chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Tendon injury
Clinical narrative: This medically confirmed literature report (initial receipt 13-Oct-2015) concerns a 34 year old female patient. On an unknown date, the patient received an intramuscular injection of an influenza virus vaccine (brand and batch number unspecified) to the deltoid region of the arm. The patient reported 3 weeks of right shoulder pain beginning during vaccination. She noted more pain than usual during the vaccination and stabbing.  The patient experienced 9/10 shoulder pain with internal/external rotation and adduction afterwards. She denied any instability, clicking/popping, neurologic symptoms in the arm/hand, or any new repetitive activity. On examination, active internal/external rotation, resisted external rotation both with the shoulder adducted and abducted to 90 degrees and shoulder impingement maneuvers were painful. Reflexes, strength, sensation and AC joint provacative maneuvers were normal. Traumatic infraspinatus and/or teres minor tendon injury was suspected as the cause of her pain. She received little benefit from oral anti-inflammatory medication, a diagnostic subacromial lidocaine injection and 6 physical therapy sessions. T2-weighted shoulder MRI demonstrated infraspinatus tendinosis without frank tear. She was scheduled to undergo ultrasound-guided diagnostic lidocaine injection of the infraspinatus tendon sheath. The outcome was not reported. Reporter's Comments: Reporter's comments: In this case, improper injection proximally into the deltoid muscle resulted in infraspinatus tendon injury. Iatrogenic infraspinatus tendon injury during deltoid IM injection is a rare complication. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted, except for injection site pain. Causality: Possible. Increased pain was noted upon vaccine injection, with eventual development of impairment of shoulder joint motion and pain in the following 3 weeks. This patient developed signs and symptoms consistent with previously described cases of shoulder injury related to vaccine administration (SIRVA) in literature. SIRVA is due to an inflammatory effect from vaccine administration into the subdeltoid bursa. This inflammatory response may be due either to the antigenic or nonantigenic components of the vaccine. Given the temporal relationship and the plausible mechanism, this case is assessed as possibly related.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mass, Oedema, Pain
Clinical narrative: Erythema, edema, hard painful lump. Looks like a wasp bite. Size of nickel or quarter.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Within minutes post administration of vaccines patient broke out in rash on face, abdomen and b/l thighs. No difficulty breathing or facial swelling.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unspecified age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, concomitant medications were not provided. The pharmacist stated that, on 18-JAN-2016, an expired dose of VAQTA (adult) with lot# K010195 and expiration date: 15-JAN-2016; (dose number, dose and route was unspecified), was inadvertently administered to the patient. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 59 years old female patient concerning herself. The patient had no pertinent medical history. In December 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were not reported) in the left arm. She got the first episode of shingles in March 2013, and started getting another episode of the shingles on Saturday, 16-JAN-2016. She had read an article that sometimes a booster of the ZOSTAVAX was recommended. She sought medical attention via talking to her doctor about the 2 outbreaks she had had after getting the vaccine. She had only been given acyclovir (800mg, 5 times a day) to help with the symptoms of the shingles. The outcome of these events was unknown. Causality was not reported. Additional information is not expected because the physician would not like to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist via field representative referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date, after vaccination, the patient developed cellulitis (unspecified location). The outcome of cellulitis was unknown. The causality between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with GARDASIL (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-JAN-2016 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K011083 with expiration date: 08-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-DEC-2015 the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX 0.5 ml, subcutaneous, lot # L029472, expiration date in: 06-AUG-2017 (dose was not provided). Concomitant therapies were not provided. The register nurse reported a temperature excursion with the following vaccine: (Oka/Merck) VARIVAX, (Lot #, L02942 Expiration date on 06-AUG-2017), Temperature: 7 C, Time frame: 1 month, Outcome of excursion (Oka/Merck) VARIVAX must be used with in 1 month. No adverse events were reported. No product quality complaint was involved. This is one of two cases from the same reporter (MARRS # 1601USA005965). 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 healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 16-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K011083 with expiration date: 08-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 07-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 07-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Dysuria, Headache, Myalgia
Clinical narrative: Fever of 102.5 F. Nausea, chills, headache, muscle ache, stomach ache, and difficulty urinating.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 102.5 F. Nausea, chills, headache, muscle ache, stomach ache, and difficulty urinating.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L005293, expiration date 17-AUG-2016, dose and route were unknown). The PROQUAD (Merck) was stored under -11.8 F for 47 hours and 3 minutes. There was no previous temperature excursion. It was called because of a "data logger". No adverse effect reported. This is one of two 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 a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L001327, expiration date 13-JAN-2017, dose and route were unknown). The VARIVAX (Merck) was stored under -11.8 F for 47 hours and 3 minutes. There was no previous temperature excursion. It was called because of a "data logger". No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ orally (dose, lot# and expiration date were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with oral, ROTATEQ (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 18-JAN-2016, the patient was vaccinated with expired M-M-R II lot # K000738, expiration date- 16-JAN-2016 (expired product administered). No adverse event was reported. No concomitant medication was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with RECOMBIVAX HB (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age. The patient was vaccinated with ROTATEQ (dose 1 on 18-NOV-2015, lot number # L008059, expiration date 18-DEC-2015, dose 2 on 14-JAN-2016, lot number # L013202, expiration date 27-JAN-2017 and dose 3 on 19-JAN-2016, lot number # L013202, expiration date 27-JAN-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. The patient was vaccinated with a third dose of GARDASIL (dose, strength, route of administration, lot# and expiry date were not reported) on an unknown date, 30 days too early. It was not known if the patient received GARDASIL or GARDASIL 9. 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 nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored (29.6 F for 26 hours) RECOMBIVAX HB (lot # K012874, Exp. 19-JUN-2016, dose and route of administration was not provided). No concomitant therapy was reported. There was no previous temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. Information regarding relevant medical history and concurrent condition were not reported. "About a year ago", in approximately 2015, the patient completed the vaccination series for M-M-R II (dose, lot # and route not reported). On an unknown date, the patient received an extra dose of M-M-R II (lot # and route not reported) beyond what was recommended in the prescribing information (off label use and extra dose administered). No adverse experience reported. The outcome of the events was unknown. This is one of two reports refers to the same patient (related case ID: 1601USA007215). Additional information is not expected because there was no reporter's and health care professional's contact information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 15-JAN-2016, at approximately 11:30 AM the patient was vaccinated with improperly stored ZOSTAVAX (dosing details were not reported) (lot # L028280 and expiration date 28-OCT-2016) at temperature 47F, possibly as much as 13 hours time frame. There was no previous temperature excursion. No adverse experience was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has bee received from a physician referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose, lot # and route were not reported) 2 months after the first dose and then was vaccinated with the third dose of GARDASIL 2 months after the second dose (inappropriate schedule of vaccine administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored (29.6 F for 26 hours) GARDASIL (lot # K007264, Exp. 21-MAR-2017, dose and route of administration was not provided). No concomitant therapy was reported. There was no previous temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-DEC-2015, the patient was vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date: 04-MAR_2017; dose and route were not provided) and VAQTA (lot # L009445, expiration date: 01-JUN-2017; dose and route were not provided). The vaccines were exposed to -0.1 Celsius degrees for 1 hours. There was no previous temperature excursion. No adverse effects were reported. 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 healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 17-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K011083 with expiration date: 08-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored (29.6 F for 26 hours), Oral, ROTATEQ (lot # L008996, Exp. 01-DEC-2016, dose and route of administration was not provided). No concomitant therapy was reported. There was no previous temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Full blood count, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist refers to a female patient who is currently 27 year old. The concurrent condition and medical history was not reported. On 06-NOV-2015, the patient was vaccinated with GARDASIL 9 (lot # L017407, exp. 15-AUG-2017, 0.5 ml, intramuscular). Concomitant therapies included ranitidine, docusate sodium, acetaminophen, Prenatal Vitamin and Vitamin B6. The patient became pregnant on an unknown date after vaccination. The patient sought medical attention. The gestational age was 14 weeks and 2 days. No treatment was given for the events. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Herpes zoster, Pain in extremity, Rash vesicular
Clinical narrative: Information has been received from a 76 year old female patient referring to herself. In September 2015 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prevention (dose, dose #, lot # and application site were not reported), and "almost immediately developed a zoster-like rash". The patient stated she went to her primary physician who confirmed she had developed shingles. The patient also stated that she not only still had the zoster-like rash on her arms and wrists, but she also had pain in her "little finger and ring finger" (unspecified left or right hand). The patient stated she did not have strength enough in her hand to grip things, and had also had to see a neurosurgeon as a result (onset date unknown). The patient was given unspecified pain medications to treat the events. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. Information regarding relevant medical history and concurrent condition were not reported. "About a year ago", in approximately 2015, the patient completed the vaccination series for VARIVAX (Merck) (dose, lot# and route not reported). On an unknown date, the patient received an extra dose of VARIVAX (Merck) (lot # and route not reported) beyond what was recommended in the prescribing information (off label use and extra dose administered). No adverse experience reported. The outcome of the events was unknown. This is one of two reports refers to the same patient (related case ID: 1601USA007074). Additional information is not expected because there was no reporter's and health care professional's contact information provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a three unspecified patients of unknown ages and genders. The patient's concurrent conditions and medical history were not provided. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL lot # K016966, expiration date 10-MAY-2017 (route and dose were not provided). Concomitant therapies were not provided. It was unknown if the patient's sought medical attention. No adverse events were reported. No product quality issue as involved. 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 healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date in July 2015 the patient was vaccinated with one dose of the GARDASIL series (dose 1, strength and route of administration not reported). Concomitant medications were not reported. On 15-JAN-2016 the patient received a dose of GARDASIL 9 (dose 1, strength and route of administration not reported) (reported as second dose in the series). (Incorrect schedule of drug administered) (wrong drug administered). The patient was present at the office at the time of report. No adverse effects were reported. Causality assessment was not provided. 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 healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degree Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 02-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature of excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. 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 licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored of RECOMBIVAX HB (dose, lot #, expiration date and route of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Respiratory tract congestion, Sneezing
Clinical narrative: Rectal temp 102.2 after imms. congestion, sneezing.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pt received vaccine in left deltoid. Reported the next day that her arm was very tender, warm and swollen with difficulty moving arm x 2 days.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt received vaccine in LD. 4 hours later developed severe pain, swelling, redness and soreness moving left arm for several days.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: Developed nausea with vomiting X 1 and a bout of diarrhea.  Mild soreness at injection.  Today feels nauseated.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis
Clinical narrative: Patient had chest pain that required him to be admitted to the hospital with a diagnosis of pericarditis-myocaraditis. He was started on indomethacin 1/18 with recurrent pain overnight - med was increased and pain was relieved with Toradol and colchine was added. Currently still inpatient.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis, Pericarditis
Clinical narrative: Patient had chest pain that required him to be admitted to the hospital with a diagnosis of pericarditis-myocaraditis. He was started on indomethacin 1/18 with recurrent pain overnight - med was increased and pain was relieved with Toradol and colchine was added. Currently still inpatient.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: Pt received PNEUMOVAX 0.5cc S.C into (L) deltoid. Several hours later her arm became very tender, red, swollen with pain on movement that lasted 3 days.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician concerning a male patient of unknown age. His medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of an unidentified Merck HPV vaccine (name and lot number not provided) in the arm (dose and frequency were unspecified). Concomitant medications were not provided. On an unknown date, the patient's arm became "extremely swollen" for an unspecified amount of time following the administration of the vaccine. The physician felt this was an allergic reaction to the unidentified Merck HPV vaccine (name and lot number not provided). The patient sought for medical attention. No hospitalization was required. At the time of this report, the outcome of hypersensitivity was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unspecified dates (reported as after temperature excursion on 21-SEP-2015), the patients were vaccinated orally with improperly stored doses of oral ROTATEQ lot # K019370, expiry date 16-JUL-2017; lot # K013410, expiry date 27-FEB-2016; lot # L013197, expiry date 26-JAN-2017 (dose was not reported). Administered dose of vaccine experienced the temperature excursion of 48.7 Fahrenheit degrees for 55 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Lot # L013197 has been verified to be a valid lot number of oral ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, dose, lot number and expiration date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient developed shingles. Product quality complaint (PQC) was not involved. The outcome of shingles was not reported. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unspecified dates (reported as after temperature excursion on 21-SEP-2015), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L006545, expiry date 16-NOV-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced the temperature excursion of 48.7 Fahrenheit degrees for 55 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (dose and route of administration were not reported, lot # K009470, expiration date 03-JAN-2016). This dose had no history of being stored improperly. No adverse effects were reported. No product quality complaint was involved. 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 healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 03-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. 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 nurse and a nurse manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On the following dates: 29-OCT-2015, 03-DEC-2015, 11-DEC-2015 and 22-DEC-2015, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# L004754, expiry date 10-NOV-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The nurse manager stated that the doses of RECOMBIVAX HB were exposed to the temperature of 34.7 degrees Fahrenheit for a total cumulative time of 31 minutes. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information is not expected as the reporters declined any further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received 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 as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 01-DEC-2015 the patients was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 15 cm x 15 cm raised, swollen, and red area on R deltoid.  Also reddened posterior deltoid red area and under arm and anterior bicep reddened area.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Pyrexia, White blood cell count increased
Clinical narrative: Patient received pneumococcal vaccine on 10/8/15 during hospital stay for surgery. She was discharged on 10/8/15 and she presented to the ER on 10/10 with complaints of pain at injection site and reported fever of 102.5F. At the ER, her temperature was 102.7F and she was diagnosed with cellulitis in upper arm at injection site. She was treated with IV antibiotics and discharged on 10/12/15.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Muscle ache in right leg; right leg jumpy/spasm approximately every 45-60 seconds.  Woke me up from a sound sleep.  Symptoms lasted about 3 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pallor, Pruritus, Swelling face
Clinical narrative: 1200 - patient began having facial itching, swelling of cheeks, and skin tone became pale. 1340 - patient in pediatrician office, began having small amount of redness of skin around face and mild swelling.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: C/O redness and increased warmth at left arm injection site. Instructed to place cool compress on injection site. Instructed to use OTC BENADRYL every 6 hours PRN.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Total body skin reaction of hives and fever (101.5-102) 3-4 days after vaccine. No respiratory distress.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Cold sweat, Gait disturbance, Hyperventilation
Clinical narrative: Shot in left arm - pain in left knee joint could barely lift leg - pain in neck and jaw left side - became weak - clammy and had heavy breathing. Called dr in morning told to go to emergency room. Diagnosed immunization reaction.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain in jaw
Clinical narrative: Shot in left arm - pain in left knee joint could barely lift leg - pain in neck and jaw left side - became weak - clammy and had heavy breathing. Called dr in morning told to go to emergency room. Diagnosed immunization reaction.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Gastrooesophageal reflux disease, Musculoskeletal pain, Nasopharyngitis, Pain in extremity
Clinical narrative: Pt received vaccine on 10-9-15. One week passed and pt experienced severe arm and shoulder pain. Also complained of extreme Gerd. Sx's subsided 1 month. On 1-1-16 Pain returned after catching a cold.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over body beginning about 8 hours after vaccine treated with BENADRYL-would clear up then come back after BENADRYL wore off. Cleared up completely 1/2/16.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain, Pain in extremity
Clinical narrative: For two days, after vaccine administered, very painful. But it never improved. Arm continued to be sore, difficult time to raise and lower left arm. Difficulty changing shirts, reaching, setting hair, lying on left side or doing anything w.my left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed a rash at the injection site (5 x 3 cm area of erythema).
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: My right arm was so very painful that I couldn't even move it for 4 wks. Couldn't lift it to comb my hair, couldn't sleep for over a week because of the pain. Had a fever for almost a week from it. Took 650 mg of aspirin every 4 hrs. and it didn't take pain away! From Oct 25th 2015 to after Nov. 25th before I could lift my arm. Still had pain in the arm where shot was given over 2 months later.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Client noted soreness to (L) arm the day after injection lasting the entire next week, from elbow to shoulder - soreness with ROM to upper arm. On 1/11/16 noted soreness to (L) wrist. Condition is improving - no tenderness or redness reported to injection site at any time.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Bacterial test positive, Blood test, Body temperature increased, Chest X-ray, Chills
Clinical narrative: 3 immunizations on 11-12-15. Resulted in high fever and an emergency room visit on 11-14-15. Blood test results showed white cells in blood. PA and hospital report indicates it could be from the injections. Three (3) different vaccines administered, Thursday, November 12, 2015 about Noon-12:15 pm, by pharmacist. I reported this reaction by phone to my doctor (Monday, Nov. 16?), and also a pharmacist (19th) where the injections were given. All 3 injections were given in my left arm/shoulder because I have a torn rotator cuff on my right shoulder. The shingles vaccine was injected under the skin under my upper left arm and the other 2 injections were given in the top of my shoulder. As I expected, my left shoulder was tender to the touch, and very uncomfortable when leaning on it, similar to past immunizations. I report this because I had to go to the emergency room where white cells/bacteria were found in my blood. I was told there by the PA that it was probably introduced with the vaccine injections. On 11-12-15 I had a 10:00 a.m. appointment with Dr. at the local clinic, not for an illness, but for a routine, 6-month appointment, including a routine blood test. Everything was fine. I talked with Dr. about having the 3 immunizations that another clinic had recommended when I was there Sept. 22. Both Dr. and a pharmacist said it shouldn't be a problem to have all three vaccines at one time. She contacted the local pharmacy. I had no problems until about 10:50 p.m. that night. I felt intermittent chills, and after I was in bed, my body started sharking uncontrollably for what seemed like a long time, until I went to sleep. The next morning, Friday the 13th, my temperature was about 100 degrees, and it kept rising all day. I had a terrible headache, couldn't think clearly and was unable to get out of bed except to go to the bathroom. I did not eat all day, and when I drank a glass of skim milk, it curdled and came up. After I woke up Saturday, all morning my temperature varied from 102 degrees to over 103 degrees (103.7 degrees at one point). In mid-morning when my daughter phoned, she told me that I wasn't making any sense. When I didn't recognize my husband, he took me over to our local hospital to the emergency room. They did a variety of tests (blood test, urine, chest x-ray), and the PA said there were white cells in my blood, saying it was bacteria most likely.