chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza virus test positive, Pneumonia, Polymerase chain reaction positive
Clinical narrative: Initial unsolicited report received from literature on 21 October 2015 and additional information received on 23 October 2015. OBJECTIVE: To assess the association between influenza vaccination status and hospitalization for community-acquired laboratory-confirmed influenza pneumonia. Results: Forty-six percent of patients enrolled in the study (2342/ 5109) were excluded for the following reasons: age younger than 6 months (n 342, 7 percent), enrollment outside of the influenza season (714, 14 percent), children with partial vaccination (300, 6 percent), vaccination within 14 days of disease onset (115, 2 percent), self reported vaccination (518, 10 percent), self-reported vaccination with unknown vaccination date (52, 1 percent), unknown vaccination status (210, 4 percent), and unknown influenza infection status (91, 2 percent). After exclusions, 2767 patients were included in this study. Conclusions: Among children and adults hospitalized with community acquired pneumonia, those with laboratory-confirmed influenza-associated pneumonia, compared with those with pneumonia not associated with influenza, had lower odds of having received influenza vaccination. 162 influenza-associated pneumonia cases, 28 (17 percent) were vaccinated compared with 766 of 2605 (29 percent) influenza negative controls. The adjusted odds ratio comparing the odds of prior vaccination among those with influenza-positive pneumonia (cases) with the odds of prior vaccination among those with influenza-negative pneumonia (controls) was 0.43 (95 percent CI, 0-28-0.68; estimated vaccine effectiveness, 56.7 percent; 95 percent CI, 31.9 percent-72.5 percent). This case involves 28 patients [age and gender unknown] who were vaccinated with a [route and dose in series were not reported] dose of Influenza Vaccine (batch number, expiry date and site of administration were not reported) on an unspecified date. On an unspecified date following the vaccination, patients diagnosed with pneumonia tested positive for influenza. On an unspecified date patients were hospitalized. Laboratory investigations included RT-PCR which was positive for influenza. Corrective treatments were not reported. Outcome of the event was not reported. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Urticaria
Clinical narrative: Headache, hives happened 3 hours after shot. She took some BENADRYL.
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Pneumonia, Rash, Swollen tongue
Clinical narrative: Initial unsolicited report received from a nurse on 21-Oct-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration was not reported) on an unspecified date (May be two weeks before the date of reporting). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. On 19-Oct-2015, about two weeks after vaccination, the patient experienced rash hives, swollen tongue, shortness of breath and back pain. The patient required ER/doctor visit. When patient went to the hospital, she was diagnosed with pneumonia. It was unknown if the patient received any previous vaccination. Laboratory investigations and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 21-Oct-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration was not reported) on an unspecified date (May be two weeks before the date of reporting). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. On 19-Oct-2015, about two weeks after vaccination, the patient experienced rash hives, swollen tongue, shortness of breath and back pain. The patient required ER/doctor visit. When patient went to the hospital, she was diagnosed with pneumonia. It was unknown if the patient received any previous vaccination. Laboratory investigations and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pyrexia
Clinical narrative: I received FLUZONE High-Dose 2015-16 syr 0.5 ml injection on Oct. 22, 2015 by pharmacist. Pharmacist assured me that I would not have a reaction because she said that the viruses are not live. However, by 6:30pm that day I was very dizzy and feverish. After sleeping that night the next day I was fine.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Gastrointestinal viral infection, Influenza B virus test positive, Nausea, Pneumonia
Clinical narrative: Initial unsolicited report received from a consumer on 23 October 2015. This case involves a 14-year-old male patient who was vaccinated with a intramuscular [dose in series were not reported] dose of FLUZONE QIV (batch number UI464AA, and expiry date 30 June 2016) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was amoxicillin allergy. The patient concomitant medications were not reported. On 15 October 2015, two days following the vaccination, the patient experienced nausea, vomiting, chills and high fever which later diagnosed as pneumonia and gastrointestinal (GI) virus diagnosed during the emergency room visit. On 16 October 2015, patient went to doctor with fever 104 Fahrenheit and with diagnosis of gastrointestinal (GI) bug. Lab data included on 19 October 2015, patient had flu test which showed B strain positive (test unknown). Corrective treatment was not reported. The outcome of event was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event nausea, vomiting, chills, high fever and pneumonia. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 23 October 2015. This case involves a 14-year-old male patient who was vaccinated with a intramuscular [dose in series were not reported] dose of FLUZONE QIV (batch number UI464AA, and expiry date 30 June 2016) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was amoxicillin allergy. The patient concomitant medications were not reported. On 15 October 2015, two days following the vaccination, the patient experienced nausea, vomiting, chills and high fever which later diagnosed as pneumonia and gastrointestinal (GI) virus diagnosed during the emergency room visit. On 16 October 2015, patient went to doctor with fever 104 Fahrenheit and with diagnosis of gastrointestinal (GI) bug. Lab data included on 19 October 2015, patient had flu test which showed B strain positive (test unknown). Corrective treatment was not reported. The outcome of event was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event nausea, vomiting, chills, high fever and pneumonia. List of documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL. No concomitant medication was reported. On an unknown date the patient experienced hives. The outcome of hives was unknown. Causality between hives and GARDASIL was unknown. Additional information is not expected because reporter does not want to get contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored GARDASIL (Lot #, dosage regimen were not reported). No adverse effects were noted. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Muscle spasms, Myalgia, Swollen tongue
Clinical narrative: Chills, muscle soreness, cramps, swollen tongue.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia oral, Rash, Swelling face
Clinical narrative: Tingling around mouth, facial swelling, and rash.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent pain in left deltoid since injection.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT STATED THAT HE BEGAN TO HAVE A LOT OF ITCHING BEHIND HIS KNEES AND ON HIS UPPER ARMS. HE BROKE OUT IN WELTS ON THE BACKS OF HIS ARMS BILATERALLY. THIS OCCURRED ONE WEEK AFTER RECEIVING THE FLU VACCINE. HE SAID THAT THE ITCHING A WELTS WERE BEGINNING TO SUBSIDE.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Back pain, Dyspnoea, Erythema, Throat tightness
Clinical narrative: PATIENT TOLD MOM STOMACH HURT AND STARTED CLUTCHING AT THROAT, SOB, RED IN FACE, STATED BACK HURTS. 5:00PM EPI JR ADMINISTERED. 911 CALLED, CHILD TAKEN TO ER.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Urticaria
Clinical narrative: Migraine and Hives.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt complains of sore arm even a month after vaccination, says she cannot raise arm.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Patient stated that she began to develop a reaction the morning after receiving the vaccine. Reaction was reported to vaccine provider on 10/30/15 at 10:25am.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Tendonitis
Clinical narrative: Severe pain and stiffness in shoulder where injection was given, doctor diagnosed tendonitis in left shoulder, SIRVA.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored PROQUAD (Merck) injection (lot # L023111, expiry date: 24-DEC-2016; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L011080, expiration date 01-OCT-2016, exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of -13.3C for 208 hours before administration. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several received from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Pt. received flu shot at hosp - her place of work at 0900, developed red maculopapular rash over (R) arm, (R) neck and chest approx 90 minutes after. Also reports hx flu-like illness to flu vaccine.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Gait disturbance, Rash, Swelling
Clinical narrative: Pt called pharmacy on 10/22/15 around 9 am. He said after 7 days of getting Flu shot he now has symptoms such as can't open mouth properly, can't talk properly, has swelling and rash. I told him to see his MD right away. He was concerned why it happened a week later.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored GARDASIL injection (lot # K010215, expiry date: 05-MAY-2017; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: This spontaneous unconfirmed report as received from a pharmacist referring to an unspecified number of patient of unknown age and gender. Pharmacist reported that a consumer saw a report on television which stated that the patients who were on therapy with unspecified cholesterol medications, including unspecified statins (all manufacturers unspecified) each received a dose of ZOSTAVAX (dose, frequency and route of administration were not reported). The ZOSTAVAX was "ineffective" against preventing shingles in these unspecified patients specifically due to their concomitant therapy with unspecified cholesterol medications. It could not be determined whether the unspecified cholesterol medications were Merck products. The outcome of lack of effect was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age consumer reporting on herself. On 03-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and indication were not reported). After receiving the injection, the patient was informed by her physician, that she already had the injection on 24-SEP-2012. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions and allergies were reported. On 02-NOV-2015 the patient was vaccinated with improperly stored oral, ROTATEQ suspension 2 (strength, dose, frequency and route were not reported) lot # L001316 with an expiry date of 10-NOV-2016. No concomitant medications were reported. No symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Cough, Pyrexia, Vomiting
Clinical narrative: Flu shot 10/29/15. 10/31/15 pt reported fever 101 degrees, upset stomach, vomiting. 11/1/15 cough, self medicated with MUCINEX. Referred to private MD for evaluation and follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (strength, dose, frequency and route were not reported) lot # K016131 and lot # K007781, expiry dates not reported. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Pt rec'd Hi Dose FLUZONE on 10/30/15 on 11/3/15 she reported a dissipating bruise approximately 4 inches wide in that area.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Asthenia, Cold sweat, Dyspnoea, Heart rate irregular, Hot flush
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Tachycardia
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Asthenia, Blood pressure increased, Cold sweat, Dyspnoea, Flushing
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Heart rate increased, Heart rate irregular, Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Palpitations
Clinical narrative: 10/30/2015 6 AM shortness of breath. 12:30 PM acute tachycardia. 1:42 pulse with hot flushing, clamminess and weakness. Also site reaction of redness, pain and itching and swelling as well as bruising, Blood pressure of 145/102. 10/30/15  11/1/15 continuing erratic pulse continued with pulse in 90's until morning of 11/1/15.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Asthenia, Cold sweat, Dyspnoea, Heart rate irregular, Hot flush
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Tachycardia
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Asthenia, Blood pressure increased, Cold sweat, Dyspnoea, Flushing
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Heart rate increased, Heart rate irregular, Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Palpitations
Clinical narrative: Shortness of breath, pounding heart, elevated pulse and blood pressure, cold clammy, flushed face, weak, erratic heart rate.  Local site reaction - red swollen, bruised, itchy and hot.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: C/O pain in (L) arm, pt sts he feels like there is something inside the muscle since 10/10/15. C/O fatigue and tenderness at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX injection (lot # L006384, expiry date: 25-FEB-2017; lot # L017143, expiry date: 13-MAY-2017; lot # L012034, expiry date: 07-APR-2017; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports 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 was received from a registered nurse refers to unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored VAQTA (Lot #, dosage regimen were not reported). No adverse effects were noted. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX via plaque forming unit (lot # L024997, expiration date 06-OCT-2016; dose not reported) intramuscularly in the upper, posterior aspect of left arm. On an unknown date the patient developed redness at the injection site an unspecified period of time after receiving the ZOSTAVAX. The reporter stated that the patient was not exhibiting a rash. The outcome of the event redness at the injection site was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abasia
Clinical narrative: Information was received from a pediatrician via a company representative concerning a female patient of unknown age, who on an unknown date was vaccinated with either GARDASIL 4 or GARDASIL 9 (dosage, lot number, and route of administration not provided. The pediatrician reported that an ex-patient was unable to walk (onset not provided) after receiving GARDASIL 4 or GARDASIL 9 (exact one unknown). The pediatrician reported that she learned of this adverse reaction from the news media in September 2015. The outcome of unable to walk is unknown. No further information provided. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacists via a company representative refers to a female in her late sixties to early seventies. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient experienced injection site redness and injection site swelling for 6 days after receiving PNEUMOVAX23 concurrently with an unspecified Flu vaccine. The outcome of the events injection site redness and injection site swelling was not reported. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD, lot# L016394, expiration date- 08-NOV-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II, lot # reported as L009219, expiration date 17-MAR-2017; lot # reported as L020189, expiration date 03-JUN-2017 (strength, dose, route of administration and albumin status were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L007495, expiration date 24-FEB-2017; lot # 019286, expiration date 14-SEP-2017; lot # 027282, expiration date 21-SEP-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient received two doses of ZOSTAVAX about one year apart from one another. The first dose of ZOSTAVAX was administered in approximately 2014 (exact date, dose and lot # were not provided). On 27-OCT-2015 the patient was vaccinated with the second dose of ZOSTAVAX (dose was not provided), lot # L0121610, expiry date 10-SEP-2016. In approximately October 2015 the patient felt "run down and tired" after receiving the second dose of ZOSTAVAX. The outcome of felt "run down and tired" was unknown. The relatedness between the event of felt "run down and tired" and the therapy with ZOSTAVAX was unknown. 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 nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as L017406, expiration date: 26-FEB-2017 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 66 years old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-OCT-2015, the patient was erroneously vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route of administration and anatomical location were not reported) instead of ZOSTAVAX with the intention to prevent shingles. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Inofrmation has been received from a pharmacist referring to a female patient of unknown age with allergies to codeine and KEFLEX. Pertinent medical history was not reported. On 15-SEP-2015 the patient was given a dose of ZOSTAVAX, lot # L021602, expiration date 10-SEP-2016 (dose and route were not reported), on an unspecified location on her left arm by an unspecified physician. Concomitant therapies included oxycodone, gabapentin, losartan, furosemide and cyclobenzaprine hydrochloride. Then the next day, 16-SEP-2015, the patient started to experience unspecified right sided torso pain. On an unknown date in 2015, the patient confirmed with the physician that she did not develop a rash. At the time of reporting, the patient did not recover. The causality was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Rash generalised, Urticaria
Clinical narrative: C/o body rash and hives with a cough 1 1/2 hrs after injection had also just eaten chinese.
Age: 58.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The female subject received FLUBLOK intramuscular on 14Oct2015. On 16Oct2015, the subject called to report injection area redness and slight swelling at injection site. Reddened area was 5 cm by 7 cm. She denied any itching at site. At the time of the report, the outcome for the events was unknown. Concomitant medications were not reported. The company's assessment of the causal relationship between injection area and redness and FLUBOK and injection area swelling and FLUBLOK is a possible relationship. In light of the safety profile information, injection site erythema and swelling are expected events. In summary, this case report does not change the known safety profile of FLUBLOK.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure, unresponsive for several min, lips blue.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients with unknown demographics. Concurrent conditions and medical history were unknown. On an unknown date, the unspecified patients were vaccinated with 7 doses of improperly stored ZOSTAVAX (lot # L028279; expiry date: 28-OCT-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored MMR II lot # K024036, expiration date: 26-NOV-2016, lot # K003823, expiration date: 14-MAR-2016 and lot # reported as L015282, expiration date: 30-APR-2017 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse who had read reviews on an unspecified web site on the Internet that refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with unspecified doses of ZOSTAVAX (route of administration, anatomical location, lot number and expiration date were not reported). There were no concomitant medications provided. The registered nurse reported that many of the reviews from an unspecified web site, stated that the patients developed shingles about 2 years after receiving an unspecified dose of ZOSTAVAX. The outcome of herpes zoster was not reported. The reporter did not assess the relatedness of ZOSTAVAX. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of GARDASIL 9 lot # L016429 (route of administration, dose and expiration date were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K015462, expiration date 10-JUL-2017) (dosage, strength and route of administration not reported). There was no concomitant medication reported. At the time of this report, no adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomiatnt medications, concurrent condditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of VAQTA lot # L028666 exp. 04-NOV-2016 (route of administration, dose were not reported). There were no adverse effects reproted. This is one of several reports received from the same reporter. Additional informaiton has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 59 year old female patient. The patient had no pertinent medical history. On 26-OCT-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date, the patient developed red circle at the injection site, the rash appeared around the injection site and it was warmth to touch. She went to the pharmacy for medical assistance and the events were treated with hydrocortisone cream. The outcome of the events was unknown. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Fatigue, chills. Erythema and warmth around injection site measuring 12 x 15.5cm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Wheezing
Clinical narrative: Itching, shortness of breath, and wheezing.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Vaccine administer Monday evening at 6pm into the right deltoid and the following evening, the arm began to swell and become red. They returned to clinic the morning of the 4th with redness and swelling from the shoulder to the elbow.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Pruritus
Clinical narrative: Chest pain/heaviness/tightness, itching.
Age: 32.0
Sex: F
Vaccine: FLUR3
Symptoms: Abdominal pain, Diarrhoea, Headache, Paraesthesia oral, Urticaria
Clinical narrative: Lip/Tongue tingling, headache, severe abdominal cramping, diarrhea, hives.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Mom states that patient had fever that was 104.0*F on Saturday, 10/31/15 and continued to have intermittent fever until Sunday afternoon, 11/1/15.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reported almost one month later that their right arm swelled, was red and warm.  It reportedly lasted two weeks.  They did not seek medical care and reported the incident 26 days later.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: REDNESS AT INJECTION SITE, SORENESS, CANNOT RAISE ARM.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Injection site pruritus, Injection site swelling
Clinical narrative: Fever, chills, headache, dizziness, swelling, pruritis, and heat at the injection site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever, chills, headache, dizziness, swelling, pruritis, and heat at the injection site.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Rash
Clinical narrative: Patient developed a rash/infection on the arm that the vaccine was given in.  The exact time of onset is unknown.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of RECOMBIVAX HB lot # L016427 exp. 13-APR-2017 (route of administration, dose were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of ROTATEQ orally, lot # L008997 exp. 04-DEC-2016 (dose was not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Addiitonal information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lip blister, Lip pain
Clinical narrative: This spontaneous report was received from a health professional referring to herself, a 61 year old female patient without any pertinent medical history or any drug reaction or allergies. On 11-NOV-2008, the patient was vaccinated with a dose of ZOSTAVAX (Lot# AKABB132AC; expiration date was not reported) dose and route of administration were not reported. Concomitant therapies included methimazole 5mg (manufacturer unknown) and montelukast sodium (manufacturer unknown). On an unspecified date in February 2013, the patient experienced shingles and "blisters" on "the right side of her lip". She was seen by the physician on an unspecified date in February 2013, who then prescribed valacyclovir hydrochloride tablets and ZOVIRAX ointment. The reporter stated that "it took one week to heal up" after starting the prescribed medications. The reporter stated that she again was seen by the same physician on an unspecified date in October 2015 after experiencing "a sharp shooting pain in my lip and a couple of blisters". The reporter stated that the physician told her she was "having a flare up of shingles", and the physician prescribed "a one day treatment of valacyclovir hydrochloride tablets" and that "within 2 days I was cleared of it". There were no lab diagnostic studies performed. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction, Erythema, Fatigue, Headache, Injection site inflammation
Clinical narrative: This spontaneous report was received from a physician assistant via company representative and refers to a 15 year old female patient. The patient's current conditions included type 1 diabetes mellitus and medical history was not reported. On 19-SEP-2014, the patient was vaccinated with the first dose of GARDASILI (formulation, strength, dose, route and lot number were not reported). On 07-NOV-2014 the patient was vaccinated with the second dose of GARDASIL (formulation, strength, dose, route and lot number were not reported). Other suspect therapies included the third dose of GARDASIL 9 injection given on 25-SEP-2015 (strength, dose, route and lot number were not reported) and influenza virus vaccine (unspecified) (manufacturer unknown, reported as Quadrivalent flu vaccine) given in the separate arm on 25-SEP-2015. Concomitant therapies doses of GARDASIL. On 26-SEP-2015 and 28-SEP-2015, the patient reporter received a call from the patient's mother. In September 2015, the patient had developed severe reaction, systemic rash, throwing pain and redness greatly above normal, significant fatigue and headache. The patient sought medical attention and on 30-SEP-2015 she was seen in the physician's office and she was much better. On an unknown date in 2015, the patient still had some inflammation around the injection site, unspecified site, rash was mostly cleared up, was still itchy, swelling, pain and redness was still slightly evident. No product quality complaints (PQC) was involved. No further details were noted. The outcome of the events "first two doses of GARDASIL and GARDASIL 9 was administered for the third dose", headache, significant fatigue and severe reaction was unknown. The outcome of systemic rash, some inflammation around unspecified site, some inflammation around the injection site, swelling, redness greatly above normal and throwing pain was reported as resolving. The outcome of itchy was reported as not resolved. The reporter did not provide causal relationship between the events and suspect therapies. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, Pain, Pruritus, Rash, Swelling
Clinical narrative: This spontaneous report was received from a physician assistant via company representative and refers to a 15 year old female patient. The patient's current conditions included type 1 diabetes mellitus and medical history was not reported. On 19-SEP-2014, the patient was vaccinated with the first dose of GARDASILI (formulation, strength, dose, route and lot number were not reported). On 07-NOV-2014 the patient was vaccinated with the second dose of GARDASIL (formulation, strength, dose, route and lot number were not reported). Other suspect therapies included the third dose of GARDASIL 9 injection given on 25-SEP-2015 (strength, dose, route and lot number were not reported) and influenza virus vaccine (unspecified) (manufacturer unknown, reported as Quadrivalent flu vaccine) given in the separate arm on 25-SEP-2015. Concomitant therapies doses of GARDASIL. On 26-SEP-2015 and 28-SEP-2015, the patient reporter received a call from the patient's mother. In September 2015, the patient had developed severe reaction, systemic rash, throwing pain and redness greatly above normal, significant fatigue and headache. The patient sought medical attention and on 30-SEP-2015 she was seen in the physician's office and she was much better. On an unknown date in 2015, the patient still had some inflammation around the injection site, unspecified site, rash was mostly cleared up, was still itchy, swelling, pain and redness was still slightly evident. No product quality complaints (PQC) was involved. No further details were noted. The outcome of the events "first two doses of GARDASIL and GARDASIL 9 was administered for the third dose", headache, significant fatigue and severe reaction was unknown. The outcome of systemic rash, some inflammation around unspecified site, some inflammation around the injection site, swelling, redness greatly above normal and throwing pain was reported as resolving. The outcome of itchy was reported as not resolved. The reporter did not provide causal relationship between the events and suspect therapies. 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 registered nurse refers to unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored PNEUMOVAX23 (Lot #, dosage regimen were not reported). No adverse effects were noted. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored PEDVAXHIB injection (lot # L014426, expiry date: 18-MAR-2018: strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K021485 and expiration date 03-NOV-2016; lot # K026386 and expiration date 15-DEC-2016; lot # L001327 and expiration date 13-JAN-2017; lot # L006386 and expiration date 25-FEB-2017, exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of -13.3C for 208 hours before administration. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.