chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Photophobia, Pyrexia, Rash, Rash vesicular, Slit-lamp examination
Clinical narrative: I had the normal inflammation/swelling at the injection site 1-2 days after receiving the vaccine. Then about a week after the injection (12/04/16) I started having left eye pain/pressure and light sensitivity. A couple days later I had fever and malaise. My eye got really red and painful and extremely light sensitive. The eye doctor thought it was viral pink eye at first but it developed into a full blown iritis. About a week and a half after starting on steroids for the iritis I got a vesicular rash on my mouth/nose. I was prescribed valacyclovir for suspected shingles iritis.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Eye inflammation, Herpes zoster, Iritis, Oral mucosal eruption, Rash vesicular
Clinical narrative: I had the normal inflammation/swelling at the injection site 1-2 days after receiving the vaccine. Then about a week after the injection (12/04/16) I started having left eye pain/pressure and light sensitivity. A couple days later I had fever and malaise. My eye got really red and painful and extremely light sensitive. The eye doctor thought it was viral pink eye at first but it developed into a full blown iritis. About a week and a half after starting on steroids for the iritis I got a vesicular rash on my mouth/nose. I was prescribed valacyclovir for suspected shingles iritis.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Pt first started developing a rash on ankle, thought it was a bug bite because of intense itching.  Rash began to quickly spread all over body. Realized it was hives.  Pt was itching all over body.  took 50 mg of benadryl at 6:15 and again at midnight.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Photopsia
Clinical narrative: I had light flashes in the right eye. I had never experienced that before. I researched the symptom, and retinal detachment is one of the causes. I then researched causes of retinal detachment, and Hepatitis B is one of the causes.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Myalgia, Tinnitus
Clinical narrative: Felt fine in office after administration of TDaP last visit, but approx 20m later out in the car felt a "wave" of overall physical sensitivity, body "reactive" that day, no ache at the injection point, no pain.  Went to bed early but had severe ringing in his ears, gone the next AM.  He only had minor soreness in the muscle a couple of days later.  Felt it was odd enough that he should report it.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Deafness, Dizziness, Ear swelling, Nausea
Clinical narrative: Fever on 10/01/16, continued to 10/02/16.  Fever resolved.  On 10/04/16, reported a "loud buzzing, like a motor".  Rested, upon waking, stated that he could not hear anything, complete hearing loss.  One week later, developed dizziness, nausea, and weakness.  At this time, reports he has recovered 20% of hearing, but has been told that it may be permanent hearing loss.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia, Tinnitus
Clinical narrative: Fever on 10/01/16, continued to 10/02/16.  Fever resolved.  On 10/04/16, reported a "loud buzzing, like a motor".  Rested, upon waking, stated that he could not hear anything, complete hearing loss.  One week later, developed dizziness, nausea, and weakness.  At this time, reports he has recovered 20% of hearing, but has been told that it may be permanent hearing loss.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Contusion, Immediate post-injection reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient immediately noted bruising over right deltoid and had mild pain at right deltoid and in post right upper arm. Posterior arm became very swollen, painful, and warm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates in 2016, the patients were vaccinated with unspecified improperly stored doses of PROQUAD (lot # M014301, expiration date 22-SEP-2017; dose and route were unknown) for prophylaxis. No adverse effects were reported. The excursion temperature included 9.9 Fahrenheit degree for 30 minutes on 10-AUG-2016 and 24.4 Fahrenheit degree for 1 hour and 30 minutes on 25-AUG-2016. Data logger was involved. No product quality complaint (PQC) was involved.  Albumin status for PROQUAD M014301 is rHA (recombinant human albumin). As of 21-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1610USA009666:Mfr number.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 13-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ 2 ml, orally, lot # L008053, expiration date: 30-NOV-2016. No adverse effects were noted. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot # M023169 and expiry date 13-JUN-2018) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013518: US-009507513-1612USA013519: US-009507513-1612USA013517: US-009507513-1612USA013520.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, lots# M030380 and M023169, expiration date 01-FEB-2019 and 13-JUN-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lots# M037248 and M026309 expiration date 21-FEB-2019 and 11-NOV-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lots#  M021365, M016238, M00611and M025565, expiration date 26-JAN-2018, 07-DEC-2017, 18-NOV-2017 and 06-NOV-2017 respectively (strength, dose and frequency were not reported) orally for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K010215 and expiry date 30-MAY-2017) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. Additional information has been requested. Sender's Comments: US-009507513-1612USA013519: US-009507513-1612USA010663: US-009507513-1612USA013518: US-009507513-1612USA013520.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot # M016238 and expiry date 07-DEC-2017) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013520: US-009507513-1612USA013519: US-009507513-1612USA010663: US-009507513-1612USA013517.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (lot # M001814 and expiry date 15-OCT-2018 or Lot # M027882 and expiry date 14-APR-2019) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013518: US-009507513-1612USA013520: US-009507513-1612USA010663: US-009507513-1612USA013517.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Age: 1.83
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 22-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 31-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates in 2016 (reported as "since 29-AUG-2016"), the patients received improperly stored doses of  (lot # M002063, expiration date: 12-JAN-2018; lot # M004328, expiration date: 26-JAN-2018; lot # M009768, expiration date: 23-FEB-2018; lot # M014309, expiration date: 21-MAR-2018; exact doses and route of administration were not reported). It was reported that the administered doses of VARIVAX were improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Follow up information was received on 19-DEC-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Sender's Comments: US-009507513-1610USA011133.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Sex: U
Vaccine: FLU4
Symptoms: Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with birth defects. Serious criteria included congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the birth defects may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of multiple birth defects in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed multiple birth defects. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between multiple birth defects and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Sex: U
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Neonatal hypoxia
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of neonatal hypoxia in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate was diagnosed with neonatal hypoxia. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of neonatal hypoxia was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the neonatal hypoxia may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of neonatal hypoxia in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient experienced neonatal hypoxia. This case has been considered as serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between neonatal hypoxia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, TD, VARCEL
Symptoms: Injection site abscess
Clinical narrative: 12-29-16 Health center called an stated the patient showed up to their clinic on 12-22-16 with what appeared to be an abscess to left deltoid area.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: Pt. was accidently given wrong dose of influenza of the .25 ml and not .5 ml. New employee - correct dose will be given to the patient. No adverse reaction was noted.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Joint range of motion decreased, Neck pain, Pain
Clinical narrative: (R) arm pain. Decreased range of motion. Pain across chest and back. Throbbing pain down (R) arm into fingertips after injection. Stabbing pain - back-neck-chest.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: (R) arm pain. Decreased range of motion. Pain across chest and back. Throbbing pain down (R) arm into fingertips after injection. Stabbing pain - back-neck-chest.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Local reaction, Mass, Pain, Swelling
Clinical narrative: After shot patient developed lump that was believed to be local reaction to vaccine and over last several months lump persisted and then in November area became more red and swollen. It went down with Benadryl. Has been having intermittent redness and swelling since November. In December she was treated with keflex for possible cellulitis in area due to pain, redness, and swelling. On 12-28-16 redness had resolved but patient complained of pain around area and had questionable swelling. Had ultrasound done of area which was normal.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Ultrasound scan normal
Clinical narrative: After shot patient developed lump that was believed to be local reaction to vaccine and over last several months lump persisted and then in November area became more red and swollen. It went down with Benadryl. Has been having intermittent redness and swelling since November. In December she was treated with keflex for possible cellulitis in area due to pain, redness, and swelling. On 12-28-16 redness had resolved but patient complained of pain around area and had questionable swelling. Had ultrasound done of area which was normal.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Headache, Immunoglobulin therapy, Influenza, Lumbar puncture
Clinical narrative: 10-13-16 Shot (Flu) felt sick/headache. 10-14- flu symptoms, at doctor. 10-16 - Paralyzed 7:45 am. EMR, Diagnosed GBS. 10-16 - started 5 IVIG treatments.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: 10-13-16 Shot (Flu) felt sick/headache. 10-14- flu symptoms, at doctor. 10-16 - Paralyzed 7:45 am. EMR, Diagnosed GBS. 10-16 - started 5 IVIG treatments.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Woke up with pain in injection site. Upon examination found ping pong ball sized hard lump and injection site with redness and warmth to the touch. Placed a call with physician who dismissed all symptoms and advised to apply cold packs and administer Tylenol. Following day lump doubled in size and was about 3.5 inches in diameter and about the size of a goofball. Redness had dramatically increased as well as tenderness and patient could not put weight on leg. Injection site was still extremely sore and patient will not allow it to be touched. Called nurse advice line and was advised to continue to monitor patient for infection/fever/worsening symptoms and keep same route of Tylenol and ice packs. Three days later and the redness has subsided a bit, but swelling is still noticeable and pain isn't as significant.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMRV
Symptoms: Weight bearing difficulty
Clinical narrative: Woke up with pain in injection site. Upon examination found ping pong ball sized hard lump and injection site with redness and warmth to the touch. Placed a call with physician who dismissed all symptoms and advised to apply cold packs and administer Tylenol. Following day lump doubled in size and was about 3.5 inches in diameter and about the size of a goofball. Redness had dramatically increased as well as tenderness and patient could not put weight on leg. Injection site was still extremely sore and patient will not allow it to be touched. Called nurse advice line and was advised to continue to monitor patient for infection/fever/worsening symptoms and keep same route of Tylenol and ice packs. Three days later and the redness has subsided a bit, but swelling is still noticeable and pain isn't as significant.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: PATIENT STATES INJECTION SITE GOT HARD, SWOLLEN AND HOT RIGHT AWAY, AND THEN PAIN IN ARM GOT PROGRESSIVELY WORSE. SHE HAS DIFFICULTY LIFTING HER ARM AND STILL FEELS A HARD SPOT AT SITE OF INJECTION.  ADVISED PATIENT TO SEE HER DOCTOR.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque forming units (PFU) lot # M030140, expiration date: 18-AUG-2017, as prophylaxis. (Dose and route of administration were not reported), which experienced a temperature excursion of max 9 Fahrenheit degrees for 1 hour and 21 minutes. A previous temperature excursion was reported of max 12.8 Fahrenheit degrees for 4 hours and 2 minutes. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports from the same source (MARRS linked report 1612USA008766). Additional information has been requested. Sender's Comments: US-009507513-1612USA008766.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ lot # L046318, expiration date: 28-SEP-2017, then, on 21-SEP-2016,  the patient received the second dose with lot # M004542, expiration date: 18-OCT-2017, the third dose was administered on 14-NOV-2016, with lot # reported as M022371, expiration date: 18-FEB-2018 and then, a fourth dose was administered on 14-DEC-2016, with a lot # M029251, expiration date: 14-MAR-2018, this last dose was outside the recommendations per the ROTATEQ prescribing information. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. No concomitant medication information was provided. On an unknown date, the patient started therapy with methotrexate (manufacturer unknown) tablets, per oral, for an unknown indication (dose, frequency, lot number and expiration date were not reported). While on therapy with methotrexate (manufacturer unknown), the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site rash
Clinical narrative: Information has been received from a 65 year old female patient referring to herself with heart failure and unspecified allergies. The patient was allergic to unspecified antibiotics. Concomitant therapies included ATACAND and COREG. On 21-DEC-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # M038359, expiration date, dose, route and site of administration were not reported) for prevention of pneumonia. On the same day, the patient experienced fatigue, "the chills", and an injection site rash on her arm for an unspecified reason. The patient sought medical attention by physician office visit. Cephalexin was used as treatment for the adverse events. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Amputation, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Diarrhoea
Clinical narrative: This literature marketed report was received from the authors of a published article. This report refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis. The patient had immune thrombocytopenic purpura (ITP) post-splenectomy who presented with fever, vomiting, diarrhea, increased white count and drop in platelets to 58. He was admitted to the ICU and required vasopressors for hemodynamic instability. He had streptococcus pneumonia bacteremia even after immunization with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) before his splenectomy (Vaccination failure and Pneumococcal sepsis). His lower extremities developed purpura fulminans-like rash possibly secondary to streptococcus pneumonia bacteremia and gangrenous wounds on lower extremities which warranted amputation due to concern for non-viable necrotic tissue. He was later found to have common variable immune deficiency (CVID) with low levels of IgG, IgA and IgM in his blood on evaluation for recurrent respiratory tract infections. It was reported that, ITP could be the presenting symptom of CVID and hence it may not be unreasonable to test for immunoglobulin levels on diagnosis of ITP. In this patient, inadequate response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) due to co-existing CVID may have resulted in overwhelming pneumococcal sepsis. Adequate gamma-globulin replacements before proceeding with vaccinations could have helped. At the time of this report, the outcome of the events was unknown. Upon internal review, event pneumococcal sepsis was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Gangrene, Intensive care, Platelet count decreased, Pneumococcal sepsis, Pneumonia streptococcal
Clinical narrative: This literature marketed report was received from the authors of a published article. This report refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis. The patient had immune thrombocytopenic purpura (ITP) post-splenectomy who presented with fever, vomiting, diarrhea, increased white count and drop in platelets to 58. He was admitted to the ICU and required vasopressors for hemodynamic instability. He had streptococcus pneumonia bacteremia even after immunization with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) before his splenectomy (Vaccination failure and Pneumococcal sepsis). His lower extremities developed purpura fulminans-like rash possibly secondary to streptococcus pneumonia bacteremia and gangrenous wounds on lower extremities which warranted amputation due to concern for non-viable necrotic tissue. He was later found to have common variable immune deficiency (CVID) with low levels of IgG, IgA and IgM in his blood on evaluation for recurrent respiratory tract infections. It was reported that, ITP could be the presenting symptom of CVID and hence it may not be unreasonable to test for immunoglobulin levels on diagnosis of ITP. In this patient, inadequate response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) due to co-existing CVID may have resulted in overwhelming pneumococcal sepsis. Adequate gamma-globulin replacements before proceeding with vaccinations could have helped. At the time of this report, the outcome of the events was unknown. Upon internal review, event pneumococcal sepsis was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Purpura fulminans, Pyrexia, Respiratory tract infection, Streptococcal bacteraemia, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article. This report refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis. The patient had immune thrombocytopenic purpura (ITP) post-splenectomy who presented with fever, vomiting, diarrhea, increased white count and drop in platelets to 58. He was admitted to the ICU and required vasopressors for hemodynamic instability. He had streptococcus pneumonia bacteremia even after immunization with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) before his splenectomy (Vaccination failure and Pneumococcal sepsis). His lower extremities developed purpura fulminans-like rash possibly secondary to streptococcus pneumonia bacteremia and gangrenous wounds on lower extremities which warranted amputation due to concern for non-viable necrotic tissue. He was later found to have common variable immune deficiency (CVID) with low levels of IgG, IgA and IgM in his blood on evaluation for recurrent respiratory tract infections. It was reported that, ITP could be the presenting symptom of CVID and hence it may not be unreasonable to test for immunoglobulin levels on diagnosis of ITP. In this patient, inadequate response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) due to co-existing CVID may have resulted in overwhelming pneumococcal sepsis. Adequate gamma-globulin replacements before proceeding with vaccinations could have helped. At the time of this report, the outcome of the events was unknown. Upon internal review, event pneumococcal sepsis was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This literature marketed report was received from the authors of a published article. This report refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis. The patient had immune thrombocytopenic purpura (ITP) post-splenectomy who presented with fever, vomiting, diarrhea, increased white count and drop in platelets to 58. He was admitted to the ICU and required vasopressors for hemodynamic instability. He had streptococcus pneumonia bacteremia even after immunization with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) before his splenectomy (Vaccination failure and Pneumococcal sepsis). His lower extremities developed purpura fulminans-like rash possibly secondary to streptococcus pneumonia bacteremia and gangrenous wounds on lower extremities which warranted amputation due to concern for non-viable necrotic tissue. He was later found to have common variable immune deficiency (CVID) with low levels of IgG, IgA and IgM in his blood on evaluation for recurrent respiratory tract infections. It was reported that, ITP could be the presenting symptom of CVID and hence it may not be unreasonable to test for immunoglobulin levels on diagnosis of ITP. In this patient, inadequate response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) due to co-existing CVID may have resulted in overwhelming pneumococcal sepsis. Adequate gamma-globulin replacements before proceeding with vaccinations could have helped. At the time of this report, the outcome of the events was unknown. Upon internal review, event pneumococcal sepsis was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose, Blood test, Electrocardiogram, Electrocardiogram ambulatory, Feeling abnormal
Clinical narrative: Upon exiting exam room, he turned a grayish color and collapsed to the floor in the Pharmacy where the clinic was located.  NP took his BP and it was rather low.  She continued to monitor him until he was showing signs of stabilizing. Once stable, we left the Pharmacy.  2nd episode occurred at around 2:20 PM.  Took him into the ER.  There he was put on a monitor, had an EKG, bloodwork drawn, blood sugar levels checked and an IV of fluids given.  Was in the ER for approximately 4 hours being monitored before being discharged.  He was diagnosed as having Syncope with collapse; vaccination side effect.  Upon arriving home from the ER stay, he started to feel bad once again and his coloring was grayish.  Once he was lying down, he started to regain his coloring and felt better.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypotension, Laboratory test normal, Skin discolouration, Syncope, Vaccination complication
Clinical narrative: Upon exiting exam room, he turned a grayish color and collapsed to the floor in the Pharmacy where the clinic was located.  NP took his BP and it was rather low.  She continued to monitor him until he was showing signs of stabilizing. Once stable, we left the Pharmacy.  2nd episode occurred at around 2:20 PM.  Took him into the ER.  There he was put on a monitor, had an EKG, bloodwork drawn, blood sugar levels checked and an IV of fluids given.  Was in the ER for approximately 4 hours being monitored before being discharged.  He was diagnosed as having Syncope with collapse; vaccination side effect.  Upon arriving home from the ER stay, he started to feel bad once again and his coloring was grayish.  Once he was lying down, he started to regain his coloring and felt better.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and bumps on Lt anterior thigh and then spread to Rt anterior thigh.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Irritability, Muscle spasms, Pyrexia, Rash, Screaming
Clinical narrative: High fever of any where from 100.1 103.2, screaming fits for hours while throwing his head and body backwards, a rash on his back and abdomen, he is very grumpy and whiny, he is also having what appear to be spasm's in both feet. He was treated with 3.5mls of motin at night.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a currently 75 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX injection for prevention of shingles. (Strength, dose, route, lot number and expiration date were not reported). On an unspecified date (reporter as recently), the patient had a severe breakthrough case of shingles. The patient sought medical attention and sawthe physician; who treated patient with unspecified antivirals but any other treatment was unknown by the physician. It was unknown if lab test were performed. At the time of reporting, the patient had not recovered from the event. The causal relationship between ZOSTAVAX and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PEDVAXHIB (lot # L036685 expiration date: 12-AUG-2018; lot # M027881 expiration date: 13-APR-2019; lot # M027884 expiration date 19-APR-2019; lot # M032148 expiration date: 18-APR-2019; lot # M032150 expiration date: 21-APR-2019;). The vaccines were exposed to 68.7 °F for 5 hours. Vaccine with lot # M020102 expiration date: 08-MAR-2019 was exposed to 54.5 °F for 5 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010217: US-009507513-1612USA010218: US-009507513-1612USA010219: US-009507513-1612USA010220.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that multiple unspecified patients with an unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with multiple doses of an incorrect storage of PEDVAXHIB (Lot # M001813, exp. 14-OCT-2018, lot # M014925, exp. 16-FEB-2019, lot # M020102, exp. 03-FEB-2019) (route, anatomical location and dose were not reported) for prophylaxis. No adverse effects were reported.  No other information was provided. Temperature excursion was 33.1 F for 90 minutes as per data logger. This is one of several reports received from the same reporter. As of 27-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1701USA001215: US-009507513-1610USA006216: US-009507513-1701USA001214.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pulse abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: Client sitting in chair in lobby after getting a TBST and a flu shot. She indicated to the person she came to the health department with that she was not felling well. He in turn called for the  nurse. That nurse called for this nurse and when I arrived, client was being lowered to the floor.  She was non responsive and pulse was weak. She started to have a seizure. This lasted approximately 1 minute.  Her eyes opened and she immediately tried to get up.  We explained where she was and what had happened.  EMS was called  from down the hall and they took over care of client.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Began to have numbness/tingling that extended to elbow ("like I hit my funny bone"); states this resolved without treatment.  Soreness of Rt shoulder continues, however, with certain movements or with sleeping on Rt shoulder.  States pain now localized.  Has improved with NSAIDs and Physical Therapy, but still has pain w/ lifting or reaching above shoulder-height.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: Death.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Burning sensation, Condition aggravated, Mobility decreased, Musculoskeletal pain
Clinical narrative: My arm burned to the hand before bedtime.  I could not move normally in the morning, and had to leave the bed by crawling on my knees on the floor and then pulling myself up.  The pain moved to my right shoulder and neck.  I ended up needing x-rays and PT.  Arthritis, tendons and rotater cuff all seemed to get set off from the shot.  I am still needing PT, and possibly a shot of cortisone.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Neck pain, Rotator cuff syndrome, Tendon disorder, X-ray limb abnormal
Clinical narrative: My arm burned to the hand before bedtime.  I could not move normally in the morning, and had to leave the bed by crawling on my knees on the floor and then pulling myself up.  The pain moved to my right shoulder and neck.  I ended up needing x-rays and PT.  Arthritis, tendons and rotater cuff all seemed to get set off from the shot.  I am still needing PT, and possibly a shot of cortisone.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Burning sensation, Condition aggravated, Gait disturbance, Mobility decreased
Clinical narrative: My arm burned to the hand before bedtime.  I could not move normally in the morning, and had to leave the bed by crawling on my knees on the floor and then pulling myself up.  The pain moved to my right shoulder and neck.  I ended up needing x-rays and PT.  Arthritis, tendons and rotater cuff all seemed to get set off from the shot.  I am still needing PT, and possibly a shot of cortisone.