chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of PEDVAXHIB (lot #K008679, expiration date: 05-MAR-2017, L014427, expiration date: 09-MAR-2018) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to two patients of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX 1 shot subcutaneously. Concomitant medication included other unspecified vaccines. On an unknown date, the patients developed a rash that spread across the body. It was stated that the rash "was not a big deal" and that it was clearing on its own. The patient had sought medical attention. The outcome of rash was reported as recovering (reported as improving on therapy). The reporter could not single out ZOSTAVAX, as the cause since the patient's were also administered with other unspecified vaccines. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of PNEUMOVAX 23 (lot # L003188, expiration date: 06-JUL-2016) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Age: 0.58
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 7 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2016, the patient was inadvertently vaccinated with a dose of VAQTA lot # L036300, expiration date 04-NOV-2016 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) thigh - 1 cm redness and indurated, nontender, not warm.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 03-MAR-2016, the patient was vaccinated with an expired dose of oral, ROTATEQ (Lot # K006458; expiration date: 24-FEB-2016), 2 ml, oral. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving GARDASIL.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: 5-6 hours after immunization developed high pitch cry and 50 cent piece eye swelling (R) upper thigh and redness in area of PEDVAX HIB.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified dates in October 2015) of M-M-R II with lot/batch # K024035, expiry date 26-NOV-2016 and lot/batch # K024038, expiry date 26-NOV-2016 (dose, dose number, vaccination site and route of administration not provided). There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of M-M-R II (lot # K000174, expiration date: 08-JAN-2016, K011317, expiration date: 13-AUG-2016, L009213, expiration date: 17-MAR-2017, K022284, expiration date: 12-NOV-2016) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient developed swelling and redness of right arm after receiving GARDASIL vaccine. 4 cm x 6 cm. Advised to take prednisone 3-5 days, MOTRIN for swelling as well.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Upper extremity mass
Clinical narrative: Pt. has small red lump with small amount of swelling, warm to touch with no induration. Told pt. to place cold compress on arm and take BENADRYL 2 to 3 time a day per FNP.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. After 19-FEB-2016, the patient were vaccinated with 1 dose of improperly stored PROQUAD (Merck) lot # L030591, expiration date- 10-FEB-2017, lot no. L044055, expiration date- 02-MAY-2017 and lot # L008353, expiration date- 11-SEP-2016. No adverse event was reported. The outcome of the event was unknown. Temperature was 7.1 F, Time frame: 30 minutes, no previous temperature excursion, call was because of data logger and outcome was supported until labeled expiry. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 19 year old patient of unknown gender. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not reported. On 07-MAR-2016, the patient was vaccinated with an adult dose of RECOMBIVAX HB (lot # L000717, expiry date: 15-APR-2017). No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Hives, pain, redness, swelling, warmth at injection site.
Age: 25.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Pain in extremity
Clinical narrative: Hives, pain, redness, swelling, warmth at injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 03-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Rash, Wheelchair user
Clinical narrative: Rash on body (severe) current status: cannot walk and is confined to a wheelchair.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Nerve injury, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Rash on body (severe) current status: cannot walk and is confined to a wheelchair.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Wheelchair user
Clinical narrative: Rash on body (severe) current status: cannot walk and is confined to a wheelchair.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Laboratory test normal, Nerve injury, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Rash on body (severe) current status: cannot walk and is confined to a wheelchair.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash generalised, Skin disorder, Weight decreased, Wheelchair user
Clinical narrative: Rash on body (severe) current status: cannot walk and is confined to a wheelchair.
Age: 19.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US029392, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 616582) website on 29 Feb 2016. This report refers to a 19 years old female patient. Past medical history was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which caused syncope (see case: PHHY2016US029417). The patient was vaccinated with FLUVIRIN (batch number: 157201) into left arm on 28 Dec 2015. One minute after vaccination, the patient experienced syncope and immediately regained consciousness. The patient visited emergency room on an unknown date. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. The seriousness of the events "loss of consciousness and syncope" was upgraded based on information available in the source document. Quality assurance reported that the given batch number was not a valid FLUVIRIN batch number and would not be investigated. Follow up report received from quality assurance department on 08 Mar 2016: Added comment from quality assurance department.
Age: 19.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Syncope
Clinical narrative: Case number PHHY2016US029392, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 616582) website on 29 Feb 2016. This report refers to a 19 years old female patient. Past medical history was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which caused syncope (see case: PHHY2016US029417). The patient was vaccinated with FLUVIRIN (batch number: 157201) into left arm on 28 Dec 2015. One minute after vaccination, the patient experienced syncope and immediately regained consciousness. The patient visited emergency room on an unknown date. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. The seriousness of the events "loss of consciousness and syncope" was upgraded based on information available in the source document. Quality assurance reported that the given batch number was not a valid FLUVIRIN batch number and would not be investigated. Follow up report received from quality assurance department on 08 Mar 2016: Added comment from quality assurance department.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Eye pain, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Information has been received from a 56 year old male patient referring to himself. The patient was allergic to penicillin and codeine. On 15-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # L032397, expiration date not reported) subcutaneously (dose was not reported). On 20-FEB-2016 the patient developed a painful spot on surface of his skin on the right side of his chest. The painful spot was not a rash. Several days later, on an unknown date in 2016, the patient developed a corneal ulcer and infection in his right eye revealed by eye exams. The patient sought medical attention by visiting 3 ophthalmologists and unspecified treatment was given to the patient. At the time of this report, the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Information has been received from a 56 year old male patient referring to himself. The patient was allergic to penicillin and codeine. On 15-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # L032397, expiration date not reported) subcutaneously (dose was not reported). On 20-FEB-2016 the patient developed a painful spot on surface of his skin on the right side of his chest. The painful spot was not a rash. Several days later, on an unknown date in 2016, the patient developed a corneal ulcer and infection in his right eye revealed by eye exams. The patient sought medical attention by visiting 3 ophthalmologists and unspecified treatment was given to the patient. At the time of this report, the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Information has been received from a 56 year old male patient referring to himself. The patient was allergic to penicillin and codeine. On 15-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # L032397, expiration date not reported) subcutaneously (dose was not reported). On 20-FEB-2016 the patient developed a painful spot on surface of his skin on the right side of his chest. The painful spot was not a rash. Several days later, on an unknown date in 2016, the patient developed a corneal ulcer and infection in his right eye revealed by eye exams. The patient sought medical attention by visiting 3 ophthalmologists and unspecified treatment was given to the patient. At the time of this report, the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination abnormal, Pain of skin, Ulcerative keratitis
Clinical narrative: Information has been received from a 56 year old male patient referring to himself. The patient was allergic to penicillin and codeine. On 15-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # L032397, expiration date not reported) subcutaneously (dose was not reported). On 20-FEB-2016 the patient developed a painful spot on surface of his skin on the right side of his chest. The painful spot was not a rash. Several days later, on an unknown date in 2016, the patient developed a corneal ulcer and infection in his right eye revealed by eye exams. The patient sought medical attention by visiting 3 ophthalmologists and unspecified treatment was given to the patient. At the time of this report, the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, IPV, PNC13, RV5, TD
Symptoms: Decreased appetite, Seizure, Somnolence
Clinical narrative: 10-20 second seizure followed by hours of sleepiness and loss of appetite.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Anthrax vaccination administered via left deltoid.  Patient noticed increased pain and erythema over injection site approx. 1-2 days afterwards.  Area became erythematous with approx. 10 cm of induration.  No discharge noted over injection site.  Discussed case with Dermatologist and Allergist.  Elected to treat symptomatically and stressed return precautions.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Bronchial disorder, Influenza like illness, Injection site bruising, Lower respiratory tract infection
Clinical narrative: Initial solicited report received from a Consumer on 24 February 2016. This case involves a male patient (age was not reported) who was vaccinated with dose of Flu Shot (batch number, expiration date, dose, dose in series, route and site of administration was not reported) on an unspecified date and administered with 75 mg subcutaneous dose of PRALUENT (batch number, expiration date, dose in series, site of administration was not reported) on 7 December 2015. It was reported that patient was taking PRALULENT from 7 December 2015 every two weeks. Patient took a flu shot about week after starting PRALUENT. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had bronchial stuff and like cold in his chest. It was reported that it was like mild flu but it didn't really bother him. It was also reported that while receiving injection patient got a bruise about size of silver dollar when pinched the skin up but he didn't get bruise when skin didn't pinch. Lab data and corrective treatment were not reported. Outcome of events was reported as unknown. It was reported that patient think it was because of the medication. Upon internal review, the company decided to consider the event serious because of important medical event: bronchial stuff and like a cold in his chest. List of documents held by sender: none. Sender's Comments: This is a poorly documented and non-medically confirmed case. Further information on the vaccination details, time to onset, medical confirmation of the case, lab data confirming the final diagnosis, etc. will be required for complete assessment of this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Reoccurrence of fever blisters. Treated with antiviral and Abreva.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported that she had swelling, redness, heat and itching at the site of the injection (deltoid), that spread down to her elbow. This lasted for 2 weeks, and resolved on its own.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Urticaria
Clinical narrative: Patient developed generalized malaise and localized urticarial rash affecting proximal 1/2 of vaccinated upper extremity still present one week post- vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4, HEPAB, MMR
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Redness, Hot to Touch, Soreness on Right Arm.
Age: 69.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Arthritis, Bursitis, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain and unable to move shoulder.
Age: 69.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Rotator cuff syndrome, Tendonitis
Clinical narrative: Pain and unable to move shoulder.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Individual states that her left arm was sore the night she received the vaccine and was fine until 3/4/2016 when she experience significant left shoulder pain. States that it is better during day, but can still notice. States that at night it is much worse. Explains that it has affected ROM, ADL, as well as difficulty with sleep. Has not consulted a provider. Has used ibuprofen and heat, with some relief.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Cough, Influenza virus test negative, Injection site erythema, Injection site urticaria
Clinical narrative: Mom states that patient developed at temp that evening of 99, then the following day 100.6.  Treated with acetaminophen.  Patient developed large red welts on back of thighs, and down front of legs, but deny being located around the infection site. Patient has a cough and runny nose, and mom dx with strep just previously.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Rhinorrhoea
Clinical narrative: Mom states that patient developed at temp that evening of 99, then the following day 100.6.  Treated with acetaminophen.  Patient developed large red welts on back of thighs, and down front of legs, but deny being located around the infection site. Patient has a cough and runny nose, and mom dx with strep just previously.
Age: 1.13
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Choking, Dehydration, Dysphagia, Influenza virus test negative, Pyrexia
Clinical narrative: 104 fever, hyper salivation, couldn't swallow, choking, dehydration.
Age: 1.13
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Salivary hypersecretion, Streptococcus test negative
Clinical narrative: 104 fever, hyper salivation, couldn't swallow, choking, dehydration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema, Pain, Pruritus
Clinical narrative: Vaccine was given in my left upper underarm. Reaction (which is continuing as of time of report, 3/10/2016) is a hardened reddened area, 2x3 inches, surrounded by slight edema which extends about 1-2 inches beyond the reddened area.  Painful to touch, otherwise slightly itchy.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLUN4, HEP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: FEVER; Erythema, edema to left upper arm, shoulder to elbow beginning morning after vaccine and progressing into next day; fever day one after vaccine.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The first days the area on top of the arm was red and swollen.  No where near the vaccination site.  As time went on until today, the pain level is very bad on top of the arm from wrist to elbow.  Not red or swollen.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMRV
Symptoms: Antibody test positive, Rash erythematous
Clinical narrative: Red rash all over face, arms and torso.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Clostridium test positive, Haematochezia, Imaging procedure, Middle insomnia
Clinical narrative: Cycles of abdominal pain with calm periods in between, all day and woke her from sleep at night. Developed bloody stools on 3/9/16.
Age: 1.01
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 3 days. Rash for 3 days. Cleared up for 2. Fever returned on 3/6/16. Rash returned on 3/8/16.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Ear pain, Injection site pain, Lymph node pain, Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: EXTREME jaw pain, both sides, and ear pain in both ears.  Sore neck glands on both sides, and right shoulder pain.  Saw Primary care doctor after 2 weeks of pain.  Ate only soft foods for 2 weeks & took Tylenol.  Then saw Dentist who prescribed a muscle relaxant & Aleve.  I am still in horrid pain in my jaw & ear (right side).  Diagnosed with TMJ by both my Internal Medicine doc & my DDS.  I've been avoiding chewing, support my jaw when yawning, chew only on the left side.  Aleve, even 2 at a time (which exceeds the dosage) does NOT help.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Vaccine given on 03/07/2016 had expired on 03/04/2016.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: INJECTION SITE REACTION --SWOLLEN, HOT TO TOUCH, RED. PT STARTED WITH LITTLE RASH ON ONE HAND, FEW HOURS LATER DEVELOPED LITTLE RASH ON CALF, THEN NEXT DAY DEVELOPED LITTLE RASH ON STOMACH AREA.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No Adverse events.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Unusual & increasing pain in upper arm with increasingly limited range of motion continuing to this date with some improvement.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Patient states that about 20 minutes after leaving clinic, he noted dizziness and lightheadedness. Nausea/vomiting started about 25 minutes later. Pt reports minor headache. Pt denies having any side effects to vaccines in past, and NKDA. Pt denies redness/swelling in arm. Pt denies any SOB. Pt denies any vision changes or ringing in ears.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Diet refusal, Nausea, Pyrexia, Vomiting
Clinical narrative: Starting at around 4PM, patient started complaining of nausea. He refused dinner at around 6pm. By 6:30, he developed a fever of 102F. At 7, he started vomiting. He couldn't keep down water or antipyretics. This continued into the morning. I called his physician's office, and they called in Zofran. I was able to give that to him at noon. The nausea subsided. The fever reimagined until approximately 6pm on 3/9/2016.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy and complains of injection site being warm, itchy and raised. It occurred 4 days after vaccination. Told patient she should make an appointment with her PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Swollen tongue
Clinical narrative: Patient complained her heck was tightening up. Checked with patient after gave her Benadryl, she said no difficulty breathing, and no hives. She said her tongue might have swelled up a little bit, but got better.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Middle insomnia, Mobility decreased, Myalgia
Clinical narrative: Excruciating pain in muscle and shoulder joint. Unable to move arm. Waking up at night from pain. Shoulder joint pain still persisting.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cough, Dyspnoea, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Cough started as a tickle in throat, became so bad she could not breathe only breath was between coughs, took her to the ER.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain underneath Pneumovax injection site.
Age: 16.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: DEVELOPED AN ERYTHEMATOUS SWOLLEN AREA OF CELLULITIS TO RIGHT DELTOID. TREATED WITH BENADRYL OVER 3 DAYS PERIOD, BACTRIM DS FOR BACTERIAL COVERAGE. WAS SENT TO ER 03/08/2016 AND WAS GIVEN MOTRIN.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Deltoid area of arm is red, hot and swollen 5 inch by 3 inch area when pt came back to clinic 48 hours after vaccine.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: 3 cm redness, tenderness on R shoulder, pruritus and mild edema.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nodule, Nuclear magnetic resonance imaging, Pain in extremity, Thrombosis
Clinical narrative: Once PNEUMOVAX 23 inj. 25/0.5 was administered that is when the problem began. First started with blood clot, bumps in arm, pain and immobility of arm. On 7/1/15 Pneumonia shot was administered in my local pharmacy with referral from my doctor. Same day left developed blood clot. Excruciating pain developed and immobility to use arm occurred.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: Once PNEUMOVAX 23 inj. 25/0.5 was administered that is when the problem began. First started with blood clot, bumps in arm, pain and immobility of arm. On 7/1/15 Pneumonia shot was administered in my local pharmacy with referral from my doctor. Same day left developed blood clot. Excruciating pain developed and immobility to use arm occurred.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Eye swelling, Laboratory test abnormal
Clinical narrative: After getting the ZOSTAVAX INJ to prevent shingles, on Jan 29, 2016 - I suddenly lost vision due to what may be "Macro Pucker". Symptom in the right eye became solid blocking a quarter percent of the upper right quadrant of the eyes vision. This became permanent after 3 weeks following the injection as a possible immune reaction in the eyes defense.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Patient received MMR and VZV about 10 minutes later pt came back with swollen eye and SOB. Treatment 1 EPIPEN Jr 15mg given 12:10pm Albuterol .5.
Age: 47.0
Sex: U
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Soreness, clawing.
Age: 8.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Extra dose administered, Full blood count normal, Metabolic function test normal, Seizure
Clinical narrative: A febrile seizure 10 days after VARIVAX, Flu shot and Hepatitis A seen at ER at local hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Flat red sl tender rash at injection site appeared 2 days after inj. and enlarged to 3x5 cm. Now fading. Pain (L) shoulder region developed 2 days post-injection and worsened w/limited ROM. Vaccine administered on 2/23/16.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cough, Irritability, Pyrexia, Rash papular, Rhinorrhoea
Clinical narrative: Pt. rec'd 12 mo immunizations in office on 3/04/16. Seen again 3/09/16 for c/o rash (pink papular) on trunk. Other s/s -> fussy, cough, runny nose, fever (100.5-max), sneezing. Dx as URI/cough/vaccine-related rash. (Viral illness) tx with TYLENOL/MOTRIN PRN. Return if fever > 5 days or worsening.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Sneezing, Upper respiratory tract infection, Viral infection
Clinical narrative: Pt. rec'd 12 mo immunizations in office on 3/04/16. Seen again 3/09/16 for c/o rash (pink papular) on trunk. Other s/s -> fussy, cough, runny nose, fever (100.5-max), sneezing. Dx as URI/cough/vaccine-related rash. (Viral illness) tx with TYLENOL/MOTRIN PRN. Return if fever > 5 days or worsening.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Night sweats, Pyrexia
Clinical narrative: Client states around 9 PM she had a low grade fever which maxed at 100.8 degrees F. She also stated she had night sweats, she took an ibuprofen and felt better. Night sweats returned the next night - 3/9/16. But went away and she has had no other symptoms since.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with dose of ZOSTAVAX (lot # L034724, expiration date 09-DEC-2016, route not provided) (incorrect product storage). Concomitant therapies were not provided. The doses were exposed to the following conditions. No adverse effects were reported. The outcome of events was unknown. There were no product quality issue (PQC) involved. Temperature: 29F. Time frame: less than 30 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No.  Was call because of a "data logger"? No. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route not reported, lot # L019996, expiration date 02-DEC-2016). Temperature was 8.6 F. Time frame was 9.5 hours. There was no previous temperature excursion. No adverse effect reported. This is one of two reports 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 registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 57 F for 7 hours, data logger involved) doses of ROTATEQ, lot # K022990, expiry date 26-JUN-2016; lot # L006184, expiry date 13-DEC-2016; lot # L023870, expiry date 20-APR-2017, lot # L027067, expiry date 06-APR-2017; lot # L035508, expiry date 12-MAY-2017; and lot # L029615, expiry date 15-MAY-2017, (dose and frequency not reported). No adverse effects reported. No previous excursions were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L034372, expiration date 08-SEP-2017). Temperature was 8.6 F. Time frame was 9.5 hours. There was no previous temperature excursion. No adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patient were vaccinated with improperly stored doses of VAQTA, lot # L002717, expiry date 02-JUN-2017; lot # K018181, expiry date 04-JUN-2017; lot # L015460, expiry date 20-JUL-2017; lot # L015460, expiry date 20-JUL-2017; lot # L045713, expiry date 14-JAN-2017; lot # K018181, expiry date 04-JUN-2017; and lot # L034381, expiry date 21-DEC-2016, (dose and frequency not reported). No adverse effects reported. No previous excursions were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker refers to a 61 year old female patient. The patient's medical history included shingles in 2014. on 07-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot# L035505 with expiration date 16-DEC-2016, 0.65 ml/once, subcutaneous) for vaccination. Concomitant drugs included multiple unspecified medications. On the same day the patient started experiencing redness at the injection site, the area was mildly warm to the touch with swelling measuring 3 centimeters in diameter. The patient was seen in the office by the physician on 08-MAR-2016. No treatment was given for the events. No lab tests were performed. Outcome of the events was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# L035505 with expiration date 16-DEC-2016). Concomitant medications were not reported. On an unknown date the patient experienced injection site swelling and redness that was warm to the touch. Outcome of the events was unknown. The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# L035505 with expiration date 16-DEC-2015). Concomitant medications were not reported. On an unknown date the patient experienced injection site swelling and redness that warm to the touch, headache, and "generalized achiness". Outcome of the events was unknown. The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # L035505 with expiration date 16-DEC-2016). Concomitant medications were not reported. On an unknown date the patient experienced injection site swelling and redness that was warm to the touch, headache, and "generalized achiness". Outcome of the events was unknown. The causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2016 ("between 09-FEB-2016 and 03-MAR-2016"), the patients were vaccinated with doses of improper stored VARIVAX (Merck) (lot # L007225, expiration date 03-MAR-2017; lot # L017142, expiration date 13-MAY-2017; lot # L021211, expiration date 10-JUN-2017) (dose and route were not reported). The vaccine was exposed to temperature 35F for 15 hours 45 minutes. There was no previous temperature. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old female patient. The patient's concurrent condition included asthma. The patient's medical history and drug reactions or allergies were not reported. On 29-FEB-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035686, exp. date: 16-FEB-2017). Concomitant therapies included AVIANE and albuterol HFA inhaler. On the same day, the patient's arm as sore at the injection site following the administration of PNEUMOVAX 23. The soreness radiated to her upper arm. On 01-MAR-2016, the patient had pain in her arm and her arm was red and swollen at the injection site and "it looked like hives at the injection site". On 02-MAR-2016, the patient's arm was still painful. The patient was treated with BENADRYL and ibuprofen. None of the labs diagnostics were performed. The patient called to the physician's office.  The outcome of the patient's events was reported as recovering. The relatedness between vaccination with PNEUMOVAX 23 and the patient's events was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old female patient. The patient's concurrent condition included asthma. The patient's medical history and drug reactions or allergies were not reported. On 29-FEB-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035686, exp. date: 16-FEB-2017). Concomitant therapies included AVIANE and albuterol HFA inhaler. On the same day, the patient's arm as sore at the injection site following the administration of PNEUMOVAX 23. The soreness radiated to her upper arm. On 01-MAR-2016, the patient had pain in her arm and her arm was red and swollen at the injection site and "it looked like hives at the injection site". On 02-MAR-2016, the patient's arm was still painful. The patient was treated with BENADRYL and ibuprofen. None of the labs diagnostics were performed. The patient called to the physician's office.  The outcome of the patient's events was reported as recovering. The relatedness between vaccination with PNEUMOVAX 23 and the patient's events was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) upper arm at injection site 31 mm redness site flat warm to touch. (R) upper arm at injection site 40 mm redness flat warm to touch.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician via a company representative referring to a 2 month old female patient. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date of 2016 (reported as "sometime last week"), the patient received a dose of ROTATEQ (oral, lot#, dose and dose number were unspecified) to prevent rotavirus. On an unspecified date after this, the "patient's whole family, and possibly also the patient, developed diarrhea". No lab diagnostics study was performed. The present status of the patient and the patient's family was unspecified. It was unspecified how many people were included in the patient's "family". Additional information is not expected because there was no consent to contact the physician.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 05-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 16-DEC-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 5 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Vaccine administered 3/1/16. Persistent tenderness of upper arm. 3/8/16 patient noticed redness and induration medial and lateral to injection site. No redness or induration at injection site.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Vaccine administered 3/1/16. Persistent tenderness of upper arm. 3/8/16 patient noticed redness and induration medial and lateral to injection site. No redness or induration at injection site.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Tenderness
Clinical narrative: Vaccine administered 3/1/16. Persistent tenderness of upper arm. 3/8/16 patient noticed redness and induration medial and lateral to injection site. No redness or induration at injection site.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Muscle swelling, Skin warm, Tenderness
Clinical narrative: Swollen muscle, tenderness, redness, warm to touch.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Adverse rxn including pain, redness, severe swelling at injection site. Arthralgia, myalgia.