chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (Lot # L033690 with expiration 14-JUN-2018; lot # L030865 with expiration 07-JUN-2018; lot # L012838 with expiration 10-MAR-2018; lot # L004740 with expiration 16-NOV-2017, dose and route were not reported) (incorrect product storage). The vaccines were exposed to two excursions: 9.8 centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L019297 with expiration 18-AUG-2017; lot# L020015 with expiration 16-AUG-2017; lot # L013429 with expiration 21-JUL-2017; lot# L000610 with expiration 31-JAN-2017, dose and route were not reported). The vaccines were exposed to two excursions: 9.8 centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPAB, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 7 year old male patient with heart murmur and "ADHA". On 11-FEB-2016, at 10:44 pm, the patient was vaccinated with the second dose of PROQUAD (Merck) (lot# L040414, subcutaneous, dose unknown) which was improperly stored. Concomitant therapies included DTaP, influenza virus vaccine (unspecified), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified) and IPV (unspecified). No adverse event was reported. There was no illness at time of vaccination. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected since all follow up attempts has been received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored LIQUID PEDVAXHIB (lot #K019701, expiration date: 17-JUL-2017, dose, route of administration and injection site were not reported). Administered doses of LIQUID PEDVAXHIB underwent temperature excursions at 58 Fahrenheit degrees, for 26 hours.  Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dysphonia, Endoscopy abnormal, Nasopharyngitis, Vocal cord paralysis
Clinical narrative: Information has been received from a consumer referring to her 69 year old husband with arthritis, diabetes mellitus, hypertension and retinal vein occlusion. The patient was a pacemaker user and allergic to amiodarone and azithromycin. The patient's medical history included triple bypass and back surgery. In approximately October 2015 (reported as "4 or 5 months ago"), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date unknown, 1 shot, subcutaneous). Concomitant therapies included PRAVACHOL, LASIX, hydralazine (reported as "hydrolazine"), potassium (unspecified), NORVASC, ZESTRIL, TORPOL XL tablets, allopurinol, fenofibrate and warfarin. In approximately October 2015, within a week after the vaccination of PNEUMOVAX 23, the patient developed a cold-like infection and has raspiness in his throat. The raspiness had been gradual but had continued to become worse. The patient sought medical attention and the doctor recommended anti-allergy medications such as ZYRTEC (reported as "ZYRTEK") and using a humidifier but without improvement. Then the patient consulted a specialist who performed an endoscopy and stated that there appeared to be some paralysis in the vocal cords. The outcome of the events was reported as not recovered/not resolved. The causality between the events and PNEUMOVAX 23 was unspecified. Upon internal review, the event vocal cord paralysis was considered to be medically significant. 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 and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concomitant conditions and concomitant medications were provided. On unknown dates, multiple unspecified patients received doses of improperly stored M-M-R II (lot #K015375, expiration date: 18-SEP-2016, dose, route of administration and injection site were not reported). Administered doses of M-M-R II underwent temperature excursions at 58 Fahrenheit degrees, for 36 hours. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # L019835, expiry date 23-MAR-2017 (dose, route and site of administration not reported). On an unknown date, the patient experienced unspecified anaphylactic reaction. The outcome of anaphylactic reaction was unknown. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-MAR-2016, the patient was vaccinated an improperly stored dose of ROTATEQ (lot # M002252, expiration date 28-FEB-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses of ROTATEQ was improperly stored in a temperature of -1.4 C, the time frame was 1 hour. There was no previous temperature excursion reported. The vaccines involved included ROTATEQ (lot # L027070 (exp 30-APR-2017) and (Lot # M002252, exp 28-FEB-2017). No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-MAR-2016, the patient was administered an expired dose of PNEUMOVAX23, intramuscularly, lot # K008409, expiration date: 04-MAR-2016 (exact dose and anatomical location were not provided. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, public health consultant, referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # K008931, route, dose and expiration date were unknown) which were improperly stored (lot # K008931 in 30.6 Fahrenheit (F) for 69 hours). There was no previous temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 29-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAZX (1 dose form (DF), lot #, expiration date and route unspecified), which was reconstituted with expired sterile diluent (Merck Sterile Diluent) (lot # L003601, expiration date 24-JAN-2016) (product preparation error and expired product administered). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (lot numbers L013066, L016125, L024256, temperature: 18 degree Fahrenheit for 65 hours) and (lot # L028276, temperature: 22 degree Fahrenheit for 13 hours) which were improperly stored. No adverse effects were reported. No PQC involved. Additional information is not expected as the reporter did not provide consent for further follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L004014 with expiration date or lot # L013429 with expiration date 21-JUL-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016"} the patients were vaccinated with improperly stored RECOMBIVAX HB (dosing regimen unspecified) (lot L027733, expiry 13-SEP-2017; lot L033343, expiry 13-SEP-2017; lot L044694, expiry 04-FEB-2018). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature:1C, Time frame: 23 hours, there was no previous temperature excursion. It was a call because of the data logger. No adverse effect reported. GARDASIL and M-M-R II appear in the product list as these products were involved in the excursion, however, no improperly stored doses of GARDASIL or M-M-R II were administered. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified)(lot L029934, expiry 01-MAY-2017; lot L035276, expiry 09-JUN-2017; lot L039297, expiry 19-JUN-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported, GARDASIL 9 and M-M-R II appear in the product list as these products were involved in the excursion, however, no improperly stored doses of GARDASIL 9 or M-M-R II were administered. No additional information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Oedema peripheral, Peripheral swelling, Skin warm
Clinical narrative: PATIENT REFERS THAT AFTER THE VACCINE ADMINISTRATION, SHE FELT A BURNING SENSATION, AND SHE NOTICED HER RIGHT ARM WITH EDEMA, SWOLLEN, RED, AND HOT TO THE TOUCH. SHE RECEIVED ANTIBIOTICS IV (ROCEPHIN) FOR ONE WEEK.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ultrasound Doppler normal
Clinical narrative: PATIENT REFERS THAT AFTER THE VACCINE ADMINISTRATION, SHE FELT A BURNING SENSATION, AND SHE NOTICED HER RIGHT ARM WITH EDEMA, SWOLLEN, RED, AND HOT TO THE TOUCH. SHE RECEIVED ANTIBIOTICS IV (ROCEPHIN) FOR ONE WEEK.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red rash noted to lower abdomen and around umbilicus. Has Dr. apt today (3/22). Had low grade temp x 3 days last week according to mother.
Age: 36.0
Sex: F
Vaccine: FLU4, HEP, HEPA, TD
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Pt called dept to say her eyelids and face were swollen, she attributed it to hepatitis B vaccine. Said she had a milder reaction when she previously received hep B: mild eyelid swelling 1 week post vaccination. Note: she also received TD at the same time, both occasions.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Aphonia, Cough, Oropharyngeal pain
Clinical narrative: Sore throat, cough, loss of voice.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient developed painful induration at site of BEXSERO injection about 2 cm in diameter. Induration lasted > 8 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 4 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 02-SEP-2015, the patient was vaccinated in right thigh with dose of improperly stored VARIVAX (Merck) (dose and route were unspecified) lot # L018001, expiration date: 19-MAY-2017. Concomitant therapies included M-M-R II vaccinated in left thigh, poliovirus vaccine inactivated (unspecified) vaccinated in right thigh and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid in left thigh. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: M
Vaccine: MMRV
Symptoms: Exposure via direct contact, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-MAR-2016, while the patient's 4 year old child was receiving a dose of PROQUAD (Merck) injection (dose, lot# and expiration date were not reported), the vaccine splashed an unspecified way into the patient's right eye. The patient was seen by a physician on the same day for an eye exposure with PROQUAD (Merck). The patient experienced no adverse effects following the eye exposure. The reporter confirmed that the patient's child received a full dose of PROQUAD (Merck). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-MAR-2016 (also reported as yesterday), the patient was vaccinated with the dose of expired ZOSTAVAX injection, 0.65 ml, subcutaneously in the left arm, lot # L000449, expiration date 08-MAR-2016. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 4 year old female patient. Concurrent conditions and medical history of the patient were not provided. On 14-SEP-2015, the patient was vaccinated in right thigh with dose of improperly stored (Oka/Merck) VARIVAX (dose and route were unspecified) (lot # L018001, expiration date: 19-MAY 2017). Concomitant therapies included M-M-R II vaccinated in left thigh. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In July 2014, the patient received the first dose in the series of GARDASIL (injection; dose, lot# and expiration date were not reported). In July 2015, the patient received the second dose in the series of GARDASIL (injection; dose, lot# and expiration date were not reported). On 17-MAR-2016 (reported as now), the patient was in the office to receive the third dose in the series of GARDASIL (it was unknown if the patient received the dose). No adverse effects were reported. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 9 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 15-MAR-2016, the patient was vaccinated with incorrectly stored M-M-R II injection (recombinant human albumin) (lot #L032181, dose of 0.5 ml, subcutaneously) that was out of range for an unspecified amount of time. No adverse effects were being reported. Additional information had been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: One week after vaccine noticed fatigue, malaise, redness, swelling, itching and mild pain and injection site.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: One week after vaccine noticed fatigue, malaise, redness, swelling, itching and mild pain and injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 15-MAR-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX injection, lot # reported as K02362, expiration date on 19-FEB-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Additionally, the reporter requested information about when the patient could be revaccinated. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Seizure
Clinical narrative: A spontaneous report had been received from a Physician via Medical representative concerning a 6 years old male patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received one dose of FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration on 27-Feb-2016. A day later, the patient developed a seizure, 28-Feb-2016. The BSS (Biotech Sales Specialist) believed that the patient was hospitalized but not sure, patient was in home and was doing ok. Action taken with FLUMIST and the outcome of the event of seizure was unknown. Company physician considered the event of seizure to be serious with seriousness criteria of hospitalization. The patient's neurologist believed seizure was related to the FLUMIST.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness at site of injection approximately 2x3 inches. Slight itching.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Flushing, Influenza like illness, Pain
Clinical narrative: Increasing and persistent itching at site of previous case of shingles (ca. 5 years ago). Increased to burning sensation by evening of 3/18. No rash. Burning ceased on 3/19, but itching has continued.  Onset of mild flu-like symptoms on 3/19: achiness, flushed, fatigue; worst on 3/21.  Called doctor on 3/21 am; told it was likely a reaction to shingles vaccine. On 3/22 am, symptoms are less, but not gone.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Increasing and persistent itching at site of previous case of shingles (ca. 5 years ago). Increased to burning sensation by evening of 3/18. No rash. Burning ceased on 3/19, but itching has continued.  Onset of mild flu-like symptoms on 3/19: achiness, flushed, fatigue; worst on 3/21.  Called doctor on 3/21 am; told it was likely a reaction to shingles vaccine. On 3/22 am, symptoms are less, but not gone.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist reported that the patient was vaccinated with the first dose of RECOMBIVAX HB on 09-DEC-2015 and the second dose of the vaccine was administered on 07-MAR-2016 (lot#, expiration date were not provided for the vaccines) (inappropriate schedule of vaccine administration). Concomitant therapies were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Headache, Injection site swelling, Pyrexia, Rash
Clinical narrative: Rash on right arm. Swollen left arm around injection site of vaccination. Fever. Headache.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 11 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone QIV) (batch number: UI446AB, expiry date: 30 June 2016 and site of administration was not reported.) intramuscularly on 29 October 2015. Patient's medical history and concomitant medication was not reported. It was unknown whether the patient received any other vaccination on 29 October 2015. On 30 October 2015, one day following the vaccination in evening the patient experienced chills, fever, hip pain, weakness and low grade fever. Lab data was reported none. It was reported that patient didn't seek medical treatment and physician was unaware of any treatments or OTC medication patient may have taken. On 1 November 2015 the patient had recovered. List of documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Arthropod bite, Rash erythematous, Rash pruritic
Clinical narrative: He woke the morning after finishing pill #2 of a 4 dose series of oral typhoid with a solid itchy red rash under both arms and in armpits. The night prior to rash onset, he had 2-3 mosquito bites on shoulder and back.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Red pimple like rash - first noticed on face - then also on back and legs. Approx #10. Afebrile not itchy. No other symptoms reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 57 year old female patient, reporting on herself. The patient medical history included reoccurring shingles. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX, 1 shot for the treatment of reoccurring shingles (route, anatomical location or lot # were not provided). Concomitant medications were not reported. On 19-MAR-2016, the patient experienced shingles. No treatment was given for the event and the patient was not hospitalized. The patient sought for medical attention by calling the office. No product quality issue was informed. At the reporting time, the outcome of shingles was reported as not recovered. The relatedness between the event and suspect therapy was not provided. Additional information is not expected as no contact information was provided.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Pt was given vaccine Friday 3-11-16 and over weekend had fever (resolved), wouldn't walk (resolved), red streak (resolved) and leg was twice the size of other leg.
Age: 93.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling arm at site of ADACEL given.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abnormal faeces, Diarrhoea haemorrhagic, Mucous stools, Stool analysis normal
Clinical narrative: After these vaccines he developed blood diarrhea for a few days. Mom reports after 2 and 4 month vaccines he developed mucoid foul stools for weeks. Allergist referral being done.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Febrile convulsion, Otitis media acute, Upper respiratory tract infection
Clinical narrative: Pt received MMR, PCV-13 and Hep A vaccines 12/29. Pt had first lifetime simple febrile seizure (also had AOM and URI) on 1/10.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Glassy eyes, Hypoaesthesia
Clinical narrative: Right arm- her arm began to burn no tingle and she had a little numbness in this arm also. This was the arm the vaccine was administered. Shortly after she a had a glaze over her eyes. She reports all this in 20 min. of receiving vaccine. She rto to discuss. Felt fine with 1-2 hours; No obvious problems noted, no lesions, eye/vision exam intact.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Two small pea size welts just above the MMR injection site. Red, warm to touch. Ice applied to site, swelling decreased within 15 minutes. Pt denied itching or pain at site.
Age: 3.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site of injection. Symptomatic treatment advised.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Computerised tomogram head, Differential white blood cell count normal, Eye pain, Fatigue, Full blood count normal
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Headache, Metabolic function test normal, Myalgia, Platelet count normal, Rash
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Scan myocardial perfusion, Thyroxine normal
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Blood test normal, Computerised tomogram, Differential white blood cell count, Eye pain, Fatigue
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Headache, Metabolic function test, Myalgia, Nuclear magnetic resonance imaging, Platelet count
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Rash, Scan with contrast, Thyroxine free
Clinical narrative: After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
Age: 0.43
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on forearms.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, MMRV, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered PROQUAD vaccine (MMRV) instead of MMR. Also rec'd varicella vaccine that day no s/s or tx noted/given.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PPV, RV5, DTAPIPVHIB, FLU3, HEP, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: No adverse event. Wrong vaccine given. Pneumococcal 23 given instead of PREVNAR 13.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe upper arm pain, especially noticeable at night. I would wake up in pain. Unable to lift arm laterally. Pain from 10/14/15 to 3-1-16. Suddenly healed.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: Dizziness, numbness of arms, difficulty focusing. "Felt abnormal for 2 days", started one day after vaccines were given. Home care treatment only.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: Blotchy skin 5 cm x 5 cm raised swollen bump inside the arm (pt stated that before she took BENADRYL, the area was from injection site all the way to inner arm).
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia, Rash
Clinical narrative: (L) arm pain and decrease ROM fever and upper body rash.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Circular erythematous area on left thigh approximately two weeks after first set of immunizations. (Child previously immunizes). Treated with mupirocin ointment.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Circular erythematous area on right thigh approximately 3 weeks after first set of immunizations (child previously unimmunized). Mupirocin ointment prescribed.
Age: 26.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Eczema, Respiratory disorder
Clinical narrative: Eczema; respiratory disorders.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site rash, Lethargy, Pallor
Clinical narrative: 1 hr after vaccines given, pt's right thigh had red rash, generalized pallor, lethargy. PEDVAXHIB and PREVNAR 13 given in right thigh.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Induration, Malaise, Pruritus
Clinical narrative: Thirty minutes after receiving injection pt c/o burning and itching w/8 cm local erythema w/malaise. No fever. W/6 cm center was warm, firm, swollen and tender. Advise pt to take CLARITIN, TYLENOL and use ice pack.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Thirty minutes after receiving injection pt c/o burning and itching w/8 cm local erythema w/malaise. No fever. W/6 cm center was warm, firm, swollen and tender. Advise pt to take CLARITIN, TYLENOL and use ice pack.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Pain in upper arm, "Debilitating", according to patient. Pain still present as of 3/22/16. When vaccine given 10/30/15. Pt states vaccine was given below the deltoid.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Received vaccine on 3/21/16 - now has a lesion on right deltoid approx. 2 in diameter - redness/subcut firm swelling, very tender to touch instructed to take BENADRYL, ice arm TID - 20 min at a time move arm as much as possible.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Dysuria, Liquid product physical issue, Nervousness
Clinical narrative: Case number PHEH2015US013578 is an initial spontaneous report from a pharmacist received on 10 JUL 2015 with the follow-up information received from Quality Assurance Department (reference number: 381256) on 10 AUG 2015 and a combined follow up report from the pharmacist received on 14 JUL 2015 and on 17 AUG 2015. This was also a quality complaint (QA reference number 381256). This report refers to a 55-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with RABAVERT first dose on 22 JUN 2015 (batch number: not reported), second dose on 25 JUN 2015 (batch number: not reported) and third dose on 29 JUN 2015 (batch number 556011A expiry date: FEB 2018). It was reported that after the third dose of RABAVERT, he had urinary burning. He stated that the third dose "appeared cloudy" in the vial. The pharmacist stated that the appearance of the product looked fine for the nurse and they felt that the patient was mostly a nervous patient. The outcome, seriousness and causality assessment of the event was unknown. He received the fourth dose on 06 JUL 2015 and everything appeared normal and there were no issues. IT was reported that this was the first complaint for this batch for this issue. This is the seventh complaint for this batch. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 556011A) was manufactured in accordance with the approved internal procedures and it wa sin compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 381256) on 10 AUG 2015: Updated RABAVERT batch review report. Combined follow up report from the pharmacist received on 14 JUL 2015 and on 17 AUG 2015: Nurse comments regarding the appearance of product and patient's condition after the fourth dose of RABAVERT were updated.
Sex: F
Vaccine: RAB
Symptoms: Injury associated with device, Pain in extremity
Clinical narrative: Case number PHEH2015US012472 is an initial spontaneous report received from a nurse on 29 JUN 2015. This report refers to a female patient. Past medical history and concomitant medications were not reported. It was reported that while administering RABERVET (batch number: not reported) to a patient on an unknown date in JUN 2015, she accidentally pricked herself in the finger with the needle. The affected finger was sore after the needle prick. The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported. The reporter did not wish to provide additional information.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Product preparation error
Clinical narrative: Case number PHEH2015US010531, is an initial spontaneous report received from a nurse on 01 JUN 2015. This report refers to a 21 year old male patient. Historical condition and concomitant medication were not reported. On 29 MAY 2015, he was vaccinated only with the liquid component of RABAVERT (batch number: 564011A) via intramuscular route, second dose. After vaccinating the patient stated that "the medication burned".  Outcome of the event was reported as complete recovery on the same day. Seriousness and causality was not reported.
Sex: F
Vaccine: RAB
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Case number PHEH2015US012331 is an initial spontaneous report from a healthcare professional received on 24 JUN 2015. This report refers to a female patient of unspecified age. Medical history and concomitant medications were not reported. It was reported that a female staff member experienced a needle stick injury after patient administration with RABAVERT (batch number: unknown on 22 JUN 2015). There was no patient harm. No adverse event was reported.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Injection site pain, Product preparation error
Clinical narrative: Case number PHEH2015US016740, is a combined initial and follow-up spontaneous report from a health care professional received on 26 Aug 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication included ORTHO-TRI-CYCLEN LO. Her vaccination history included administration of first dose of RABAVERT (batch number: not reported) on 20 Aug 2015 after a bat was found in their home. The patient was inadvertently vaccinated only with the diluent as the second dose of RABAVERT (batch number: not reported) into left deltoid muscle on 23 Aug 2015. The patient also received IG injection for the post exposure. The patient experienced immediate pain with the injection in the left deltoid muscle that lasted about an hour and resolved. The patient did receive the actual vaccine for the second dose but that was administered in right thigh. Seriousness and causality of the event were not reported.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Immediate post-injection reaction, Injection site discomfort, Injection site pain, Product preparation error
Clinical narrative: Case number PHEH2015US016744, is a combined initial and follow-up spontaneous report from a patient (also health care professional) received on 26 Aug 2015. This report refers to a 25 years old male patient. Medical history was not reported. Concomitant medication included 5 HTP. His vaccination history included administration of first dose of RABAVERT (batch number: not reported) on 20 Aug 2015 after a bat was found in their home. The patient was inadvertently vaccinated only with the diluent as the second dose of RABAVERT (batch number: not reported) into deltoid muscle of right upper arm on 23 Aug 2015. The patient also received IG injection for the post exposure. The patient experienced immediate pain with the injection in his deltoid muscle and felt faint after the injection. The patient recovered from felt faint on the same day. On 26 Aug 2015 morning the patient noticed mild discomfort at the injection site of his right upper arm. The patient did receive the actual vaccine for the second dose but that was administered in left thigh. Outcome of the events pain and discomfort at the injection site was reported as not recovered. Seriousness and causality of the events were not reported.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Injury associated with device
Clinical narrative: Case number PHEH2015US020014, is an initial spontaneous report from a pharmacist received on 05 Oct 2015. This report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. It was reported that when the pharmacist was preparing the RABAVERT (batch number: 556011A, expiration date: 28 Feb 2018) the pharmacist poked herself with the vaccine needle on 05 Oct 2015. Final outcome of the event was unknown. Seriousness and causality were not reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, CSF test normal, Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: The patient was diagnosed with Miller Fisher syndrome, a rare variant of Guillain Barre Syndrome.  The patient had ataxia and ophthalmoplegia.  The patient received 5 days of IV immune globulin 0.4 grams/kg daily for 4 days and then was discharged to a rehab facility.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Ophthalmoplegia
Clinical narrative: The patient was diagnosed with Miller Fisher syndrome, a rare variant of Guillain Barre Syndrome.  The patient had ataxia and ophthalmoplegia.  The patient received 5 days of IV immune globulin 0.4 grams/kg daily for 4 days and then was discharged to a rehab facility.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt states at site of injection, left deltoid, she is experiencing red, raised bump, swelling in he rlymph node under her arm pit and headaches.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Pt stated on the evening of March 10th he developed tenderness and redness at injection site.  When he presented to the clinic following day, redness and tenderness at injection site was still present, and extended to torso and left upper arm.  Pt also noted mild light headedness.  Pt reported no other symptoms.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Full blood count, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented with redness of the arm, soreness and some swelling.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Had a 4 minute seizure within 2 hours after the flu shot. He has had 4 other seizures to date.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chest X-ray, Chills, Cough, Impaired work ability, Influenza A virus test positive
Clinical narrative: Fevers 104, chills, congestion, cough, vomiting. I had to seek emergency care, require chest X-ray, I had to miss 4 days of work. My 15 month infant also tested positive for influenza A even though she required the flu shot.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Fevers 104, chills, congestion, cough, vomiting. I had to seek emergency care, require chest X-ray, I had to miss 4 days of work. My 15 month infant also tested positive for influenza A even though she required the flu shot.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Cough, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Fevers 104, chills, congestion, cough, vomiting. I had to seek emergency care, require chest X-ray, I had to miss 4 days of work. My 15 month infant also tested positive for influenza A even though she required the flu shot.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory tract congestion, Vaccination failure, Vomiting
Clinical narrative: Fevers 104, chills, congestion, cough, vomiting. I had to seek emergency care, require chest X-ray, I had to miss 4 days of work. My 15 month infant also tested positive for influenza A even though she required the flu shot.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Asthenia, Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia, Paraesthesia oral
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Blood test, Dysphagia, Dysphonia, Facial paralysis
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Lumbar puncture abnormal, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Vomiting
Clinical narrative: Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Pt was given the Boostrix and advised to stay at the pharmacy for 5-10 minutes just in case if there's any allergic reaction. 10 minutes later, Pt felt that he has difficulty of breathing, but there's no swelling of the face/tongue, etc. Pt was given an Epi-pen junior while the staff call 911.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Echocardiogram normal, Eczema, Electrocardiogram normal, Gastrooesophageal reflux disease
Clinical narrative: Increased heart rate, eczema, acid reflux/colic, irritability.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Irritability
Clinical narrative: Increased heart rate, eczema, acid reflux/colic, irritability.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Autoimmune disorder, Blood test, Borrelia test positive, Headache, Immediate post-injection reaction
Clinical narrative: Immediately the shot hurt.  The arm swelled up and was hot to the touch.  Headache started the following day and has not gone away since.  Entire body hurts and has muscle cramping and spasms that need to be controlled by muscle relaxers.  Physicians believe there is now an autoimmune disorder from the reaction to the tetanus vaccine and my tendons are now susceptible to tearing, my posterior tibial tendon is now torn and needs surgery.  I have had blood work, MRI's, Xrays.  I now have Lyme disease and several courses of antibiotics have not been successful in treating it.  I still test positive for multiple strains.  They are putting me in the infectious disease unit to do IV antibiotics now.  I have to take HCTZ for weird parts of my body that suddenly swell.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Lyme disease, Muscle spasms, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Immediately the shot hurt.  The arm swelled up and was hot to the touch.  Headache started the following day and has not gone away since.  Entire body hurts and has muscle cramping and spasms that need to be controlled by muscle relaxers.  Physicians believe there is now an autoimmune disorder from the reaction to the tetanus vaccine and my tendons are now susceptible to tearing, my posterior tibial tendon is now torn and needs surgery.  I have had blood work, MRI's, Xrays.  I now have Lyme disease and several courses of antibiotics have not been successful in treating it.  I still test positive for multiple strains.  They are putting me in the infectious disease unit to do IV antibiotics now.  I have to take HCTZ for weird parts of my body that suddenly swell.