chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Migraine, Oropharyngeal pain, Pharyngeal oedema, Wrong drug administered
Clinical narrative: Swelling and redness (L) arm. No fevers or body rashes. Pt was given Hib instead of HepB.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site induration, Injection site nodule, Injection site swelling, Swelling
Clinical narrative: Had DTaP and IPV on 6/25/14. Mom noticed swelling 2 days ago but the redness was right away. Left thigh swollen and hard knot under injection site 3 inch circumferential raised area.
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2014US012586 is an initial spontaneous report from the nurse received on 18 Jun 2014. This report refers to a female patient of unknown age. She was vaccinated with MENVEO, (batch number: A13012) 0.5 ml intramuscularly into right deltoid on 18 Jun 2014 at 14:30. On the same day, after vaccination she developed cellulitis at site 5 cm diameter. On 20 Jun 2014 KEFLEX 500 BID was used as treatment drug for seven days. The final outcome of the event was recovered. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2014US012397 is an initial spontaneous report from the nurse received on 13 Jun 2014, and with a follow up report received from a nurse on 18 Jun 2014. This report refers to a male patient of unknown age. He was vaccinated with MENVEO (batch number: A13012) 0.5 ml intramuscularly into right deltoid on 18 Jun 2014 at 14:00. On the same day, after vaccination he developed cellulitis at site 8 cm diameter. On 19 Jun 2014, KEFLEX 500 BID was used as treatment drug. On 21 Jun 2014, KEFLEX was changed to SEPTRA DS BID for 7 days and the event was resolving. The final outcome of the event was recovered. The seriousness and causality of the events were not reported. Follow up report received from a nurse on 18 Jun 2014. Updated patient details, vaccination date and deleted events (red, painful mass at the injections site).
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Agitation, Dizziness, Irritability, Nausea
Clinical narrative: Nausea, light-headed, agitation, irritability.
Age: 1.13
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Crying, Laboratory test, Pyrexia
Clinical narrative: Started crying on 6/27/14 at 1:00 am, had fever 20 min later had first seizure. They continued into morning. Admitted into hospital. Treated with TYLENOL and MOTRIN. Testing performed. He recovered and was discharged from hospital.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Aphthous stomatitis, Blister, Injection site erythema, Injection site induration, Macule
Clinical narrative: 15 days from date of receiving Varivax, developed itchy bumps and canker sore in mouth. Scattered 0.5-1cm macules with central pustule, vesicle or papule on upper back, chest dorsum L hand, temple and scalp. 3.5 cm x 7cm mild erythema mild induration at injection site.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Papule, Rash pruritic, Rash pustular
Clinical narrative: 15 days from date of receiving Varivax, developed itchy bumps and canker sore in mouth. Scattered 0.5-1cm macules with central pustule, vesicle or papule on upper back, chest dorsum L hand, temple and scalp. 3.5 cm x 7cm mild erythema mild induration at injection site.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Local reaction, Rash pruritic
Clinical narrative: 15 days from date of receiving Varivax, developed itchy bumps and canker sore in mouth. Scattered 0.5-1cm macules with central pustule, vesicle or papule on upper back, chest dorsum L hand, temple and scalp. 3.5 cm x 7cm mild erythema mild induration at injection site.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion, Skin reaction
Clinical narrative: 15 days from date of receiving Varivax, developed itchy bumps and canker sore in mouth. Scattered 0.5-1cm macules with central pustule, vesicle or papule on upper back, chest dorsum L hand, temple and scalp. 3.5 cm x 7cm mild erythema mild induration at injection site.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Hearing impaired, Insomnia, Mental disorder, Nausea, Regurgitation
Clinical narrative: Pt thinks he is having reaction to Tdap vaccine, nausea, no sleep, auditory problems. I advised pt to have someone drive him here.   HPI: Patient is brought in by his father. We have permission to talk to him. I was unable to talk to patient. I came in the room and he was wearing ear muffs. He was communicating by writing on his smart phone pad/paper. He wrote down "I have a anechoic tumor". He wrote down that any noise goes to the nerves in his teeth. When he called earlier this morning he said he had some nausea, regurgitation and could not sleep. He denied fever vomiting or redness at the site of injection or rash. I had to interview his dad in a different room because he could not tolerate me talking at all. Father says that he has not seen any reaction or rash on his body. Father is unaware that he has a diagnosis of tumor in his brain. Father agrees with me that something is wrong mentally with him today. He has a history of depression treated with ECT in the past but no history of schizophrenia or bipolar disorder as far as I know. After talking to his dad I went back to the room. Could not communicate verbally with him but was able to give him a written note saying that he needs to go to ER. Father wants to take him to the ER.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Screaming, Urticaria
Clinical narrative: 4 hours of unconsolable screaming, followed by a temp of 100.3, followed by HIVES seen the next day in the ER on the 24th and then came to see me the 25th at which time, he was well again.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red raised rash (on face), warm to the touch. Mom gave Claritin immediately and antihistamine was given in the doctors office.
Age: 0.37
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Immediate post-injection reaction
Clinical narrative: Started having diarrhea right after the rotavirus vaccine. Diarrhea continued for more than two weeks.
Age: 18.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: ERROR in giving vaccination, wrong vaccination given. Should have given Meningococcal vaccine and not Hib (HbOC). No adverse reaction or symptoms as a result of wrong vaccine given.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: AFTER 2 HOURS OF RECEIVING THE VACCINE PATIENT DEVELOPED DIARRHEA.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Mobility decreased, Pain, Tetany
Clinical narrative: This woman has developed significant muscle tetany, which causes restriction of movement, and significant pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dysgeusia, Hypoaesthesia, Injection site erythema, Muscular weakness
Clinical narrative: Patient experienced numbness, weakness in left arm (vaccine admin in left)and both legs.  Metallic taste in mouth. Clammy feeling all over.  Redness, raised area where vaccine admin.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Patient experienced numbness, weakness in left arm (vaccine admin in left)and both legs.  Metallic taste in mouth. Clammy feeling all over.  Redness, raised area where vaccine admin.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Bradycardia, Full blood count normal, Heart rate decreased, Oxygen saturation decreased
Clinical narrative: Infant started having new and worsening bradycardic and desaturation events; heart rate dropped to 40's-60's; O2 sats dropped to 60's-70's, some requiring tactile stimulation and increasing FiO2 to recover.  Progressed to apneic events with bradycardia and desaturation about 18 hours post immunizations.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: 5:00 PM soreness and knot where vaccine given.  8:00 AM on 7/1/2014 larger knot around vaccine area, entire body soreness, body aches, diarrhea, tiredness.  10:00 AM weakness, tiredness, joint pain, headache.  11:00 AM very fatigue left work to go home. 12:00 PM slept for an hour now redness, pain and swelling along with knot around vaccine area.  Symptoms continued through the day it is now 9:33 PM same day and no change or relief in syptoms above.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: 5:00 PM soreness and knot where vaccine given.  8:00 AM on 7/1/2014 larger knot around vaccine area, entire body soreness, body aches, diarrhea, tiredness.  10:00 AM weakness, tiredness, joint pain, headache.  11:00 AM very fatigue left work to go home. 12:00 PM slept for an hour now redness, pain and swelling along with knot around vaccine area.  Symptoms continued through the day it is now 9:33 PM same day and no change or relief in syptoms above.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: 5:00 PM soreness and knot where vaccine given.  8:00 AM on 7/1/2014 larger knot around vaccine area, entire body soreness, body aches, diarrhea, tiredness.  10:00 AM weakness, tiredness, joint pain, headache.  11:00 AM very fatigue left work to go home. 12:00 PM slept for an hour now redness, pain and swelling along with knot around vaccine area.  Symptoms continued through the day it is now 9:33 PM same day and no change or relief in syptoms above.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain
Clinical narrative: 5:00 PM soreness and knot where vaccine given.  8:00 AM on 7/1/2014 larger knot around vaccine area, entire body soreness, body aches, diarrhea, tiredness.  10:00 AM weakness, tiredness, joint pain, headache.  11:00 AM very fatigue left work to go home. 12:00 PM slept for an hour now redness, pain and swelling along with knot around vaccine area.  Symptoms continued through the day it is now 9:33 PM same day and no change or relief in syptoms above.
Age: 0.52
Sex: F
Vaccine: DTAP, HEP, IPV, PPV, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever (100-102 degrees) for 8 days, treated with acetaminophen.  Diarrhea for 5 days, no treatment.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth, Lymphadenopathy
Clinical narrative: Hives and redness around injection site, huge swollen gland in armpit, swollen around injection site, hot to touch.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 103.1, was given TYLENOL.
Age: 0.13
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Pain
Clinical narrative: From time of vaccine administration (approx 10 AM) until at least 1600 (6 hours) inconsolable, "screechy" cry and achy - not typical cry and very uncharacteristic in this happy baby.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dysstasia, Pallor
Clinical narrative: This spontaneous report was received from a physician via field representative regarding a 15 years old male patient. The information on pertinent medical history and drug reactions or allergies was unknown. On 25-JUN-2014, the patient was vaccinated with GARDASIL (Product Lot #/Expiry date unknown) intramuscular injection, one single shot, intramuscularly. The concomitant medication was not reported. The physician reported that on 25-JUN-2014, after receiving GARDASIL the patient became dizzy, was unable to stand and his complexion turned pale. There was no product quality complaint involved. The outcome and causality of the events were unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Crying, Opisthotonus
Clinical narrative: 3-5 hours after vaccine administered she had inconsolable screeching cry and arching back, pulling away for 45 minutes until fell asleep - very uncharacteristic behavior.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to an unspecified number of patients. Field employee stated pharmacist had no patient details and no specific lot information. On an unknown date, the unspecified number of patients were concoi6tantly vaccinated with ZOSTAVAX, 0.65 ml (milliliter), once and PNEUMOVAX23, o.5 ml for unknown indication, for an unspecified period of time. Field employee learned from pharmacist that some of the patients who received concomitantly administered ZOSTAVAX and PNEUMOVAX23 developed nausea and fever post vaccination. Patient sought medical attention (consulted pharmacist). There was no intervention to Prevent Serious Criteria. Action taken with respect to suspect therapy was not applicable. Te outcome of events was unknown. Causality was not provided. No product quality complaint (PQC) was involved. No further information provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL (lot # not reported). 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 storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patiens were vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. NO co-suspect and concomitant therapies were reported. The nurse reported that (Oka/Merck) VARIVAX vials also had been exposed to temperature excursion and improperly stored (Oka/Merck) VARIVAX doses had been administered. Nurse stated that since the excursions, 6 doses of (Oka/Merck) VARIVAX had been administered. No adverse effects reported.  This is one of two reports from the same source (other case # 1406USA011997). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash generalised, Rash pruritic
Clinical narrative: Patient received zoster vaccine Lot J011828 on 5/16/14 (manufactured by Merck - exp date 12-26-14). Five days after administration patient developed generalized rash pruritic in nature and few blisters in arms. No fever, no SOB, no DOA, no swelling, no desquamation.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Menstrual disorder, Metrorrhagia
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 12 year old female patient. On an unknown date in June 2012, the patient was vaccinated with first dose of GARDASIL, dose (unknown), intramuscular injection, for prevention of HPV. In approximately August 2012 (also reported as 2 doses 2 months apart), patient was vaccinated with second dose of GARDASIL, lot number H009746, dose (unknown), intramuscular injection, for prevention of HPV. On an unknown date in July 2012, the patient develop interruption in her menstrual cycle that started a month after receiving each dose and patient had spotting during those months. The representative stated that the patient refused the 3rd dose of GARDASIL due to the interruption in her cycle. Patient did not seek medical attention. There was no intervention to prevent serious criteria. No treatment was given for adverse event. On an unknown date September 2012, therapy with GARDASIL was discontinued. On an unspecified date, outcome of events was resolved. Causality was not provided. No product quality complaint was involved. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The nurse reported that on an unknown date these unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot #, dose, route, indication not reported) exposed to -9C for an undetermined time frame. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Client reports did home test - positive for pregnancy past week ago - will f/u w/dr thru another program.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The consumer reported that on an unknown date, 3-4 days after getting ZOSTAVAX, she experienced itchiness and a red, hard area at injection site. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received via a company representative from a physician refers to a male patient of unknown age. The patient's current conditions or medical history were not reported. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX vial 0.65 ml subcutaneous injection (lot number and expiration date not reported). On an unspecified date in 2008, shortly after receiving ZOSTAVAX the patient developed a rash on a small area on one unspecified side of his buttocks. The patient sought for medical attention and received LYRICA as treatment. Outcome of rash on a small area on one unspecified side of his buttocks was unknown at the time of the report. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 6-26-14 - Right deltoid area red, painful and itchy with a 6cm area of induration around injection site. Mother put hydrocortisone cream to area. Area back to baseline (no redness, itching or pain) by 6-28-14.
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Condition aggravated, Cough, Eczema, Pyrexia, Rhinorrhoea
Clinical narrative: 1-2 weeks after mom states - got sick: runny nose, cough, fever, traveled with grandmother for 1 mo. For 1 week had runny nose without cough or fever. Then they came back and she was still sick for another week or two. Got better. Was not sick enough to see a doctor. #2 stomach eczema spread to buttocks.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, the patients were inadvertently vaccinated with improperly stored doses of RECOMBIVAX HB (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, the patients were inadvertently vaccinated with improperly stored doses of VAQTA (lot # not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-JUN-2014, the patient was vaccinated with expired dose of ZOSTAVAX 10 vials of 1, 0.65 ml (milliliter), once, subcutaneously. No concomitants were reported. No adverse effects were reported. The outcome of events was unknown. No product quality complaint was involved. No IRRE was reported. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with (Oka-Merck) PROQUAD. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patient was administered (Oka-Merck) PROQUAD that was stored improperly (on an unknown date). No adverse effects reported. Nurse also stated that since the excursions, 5 doses of (Oka-Merck) PROQUAD had been administered. This is one of two reports from the same source (other case # 1407USA000488). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: Patient received vaccine and within 5 minutes had a syncope episode. Turned pale did not feel well and fainted. Was out for about 30 seconds. She required no treatment. I observed her for 25 min and she was fine.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Loss of consciousness, Malaise, Pallor, Syncope
Clinical narrative: Patient received vaccine and within 5 minutes had a syncope episode. Turned pale did not feel well and fainted. Was out for about 30 seconds. She required no treatment. I observed her for 25 min and she was fine.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year and 3 month old male patient. On 19-JUN-2014 the patient was vaccinated with VAQTA, vial (lot# and expiration date not provided) (dose: 1ml). On 19-JUN-2014, a pediatric patient received adult 1ml dose of VAQTA inadvertently. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Asthenia, Axillary nerve injury, Blood pressure increased, Injected limb mobility decreased, Injection site atrophy
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain, Injury, Musculoskeletal pain, Nodule, Sensory loss
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Tenderness
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Joint range of motion decreased, Reflex test normal
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Sensory loss
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Axillary nerve injury, Blood pressure increased, Immediate post-injection reaction, Injected limb mobility decreased, Injection site atrophy
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Reflex test normal, Sensory loss
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Muscular weakness, Reflex test normal
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Axillary nerve injury, Muscular weakness, Musculoskeletal pain
Clinical narrative: Initial report received from literature on 20 June 2014: An male patient, date of birth, medical history and concomitant medications were not reported, had received an intramuscular dose of Influenza vaccine (manufacturer unknown, batch number, dose in series and site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed shoulder pain and abduction weakness for 8 weeks and he was diagnosed with injection-induced axillary nerve injury. Laboratory  investigations and corrective treatments were not reported. On an unspecified date the patient had recovered. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Erythema, Local swelling, Wrong drug administered
Clinical narrative: Was given HIB by mistake, swelling the size of a quarter, redness, pain, heat at injection site, on 6/25/2014 the swelling and redness had spread to twice the size it was day before the size of 2 quarters and still had pain, was brought back to dr's who said was normal but keep watch. On 6/27/2014 migraine headache that lasted 24 hours no change in swelling, redness or size. 7/12014 has been complaining of sore and swollen throat called dr's office they said it was not related to vaccine. Today 7/2/2014 today the swelling is still present but less and can still clearly see some redness and there is now a very hard lump at injection site and still painful.
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Was given HIB by mistake, swelling the size of a quarter, redness, pain, heat at injection site, on 6/25/2014 the swelling and redness had spread to twice the size it was day before the size of 2 quarters and still had pain, was brought back to dr's who said was normal but keep watch. On 6/27/2014 migraine headache that lasted 24 hours no change in swelling, redness or size. 7/12014 has been complaining of sore and swollen throat called dr's office they said it was not related to vaccine. Today 7/2/2014 today the swelling is still present but less and can still clearly see some redness and there is now a very hard lump at injection site and still painful.
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Migraine, Oropharyngeal pain, Pharyngeal oedema, Wrong drug administered
Clinical narrative: Was given HIB by mistake, swelling the size of a quarter, redness, pain, heat at injection site, on 6/25/2014 the swelling and redness had spread to twice the size it was day before the size of 2 quarters and still had pain, was brought back to dr's who said was normal but keep watch. On 6/27/2014 migraine headache that lasted 24 hours no change in swelling, redness or size. 7/12014 has been complaining of sore and swollen throat called dr's office they said it was not related to vaccine. Today 7/2/2014 today the swelling is still present but less and can still clearly see some redness and there is now a very hard lump at injection site and still painful.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse professional refers to a 17 year old female pregnant patient. No pertinent medical history, drug reactions or allergies were reported. On 13-JUN-2014, the patient was accidentally vaccinated with a dose of GARDASIL lot # J013324, expiration date 12-FEB-2016, 0.5 ml dose, intramuscular (dose number not reported) instead of a tetanus vaccine. It was reported that the patient received a dose of GARDASIL previously on 12-DEC-2010 (dose, dose number, lot/batch number, expiration date not reported). Concomitant therapy included prenatal vitamins and iron. The patient became pregnant (gravida 1, para 0) with last menstrual period (LMP) of 30-SEP-2013 and estimated due date (EDD) of 07-JUL-2014. Initial exposure to GARDASIL was at 36 week of pregnancy. There was no treatment given for the adverse event. There was no lab diagnostics studies performed. The patient did not seek medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Local swelling, Pharyngitis streptococcal, Rash
Clinical narrative: Client started with a rash on 6/2/2014 on her face and sides. She went to her PCP on 6/23/2014 and was diagnosed with strep throat and given ATB as well as prednisone. On 6/17/2014 her legs started swelling and then on 6/30/2014 her arms and joints started welling and becoming painful.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test positive
Clinical narrative: Client started with a rash on 6/2/2014 on her face and sides. She went to her PCP on 6/23/2014 and was diagnosed with strep throat and given ATB as well as prednisone. On 6/17/2014 her legs started swelling and then on 6/30/2014 her arms and joints started welling and becoming painful.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: After vacccine was given patient started complaining about minor tingling in her vaccinated left arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2014, the patient was vaccinated with VARIVAX lot # J012210, expiration date 28-SEP-2015. No concomitant medication reported. The reporter stated that VARIVAX was exposed to improperly stored temperatures outside the product insert. No adverse effects were reported. Causality was not reported. This case has been linked to 1406USA006736, 1406USA013598, 1406USA006998 and 1407USA000740. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2014, the patient was vaccinated with VARIVAX lot # J007023, expiration date 05-JUN-2015. No concomitant medication reported. The reporter stated that VARIVAX was exposed to improperly stored temperatures outside the product insert. No adverse effects were reported. Causality was not reported. This case has been linked to 1406USA006736, 1406USA013598, 1406USA006998 and 1407USA000763. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient might have received 1 or 2 doses of GARDASIL starting in March 2013 and a dose of GARDASIL at an unspecified time last week (estimated as June 2014) (lot# and dose were unspecified). No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of MMR II, route and site of injection, therapy type, lot# and expiration date not reported. Other suspect therapies included vaccination (on an unknown date) with VARIVAX, route and site of injection, lot# and expiration date not provided. On an unknown date the patient had a blood test showing low titers (non-immunity) for rubella and varicella. On an unknown date the patient sought medical attention, method unspecified. The outcome of the adverse event was unknown. Relatedness between use of MMR II and VARIVAX and the adverse event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as recovered from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, dose number, lot/batch number, expiration date and indication not reported). On an unknown date, the had his titers drawn for verification of immunity for measles, rubella, mumps and varicella which came back negative for measles, rubella, mumps and varicella. No adverse effect was reported. It was reported that the patient had proof of vaccination on an unspecified dates for all vaccines prior to the titers being drawn. The outcome of the event was unknown. The related between the evens and MMR II was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness, bruise 6-8 inches long at injection site, left tricep.
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Injection site erythema, Injection site pain, Injection site rash, Malaise
Clinical narrative: Administered 6/25/14: On 6/26/14 pt experience severe malaise, tenderness at injection site, face was flushed. 6/27/14 pt presented to the office with a rash below the injection site w/erythema. Pt given KEFLEX 1 QID x 7 days.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Vaccine administered on 6-24-14. Fever of 101.2 was reported the next day. Full body rash was noted on 6-26-14.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Local swelling
Clinical narrative: (L) arm swelling/cellulitis. On BENADRYL and ABx: Cephalexin 250mg every 8 hours.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Redness, warmth, tenderness, swelling, given steriods and will follow up with PCM 3 July 14 to monitor.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Joint range of motion decreased, Oedema, Pain, Pruritus
Clinical narrative: Redness, warmth, tenderness, swelling, given steriods and will follow up with PCM 3 July 14 to monitor.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash
Clinical narrative: Redness, warmth, tenderness, swelling, given steriods and will follow up with PCM 3 July 14 to monitor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash on left thigh and fever. Instructed to use warm compresses, Tylenol/Motrin, and push fluids.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as recovered from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chills, Headache, Malaise, Nausea, Photophobia
Clinical narrative: H/a, f/c, malaise, nausea, photophobia.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: H/a, f/c, malaise, nausea, photophobia.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Headache, Malaise, Nausea, Photophobia
Clinical narrative: H/a, f/c, malaise, nausea, photophobia.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with a swollen, red, post-injection site. It was warm to the touch. The site is about 2" x 1 1/2" wide. Became a infection.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect storage of drug
Clinical narrative: RABAVERT was mistakenly put in freezer instead of refrigerator.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Livedo reticularis, Pallor, Vaccination site pain, Vaccination site reaction
Clinical narrative: Vaccines DTAP and IPV given on 6/17/14. Pt returned to clinic on 6/19/14 with blanching mottled redness below vaccine site, mildly to mod. swollen from about 4" above kneecap to 1" above knee cap width 2" - painful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vaccination site swelling
Clinical narrative: Vaccines DTAP and IPV given on 6/17/14. Pt returned to clinic on 6/19/14 with blanching mottled redness below vaccine site, mildly to mod. swollen from about 4" above kneecap to 1" above knee cap width 2" - painful.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling approx. 6 inches around injection site. She called MD and was told to the BENADRYL and ice pack.
Age: 0.94
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 105 degrees. About 10 hours after shots given, mom noticed fever. Took to hosp.; TYLENOL and ibuprofen given. Sent home. Fever gone by next day.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Purulent discharge
Clinical narrative: Swelling and pain at injection site with purulent drainage after antibiotics given.
Age: 1.34
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 17 month old female patient. On 13-MAY-2014 the patient was vaccinated with VARIVAX (dose, route not reported) lot # J009987 and expiration date 12-AUG-2015. On 19-JUN-2014, the patient developed a rash. The patient sought medical attention by office visit. At the time of the report the outcome of the event was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site cellulitis
Clinical narrative: 6-23-14 received a ZOSTAVAX vaccine at MD office. Area was clean and prepped with alcohol. Shot was not given in deltoid region and skin was not pinched, so I am not sure if it was administered sub q as manufacturer directed. Subsequently developed large, cellulitis spreading from area of administration over entire arm and axilla. Two additional office visits. Prescribed course of prednisone, cephalosporin, and probiotics. I am not sure if the skin is highly irritated from wrong administration technique of it med was contaminated. No known allergies to ingredients.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Injection site irritation, Skin irritation
Clinical narrative: 6-23-14 received a ZOSTAVAX vaccine at MD office. Area was clean and prepped with alcohol. Shot was not given in deltoid region and skin was not pinched, so I am not sure if it was administered sub q as manufacturer directed. Subsequently developed large, cellulitis spreading from area of administration over entire arm and axilla. Two additional office visits. Prescribed course of prednisone, cephalosporin, and probiotics. I am not sure if the skin is highly irritated from wrong administration technique of it med was contaminated. No known allergies to ingredients.
Age: 16.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: 40 cm length 50 cm width red and swollen. Temp 98.7, O2 sat 97%, P 84. ATARAX Rx admin.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Swelling
Clinical narrative: Tennis ball size erythema with 1/4 inch swelling from background skin. Went to urgent care.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cold sweat, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site and on upper arm. Low grade fever, malaise, shivering and hot clammy.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Redness and swelling at site and on upper arm. Low grade fever, malaise, shivering and hot clammy.
Age: 19.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cold sweat, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Nervous before shots, mom held her hand. Fine after first shot. Immediately felt hot, clammy, sweaty, also was unresponsive for 20-30 seconds. Called 911. EMT took BP 2 x and it improved by 2nd reading (103/70). Patient declined to go to hospital. Felt and looked better. Walked out under own power at 450pm.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 17-APR-2014, 01-MAY-2014 and 17-JUN-2014 the patient was intramuscularly vaccinated with the first, second and third 0.5 ml dose of GARDASIL (lot number for all vaccines J012212, expiration date 18-FEB-2014). No adverse events were reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Asthenia, Headache, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Headache within one hour. Nausea and weak within one hour. (R) arm numbness that day. (R) arm very red and swollen at area of varicella shot.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Headache within one hour. Nausea and weak within one hour. (R) arm numbness that day. (R) arm very red and swollen at area of varicella shot.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Pain/numbness at injection site.