malaise, Pain, Vomiting
Clinical narrative: I received the GARDASIL shot and became sick the day after. Started off with dizziness and short of breath. Then very lightheaded. Then the next day I couldn't stop throwing up, I was in agonizing body pain. And I couldn't keep anything down.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician via a company representative concerning an adult female patient of approximately 40 years old reported as "about 40 years old". The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were unknown by reporter. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, (lot #, expiration date, strength, route of administration and dose were not provided). There was no concomitant therapy reported. On an unknown date, after receiving the dose of (Oka/Merck) VARIVAX the patient developed shingles. The patient sought medical attention by visiting the physician. However, it was unknown by reporter if the patient received treatment for the adverse event and also if there were laboratories performed. At the reporting time, the outcome of shingles was not reported. The causal assessment of shingles to (Oka/Merck) VARIVAX was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given BEXSERO 7/11/2016 #2 - no previous reaction to immunization given 6/8/2016.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient states hives in "creases/warm areas" called on day four and reports she had been taking BENADRYL for the hives and they are almost gone now. Advise 25mg BENADRYL is 10mg ZYRTEC BID.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt injection site got red and swollen.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Local reaction
Clinical narrative: Local reaction to vaccination over the counter TYLENOL or ibuprofen prn pain and fever. Warm compress as needed.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Erythema
Clinical narrative: 18 mo. old boy received DAPTACEL in his left vastus lateralis on 6/7/16. That night developed redness. Seen in ER on 6/8/16. Diagnosed with cellulitis, treated with clindamycin.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: After supper on 10/26/15 I noticed my arm was sore and hurt when I moved it. This pain and restricted movement has not changed since then. I have seen doctors and done their exercises. I received a cortisone injection in Jan 2016.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Patient inadvertently given Hepatitis A second dose 2 months after the first dose. Mother reported diarrhea.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received Hepatitis A at 2 months of age.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Local swelling, Mobility decreased
Clinical narrative: 1/2 hour after leaving clinic, left arm started hurting. Went to sleep when arrived home. Woke at approximately 7pm for work and could not move left arm. Went to work where sxs continued to progress. Neck became swollen. After work at 0740 11/4, pt called triage nurse to discuss sxs. Fingers began tingling and pt felt nauseated. Injection site was red and swollen. Could not move arm >4 inches. Triage nurse instructed pt to report to clinic ASAP and to apply cold pack to site. Also encouraged to take APAP for swelling. When arrived at clinic, temp was 99.1 and increased to 100.9 over visit. Given diphenhydramine and APAP. Allergist consulted. Symptoms: 1. Headache, 2. Myalgia, 3. Phlebitis, 4. Fever, 5. NauseaVomiting Suspect Drug # 1 Dosing: Left arm. Treatment Drugs Used: 1 - Acetaminophen Dose: 650 Units: Freq: QID Route: PO, 2 - Diphenhydramine Dose: 25 Units: Freq: QID Route: PO.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea, Paraesthesia, Phlebitis, Pyrexia
Clinical narrative: 1/2 hour after leaving clinic, left arm started hurting. Went to sleep when arrived home. Woke at approximately 7pm for work and could not move left arm. Went to work where sxs continued to progress. Neck became swollen. After work at 0740 11/4, pt called triage nurse to discuss sxs. Fingers began tingling and pt felt nauseated. Injection site was red and swollen. Could not move arm >4 inches. Triage nurse instructed pt to report to clinic ASAP and to apply cold pack to site. Also encouraged to take APAP for swelling. When arrived at clinic, temp was 99.1 and increased to 100.9 over visit. Given diphenhydramine and APAP. Allergist consulted. Symptoms: 1. Headache, 2. Myalgia, 3. Phlebitis, 4. Fever, 5. NauseaVomiting Suspect Drug # 1 Dosing: Left arm. Treatment Drugs Used: 1 - Acetaminophen Dose: 650 Units: Freq: QID Route: PO, 2 - Diphenhydramine Dose: 25 Units: Freq: QID Route: PO.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: 1/2 hour after leaving clinic, left arm started hurting. Went to sleep when arrived home. Woke at approximately 7pm for work and could not move left arm. Went to work where sxs continued to progress. Neck became swollen. After work at 0740 11/4, pt called triage nurse to discuss sxs. Fingers began tingling and pt felt nauseated. Injection site was red and swollen. Could not move arm >4 inches. Triage nurse instructed pt to report to clinic ASAP and to apply cold pack to site. Also encouraged to take APAP for swelling. When arrived at clinic, temp was 99.1 and increased to 100.9 over visit. Given diphenhydramine and APAP. Allergist consulted. Symptoms: 1. Headache, 2. Myalgia, 3. Phlebitis, 4. Fever, 5. NauseaVomiting Suspect Drug # 1 Dosing: Left arm. Treatment Drugs Used: 1 - Acetaminophen Dose: 650 Units: Freq: QID Route: PO, 2 - Diphenhydramine Dose: 25 Units: Freq: QID Route: PO.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX once, subcutaneously, lot # M004326, expiration date 25-JAN-2018 (strength, dose and anatomical location were not provided). No adverse effects were reported. It was reported that the patient did not discontinue the therapy with (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: F
Vaccine: TYP
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a healthcare professional on 11-Aug-2015. Manufacturer number: 2015260439. A female patient (age not reported) whose medical history and concomitant medications were not provided had received a dose of TYPHOID VI (batch number, expiry date, dose details, route and site of administration were not provided) on an unspecified date. On an unspecified date, 12 minutes post-vaccination, the patient developed rash, swelling and hives. Laboratory investigations and corrective treatment was not reported. At the time of this report, the outcome of the events was not reported. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Foreign body aspiration, Nasal discomfort, Needle issue
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 August 2015. This case involves a 42 years female patient who got exposed to vaccine due to nasal aspiration of Typhim VI (batch number not applicable) on 22 August 2015. The patient's medical history and concomitant medications were not reported. Patient previous medication includes Thyroid medications. It was a case of occupational exposure via inhalation of product due to needle issue as the needle came loose from the syringe, and she aspirated some of the vaccine while administering it to another patient. On 22 August 2015, same day following the exposure, the patient experienced burning in her nose and could smell the vaccine. No other symptoms reported. Lab data and corrective treatments were not reported. It was reported that the event lasted in few minutes. List of documents held by sender: none.
Sex: M
Vaccine: MEN
Symptoms: Meningitis
Clinical narrative: Initial unsolicited report received from a consumer (patient's grandmother) via social media on 06 July 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of MENINGOCOCCAL VACCINE (batch number, expiration date, dose in series, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, patient had meningitis. Lab data and corrective treatment was not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: meningitis. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of meningitis. Temporal association between meningitis and MENINGOCOCCAL VACCINE cannot be established as dates of administration of vaccine and occurrence of the event was not provided. Based on the data provided, the role of vaccine cannot be assessed.
Sex: F
Vaccine: HPV4
Symptoms: Genital neoplasm malignant female
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). The patient received three doses of GARDASIL, each dose on a separate unspecified date. On an unknown date, an unspecified time after receiving GARDASIL (it was unspecified if this occurred after the first dose, the second dose, or the third dose) the patient was diagnosed with an unspecified reproductive cancer. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of unspecified reproductive cancer was considered to be medically significant. Additional information is not expected because there was no consent to contact a physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M004328, expiration date 26-JAN-2018, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 9.6 Celsius degrees for 1 hour before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received 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 multiple unspecified patients of unknown age and gender. The concurrent condition, medical history and concomitant medications was not reported. On unknown dates the patient were vaccinated with improperly stored doses of PROQUAD, (lot# L050909, expiration date 14-JUN-2017, dose and route were unknown). The vaccine was stored at 14 degree centigrade for 4 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L026406 expiration date 15-JUL-2017, dose and route were unknown). The vaccine was stored at 14 degree centigrade for 4 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates (reported as each on a separate unspecified date), the patient was vaccinated with two doses of ZOSTAVAX (lot #, frequency and route were not reported). No adverse effect was reported. The reporter wanted to know what the ramification was when a patient received more than one dose of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # reported as M006105, expiration date 01-AUG-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Logger. It was reported that the vaccines were exposed to temperature of 9.6 Celsius degrees for 1 hour before administration to the patients. No previous temperature excursion was reported. No adverse effect were reported. This is one of several reports received 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 as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX injection (lot # M002061, expiration date 12-JAN-2018, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot #K008334 and expiration date 09-JUN-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. The temperature of excursion was 1 Celsius degree. The time frame of excursion was not available at the time of the report. There was no previous temperature excursion. It was stated that the call was because of a data logger. On the same day, the patient received an expired dose of M-M-R II (captured in 1607USA004581). Additional information is not expected as no contact details were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On 29-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) and a dose of (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On  23-JUN-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # K023432, expiration date: 18-JUN-2016) 0.5 ml, intramuscularly. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUN-2016, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot# and expiry date were not reported) and with a dose of M-M-R II injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician referring to a approximately 52 year old female patient (also reported as "he"). Concurrent condition and medical history of the patient were not reported. On an unknown date in February 2016, the patient was vaccinated with her first dose of VARIVAX (lot#, expiration date, dose and route unspecified). On an unknown date in 2016, the physician stated the patient recently completed serologic testing and the result shown negative titer for varicella (Antibody test negative). Physician stated patient had no other adverse effects. Treatment was given for the event "negative titer for varicella". The patient was "doing fine" at the reporting time. Additional information is not expected as we are not permitted to contact the physician.
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Weight decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#, expiry date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced loss of appetite and weight loss. The outcome of events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. It was reported that on an unknown date, the patient might be vaccinated with the fourth dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). No adverse effects were reported. 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # reported as L036851, expiration date 23-SEP-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 9.6 Celsius degrees for 1 hour before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L025210 with expiry date 07-JUL-2017 and lot # L001331 with expiry date 13-JAN-2017; dose, frequency and route were not reported; data logger involved). The VARIVAX was improperly stored at the temperature of 30.6 Fahrenheit (F) for 6 hours and 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (rHA, lot # L032760 with expiry date 24-FEB-2017; dose, frequency and route were not reported; data logger involved). The PROQUAD was improperly stored at the temperature of 30.6 Fahrenheit (F) for 6 hours and 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 07-JUL-2016, the patient was vaccinated with PNEUMOVAX 23, (lot # L001311, dose and route were not reported) which expired on 06-JUL-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) referring to two patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (dose, route, lot# and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information was received from a nurse referring to a currently 18 years old male patient of unknown age. The patient had no medical history, concurrent condition and no known drug allergy. On unspecified dates in 1998, the patient received 3 doses series of RECOMBIVAX HB (lot #, expiration date, frequency and route unknown). On an unknown date, titers were drawn for college admittance and were negative. No treatment was given to the patient. The patient had sought for medical attention via coming to the office. The outcome of the event was unknown. The causality was not reported. Additional information is not expected as no contact information was provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to one patient of an unknown age and an unknown gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L003227, expiry date: 13-OCT-2016; dose and route of administration were not reported). The vaccine was stored at 46.4 degrees Fahrenheit for a time frame of 36 minutes and was administered to the patient. There was no previous temperature excursion. The call was a result of "data logger". No adverse symptoms were reported. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report was received from a nurse and a physician via company representative referring to 7 patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with doses of M-M-R II injection (lot #, Expiry date and dose were not reported) subcutaneously. On an unknown day with in 3 minutes after receiving the vaccine doses, the patients experienced "a welt about the size of a nickel and redness about the size of a 50 cent piece" at the injection site. The patients did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# L046900, expiration date, dose and route not reported). Concomitant therapy was not reported. On an unknown date (reported as "recently") the patient had stopped taking long term prednisone and had also just stopped chemotherapy, developed blisters on her hip the size of a silver dollar. Treatment was given to the event. The patient recovered from the event. Reporter's causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On 08-JUL-2016 (also reported as today), the patients were vaccinated with expired doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information is not expected as the reported did not wish to be contacted.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Blood cholesterol normal, Blood glucose normal, Chills, Haemoglobin normal, Headache
Clinical narrative: Roughly 1 hr after receiving hepatitis a (#1) and TRUMENBA (#1), pt had severe headache (>10/10), shivering and moaning. Referred to ER, waited at ER. Was never seen. Headache improved, shaking stopped, eating/drinking w/o difficulty. No lingering symptoms day after.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: High density lipoprotein normal, Low density lipoprotein normal, Moaning, Tremor
Clinical narrative: Roughly 1 hr after receiving hepatitis a (#1) and TRUMENBA (#1), pt had severe headache (>10/10), shivering and moaning. Referred to ER, waited at ER. Was never seen. Headache improved, shaking stopped, eating/drinking w/o difficulty. No lingering symptoms day after.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's current conditions medical history and concomitant medication were not reported. On 02-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (therapy type - digital data locker, lot # L013206 and expiry date 29-JAN-2017). Temperature excursion was 30.1 F and time frame was 67.78 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II lot # L003855, expiry date 05-FEB-2017 and lot # L026553, expiry date 16-JUL-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication was reported. On an unknown date, doses of PNEUMOVAX 23 were affected by the temperature excursion. Maximum temperature was 68 degrees Fahrenheit. The power in the refrigerator was out for 20 hours, which is the maximum amount of time the product was out of temperature range. It was unspecified if any patients received the affected PNEUMOVAX 23 but it could not be ruled out. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: TDAP
Symptoms: Antibody test, Clostridium test negative, Corynebacterium test negative
Clinical narrative: Initial unsolicited report received from the literature on 01 June 2016. This case is linked to Case is linked with 2016SA108588, 2016SA108584 and 2016SA108560 (same literature). The following is verbatim from the article: Background. Many adult immunization schedules recommend that tetanus and diphtheria vaccination be performed every 10 years. In light of current epidemiological trends of disease incidence and rates of vaccine-associated adverse events, the 10-year revaccination schedule has come into question. Methods. We performed cross-sectional analysis of serum antibody titers in 546 adult subjects stratified by age or sex. All serological results were converted to international units after calibration with international serum standards. Results. Approximately 97% of the population was seropositive to tetanus and diphtheria as defined by a protective serum antibody titer of 0.01 IU/mL. Mean antibody titers were 3.6 and 0.35 IU/mL against tetanus and diphtheria, respectively. Antibody responses to tetanus declined with an estimated half-life of 14 years (95% confidence interval, 11-17 years), whereas antibody responses to diphtheria were more long-lived and declined with an estimated half-life of 27 years (18-51 years). Mathematical models combining antibody magnitude and duration predict that 95% of the population will remain protected against tetanus and diphtheria for 30 years without requiring further booster vaccination. Conclusions. These studies demonstrate that durable levels of protective antitoxin immunity exist in the majority of vaccinated individuals. Together, this suggests that it may no longer be necessary to administer booster vaccinations every 10 years and that the current adult vaccination schedule for tetanus and diphtheria should be revisited. This case involves a 61-year-old patient (gender not reported) who was vaccinated with a dose of TDAP (manufacturer: unknown) (batch number, expiration date, dose, site and route of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date following the vaccination the patient lacked immunity to both (diphtheria and tetanus) toxins. A serum antibody titer was performed (results not provided). Other laboratory data and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a nurse on 27 June 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Tdap (manufacturer, batch number, dose in series, route and site of administration: unknown, expiry date: not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On an unspecified date, after vaccination, patient had a reaction to a Tdap vaccine. The patient's laboratory data was not reported. Patient was given unspecified medicine as a corrective treatment. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Dehydration, Pyrexia, Vomiting
Clinical narrative: Developed fever 102.5, abd pain and vomiting for 3 days. Returned to office 7/7/16 for worsening abd pain, dehydration and sent to ED for IVF and to R/o appendicitis.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Headache, Painful respiration
Clinical narrative: Five to ten minutes after the administration of the vaccines patient complaint of pain on the back of the head and chest pain she she breaths.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Chest discomfort, Dry mouth
Clinical narrative: Chest tightness upon inhalation, mouth dryness. Patient was treated at clinic.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The boy fainted a few fours after the vaccines being administrated.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to left arm due around injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Kinrix (GSK)- DTap/IPV vaccine administered, instead of single dose DTap and IPV. MCIR reviewed: DTap counts as a dose and next dose due 01/11/2017. IPV vaccine counts as a completed series.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old male patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD). The patient do not have drug reactions/allergies. On 01-JUN-2016, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included montelukast sodium, SPIRIVA, ADVAIR, PROAIR and omeprazole. On 01-JUN-2016, an unknown time after receiving vaccine, the patient experienced COPD exacerbation. On 16-JUN-2016, as a treatment the patient was prescribed albuterol, levofloxacin, and a 3-day course of prednisone (all manufactures unspecified). On 24-JUN-2016, the patient was prescribed a "16-day high-dose prednisone taper" for an unknown reason. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist referring to a female patient who was a healthcare worker of unknown age. Concurrent condition and historical condition were reported as none. On unknown dates the patient was vaccinated separately with three doses of RECOMBIVAX HB (dose, route, lot number and expiration date unknown). Concomitant therapy was reported as none. On an unknown date after the third dose, the patient had titers drawn and it showed "a lack of protection". No treatment was given. The outcome of event was unknown. The causality was not provided. Additional information is not expected as no reporter's contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # K005083, expiry date 04-NOV-2016 and lot # K010215, expiry date 05-MAY-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On 08-JUL-2016 (also reported as today), the patients were vaccinated with expired doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information is not expected as the reported did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ, orally, lot # L03551, expiry date 21-MAY-2017, lot # K022993, expiry date 20-JUL-2016 and lot # L029618, expiry date 20-MAY-2017 (dose and site of administration were not reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours and 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMIVAX HB lot # L033343, expiry date 13-SEP-2017 and lot # M006708, expiry date 02-JUN-2018 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines with lot # L033343 experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. The vaccines with lot # M006708 experienced temperature excursion of maximum temperature of 22. 7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 7 hours 36 minutes. This is one of several reports received from the same source. Additional information has been requested.