chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M042171 with expiration date of 07-JUN-2018 and lot# M042822 with expiration date of 19-JUN-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001232:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of PROQUAD injection (dose, route of administration, lot number and expiration date were not reported). The vaccine was stored in the refrigerator at an unknown temperature for an unknown amount of time. It was unknown if any doses had been administered. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of potentially administered vaccines did not undergo an excursion. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAY-2017, the patient was vaccinated with expired dose of M-M-R II lot # L009213, expiration date 17-MAR-2017 (dose and route of administration were not reported) reconstituted with sterile diluent (MRK) lot # reported as L014262, expiration date 17-FEB-2018 (dose and route of administration were not reported). Vaccine was supported via post-expiry memo. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017, the patient was vaccinated with a dose of ZOSTAVAX for immunization (dose, route, lot # and expiration date were not reported). It was reported that after vaccination the patient experienced infection around the injection site. It was stated that the patient went to her physician's office and was treated with an unspecified antibiotic. At the time of reporting the outcome of the event was reported as fully recovered. A product quality complaint was not involved. The causality assessment between the adverse event and ZOSTAVAX was not provided. This is one of two reports from the same reporter.    Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004653:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4 month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-AUG-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 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-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a nurse of unknown age and gender, regarding him/herself. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient administered valacyclovir hydrochloride(VALTREX) concomitantly (concentration, dose, frequency and indication were not reported) less than 24 hours prior to administration of ZOSTAVAX 19400 PFU (dose, anatomical place of vaccination, route, lot# and expiration date were not provided), for prophylaxis and then, also in the days after administration of ZOSTAVAX.  No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 15-SEP-2012 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-DEC-2015, the patient was treated at a medical group center for a painful rash that was diagnosed as shingles. The patient has been prescribed valacyclovir (VALTREX) and tramadol to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 07-AUG-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2016, the patient was treated by her physician for a painful rash that was diagnosed as shingles with herpes zoster ophthalmicus. The patient was prescribed valacyclovir (VALTREX) for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 07-NOV-2011 at the clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. While shingles is a persistent viral condition, the patient has been prescribed vancomycin and acyclovir to manage his symptoms. The patient was later diagnosed by a physician, an Ophthalmologist, for a serious condition in which the shingles spread to his right eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Upon internal review, shingles spread to his right eye was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-MAY-2017, the patient was inadvertently vaccinated with an expired single dose of M-M-R II with lot # M032153 and expiration date of 22-APR-2017, subcutaneously (strength and dose were unknown) for prophylaxis. No adverse effects were reported. Additional information is not expected as no permission to contact was provided.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-MAY-2017,  the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # K021950, expiration date 10-NOV-2016 (dose and route of administration were not reported) for prophylaxis. The M-M-R II  was reconstituted with a sterile diluent (STERILE DILUENT), lot# reported as K021920, expiration date 15-SEP-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumococcal sepsis
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 61-year-old male patient received PREVNAR 13 (lot R49358, exp.date 30Apr2018) for Pneumococcal immunization on 02May2017 02:59 at 0,5ml single dose via an unspecified route of administration in the left deltoid muscle. Relevant medical history included ongoing Crohn's disease.  On 04May2017 the patient was admitted with pneumococcal sepsis. The patient was discharge on levofloxacin for 12 days. The outcome of the event was unknown. Sender's Comments: Reported event of Pneumococcal sepsis occurred 2 days following vaccination with PREVENAR 13. Considering the timeframe between the event and vaccination date far shorter than 14 days, the minimum time interval after vaccine administration for a person to develop antibody response to PREVENAR 13 containing serotyped pneumococcal infection, the occurrence of the event is not due to the lack of efficacy with PREVENAR 13 but instead most likely indicates that the very short time lag cannot elicit adequate antibody response to provide full protection against pneumococcal infection. Further information like confirmative serotype results are needed for full medical assessment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal X-ray, Abdominal pain, Blood test, Chest X-ray, Influenza
Clinical narrative: Redness, swelling, hot injection site first noticed day after shots, 2-10. Flu-like symptoms 2-18. Fever 105.6 on 2-20. Diagnosed with flu, then pneumonia 2-23. ER visit with extreme abdominal pain 2-26. White chalky penile discharge 2-28 and 3-7-2017.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Penile discharge
Clinical narrative: Redness, swelling, hot injection site first noticed day after shots, 2-10. Flu-like symptoms 2-18. Fever 105.6 on 2-20. Diagnosed with flu, then pneumonia 2-23. ER visit with extreme abdominal pain 2-26. White chalky penile discharge 2-28 and 3-7-2017.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pneumonia, Pyrexia, Ultrasound abdomen, Urine analysis
Clinical narrative: Redness, swelling, hot injection site first noticed day after shots, 2-10. Flu-like symptoms 2-18. Fever 105.6 on 2-20. Diagnosed with flu, then pneumonia 2-23. ER visit with extreme abdominal pain 2-26. White chalky penile discharge 2-28 and 3-7-2017.
Age: 24.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Rash erythematous, Rash pruritic, Vaccination site reaction
Clinical narrative: Red, raised, pruritus rash in area where the vaccine was given.  05/15 patient presented to clinic - rash no longer raised and patient reports rash being less pruritus.  Borders irregular and area approximately 2 inches in diameter.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site mass
Clinical narrative: Lump on left upper leg.
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 16 year-old male patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 07-FEB-2017 at 15:00, the patient was vaccinated by a now "retired nurse practitioner" with the first dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV). Subsequently on that day at about 22:00, according to the nurse practitioner's notes, the patient's mother reported that her son had a "fever of 102 degrees, and had begun vomiting". The patient's mother reported to the nurse practitioner the fever and vomiting were resolved and lasted a total of 36 hours; also, no treatment was given for any symptoms. He did not have follow-up visits made at that time, and since the onset of these adverse events, the nurse practitioner has retired and the patient was being seen by a physician. The physician stated to the representative that the patient's mother was uncertain as to whether or not they want the patient to complete the GARDASIL 9 series. At this time, they were consulting with another specialist (unspecified) as to whether or not the GARDASIL 9 series should be completed, and would also welcome input from MERCK. The causality between the mentioned adverse events and the GARDASIL was unknown. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Adverse event, Product used for unknown indication
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 3-month-old male patient. The patient's medical history included respiratory syncytial virus infection. The patient did not take any concomitant medications and did not have drug reactions or allergies. On 31-MAR-2017, the patient was vaccinated with a first dose of ROTATEQ one dose orally, lot # M034799, expiration date 01-FEB-2018 for prophylaxis. On an unspecified date in approximately April 2017 (reported as sometime after receiving the vaccination), the patient was prescribed oral prednisone (manufacturer unknown) for an unspecified reason. The patient's last dose of prednisone (manufacturer unknown) was on 28-APR-2017. The outcome of the adverse event and the relatedness between the event and vaccination with ROTATEQ were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a unspecified patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies were not reported. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of  RECOMBIVAX HB lot # M046373/expiration date 04-NOV-2018, as well as an improperly stored dose of VAQTA lot # N005605/expiration date 08-APR-2018, both for prophylaxis (the route, strength, frequency and dose were not provided). It was reported that the vaccines were exposed to temperature of 47° F to 77°F (9°C to 25°C) for a time frame of 6 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reporter as nurse prescriber), concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L012479 and expiration date on 10-APR-2017 (strength, dose, route of administration or anatomical location were not provided); administered as prophylaxis. The patient did not experience any effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a public health nurse and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M001814, expiration date 15-OCT-2018; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccines were exposed to a temperature excursion range from 32°F to 35°F for a total time frame of 53 minutes. A previous temperature excursion measured a temperature of 34°F recorded on a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with first and second dose of M-M-R II (unknown albumin status) for prophylaxis (doses, anatomical location, lot# and expiration date were not reported; route of administration reported as vaccination). On an unknown date, the patient experienced mumps. The outcome of mumps was unknown. The relatedness between the event of M-M-R II was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 13-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2013, the patient was treated by her physician for a painful rash that was diagnosed as shingles. The patient has been prescribed valacyclovir  to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 12-SEP-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated by her nurse practitioner at a health center for a painful rash that was diagnosed as shingles. On or about 06-SEP-2016, the patient was diagnosed with post herpetic neuralgia at the same facility, as worsening and residual effect of shingles. The patient was prescribed valacyclovir (VALTREX), lidocaine (LIDODERM), pregabalin (LYRICA)  and betamethasone dipropionate cream for management of these symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain in extremity, Sensory loss
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO (batch number 157501, expiry date August 2017). On 7th April 2017, the patient received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced pain in arm, myalgia upper extremities and loss of sensation. On an unknown date, the outcome of the patient in arm, myalgia upper extremities and loss of sensation were unknown. It was unknown if the reporter considered the pain in arm, myalgia upper extremities and loss of sensation to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2017, reporter received a call from the guardian (Mother of the patient) reporting pain, myalgia and loss of some sensation all over the arm where the vaccine was administered, still 13 days after administration of vaccine. The patient's mother was oriented about side effects and was told to visit his paediatrician who is in the same office for proper evaluation. However, the patient mother never calls back for feedback or set an appointment with patient's paediatrician. By the time the patient mother report the event, she hadn't either visited any other to inform and request evaluation.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Myelitis transverse
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Inflammation, Nuclear magnetic resonance imaging, Pain in extremity, Synovitis
Clinical narrative: The patient noticed an aching in the arm she received a FLUZONE HD vaccine in (left arm) about one month after the vaccine. She saw the doctor, but it was not bothering her enough to warrant any action. In December she was given a topical nsaid for the pain and it helped. She then had an x-ray done at the end of December and started physical therapy around January. She has been in physical therapy for 3.5 months now. She recently had an MRI and another x-ray and has been diagnosed with tendonitis, synovitis, and arthritis. She is concerned that a component of the vaccine may have lead to the inflammation that is present in her arm now.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, X-ray
Clinical narrative: The patient noticed an aching in the arm she received a FLUZONE HD vaccine in (left arm) about one month after the vaccine. She saw the doctor, but it was not bothering her enough to warrant any action. In December she was given a topical nsaid for the pain and it helped. She then had an x-ray done at the end of December and started physical therapy around January. She has been in physical therapy for 3.5 months now. She recently had an MRI and another x-ray and has been diagnosed with tendonitis, synovitis, and arthritis. She is concerned that a component of the vaccine may have lead to the inflammation that is present in her arm now.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, warmth and bruising at injection site, 3 days post-vaccination. Ice as needed.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in left arm after swimming the day following the injection.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Dizziness postural, Fatigue, Loss of consciousness
Clinical narrative: SHE BEGAN TO COMPLAIN OF JOINT PAIN AND MUSCLE PAIN IN HER KNEES AND LEGS. CALLED THE PHONE NURSE AND WAS TOLD THAT IT WAS PROBABLY JUST GROWING PAINS TO TAKE SOME TYLENOL AND ADVIL. THESE SYMPTOMS CONTINUED AND THEN SHE RECEIVED HER SECOND DOSE AND THEN THE FINAL DOSE ON 12/21/2012. THOSE SYMPTOMS CONTINUED AND THEN SHE STARTED TO BECOME DIZZY AT TIMES WHEN SHE WOULD STAND FOR TOO LONG OR GO FROM A SITTING TO A STANDING POSITION AND AS THE MONTHS WENT ON SHE BECAME MORE AND MORE FATIGUED. BY NOVEMBER OF 2014 HER DIZZINESS BECOME SO SEVERE THAT SHE PASSED OUT IN THE SHOWER AND WE THOUGHT SHE HAD A SEIZURE AND IT WAS NOT IT TURNED OUT TO BE POTS.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Postural orthostatic tachycardia syndrome
Clinical narrative: SHE BEGAN TO COMPLAIN OF JOINT PAIN AND MUSCLE PAIN IN HER KNEES AND LEGS. CALLED THE PHONE NURSE AND WAS TOLD THAT IT WAS PROBABLY JUST GROWING PAINS TO TAKE SOME TYLENOL AND ADVIL. THESE SYMPTOMS CONTINUED AND THEN SHE RECEIVED HER SECOND DOSE AND THEN THE FINAL DOSE ON 12/21/2012. THOSE SYMPTOMS CONTINUED AND THEN SHE STARTED TO BECOME DIZZY AT TIMES WHEN SHE WOULD STAND FOR TOO LONG OR GO FROM A SITTING TO A STANDING POSITION AND AS THE MONTHS WENT ON SHE BECAME MORE AND MORE FATIGUED. BY NOVEMBER OF 2014 HER DIZZINESS BECOME SO SEVERE THAT SHE PASSED OUT IN THE SHOWER AND WE THOUGHT SHE HAD A SEIZURE AND IT WAS NOT IT TURNED OUT TO BE POTS.
Age: 0.58
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Polio vaccination was given at this date, however it was never added into record. The lot number was L1130-1.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in right deltoid.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Client age 18y 9m, given an adult dose of Hepatitis A. No adverse reaction noted.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dysstasia, Injection site erythema, Injection site swelling
Clinical narrative: Full body muscle aches, joint pain, chills, nausea, swelling and redness at inj site, standing difficulty.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: Full body muscle aches, joint pain, chills, nausea, swelling and redness at inj site, standing difficulty.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient got vaccine on 5/17 she came today 5/14 and told me she has sore and warmness in the area where the vaccine was given and she has little pain in the injection area. I told her that it is the side effects and ask her to put ice and use ibuprofen and also told her to check with her primary physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient developed bursitis-raised red area w/pain and inflammation at injection site.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None listed.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Eye swelling, Feeling abnormal, Feeling jittery, Pain
Clinical narrative: Pt. reports swollen eyes and face, chills, jittery and pain. Took BENADRYL with some relief. Next AM felt like airway is tight. No SOB or wheezing. "Just doesn't feel right". Went to urgent care and treated with oral steroid.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face, Throat tightness
Clinical narrative: Pt. reports swollen eyes and face, chills, jittery and pain. Took BENADRYL with some relief. Next AM felt like airway is tight. No SOB or wheezing. "Just doesn't feel right". Went to urgent care and treated with oral steroid.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unspecified date in July 2015, the patient was vaccinated with PNEUMOVAX23, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 21-APR-2017, the patient was vaccinated with a second dose of PNEUMOVAX23 lot # M027552 dose 2 for prophylaxis (dose and route of administration) (inappropriate schedule of drug administration). The pharmacist was informed about the patient's first dose vaccine administered, until 21-APR-2017. No adverse effect reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 28-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L012481 and expiration date 10-APR-2017) for prophylaxis (dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Necrotising retinitis, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 11-NOV-2014 at a hospital, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-NOV-2014, the patient was treated at a hospital for a painful rash and complications that were diagnosed as shingles and acute retinal necrosis attributable to VZV. The patient was hospitalized for a period of seven days for these conditions and was prescribed acyclovir to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, acute retinal necrosis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 25-JAN-2013 at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-FEB-2014, the patient was treated by her physician at a clinic for a painful rash that was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) for treatment and management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 18-NOV-2012 at a Medical Group Center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-AUG-2016, the patient was treated by her physician for a painful rash that was diagnosed as a severe case of shingles. The patient has been prescribed valacyclovir (VALTREX) for the management of her persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 02-APR-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 29-FEB-2016, the patient was treated  by a physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Pyrexia, Seizure
Clinical narrative: Initial unsolicited case received from a nurse on 08 May 2017. This case involves five-year-old female patient who was vaccinated with third dose of DAPTACEL (Batch number: C5014BA, Expiry date: 29 Jul 2018, dose was not reported) intramuscularly in the left deltoid on 29 Nov 2016. The patient illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. On 30 Nov 2016, 1 day after the vaccination, the patient developed seizure and a fever with a 5 cm red area at injection site on left deltoid, it was also reported that the patient did not go to doctor or ER. The patient was previously vaccinated with two doses of DAPTACEL (batch number, expiry date, dose, route and site of administration was not reported) on an unknown dates. The patient relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. Upon internal review the company decided to consider the case as serious due to important medical event Seizure. List of documents held by sender: none. Sender's Comments: This case concerns 5 year old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and on next day developed seizure, fever and vaccination site erythema. Time to onset is compatible with role of vaccine. However, this case is poorly documented and 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 a complete assessment of the case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Abnormal head shaking w/out change in level of consciousness w/in 1 hr after 6m vaccines. (PENTACEL, PREVNAR, Hep B, Rota). 02/23/2017-Both parents are here due to concerns about movements. Patient had immunizations 2/14/17 and mother states that 1hr after apt he started shaking his head "back and forth" Looking right to left, and would do it for a few seconds and stop. No LOC, No perioral cyanosis, no uprolling of eyes, foaming at mouth or abn movements of limbs associated with this rocking head movement. No fever and mother noted that he is otherwise eating and drinking well with no labored breathing, inconsolable, irritability. Since that first day - this head rocking activity has been occurring Daily 2-3 times per day and up to 5-6 times lasting about 1 min but mom says his name and stops. Last episode was just prior ot arrival and parents have a video him doing this. No previous history of stereotypic movements. Reviewed history - developmentally appropriate for age. Bhx - noncontributory. Viewed phone video of and movements - for 3 seconds he had symm rocking of his head back and forth without eye movements that is associated with movement of b/l lower extremities symmetric movements. 05/11/2017- Pt is here with mom. Dad is sick with head cold mom would like patient checked - showing no sx bruise on left wrist x2 (mom states its not going away). Mother unsure about future vaccines. Had abnormal head shaking without change in level of consciousness starting within 1 hr after 6 m vaccines were administered on 2/14/17 (rec'd PENTACEL, PREVNAR, Hep B, Rota). Pt seen here by Dr on 2/23/17 for this complaint, inc video of the head movements which were felt to be benign purposeful movements. Mother has read online about other children experiencing similar head movements after vaccines and feels strongly that they are related due to the timing. Head movements have gradually decreased in pat 2 mos and now has not had any for few days. Also was more fussy after the vaccines for weeks, has finally resolved.
Age: 0.08
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema
Clinical narrative: 1 mo after KINRIX inj given, father reports a bruise type area on (L) arm. Was red initially x 24 hrs. then bruise like shadow remains now 7 mo post inj.
Age: 23.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Evening pt received vaccine, she experienced swelling, redness, pain at injection site. Pt seen in office 72 hrs later without improvement. Pt treated for local RXN with Ibuprofen and ice and antibiotic Rx'ed for possible cellulitis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Cried inconsolable per Mom for more than 3 hours after vaccines administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate redness to area where vaccine was given subcutaneously (L) arm. Patient was given 5ml BENADRYL liquid pen.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: TDaP given instead of DTap  for dose #2 of DTap.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right upper extremity given Triamcinolone Acetonide 0.1% cream.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Redness, swelling, hives, itching right arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Bowel movement irregularity, Cough, Decreased appetite, Emotional disorder
Clinical narrative: Runny nose, cough, elevated temperature 99.2-99.9 all occurred on dates 05/11/2017 and 05/12/2017. On 05/13/2017 PM she had runny nose, cough, 101.5 temperature, and spotted rash all over her body. Mainly on torso. Started on forehead and worked its way down her body. She was very irritable and inconsolable. No appetite. Irregular bowel movements. Lethargy. 5/14/2017 AM &PM elevated temp 99.3-99.8, runny nose reddish/pink speckled rash on body. Irritable, cough, lethargy. 5/15/2017 elevated temp 99.4 . Runny nose. Light pink speckled rash. Slightly fussy, mainly content. Tired. Called on call dr at  hospital and she suggested roseola, and said to keep my child home on 5/13/2017 PM. Called pediatricians office to inform them of the situation on 5/15/2014 AM and nurse suggested reaction from vaccine. And said to stay home until rash clears. *all temps taken on forehead.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Irritability, Lethargy, Rash erythematous, Rash generalised
Clinical narrative: Runny nose, cough, elevated temperature 99.2-99.9 all occurred on dates 05/11/2017 and 05/12/2017. On 05/13/2017 PM she had runny nose, cough, 101.5 temperature, and spotted rash all over her body. Mainly on torso. Started on forehead and worked its way down her body. She was very irritable and inconsolable. No appetite. Irregular bowel movements. Lethargy. 5/14/2017 AM &PM elevated temp 99.3-99.8, runny nose reddish/pink speckled rash on body. Irritable, cough, lethargy. 5/15/2017 elevated temp 99.4 . Runny nose. Light pink speckled rash. Slightly fussy, mainly content. Tired. Called on call dr at  hospital and she suggested roseola, and said to keep my child home on 5/13/2017 PM. Called pediatricians office to inform them of the situation on 5/15/2014 AM and nurse suggested reaction from vaccine. And said to stay home until rash clears. *all temps taken on forehead.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rhinorrhoea, Roseola, Vaccination complication
Clinical narrative: Runny nose, cough, elevated temperature 99.2-99.9 all occurred on dates 05/11/2017 and 05/12/2017. On 05/13/2017 PM she had runny nose, cough, 101.5 temperature, and spotted rash all over her body. Mainly on torso. Started on forehead and worked its way down her body. She was very irritable and inconsolable. No appetite. Irregular bowel movements. Lethargy. 5/14/2017 AM &PM elevated temp 99.3-99.8, runny nose reddish/pink speckled rash on body. Irritable, cough, lethargy. 5/15/2017 elevated temp 99.4 . Runny nose. Light pink speckled rash. Slightly fussy, mainly content. Tired. Called on call dr at  hospital and she suggested roseola, and said to keep my child home on 5/13/2017 PM. Called pediatricians office to inform them of the situation on 5/15/2014 AM and nurse suggested reaction from vaccine. And said to stay home until rash clears. *all temps taken on forehead.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Within hours of receiving vaccination, pt developed shingles. She came to clinic to report on 5/12/2017. The area was from her shoulder to elbow.
Age: 55.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Patient stated about an hour after the injection she stated feeling dizzy, nauseous, headache, and fatigue for about 2 days. Also at the site of injection it swelled up to about baseball size, red and very hard. There was one blister at the injection site. Today, 5/15/17, it was about the size of a golf ball.
Age: 55.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Nausea
Clinical narrative: Patient stated about an hour after the injection she stated feeling dizzy, nauseous, headache, and fatigue for about 2 days. Also at the site of injection it swelled up to about baseball size, red and very hard. There was one blister at the injection site. Today, 5/15/17, it was about the size of a golf ball.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Culture, Injection site cellulitis
Clinical narrative: Patient developed cellulitis at injection site. Treated with clindamycin and cephalexin x 7 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Chest pain, Feeling hot
Clinical narrative: Patient reported feeling hot and having chest pain and tightness. I called 911 and she was moved via ambulance to medical center.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Pt was diagnosed with cellulitis, and Rx'ed Cephalexin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Alopecia, Alopecia areata, Blood thyroid stimulating hormone normal, Full blood count normal, Laboratory test normal
Clinical narrative: Alopecia areata - hair loss noted 7 days after vaccine.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented with pain at the injection site, which radiated down through tricep region. The area was red and warm due to blood pooling in the area.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said arm was painful and limited motion.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Blood test normal, Impaired driving ability, Lip injury, Seizure, Unresponsive to stimuli
Clinical narrative: Shortly before 6 am, patient was found down by friends convulsing. Seizure reported to last nearly 6 minutes from time she was found down, patient unable to respond for an additional 3 minutes after convulsions stopped. Upper lip cut, unsure if bit or related to fall. Patient was taken to ER via ambulance for tests, observation, and discharged on seizure medication, driving privileges revoked.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Urine analysis normal
Clinical narrative: Shortly before 6 am, patient was found down by friends convulsing. Seizure reported to last nearly 6 minutes from time she was found down, patient unable to respond for an additional 3 minutes after convulsions stopped. Upper lip cut, unsure if bit or related to fall. Patient was taken to ER via ambulance for tests, observation, and discharged on seizure medication, driving privileges revoked.