chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 31-JUL-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA008561; #1312USA011523; #1312USA011524; #1312USA011526). 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 an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 21-JUN-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA008561; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). 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 an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 02-APR-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA008561; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Irritability, Local swelling, Pain, Skin induration, Skin warm
Clinical narrative: Thigh swollen, not red, but warm and firm. Pt c/o pain and very fussy and not bearing it. Treated w/Benadryl/Advil/Motrin prn.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Cough, Dehydration, Dyspnoea, Pain
Clinical narrative: Symptoms: cough and body aches. Symptoms increased to chills, rigors, difficulty breathing, and the following days. Throughout the week, she became dehydrated and symptoms increased but she did not take any medicaton. She sought medical attention 12/29 in the ER.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Balance disorder, Feeling abnormal, Gait disturbance, Insomnia
Clinical narrative: Felt pretty weird for a few hours,  Went to bed and by 6am I could hardly walk straight to the bathroom, my legs were wobbly and strangely weak.  I also felt some pins sensations in arms and legs.  I had to lay on the sofa all day. I did not go to the ER because of an ice storm that day.  By bedtime I felt a little better, but was anxious beyond belief and could not sleep in the dark. I have never had a flu shot reaction before in all the years I have taken them.  By Monday 1/06/14, I woke up feeling normal again.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Felt pretty weird for a few hours,  Went to bed and by 6am I could hardly walk straight to the bathroom, my legs were wobbly and strangely weak.  I also felt some pins sensations in arms and legs.  I had to lay on the sofa all day. I did not go to the ER because of an ice storm that day.  By bedtime I felt a little better, but was anxious beyond belief and could not sleep in the dark. I have never had a flu shot reaction before in all the years I have taken them.  By Monday 1/06/14, I woke up feeling normal again.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Asthenia, Blood glucose, Cold sweat, Cyanosis
Clinical narrative: Loss of hearing, ringing in ears, loss of vision, cold sweats, pallor, lips blue, eyes rolled back, could not move or speak. EMS called. Recovered within 30 min however reporting ringing in ears and weakness over 24 hours after shot given.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Gaze palsy, Hypokinesia, Pallor, Tinnitus
Clinical narrative: Loss of hearing, ringing in ears, loss of vision, cold sweats, pallor, lips blue, eyes rolled back, could not move or speak. EMS called. Recovered within 30 min however reporting ringing in ears and weakness over 24 hours after shot given.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Blindness, Blood glucose, Cyanosis, Deafness
Clinical narrative: Ringing in ears, loss of sight and hearing, pallor, blue lips, unable to move or speak, EMS called.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pallor, Tinnitus
Clinical narrative: Ringing in ears, loss of sight and hearing, pallor, blue lips, unable to move or speak, EMS called.
Age: 21.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Papule, Pruritus generalised, Rash
Clinical narrative: Rash, itching all over body. Small red papules all over body, with the worst being around the ankle area.
Age: 13.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-11-03.
Age: 13.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Serum sickness, Vaccination complication
Clinical narrative: Ot serum react d/t vacc on 2013-11-03.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Constipation, Crying, Febrile convulsion, Glassy eyes, Hypotonia
Clinical narrative: Immediately after the shots (the same day), he was very lethargic.  He continued to be fussy and crying non stop and his eyes were glossy and unfocused. I called the nurse on call because he was also constipated for several days after which was very unlike him.  He continued to get sicker and sicker until we took him the ER on 01/18/11 for SEVERE vomiting.  He was throwing up non stop and couldn't stop.  After he was released from the ER, he continued to worsen over the next 2 weeks.  I took him to the dr's 8 times in the next 12 days and he was finally hospitalized for pneumonia at the start of February 2011. From the day he received his shots on 01/07 until his hospitalization, he kept getting worse and worse.  He lost all control of his neck muscles and could only lay in bed all day and whimper. He had a fever on and off and was just like a ragdoll.  While in the hospital we also observed seizure like activity that we had seen shortly after the shots. We caught it on video in the hospital and the doctors told us it appeared to be febrile seizures.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immediate post-injection reaction, Irritability, Lethargy, Muscular weakness, Pneumonia
Clinical narrative: Immediately after the shots (the same day), he was very lethargic.  He continued to be fussy and crying non stop and his eyes were glossy and unfocused. I called the nurse on call because he was also constipated for several days after which was very unlike him.  He continued to get sicker and sicker until we took him the ER on 01/18/11 for SEVERE vomiting.  He was throwing up non stop and couldn't stop.  After he was released from the ER, he continued to worsen over the next 2 weeks.  I took him to the dr's 8 times in the next 12 days and he was finally hospitalized for pneumonia at the start of February 2011. From the day he received his shots on 01/07 until his hospitalization, he kept getting worse and worse.  He lost all control of his neck muscles and could only lay in bed all day and whimper. He had a fever on and off and was just like a ragdoll.  While in the hospital we also observed seizure like activity that we had seen shortly after the shots. We caught it on video in the hospital and the doctors told us it appeared to be febrile seizures.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Posture abnormal, Pyrexia, Seizure like phenomena, Vision blurred, Vomiting
Clinical narrative: Immediately after the shots (the same day), he was very lethargic.  He continued to be fussy and crying non stop and his eyes were glossy and unfocused. I called the nurse on call because he was also constipated for several days after which was very unlike him.  He continued to get sicker and sicker until we took him the ER on 01/18/11 for SEVERE vomiting.  He was throwing up non stop and couldn't stop.  After he was released from the ER, he continued to worsen over the next 2 weeks.  I took him to the dr's 8 times in the next 12 days and he was finally hospitalized for pneumonia at the start of February 2011. From the day he received his shots on 01/07 until his hospitalization, he kept getting worse and worse.  He lost all control of his neck muscles and could only lay in bed all day and whimper. He had a fever on and off and was just like a ragdoll.  While in the hospital we also observed seizure like activity that we had seen shortly after the shots. We caught it on video in the hospital and the doctors told us it appeared to be febrile seizures.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-11-12.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Adv eff bact vac NEC/NOS on 2013-11-14. Clinician comment: The patient developed redness, warmth and swelling distally from the site of her immunization for PNEUMOVAX. She had apparently gone straight from our office to 2 different exercise classes, one involving weights, the other involving aerobic exercise.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Mom reported fever of 102.3 rectal (uncorrected) 30 hours after recieving Pediarix (left leg IM),Prevnar 13 (left leg IM), HIB (right leg IM), and Rotarix (right leg IM). No other symptoms, fever resolved with Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Mumps
Clinical narrative: Mumps uncomplicated on 2013-11-15. Clinician comment: Had mumps 2 weeks after getting the MMR vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Injection site soreness inflammation and excrucating pain last more than 1 month.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Adv eff mix bact vaccine on 2013-11-18.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Adv eff bact vac NEC/NOS on 2013-12-04.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-12-11.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever for 5 days, the highest over 103 degrees the 1st 3 days. Fever treated with infant TYLENOL.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever NOS on 2013-12-16. Clinician comment: Non focal fever symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Full blood count, Inflammation, Local swelling, Metabolic function test
Clinical narrative: Patient had influenza vaccine on 10/10/13 and had abnormal reaction. According to the patient, the reaction began between 8-9pm that evening. Patient said her arm began to hurt and could not raise it. Next day, got progressively worse. Patient said the inflamed area of the arm was swollen approximately 1/4 inch compared to the rest of arm and redness almost circled arm. Patient was treated with prednisone at local ER on 10/12/13. Patient states it took between 7-10 days for arm to appear normal but about 2 weeks for pain to subside.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Patient had influenza vaccine on 10/10/13 and had abnormal reaction. According to the patient, the reaction began between 8-9pm that evening. Patient said her arm began to hurt and could not raise it. Next day, got progressively worse. Patient said the inflamed area of the arm was swollen approximately 1/4 inch compared to the rest of arm and redness almost circled arm. Patient was treated with prednisone at local ER on 10/12/13. Patient states it took between 7-10 days for arm to appear normal but about 2 weeks for pain to subside.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Enlargement lymph nodes on 2013-12-20. Clinician comment: Infra clavicular and epitrochlear lymph nodes. No fevers. Benign CBC.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Palpitations
Clinical narrative: Shortness of breath; rapid heartbeat; strong heart palpitations; fatigue: easily winded lasted all day.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Skin infection
Clinical narrative: Cellullitis, infection of skin.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient is complaining of tingling and numb feeling in right side of face, right arm, right leg.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted w/in minutes of HPV shot. Recovered near immediately.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site bruising
Clinical narrative: Patient has a bruise that keeps getting bigger and bigger at injection site (per pt). Also has flu like symptoms. Patient informed to see MD ASAP (12/28/13) when called pharmacy.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Hyperhidrosis, Pallor
Clinical narrative: On 12/26/13 I administered 0.5mL of FLUVIRIN to patient, approximately 5 minutes later a customer ran up to the pharmacy and reported a man down in the store. I responded and found patient laying on the floor. He was sweating and looked pale. I removed his jacket and fanned him for a bit. Checked his BP = 88/55.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin reaction, Skin warm
Clinical narrative: I suspect this to be a local skin reaction to his immunization shot. Rash, red in color, three inches by an inch and a half. Rash, feverish to touch.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Chills, Dizziness
Clinical narrative: 2 hrs after, arm hard and swollen. 4 hrs after stomach aches, cold, shivers. 5 hrs after achy and weak, skin burning. That evening fainted 3 times, terrible headache took FIORICET, next morning lightheaded and HA. Tues - still feeling a bit unsteady.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Headache, Induration, Local swelling, Pain
Clinical narrative: 2 hrs after, arm hard and swollen. 4 hrs after stomach aches, cold, shivers. 5 hrs after achy and weak, skin burning. That evening fainted 3 times, terrible headache took FIORICET, next morning lightheaded and HA. Tues - still feeling a bit unsteady.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Reflex test normal, Skin burning sensation, Syncope
Clinical narrative: 2 hrs after, arm hard and swollen. 4 hrs after stomach aches, cold, shivers. 5 hrs after achy and weak, skin burning. That evening fainted 3 times, terrible headache took FIORICET, next morning lightheaded and HA. Tues - still feeling a bit unsteady.
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 an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 05-SEP-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H018979, exp. date: 24-OCT-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA008561; #1312USA011524; #1312USA011526). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and genders. For up to three years, approximately in 2010, temperature recordings of up to -3 for ZOSTAVAX have not been assessed. Unspecified doses of ZOSTAVAX have been administered to unspecified patients. At the time of this report, the nurse does not known the patient identifiers and she does not have the specific details to provide. She was attempting to organize the lot numbers, the dates of excursions, the length of time and the temperature out of range, and the dates of administration with patient identifiers. She will collate her data and send it. She would like to know if revaccination is appropriate. No adverse experience has been reported at this time. This is one of several reports from the same source (MARRS # 1312USA001395). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and genders. For up to three years, approximately in 2010, temperature recordings of up to -3 for ZOSTAVAX have not been assessed. Unspecified doses of ZOSTAVAX have been administered to unspecified patients. At the time of this report, the nurse does not known the patient identifiers and she does not have the specific details to provide. She was attempting to organize the lot numbers, the dates of excursions, the length of time and the temperature out of range, and the dates of administration with patient identifiers. She will collate her data and send it. She would like to know if revaccination is appropriate. No adverse experience has been reported at this time. This is one of several reports from the same source (MARRS # 1312USA010979). Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Pt c/o nausea, soreness in arm, chills for brief time after receiving 2013 flu vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Patient had bruising at injection site and sore inflammation associated with the immunization area.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Chest discomfort, Chest pain, Dry throat, Dysphagia, Headache
Clinical narrative: Case number PHEH2013US026655 is an initial spontaneous report received from a consumer on 30 Dec 2013. This report refers to a 45-years-old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013. It was reported that she had her third dose of RABAVERT (batch number: not reported) intramuscularly on 07 Dec 2013. On the same day, sometime after the third dose she experienced difficulty in swallowing and a very dry throat. She also had tightness and pain under her left breast and ribs as well as tightness and pressure in the back and front of her head. It was reported that the dog eventually tested negative for rabies. The outcome of the events was reported as condition unchanged. No further information was provided.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Sensation of pressure, Tension headache
Clinical narrative: Case number PHEH2013US026655 is an initial spontaneous report received from a consumer on 30 Dec 2013. This report refers to a 45-years-old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013. It was reported that she had her third dose of RABAVERT (batch number: not reported) intramuscularly on 07 Dec 2013. On the same day, sometime after the third dose she experienced difficulty in swallowing and a very dry throat. She also had tightness and pain under her left breast and ribs as well as tightness and pressure in the back and front of her head. It was reported that the dog eventually tested negative for rabies. The outcome of the events was reported as condition unchanged. No further information was provided.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Chest discomfort, Chest pain, Dysphagia, Ear discomfort, Headache
Clinical narrative: Case number PHEH2013US026655 is an initial spontaneous report received from a consumer on 30 Dec 2013. This report refers to a 45-years-old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013. It was reported that she had her third dose of RABAVERT (batch number: not reported) intramuscularly on 07 Dec 2013. On the same day, sometime after the third dose she experienced difficulty in swallowing and a very dry throat. She also had tightness and pain under her left breast and ribs as well as tightness and pressure in the back and front of her head. It was reported that the dog eventually tested negative for rabies. The outcome of the events was reported as condition unchanged. No further information was provided.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Incomplete course of vaccination, Influenza like illness, Rash
Clinical narrative: Case number PHEH2013US026655 is an initial spontaneous report received from a consumer on 30 Dec 2013. This report refers to a 45-years-old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013. It was reported that she had her third dose of RABAVERT (batch number: not reported) intramuscularly on 07 Dec 2013. On the same day, sometime after the third dose she experienced difficulty in swallowing and a very dry throat. She also had tightness and pain under her left breast and ribs as well as tightness and pressure in the back and front of her head. It was reported that the dog eventually tested negative for rabies. The outcome of the events was reported as condition unchanged. No further information was provided.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Pain started immediately - from shoulder to elbow - cannot lift up without severe pain - cannot sleep for more than a hour without pain waking up - cannot lift arm upward.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Muscle soreness and weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Patient came to the pharmacy on 1/4/14 and the vaccine was administered, she said that the area started to itch and bodered. Came to the pharmacy on 01/06/14 and reported that the area was hot, red and swelled. Patient called the doctor.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count, Local reaction, Local swelling, Pain in extremity
Clinical narrative: Call received symptoms: swollen sore arm with redness and warmth. Hospitalized and given IV antibiotic therapy. Final diagnosis: Local reaction to PNEUMOVAX 23.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Call received symptoms: swollen sore arm with redness and warmth. Hospitalized and given IV antibiotic therapy. Final diagnosis: Local reaction to PNEUMOVAX 23.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Soreness, redness, warm to the touch, itchiness. Possible hives.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a community nursing service regarding a patient (demographics unknown), who on an unknown date, was vaccinated with PROQUAD (Merck), Lot # J004322, expiration date 17-OCT-2014, which was improperly stored. The outcome of the vaccination was not provided. Follow-up information was received from a registered nurse, who reported that the patient has been revaccinated. No symptoms were reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain began immediately upon injection. I have received flu shots regularly and pain has never lasted more than 2-3 days. Currently, the shoulder pain is unresolved more than 4 weeks after injection. Pain is increasing in severity, and unresolved as of date of this report. It will likely require some type of medical intervention.
Age: 32.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Incorrect route of drug administration, Musculoskeletal pain, Tendonitis, X-ray limb abnormal
Clinical narrative: Pain began immediately upon injection. I have received flu shots regularly and pain has never lasted more than 2-3 days. Currently, the shoulder pain is unresolved more than 4 weeks after injection. Pain is increasing in severity, and unresolved as of date of this report. It will likely require some type of medical intervention.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Local swelling, Skin warm
Clinical narrative: After patient received vaccine, she had itching at site. On 01/01/2014 patient noted redness, warmth, swelling of left medial aspect of biceps not where injection was. Patient was treated with Rocephin 1 gram x 1 dose IM in clnic on 01/02/2014 and will follow up for exam again 01/03/2014.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Tenderness, Tendonitis
Clinical narrative: EXTREME ARM PAIN. DOCTOR DIAGNOSED IT AS TENDONITIS. ADMINISTERED A CORTISONE INJECTION IN EARLY NOVEMBER, 2013. HE ADVISED ME THAT IT SHOULD GET BETTER. NEVER GOT BETTER. WENT BACK TO IN LATE NOVEMBER, 2013. HE RECOMMENDED PHYSICAL THERAPY. AS OF TODAY, MY ARM IS NOT BETTER AND HURTS ON A DAILY BASIS. I CAN'T USE IT NORMALLY OR SLEEP ON IT.
Age: 34.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Pruritus
Clinical narrative: Pruritus on arms, legs and abdomen beginning one hour after dose #1 of anthrax vaccine and dose #1 of typhoid fever vaccine.  No hives.  Treated in Allergy/Immunology clinic and has follow up with an allergist.
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo followed by vomiting.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Bronchiolitis, Erythema, Excoriation, Polymerase chain reaction
Clinical narrative: First noted what appeared to be an abrasion approx. dime sized with redness around it.  Next AM red circular area approx. size of silver dollar posterior/lateral right upper arm which is warmer to touch than surrounding skin.  Reported to Dr. Treatment 1) Keflex 250mg QID x 5 days 2)  Moist heat to lesion rt. upper arm x 20 min TID x 3 days.  3) Dr. to recheck on 12-24-13.  Red areas and pustules continued to spread, noted by nursing and reported to Dr. Vital signs within normal limits and reported to Dr. 12-27-13 swabs of vesicle fluid for varicella PCR testing collected and sent to lab.  Test positive for G-A2oo Positive.  1-1-14 sent to ER due to O2 Sat of 85%, B/P 156/100.  Heart rate 120.  Diagnosis Exacerbation of chronic Bronchiolitis.  Treatment Azithromycin 250mg two tabs now then one tab x4 more days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular, Skin lesion, Skin warm, Varicella virus test positive
Clinical narrative: First noted what appeared to be an abrasion approx. dime sized with redness around it.  Next AM red circular area approx. size of silver dollar posterior/lateral right upper arm which is warmer to touch than surrounding skin.  Reported to Dr. Treatment 1) Keflex 250mg QID x 5 days 2)  Moist heat to lesion rt. upper arm x 20 min TID x 3 days.  3) Dr. to recheck on 12-24-13.  Red areas and pustules continued to spread, noted by nursing and reported to Dr. Vital signs within normal limits and reported to Dr. 12-27-13 swabs of vesicle fluid for varicella PCR testing collected and sent to lab.  Test positive for G-A2oo Positive.  1-1-14 sent to ER due to O2 Sat of 85%, B/P 156/100.  Heart rate 120.  Diagnosis Exacerbation of chronic Bronchiolitis.  Treatment Azithromycin 250mg two tabs now then one tab x4 more days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Induration, Local reaction, Rash macular, Rash papular
Clinical narrative: First noted what appeared to be an abrasion approx. dime sized with redness around it.  Next AM red circular area approx. size of silver dollar posterior/lateral right upper arm which is warmer to touch than surrounding skin.  Reported to Dr. Treatment 1) Keflex 250mg QID x 5 days 2)  Moist heat to lesion rt. upper arm x 20 min TID x 3 days.  3) Dr. to recheck on 12-24-13.  Red areas and pustules continued to spread, noted by nursing and reported to Dr. Vital signs within normal limits and reported to Dr. 12-27-13 swabs of vesicle fluid for varicella PCR testing collected and sent to lab.  Test positive for G-A2oo Positive.  1-1-14 sent to ER due to O2 Sat of 85%, B/P 156/100.  Heart rate 120.  Diagnosis Exacerbation of chronic Bronchiolitis.  Treatment Azithromycin 250mg two tabs now then one tab x4 more days.
Age: 28.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Drug administered to patient of inappropriate age, Incomplete course of vaccination, No adverse event
Clinical narrative: HPV vaccine was given outside of age range. No adverse reactions occured. PT recieved one HPV vaccine on 14 May 2013 and a second 30 Jul 2013. Pt was denied third round of vaccine due to age limit and no provider order.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient stated she had a red streak crossways on arm approximately one inch in length and was warm to the touch.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoeic attack, Blood culture negative, Culture urine negative, Full blood count normal, Metabolic function test normal
Clinical narrative: 3 apneic episodes two days after receiving first flu vaccine. The first two were apnea only. The third time she was unresponsive for 15 or 20 secs. No pallor or cyanosis.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: 3 apneic episodes two days after receiving first flu vaccine. The first two were apnea only. The third time she was unresponsive for 15 or 20 secs. No pallor or cyanosis.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Rash, Swollen tongue
Clinical narrative: Facial numbness, tongue swelling. Rash to arm and back. Treatment with Prednisone, Benadryl, Pepcid.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Choking, Cough, Rash generalised
Clinical narrative: On 1/3/14, patient developed a choking cough. At 6:30 PM on 1/4/14, he developed a moderate rash all over his body. I took him to the ER. As nothing had changed in his routine or diet to suggest an allergic reaction, the doctors diagnosed it as a possible reaction to his Hepatitis A booster or a viral rash. Prescribed 2.5 mL of Benadryl every 6 hours.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre Syndrome. Feet paralyzed next day after vaccination. Had been in and out hospital few times during past 2 mths. Symptoms come and go.
Age: 44.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Arthralgia, Asthenia, Pain, Sluggishness
Clinical narrative: Felt a general weakness and pain starting in joints (knees, hips, elbows, shoulders). Approx 2 days later the joint pain increased. Treated with 800mg ibu 3X/day. No relief. Next day Aleve with minimal relief. On 4th day pain increased to burning searing pain in joints and a continued sluggishness. Now on day 6 and pain is just now starting to subside. Burning pain still exists. (lost work = 3 days so far)
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site warmth, Localised oedema
Clinical narrative: The patient has local erythema, edema (50mm x 100mm), and the site is warm to the touch. He is being seen and treated here at the Clinic by one of the IDCs.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Pt got 101 degrees fever, achy, especially legs that night.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Crohn's disease, Gastrointestinal haemorrhage, Laboratory test, Type 1 diabetes mellitus
Clinical narrative: I developed GI bleeding which grew worse over months. I was diagnosed with Crohn's disease in July 2010. I was also diagnosed with Type 1 Diabetes in October 2010.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Patient received vaccine 1/5/14 and called 1/6/14 that lips had swollen. No trouble breathing or any other issues. Ice helped the swelling go down.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Few hours after shot had pain in shoulder a day or 2 pain got worse and range of motion was limited. Few days later went to doctor and was put on an oral steroid. After about a week pain and range of motion was worse. Called doctor he put me on pain pills. Ordered an MRI. Pain and limit range of motion till this day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Laboratory test, Local reaction
Clinical narrative: Patient developed local reaction to ZOSTAVAX. Welt formed at site of injection about the size of a quarter and flat redness developed around the area. No other signs of allergic reaction developed. She did also note a reaction to the adhesive on the bandage.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Erythema, Feeling abnormal, Posture abnormal, Syncope
Clinical narrative: She felt strange so she sat down then fainted (her head fell to the side) then she turned blue. In a few seconds, she awoke then turned bright red. The redness lasted for seconds 911 was called who determined her reaction was no way related to the shot.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: Has developed urticaria overnight. The only medication he had while in the hosp was an influenza immunization so have to assume allergy to it. He has large urticaria of both antecubetal spaces axillae groin, buttocks. His eyelids are puffy. He is itching. Otherwise he is doing ok.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient called today 1/6/14 stating he started experiencing tingling and numbness in right hand sometime between 11/4/13 when he received immunization and 11/23/13. Since then it has also moved to other hand both wrists and shoulder. Saw family MD 11/23/13 - also saw pain doctor who referred to neurologist: none could diagnose unsure of dates.
Age: 0.93
Sex: F
Vaccine: FLU3, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No known adverse effects - child was given 3rd ROTATEQ at 11 months of age - which is outside recommended age category.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose, route and lot # unknown) and VARIVAX (Merck) (dose, route and lot # unknown) on the same day. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that a 0.5 mL vial of PROQUAD (Merck) was reconstituted with 0.7 mL of sterile water and drawn into a syringe. The syringe with the reconstituted PROQUAD (Merck) was then injected into another un-reconstituted 0.5 mL vial of PROQUAD (Merck) and was then re-drawn into a syringe. Nurse stated this "double dose" of PROQUAD (Merck) (indication, route and lot # unknown) was then administered to a patient on 20-DEC-2013. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The reporter reported the patient was vaccinated with VARIVAX (Merck) (lot # unspecified), injection (dose, frequency, route and indication unspecified) at an unknown time in the past and now had a negative titer for varicella. No adverse effect reported. Outcome of the event was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, C-reactive protein normal, Free thyroxine index normal, Full blood count normal
Clinical narrative: This spontaneous report as received from nurse refers to a 12 year old female patient with asthma, allergic rhinitis, atopic dermatitis, chronic sinusitis and unspecified food allergies. The patient's medical history included recurrent staph dermatitis and headaches. On 16-Sep-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006236, exp. date 25-FEB-2016) 0.5 ml, intramuscular for standard vaccination. When the patient received dose 1 of GARDASIL, she also received MENACTRA (unspecified manufacturer), ADACEL (unspecified manufacturer) and Dose 2 of VAQTA (lot J002347, expiration date 04-SEP-2015, unspecified dose, unspecified therapy route) during the same visit. Concomitant therapies included ALLEGRA, VENTOLIN, SINGULAIR, FLOVENT, AUVI-Q and ZETONNA. The patient experienced hair loss beginning 20 days after vaccination (approximately 06-OCT-2013). The patient had balding areas, clumps of hair on her pillow, large hair loss in the shower and her hair was thinning. All of the patient's lab work, including complete blood count (CBC), ferritin levels, serum free triiodothyronine (FT)4 level, thyroid-stimulating hormone (TSH) level, c-reactive protein (CRP) level, comprehensive metabolic panel (CMP), came back normal. The patient sought medical attention by visiting office on 23-OCT-2013. The outcome of hair loss was reported as not recovered/not resolved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal, Serum ferritin normal
Clinical narrative: This spontaneous report as received from nurse refers to a 12 year old female patient with asthma, allergic rhinitis, atopic dermatitis, chronic sinusitis and unspecified food allergies. The patient's medical history included recurrent staph dermatitis and headaches. On 16-Sep-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006236, exp. date 25-FEB-2016) 0.5 ml, intramuscular for standard vaccination. When the patient received dose 1 of GARDASIL, she also received MENACTRA (unspecified manufacturer), ADACEL (unspecified manufacturer) and Dose 2 of VAQTA (lot J002347, expiration date 04-SEP-2015, unspecified dose, unspecified therapy route) during the same visit. Concomitant therapies included ALLEGRA, VENTOLIN, SINGULAIR, FLOVENT, AUVI-Q and ZETONNA. The patient experienced hair loss beginning 20 days after vaccination (approximately 06-OCT-2013). The patient had balding areas, clumps of hair on her pillow, large hair loss in the shower and her hair was thinning. All of the patient's lab work, including complete blood count (CBC), ferritin levels, serum free triiodothyronine (FT)4 level, thyroid-stimulating hormone (TSH) level, c-reactive protein (CRP) level, comprehensive metabolic panel (CMP), came back normal. The patient sought medical attention by visiting office on 23-OCT-2013. The outcome of hair loss was reported as not recovered/not resolved. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Death, Myocarditis
Clinical narrative: Death; myocarditis.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Hypersensitivity, Hypoaesthesia, Paraesthesia, Swollen tongue
Clinical narrative: Initial report received from a healthcare professional on 23 December 2013. A male patient had received a dose of FLUZONE QIV (lot number: U4771AA expiry date: 30 June 2014, route and site of administration was not reported) on 16 October 2013. The patient had no illness at time of vaccination and had no known drug allergy. On 16 October 2013, 5 to 6 hours after vaccination, the patient developed swelling of the tongue, numbness and tingling in the legs, vomiting and diarrhea. Laboratory investigations were not reported and the patient took DILAUDID, ZOFRAN and I.V fluids as corrective treatment. The patient was taken to the ER and admitted for 23 hour and diagnosis was either allergy or viral syndrome reaction. On an unspecified date the patient was fully recovered and discharged. The patient required ER/doctor visit. Upon internal review the company considered this case as serious (due to swelling of the tongue) other medically significant. Documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Viral infection, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 23 December 2013. A male patient had received a dose of FLUZONE QIV (lot number: U4771AA expiry date: 30 June 2014, route and site of administration was not reported) on 16 October 2013. The patient had no illness at time of vaccination and had no known drug allergy. On 16 October 2013, 5 to 6 hours after vaccination, the patient developed swelling of the tongue, numbness and tingling in the legs, vomiting and diarrhea. Laboratory investigations were not reported and the patient took DILAUDID, ZOFRAN and I.V fluids as corrective treatment. The patient was taken to the ER and admitted for 23 hour and diagnosis was either allergy or viral syndrome reaction. On an unspecified date the patient was fully recovered and discharged. The patient required ER/doctor visit. Upon internal review the company considered this case as serious (due to swelling of the tongue) other medically significant. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB decreased, Blood creatine phosphokinase increased, Brain natriuretic peptide decreased, Cardiac enzymes increased
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.