chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt received varicella vaccine on 1-25-17. He noticed diffuse rash 10 d later on 2-4-17. Diagnosed with varicella by lab work.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: PPSV23 vaccine to left deltoid on 2-13-17. Swelling and pain began that day with relief of swelling over next 2 days but called on 3-2-17 to report arm is still painful with some movements. Encouraged to have evaluated by her primary physician.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Got flu vaccine at 14 weeks of age. Mom requested flu and age was not checked prior to vaccination. Mom informed will need at 6 mos.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Got flu vaccine at 14 weeks of age. Mom requested flu and age was not checked prior to vaccination. Mom informed will need at 6 MOS.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Local area (MMR) Hives to back, legs, head BENADRYL given No swelling, airway was clear.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Swelling in armpit/axillae region of arm that was vaccinated.
Age: 25.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Asthenia, Speech disorder, Vertigo
Clinical narrative: Patient had just completed administration TDaP, Typhoid and Hepatitis A. As soon as I completed those injections client and states she felt weak and "head started to spin". States started after 1st inj but could not get words out to tell me. Fan turned to Pt, cool wet compresses to face and back of neck. Head lowered between knees. Snack bar given to client and coke. States feels better yellow fever then administered.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Developed swollen (L) axillary node, tender. Day after Meningitis B vaccine which was administered - (L) deltoid; Treated with oral antibiotics.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling, erythema and pain at injection site over the course of the day. No shortness of breath or wheezing. No hives.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Erythema on Right deltoid. It was warm touch. Pt does not complain of pain. Mom said after administration of vaccine, Pt had a fever. No more fevers since the day is was administered.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Within hours of vaccination, patient C/O pain, tingliness and weakness both upper extremities. This has improved but to date but periodically present. No fever, rash, GI or lung components.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Non tender, erythema that is raised in left arm.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Electrocardiogram normal, Pain, Syncope, Ultrasound scan normal, Vomiting
Clinical narrative: Severe pain/vomiting/fainting hours after vaccine administration.
Age: 1.08
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives after Pt went home. Mom gave BENADRYL and hives got better.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Muscular weakness, Pain, Pain in jaw, Paraesthesia
Clinical narrative: Received vaccine yesterday. Pt. with (L) jaw pain that day. Also (L) arm, (L) leg weakness, tingling, pain. NL gait, no other S/S. TX = MOTRIN, Ice. F/up in 3 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza virus test negative, Nuclear magnetic resonance imaging brain normal, Pain, Pyrexia
Clinical narrative: Headache, fever, body aches next day MRI brain to rule out other etiology Butalbital-acetaminophen
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Dizziness postural, Fatigue, Headache, Immunology test normal, Migraine
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Poor quality sleep, Viral titre
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood pressure decreased, Body temperature decreased, Dizziness, Erythema, Fatigue
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Feeling abnormal, Headache, Induration, Limb mass, Loss of consciousness
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Musculoskeletal pain, Pain in extremity, Seizure, Skin irritation, Vomiting
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Wrong drug administered
Clinical narrative: The immunization clinic accidentally gave my just turned 15 yo daughter the anthrax vaccine instead of giving her a TB test. Within minutes, she passed out and convulsed (three times within half hour) and vomited. Her blood pressure dropped, her temperature dropped, she developed a headache, dizziness, and pain in her arm and shoulder. They kept her there for watch for about another hour or so, then said we could leave and rest at home. She still has a headache, there is a very hard lump in her arm that is red and irritated, she is extremely tired, and feels "out of it" continuously. We have consulted with the nurse line and the health department, who both said to go to the ER if symptoms don't improve or worsen.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: I was pregnant and received the Tdap vaccine on 10/24. On 10/29 my daughter was stillborn.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 01-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX 0.5 ml lot # M035692, expiration date: 07-OCT-2017, subcutaneously for prophylaxis; nevertheless, the reporter stated that the vaccine was reconstituted with 0.5 ml of diluent (manufacturer unknown)  rather than full contents of diluent (lot # reported as L008523, expiration date 26-NOV-2017). No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD lot number M035690 with an expiration date on 06-FEB-2018; lot number M032496 with an expiration date on 02-JAN-2018 or lot number reported as "M037012 with an expiration date on 21-FEB-2018" (strength, dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccines had an unspecified temperature excursion (reported as more than 14 Fahrenheit (F) and less than 46 F) during a time frame of 1125 hours. Also it was reported that no previous temperature excursions occurred or a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA001163.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 69 years old female patient with unspecified dental problems. There was no medical history reported and the patient did not have any drug reaction or allergy. The concomitant therapies included acetaminophen (+) oxycodone (PERCOCET). On 12-FEB-2017, the patient was vaccinated with an intramuscular dose of PNEUMOVAX23 (dose, frequency, lot # and expiration date were not reported) for increased risk of pneumococcal disease due to age and then, she experienced soreness, stiffness, swelling and erythema from the shoulder to the elbow beginning at an unspecified time after receiving the vaccine. The patient sought medical attention by contacting the primary reporter. The outcome of the adverse events was reported as not recovered at the time of reporting. No product quality complaint (PQC) was involved.  The causality between the mentioned adverse events and PNEUMOVAX23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006019: US-009507513-1706USA005964: US-009507513-1702USA006102:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of more than - 15 but less than -10 degrees Celsius for 3 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001482:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance, concerning a patient of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 14-FEB-2017, the patient was vaccinated with an expired dose of MMRII (dose, frequency and route were not reported), for prophylaxis. Lot # L004658 with expiration date of 02-FEB-2017. The vaccine did not have any previous temperature excursions. No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 15-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (0.65 ml once, subcutaneously), lot # L016283 with expiration date of 07-AUG-2016, for prophyalxis. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from an office administrator concerning a female patient of unknown age. On 14-FEB-2017, the patient was inadvertently given a dose of PROQUAD (lot #M037012, expiration date 21-FEB-2018; dosage and route of administration not provided) instead of M-M-R II (albumin status and lot number not provided). The administrator was unable to provide a reason why the incorrect vaccine was given. No adverse effect reported. No additional information was provided. 03-MAR-2017: Lot #M037012, albumin status rHA, was verified to be a valid lot number for PROQUAD. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from an approximately 55 years old male patient of unknown age regarding himself via twitter (social media). It was reported that the patient had no pertinent medical history and drug allergies/reactions. On an unknown date approximately in 2012 (reported as around 4 to 5 years ago), the patient was vaccinated with ZOSTAVAX, 1 dose (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prevention of shingles. It was reported that the patient was not taking any medications concomitantly. On an unknown date approximately in 2015 ( reported as around two years ago), the patient developed shingles (herpes zoster) after receiving ZOSTAVAX and the patient further stated that it was "the most painful experience of my life" (pain). It was reported that the patient sought medical attention and visited office with the physician. The patient received treatment. On an unknown date a routine blood test was performed results and values were not reported. The outcome of herpes zoster was reported as recovered and the outcome of pain was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. 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: Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored M-M-R II (lot#, expiration, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001263:  US-009507513-1703USA001265: US-009507513-1703USA001264:
Sex: U
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (dose, route, lot number and expiration date were not reported) for routine vaccination. On an unknown date after received the vaccination with GARDASIL or GARDASIL 9, the patient experienced a seizure. The patient was undergoing unspecified evaluation to determine if a seizure disorder was present. A product quality complaint was not involved. At the time of the report, the outcome of the seizure was unknown. The causal relationship between the event and GARDASIL or GARDASIL 9 was not reported. Upon internal review seizure was considered to be as medically significant. Additional information has been requested. This is one of the several cases reported from the same source. Sender's Comments: US-009507513-1702USA012168.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-FEB-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration were not reported) lot number L001312 that had expired 24-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diplegia, Paralysis
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-SEP-2016, the patient was vaccinated with a dose of GARDASIL (Dose, lot number, expiration date, route and anatomical location were not reported). The patient's mother stated that on an unknown date, her daughter's limbs became paralyzed (diplegia) as a result of receiving GARDASIL. At the time of reporting the outcome of diplegia was unknown. There was no product quality complaint (PQC) involved. Upon internal review diplegia was determined to be medically significant. The primary reporter assessed the causality between the event and GARDASIL as related. Additional information is not expected as there is no contactable information available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1703USA001139: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001135: US-009507513-1702USA009844.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored VAQTA (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001139: US-009507513-1702USA009844: US-009507513-1703USA001138: US-009507513-1703USA001135: US-009507513-1703USA001136:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001139: US-009507513-1703USA001137: US-009507513-1702USA009844: US-009507513-1703USA001135: US-009507513-1703USA001135:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. (1)The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009844: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001135: US-009507513-1703USA001136:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M035140 with expiration date on 03-AUG-2018 (strength, dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccines had an unspecified temperature excursion (reported as more than 14 Fahrenheit (F) and less than 46 F) during a time frame of 1125 hours. Also it was reported that no previous temperature excursions occurred or a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. ; Sender's Comments: US-009507513-1702USA006140:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored ZOSTAVAX (lot#, expiration, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA001265: US-009507513-1702USA011328: US-009507513-1703USA001264.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored VARIVAX (lot#, expiration date, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001263: US-009507513-1703USA001265: US-009507513-1702USA011328:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored PROQUAD (lot#, expiration date, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA001263: US-009507513-1702USA011328: US-009507513-1703USA001264.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of more than - 15 but less than -10 degrees Celsius for 3 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006632.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Initial unsolicited report received from the consumer (patient's wife). This case involves a 28-years-old male patient who was vaccinated with a dose of SMALLPOX VACCINE (SMALLPOX) in left deltoid and the dose of ANTHRAX VACCINE (ANTHRAX) in right deltoid (batch number, expiry date, dose in series, dose and route of administration was not reported) on 11 February 2017. Illness at the time of vaccination and other medical history was none. Concomitant medications were not reported. On 17 February 2017, six days following the vaccination, the patient had experienced pain and swelling at the site of the smallpox vaccination along with a fever of 100F, chills, muscle and joint aches. Other relevant laboratory data was not reported. The patient was self-medicating with Ibuprophen as corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vaccination site swelling
Clinical narrative: Initial unsolicited report received from the consumer (patient's wife). This case involves a 28-years-old male patient who was vaccinated with a dose of SMALLPOX VACCINE (SMALLPOX) in left deltoid and the dose of ANTHRAX VACCINE (ANTHRAX) in right deltoid (batch number, expiry date, dose in series, dose and route of administration was not reported) on 11 February 2017. Illness at the time of vaccination and other medical history was none. Concomitant medications were not reported. On 17 February 2017, six days following the vaccination, the patient had experienced pain and swelling at the site of the smallpox vaccination along with a fever of 100F, chills, muscle and joint aches. Other relevant laboratory data was not reported. The patient was self-medicating with Ibuprophen as corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a Physician on 20 February 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. It was reported that patient received flu vaccine two years in a row. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient had a breakthrough of influenza. It was reported that additional testing being needed on whether the patient was immune deficient. Other lab data and corrective treatment were not reported. Outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: Influenza. List of documents held by sender: none. Sender's Comments: This case concerns an unknown age patient received INFLUENZA QUADRIVAL A-B VACCINE 2 years in a row and had a breakthrough of influenza. Time to onset is unknown. This is not a vaccination failure considering that no detail on virus identification was mentioned. Additional information regarding medical history of patient date of vaccination, time to onset, concurrent condition, confirmatory result (for type of influenza) and etiology of disease are needed for complete assessment of the case. Based on the available information no conclusion can be drawn.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cyanosis, Febrile convulsion, Loss of consciousness, Seizure, Tremor
Clinical narrative: Initial unsolicited report received from family nurse Practitioner on 21-FEB-2017. This case involves a three-month-old male patient (Age reported as four months) who was vaccinated with a dose of PENTACEL (batch number: C5249AA and expiry date: 27 Nov 2017) intramuscularly in right thigh, dose of HEP B (batch number: 443A2 and expiry date not reported ) intramuscularly in left thigh, PREVENAR 13 (batch number: N90908 and expiry date not reported) intramuscularly in right thigh and dose of ROTAVIRUS (batch number: M005732 and expiry date not reported) orally on 30 Jan 2017. The patient did not have any Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 30 Jan 2017, six hours following vaccination, the patient had a seizure lasting 30 seconds, lost consciousness; patient was shaking, and turned blue. It was reported that mother picked the child up and he was still trembling. On an unspecified date patient was taken to the emergency room. Diagnosis was reported as febrile seizure. Patient's mother had taken the temp at home and it was 100.3F. Other laboratory data and corrective treatment were not reported. On an unspecified date patient was recovered from events. Duration for seizure reported as 30 minutes. Upon internal review the case was considered as serious because of important medical event: febrile seizure. List of documents held by sender: none. Sender's Comments: This case concerns 4 month old male patient who received DIPHTHERIA/TETANUS/5HYBRID AC PERTUSSIS/IPV(MRC5)/HIB (PRP/T)VACCINE along with HEPATITIS B VACCINE, PNEUMOCOCCAL PLYSACCHARIDE VACCINE and ROTA VIRUS VACCINE. Patient developed febrile seizure. Time to onset is compatible with the role of vaccination. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case. Multiple vaccines administered simultaneously making it difficult to assess role of particular vaccine.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Death, Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Death
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Adrenal haemorrhage, Adrenocortical insufficiency acute, Anaemia, Arthralgia, Autopsy
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Back pain, Bacterial toxaemia, Bone pain, Cardiac arrest, Death
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: General physical health deterioration, Haemolysis, Headache, Hypotension, Hypovolaemic shock
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Meningococcal bacteraemia, Meningococcal infection, Necrosis, Neisseria test positive, Neutrophil count increased
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Pain in extremity, Paroxysmal nocturnal haemoglobinuria, Purpura, Resuscitation, Stupor
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Transfusion, Unresponsive to stimuli, Vaccination failure, Waterhouse-Friderichsen syndrome, White blood cell count normal
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Soreness at injection site - over the next few days, significant swelling of arm from elbow to shoulder, a band of red marks across half my arm, extreme soreness from elbow to shoulder, arm from elbow to shoulder is hot to touch.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: HEAD ACHE, FEVER, BODY ACHE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Significant swelling of upper left arm and pain.  Treated with ice and naproxen.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Full blood count, Laboratory test
Clinical narrative: Weakness, shortness of breath.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Full blood count, Haemoglobin
Clinical narrative: Weakness, shortness of breath.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Laboratory test, Transfusion
Clinical narrative: Weakness, shortness of breath.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: Weakness, shortness of breath.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Hypotension, Transfusion
Clinical narrative: Weakness, shortness of breath.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple unspecified 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 improperly stored doses of GARDASIL 9, lot number M018810, expiration date 08-MAY-2018 (dose, route, and anatomical location were not reported), for an unknown indication were administered to the patients' on an unknown date. The vaccine was exposed to a temperature between 32 Fahrenheit (F) and 36 F for 64 hours, due to a data logger issue. The previous temperature excursion was between 32 F and 36 F for 24 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.