chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgic amyotrophy, Neuropathic muscular atrophy, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Pain and red at inject. site, flu-like aches and pains. Severe pain, spasms neck, shoulder, arm and hand. Pain down both legs. Loss of function and weakness left arm and hand-fingers. Severe cramping in hands, fingers, leg and feet. Left hand muscle wasting and denervation. Headaches.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-MAR-2016, the patient was vaccinated with a dose of MMR II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist regarding a unspecified female patient of unknown age with none medical history or concurrent conditions. On 11-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (0.65ml, intramuscularly; however, lot number and expiration date were not provided). There was none concomitant medications. On an unspecified date, reported as "a couple of days" after received ZOSTAVAX, the patient developed a fever and a swollen welt at the injection site which lasted for a couple of weeks (dates unspecified). The patient did not received treatment for the adverse events and did not seek medical attention. Laboratories tests were not performed. On an unspecified date, the patient's fever and the swollen welt resolved. At the time of reporting, causality between ZOSTAVAX and the adverse events were not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: After 36 hrs after vaccination patient noted to have red area 11cm x 8.5 cm warm to touch and firm with induration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Dyskinesia, Hypotonia, Pallor
Clinical narrative: She became pale, limp, and jerking movement in head minutes after injections. Immediately alert, and oriented when moved to exam table and laid down. VS stable. Monitored x 20 min post injection.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product reconstitution issue
Clinical narrative: Gave pt PENTACEL vaccine without reconstituting the Hib component.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Back pain, Fatigue, Lymphadenopathy
Clinical narrative: Enlargement of lymph nodes. Fatigue. Backache. Last visit to immunologist 4/6/16 symptoms persist.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Axillary mass, Local swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Pain left arm - lump under arm - states she had swelling in arm, neck, chest, back received 3rd dose, after symptoms appeared.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 24-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (dose: 0.5 ml, lot # L040421, expiry date: 15-OCT-2017) via intramuscular route (incorrect product storage). Nurse reported that the vaccine underwent a temperature excursion of 37 degree Fahrenheit for 96 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Influenza like illness, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Pain and redness at inject site, aches and flu-like symp. gradual onset of extreme pain in upper back, neck, and arms/hands. Arm and hand weakness from approx. 10-13 thru 1-14. "heavy arms and intense pain for approx. 4 mos. Unable to sleep due to pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness, Myelitis transverse, Neck pain, Pain
Clinical narrative: Pain and redness at inject site, aches and flu-like symp. gradual onset of extreme pain in upper back, neck, and arms/hands. Arm and hand weakness from approx. 10-13 thru 1-14. "heavy arms and intense pain for approx. 4 mos. Unable to sleep due to pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain and redness at inject site, aches and flu-like symp. gradual onset of extreme pain in upper back, neck, and arms/hands. Arm and hand weakness from approx. 10-13 thru 1-14. "heavy arms and intense pain for approx. 4 mos. Unable to sleep due to pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of injection site and fever in the same area saucer sized.  The biceps of my arm was twice the normal size. On 03/19/2016 went to doctor on advice of Pharmacist.  Arm was swollen twice the size from shoulder to elbow and red and feeling very hot to touch.  Dr. diagnosis was cellulitis of right upper arm.  Prescribed clindamycin HCI 300 mg capsule one tab 4 x daily for 10 days.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Flushing, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Right arm turned red and itchy at site on injectio, profuse sweating and facial flushing occurred approximately 45 minutes post injection. right hand became itchy and patient stated she "felt funny". Referred to ED. Dexamethasone 10mg given IM and Benadryl 50mg given PO. Medrol dose pack PO prescribed.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Right arm turned red and itchy at site on injectio, profuse sweating and facial flushing occurred approximately 45 minutes post injection. right hand became itchy and patient stated she "felt funny". Referred to ED. Dexamethasone 10mg given IM and Benadryl 50mg given PO. Medrol dose pack PO prescribed.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 15-MAR-2016, the patient was vaccinated with a dose of M-M-R II (lot #, L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time from were unknown at the time of reporting). No adverse effects were reported. This is one of several 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 healthcare worker/vaccine coordinator who refers to a unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. It was reported that on an unspecified date, an unspecified number of patients received unspecified doses of VARIVAX (Merck) (lot # K010339, expiration date: 22-JUL-2016) (Lot # L016126, expiration date: 06-MAY-2017) (dose and route were not reported), that were improperly stored and were part of a immunization series. No concomitant medication was reported. The temperature of storage was reported as 27.9 degrees F as maximum. The time frame was 1008 hours. It was reported that there was cumulative exposures from 16-FEB-2016 through 29-MAR-2016. No PQC involved and no adverse effects were reported. 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 licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-MAR-2016, the patient was vaccinated with a dose of M-M-R II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. 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 licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 17-MAR-2016, the patient was vaccinated with a dose of M-M-R II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician regarding a 20 year old female patient. Information on her concurrent condition was not reported. She had no pertinent medical history and drug allergies. On 12-JAN-2016, the patient was vaccinated with first dose of MMR II (lot and expiry date were not specified), and on 02-MAR-2016, second dose of MMR II (lot and expiry date were not specified) both 0.5 ml, subcutaneously (inappropriate schedule of drug administration). There was no concomitant medication reported. On un unknown date the patient became pregnant. The Last Menstrual Period and Estimated Due Date were not known. The pregnancy outcome was unknown at the time of reporting. On 31-MAR-2016 (today), the patient had performed a "home pregnancy urine test" that was positive for pregnancy (exposure during pregnancy). There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient had intermittent episodes of non billious, no bloody vomiting 24 hours after vaccinations. No diarrhea and no decrease in wet diapers. Symptomatic treatment including Pedialyte.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Vaccination complication
Clinical narrative: Left arm red, swollen, est. 4 x 5" diameter. Began 4-11-16 afternoon (same day as injection).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 11-APR-2016 (reported as "today"), the patient was vaccinated with an expired dose of ZOSTAVAX, which had a lot # of L029480 and an expiration date of 16-MAR-2016 (dose, dosage number, route of administration and anatomical location were not reported). However, no adverse effects were reported. Additional information is not expected since consent to be contacted for follow up information was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a female patient of unknown age. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 04-APR-2016 (reported as "today"), the patient was vaccinated with an expired dose of ZOSTAVAX, which had a lot # of L029480 and an expiration date of 16-MAR-2016 (dose, dosage number, route of administration and anatomical location were not reported). However, no adverse effects were reported. Additional information is not expected since consent to be contacted for follow up information was not provided.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: (L) arm redness/warmth at site.
Sex: F
Vaccine: IPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a healthcare professional (Pharm D) on 05 May 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of TDAP IPV (batch number, route of administration, site of administration were not reported) on an unspecified date. On an unspecified date; after vaccination, the patient had reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report outcome of event was unknown. Documents held by sender: none. Follow-up information received from a Pharmacist on 8 June 2015. No new information reported as the reporter was unable to recall who the patient was. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Body temperature increased, Flushing, Headache, Immediate post-injection reaction
Clinical narrative: Initial unsolicited report received from a healthcare professional (patient's mother) on 22 March 2016. This case involves a 4-year-old male patient who was vaccinated with a dose of DAPTACEL (batch number not reported) by intramuscular route in deltoid and also received a dose of IPOL (batch number not reported) by intramuscular route in deltoid on 21 March 2016. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions medical history were reported as none and concomitant medications were not reported. On 21 March 2016, few seconds (reported as immediately after vaccination) following the vaccination, the patient's arm turned red and had rash, became flushed and about 20 minutes following the vaccination, the patient had experienced increased temperature (99.7) and same day following the vaccination, the patient had experienced headache and stomach ache. Laboratory data was reported as none. The patient had received Advil and a nap as corrective treatment. On an unspecified date, the patient was recovered from events. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Initial unsolicited report received from a healthcare professional (patient's mother) on 22 March 2016. This case involves a 4-year-old male patient who was vaccinated with a dose of DAPTACEL (batch number not reported) by intramuscular route in deltoid and also received a dose of IPOL (batch number not reported) by intramuscular route in deltoid on 21 March 2016. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions medical history were reported as none and concomitant medications were not reported. On 21 March 2016, few seconds (reported as immediately after vaccination) following the vaccination, the patient's arm turned red and had rash, became flushed and about 20 minutes following the vaccination, the patient had experienced increased temperature (99.7) and same day following the vaccination, the patient had experienced headache and stomach ache. Laboratory data was reported as none. The patient had received Advil and a nap as corrective treatment. On an unspecified date, the patient was recovered from events. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza B virus test positive, Vaccination failure
Clinical narrative: Case number PHEH2016US009056, is an initial spontaneous report received from a pharmacist on 11 Apr 2016. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) 0.5 ml intramuscularly in Sep 2015. On 11 Apr 2016, the patient tested positive for flu B (vaccination failure). Outcome of the events was not reported. Seriousness of the events was reported as non serious. Causality was not reported. Seriousness of the events Influenza B virus test positive and vaccination failure was upgraded based on the available information in the source document.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage, Injection site pain, Joint injection, Joint range of motion decreased
Clinical narrative: Immediate pain at injection site. Employee asked if I was on anti coag, I advised not. She advised I was bleeding. Bandaid placed. Short time later bruise appeared distal to bandaid. Subsequent pain, inability to weight bear with that arm. Went to PCP, confirmed DIT vaccine. PO meds (ibuprofen) went to ortho also conf. Give inj to shoulder. Subsequent ortho visit po steroid. Shoulder place film and shoulder MRI conf. adhesive capsulitis. Daily pain since injection. Severe decreased ROM.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Weight bearing difficulty
Clinical narrative: Immediate pain at injection site. Employee asked if I was on anti coag, I advised not. She advised I was bleeding. Bandaid placed. Short time later bruise appeared distal to bandaid. Subsequent pain, inability to weight bear with that arm. Went to PCP, confirmed DIT vaccine. PO meds (ibuprofen) went to ortho also conf. Give inj to shoulder. Subsequent ortho visit po steroid. Shoulder place film and shoulder MRI conf. adhesive capsulitis. Daily pain since injection. Severe decreased ROM.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: Case number PHEH2016US009025, is an initial spontaneous report received from a pharmacist via phone on 11 Apr 2016. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (Batch number: not reported) in Sep 2015. The patient was tested positive for flu strain B since she received vaccination. Outcome of the event was unknown. Seriousness and causality of the event was not reported. Seriousness of the event "Influenza B virus test positive" was upgraded based on the available information in the source document.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Pain in extremity, Pruritus
Clinical narrative: Initial unsolicited report received from a healthcare professional on 22 September 2014. An 80-year-old female patient, had received first dose of ADACEL, (batch number U4965AA, route of vaccination was not reported) in left deltoid on 18 September 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include sulfa and codeine allergy. The patient did not receive any concomitant medications. On 19 September 2014, the patient experienced pain in left arm, itching and burning. No laboratory tests were performed. The patient was treated with Benadryl. The patient was taken to emergency room visit for doctor visit. At the time of this report, the outcome of event was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 07 January 2015. It was reported that ADACEL was administered intramuscularly. Documents held by sender: none. Follow up information received from healthcare professional on 8 June 2015. At the time of this report, the patient was recovered from the events. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Inflammation, Pruritus, Skin warm, Tenderness
Clinical narrative: Initial unsolicited report received from a health care professional (Nurse) on 13 October 2015. This case involves a 55 years old female patient whose was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number, dose, dose number were unknown) via unspecified route in right deltoid and also received a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (batch number, dose, dose number were unknown) via unspecified route in left deltoid both vaccines on 9 October 2015. Patient's medical history includes penicillin allergy and rheumatoid arthritis and concomitant medications was not reported. It was reported that, on 10 October 2015 (1 day after vaccination), patient developed a large area of redness warm and itchiness with inflammation localized, localized itching and tender to touch. Lab data was reported as none and corrective treatment was not reported The outcome of the events were not recovered at the time of this report. List of documents held by sender: none.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Bacterial infection, Chills, Influenza like illness, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 34-years-old male patient who was vaccinated with first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U5241AA, expiry date: 13 January 2018, dose was not reported) intramuscularly in right deltoid and with a dose of TUBERCULIN PPD(M) 5 TU (Tubersol) (batch number: C4653AA, dose, dose in series, expiry date were not reported) via intradermal route in right forearm on 13 October 2015. The patient's illness at time of vaccination reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions reported as asthma. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, same day following the vaccination, the patient had developed redness at injection site; redness and swelling progressed under the patient's right arm. On 15 October 2015, two days following the vaccination, the patient had experienced flu like symptoms, night sweat, chills, pain and numbness at injection site. The patient was diagnosed with bacterial infection caused by the vaccination but no culture done. The patient required ER/doctor visit. Laboratory data was not reported. The patient was treated with IM antibiotic; oral antibiotic and IM pain medication. The outcome of event was unknown. List of documents held by sender: none. Follow-up information received from the healthcare professional on 18 January 2016. It was reported that the patient had received 0.5 ml dose of adacel and 0.1 ml dose of tubersol. The county and state of vaccination were also updated. No further information on recovery reported.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Night sweats
Clinical narrative: Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 34-years-old male patient who was vaccinated with first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U5241AA, expiry date: 13 January 2018, dose was not reported) intramuscularly in right deltoid and with a dose of TUBERCULIN PPD(M) 5 TU (Tubersol) (batch number: C4653AA, dose, dose in series, expiry date were not reported) via intradermal route in right forearm on 13 October 2015. The patient's illness at time of vaccination reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions reported as asthma. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, same day following the vaccination, the patient had developed redness at injection site; redness and swelling progressed under the patient's right arm. On 15 October 2015, two days following the vaccination, the patient had experienced flu like symptoms, night sweat, chills, pain and numbness at injection site. The patient was diagnosed with bacterial infection caused by the vaccination but no culture done. The patient required ER/doctor visit. Laboratory data was not reported. The patient was treated with IM antibiotic; oral antibiotic and IM pain medication. The outcome of event was unknown. List of documents held by sender: none. Follow-up information received from the healthcare professional on 18 January 2016. It was reported that the patient had received 0.5 ml dose of adacel and 0.1 ml dose of tubersol. The county and state of vaccination were also updated. No further information on recovery reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Pt stated that injection was given into the muscle and she developed a large welt on her skin.  The injection site was hot and she had a fever for several days.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Serum sickness-like reaction
Clinical narrative: Employee provided note from her personal physician that stated that she had a "serum sickness type reaction to the Hepatitis B vaccine" No other details known.
Age: 70.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Grip strength decreased, Pain in extremity, Paraesthesia
Clinical narrative: Severe tingling in arm down to the hand, severe pain in upper arm, loss of grip in hand. Doctor said give it a few months. No help.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Enterovirus test positive, Polymerase chain reaction positive, Pyrexia, Somnolence
Clinical narrative: Parents were not able to wake pt and fever developed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, itchy swollen, area at injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling about the size of a half dollar, warm to touch. No fever.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Tendonitis
Clinical narrative: Initial report received from a healthcare professional on 12 June 2014: A 50-years-old female patient, whose medical history and concomitant medications were not reported received an intramuscular dose of ADACEL in the left deltoid (batch number: U4869AA) on 16 May 2014. On 16 May 2014 i.e. on the same day of vaccination the patient experienced redness at the vaccination site. Patient also experienced "bicipital tendonitis" that persisted till the date of report i.e. until 12 June 2014. Laboratory investigations and corrective treatments were not reported. The outcome was unknown at this time of report. List of documents held by sender: none. Follow-up information received from a healthcare professional on 4 May 2015. The patients had a medical history of allergic rhinitis, migraines, asthma, depression/anxiety, GERD, hyperlipidemia and menorrhagia. It was also reported that patient had received Ventolin PRN, Maxalt PRN, ADVAIR, simvastatin, Tdap 0.5 ml on 14 May 2014 in left deltoid (batch no 44869AA, expiry date 2 October 2016). No corrective treatments were given to the patient except ibuprofen OTC PRN (recommendation). NO laboratory investigations were performed. It was also reported that the patients symptoms gradually improved no clear stop date reported.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Limb discomfort, Myalgia, Rotator cuff syndrome
Clinical narrative: Initial unsolicited report received from a Medical Assistant on 12-Jan-2015. A 57 years old female patient had received a dose of ADACEL (batch number: U4886AA, via intramuscular route in the left arm) on 05-Dec-2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies and patient had no medical history and concomitant medications were not reported. On 05-Dec-2014, the patient experienced muscle soreness of arm and "impingement upon raising her arm". The symptoms continued till 12-Jan-2015. She stated that the symptoms may have improved somewhat but continues to have the symptoms. Laboratory investigations and corrective treatments were not reported. The patient required ER/doctor visit. At the time of this report, the outcome of the patient was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional (physician Assistant- certified) on 07 April 2015. The patient did not have any illness at the time of vaccination and patient had medical history of anxiety, post-menopausal symptoms and no known allergies. The patient had received LEXAPRO 10 mg, Premarin tablet, Xanax 0.5 tablet. It was reported that, patient had not received any vaccine within 4 weeks prior to vaccination. The patient was vaccinated at private doctor's office/hospital and vaccine purchased with private fund. The patient did not experienced adverse event following prior vaccination. Documents held by sender: none. Follow-up information received from a health care professional on 11 May 2015. As of 13 February 2015, it was reported that the patient was still continuing to have pain in left upper arm and some discomfort as the patient lies on the arm during night. List of Documents held by Sender: None. Follow-up information received from a health care professional on 06 Jul 2015. It was reported that, as of 02 April 2015, the patient continued to have mild muscle tenderness in left arm but definitely continuing to improve. The patient was recovering from the muscle soreness of arm and mild muscle tenderness. List of Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV, PPV
Symptoms: Blood urine absent, Culture urine negative, Eye movement disorder, Glucose urine absent, Gram stain negative
Clinical narrative: Patient had an episode where he stiffened and eyes rolled back, lasted 10 sec. Mother denies color change, no shaking. Pt returned to baseline after episode and then went to sleep.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV, PPV
Symptoms: Musculoskeletal stiffness, Nitrite urine absent, Protein urine absent, Specific gravity urine normal, Urine abnormality
Clinical narrative: Patient had an episode where he stiffened and eyes rolled back, lasted 10 sec. Mother denies color change, no shaking. Pt returned to baseline after episode and then went to sleep.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV, PPV
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine decreased, pH urine normal
Clinical narrative: Patient had an episode where he stiffened and eyes rolled back, lasted 10 sec. Mother denies color change, no shaking. Pt returned to baseline after episode and then went to sleep.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Redness and swelling in arm with decreased movement. Given Benadryl and placed on antibiotics per ER physician.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: In the evening of 4/6/2016 I had a fever of 99.4F and I noticed swelling and redness at the injection site (left shoulder). Thursday 4/7/2016 my fever went up to 101.6 and the injection site and the left side of my arm/ shoulder area was bright red, very itchy, painful to the touch, swollen, with a few small blisters popping up. I put cold compresses on it the heat of the site came right through the compress. I  took 600 mg of ibuprofen for pain and to reduce the fever. On Friday the fever was back down to 99F, but the site was still swollen, itchy, bright red, and blisters. Went to the Drs office that day. Took Clindamycin 4 tines a day for a week.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: In the evening of 4/6/2016 I had a fever of 99.4F and I noticed swelling and redness at the injection site (left shoulder). Thursday 4/7/2016 my fever went up to 101.6 and the injection site and the left side of my arm/ shoulder area was bright red, very itchy, painful to the touch, swollen, with a few small blisters popping up. I put cold compresses on it the heat of the site came right through the compress. I  took 600 mg of ibuprofen for pain and to reduce the fever. On Friday the fever was back down to 99F, but the site was still swollen, itchy, bright red, and blisters. Went to the Drs office that day. Took Clindamycin 4 tines a day for a week.
Age: 17.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Severe pain began about 1 hour after injection, now (04/14/16) came to clinic due to immobility of arm due to pain of muscles radiating from right chest to elbow per patient.  Pain medication prescribed.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash, intermittent.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Swelling and bruising at injection site. Swelling to lower part of upper arm, down to elbow. Advised to treat with Benadryl and ice pack.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Death
Clinical narrative: She passed away.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: SWELLING AND PAIN OVER THE LEFT DELTOID AREA FOLLOWED BY INTENSE ITCHING AND DEVELOPMENT OF PAPULAR ERUPTIONS WITHIN AN AREA OF 8 CM AROUND THE INJECTION SITES DIAGNOSIS; CELLULITIS DELTOID AREA.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash papular
Clinical narrative: SWELLING AND PAIN OVER THE LEFT DELTOID AREA FOLLOWED BY INTENSE ITCHING AND DEVELOPMENT OF PAPULAR ERUPTIONS WITHIN AN AREA OF 8 CM AROUND THE INJECTION SITES DIAGNOSIS; CELLULITIS DELTOID AREA.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Inconsolable crying for 3 hours.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Injection site hypoaesthesia, Musculoskeletal pain, Neck pain, Vision blurred
Clinical narrative: Left eye blurred and left shoulder, neck and head pain and numbness where shot was administered.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Small red bumps on flexor surface of forearms and legs, abdomen and back.  Itchy.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Cytogenetic analysis, Developmental delay, Loss of consciousness, Microcephaly
Clinical narrative: My son passed out shorty after receiving his 2 month vaccines. Seconds later he woke up, but was not the same child. He was very quiet and would share off. As days passed he was acting strange and could not extend his right arm. After muitiple visits to his pediatrician and specialist, he was diagnosed at 5 months with microcephaly. Till this day he is very delayed and It was because of those vaccines.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Staring
Clinical narrative: My son passed out shorty after receiving his 2 month vaccines. Seconds later he woke up, but was not the same child. He was very quiet and would share off. As days passed he was acting strange and could not extend his right arm. After muitiple visits to his pediatrician and specialist, he was diagnosed at 5 months with microcephaly. Till this day he is very delayed and It was because of those vaccines.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction, Vasodilatation
Clinical narrative: PT HAS EXPERIENCED REDDENING AND ENLARGED VEINS BELOW INITIAL VACCINATION SITE OF LEFT DELTOID.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hyperhidrosis, Mouth breathing, Pain, Pyrexia
Clinical narrative: SEVERE chills and body aches, fever 99.5, mouth breathing, sweating.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Erythema, Furuncle, Lymphadenopathy, Pain
Clinical narrative: I had been scheduled to have a Flu shot at clinic. I have received FLUARIX - Flu shot at clinic, and few days later I have a lot of very painful and red furuncles (like swallowing lymph node) all over my body including on my neck, head, right chest and etc. I have never experience this problem before during my entire life, and I have regularly received Flu shots every year. I am suspect something is wrong with that Flu shot from clinic. Please advise.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Blood culture, Blood lactic acid, C-reactive protein, Cellulitis, Culture wound
Clinical narrative: I had been scheduled to have a Flu shot at clinic. I have received FLUARIX - Flu shot at clinic, and few days later I have a lot of very painful and red furuncles (like swallowing lymph node) all over my body including on my neck, head, right chest and etc. I have never experience this problem before during my entire life, and I have regularly received Flu shots every year. I am suspect something is wrong with that Flu shot from clinic. Please advise.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Differential white blood cell count, Full blood count, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: I had been scheduled to have a Flu shot at clinic. I have received FLUARIX - Flu shot at clinic, and few days later I have a lot of very painful and red furuncles (like swallowing lymph node) all over my body including on my neck, head, right chest and etc. I have never experience this problem before during my entire life, and I have regularly received Flu shots every year. I am suspect something is wrong with that Flu shot from clinic. Please advise.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nonspecific reaction, Personality change
Clinical narrative: My daughter has had several odd and unusual health issues since having these vaccinations. She was an otherwise healthy and happy child prior to this. She has had a complete turn around in personality and numerous health issues of unknown origin. I can only attribute many of these to this vaccine.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt had very large area on left arm with redness and warmth and was painful, happening 2 days after vaccination (started the night after vaccination) pt was put on antibiotic 4/14/16 in case of infection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 30-MAR-2016 the patient was vaccinated with first dose of ZOSTAVAX 19400 PFU (0.65 ml, lot # L039096 with an expiry date of 08-JAN-2017), subcutaneous. No concomitant medications were reported. On an unknown date in 2016 the patient experienced swelling at the injection site the size of a baseball which was red and hot (injection site swelling, injection site warmth and injection site redness). The patient sought medical attention by making a call to the pharmacists. The outcome of the events was reported as not recovered/not resolved. The reporter did not provided the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a 13 year old female patient. The patient's pertinent medical history and concurrent condition was not reported. On 30-NOV-2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). The patient received the second dose of GARDASIL on 21-MAR-2010 and receive the third dose of GARDASIL on 22-MAR-2012 at another practice. The nurse practitioner was not able to provide the lot numbers and expiration dates of the doses of GARDASIL that had been administered because they were not transferred with the patient's records from the previous practice. The nurse practitioner reported that on 23-MAR-2016 the patient was administered a dose of GARDASIL 9 (lot number L043213, expiry 28-AUG-2017). The patient did not experience any adverse effects. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Product name confusion
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse may be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Immunodeficiency, Inappropriate schedule of drug administration, Infection, Mechanical ventilation, Pneumonia
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse may be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Product name confusion, Sinusitis, Streptococcus test positive, Viral test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse may be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 07-APR-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # 014587 with expiration date of 15-JAN-2016 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. There was no adverse event reported due to vaccination with VAQTA and no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L035505 expiration date: 16-DEC-2016; and lot # L039096 expiration date: 08-JAN-2017, (administration routes were not reported). No concomitant therapies were reported. The pharmacist stated that he had no knowledge if adverse events were reported or not. This is one of several reports from the same reporter. Additional information is not expected, since there was no consent to contact the reporter to follow up.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-JAN-2012 the patient was vaccinated with VARIVAX (Merck) dose 1; on 26-NOV-2014, dose 2  and on 25-MAR-2016, dose 3 (inappropriate schedule of drug administration) (route, anatomical location and lot# not provided). Concomitant therapy included M-M-R II (therapy type unspecified), which was given on 12-OCT-2011, dose 1, on 26-NOV-2014, dose 2 and on 25-MAR-2016, dose 3. These are indications outside of the VARIVAX (Merck) and M-M-R II prescribing information. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: On 7/2/15, pt presented with erythema, swelling and soreness at site of varicella vaccination received on 6/30/15. First s/s noted by pt 24 hrs after vaccination. Resolved without treatment and no complications.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L037561 expiration date: 29-SEP-2017 (administration routes were not reported). No concomitant therapies were reported. The pharmacist stated that he had no knowledge of adverse events were reported or not. This is one of several reports from the same reporter. Additional information is not expected, since there was no consent to contact the reporter to follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored (Temperature -15.5C to -10.2C; from 01-JAN-2016 to 22-MAR-2016) dose of (Oka-Merck) PROQUAD lot # l040411 expiration date 13-APR-2017, (administration routes were not reported). No concomitant therapies were reported. The Pharmacist stated that he had no knowledge if adverse events were reported or not. This is one of several reports from the same reporter. Additional information is not expected, since there was no consent to contact the reporter to follow up.