chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that, since 09-MAR-2017, the patients received an improperly stored dose of PROQUAD recombinant human albumin (rHA) lot number M038227, expiration date: 06-MAR-2018; lot number: M033209, expiration date: 09-JAN-2018; and lot number: M019232, expiration date: 17-OCT-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. The licensed practical nurse did not have access to the lot numbers and expiration dates for the diluent that was used. The vaccine was exposed to a temperature between 15 and 46 Fahrenheit (F) for 15 hours. The call was not because of a data logger, and there was no previous temperature excursion. No adverse effects had been reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007551.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, regarding a 16 year old female patient. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection administered intramuscularly (strength, dose, lot number and expiration date were not reported) for the prevention of HPV (Human Papillomavirus). On an unspecified date (reported as "right after receiving GARDASIL 9"), the patient felt dizzy and fell down in the physician's office. It was unknown if laboratories were performed or treatment was given for the events. No intervention to prevent serious criteria was performed. At the time of reporting, the patient had not recovered from the events. The reporter did not provide a causality statement between the event and the suspect vaccine. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I normal
Clinical narrative: Initial solicited report on 21 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 01 February 2017. On 13 February 2017, 12 days after vaccination the subject was diagnosed with i30.9 acute pericarditis, unspecified. The subject's lab data included, Troponin I result was normal done on 09 February 2017, ECG was abnormal done on 10 February 2017, Echocardiogram was normal performed on 03 March 2017. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 21-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis and pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Age: 27.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Papule, Polymerase chain reaction, Rash pustular, Viral test negative
Clinical narrative: Papules and pustules on bilateral thighs, posterior neck, and bilateral lower eyelids starting 9 days after vaccination.  Patient started on viroptic eye drops until cleared by Opthamology.
Age: 28.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness around injection sight. Patient had fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received Dtap-IPV in deltoid, injection site red, and swollen about 4-5 inches. Area not tender.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 14-MAR-2017 from a nurse who reported that a 45 year old male patient received an expired dose of VAQTA (lot# L031196, expiration 05-FEB-2017) 50/1.0 U/ml (route of administration not reported) on 14-MAR-2017. No adverse effects were reported in the patient. No other information is available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blood test, Fungal test negative, Hypersensitivity, Rash erythematous
Clinical narrative: Information was received from a 63 year old female patient with allergy to codeine, arthritis (since 2000), and history of "blood condition for six years" (unspecified), knee replacement and shoulder replacement.  In late December 2016, the patient was vaccinated by an unspecified pharmacist with ZOSTAVAX 19400 PFU injection (lot number, exact dosage, and route of administration not provided) to prevent shingles.     Concomitant therapies included lisinopril (manufacturer unknown), oxycodone, and "Zanas" (spelling confirmed). In approximately January 2017 (reported as within 4-5 days after being vaccinated), the patient reported that a "red, bumpy, itchy rash developed on the left side of her head onto the scalp area. Within the last 2 months the rash spread to her left shoulder, upper legs, right hip and lower back areas." The patient was currently being treated by a physician and had an office visit with a dermatologist who performed a biopsy. Treatment was reported as prednisone 20 mgs and unspecified ointments. She underwent unspecified blood work (results not provided). The outcome of the events was reported as not recovered. No further details available. Follow-up information was received on 22-MAR-2017 from medical records provided by the patient. Biopsy of left anterior distal upper arm was performed on 09-MAR-2017 with clinical information of erythematous papules, rash unspecified versus contact dermatitis other versus hypersensitivity reaction versus drug eruption. Dermatopathology report diagnosis: Spongiotic dermal hypersensitivity reaction. Differential could include an arthropod assault reaction or other hypersensitivity reaction, such as to a drug, contactant or allergen. Clinical correlation suggested. Periodic acidSchiff (PAS) stain was negative for fungal organisms. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information was received from a 63 year old female patient with allergy to codeine, arthritis (since 2000), and history of "blood condition for six years" (unspecified), knee replacement and shoulder replacement.  In late December 2016, the patient was vaccinated by an unspecified pharmacist with ZOSTAVAX 19400 PFU injection (lot number, exact dosage, and route of administration not provided) to prevent shingles.     Concomitant therapies included lisinopril (manufacturer unknown), oxycodone, and "Zanas" (spelling confirmed). In approximately January 2017 (reported as within 4-5 days after being vaccinated), the patient reported that a "red, bumpy, itchy rash developed on the left side of her head onto the scalp area. Within the last 2 months the rash spread to her left shoulder, upper legs, right hip and lower back areas." The patient was currently being treated by a physician and had an office visit with a dermatologist who performed a biopsy. Treatment was reported as prednisone 20 mgs and unspecified ointments. She underwent unspecified blood work (results not provided). The outcome of the events was reported as not recovered. No further details available. Follow-up information was received on 22-MAR-2017 from medical records provided by the patient. Biopsy of left anterior distal upper arm was performed on 09-MAR-2017 with clinical information of erythematous papules, rash unspecified versus contact dermatitis other versus hypersensitivity reaction versus drug eruption. Dermatopathology report diagnosis: Spongiotic dermal hypersensitivity reaction. Differential could include an arthropod assault reaction or other hypersensitivity reaction, such as to a drug, contactant or allergen. Clinical correlation suggested. Periodic acidSchiff (PAS) stain was negative for fungal organisms. All available medical records will be provided upon request. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 25-JUN-2013, the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Then, on 05-AUG-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (lot number reported as M011840, expiration date 01-FEB-2018; dose and route of administration were not reported) (interchange of vaccine products). No adverse effects were reported. The outcome of the event interchange of vaccine products and its causal relationship to therapy with GARDASIL and GARDASIL 9 were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, regarding an "over 15 years old" patient of unknown age. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date (reported as "6 months later"), the patient received another dose of GARDASIL 9 (lot # and expiration date were unknown). No adverse effects were reported. 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 referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. It was reported that since 16-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M032650, expiration date on 31-MAR-2019 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The doses of GARDASIL 9 were in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was a previous temperature excursion as: 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001059: US-009507513-1704USA001060: US-009507513-1704USA001058:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. On 03-APR-2017, the patients were vaccinated with improperly stored ZOSTAVAX, lot # M039453, expiry date 19-DEC-2017 (dose and route not reported). Digital data logger was involved. The product was stored in temperatures between 15 and 46 degrees Fahrenheit for 4 hours before its administration to the patients. Previous temperature excursion was not recorded. The pharmacist confirmed that sterile water diluent (unspecified lot and expiration), used to reconstitute the vaccine, was properly stored. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No historical conditions, concurrent conditions or concomitant therapies were reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M038859, expiration date 14-SEP-2018, dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature ranging from 6 to 14 degrees F for 1 hour and 8 minutes. This excursion was captured via a digital data logger. There were no previous temperature excursions. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: M
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial unsolicited report received from a consumer on 21-MAR-2017. This case involves a 10-year-old male patient who was vaccinated with a sixth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date and also received other five doses of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified dates. Patient's medical history and concomitant medications were not reported. Patient's Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Milk allergy. On an unspecified date, following the vaccination, the patient experienced pertussis. It was reported that the patient required emergency room/doctor visit. Lab data (reported as Unknown) and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. Upon medical review, the case was considered as serious due to important medical event: Pertussis. List of documents held by sender: none.; Sender's Comments: This case concerns a 10 years old male patient who experienced pertusis after the vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Manufacturer unknown). Time to onset is unknown. Further information on medical history including birth history, time to onset, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site vesicles, Scab
Clinical narrative: Red raised area and vesicle at site of injection.  worsened over next two days and two vesicles appeared on abdomen and back.  Reported to OHP on 4/4/17 and vesicles crusted over.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Herpes zoster, Rash, Rhinorrhoea, Varicella virus test positive
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash, cough, and runny nose. No antiviral treatment.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Exposure during pregnancy, Premature delivery, Premature separation of placenta, Uterine contractions during pregnancy
Clinical narrative: Contractions and severe stomach pain, followed by a placenta abruption on 5/4/2015 and a preterm 33 week baby.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster diagnosis in a 1 dose varicella vaccine recipient. Painful unilateral rash. Given antiviral treatment.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Pneumonia, Urinary tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a adult female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 5ZP2021, expiry date 28th February 2017) for chronic obstructive pulmonary disease. In January 2017, the patient received Influenza vaccine Quadrivalent. In 2007, the patient started ADVAIR DISKUS (inhaled) at an unknown dose and frequency. In January 2017, less than a month after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR DISKUS, the patient experienced pneumonia (serious criteria GSK medically significant), urinary tract infection and expired vaccine used. The action taken with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the pneumonia was not recovered/not resolved and the outcome of the urinary tract infection and expired vaccine used were unknown. It was unknown if the reporter considered the pneumonia and urinary tract infection to be related to Influenza vaccine Quadrivalent and ADVAIR DISKUS. Additional details were reported as follows: The age at vaccination was not reported. In January 2017, the patient received Influenza vaccine Quadrivalent which was already expired. The patient reported that, she developed pneumonia from a flu shot which she received while seeking treatment for an urinary tract infection (UTI). The patient had denied permission to contact their physician.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema
Clinical narrative: Erythema.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Herpes zoster, Rash pruritic, Varicella virus test positive
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Itchy unilateral rash for less than 4 weeks. Unknown if antiviral treatment was given.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLUX, IPV, MMR, VARCEL, DTAP, FLU(H1N1), FLUX, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Nausea, Pyrexia, Rash
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash lasting less than 4 weeks, nausea, and fever. No antiviral treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information was received from a pharmacist concerning a 60 year old female patient, who on 20-FEB-2017 received a dose of ZOSTAVAX 19400 PFU, lot # M037014, expiration date 22-NOV-2017, 0.65 ml, subcutaneously, which was reconstituted with sterile diluent lot #L008523, expiration date 26-NOV-2017. On 13-MAR-2017, the patient was given a prescription for prednisone. The pharmacist did not know the reason why the patient was given a prescription for prednisone. The pharmacist was not aware of the patient having an adverse reaction to ZOSTAVAX. The outcome of adverse event is unknown. No further details provided. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Blood test, Bone marrow disorder, Cough, Ear pain
Clinical narrative: This spontaneous report was received from a 39 year old non-pregnant female patient concerning herself. The patient's concurrent conditions included asthma. The patient's medical history included pulmonary embolism. The patient's drug reactions/allergies included clarithromycin, neomycin(DIAXIN), amoxicillin (+) clavulanate potassium(AUGMENTIN), amoxicillin, prilocaine, corn and soy based ingredients, adhesive, perfume and dust-mites. On an unspecified date in approximately 2007 (reported as 10 years ago), the patient was vaccinated with the first dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies included cetirizine hydrochloride(ZYRTEC) and montelukast sodium(SINGULAIR). On 06-FEB-2017, 45 min after vaccination the patient experienced a drop in her blood pressure which was recorded by her hematologist as 77/56 (units not provided) (blood pressure decreased). As the day progressed she developed  aurora migraines (migraine), ear pain, congestion (nasal congestion) and persistent coughing (cough), fatigue, nausea and vomiting. On 07-FEB-2017 morning (reported as by the next morning), the patient felt like "the marrow in her bones was going to explode" also described as a feeling of intense pressure from the inside of every bone in her entire body (bone marrow disorder). On the same day, she experienced muscle fatigue all over her body and she could not move her left arm (injected limb mobility decreased) were the vaccine was administered, without excruciating pain (pain in extremity). On an unspecified date in February 2017 (also reported as several days after getting vaccinated), the patient experienced a bad cold (nasopharyngitis), the patient called her allergist and the allergist thought that she might had an "histamine reaction" to the vaccine, the patient belief that she may had reacted to the inactive ingredient called phenol found in the vaccine especially if the ingredient was derived from a corn source because she was allergic to corn based ingredients (reaction to preservatives). The patient reported that her symptoms lasted for about 18 days. She received an unspecified treatment for the events. A chemistry panel and a blood work were performed, however no results were provided. The outcome of the events was reported as recovered on an unspecified date in February 2017. The reporter did not provide the causality between the events and PNEUMOVAX23.        Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injected limb mobility decreased, Laboratory test abnormal, Migraine with aura, Muscle fatigue
Clinical narrative: This spontaneous report was received from a 39 year old non-pregnant female patient concerning herself. The patient's concurrent conditions included asthma. The patient's medical history included pulmonary embolism. The patient's drug reactions/allergies included clarithromycin, neomycin(DIAXIN), amoxicillin (+) clavulanate potassium(AUGMENTIN), amoxicillin, prilocaine, corn and soy based ingredients, adhesive, perfume and dust-mites. On an unspecified date in approximately 2007 (reported as 10 years ago), the patient was vaccinated with the first dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies included cetirizine hydrochloride(ZYRTEC) and montelukast sodium(SINGULAIR). On 06-FEB-2017, 45 min after vaccination the patient experienced a drop in her blood pressure which was recorded by her hematologist as 77/56 (units not provided) (blood pressure decreased). As the day progressed she developed  aurora migraines (migraine), ear pain, congestion (nasal congestion) and persistent coughing (cough), fatigue, nausea and vomiting. On 07-FEB-2017 morning (reported as by the next morning), the patient felt like "the marrow in her bones was going to explode" also described as a feeling of intense pressure from the inside of every bone in her entire body (bone marrow disorder). On the same day, she experienced muscle fatigue all over her body and she could not move her left arm (injected limb mobility decreased) were the vaccine was administered, without excruciating pain (pain in extremity). On an unspecified date in February 2017 (also reported as several days after getting vaccinated), the patient experienced a bad cold (nasopharyngitis), the patient called her allergist and the allergist thought that she might had an "histamine reaction" to the vaccine, the patient belief that she may had reacted to the inactive ingredient called phenol found in the vaccine especially if the ingredient was derived from a corn source because she was allergic to corn based ingredients (reaction to preservatives). The patient reported that her symptoms lasted for about 18 days. She received an unspecified treatment for the events. A chemistry panel and a blood work were performed, however no results were provided. The outcome of the events was reported as recovered on an unspecified date in February 2017. The reporter did not provide the causality between the events and PNEUMOVAX23.        Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Nausea, Pain, Viral upper respiratory tract infection, Vomiting
Clinical narrative: This spontaneous report was received from a 39 year old non-pregnant female patient concerning herself. The patient's concurrent conditions included asthma. The patient's medical history included pulmonary embolism. The patient's drug reactions/allergies included clarithromycin, neomycin(DIAXIN), amoxicillin (+) clavulanate potassium(AUGMENTIN), amoxicillin, prilocaine, corn and soy based ingredients, adhesive, perfume and dust-mites. On an unspecified date in approximately 2007 (reported as 10 years ago), the patient was vaccinated with the first dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies included cetirizine hydrochloride(ZYRTEC) and montelukast sodium(SINGULAIR). On 06-FEB-2017, 45 min after vaccination the patient experienced a drop in her blood pressure which was recorded by her hematologist as 77/56 (units not provided) (blood pressure decreased). As the day progressed she developed  aurora migraines (migraine), ear pain, congestion (nasal congestion) and persistent coughing (cough), fatigue, nausea and vomiting. On 07-FEB-2017 morning (reported as by the next morning), the patient felt like "the marrow in her bones was going to explode" also described as a feeling of intense pressure from the inside of every bone in her entire body (bone marrow disorder). On the same day, she experienced muscle fatigue all over her body and she could not move her left arm (injected limb mobility decreased) were the vaccine was administered, without excruciating pain (pain in extremity). On an unspecified date in February 2017 (also reported as several days after getting vaccinated), the patient experienced a bad cold (nasopharyngitis), the patient called her allergist and the allergist thought that she might had an "histamine reaction" to the vaccine, the patient belief that she may had reacted to the inactive ingredient called phenol found in the vaccine especially if the ingredient was derived from a corn source because she was allergic to corn based ingredients (reaction to preservatives). The patient reported that her symptoms lasted for about 18 days. She received an unspecified treatment for the events. A chemistry panel and a blood work were performed, however no results were provided. The outcome of the events was reported as recovered on an unspecified date in February 2017. The reporter did not provide the causality between the events and PNEUMOVAX23.        Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with ROTATEQ oral liquid (lot #: M031651 with expiration date: 30-MAR-2018 and lot# M004542 with expiration date 18-OCT-2017) (dose, strength and frequency were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013304: US-009507513-1703USA013305.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with RECOMBIVAX HB (lot #: M035487 with expiration date: 23-FEB-2019 and lot# M042322 with expiration date 21-FEB-2019) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013305: US-009507513-1703USA011239:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with VAQTA (lot #: M039202 with expiration date: 11-MAR-2018 and lot# M047658 with expiration date 28-OCT-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011239: US-009507513-1703USA013304.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical histories, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L048465; expiration date: 02-DEC-2017 (dose, route and site of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 15°F degrees to 46°F degrees for 2 hours and 38 minutes. There were no previous temperature excursions. The call was becau6se of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 16-MAR-2017,  the patient was vaccinated with an improperly stored doses of M-M-R II lot # M028130, expiration date on 03-JUN-2018 (strength, dose number, route and anatomical location was not provided) for prophylaxis. It was reported that the vaccine M-M-R II was reconstituted with properly stored sterile diluent (manufacturer unknown). The dose of M-M-R II was in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was previous temperature excursion as 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001059: US-009507513-1704USA001060: US-009507513-1704USA000553:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-MAR-2017,  the patient was vaccinated with one of the improperly stored doses of M-M-R II  lot # M028130, expiration date 03-MAR-2018 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The dose of M-M-R II was in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was previous temperature excursion as 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000553: US-009507513-1704USA001060: US-009507513-1704USA001058.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 21-MAR-2017,  the patient was vaccinated with one of the improperly stored doses of M-M-R II  lot # M028130, expiration date 03-MAR-2018 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The dose of M-M-R II was in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was previous temperature excursion as 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001059: US-009507513-1704USA000553: US-009507513-1704USA001058:
Sex: M
Vaccine: PNC13
Symptoms: Antibody test abnormal, Ear infection
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting on behalf of her son. A male patient of an unspecified age and race/ethnicity received 4 single doses of PREVNAR 13 on unspecified dates, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was checked on an unspecified date by an immunologist and tested for antibody titers, which showed he was only protected against 3 of the 13 serotypes. Furthermore he was keeping getting ear infections since an unspecified date. The doctor recommended to get a fifth dose of the vaccine to improve the titers. Patient's mom wanted to know if this was recommended or not. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Oedema, Pyrexia, Rash erythematous, Skin plaque, Tenderness
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non HCP (a manager) and from a contactable Physician. This Physician reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at single dose at right deltoid on 13Jan2017 11:00 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced erythematous rash, which progressed to a tender, edematous plaque with fever, all treated for a cellulitis episode. The outcome of the events was apparently recovering. The AEs required an emergency room or physician visit. The patient was apparently recovering. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017070804 same reporter/drug/AE, different pt; US-PFIZER INC-2017070703 same reporter/vaccine/ event, different patient.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is a spontaneous report from a Medical Assistant reporting on behalf of a Health Care Professional  through Company Representative. A 17 year-old female patient received, on 11Aug2016, TRUMENBA (Lot. N16808, Expiration date: Jul2017) single dose, for immunization. Relevant medical history was unknown. Concomitant medications were none. On an unspecified date, the patient experienced neck stiffness, and neck pain at the left side where she got the injection. The patient's arm was swollen and red, and  hot at the injection site. Clinical outcome of the events was unknown at time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. An adult male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history ad concomitant medications were not reported. The patient experienced decreased sleep a few weeks after vaccination on an unspecified date with outcome of unknown.
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. This consumer reported similar events for herself and her husband. This is the second of two reports. A male patient of an unspecified age, gender and race received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced vaccination site stinging (major stinging after receiving pneumococcal 13-val conj vac (dipht crm197 protein)). Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017142823 Same reporter/product/event, different patients.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Dizziness, Dysphagia, Laboratory test
Clinical narrative: Pt. reports chest pain, weakness and dizziness later in the day after receiving the flu vaccine. She said she called 911 and EMS ambulance brought her to the ER. 4 days later pt. C/O dizziness, heart racing, weakness and feeling faint. 911 called ant the pt was transported to E.R. by ambulance and was admitted overnight for tests. EE reports that she was having difficulty swallowing and after many tests was diagnosed with nerve damage of the esophagus and throat and said her doctor informed her the cause was a virus and that includes getting the flu shot. Pt. said that she is filing a report to the C.D.C. that she had a reaction to the flu shot. Under PMD care.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Palpitations, Vaccination complication, Viral infection
Clinical narrative: Pt. reports chest pain, weakness and dizziness later in the day after receiving the flu vaccine. She said she called 911 and EMS ambulance brought her to the ER. 4 days later pt. C/O dizziness, heart racing, weakness and feeling faint. 911 called ant the pt was transported to E.R. by ambulance and was admitted overnight for tests. EE reports that she was having difficulty swallowing and after many tests was diagnosed with nerve damage of the esophagus and throat and said her doctor informed her the cause was a virus and that includes getting the flu shot. Pt. said that she is filing a report to the C.D.C. that she had a reaction to the flu shot. Under PMD care.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Pruritus, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Itchy, painful unilateral rash. Given valacyclovir as treatment.
Age: 0.08
Sex: F
Vaccine: HEP, RV5
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given PENTACEL vaccine, diluent was not mixed with powder. Patient received only the diluent (DTaP/IPV)component.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster diagnosis in a varicella vaccine recipient. Painful unilateral rash. Given antiviral treatment.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Eye movement disorder, Eye pain, Loss of consciousness, Mydriasis, Pain in extremity
Clinical narrative: Patient's arm shaking, feels like "he's worked out for a long time." Reports blurry vision and trouble seeing. Turned pale and began to pass out. Father and I moved patient to clinic table where upon laying down, patient's head turned to right, eyes rolled back and he had a small, light seizure/convulsions for approx 10 seconds with pupils dilated. O2 98%, heart rate 65, blood pressure 108/76. After rest, was able to drink some water and sit up with complaint of eye and arm pain, Incident began approx 5 minutes after receiving vaccine. Able to walk out of store with parents with no medical assistance needed around 25 minutes later. Followed up with Father around 2pm, patient resting with no new problems to report and no further complaints.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Pallor, Posture abnormal, Seizure, Tremor, Vision blurred
Clinical narrative: Patient's arm shaking, feels like "he's worked out for a long time." Reports blurry vision and trouble seeing. Turned pale and began to pass out. Father and I moved patient to clinic table where upon laying down, patient's head turned to right, eyes rolled back and he had a small, light seizure/convulsions for approx 10 seconds with pupils dilated. O2 98%, heart rate 65, blood pressure 108/76. After rest, was able to drink some water and sit up with complaint of eye and arm pain, Incident began approx 5 minutes after receiving vaccine. Able to walk out of store with parents with no medical assistance needed around 25 minutes later. Followed up with Father around 2pm, patient resting with no new problems to report and no further complaints.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Visual impairment
Clinical narrative: Patient's arm shaking, feels like "he's worked out for a long time." Reports blurry vision and trouble seeing. Turned pale and began to pass out. Father and I moved patient to clinic table where upon laying down, patient's head turned to right, eyes rolled back and he had a small, light seizure/convulsions for approx 10 seconds with pupils dilated. O2 98%, heart rate 65, blood pressure 108/76. After rest, was able to drink some water and sit up with complaint of eye and arm pain, Incident began approx 5 minutes after receiving vaccine. Able to walk out of store with parents with no medical assistance needed around 25 minutes later. Followed up with Father around 2pm, patient resting with no new problems to report and no further complaints.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Syncope within 15 minutes of vaccine administration.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Clumsiness, Dizziness, Dysphagia, Facial paralysis, Headache
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash lasting less than 4 weeks, dizziness, nausea, Bell's Palsy, headaches, trouble swallowing, sensitivity to loud noises, clumsiness. Given acyclovir as treatment.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Hyperacusis, Nausea, Rash
Clinical narrative: Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash lasting less than 4 weeks, dizziness, nausea, Bell's Palsy, headaches, trouble swallowing, sensitivity to loud noises, clumsiness. Given acyclovir as treatment.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pediatric dose given instead of adult dose.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is sore and red and swollen, treated with antibiotic and steroids.
Age: 72.0
Sex: M
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: C/O left 3rd 4th 5th finger tingling sensation 20min later he received MMR vaccine to the left upper arm. Rt arm skin: no swelling, no redness at the MMR SQ injection site. Denied burning sensation to the  left upper extremity. ROM is intact.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pt received a gardasil instead of a hib.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: Excessive Headache.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: L axilla lymphadenopathy.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster
Clinical narrative: This is a spontaneous report received from a field representative on the after hours line on 14-MAR-2017 who received information from a physician who reported that an unspecified male patient, currently in his 60s had a dose of ZOSTAVAX a "couple of years ago" (lot number not reported). The physician noted that the patient now has a current case of the shingles and is very uncomfortable. No further details were reported. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a office manager healthcare worker and refers to 18 year old patient of unknown gender.  There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On an unknown date, the 18 year old patient was inadvertently vaccinated with PROQUAD (dose, route, lot # and expiration date were not provided) for prophylaxis. This was outside the recommendations per the prescribing  information. No adverse effects were reported.  No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse (R.N.) reporting on an 18-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that on an unknown date, a medical assistant administered to the patient a properly stored dose of PROQUAD (dose, and route of administration were not reported) (lot # M022402 with an expiration date on 01-NOV-2017) for prophylaxis (Drug administered to patient of inappropriate age). The patient did not present any adverse effects. There was no additional information or product quality complaints (PQC) reported.  Additional information is not expected as there was no consent to contact.