chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Incorrect product storage, No adverse event
Clinical narrative: Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advise for re-administration of the dose. No adverse effects reported.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Edema (arm).
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Incorrect product storage, No adverse event
Clinical narrative: Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advised for re-administration of the dose. No adverse effects reported.
Age: 73.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Patient received 2nd dose of HepA/HepB. Product problem: Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advised for re-administration of the dose. No adverse effects reported.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Pharyngitis, Pyrexia, Rash
Clinical narrative: Given MMRV vaccine on 3/21/17. Developed rash and fever 4 days later. Seen in office again on 3/31/17 for rash and fever. Treated with antibiotic for pharyngitis on 3/31/17.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Gait disturbance, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Right thigh red and swollen with softball size knot. Hot and tender to touch. Child limping. TX: Amoxicillin, Prednisolone
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site warmth
Clinical narrative: Right thigh red and swollen with softball size knot. Hot and tender to touch. Child limping. TX: Amoxicillin, Prednisolone
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood electrolytes, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Entire left upper arm is swollen, tender and red. Hurts really bad from the shoulder to the elbow.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Urine analysis
Clinical narrative: Entire left upper arm is swollen, tender and red. Hurts really bad from the shoulder to the elbow.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Diarrhoea, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever: -resolved 4/1/17 Rash: -ongoing/improving Runny nose: Prior to immunization - resolved 4/3/17 Diarrhea: -resolved 4/3/17
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: Red rash on legs and chest and lasted 20 mins. Red at site.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Otitis media, Pyrexia, Rash
Clinical narrative: Given MMRV vaccine on 3/21/17. Developed dotted rash on 3/22/17 and fever. Seen in office again on 3/31/17 for fever and rash. Treated with antibiotics for right otitis media on 3/31/17.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness measuring 6 cm x 5 cm around injection site. Will resolve on own, give 3/4 tsp. BENADRYL as needed every 6 hours until redness gone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Macule
Clinical narrative: Multiple salmon colored scattered raised macules, non tender, non-pruritic in trunk and extremities.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling pain at injection site one day after administering. Pt. used ice and otc anti-inflammatories to help. Pt stated after injection on 4/5/17 that she had previous reaction to pertussis as a child.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ulcer
Clinical narrative: 2 days after administration patient returned to pharmacy presenting shingles sores.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Fatigue, arthralgia's, fever, weakness vomiting, swelling at site of injection.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Fatigue, arthralgia's, fever, weakness vomiting, swelling at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site swelling and redness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash
Clinical narrative: Received vaccine on Friday. On Saturday inj site was red, hot to touch and painful. Sunday rash developed from site of injection and over chest area. Rash was raised with blister like pustules.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash pustular
Clinical narrative: Received vaccine on Friday. On Saturday inj site was red, hot to touch and painful. Sunday rash developed from site of injection and over chest area. Rash was raised with blister like pustules.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Pyrexia
Clinical narrative: Pt took tablet #1 of oral Typhoid Rx on 4-4-2017 at 9:30 PM. By 9:35 pm pt C/O abd cramping diarrhea and fever x 2 hours. She then went to bed and slept the night.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient developed a perfect circle red patch at injection site with slight inflammation.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea, Irritability
Clinical narrative: Diarrhea and watery stools with colicky irritability beginning 3 days after ROTARIX. Breast fed baby. Symptoms resolved after 1-2 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Nausea, Peripheral swelling, Skin warm
Clinical narrative: Left arm, swelling/reddish and hot/sweating/nauseous. Pneumococcal polysaccharide vaccine.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Rash, fevers, chills for 2 days.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that her arm has been hurting for 4 months - can't raise arm to lift things out of cupboards. Has taken TYLENOL and applied BIOFREEZE without relief. She seems to think also got flu shot same day - did not.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Tremor, Wheezing
Clinical narrative: Day after vaccination pt developed itchy white hive over injection site. Also complained of feeling itchy on the inside and unable to quit shaking, wheezing. ER gave BENADRYL 50mg IVP, DUONEB, PEPCID 20mg IVP. SOLUMEDROL 125mg IVP. Discharged to home, then returned to ER by ambulance 2 days later admitted x2 days.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received TDaP in right deltoid on Monday. On Tuesday (approximately 27hrs) later, patient began having burning and redness to injection site, redness increased throughout day Wednesday. Somewhat better today but still red and sore.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Haemoglobin normal, Pyrexia
Clinical narrative: 9:05 am no adverse reaction 15 minutes later. No treatment needed. Mother voiced understanding and will continue to monitor patient and follow up with TYLENOL every 4 to 6 hours for fever.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse reactions.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dept. of health notified by patient's employer on 4/10/17 that she would not be coming 4/11/17 for second dose. Complained of n/v, dizziness, HA, abdominal cramping on 4/4/17 at 12 noon (another report started 1730). Went to ER- given ZOFRAN. To discuss with PCP benefits vs. r/s RS continuing series. Patient to ER 4/4/17 at approximately 1900.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor, Rash erythematous
Clinical narrative: Erythematous, blanching rash on face, trunk, and arm appeared w/I 24 hours of vaccination. Well appearing otherwise.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness
Clinical narrative: Pt. felt light headed. Had pt. lay down with feet up and a cool cloth was place on forehead and Ice pack placed under neck. Pt. laid there for approximately 5 minutes. Then sat up and stood up and felt fine. Encouraged to drink water. She states hasn't drank much.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: (L) deltoid area sore, difficult ROM in 24 hrs. then swelling, redness and warmth.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccinations TDaP and MCV4 in right deltoid on 4/11/17. That night noticed it was swollen, red and warm to touch. Pt. took TYLENOL on 4/12/17 and 4/13/17. Came to PCP to report reaction on 4/13/17. Tx: cool compress, ibuprofen and clindamycin.
Age: 89.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Severe erythematous macular-papular rash with vesicles and bullae across left flank (left abd, left side, and left lower back along dermatome) typical of herpes zoster. No pain. BENADRYL - per MD note on 4/12/17 and 4/13/17.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Pt received MENACTRA vaccine (dose #2). Adverse reaction - dizzy, nauseous, pale, took 40 mins to come out of it.
Sex: F
Vaccine: FLU3, HPV9, MNQ, PNC13, TDAP
Symptoms: Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 561379). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses were reported as upper respiratory tract infection and sprained lower extremity. Information on the patient's prior vaccinations, medical history and other medications were not reported. On 13-JAN-2015 the patient was vaccinated with GARDASIL 9 lot # K004205, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot/batch# 3HG7R, dose 1 via intramuscular route in the right arm, PREVNAR 13 lot/batch# J16882, dose 1 via intramuscular route in the right arm, FLUZONE lot/batch# U1190AE, dose 1 via intramuscular route in the left arm and MENACTRA lot/batch# U4800AC, dose 1 via intramuscular route in the right arm for prophylaxis. On 13-JAN-2015, the patient experienced headache about 10-15 min after administration, self-resolved. The patient's vital signs were stable. The outcome of headache was unknown. The causality assessment for the event headache with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Hallucination, visual
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 585111). This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses, medical history and other medications. On 09-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026247 via intramuscular route for prophylaxis (dosage and dose number unspecified). On the same day, patient was also vaccinated with BOOSTRIX batch/lot # BL9BD via intramuscular route (dosage and dose number unspecified) and MENACTRA batch/lot # U5058AC via intramuscular route for prophylaxis (dosage and dose number unspecified). On 09-JUL-2015, the patient experienced visual hallucination and crying. The patient was reported to have had "hallucinations involving seeing a dark man-shaped figure, without arms or legs, crawling across the ceiling and attacking and chewing on her twin sister. Terrified of what she was seeing, crying." The reactions were reported to have lasted approximately 45-60 minutes per patient's father. The outcome of crying and hallucination, visual was unknown. The causality assessment for the events crying and hallucination, visual with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MEN, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to three patients- siblings of unknown age, gender, medical history, concomitant medications, drug reactions or allergies. On 31-AUG-2016, the patients were vaccinated with VAQTA (lot # L043209, expiration date 17-SEP-2017, dose, route of administration were not reported), for prophylaxis. The nurse reported that VAQTA doses were stored improperly. The data logger involved, prior temperature excursion reported: in July 2016 (1 Celsius degree for 69 hours 30 minutes) and in March 2017 (10 Celsius degree for 77 hours 41 minutes). No adverse effects reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness/vertigo. Will call patient's PCP to follow up if patient needs to see the doctor or not.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Gradually getting worse- swollen, red arm- tender to touch- extends to elbow- mostly on inner bicep- no treatment.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 15 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in April 2015, the patient was vaccinated with the first dose of GARDASIL 9 injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date in December 2016, the patient received the second dose of GARDASIL 9 injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as no permission has been granted to contact the physician.
Sex: M
Vaccine: HIBV, TD
Symptoms: Autism spectrum disorder, Communication disorder, Detoxification, Developmental delay, Speech disorder developmental
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 03-Apr-2017. This case involves a two-year-old male patient who was vaccinated with first, second and third doses of DIPHTHERIA-6.7/TETANUS-5 ADSORBED TOXOIDS (DT) (Batch number: U2105BA, expiry date: 29-Jan-2010 for all three vaccines) (dose, dose in series, route of administration were not reported) in thigh, first dose of ACT-HIB (Batch number: UF225AA, expiry date: 17-May-2009) in thigh and second and third doses of ACT-HIB within four weeks of other vaccinations (Batch number: UF461AA, expiry date: 21-Oct-2009 for all two vaccines) (dose, dose in series, route of administration were not reported) in thigh at 6 months, 8 months and 1 year respectively on an unspecified date of 2008. Illness at the time of vaccination was reported as reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions none developing normally until two years old. Concomitant medications were not reported. On an unspecified date of 2008, the patient had a sudden reversal of development and had a diagnosis of pervasive developmental disorder not otherwise specified which was a form of Autism marked by developmental delays and speech delays and communication avoidance. The patient required ER/ doctor visit. The patient had no laboratory data. Corrective treatment reported that patient was undergoing a detoxification program to improve his delays at age of nine years. Patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events pervasive developmental disorder not otherwise specified, sudden reversal of development, developmental delays, speech delays, communication avoidance. List of documents held by sender: none. Sender's Comments: This case concerns a 2 years old male patient who received DIPHTHERIA-6.7/TETANUS-5 ADSORBED TOXOIDS and HIB (PRP/T) VACCINE and experienced Pervasive developmental disorder not otherwise specified. Time to onset is compatible with the role of vaccine. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea
Clinical narrative: Bad Diarrhea lasting 1 day. No fever or any other symptoms.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP
Symptoms: Injection site hypoaesthesia, Myalgia, Pain
Clinical narrative: Pt c/o Numbness in Left arm at deltoid radiating down arm. Sharp, pain when raising arm. Only able to raise arm shoulder-high. Also pain in triceps when she bends arm. Pt states problem hasn't resolved since administration of vaccine. Has not sought medical care. Has taken OTC ASA for s/sx with some relief, but not total resolution.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Nausea, Pain, Pyrexia
Clinical narrative: I was given the TDAP vaccine while pregnant and immediately felt sick to my stomach. That day I developed a low fever, chills, shaking, vomiting (once), body aches and pains, and nausea. This lasted for 72 hours. I missed work for 4 days and no medicated would sooth the symptoms. Doctor's told me it was "coincidence" despite my symptoms being labeled as possible side effects for about 1/100 people! I was not given informed consent.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: I was given the TDAP vaccine while pregnant and immediately felt sick to my stomach. That day I developed a low fever, chills, shaking, vomiting (once), body aches and pains, and nausea. This lasted for 72 hours. I missed work for 4 days and no medicated would sooth the symptoms. Doctor's told me it was "coincidence" despite my symptoms being labeled as possible side effects for about 1/100 people! I was not given informed consent.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Flushing, Pyrexia, Vomiting
Clinical narrative: Face flushed, fever and vomiting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: AROUND THE INJECTION SITE WAS A RED, RAISED, RASHY AREA. IT WAS MILDLY PAINFUL. IT MEASURED APPROXIMATELY 1" X 2". THE NEXT DAY IT BEGAN TO ITCH.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX, lot # M038864, expiry date 20-DEC-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects reported. Administered vaccines experience temperature excursion of 1.9 degrees Celsius for 6 weeks and 5 days. There were no previous temperature excursion. Data logger was not involved. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 51 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with PROQUAD (lot#, expiration date, dose and route of administration were not provided) for prophylaxis. No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 50-year-old male patient. No information regarding patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On an unknown date, the patient received ZOSTAVAX, single injection, subcutaneously (lot# and expiration date were not provided) for prevention of Herpes Zoster at a pharmacy. On an unknown date, reported as "days later", the patient had shingles. The physician reported that the patient recovered on an unspecified date. It was unknown whether any treatment was given for shingles and whether the patient sought medical attention. No Product Quality Complaint (PQC) was involved. The relatedness between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
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. The patient's medical history, concomitant medications and drug reactions or allergies were not known to reporter. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified date, the patient developed rash after receiving ZOSTAVAX. No further information regarding the patient and the adverse event was known to the reporter. No Product Quality Complaint (PQC) was involved. The information regarding the outcome of the reported adverse event was not provided. The relatedness between the event of rash and the suspect therapy was not reported. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of VAQTA (lot number M033611, expiration date 02-MAR-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA006550: US-009507513-1704USA006551: US-009507513-1704USA006552: US-009507513-1704USA006552: US-009507513-1704USA006553.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot number L039660 with expiration date 04-FEB-2018, and lot number M020926 with expiration date 11-AUG-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of PEDVAXHIB (lot number L042835, expiration date 19-AUG-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA006553: US-009507513-1704USA006552: US-009507513-1704USA006550: US-009507513-1704USA005724.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of GARDASIL 9 (lot number L024993 with expiration date 17-OCT-2017, and lot number M023169 with expiration date 03-JUN-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA006553: US-009507513-1704USA005724: US-009507513-1704USA006550: US-009507513-1704USA006551.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of ROTATEQ (lot number L033693 with expiration date 31-MAY-2017 and lot number L035510 with expiration date 13-MAY-2017). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA005724: US-009507513-1704USA006552: US-009507513-1704USA006550: US-009507513-1704USA006551.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood follicle stimulating hormone increased, Blood oestrogen increased, Premature menopause, Ultrasound scan vagina
Clinical narrative: June(ish) 2015 stopped birth control. October 2016 period stopped. December 2016 diagnosed with Premature Ovarian Failure.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No signs or symptoms of adverse effect.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Information was received on 04-APR-2017 from a pharmacist via a company representative regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date (reported as "about a month ago") the patient received a PNEUMOVAX vaccine (lot # not reported), and now has pain at the injection site and it is "very painful" for the patient to move her arm. The patient's doctor "prescribed" an OTC pain medication. The representative did not know if the OTC pain medication was relieving the pain. Action taken with PNEUMOVAX is not applicable and the outcome of adverse events was not reported. The causal relationship was not rated. The representative did not have complete AE information. No additional information was provided. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Feeling hot
Clinical narrative: Patient started to feel warm and her face was red. She felt dizzy and like she needed to sit down right away. We checked her blood pressure and it was 105/84 with pulse 101. She was shopping the store and it was warm in the store and there were lots of people crowded in the aisles as it is right before Easter. We brought her back the pharmacy and had her sit on the bench. We gave her a bottle of cold water. She denied and swelling of the throat, tongue or face. She sat on the bench for about 10 minutes and the symptoms slowly resolved and she felt well enough to continue her shopping.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia, Blood alkaline phosphatase abnormal, Chest pain, Confusional state, Decreased appetite
Clinical narrative: Loss of short term memory, confusion, hypesthesia, unable to urinate, high blood pressure and pulse, loss of appetite, pain in chest was unable to function at school, clinicals, and work from 02/14/2017-02/20/17.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Hypertension, Hypoaesthesia, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Loss of short term memory, confusion, hypesthesia, unable to urinate, high blood pressure and pulse, loss of appetite, pain in chest was unable to function at school, clinicals, and work from 02/14/2017-02/20/17.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Urinary retention, Urine bilirubin increased, Urine ketone body present
Clinical narrative: Loss of short term memory, confusion, hypesthesia, unable to urinate, high blood pressure and pulse, loss of appetite, pain in chest was unable to function at school, clinicals, and work from 02/14/2017-02/20/17.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Chronic arm pain. Numbness in hand. Limited use of arm/hand. Interferes with daily activities and sleep.
Age: 27.0
Sex: M
Vaccine: TTOX
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea, fatigue, sweating, vomiting, difficulty breathing. Went back to doctor on 4/13/17 and was prescribed ZOFRAN and Prednisone.
Age: 0.42
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Choking, Cyanosis, Diarrhoea, Hypopnoea, Hypotonia
Clinical narrative: Woke up from a nap, choking on vomit, went unconscious, turned blue, body limp, rushed to ER, unresponsive, sternum rubs, oxygen, IV, EVEN NARCAN as a precaution, fever 102.6, shallow breathing, explosive diarrhea.
Age: 0.42
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Loss of consciousness, Pyrexia, Unresponsive to stimuli, Vomiting, White blood cell count increased
Clinical narrative: Woke up from a nap, choking on vomit, went unconscious, turned blue, body limp, rushed to ER, unresponsive, sternum rubs, oxygen, IV, EVEN NARCAN as a precaution, fever 102.6, shallow breathing, explosive diarrhea.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: LEG IS VERY SWOLLEN FROM INJECTION SITE, ALL THE WAY TO THE KNEE WITH A LARGE MASS PRESENT..VERY RED AND HOT TO THE TOUCH..DOCTOR STATED THAT THERE IS INFECTION AT THE INJECTION SITE..
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Detoxification, Food allergy, Food intolerance, Gastrointestinal disorder, Headache
Clinical narrative: This has been an ongoing realization for years, with no ability to pinpoint to ONE vaccine. Patient started having rash issues back in 2014 that were linked to food intolerances and liver reactions. She was allergic to everything and had immune reactions to basic foods.  We have since learned this was caused by "leaky gut" as they call it, food particles were not contained in the stomach, were entering the body, which was fighting them as foreign bodies. In 2015 she began to have constant headaches, itchiness all over constantly and in early 2017 we finally were told she was "mercury toxic" which was causing her neurological system to go "haywire".  She has been going through a mercury detox program for a few months and all her symptoms are improving, slowly, but thankfully SURELY. I am infuriated that I was vaccinating my child as recommended, with flu shots every year, just building up Mercury in her system and straining her entire little body. This cannot be traced to ONE vaccine because she had them all for her recommended age. I am writing this, even though I know it will fall on "deaf ears", but injecting children with the levels of mercury (and not to mention all the other toxic substances) is ethically one of the most evil things I have seen.  I am angry that I trusted the recommendations, only to watch my child suffer for years with these symptoms not realizing what had caused them. Thankfully, she will recover we believe.  Many do not.  And many don't speak out due to the current climate.  Vaccine makers should be held accountable, conversations should be had and MOST importantly, people should not be mandated to give any vaccines. This is basic freedom.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Metal poisoning, Nervous system disorder, Pruritus generalised
Clinical narrative: This has been an ongoing realization for years, with no ability to pinpoint to ONE vaccine. Patient started having rash issues back in 2014 that were linked to food intolerances and liver reactions. She was allergic to everything and had immune reactions to basic foods.  We have since learned this was caused by "leaky gut" as they call it, food particles were not contained in the stomach, were entering the body, which was fighting them as foreign bodies. In 2015 she began to have constant headaches, itchiness all over constantly and in early 2017 we finally were told she was "mercury toxic" which was causing her neurological system to go "haywire".  She has been going through a mercury detox program for a few months and all her symptoms are improving, slowly, but thankfully SURELY. I am infuriated that I was vaccinating my child as recommended, with flu shots every year, just building up Mercury in her system and straining her entire little body. This cannot be traced to ONE vaccine because she had them all for her recommended age. I am writing this, even though I know it will fall on "deaf ears", but injecting children with the levels of mercury (and not to mention all the other toxic substances) is ethically one of the most evil things I have seen.  I am angry that I trusted the recommendations, only to watch my child suffer for years with these symptoms not realizing what had caused them. Thankfully, she will recover we believe.  Many do not.  And many don't speak out due to the current climate.  Vaccine makers should be held accountable, conversations should be had and MOST importantly, people should not be mandated to give any vaccines. This is basic freedom.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age. The patients concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with multiple unspecified doses of VARIVAX and ZOSTAVAX (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Depressed level of consciousness
Clinical narrative: PT HAD DECREASED LEVEL OF CONSCIOUSNESS.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Hypotonia, Laboratory test normal, Pyrexia, Respiratory arrest, Streptococcus test negative
Clinical narrative: No signs of prior illness, developed a fever of 101.7 this morning and within an hour time span became limp and stopped breathing.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Urine analysis normal
Clinical narrative: No signs of prior illness, developed a fever of 101.7 this morning and within an hour time span became limp and stopped breathing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth to the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: On 4/6/17 Mom called to say pt's left leg has been red, swollen and painful to touch at injection site. Pt also had fever. Appt with doctor scheduled for 4/7/17. Per visit notes, patient had left thigh swelling and erythema s/p vaccines (PROQUAD). Itchy. Initially painful but pain resolved. Had fever x 2 days. Tmax 102. Given motrin. Fever since resolved. No concerns for infxn. Walking fine. Advised cool compresses and avoid scratching.  Benadryl prn at bedtime if uncomfortable.  Claritin daily x 1 week. Observe for tenderness, spreading redness or swelling, or fever.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Blood test, Computerised tomogram, Headache, Lumbar puncture
Clinical narrative: 8/19 approximately 8pm (Headache, Backache, Nausea)->TYLENOL/ondansetron, ranitidine. 8/20 approximately 11am (Headache-migraine like pain) TYLENOL, sinus meds. Approximately 11pm (migraine back, backache) PERCOCET/ondansetron. 8/21 approximately 9pm (migraine, nausea, muscle aches->vomiting).
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Migraine, Myalgia, Nausea, Nuclear magnetic resonance imaging, Scan with contrast
Clinical narrative: 8/19 approximately 8pm (Headache, Backache, Nausea)->TYLENOL/ondansetron, ranitidine. 8/20 approximately 11am (Headache-migraine like pain) TYLENOL, sinus meds. Approximately 11pm (migraine back, backache) PERCOCET/ondansetron. 8/21 approximately 9pm (migraine, nausea, muscle aches->vomiting).
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis, Vomiting
Clinical narrative: 8/19 approximately 8pm (Headache, Backache, Nausea)->TYLENOL/ondansetron, ranitidine. 8/20 approximately 11am (Headache-migraine like pain) TYLENOL, sinus meds. Approximately 11pm (migraine back, backache) PERCOCET/ondansetron. 8/21 approximately 9pm (migraine, nausea, muscle aches->vomiting).
Age: 0.92
Sex: M
Vaccine: HEP, IPV, PNC13
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Pyrexia, Ultrasound skull normal
Clinical narrative: Fever and "stiffness" occurring after nap 2 days after vaccines...possible febrile seizure per ER and admitted for further testing. Head MRI and spinal tap pending.
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Patient called at approximately 12 noon today 04/13/17 to report rash on torso, back legs and "a little on cheeks" starting several hours after vaccine given. She was treated with Hydrocortisone cream, told to see PCP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vasovagal reaction in a 16-year-old female patient who received BEXSERO (batch number 166801A, expiry date 31st May 2018. On 3rd April 2017, the patient received BEXSERO. In April 2017, less than a week after receiving BEXSERO, the patient experienced vasovagal reaction, pallor facial and dizziness. On an unknown date, the outcome of the vasovagal reaction, pallor facial and dizziness were unknown. It was unknown if the reporter considered the vasovagal reaction, pallor facial and dizziness to be related to BEXSERO. Additional details were provided as follows: The patient became pale in face.
Sex: U
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of tingling in a adolescent patient who received BEXSERO (batch number 15B201, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to BEXSERO. Additional details were reported as follows: The patient's age at the reporting time was 17 years. The age at vaccination was not reported. In 2017, the patient received BEXSERO on the left arm. The vaccine was administered approximately 2 weeks before the reporting date (on a Tuesday or a Thursday). In 2017, the patient experienced tingling, but the area on the body was unknown. The field representative had very limited information. All questions were asked and unknown answer was provided by the reporter. The health care professional's title was unknown. The expiry date of the vaccine was unknown. Clarification was raised regarding the qualification of primary reporter but resolution was not received.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 16-year-old male patient who received BEXSERO (batch number 165401A, expiry date 31st March 2018). Concomitant products included ibuprofen, ZYRTEC and MENACTRA. On 10th March 2016, the patient receive BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unchanged. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on left deltoid and MENACTRA on right deltoid. After receiving BEXSERO, the patient experienced pain in left arm which was lasted for 3 weeks. The patient required emergency room visit.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain in a 18-year-old male patient who received BEXSERO. In December 2016, the patient received BEXSERO. In December 2016, 1 day after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were reported as follows: This case was not reported previously to anyone. The reporter was a GSK employee who was also a pharmacist. The patient was his son. The patient had a sore arm from the injection. The symptoms ended after about 10 days. The physician's information was unknown. The reporter (GSK employee) had a discussion with another GSK employee, and was reminded that it should be reported, albeit anecdotally. The batch number of the vaccine was unknown.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Confusional state, Dizziness, Head injury, Headache, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fainting in a 16-year-old female patient who received BEXSERO (batch number 166801, expiry date 31st May 2018. Concomitant products included MENACTRA. On 22 March 2017 15:00, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 22nd March 2017, less than a day after receiving BEXSERO, the patient experienced confusion and headache. On 22nd March 2017 15:10, the patient experienced fainting, dizziness and head injury. On 22nd March 2017, the outcome of the fainting, dizziness and head injury were recovered/resolved. On an unknown date, the outcome of the confusion and headache were unknown. The reporter considered the fainting and dizziness to be possibly related to BEXSERO. It was unknown if the reporter considered the head injury, confusion and headache to be related to BEXSERO. Additional details were reported as follows: This case was reported by a medical assistant. The healthcare provider reported that the patient received MENACTRA in the left deltoid and a few seconds later received BEXSERO in the right deltoid. Approximately 10 minutes after vaccination, the patient was checking out in the waiting room and she fainted and hit the back of her head. The healthcare provider reported that the physician rushed out to examine the patient and the symptoms resolved shortly after. The patient was reportedly confused and had a headache after the event. The reporter stated that the patient stated, after she recovered, that after the vaccine was given she felt dizzy but did not mention it to the nurse or doctor at the time. During the collection of the adverse event the nurse stated they have had other patients that felt dizzy or had headaches, but  never fainted like this patient. The nurse asked them if they had reported those events and they replied no because in the past they were told that those events were most likely not related to the vaccine. The nurse was not sure who gave that information to them. No additional information was provided at the time of reporting regarding any other possible adverse events in other patients.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Erythema, Flushing
Clinical narrative: Vaccine given at approx 4:10pm. Mother reports to nurse at approx 4:25 that child complaining "can't breathe". Child developed deep red facial flush, dry cough. He put hands to neck. Escorted to ER in building at 4:27. Triaged and treated by 4:35. Given Epinephrine, Prednisone, BENADRYL and albuterol inhalant. Discharged stable 6:05pm with meds and follow up to his allergist.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Erythema
Clinical narrative: Vaccine given at approx 4:10pm. Mother reports to nurse at approx 4:25 that child complaining "can't breathe". Child developed deep red facial flush, dry cough. He put hands to neck. Escorted to ER in building at 4:27. Triaged and treated by 4:35. Given Epinephrine, Prednisone, BENADRYL and albuterol inhalant. Discharged stable 6:05pm with meds and follow up to his allergist.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Rash, Swelling
Clinical narrative: Rash and swelling/cellulitis. Acetaminophen 1-2 tab prn, Cephalexin 500 mg BID, Prednisone 20 mg every day.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Gingival bleeding, Pain in jaw, Tooth discolouration, Tooth disorder, Toothache
Clinical narrative: Bleeding gums, teeth and jaw pain constantly, discoloring of teeth at gum lines, front teeth are splitting apart.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Tremor
Clinical narrative: Two episodes of left leg shaking lasting less than five seconds. One episode of right leg shaking < 5 seconds. Fever 100.5. All events occurring on 4/13/2017.