chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of ROTATEQ (lot number, expiry date and dose were not reported), route default to oral that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unspecified dates, since 18-DEC-2014, the doses of ROTATEQ that underwent a temperature excursion, were administered to unspecified patients (default route; oral, dose, lot numbers and expiration dates were not provided) No adverse effects have been reported. This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Muscular weakness
Clinical narrative: Patient received flu shot on 12/8/14, he came to pharmacy on 1/17 and said his arm is weak since he got the shot. he has difficulty picking up stuff.
Age: 1.07
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Staring, Tremor
Clinical narrative: Febrile seizure-45 secs of blank stare and bilateral upper extremity shaking-no treatment.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient had vasovagal episode in which patient lost consciousness. Vitals remained stable, patient given ice pack, laid down, given PO fluids.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Pain, edema, redness, pruritis, welts and warmth to (L) upper arm injection site area.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Pain, edema, redness, pruritis, welts and warmth to (L) upper arm injection site area.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Per mom patient received the flu vaccine Friday 1-16-15. Saturday morning he woke up with hives on his face and they quickly spread to his body. Mom called Dr on-call and gave him BENADRYL.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site redness in a female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). On 28th October 2014, the patient received FLUARIX 1 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site redness, injection site itching and injection site scab. On an unknown date, the outcome of the injection site redness was recovered/resolved and the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site scab was unknown. It was unknown if the reporter considered the injection site redness, injection site itching and injection site scab to be related to FLUARIX. Additional information received: Patient experienced a huge red spot, which resolved, then itching and now there is scabbing.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to 8 week old male patient with duarte variant galactosemia. On 26-JAN-2015 the patient was vaccinated the first dose of ROTATEQ oral. (Lot# K015831, expiration date 18-APR-2016). On the same day the patient experienced vomiting reported as vomited up "everything was in his stomach" while still in the nurse practitioner's office. No treatment was given for the event. No lab diagnostic studies were performed. The outcome of vomiting was recovered on the same date. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV1
Symptoms: Full blood count normal, Petechiae
Clinical narrative: Petechiae bilateral legs.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, (strength, lot number, expiry date and dose were not reported) orally, which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Initial case was received from a Non health care professional on 27 January 2014. A 61-year-old female patient whose concomitant medication was not reported had received a rabies vaccine (manufacturer, dose, route and anatomical site of administratoin not reported). The patient was allergic to many chemicals and drugs. She also had a reaction to a rabies vaccine and immunoglobulin with fever, chills, hematuria a few years ago with unknown product. The outcome of the event was not recovered. The list of documents held by sender none. Additional information was received on 19 March 2014: On an unknown date, the patient was recovered after approximately two weeks and occurred more than 10 years ago. There was no information regarding the lot number, dates and dose number.
Age: 61.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Skin warm, Swelling
Clinical narrative: Initial case was received from a Non health care professional on 27 January 2014. A 61-year-old female patient whose concomitant medication was not reported had received a rabies vaccine (manufacturer, dose, route and anatomical site of administratoin not reported). The patient was allergic to many chemicals and drugs. She also had a reaction to a rabies vaccine and immunoglobulin with fever, chills, hematuria a few years ago with unknown product. The outcome of the event was not recovered. The list of documents held by sender none. Additional information was received on 19 March 2014: On an unknown date, the patient was recovered after approximately two weeks and occurred more than 10 years ago. There was no information regarding the lot number, dates and dose number.
Age: 61.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Feeling cold, Haematuria, Pyrexia
Clinical narrative: Initial case was received from a Non health care professional on 27 January 2014. A 61-year-old female patient whose concomitant medication was not reported had received a rabies vaccine (manufacturer, dose, route and anatomical site of administratoin not reported). The patient was allergic to many chemicals and drugs. She also had a reaction to a rabies vaccine and immunoglobulin with fever, chills, hematuria a few years ago with unknown product. The outcome of the event was not recovered. The list of documents held by sender none. Additional information was received on 19 March 2014: On an unknown date, the patient was recovered after approximately two weeks and occurred more than 10 years ago. There was no information regarding the lot number, dates and dose number.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2013US136193 is an initial literature report received on 23 Nov 2013. A retrospective cohort study was done using large surveillance datasets to evaluate the effect of receiving the influenza vaccine during pregnancy on fetal health outcomes, small for gestational age (SGA) and prematurity among births between 01 Jan 2005 to 31 Dec 2008. This report refers to multiple pregnant patients of unknown age. A total of 8393 women with a live birth over a 4-year period were included in this study. On an unknown date, 916 pregnant patients were vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) during pregnancy. It was reported that women with a higher risk for influenza related morbidity demonstrated higher vaccine benefits against a small for gestational age (SGA) births. The authors concluded that the impact of vaccines on birth outcomes may vary with the underlying influenza epidemiology and maternal demographic characteristics.
Age: 9.0
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US022785 is an initial spontaneous report received from a consumer on 15 Nov 2012, and with a follow up received on 07 Dec 2012: This report refers to a 9-year-old child of unknown gender. This child was vaccinated with a seasonal Influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. After vaccination this child experienced sores, redness and swelling at the injection site. No further information about outcome, causality and seriousness was reported. Follow up received on 07 Dec 2012. No new information was provided.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US117506 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 498788) on 15 Oct 2013: This report refers to a 53-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced a large painful bump at the injection site. She stated that no treatment was given for the event. The patient did not seek medical attention. Outcome of the events was reported as not recovered as of 10 Apr 2013. Seriousness and causality was not reported for the events.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain
Clinical narrative: Case number PHHY2013US117554 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 494580) website on 15 Oct 2013. This case refers to a 34-year-old female patient. Her medical history included attention deficit hyperactivity disorder (ADHD) and allergy to sulfa drugs. Her concomitant medications included LOESTRIN FE and ADDERALL. She was vaccinated with Influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unknown date. On an unknown date after vaccination the patient developed chills and aches. The outcome, seriousness and causality assessment of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2013US132342 is an initial literature report received on 18 Nov 2013. This report refers to multiple female pregnant patients. The patients were vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported) on an unknown date during pregnancy. The top three reasons women reproted for vaccination were to protect their infant from Influenza (33.2%), to protect themselves from Influenza (20.0%) and because their healthcare provider recommended vaccination (15.7%). The top three reasons reported for non vaccination were concern about safety risk to the infant (20.5%), that the vaccination would give pregnant women Influenza (13.6%), and that vaccination was not effective in preventing Influenza (10.6%). The author concluded that education messages for pregnant women needed to emphasize that vaccination during pregnancy can protect not only pregnant women themselves but also their infants during the first 6 months of life.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHHY2013US117629 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 496989) website on 15 Oct 2013. This case refers to 32-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) intramuscularly on an unknown date. It was reported that the patient had allergy to influenza vaccine. The outcome, seriousness and causality assessment of the event was not reported.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHHY2013US117733 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 487512) on 15 Oct 2013: This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced allergic reaction to Influenza vaccine. Seriousness, outcome and causality of the event were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2013US116690 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 496557) website on 15 Oct 2013. This report refers to a male patient of unknown age. His medical history included anaphylaxis (anaphylactic reaction anything related to amoxicillin in when he lost consciousness and had atrial fibrillation in 2002, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into arm (unspecified date). On an unspecified date, after vaccination with influenza vaccine (unknown arm), he experienced injection site soreness. The injection site soreness resolved two days after receiving the vaccination. He reported that he did consult his health care provider regarding the event. He again received flu shot in 2003, 2004 and another in unspecified year where he also experienced events with these vaccinations (see cases PHHY2013US122590, PHHY2013US122591 and PHHY2013US122592. No seriousness and causality was reported by the reporter.
Age: 1.05
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Pallor, Rash erythematous, Rash generalised
Clinical narrative: Pt presented to office with rash-blanching, red, raised, sharply demarcated, polygonal 1-4 mm rash; Face, scalp, soft palate, soles, feet and conjunctiva. No recent travel; symptomic tx.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: 12/2/14 same day at my home I experience severe cracial pain on my right shoulder and arm. My primary doctor referred me to physical therapy. MRI shows a tear on my right shoulder. I'm unable to lift my arm. I was referred to the orthopedic he gave me a cortisone shot. Nothing is helping after 1 month and 26 days.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: X-ray limb abnormal
Clinical narrative: 12/2/14 same day at my home I experience severe cracial pain on my right shoulder and arm. My primary doctor referred me to physical therapy. MRI shows a tear on my right shoulder. I'm unable to lift my arm. I was referred to the orthopedic he gave me a cortisone shot. Nothing is helping after 1 month and 26 days.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from health care professional on 03 June 2013. A dose of TENIVAC vaccine was administered to a patient instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Blepharospasm, Feeling jittery, Hypoaesthesia, Muscle spasms, Palpitations
Clinical narrative: Initial report received from consumer (patient) on 22 June 2013. A female patient whose concomitant medications were not reported, had received a second dose of IMOVAX (batch number: H1091 route and anatomical site of administration were not reported) on 21 June 2013. On 18 June 2013, the patient had received RIG and rabies vaccine of unknown manufacturer. The patient was allergic to TORADOL which causes itching, breathing difficulty. The patient had no other medical concerns and the patient had no illness at the time of vaccination. On an unspecified date, after receiving IMOVAX, the patient had experienced heart racing, face numbness, eye twitching, and cramps in legs. jittery feeling and vomiting. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none,
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Initial report received from consumer (patient) on 22 June 2013. A female patient whose concomitant medications were not reported, had received a second dose of IMOVAX (batch number: H1091 route and anatomical site of administration were not reported) on 21 June 2013. On 18 June 2013, the patient had received RIG and rabies vaccine of unknown manufacturer. The patient was allergic to TORADOL which causes itching, breathing difficulty. The patient had no other medical concerns and the patient had no illness at the time of vaccination. On an unspecified date, after receiving IMOVAX, the patient had experienced heart racing, face numbness, eye twitching, and cramps in legs. jittery feeling and vomiting. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none,
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 June 2013. A dose of TENIVAC that had expired in April (year not specified) was given to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Initial repot received from a Healthcare professional on 19 August 2013. A 54-year-old female patient has received second intramuscular dose of Rabies vaccine (Manufacturer: unknown Lot number: not reported) in the deltoid on 17 August 2013. The patient had no known allergies or illness at the time of vaccination. The patient's concomitant medications were not reported. The patient had exposure to bat on an unspecified date and had received first dose of post exposure rabies vaccine (may be RABAVERT, but reporter was not sure of the product and did not have lot numbers) series on 14 August 2013, intramuscularly in the deltoid. The patient did not receive rabies immunoglobulin. On 19 August 2013, 2 days after vaccination, the patient had experienced 2 slightly red, raised pruritic, rash areas on each buttock. Laboratory details and corrective medication was not reported. The outcome of the adverse event was unknown. Documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 June 2013. It was reported that post exposure dose 3 and dose 4 of IMOVAX rabies were given early. Dose 3 will not be considered as valid. Dose 4 would count as dose 3 and patient will receive dose 4 and dose 5 as per schedule. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Therapeutic response decreased, Viral titre
Clinical narrative: Initial report was received from a consumer on 17 June 2013. This case involved a cluster of 13 patients who received IMOVAX, lot number D1177-1, and had low titers. Thirteen unidentified patients had received injections of IMOVAX, lot number D1177-1, on 07 September 2011, 14 September 2011 and 05 October 2011. Titers were checked on 14 May 2013 and 15 May 2013 and were low indicating need for a booster prior to the 2 year booster dose indication. No other information was available. Outcome was not reported. Follow-up information was received on 05 August 2013 from a health care professional. Upon internal review it was determined this case did not meet seriousness criteria and has therefore been down grade from serious to non-serious. A 24 year-old  male patient had received dose one intramuscular left deltoid injection of IMOVAX, lot number D1177-1, on 21 September 2010, dose two intramuscular left deltoid injection of IMOVAX, lot number on an unspecified date and dose three intramuscular left deltoid injection of IMOVAX, lot number D1177-1. The patient had no illness at the time of the event and had a history of allergy to Amoxil. No further information was available at the time of the report. The patient's outcome was unknown. The reporter for this case is the same as for case 2013-08317 and 2013-08318. Documents held by sender: None.
Sex: U
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 August 2013. This case is invalid as the individual patient identifiers were no reported. A patient received first dose of IMOVAX Rabies vaccine in the gluteal region. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Widespread intermittent hives starting 1/22/15.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Acute urticaria. Pt described as the rash began the after the vaccine it was on both legs and arms. It itched and turned into hives.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Injection site erythema, Skin warm
Clinical narrative: Rcv'd PREVNAR vaccine on Friday, Jan 23rd, 2015 AM. Sunday, Jan 25, 15: Red spot, quarter size at site of injection. Wed, Jan 28, 15: Bruising further down the arm. Arm feels warm to touch. No loss of feeling, no other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: (L) Leg tender to touch won't bear weight on 1/30/15. Received vaccines 1/29/15 PM
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. Patient's pertinent medical history and drug reactions were not reported. On 30-JAN-2015 the patient was administered with an expired dose of ZOSTAVAX (lot # J011338, expiration date: 19-DEC-2014). Concomitant medications were not reported. On the same day patient experienced expired product administered. The patient who received the ZOSTAVAX did not reported any adverse effects. No product quality complaint (PQC) was involved. Reporter considered the event, expired product administered to be not related to ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Trismus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions were not specified. On 05-JAN-2015 the patient was vaccinated with PNEUMOVAX23 (dose, frequency, therapy route, lot # and expiration date unspecified). Concomitant therapies included CRESTOR, LIPITOR and SINGULAIR. Since an unknown date, patient began taking SINGULAIR for an unknown diagnosis. Beginning on unknown date, patient developed lock jaws like symptoms and lower back pain. No product quality complaint (PQC) was involved. Patient took Ibuprofen. On an unknown date, patient sought medical attention and spoke with pharmacist. Over-the counter (OTC) medications were given as treatment for the adverse events. On an unknown date, lock jaws like symptoms resolved. The outcome of lower back pain was reported as recovering. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On an unknown dale, the patient was vaccinated with a dose of M-M-R II, injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The physician reported that the patient experienced a lo rubella titer after receiving M-M-R II on an unknown date. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 28-JAN-2015 the patient was vaccinated with PNEUMOVAX23 (lot # J013344, route of administration, dose and anatomical location was unknown) which was expired on 22-JAN-2015 (Expired product administered). Concomitant medications were unspecified by reporter. No known adverse effects. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as receivd from the nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between November 2014 until 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored PEDVAXHIB (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report received from the nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between November 2014 until 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored M-M-R II (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 26-JAN-2015 the patient was administered a dose of PROQUAD (Merck), 0.5 ml, subcutaneous, that underwent a temperature excursion (dose number, lot number and expiration date were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 18 year old female patient. It was reported that the patient received two complete, three dose series injections of GARDASIL from two different HCP's. The first series of three GARDASIL injections were given on 10-SEP-2009; 09-NOV-2009; and 23-MAR-2010 (intramuscularly, dose, lot numbers and expiration dates were not provided), at the patient's pediatric office. The second series of three GARDASIL injections were given on 04-JUN-2012, 15-SEP-2014, and 18-NOV-2014 (intramuscularly, dose, lot numbers and expiration dates were not provided), at the patient's gynecologists office. The patient did not seek medical attention. No treatment was given. No AE effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2015, the patient was vaccinated with the fourth dose of GARDASIL (dose: 0.5 ml, route intramuscular, lot number and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 60 year old patient of unknown gender. No concurrent condition or medical history were reported. On 29-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344), 0.5 ml, intramuscular that expired on 22-JAN-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Between November 2014 and 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored GARDASIL (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This is one of several reports 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 Licensed Practical Nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot # were not reported) which were improperly stored. No adverse effects were reported. No product quality complaint was reported for PNEUMOVAX 23. This case is related to case # 1502USA000341 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between NOVEMBER 2014 until 03-dDEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored (OKA/MERCK) VARIVAX (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 30-JAN-2015 the patient was vaccinated with GARDASIL (intramuscular, dose and anatomical location was unknown) which had expired on 09-JAN-2015 (Expired product administered). Concomitant medications were unspecified by reporter. No adverse effect reported. The outcome of the events was unknown. 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 nurse refers to a patient of unknown age and gender. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, lot number, expiration date were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, lot number, expiration date were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a other via market research agency refers to a patient of unknown age. It was reported that patients over age 65 were recommended with PNEUMOVAX23 (dose, route and frequency unknown). The outcome of recommended for all over 65 was unkonwn. The reporter asked whether booster in five years would be necessary for children with high risk. The reporter considered recommended for all over 65 to be not related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with GARDASIL (dose, frequency, route and lot # were not reported) which was improperly stored. No adverse effects were reported. No product quality complaint was reported for GARDASIL. This case is linked to case # 1502USA000442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unspecified dates, since 18-DEC-2014, the doses of GARDASIL that underwent a temperature excursion, were administered to unspecified patients (dose, route, lot numbers and expiration dates were not provided). No adverse effects have been reported. No additional information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding medical history and concurrent condition was not provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot #, application site and route were not reported). Concomitant medication was not reported. On an unknown date the patient experienced and adverse event. It was not confirmed what the specific adverse event that the patient experienced. The outcome of event was unknown. The causality was not reported. Additional information is not expected because the reporter declined to complete the report because she did not have authorization from the physician in the office and there is no patient or physician's contact details.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse refers to a pediatric patient of unknown age. On 22-JAN-2015 the patient received an expired dose of PNEUMOVAX23, lot # J005068, expiry date: 18-JAN-2015 (dose and route not reported). The vaccine had been expired 4 days when it was given. No adverse effects reported.  Additional information as been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H022280, expiration date: 16-JUL-2014 (dosage and route unspecified). PNEUMOVAX23 had not been exposed to any temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H022280, expiration date: 16-JUL-2014 (dosage and route unspecified). PNEUMOVAX23 had not been exposed to any temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Smear cervix abnormal, Vulvovaginal warts
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a currently 24 year old, non pregnant female patient. No medical history or drug reactions/allergies were reported. On unspecified date the patient was vaccinated with first dose of 0.5 ml GARDASIL, intramuscularly. Subsequently, in May 2010 the patient received second dose of GARDASIL 0.5 ml, IM. In August 2010 the patient was vaccinated with GARDASIL dose 3, .65 ml, intramuscular. Concomitant therapies included TRI-SPRINTEC. The patient had CO2 laser on an unspecified date in September 2010 for vulva condyloma which developed on an unspecified date. On 26-JAN-2015 (reported as "today") the patient was in the office and underwent colposcopy due to having an abnormal pap smear (performed on 20-NOV-2014). The colposcopy showed that the patient was positive for an unspecified high risk HPV type. Patient sought medical attention. The outcome of the event (positive for an unspecified high risk HPV type and abnormal pap smear) was unknown. The outcome of vulva condyloma was resolved in September 2010. The relatedness between events and vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from an unspecified reporter, as part of a marketing research program conducted by agency, referring to an unknown number of patients of unspecified age and gender. In the last 3 months, the reporter had seen or heard that the PNEUMOVAX23 had been used for more pediatric indications (vaccination date, dose, route and lot# were not provided). Additional information is not expected as no reporter's contact information was provided.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6 x 7 cm indurated red patch of prox. lateral (L) upper arm and no significant tenderness and no fluctuance or warmth.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Redness pain swelling L upper arm stated the might be received vaccination (1/29/15) complains of headache, subjective fever, neck pain. All improving on 2/2/15.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Redness pain swelling L upper arm stated the might be received vaccination (1/29/15) complains of headache, subjective fever, neck pain. All improving on 2/2/15.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccinated arm had erythema from shoulder to elbow, warm to touch-started that day and then got better over next couple fo days.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Back pain, Computerised tomogram, Dyspnoea, Nausea
Clinical narrative: Next day started to get shortness of breath, lung congestion to the point she couldn't breath. A week later, 1/21 symptoms persisted and went to doctor. Went to ER on 1/26 and to a 2nd doctor's appointment on 1/27. Also has no energy, nausea, on back hurts in between lungs, Still has shortness of breath today.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pulmonary congestion
Clinical narrative: Next day started to get shortness of breath, lung congestion to the point she couldn't breath. A week later, 1/21 symptoms persisted and went to doctor. Went to ER on 1/26 and to a 2nd doctor's appointment on 1/27. Also has no energy, nausea, on back hurts in between lungs, Still has shortness of breath today.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Influenza virus test negative, Local reaction, Nausea
Clinical narrative: Local reaction with swelling/redness pain nausea/vomiting/low grade temp started 2 days later unclear if related. ZOFRAN given for symptomatic relief.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Swelling, Vomiting
Clinical narrative: Local reaction with swelling/redness pain nausea/vomiting/low grade temp started 2 days later unclear if related. ZOFRAN given for symptomatic relief.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VAQTA and a dose of M-M-R II (strength, lot number, expiry date, route and dose were not reported for both vaccines), which were improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reporter. (Linked to 1501USA008154, 1501USA012474, 1501USA012475, 1501USA012476). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to an unspecified number of patients of unknown age and gender who were administered an unspecified number of doses of PEDVAXHIB (lot#, expiration date, dose, strength and route not reported) on unspecified date since 26-OCT-2014 which had been improperly stored. No adverse effects reported. It was unspecified if the patients sought medical attention. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender who were administered an unspecified number of doses of GARDASIL (lot#, expiration date, dose, strength and route not reported) on unspecified dates since 28-OCT-2014 which had been improperly stored (considered as incorrect product storage). No adverse effects reported. It was unspecified if the patients sought medical attention. 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 medical assistant referring to an unspecified number of patients with unknown ages and genders. On unkonwn dates the patients were vaccinated with improperly stored GARDASIL (route, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant refers to an unspecified number of patients who on unknown dates were vaccinated with ZOSTAVAX (dose, lot #, route not provided) that were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant refers to an unspecified number of patients who on unknown dates were vaccinated with VARIVAX (dose, lot # and route not provided) that were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a market research agency concerning unspecified patients of unknown ages (less than 65 years old) and gender. No information regarding current condition or medical history was reported. In the last 3 months, on unspecified dates the patients received PNEUMOVAX 23 (lot#, dose, route not reported) (inappropriate schedule of vaccine administered). Concomitant medications were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has received from a physician referring to an unspecified number of patients with unknown ages and genders. On an unknown date the patients were vaccinated with improperly stored (OKA/MERCK) VARIVAX (route, lot#, dose and frequency unknown). No adverse effects reported. It was not specified if the patients sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, lot number, expiry date, route and dose were not reported), which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reproter linked to 1501USA008154, 1501USA012473, 1501USA012475, 1501USA012476). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown date, the patient was vaccinated with a dose of GARDASIL (strength, lot number, expiry date, route and dose were not reported), which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reporter. (Linked to 1501USA008154. 1501USA12473, 1501USA012475, 1501USA012474). Additional  information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a sales representative concerning a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions or allergies was not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not provided) (reported as "maintenance vaccine"). Concomitant therapies were not reported. On an unknown date the patient developed a case of shingles after receiving the ZOSTAVAX (reported as "post vaccination"). There were no other symptoms reported. It was reported that the patient sought medical attention and had an office visit. There was no product quality complaint involved. The outcome of shingles was reported as recovered on an unspecified date. The reporting physician did not provide the relatedness between ZOSTAVAX and the event. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Pt developed a rasied, red, patchy rash, similar to hives, size of a softball on thigh on 1/19/15. Pt said it was painful. Pt said rash is still there, improving but still there.