chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 74 year old male patient. The patient's concurrent conditions and medical history were not reported. On 03-NOV-2016, the patient received a dose of GARDASIL 9 lot # M009116; expiration date 13-JUN-2018 (dose, route and anatomical location were not reported) in error (interchange of vaccine products). The patient was indicated to receive PNEUMOVAX 23. The nurse did not know why the error occurred. No adverse effects have been reported. No additional information was provided. Product Quality Complained was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site inflammation, Injection site nodule, Rash generalised
Clinical narrative: Vaccine given 10/26/16. Inflammatory nodule noted on left leg 11/4/16. Generalized rash developed 11/6/16; clinic visit 11/7/16.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling
Clinical narrative: Allergic reaction symptoms -redness, swelling, itchiness.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dyspnoea, Pain in extremity
Clinical narrative: Approximately 5 minutes after administration, patient had difficulty breathing and pain in back and legs.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales repo and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, the outcome of the pain in arm and fatigue were unknown. The reporter considered the pain in arm and fatigue to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient was the physician's daughter. The age at vaccination was not reported. In 2016, the patient received BEXSERO on an unknown arm and was so fatigued and stays home in bed the next day. This case has been linked with case US2016161483 as reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (.65 ml, once, lot # L015414 and expiration date: 01-AUG-2016), (strength and route of administration were not reported). No adverse effects were reported and no product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding two patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. The pharmacist reported that on 14-OCT-2016, two patients received the PNEUMOVAX 23 (dose, strength, indication, route and lot# not reported). On the same day, both the patients developed similar kind of side effects on the same day of the vaccination. It was reported that both of the patients developed fever, it was not specified how high the fever was or how long it lasted and extreme pain (location of the pain was not specified). The patients sought medical attention by speaking to a pharmacist. Outcome of the events were unknown at the time of this report. No product quality complaint involved. Causality assessment was not provided. This case is linked to case 1611USA003592 (same reported link). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to unknown age and gender patient. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ intramuscularly (lot number, expiration date and dosage were not reported); the primary reported that it was outside the recommendations per the ROTATEQ prescribing information (Incorrect route of drug administration). No adverse effects were reported. The physician did not wish to answer any adverse event question. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown demographics. Information regarding the patients' concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (route of administration, anatomical location, lot number and expiration date were not reported), which were exposed to a "lighted medical refrigerator for weeks" on unspecified dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M028799 with an expiration date 18-AUG-2017 and lot# M032139 with an expiration date 02-OCT-2017 (doses, route of administration and anatomical locations were not reported). Administered doses of ZOSTAVAX experienced temperature excursion of 32 degrees Fahrenheit for 16 hours, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 1.92
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 04-NOV-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB injection, lot # K022265, expiry date 22-OCT-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information regarding patient's concomitant medications, pertinent medical history, drug reactions, or allergies provided. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX, 19400 plaque-forming units (PFU), lot # M001747, expiration date: 07-APR-2017 (dose and route of administration were not provided). No adverse effects were reported. Administered dose of vaccine underwent a temperature excursion of 16 degrees Fahrenheit for 1 hour and 30 minutes, which was detected by a data logger. The temperature was back in range after the excursion. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810 with expiration date 28-MAY-2018, dosage and route of administration were not reported), which were exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB injection (exact dose, lot#, expiration date and anatomical location were not provided). The patients were vaccinated at "0 month and 4 months". There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 25-OCT-2016 the patient was vaccinated with an expired dose of VARIVAX (dosing details were not reported) (lot # K011802, expiry date: 21-AUG-2016). There were no known adverse effects. No product quality complaint was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Information has been received from an unknown source referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with GARDASIL 9 (lot#, dose, dose# and route unknown). The patient stated that the vaccine caused headaches and severe headaches after getting up from sitting every time. The outcome of the event was unknown. Additional information is not expected since there was no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via touchpoint employee refers to a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (lot number/expiry date and dosage not reported). On an unknown date, the patient had an adverse event. No Product Quality Complaint (PQC) was involved. The outcome of the event was unknown. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site nodule, Injection site rash
Clinical narrative: This spontaneous report received from a pharmacist referred to a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2016, the patient received ZOSTAVAX subcutaneously (dose, lot number and expiry date were not reported). On 01-NOV-2016, the patient developed redness at the injection site. The injection site was swollen and angry by 02-NOV-2016 and was worse by 03-NOV-2016. The redness and swelling was approximately a 3 by 3 inch area. The injection site was currently described as a red, feverish rash with a hard knot. The patient was given unspecified treatment for the events. The rash was currently unresolved. Outcome of other events was unknown. Causality assessment was not reported for the events. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report received from a pharmacist referred to a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2016, the patient received ZOSTAVAX subcutaneously (dose, lot number and expiry date were not reported). On 01-NOV-2016, the patient developed redness at the injection site. The injection site was swollen and angry by 02-NOV-2016 and was worse by 03-NOV-2016. The redness and swelling was approximately a 3 by 3 inch area. The injection site was currently described as a red, feverish rash with a hard knot. The patient was given unspecified treatment for the events. The rash was currently unresolved. Outcome of other events was unknown. Causality assessment was not reported for the events. 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 healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored GARDASIL 9 (lot # M007764, expiry date: 30-JAN-2018; lot # M021407, expiry date: 30-APR-2018 and lot # M018810, expiry date: 28-MAY-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the 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 healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored ROTATEQ (lot # L038536, expiry date: 19-AUG-2017; lot # L048854, expiry date: 31-AUG-2017; lot # M004542, expiry date: 18-OCT-2017 and lot # M004890, expiry date: 10-NOV-2017). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the 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 as received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patient received improperly stored RECOMBIVAX HB (lot # M00442, expiry date: 31-MAR-2108; lot # M011838, expiry date: 09-AUG-2018; lot # M010212, expiry date: 21-JAN-2019; lot # M022077, expiry date: 10-MAR-2019; lot # M018654, expiry date: 31-MAY-2018 and lot # L044917, expiry date: 05-OCT-2108. She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5 C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lip swelling, Oral mucosal erythema
Clinical narrative: Information has been received on 12-OCT-2016 and from a certified medical assistant referring to 2 patients of unknown age and gender. The patients' medical history and concomitant therapy were not reported. On 12-OCT-2016, two patients were vaccinated with ROTATEQ lot # M019707, expiration 25-OCT-2016, (dose and route not reported). The patients experienced lip swelling with redness around the mouth on 12-OCT-2016 immediately following the administration of ROTATEQ. The primary reporter stated that the two patients were also administered other vaccines during the vaccination session on 12-OCT-2016, however, the reaction occurred following the ROTATEQ and not following the administration of PEDVAXHIB, PREVNAR 13 and PEDIARIX on 12-OCT-2016. The primary reporter stated that the two patients were then observed in the office for 15 to 20 minutes and the symptoms that consisted of lip swelling with redness around the mouth resolved without treatment on 12-OCT-2016. No further information was provided. Additional information has been received on 18-OCT-2016 from a nurse. The primary reporter is requesting a Lot check concerning ROTATEQ lot # M019707, expiration 25-OCT-2016. No further information was provided. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: DTaP Left thigh red, hard and tender, swollen now. 11/8 decreased redness, decreased swelling. Patient refuses to let Mom touch site no fever, not cranky.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dystonia, Irritability, Mobility decreased, Muscle spasms, Posture abnormal
Clinical narrative: Within 6 hours of vaccinations had an acute reaction of dystonic muscle spasm causing head to twist to her right shoulder and extreme irritability. She was unable to move her head for minutes, this improved but then recurred and resolved. Associated with high fever.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Within 6 hours of vaccinations had an acute reaction of dystonic muscle spasm causing head to twist to her right shoulder and extreme irritability. She was unable to move her head for minutes, this improved but then recurred and resolved. Associated with high fever.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Swelling face
Clinical narrative: Mom called and reported swelling to face and lips.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site on (L) leg, about 2" in diameter, somewhat warm to the touch.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness on thigh bilaterally at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 y/o female due to site reaction from immunizations she rec'd yesterday. It was red and swollen will treat with antibiotic ordered, cephalexin 10mg. Mother concerned because a similar thing happened the last time she received immunization, stated she had to take child to the ED where she was given antibiotic for skin infection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen and warm to touch at injection site; no pain.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Started 11.3.16. Warm to touch. Pt. reported rash on left arm to Dr. on 11.4.16. Per MD said if not resolved within 5 days to make appointment for antibiotic.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash developed 6 hours after injection of HARVIX. Rash on trunk-itchy. No other sx. No SOB, mouth swelling, face swelling, fever, chills, diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Dizziness, Electrocardiogram, Injection site pain, Nausea, Road traffic accident
Clinical narrative: Patient passed out while driving a car and was involved in a car accident.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Syncope
Clinical narrative: Patient passed out while driving a car and was involved in a car accident.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Blood glucose, Electrocardiogram, Loss of consciousness, Neurological examination, Road traffic accident
Clinical narrative: Patient passed out while driving a car and was involved in a car accident.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis
Clinical narrative: Developed acute onset rt side facial weakness/paralysis affecting forehead and cheek muscle and rt side of mouth. Able to open and close eyelid.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Developed acute onset rt side facial weakness/paralysis affecting forehead and cheek muscle and rt side of mouth. Able to open and close eyelid.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Bursitis on left arm.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis
Clinical narrative: Bursitis on left arm.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, VARCEL, HEP, HEPA, MEN, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 45 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. On 26-OCT-2016, the patient was vaccinated in error with PROQUAD lot # L051100, (expiration date was not provided), administered per subcutaneous route. The patient was also administered during the same vaccination session on 26-OCT-2016 a dose of VARIVAX lot # L019999, (expiration date and therapy route were not provided). The reporter stated that the patient was indicated to receive M-M-R II instead of PROQUAD. The reporter did not know why the error occurred and stated that she was not aware of any adverse experience. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, VARCEL, HEP, HEPA, MEN, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 45 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. On 26-OCT-2016, the patient was vaccinated in error with PROQUAD lot # L051100, (expiration date was not provided), administered per subcutaneous route. The patient was also administered during the same vaccination session on 26-OCT-2016 a dose of VARIVAX lot # L019999, (expiration date and therapy route were not provided). The reporter stated that the patient was indicated to receive M-M-R II instead of PROQUAD. The reporter did not know why the error occurred and stated that she was not aware of any adverse experience. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: Started with headache and fever, progressed to chills at 7:00 PM 11/08/2016. 11/09/2016 fever continued, chills diminished overnight, treated symptoms with ADVIL and TYLENOL. Lower back pain and pain in thighs set in during the day 11/09/2016. Fever and headache continued. In the afternoon, dizziness set in for a few hours. Overnight 11/09/2016 back pain became severe, couldn't sleep because of it. 11/10/2016 fever seems to be gone, took 1000mg ADVIL for back pain, headache continues. Symptoms are continuing still.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Started with headache and fever, progressed to chills at 7:00 PM 11/08/2016. 11/09/2016 fever continued, chills diminished overnight, treated symptoms with ADVIL and TYLENOL. Lower back pain and pain in thighs set in during the day 11/09/2016. Fever and headache continued. In the afternoon, dizziness set in for a few hours. Overnight 11/09/2016 back pain became severe, couldn't sleep because of it. 11/10/2016 fever seems to be gone, took 1000mg ADVIL for back pain, headache continues. Symptoms are continuing still.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hive at injection site.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Rash, hives, itching over entire body from head to calves. Progressively got worse until extra over the counter allergy medication was taken around 1pm. Symptoms started to improve within 45 minutes after this.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Electrocardiogram normal, Full blood count normal, Hypoaesthesia, Metabolic function test normal
Clinical narrative: Numbness of both upper extremities.
Sex: F
Vaccine: FLU4
Symptoms: Drug interaction, Rash
Clinical narrative: Initial unsolicited report received from a physician on 27-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with Fluzone intradermal (batch number: unknown, expiry date and route of administration: not reported) on September 2016 (unspecified date). Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date, post vaccination, the patient claims that the Fluzone interacted with steroid and caused bumps on face. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Initial unsolicited report received from a physician on 31 October 2016. This case involves a 41-year-old female patient who was vaccinated with second dose of FLUZONE QIV (batch number: UI658AB; expiry date- 30 June 2017, dose, site of administration) in right deltoid on 12 October 2016. The patient had a medical history of seasonal allergies, migraines, GERD, anxiety and depression. Illness at the time of vaccination was none. The patient did not receive any other vaccinations within four weeks of above vaccination. No other information regarding concomitant medications was available. On 13 October 2016, one day following the vaccination, the patient developed low back pain non-radiating. It was reported that previously the patient had received first dose of FLUZONE QIV. The patient required ER/doctor visit. Laboratory data was reported as none. The patient received corrective treatment with anti-inflammatory, ice and heat with rest. The outcome of the event was recovering (reported as 'she is improving at this point but not recovered'). List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a nurse via consumer's spouse on 01 November 2016. This case involves a 64-year-old female patient who was vaccinated with INFLUENZA VACCINE (batch number, expiry date of the product, dose and dose in series, route and site of administration were not reported) on an unspecified date (reported as 'last week'). The patient had a medical history of multiple sclerosis. The patient's concomitant medication included LEMTRADA at a dose of 12 mg daily from 22 August 2016 till 26 August 2016 for 5 days for multiple sclerosis. On an unspecified date and duration following the vaccination (the vaccination was reported as to be administered 'last week'), the patient developed low grade flu symptom. Laboratory data and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain, redness of entire upper extremity.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling redness warmth upper extremity.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Hives developed and were noticed at about 6:00 pm. BENADRYL was administered. Itching subsided but splotches still there and still remain in the morning 11/10/2016 more meds given for itching.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Hypersensitivity, Pallor, Throat irritation, Throat tightness
Clinical narrative: Student went back to class after vaccination.  Student was in Gym Class, when he started complaining of cough, and stated "his throat felt tight" to the teacher.  Teacher took him to the Health Room.  At 10:45, school nurse, and clinic nurse evaluated student who was clearing his throat and complained of tight feeling, color - pale, lips - pale.  BP:102/64, pulse 100, pulse ox 97%.  At 10:45, 2tsp Benadryl given, pulse ox down to 88% (pulse ox questionable due to equipment).  At 10:50 Epi Pen Jr administered, 911 called, parent called, noted relief within seconds.  Breathing normal, student reported "feeling good".  Pulse ox improved. Paramedics arrived by 11:00 - 11:05 am.  Student alert, cooperative.  Student transported to Hospital for evaluation. A school teacher accompanied student.  Parents met student there.  Child evaluated and kept at the ER for 2 hours.  No other complications noted at the time.  Discharged home with parents.  Parents reported that ER stated "allergic reaction".  However, did not state related to flu vaccine.  Child has had flu vaccine in the past.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Arteriovenous shunt operation, Balance disorder, Computerised tomogram, Emotional disorder, Fall
Clinical narrative: Pt. developed headache, blurred vision, loss of balance and was falling at school.  Also, reported feeling emotional and frustrated. On 10/11/2016 symptoms were continuing and she was taken to the ER.  A cat scan was done on 10/11/16 and she was admitted.  On 10/12/2016 an MRI was done.  She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time.  She was seen on 10/26/2016 and a spinal tap done to relieve pressure/fluid.  She is having a shunt placed on 11/14/2016.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Frustration tolerance decreased, Headache, Hydrocephalus, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt. developed headache, blurred vision, loss of balance and was falling at school.  Also, reported feeling emotional and frustrated. On 10/11/2016 symptoms were continuing and she was taken to the ER.  A cat scan was done on 10/11/16 and she was admitted.  On 10/12/2016 an MRI was done.  She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time.  She was seen on 10/26/2016 and a spinal tap done to relieve pressure/fluid.  She is having a shunt placed on 11/14/2016.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Vision blurred
Clinical narrative: Pt. developed headache, blurred vision, loss of balance and was falling at school.  Also, reported feeling emotional and frustrated. On 10/11/2016 symptoms were continuing and she was taken to the ER.  A cat scan was done on 10/11/16 and she was admitted.  On 10/12/2016 an MRI was done.  She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time.  She was seen on 10/26/2016 and a spinal tap done to relieve pressure/fluid.  She is having a shunt placed on 11/14/2016.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Syncope
Clinical narrative: Student vaccinated, reported  back to class. Student fainted in class. Health Room notified. Student escorted to health room. Laid down, cool compress applied. School nurse and clinic nurse notified and went to health room to second assess. Student alert, oriented, still pale. Given fluids, parents notified. Parent took student home. Student recovered.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness
Clinical narrative: Pt. appeared to faint after receiving second vaccination, lasted for several seconds.
Age: 0.67
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Autism, Regressive behaviour
Clinical narrative: He had a very big red circle around the area of vaccination on the 3 times he got the dose of DTAP, and I noticed that he regressed after the last one on 12/5/12 and eventually was diagnose with Autism at age of 2, after going thru early steps at an earlier age.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Muscle spasms, Oesophageal spasm, Palpitations
Clinical narrative: Dizziness, extreme muscle cramps, heart racing, esophageal spasm, fatigue, heart skipping beats.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rhinorrhoea, Urticaria
Clinical narrative: Patient within 10 min "felt funny" took 3 ibuprofen now experiencing flushing- hot skin on arms- hives on neck 11:45 108/94-92-24 clear nose running on site. Co nurse gave BENADRYL 25 mg and took over care BP down 128/87 12:15.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache, fatigue, nausea.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Urticaria
Clinical narrative: Approximately fist sized welt appeared and felt warm to the patient. Patient was informed to apply ice compresses. Follow up in 3 days and there were no residual effects of vaccination.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site pain, Peripheral swelling
Clinical narrative: Left arm swelled in size, site of injection was red, irritated, and painful to touch. Redness spread down left bicep to below elbow.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis, Rash erythematous, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a consumer on 27-Oct-2016. This case involves a 55-year-old female patient who was vaccinated with a dose of Flu shot (batch number: unknown, expiry date and route of administration: not reported) in the abdomen on 03-Oct-2016. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications includes PRALUENT (alirocumab) for cardiovascular. On 03-Oct-2016, few minutes post vaccination, "all of a sudden patient got sick". On an unspecified date, post vaccination, the patient experienced cold and congestion. On 25 Oct 2016 (reported as Tuesday) 22 days post vaccination, the patient had "little bitty rash on arm" like a patch of little red bumps. Lab test and corrective treatment was not reported. On an unspecified date, the patient recovered from the event "little bitty rash on arm" (reported as gone now) and outcome of the other event was not reported. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Diet refusal, Feeling hot, Headache, Irritability
Clinical narrative: Initial unsolicited report received from a other non health care professional on 01 Nov 2016. This case involves a 07-year-old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose not reported) intramuscularly in the left arm on 29 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination were reported as unknown. Concomitant medications were not reported. On 29 Oct 2016, eight hour following the vaccination, the patient experienced irritable and cranky with a headache and did not want to eat. On 29 Oct 2016 at 08:00 pm, same day following the vaccination, the patient had fever (102 F oral). On an unspecified date, post vaccination, the patient felt hot during the night and felt better next day. Lab data was not reported. Corrective treatment includes ibuprofen. On an unspecified date, the patient was recovered from the event (reported as symptoms are gone). List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a other non health care professional on 01 Nov 2016. This case involves a 07-year-old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose not reported) intramuscularly in the left arm on 29 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination were reported as unknown. Concomitant medications were not reported. On 29 Oct 2016, eight hour following the vaccination, the patient experienced irritable and cranky with a headache and did not want to eat. On 29 Oct 2016 at 08:00 pm, same day following the vaccination, the patient had fever (102 F oral). On an unspecified date, post vaccination, the patient felt hot during the night and felt better next day. Lab data was not reported. Corrective treatment includes ibuprofen. On an unspecified date, the patient was recovered from the event (reported as symptoms are gone). List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Bursa injury, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severe shoulder pain. MRI revealed trauma to bursa-sac.
Age: 9.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: At school, flu vaccine given. Pt went to classroom school nurse reported 20 mins later-patient started having hives breaking out all over arms/backs/chest/neck. She gave BENADRYL 75mg to patient. She states "He has allergies to some things but never to flu vaccines". Hives/rash faded parent pickup going to doctor.
Age: 9.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Urticaria
Clinical narrative: At school, flu vaccine given. Pt went to classroom school nurse reported 20 mins later-patient started having hives breaking out all over arms/backs/chest/neck. She gave BENADRYL 75mg to patient. She states "He has allergies to some things but never to flu vaccines". Hives/rash faded parent pickup going to doctor.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: LEFT ARM PAIN AND RADIATED INTO MY LEFT SHOULDER, AND IT HURTS BADLY WHEN I RAISE MY LEFT ARM. IT IS VERY PAINFUL A WEEK LATER. I HAVE A DOCTORS APPOINTMENT ON 11/11/2016 AT 9AM. I ALSO CALLED THE PHARMACIST TO LET HER KNOW ABOUT THE REACTION I AM HAVING.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Crepitations, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia
Clinical narrative: LEFT ARM PAIN AND RADIATED INTO MY LEFT SHOULDER, AND IT HURTS BADLY WHEN I RAISE MY LEFT ARM. IT IS VERY PAINFUL A WEEK LATER. I HAVE A DOCTORS APPOINTMENT ON 11/11/2016 AT 9AM. I ALSO CALLED THE PHARMACIST TO LET HER KNOW ABOUT THE REACTION I AM HAVING.
Age: 57.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at site of injection. By 11/2/16, redness, warmth and itching had spread to entire width of arm. Seen by Dr. and advised ice compresses and oral BENADRYL for allergic reaction.
Age: 57.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pruritus, Skin warm
Clinical narrative: Redness at site of injection. By 11/2/16, redness, warmth and itching had spread to entire width of arm. Seen by Dr. and advised ice compresses and oral BENADRYL for allergic reaction.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Temp 99.8, 6 episodes of vomiting, brown diarrhea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Right arm edema, pain, and redness.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Patient complains of ongoing headache, malaise and lightheadedness.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling, itching, hot to touch and began to spread to 6 inches by 5 inches over left thigh.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain, Swelling, Tenderness
Clinical narrative: Red, swollen, raised, pain (touch and movement), bruising.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PPV, RVX
Symptoms: Crying, Feeling abnormal, Hypotonia, Injection site erythema, Pain
Clinical narrative: Excessive crying, redness at site, very distressed, "out of it", glazed eyes, limpness in limbs, cannot sleep, in obvious pain, won't eat much, high fever of 102.5 with Tylenol administered (night of shots). It has now been over 24 hours and still experiencing all of the above. He barely slept through the night.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PPV, RVX
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Excessive crying, redness at site, very distressed, "out of it", glazed eyes, limpness in limbs, cannot sleep, in obvious pain, won't eat much, high fever of 102.5 with Tylenol administered (night of shots). It has now been over 24 hours and still experiencing all of the above. He barely slept through the night.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site urticaria, Mobility decreased, Nausea
Clinical narrative: Extremely tired, aches, nausea, chills, no fever within hours after injection. Very immobile shoulder with pain. One week after I started with hives on upper arm of injection site, itchy, then a diffuse rash for several days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Extremely tired, aches, nausea, chills, no fever within hours after injection. Very immobile shoulder with pain. One week after I started with hives on upper arm of injection site, itchy, then a diffuse rash for several days.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Aspiration pleural cavity, Autopsy, Chest X-ray, Computerised tomogram
Clinical narrative: Received flu vaccine requisite to his service as a volunteer at hospital ER.  Previously healthy. Within 1 day of vaccination began complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB.  Was hospitalized, then released to home where he expired.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Cytology, Death, Dyspnoea, Haematology test, Influenza like illness
Clinical narrative: Received flu vaccine requisite to his service as a volunteer at hospital ER.  Previously healthy. Within 1 day of vaccination began complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB.  Was hospitalized, then released to home where he expired.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Pericardial effusion, Pericarditis, Pleural effusion, Pneumonia
Clinical narrative: Received flu vaccine requisite to his service as a volunteer at hospital ER.  Previously healthy. Within 1 day of vaccination began complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB.  Was hospitalized, then released to home where he expired.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Pt reported throat tried to close off, SOB.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: 11/10/2016 @ 0918 I got a call from the patient reporting that she noticed some swelling at her HPV vaccine injection site on right deltoid last night around 6 pm that looked like a mosquito bite. Her arm hurt throughout the night and now her entire arm is red (she denied a splotchy or rash-like appearance), it is swollen from her deltoid nearly halfway down to her elbow, and it itches. She reports that her right pinky is slightly tingly. She denied any known medical conditions and denied any known allergies. She reports that she didn't have any reaction with either of the previous 2 doses of HPV vaccine she has received.  I recommended that she try taking some diphenhydramine and go to an urgent care or her primary care provider today.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: 11/10/2016 @ 0918 I got a call from the patient reporting that she noticed some swelling at her HPV vaccine injection site on right deltoid last night around 6 pm that looked like a mosquito bite. Her arm hurt throughout the night and now her entire arm is red (she denied a splotchy or rash-like appearance), it is swollen from her deltoid nearly halfway down to her elbow, and it itches. She reports that her right pinky is slightly tingly. She denied any known medical conditions and denied any known allergies. She reports that she didn't have any reaction with either of the previous 2 doses of HPV vaccine she has received.  I recommended that she try taking some diphenhydramine and go to an urgent care or her primary care provider today.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient complaints of extended muscle pain in arm post vaccination for over 1 month. Patient states that it was difficult to hold arm above head and that the muscle pain lasted longer than usual.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site rash, Pruritus, Rash, Rhinorrhoea
Clinical narrative: Symptoms appeared 2 weeks after receiving the Varicella vaccine. Noticed many bumps on my son's upper arms. Over the next 24 house the bumps spread to his whole arms, shoulders, whole legs and a few on his back. His face, chest and stomach were not affected. Most of the bumps started out as not colored except his elbows and ankles which were large red welts. Over the past week these have been itchy and have now turned to red sore like scabs which are worse on his legs and shoulders. The welts remain. He is not sick otherwise (except runny nose) and has no fever. The clinic where it was administered as well as a pediatrician said they had not seen this reaction before. He was told to take Benadryl and was prescribed a cortisone cream. I have photos if required.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Urticaria
Clinical narrative: Symptoms appeared 2 weeks after receiving the Varicella vaccine. Noticed many bumps on my son's upper arms. Over the next 24 house the bumps spread to his whole arms, shoulders, whole legs and a few on his back. His face, chest and stomach were not affected. Most of the bumps started out as not colored except his elbows and ankles which were large red welts. Over the past week these have been itchy and have now turned to red sore like scabs which are worse on his legs and shoulders. The welts remain. He is not sick otherwise (except runny nose) and has no fever. The clinic where it was administered as well as a pediatrician said they had not seen this reaction before. He was told to take Benadryl and was prescribed a cortisone cream. I have photos if required.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Breast swelling, Ear pain, Erythema, Mobility decreased, Neck pain
Clinical narrative: Swelling of Right arm into Right breast along with neck and ear pain. Redness and extremely hot to the touch. Unable to move arm. Went to Dr. on 11/09/16 and was given Amoxicillin.