chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031945, expiration date 27-DEC-2017 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 6°Fahrenheit (F) and 14°F (11.2F), for a time frame of 8 hours. There was no previous temperature excursion and no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # L040419, expiration date 14-OCT-2017; lot # M008171, expiration date 15-FEB-2018; lot # M024683, expiration date 18-MAY-2018; and lot # M027347, expiration date 01-JUN-2018 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 6°°Fahrenheit (F) to 14°F (11.2F), for a time frame of 8 hours. There was no previous temperature excursion and no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. The patient was vaccinated with the first, second and third dose of GARDASIL 9 (which had a lot # of M034780 with an expiration date of 15-APR-2019; however, the dose, frequency, anatomical location and route of administration details were unknown) on 14-SEP-2012, 28-NOV-2012, and 20-MAR-2013, respectively, for prophylaxis. Then, on 27-MAR-2017, she was inadvertently vaccinated with another dose of the vaccine, having the same dosage details as provided earlier. Despite this, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event, Product lot number issue
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies. On 29-MAR-2017, the patient was inadvertently vaccinated with an expired GARDASIL lot number K009482, expiration date 06-MAR-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The reporter reported also the GARDASIL 9, then, unidentified expired Merck HPV vaccine was administered. Additionally, the lot number K009482 was valid only for GARDASIL. No adverse effects were reported. Product quality complain was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042324 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1703USA014121: US-009507513-1703USA014122: US-009507513-1703USA012983.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ orally, lot # M03180 (doses and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1703USA012983: US-009507513-1703USA014122: US-009507513-1703USA014120:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 lot # reported as M041213 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1703USA014121: US-009507513-1703USA012983: US-009507513-1703USA014120:
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a nurse on 16-Mar-2017. This case involves a male patient (age reported as 40's) who was vaccinated with a dose of ACAM2000 (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 26-Jan-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included gout. Illness at the time of vaccination was also not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 08-Feb-2017, 13 days following the vaccination, the patient reported pain, swelling in left ankle. It was also reported that patient continued to foot swelling and joint pain. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. It was also reported that patient was sent for diagnostic tests and referral, with unknown results. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a nurse on 16-MAR-2017. This case involves a 40-years old male patient who was vaccinated with a dose of ACAM2000 (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 04-AUG-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and Illness at the time of vaccination was reported as not applicable. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 23-AUG-2016, 19 days of following the vaccination, the patient had developed swelling and pain in left hand, arm and upper extremity. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Haematoma, Injection site reaction, Laceration, Pain
Clinical narrative: This is a reaction based on technician error: 3 year old boy receiving 4th dose of PREVNAR 13 (catching up). According to technician, child moved his leg. The needle came out of the initial injection site, cutting across his leg, and reentering at another point. Vaccine components spilled out so it is unclear exactly how much the child received. Child is unable to walk without pain and has a hematoma. Watching for signs of infection or other illness.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Underdose
Clinical narrative: This is a reaction based on technician error: 3 year old boy receiving 4th dose of PREVNAR 13 (catching up). According to technician, child moved his leg. The needle came out of the initial injection site, cutting across his leg, and reentering at another point. Vaccine components spilled out so it is unclear exactly how much the child received. Child is unable to walk without pain and has a hematoma. Watching for signs of infection or other illness.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received PREVNAR 13 and was not aware that she received PNEUMOVAX 23 at her physicians office during the previous month. She did not have any reactions from either vaccination and did not report any adverse events.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a regisetred nurse referring to an unspecified number of patients of unspecified demographics.  On 06-MAR-2017, the the patients received improperly stored doses of PROQUAD administered subcutaneously (lot number M031944, expiration date 27-DEC-2017, dose was not reported). No adverse events were reported. The doses of vaccine experienced a temperature excursion of 61F and 47F to 77F for 27.5 hours which was detected by a digital datalogger. There was no previous excursion reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014442:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies were not provided.  On an unspecified date, the patient received an improperly stored dose of vaccinated with M-M-R II, (dose, frequency, and route were not provided), (lot # was reported as M034856, with an expiration date of 27-JUL-2018) for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT) used to reconstitute the dose of M-M-R II, (lot # and expiration date were not provided).  The physician reported that the dose of M-M-R II, may have been exposed to light due to "the M-M-R II was stored in the refrigerator without the lid on the box". No adverse effect reported. Product quality compliant was not involved. No additional information was provided. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 15-MAR-2017 from a nurse regarding a female patient of unknown age. No medical history or concomitant medications were reported. The nurse reported that on 15-MAR-2017 the patient received a dose of improperly stored M-M-R II (albumin status unknown) (lot M025607, expires 18-MAY-2018)(dose, site not reported). The nurse had no lot number or expiration for the sterile diluent that was used to reconstitute the vaccine. No adverse effects were reported. The temperature was out of range for 29 minutes as recorded by data logger. Additional information is not expected. No additional information is available.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist concerning a non pregnant female patient who is currently 41 years old. Medical history and concurrent conditions were not provided. Approximately in 2007 (reported as 10 years ago), the patient was vaccinated with series of M-M-R II (dose, route, frequency, lot# and the expiration date were not reported) for routine vaccination. There was no concomitant medication provided. Approximately in 2017 (reported as currently), the patient had "low titers for measles" (measles antibody negative). The pharmacist did not know why the patient had titers for measles drawn. She stated that the patient was "otherwise healthy," and she did not have any prescriptions filled at her pharmacy for any chronic conditions. The patient sought medical attention at her pharmacy to receive a booster of M-M-R II. The patient had not, at this current time, received a booster of M-M-R II. At the time of reporting, the outcome of measles antibody negative was not recovered. The relatedness between the therapy with M-M-R II and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a pharmacist, via company representative, referring to a group of unspecified patients (demographics were not reported). The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, PNEUMOVAX 23 and ZOSTAVAX (strength, doses, routes, lot #, expiration dates or anatomical locations, for both vaccines were not reported) were administered with sterile water diluent to unspecified patients for prophylaxis, at shorter intervals than recommended; they might have been administered simultaneously, or up to a week apart. No adverse effects were reported and no additional information was provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an adult female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 28-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 expiration date: February 2017, as prophylaxis (Strength, dose, route of administration and lot # were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report has been received from a pharmacist (a patient's husband) via Pfizer Inc. (manufacturer control # 2017120766) and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated by the reporter with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported) and with PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as recently), the patient was admitted to the hospital due to pneumonia (onset date was not provided). The patient was discharged from the hospital on an unspecified date. The outcome of pneumonia was reported as recovering. The relatedness between the event and suspect therapies was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Arthroscopy, Asthenia, Bursitis, Drug administered at inappropriate site, Injection site pain
Clinical narrative: Initial unsolicited misuse report received from the literature on 16-MAR-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of TETANUS TOXOID injection (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced left shoulder pain/ left shoulder arthroscopy for continued pain and weakness, severe pain during an injection of tetanus toxoid in her left deltoid, partial-thickness tear of the supraspinatus tendon/ delaminated rotator cuff tear and significant glenohumeral synovitis and subacromial bursitis. It was reported that patient's shoulder was immobilized in an abduction brace for 4 weeks. It was also a case of wrong route of administration as Rotator cuff tear resulting from intratendinous injection during attempted deltoid intramuscular vaccination. On an unspecified date, other lab data included MRI examination with intraarticular contrast was performed. The patient elected to undergo left shoulder arthroscopy for continued pain and weakness, and arthroscopic subacromial decompression and transtendinous rotator cuff repair with a double-row, suture-bridge construct was performed. The patient received corrective treatment with 6 weeks of physical therapy. Physical therapy was started the day after surgery for passive range of motion, and the patient progressed through the rehabilitation protocol. On an unspecified date, the patient recovered from the events. The case was reported serious by the reporter due to Disability. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with tetanus and given by intratendious route which lead to Rotator cuff tear with associated symptoms and vaccination site pain. Time to onset is compatible, as the event occurred due to wrong route of vaccination, but additional information regarding patient medical history, any trauma history are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
Sex: F
Vaccine: TTOX
Symptoms: Joint stabilisation, Nuclear magnetic resonance imaging, Orthosis user, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Initial unsolicited misuse report received from the literature on 16-MAR-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of TETANUS TOXOID injection (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced left shoulder pain/ left shoulder arthroscopy for continued pain and weakness, severe pain during an injection of tetanus toxoid in her left deltoid, partial-thickness tear of the supraspinatus tendon/ delaminated rotator cuff tear and significant glenohumeral synovitis and subacromial bursitis. It was reported that patient's shoulder was immobilized in an abduction brace for 4 weeks. It was also a case of wrong route of administration as Rotator cuff tear resulting from intratendinous injection during attempted deltoid intramuscular vaccination. On an unspecified date, other lab data included MRI examination with intraarticular contrast was performed. The patient elected to undergo left shoulder arthroscopy for continued pain and weakness, and arthroscopic subacromial decompression and transtendinous rotator cuff repair with a double-row, suture-bridge construct was performed. The patient received corrective treatment with 6 weeks of physical therapy. Physical therapy was started the day after surgery for passive range of motion, and the patient progressed through the rehabilitation protocol. On an unspecified date, the patient recovered from the events. The case was reported serious by the reporter due to Disability. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with tetanus and given by intratendious route which lead to Rotator cuff tear with associated symptoms and vaccination site pain. Time to onset is compatible, as the event occurred due to wrong route of vaccination, but additional information regarding patient medical history, any trauma history are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
Sex: F
Vaccine: TTOX
Symptoms: Scan with contrast, Synovitis, Tendon rupture
Clinical narrative: Initial unsolicited misuse report received from the literature on 16-MAR-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of TETANUS TOXOID injection (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced left shoulder pain/ left shoulder arthroscopy for continued pain and weakness, severe pain during an injection of tetanus toxoid in her left deltoid, partial-thickness tear of the supraspinatus tendon/ delaminated rotator cuff tear and significant glenohumeral synovitis and subacromial bursitis. It was reported that patient's shoulder was immobilized in an abduction brace for 4 weeks. It was also a case of wrong route of administration as Rotator cuff tear resulting from intratendinous injection during attempted deltoid intramuscular vaccination. On an unspecified date, other lab data included MRI examination with intraarticular contrast was performed. The patient elected to undergo left shoulder arthroscopy for continued pain and weakness, and arthroscopic subacromial decompression and transtendinous rotator cuff repair with a double-row, suture-bridge construct was performed. The patient received corrective treatment with 6 weeks of physical therapy. Physical therapy was started the day after surgery for passive range of motion, and the patient progressed through the rehabilitation protocol. On an unspecified date, the patient recovered from the events. The case was reported serious by the reporter due to Disability. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with tetanus and given by intratendious route which lead to Rotator cuff tear with associated symptoms and vaccination site pain. Time to onset is compatible, as the event occurred due to wrong route of vaccination, but additional information regarding patient medical history, any trauma history are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives spread all over body, itching, Benadryl given.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Limb discomfort, Local swelling, Pruritus
Clinical narrative: R Arm: Heaviness, itching, localized swelling.  Tx: Hydrocortisone Cream TID.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: REPORTS REDNESS, SWELLING AT SITE, WITH HARDENED AREA MEASURING ABOUT 3 INCHES. CHILD TAKEN TO ER ON 03/28/2017 AT 2000.  ER DOCTOR ADVISED TO USE IBUPROPHEN AND APPLY HYDROCORTISONE TO AREA.
Age: 19.0
Sex: F
Vaccine: HEPAB, MENB
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pt stated that approximately 1hr after administration, she experienced fever >100, extreme muscle pain, and swelling of upper left arm. Pt states she went to the ER around 2:00AM on 03/22/2017. Pt states she was given IV BENADRYL, and "anti-swelling" medication and was discharged afterwards.
Age: 19.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Ear congestion, Feeling abnormal, Mononucleosis heterophile test positive, Neck pain, Oropharyngeal pain
Clinical narrative: Several hours after injections, she developed pain posterior neck. Reports she has had mild, intermittent sore throat for several days. When she awoke the next day, she had sore throat, pain had extended to anterior neck, ears felt congested, and felt "fuzzy headed."
Age: 19.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: White blood cell count increased
Clinical narrative: Several hours after injections, she developed pain posterior neck. Reports she has had mild, intermittent sore throat for several days. When she awoke the next day, she had sore throat, pain had extended to anterior neck, ears felt congested, and felt "fuzzy headed."
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 21-year-old male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with M-M-R II injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date the patient received VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient came to the pharmacy to receive booster vaccines of M-M-R II and VARIVAX at his school request due to his antibody levels were low. The mumps antibody was reported low at 9 and varicella antibody level was low at 135. The outcome of the adverse event was unknown. The relatedness between the adverse events and M-M-R II and VARIVAX was not reported. 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 nurse practitioner and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unspecified dates, improperly stored doses of VARIVAX (dosage and route administration were not provided; lot # M006157, expiry date 05-FEB-2018) were administered to the patients. The vaccines were stored in the temperature 8 degrees Fahrenheit for 1 hour and 25 minutes. There were previous temperature excursions over 6 degrees Fahrenheit but under 14 degrees Fahrenheit for 2 hours and 25 minutes and over 15 degrees Fahrenheit but under 46 degrees Fahrenheit for 17 hours and 50 minutes on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA014480:
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On an unknown date, the patient missed the third and final dose of GARDASIL 9 (strength and dose were not reported), intramuscularly (lot # L013429; expiration date: 21-JUL-2017) for prophylaxis, because the product was defective and needed replacement. No adverse effect was reported. A product quality complaint was involved. 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 a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 29-MAR-2017, the patient was inadvertently administered an expired dose of GARDASIL 9 lot # L000610, expiry date 31-JAN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unspecified dates, improperly stored doses of ZOSTAVAX (dosage and route administration were not provided; lot # M009773 with expiry date 17-MAY-2017 and lot # M036296 with expiry date 14-NOV-2017) were administered to the patients. The vaccines were stored in the temperature 8 degrees Fahrenheit for 1 hour and 15 minutes. There were previous temperature excursions over 6 degrees Fahrenheit but under 14 degrees Fahrenheit for 2 hours and 25 minutes and over 15 degrees Fahrenheit but under 46 degrees Fahrenheit for 17 hours and 50 minutes on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1703USA013637.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial unsolicited case received from a consumer on 13 Mar 2017. This case involves a 62 year old female patient who was vaccinated with a dose of ADACEL (Batch number: U5476AA, expiry date: 04 Nov 2018, dose, dose in series was not reported) administered intramuscularly in left deltoid on 03 Mar 2017. The patient had no illness at the time of vaccination, and the patient had penicillin, and erythromycin allergies. Concomitant medications were not reported. On 03 Mar 2017, same day following the vaccination the patient experienced swelling, rash, soreness of upper arm muscle of left arm. Stated also within 24 hours the rash extended from upper arm down to wrist, experienced fever, headache, nausea, diarrhea, general malaise, and it was reported as of today on 13 Mar 2017, the patient still has swelling of upper arm, soreness of arm, and rash on arm. The patient required ER visit and was seen by her own physician for evaluation. The patient relevant lab tests were not reported. The patient was treated with antibiotic. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nausea, Pyrexia, Rash
Clinical narrative: Initial unsolicited case received from a consumer on 13 Mar 2017. This case involves a 62 year old female patient who was vaccinated with a dose of ADACEL (Batch number: U5476AA, expiry date: 04 Nov 2018, dose, dose in series was not reported) administered intramuscularly in left deltoid on 03 Mar 2017. The patient had no illness at the time of vaccination, and the patient had penicillin, and erythromycin allergies. Concomitant medications were not reported. On 03 Mar 2017, same day following the vaccination the patient experienced swelling, rash, soreness of upper arm muscle of left arm. Stated also within 24 hours the rash extended from upper arm down to wrist, experienced fever, headache, nausea, diarrhea, general malaise, and it was reported as of today on 13 Mar 2017, the patient still has swelling of upper arm, soreness of arm, and rash on arm. The patient required ER visit and was seen by her own physician for evaluation. The patient relevant lab tests were not reported. The patient was treated with antibiotic. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 16-MAR-2017. This case involves a 40-years old female patient who was vaccinated with a dose of ACAM2000 (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 04-AUG-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and Illness at the time of vaccination was reported as not applicable. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 14-AUG-2016, 10 days of following the vaccination, the patient had developed pain and wrist swelling in arm opposite of vaccination site. The patient did not required emergency room (ER) or doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain of skin, Pyrexia
Clinical narrative: Patient complained of skin to be tender to touch and fevers some site reaction (pain, red, warmth).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Rash on anterior Bicep. First noticed Sunday morning. Patient complained of it itching and it being warm. Recommended OTC anti-itch products.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Asthenia, Decreased appetite, Dizziness, Influenza virus test, Injection site mass
Clinical narrative: Patient had fever, body aches, poor appetite, dizziness, weakness, and lump to injection site.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Pyrexia, Streptococcus test, Urine analysis
Clinical narrative: Patient had fever, body aches, poor appetite, dizziness, weakness, and lump to injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Localised oedema
Clinical narrative: Local erythema and edema.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Vaccination site pain
Clinical narrative: 59 year old female with history asthma presented to Immunizations clinic on 29 March and received PNEUMOAVAX 23. She had previously received PNEUMOAVAX 23 in 2010. Approximately 12 hours after receiving the vaccination she noted pain affecting the vaccination site and her left upper arm. Over the past two days she notes redness and swelling affecting her left upper arm which she feels has progressively increased. She also complains of mild discomfort in her left axilla. She denies fever/chills, purulent drainage from vaccination site, generalized cutaneous symptoms, and systemic symptoms. She denies prior vaccine adverse reactions. She has been taking OTC Benadryl and Ibuprofen for the past day. A/P Large local reaction to PNEUMOVAX 23. Discussed with her that this reaction represents a delayed (cell-mediated) reaction to the vaccine or its components. No systemic symptoms. No signs/symptoms suggestive of infection. Discussed diagnosis, recommendations for treatment, expected course, and indications for urgent/emergent evaluation (fever/chills, purulent drainage, streaking, systemic symptoms). Recommend resting and elevating extremity, application of cool compresses, Zyrtec 10mg daily at bedtime, and ibuprofen 600mg with food every 8 hours as needed for the next 48-72 hours. If her symptoms persist or worsen will have her return to my clinic. VAERS report entered. She indicated she understands and agrees with the plan.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood test, CSF test, Diplegia, Inflammation, Nervous system disorder
Clinical narrative: Spinal neurological damage, inflammation in thoracic spine, partial paralysis in feet and legs,  urinary incontinence.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nuclear magnetic resonance imaging, Spinal cord injury, Urinary incontinence, X-ray
Clinical narrative: Spinal neurological damage, inflammation in thoracic spine, partial paralysis in feet and legs,  urinary incontinence.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site papule, Injection site rash
Clinical narrative: RASH TO RIGHT THIGH WITH PAPULES, REDNESS AND HEMATOMA.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: PARENT OF PATIENT CALLED CLINIC WITH PATIENT COMPLAINTS OF COASTER SIZE REDNESS AT INJECTION SITE, WARM TO TOUCH & UNABLE TO MOVE LEFT ARM WITHOUT PAIN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash started on should and neck and spread to right arm.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer refers to an adult patient of unknown age and gender. 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 M-M-R II, subcutaneous (lot number and expiration date not reported). No further information reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This solicited report was received from a consumer via vendor's representative referring to an unspecified number of patients of unknown age and gender who were enrolled in a market research. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of GARDASIL (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. It was reported that, on unknown dates, the patients had unspecified bad reactions with GARDASIL. The outcome of adverse reaction was unknown. The causality between GARDASIL and the event was not provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Information had been received on 15-MAR-2017 from a medical assistant who reported that a 20 year old female patient received her first dose of GARDASIL 9 0.5ml (unspecified lot#/expiration date) on 15-SEP-2016 and then a second dose of GARDASIL 9 (lot# L036301, expiration 20-DEC-2017) via the intramuscular route in her left deltoid on 15-NOV-2016. The medical assistant stated that an unspecified time after the patient received the second dose of GARDASIL 9, she developed a "large lump that feels like fluid underneath the skin" at the injection site where the second dose of GARDASIL 9 was administered. The medical assistant stated the patient came into the office today, 15-MAR-2017, to receive the third dose of GARDASIL 9 but the third dose was not administered due to the lump. The medical assistant stated that the patient was being referred to an unspecified surgeon due to the lump. Patient's present status was not recovered. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 16-MAR-2017 from a pharmacist regarding a male patient (age not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 15-MAR-2017 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot number L046893, expiration date 23-FEB-2017). The pharmacist reported that the sterile water diluent (unspecified lot number and expiration date) used to reconstitute the ZOSTAVAX was not expired. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 20-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L035686 and expiration date 16-FEB-2017) (dose, route and anatomical location were not reported) for prophylaxis. There were no previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # L044530 with an expiration date on 09-FEB-2017 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M033583 with expiration date of 14-APR-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014483: US-009507513-1703USA014484: US-009507513-1703USA014485: US-009507513-1703USA014486:
Sex: F
Vaccine: PPV, TTOX
Symptoms: Antibody test negative, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Lymphocyte count normal
Clinical narrative: This literature marketed report as received from the authors of published literature article and refers to a 11-years old female patient. The patient's medical history included anaemia, adenoidectomy and tonsillectomy. The patient current condition was lactose intolerance, asthma, sinusitis, lower respiratory tract infection, lymph node palpable and hypermobility syndrome. On an unknown date, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot# not provided) for sinusitis and lower respiratory tract infection. The patient was also vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) earlier and no adverse effects were observed. Other suspect therapies included tetanus toxoid. Lab data showed that all the lymphocyte absolute counts and percentages were within the normal range (CD4 and CDS T, B and NK cells). Immunoglobulins A, M and G levels were all detectable, but lower than two standard deviations of the normal levels adjusted for age. On an unknown date reported as six weeks later, blood samples was taken in order to determine post-vaccine antibody titres. It was found that both the pneumococcal (polysaccharide) and tetanus toxoid (protein) vaccine responses did not reach protective levels (vaccination failure). The outcome of vaccination failure was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Lymphocyte percentage, Vaccination failure
Clinical narrative: This literature marketed report as received from the authors of published literature article and refers to a 11-years old female patient. The patient's medical history included anaemia, adenoidectomy and tonsillectomy. The patient current condition was lactose intolerance, asthma, sinusitis, lower respiratory tract infection, lymph node palpable and hypermobility syndrome. On an unknown date, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot# not provided) for sinusitis and lower respiratory tract infection. The patient was also vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) earlier and no adverse effects were observed. Other suspect therapies included tetanus toxoid. Lab data showed that all the lymphocyte absolute counts and percentages were within the normal range (CD4 and CDS T, B and NK cells). Immunoglobulins A, M and G levels were all detectable, but lower than two standard deviations of the normal levels adjusted for age. On an unknown date reported as six weeks later, blood samples was taken in order to determine post-vaccine antibody titres. It was found that both the pneumococcal (polysaccharide) and tetanus toxoid (protein) vaccine responses did not reach protective levels (vaccination failure). The outcome of vaccination failure was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). 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 registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M033337 with expiration date of 13-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014484: US-009507513-1703USA014485: US-009507513-1703USA014486: