chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified medical assistant refers to a 31 year old female patient. On 19-OCT-2016 the patient was vaccinated with VARIVAX lot #: M028552, expiry: 07-JUN-2018. The patient also had a PPD placement (unspecified lot/expiration date, unspecified manufacturer). On 21-OCT-2016, the patient returned to the reporter's office to have her PPD read and stated that she was pregnant with unknown date of LMP and EDD. The patient was 8 weeks pregnant. No adverse effects were reported. The outcome of pregnancy was pending. No further details provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified medical assistant refers to a 31 year old female patient. On 19-OCT-2016 the patient was vaccinated with VARIVAX lot #: M028552, expiry: 07-JUN-2018. The patient also had a PPD placement (unspecified lot/expiration date, unspecified manufacturer). On 21-OCT-2016, the patient returned to the reporter's office to have her PPD read and stated that she was pregnant with unknown date of LMP and EDD. The patient was 8 weeks pregnant. No adverse effects were reported. The outcome of pregnancy was pending. No further details provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified medical assistant and refers to a 31 year old female patient. On 19-OCT-2016 the patient was vaccinated with M-M-R II lot # L040960, expiry date: 16-OCT-2017. The patient also concomitantly had a PPD placement (unspecified lot/expiration date, unspecified manufacturer). On 21-OCT-2016, the patient returned to the reporter's office to have her PPD read and stated that she was pregnant with unknown date of LMP and EDD. The patient was 8 weeks pregnant. No adverse effects were reported. The outcome of pregnancy was pending. No further details provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, VARCEL, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified medical assistant and refers to a 31 year old female patient. On 19-OCT-2016 the patient was vaccinated with M-M-R II lot # L040960, expiry date: 16-OCT-2017. The patient also concomitantly had a PPD placement (unspecified lot/expiration date, unspecified manufacturer). On 21-OCT-2016, the patient returned to the reporter's office to have her PPD read and stated that she was pregnant with unknown date of LMP and EDD. The patient was 8 weeks pregnant. No adverse effects were reported. The outcome of pregnancy was pending. No further details provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: High fever 102.0.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Dysphonia, Eye irritation, Eye swelling
Clinical narrative: First hoarseness with a cough. Then achy followed by a 102 temperature. Then very stuffy nose with red burning swollen eyes. I took Advil and now the next day all systems are gone except really swollen eyes.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Ocular hyperaemia
Clinical narrative: First hoarseness with a cough. Then achy followed by a 102 temperature. Then very stuffy nose with red burning swollen eyes. I took Advil and now the next day all systems are gone except really swollen eyes.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Mucosal haemorrhage, Nasal congestion, Petechiae, Platelet count decreased
Clinical narrative: Fever the evening of receiving the vaccine and some nasal congestion. Rapidly spreading petechial rash on 10/28/16 with associated bruising and mucosal bleeding.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever the evening of receiving the vaccine and some nasal congestion. Rapidly spreading petechial rash on 10/28/16 with associated bruising and mucosal bleeding.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: Severe pain in shoulder, unable to move arm. Continued through day and into night, when I noticed a swelling at injection sight. On 10/29/2016 at 6:00 am I woke with mild fever, continued swelling and heat at injection site, took ibuprofen and went on a hike. The fever spiked mid day and I went home and slept. 10/30/2016 fever down and pain subsided. Arm swelling and tenderness also decreased.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Severe pain in shoulder, unable to move arm. Continued through day and into night, when I noticed a swelling at injection sight. On 10/29/2016 at 6:00 am I woke with mild fever, continued swelling and heat at injection site, took ibuprofen and went on a hike. The fever spiked mid day and I went home and slept. 10/30/2016 fever down and pain subsided. Arm swelling and tenderness also decreased.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Muscle soreness and weakness at immunization site, still unresolved.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Urticaria on trunk, upper arms, lower extremities, groin area lasting approximately 10 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Burning and itchy almost immediately; 3 inches in diameter red, raised area, warm at injection site and took aleve; on 10/29/16 2 other red, raised areas on arm with soreness in armpit.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Biopsy bone marrow, Contusion, Full blood count, Immune thrombocytopenic purpura, Menorrhagia
Clinical narrative: Heavy bruising, heavy menstrual bleeding, purpura on scalp, chest and stomach. Approximately 2 weeks later from first signs of onset, I developed 30 plus large bruises over entire body, specifically legs. I went to the doctor and they did a CBC test and discovered my platelets were under 8000. I went to the ER and they immediately admitted me. My platelets were down to 5000 when I arrived at ER. I received a platelet transfusion and was able to be released 1 day later because platelets raised to approx. 20000. Was diagonsed with ITP, Immune thrombocytopenic purpura From 2013-Current;  I have undergone many treatments to remedy this reaction, including bone marrow biopsy, weekly intravenous treatments, steroid treatments, and medications. I currently have to take medication, Promacta 25mg daily to stabilize platelet counts. I will most likely have to be on this medication for the rest of my life. It is extremely costly and could have long term side effects that are unknown at this time.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet count decreased, Platelet transfusion, Purpura
Clinical narrative: Heavy bruising, heavy menstrual bleeding, purpura on scalp, chest and stomach. Approximately 2 weeks later from first signs of onset, I developed 30 plus large bruises over entire body, specifically legs. I went to the doctor and they did a CBC test and discovered my platelets were under 8000. I went to the ER and they immediately admitted me. My platelets were down to 5000 when I arrived at ER. I received a platelet transfusion and was able to be released 1 day later because platelets raised to approx. 20000. Was diagonsed with ITP, Immune thrombocytopenic purpura From 2013-Current;  I have undergone many treatments to remedy this reaction, including bone marrow biopsy, weekly intravenous treatments, steroid treatments, and medications. I currently have to take medication, Promacta 25mg daily to stabilize platelet counts. I will most likely have to be on this medication for the rest of my life. It is extremely costly and could have long term side effects that are unknown at this time.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site. Improved by 10/26/2016.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Sore shoulder, cannot raise arm, has not been able to sleep 3 days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to right arm encompassing 1/3 of entire upper arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Joint swelling, Lymphadenopathy
Clinical narrative: Patient complained of swollen and painful joints, swollen neck glands, arm pain and red bump at site of injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient complained of swollen and painful joints, swollen neck glands, arm pain and red bump at site of injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported hives on arms, torso, and back as well as itching. Did NOT experience shortness of breath, difficulty breathing or other allergic reaction symptoms.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Vomiting
Clinical narrative: Child complained of a stomach ache. Diarrhea and vomiting several times throughout the night. Headache followed by the morning.
Age: 71.0
Sex: F
Vaccine: PNC
Symptoms: Monoplegia, Myalgia
Clinical narrative: Extreme muscle pain and partially paralyzed arm.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arteriogram coronary normal, Cardiac stress test abnormal, Catheterisation cardiac normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Chest tightness and shortness of breath that began within a few hours of receiving the flu shot.  In the ER found to be hypotensive, admitted due to his heart history but work up negative for cardiac etiology of symptoms.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hypotension, Ischaemia
Clinical narrative: Chest tightness and shortness of breath that began within a few hours of receiving the flu shot.  In the ER found to be hypotensive, admitted due to his heart history but work up negative for cardiac etiology of symptoms.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain at site of injection, which led to tenderness and swelling later and a feeling of warmth. Next day, extensive brusing/redness all the way down to the elbow.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Immediate pain at site of injection, which led to tenderness and swelling later and a feeling of warmth. Next day, extensive brusing/redness all the way down to the elbow.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash
Clinical narrative: The patient's mom came in on Sat Oct 29th and showed me a picture of her daughter's arm and side where the flu shot had been given. She had a large rash covering her arm and shoulder and the side of her chest. I told her to inform her daughter's doctor of the reaction and that we would record it in her profile also. The mom came back later that day and said she took her daughter to urgent care and it was confirmed she had an allergic reaction to the vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient experianced a rash at the injection site.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Around injection site, 1 cm erythematous patch with additional 4-5 mm erythemic papules in the same vicinity.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Syncope
Clinical narrative: Pt received flu vaccination on 10/28/16 at approx. 1700.  Next day he had a syncopal episode and was advised to hydrate with water and  Gatorade, and after reported feeling okay.  Later on at home, he noted he had a fever of 105, and did not seek medical advice or treatment, but did not report his fever until Sunday pm when further asked about the events of the previous day.  Pt required to go to ER for further eval.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity
Clinical narrative: Soreness turned into pain in the arm that the vaccine was administered into.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness and swollen at site of injection but once patient took some ibuprofen and benadryl swelling decreased. no other reaction except red and swollen also hard to touch.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypoaesthesia, Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: Sweating, muscle weakness/achiness, fever over 100F, numb chin. No complaint about site of injection. Pt reported taking Ibuprofen OTC and cold compresses to relieve symptoms. Pt reported feeling better today than Friday, but she is still feeling "flu-like symptoms," per pt.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Sweating, muscle weakness/achiness, fever over 100F, numb chin. No complaint about site of injection. Pt reported taking Ibuprofen OTC and cold compresses to relieve symptoms. Pt reported feeling better today than Friday, but she is still feeling "flu-like symptoms," per pt.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient said she went to the doctor and was diagnosed with cellulitis in the area the injection was given.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Patient came into the pharmacy with a rash on arm that spread. Area was slightly raised with a red coloration. Patient reported itching for which an antihistamine was recommended.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever, vomiting, rash.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Foetal death
Clinical narrative: Fetal demise around 10/10/2016, miscairrage 10/28/2016.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Redness, Itching, and small 3mm lump, local to injection site. Pt denies weakness, denies dizziness, denies fever, denies dyspnea, denies increase or decrease in heart rate since the time of vaccination on Friday morning 28 Oct 2016 11:54 AM.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Seizure
Clinical narrative: 1 pm: Flu shot administered. Pt states received other vaccines never flu shot. W/I 1 hr: Pt experienced diarrhea. Approximately 5 hrs: HA, pt went to day down. Call wife into room, starting convulsing seems like approximately 1 1/2 hrs. Called medical center - no directions given, subsided and no repeat. No residual problems, slight lingering HA.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruise at injection site day 1 and 2 after vaccination on 10/20/16. 10 days after still has yellow purplish bruise. No treatment, patient will keep us informed if condition worsens.
Age: 74.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site: red, warm, swollen, painful. Never had past problems w/any vaccine or injection. Ruled out causes by bug bite.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Rash, Vaccination complication
Clinical narrative: Information has been received from the authors in a published literature article and refers to a 4 patients of an unspecified age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date in 2014, the patients were vaccinated with MMR (manufacturer unknown) (strength, dosage, frequently, lot# and expiration date were not provided). Concomitant therapies were not reported. The authors explained that during an outbreak of measles, on an unspecified date in 2014, 7 to 21 days after vaccination, the 4 patients experienced rash and their genotype was A, which was the same vaccine strain. Therefore, it was categorized as a vaccine associated reaction. The outcome of the event was unknown. The reporter considered measles to be related to MMR (manufacturer unknown). Upon internal review rash was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 8" circle of redness around inj. site. Warm and itchy. Went to local nurse: told to watch area.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-OCT-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. 01-OCT-2014 the patient was vaccinated with GARDASIL 10 X 1 sdv (lot # J013324, expiration date 12-FEB-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours. The lowest recorded temperature and Celsius conversion of the lowest recorded temperature was 1 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-MAR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (also reported as 10 mg/1 ml) (lot # J001389, expiration date 07-NOV-2014; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 384, 33 and R; 248, 34 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 24 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 72hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 17-FEB-2014, the patient was vaccinated with an improperly stored dose of VAQTA lot # J006521, expiration date 23-AUG-2015 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for two tines. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) were as following: 34 F for 152 hours and 33 F for 336 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-MAR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/ 1 ml (also reported as 10 mg/1 ml) (lot # J001389, expiration date 07-NOV-2014, dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 248, 34 and R; 336, 33 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 05-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was exposed in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours. The lowest recorded temperature was reported as 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # L033343, expiration date 13-SEP-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history concurrent conditions and concomitant medications was not provided. On 12-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 300 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 15-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 372 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-MAY-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 1728 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-FEB-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 mL (lot # H017304, expiration date 05-DEC-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 72 hours. The lowest recorded temperature was 32 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016. No adverse effects were reported. This specified lot number was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 34, and R. The total cumulative excursion time (hour), the  highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48, and R; 48, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patent of unknown age and gender. On 31-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F ) was 120, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 8.4 and R; 24, 8.5 and R; 24, 9 and R; 24, 8.3 and R; 24, 8.1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-APR-2016, the patient was vaccinated with VATQA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 240 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-APR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 840, 34, and R; 168, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA, pediatric (PED), lot # L004743, expiration date 01-JUN-2017 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions twice. The storage criteria was refrigerator (R). The total cumulative excursion times (hour), the lowest recorded temperatures (Fahrenheit degree) and the type of excursions (R/F) were as following: the first time excursion 936, 34 and R; the second time excursion 168, 32 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 1 and R; 72, unknown and R; 16, 0 and R; 24, -1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAY-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 384 hours and at -0.5 Celsius Degrees for 72 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration were unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for a total of 40 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported and nor product quality complaint was involved. This is one of several cases 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 physician and a practice manager referring to a patient of unknown age and gender. On 16-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration date 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. 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 physician via company representatives and from a support services director concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 15-DEC-2014, the patient was vaccinated with an improperly stored of GARDASIL "PFS 6x1.5mg/0.5ml w/o Sfty Syr" lot # J009098, expiration date 04-DEC-2015 (route and dose were not provided). This vaccine had three temperature excursions, one of 12 hours, another for 24 hours and another one for 8112 hours. The highest temperatures recorded were 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), 47.5 degrees Fahrenheit (8.611111111 degrees Celsius) and 59.9 degrees Fahrenheit (15.5 Degrees Celsius) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L007558, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 40, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168,32 and R; 816, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 720 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 10-JUN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 120 hours with 53 C as the highest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion twice. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were as following: for the first excursion was 24, 33 and R; for the second excursion was 224, 31 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patent was inadvertently vaccinated with an expired dose of RECOMBIVAX HB, intramuscularly, lot # H018691 with expiry date: 27-FEB-2015. No adverse effect reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 26-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls  10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1380 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 18-DEC-20145, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures was of 32 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168, 32 and R; 840, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.