chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Dysmenorrhoea, Pallor, Somnolence, Syncope
Clinical narrative: Had a discussion with mom and patient regarding exercises call the benefits of exercise can sometimes help combat some of the dysmenorrhea symptoms we also discussed oral contraceptives as an effective form to help combat dysmenorrhea as well. Mother going to talk with patient and father prior to starting oral contraceptives. After vaccinations upon leaving clinic in are nurses area patient had an episode of feeling lightheaded and dizzy put herself to the ground. We proceeded to move her into the room where she had an episode of syncope. Lasting probably less than 5-10 seconds. Patient responded to her name verbally nodding her head she was okay states she felt like she just fell asleep. Pulse rate was in the 70s blood pressure was 94/52. Patient was very pasty in color. But states she felt better we did monitor here for the 20-30 min. trucks and blood pressures make sure she stable I did discuss with mom that this could be a side effect of the GARDASIL vaccination one of the most common side effects that young women experience lightheadedness, dizziness and will have a syncopal episode. Also could have been a vasovagal response to getting shots in general. Mother and patient also noted that she is very sensitive to smells, hiarspray and hand sanitizer, often make her light headed, dizzy and vomit. I explained to mom that on her subsequent vaccinations of GARDASIL we will hold her here for 15 min. postinjection making sure that she does not repeat a syncopal episode. Patient was held until 11:00 am, ate a english muffin, able to sit up without getting dizzy, able to ambulate well without symptoms. Discussed rest for the rest of the day. Mother amendable.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Headache
Clinical narrative: On Tues., 10 Jun 2014 he received HepB (ENGERIX-B) dose #1 and on Thursday developed a severe, constant, frontal headache (7/10) where he wanted to go to bed. Symptoms lasted for 3 weeks and he feels the HepB immunization may have caused it because this is the worst in his life.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Angioedema, Cough, Heart rate increased, Oxygen saturation abnormal, Wheezing
Clinical narrative: After 5-10 minutes started having acute episode of coughing, angioedema of face. Increased HR >180, O2 sat fluctuated from 80-90's -> gave 1 dose of BENADRYL -> after HR decreased 140's, did albuterol HPN and PO prednisolone. Still wheezing.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called 7/23/14 to report swollen, warm to touch arm at injection site. Pt came in to pharmacy 7/24/14. After reviewing/analyzing pt's arm, injection site is red/swollen and warm to touch. Diameter is size of half dollar. Instructed pt on 7/23/14 to take BENADRYL to see if it would help. Pt states that it did not help. Advised pt to see physician d/t possible infection.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Face injury, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient had a syncopal event following administration of vaccines resulting in the patient falling, hitting head, and a brief loss of consciousness and hit side of face and broke a tooth.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Tooth fracture
Clinical narrative: Patient had a syncopal event following administration of vaccines resulting in the patient falling, hitting head, and a brief loss of consciousness and hit side of face and broke a tooth.
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 19-JUN-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous, 0.65ml, lot # J002865 Exp 07-JUN-2014). The pharmacist reported that the patient received a dose of the expired ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dyspnoea, Hyperhidrosis, Lethargy
Clinical narrative: On 7/21/14 7 hours post vaccination child taken to hospital for diaphoresis, lethargy and difficulty breathing.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal discomfort, Dizziness, Headache, Pallor, Vomiting
Clinical narrative: Pt c/o lightheadedness, pale, sick to stomach, within 5 mins after injection. Pt immediately layed down with cool compress on head. Pt layed for 30 mins. Then after being up for 10 mins c/o severe headache, vomiting. Pt layed back down with compress also gave pt apple juice and crackers. After waiting additional 30 mins pt states feels better.
Age: 1.13
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, heard, and raised area that covers area of vastus lateralis around the back of the right thigh 11x5 cm.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Bruxism, Convulsion, Electroencephalogram, Gaze palsy, Heart rate increased
Clinical narrative: Administered Havrix RD IM and Menactra RD IM then Tdap Boostrix LD IM and Gardasil LD IM.  Client had been quietly smiling and talking with me.  I put on the last bandaid and was going to start my documentation when client suddenly went into a full, generalized seizure - eyes open and averted to upper right, back arched throwing him back off his chair (I caught him in my arms so he did not fall), full flexion and extension of arms and legs, jaw clenching, skin color pale.  This lasted 5-7 seconds after which he slowly relaxed over about 30 seconds but remained unresponsive to his name for about two minutes with his eyes closed.  His pulse was elevated, breathing normal, and over the next several minutes he was slowly able to start responding to his name and nod or answer simple yes/no questions.  Client's mother stated that he had no medical problems, was not on any medications, had not been out on the heat of the day, and only noted that he had slept in late that day.  Since the client had no history of seizures 911 was called.  The squad came within 5-8 minutes and transported him to hospital.  In subsequent phone contact with parents I found out that Dr. had said he did have a seizure and he was transported to another facility for further testing.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Joint hyperextension, Opisthotonus, Pallor, Unresponsive to stimuli
Clinical narrative: Administered Havrix RD IM and Menactra RD IM then Tdap Boostrix LD IM and Gardasil LD IM.  Client had been quietly smiling and talking with me.  I put on the last bandaid and was going to start my documentation when client suddenly went into a full, generalized seizure - eyes open and averted to upper right, back arched throwing him back off his chair (I caught him in my arms so he did not fall), full flexion and extension of arms and legs, jaw clenching, skin color pale.  This lasted 5-7 seconds after which he slowly relaxed over about 30 seconds but remained unresponsive to his name for about two minutes with his eyes closed.  His pulse was elevated, breathing normal, and over the next several minutes he was slowly able to start responding to his name and nod or answer simple yes/no questions.  Client's mother stated that he had no medical problems, was not on any medications, had not been out on the heat of the day, and only noted that he had slept in late that day.  Since the client had no history of seizures 911 was called.  The squad came within 5-8 minutes and transported him to hospital.  In subsequent phone contact with parents I found out that Dr. had said he did have a seizure and he was transported to another facility for further testing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Psoriasis
Clinical narrative: I have a rash..looks like psoriasis patch size of half dollar.  No treatment..still there 7/24/2014 at site of injection..reported to nurse. Permanent rash.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Insomnia, Pain, Swelling
Clinical narrative: Red rash to injection area, swelling, pain, unable to sleep due to pain.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: Had itching and red irritated skin all over body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: Erythema, Rash, Skin lesion
Clinical narrative: Stated scratching self. Noted to have red lesion on face neck and chest. Given Benadryl 12.5 mg. Rash fading at at 5-10 minutes past medication. Left with PGM at 4:50 Pm Dr evaluated patient.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Developed a fever and vomiting on 07/14/2014 and by 07/18/2014 has rash on top of buttocks.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWOLLEN, RED, FEVERISH SPOT AT INJECTION SITE.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Patient has rash/hives on trunk and extremities.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Excruciating pain in arm near injection site, moving to shoulder, down under the arm, and down to the hand. Loss of motion in arm, high fever, hives, nausea.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Excruciating pain in arm near injection site, moving to shoulder, down under the arm, and down to the hand. Loss of motion in arm, high fever, hives, nausea.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Nuclear magnetic resonance imaging, Vertigo, Vomiting
Clinical narrative: Severe falling down vertigo attack with vomiting and still happening to this day.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Local swelling, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Severe arm pain radiating down the arm to the hand in the arm in which the injection was given. The pain felt muscular in nature- like muscle spasms and there was some minimal swelling of the upper arm. Very limited range of motion. No fever or redness to the site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Patient stated that since receiving & completing Gardasil vaccines in 2012 she has had irregular periods, reported that menstrual cycles would go from 28 days to either 2 - 6 weeks and would be either light, normal, period; lasting about 7 days. Normal flow now, but they are spread out 3-6 weeks apart and lasts 6 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, tenderness, and burning at injection site down back of arm toward elbow.  Using acetaminophen and cold packs.
Age: 1.13
Sex: M
Vaccine: MMR
Symptoms: Antibody test positive, Biopsy bone abnormal, Bone marrow oedema, Herpes simplex serology negative, Herpes zoster disseminated
Clinical narrative: Patient developed left leg pain on date noted, which progressed despite analgesia. Admitted for IV analgesia 6/28. MRI showed bone marrow edema, underwent a bone biopsy on 6/30 (normal pathology). Also on 6/30, developed vesicular rash on left lower back extending onto thigh (L3 or L4 distribution). Also had scattered vesicular lesions on trunk and right leg (including a group of vesicles on right leg). Diagnosis: disseminated herpes zoster. Treatment: IV acyclovir x 4 days, PO valacyclovir x 12 days, oxycodone and gabapentin for pain. Also had suspected RUL pneumonia, treated with cefepime and then completed course with levofloxacin. Course complicated by leukopenia (low WBC was 3600) and neutropenia (low ANC was 900).
Age: 1.13
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Leukopenia, Neutropenia, Neutrophil count decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient developed left leg pain on date noted, which progressed despite analgesia. Admitted for IV analgesia 6/28. MRI showed bone marrow edema, underwent a bone biopsy on 6/30 (normal pathology). Also on 6/30, developed vesicular rash on left lower back extending onto thigh (L3 or L4 distribution). Also had scattered vesicular lesions on trunk and right leg (including a group of vesicles on right leg). Diagnosis: disseminated herpes zoster. Treatment: IV acyclovir x 4 days, PO valacyclovir x 12 days, oxycodone and gabapentin for pain. Also had suspected RUL pneumonia, treated with cefepime and then completed course with levofloxacin. Course complicated by leukopenia (low WBC was 3600) and neutropenia (low ANC was 900).
Age: 1.13
Sex: M
Vaccine: MMR
Symptoms: Pneumonia, Polymerase chain reaction, Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: Patient developed left leg pain on date noted, which progressed despite analgesia. Admitted for IV analgesia 6/28. MRI showed bone marrow edema, underwent a bone biopsy on 6/30 (normal pathology). Also on 6/30, developed vesicular rash on left lower back extending onto thigh (L3 or L4 distribution). Also had scattered vesicular lesions on trunk and right leg (including a group of vesicles on right leg). Diagnosis: disseminated herpes zoster. Treatment: IV acyclovir x 4 days, PO valacyclovir x 12 days, oxycodone and gabapentin for pain. Also had suspected RUL pneumonia, treated with cefepime and then completed course with levofloxacin. Course complicated by leukopenia (low WBC was 3600) and neutropenia (low ANC was 900).
Age: 1.13
Sex: M
Vaccine: MMR
Symptoms: White blood cell count decreased
Clinical narrative: Patient developed left leg pain on date noted, which progressed despite analgesia. Admitted for IV analgesia 6/28. MRI showed bone marrow edema, underwent a bone biopsy on 6/30 (normal pathology). Also on 6/30, developed vesicular rash on left lower back extending onto thigh (L3 or L4 distribution). Also had scattered vesicular lesions on trunk and right leg (including a group of vesicles on right leg). Diagnosis: disseminated herpes zoster. Treatment: IV acyclovir x 4 days, PO valacyclovir x 12 days, oxycodone and gabapentin for pain. Also had suspected RUL pneumonia, treated with cefepime and then completed course with levofloxacin. Course complicated by leukopenia (low WBC was 3600) and neutropenia (low ANC was 900).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neurological examination normal, Nodule, Paraesthesia, Scar
Clinical narrative: Started with sore thumb joint.  Progressed to intermittent tingling in hand, then forearm, then upper arm.  Note:  soon after vaccination I had inflammation and swelling at the vaccination site.  Physical therapy a month later revealed a knot of scar tissue and massaging this produced an onset of the tingling.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Started with sore thumb joint.  Progressed to intermittent tingling in hand, then forearm, then upper arm.  Note:  soon after vaccination I had inflammation and swelling at the vaccination site.  Physical therapy a month later revealed a knot of scar tissue and massaging this produced an onset of the tingling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Patient called the pharmacy and stated that she had progressive entire-arm swelling that required medical attention and a steroid shot from Dr office. That is all the info we were given, she didn't call back with further info after we left a message.
Age: 0.25
Sex: M
Vaccine: HIBV, PPV, RVX
Symptoms: Abnormal behaviour, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Redness, swelling, painful to touch at site of injection. Fussy and change in behavior.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Pain in left deltoid/shouder area since flu vaccine given 10/16/13.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient called today (Sun) after receiving vaccine on Friday - experiencing redness, swelling, pain, and a rash around injection site - patient will be seeing PCP to have it checked tomorrow (Mon).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Yesterday had a 1/2 dollar size area of redness where she got her immunization and now today that area is more red and hard and with a softball size area of itchy erythema. She has no behavior changes, fever or any other sxs.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Nasal congestion, Rhinorrhoea
Clinical narrative: Sneezing, nasal congestion, wheezing, coughing, runny nose, stomach pain, shortness of breath. Albuterol neb treatment given in office.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Sneezing, Wheezing
Clinical narrative: Sneezing, nasal congestion, wheezing, coughing, runny nose, stomach pain, shortness of breath. Albuterol neb treatment given in office.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given PROQUAD and KINRIX on 7-7-14 by mistake. He had already been given these vaccinations on 11-6-12. There were no adverse symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: 07/23/2014 Patient is being seen by PCP today at 3:15.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Area was swollen and reddish pink and patient got fever. Area was hot and painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Area was swollen and reddish pink and patient got fever. Area was hot and painful.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria with large local urticaria around injection site and several other scattered urticaria. Occurred day after vaccine.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: On day 8 post vaccination a localized raised "blistery" rash developed, 5 days of fever not other symdromes. Recheck on 7/24/14 (day 10 5/10 vaccination) doing well. Rash resolving. Afebrile.
Age: 56.0
Sex: F
Vaccine: FLUC3, PPV, VARZOS
Symptoms: Chills, Injection site inflammation, Nausea, Pyrexia, Rash
Clinical narrative: Pt. developed rash, nausea, chills, fever, inflammation around injection site 24 hr. after receiving ZOSTAVAX.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Echocardiogram normal, Full blood count normal, Heart rate increased, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's medical history included migraines history and history of fainting. Current conditions include mile case of asthma, problem with certain odors. On 09-AUG-2011 the patient was vaccinated with GARDASIL (lot # 665607/1332Y, expiry date 25-JUN-2012, dose 0.5 milliliter (ml), intramuscular in the left deltoid. Concomitant therapies included SINGULAIR, ALBUTEROL SULFATE and CLARITIN. Nurse stated client came in for office visit on 09-AUG-2011 (previously reported as 11-AUG-2014) and told her immediately post vaccination, she had numbness, swelling and redness at the injection site of left arm. On morning of 09-AUG-2011 (previously reported as 11-AUG-2014), prior to the office visit on that day, client had fainted at home. Nurse states client was examined for the injection site reaction, fainting, and was determined to have a rapid heart beat, but no sensory loss. Client was referred to a Cardiologist.  On 09-DEC-2011 cardiologist followed up with a echocardiogram test and results were normal. Client recovered. Client will not be getting any other GARDASIL doses. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's medical history included migraines history and history of fainting. Current conditions include mile case of asthma, problem with certain odors. On 09-AUG-2011 the patient was vaccinated with GARDASIL (lot # 665607/1332Y, expiry date 25-JUN-2012, dose 0.5 milliliter (ml), intramuscular in the left deltoid. Concomitant therapies included SINGULAIR, ALBUTEROL SULFATE and CLARITIN. Nurse stated client came in for office visit on 09-AUG-2011 (previously reported as 11-AUG-2014) and told her immediately post vaccination, she had numbness, swelling and redness at the injection site of left arm. On morning of 09-AUG-2011 (previously reported as 11-AUG-2014), prior to the office visit on that day, client had fainted at home. Nurse states client was examined for the injection site reaction, fainting, and was determined to have a rapid heart beat, but no sensory loss. Client was referred to a Cardiologist.  On 09-DEC-2011 cardiologist followed up with a echocardiogram test and results were normal. Client recovered. Client will not be getting any other GARDASIL doses. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypersensitivity, Injection site discomfort, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient (the reporter's wife) with high cholesterol, allergy to amoxicillin and allergy to codeine. The patient's medical history included gallbladder removal and hernia surgery. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX one dose, injection (dose, lot number and expiration date were not provided). Concomitant therapy included unspecified cholesterol medication and other unspecified medication. On 25-JUN-2014 (reported as yesterday morning) the reporters wife broke out in the rash about the size of 2 quarters at the injection site where she received ZOSTAVAX. Caller also stated that on 25-JUN-2014 (reported as last night) the area turned all red and her skin was raised, swollen, and the size of the circumference of a softball. It was also reported that on 25-JUN-2014 (reported as yesterday morning) the patient experienced itchiness at the injection site, body aches, headache and nausea after receiving ZOSTAVAX. They visited the local Emergency Room since their physician was unable to see her.  There were no lab diagnostic tests performed. The patient was not admitted. It was also reported that he read at the Internet about several thousands of people who had experienced similar reactions after receiving ZOSTAVAX. At the time of report the patient was recovering from her adverse events. The patient sought medical attention via ER visit. It was reported that the event of swelling was not improved at the time of this report. The relatedness between the patients and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient (the reporter's wife) with high cholesterol, allergy to amoxicillin and allergy to codeine. The patient's medical history included gallbladder removal and hernia surgery. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX one dose, injection (dose, lot number and expiration date were not provided). Concomitant therapy included unspecified cholesterol medication and other unspecified medication. On 25-JUN-2014 (reported as yesterday morning) the reporters wife broke out in the rash about the size of 2 quarters at the injection site where she received ZOSTAVAX. Caller also stated that on 25-JUN-2014 (reported as last night) the area turned all red and her skin was raised, swollen, and the size of the circumference of a softball. It was also reported that on 25-JUN-2014 (reported as yesterday morning) the patient experienced itchiness at the injection site, body aches, headache and nausea after receiving ZOSTAVAX. They visited the local Emergency Room since their physician was unable to see her.  There were no lab diagnostic tests performed. The patient was not admitted. It was also reported that he read at the Internet about several thousands of people who had experienced similar reactions after receiving ZOSTAVAX. At the time of report the patient was recovering from her adverse events. The patient sought medical attention via ER visit. It was reported that the event of swelling was not improved at the time of this report. The relatedness between the patients and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient (the reporter's wife) with high cholesterol, allergy to amoxicillin and allergy to codeine. The patient's medical history included gallbladder removal and hernia surgery. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX one dose, injection (dose, lot number and expiration date were not provided). Concomitant therapy included unspecified cholesterol medication and other unspecified medication. On 25-JUN-2014 (reported as yesterday morning) the reporters wife broke out in the rash about the size of 2 quarters at the injection site where she received ZOSTAVAX. Caller also stated that on 25-JUN-2014 (reported as last night) the area turned all red and her skin was raised, swollen, and the size of the circumference of a softball. It was also reported that on 25-JUN-2014 (reported as yesterday morning) the patient experienced itchiness at the injection site, body aches, headache and nausea after receiving ZOSTAVAX. They visited the local Emergency Room since their physician was unable to see her.  There were no lab diagnostic tests performed. The patient was not admitted. It was also reported that he read at the Internet about several thousands of people who had experienced similar reactions after receiving ZOSTAVAX. At the time of report the patient was recovering from her adverse events. The patient sought medical attention via ER visit. It was reported that the event of swelling was not improved at the time of this report. The relatedness between the patients and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient (the reporter's wife) with high cholesterol, allergy to amoxicillin and allergy to codeine. The patient's medical history included gallbladder removal and hernia surgery. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX one dose, injection (dose, lot number and expiration date were not provided). Concomitant therapy included unspecified cholesterol medication and other unspecified medication. On 25-JUN-2014 (reported as yesterday morning) the reporters wife broke out in the rash about the size of 2 quarters at the injection site where she received ZOSTAVAX. Caller also stated that on 25-JUN-2014 (reported as last night) the area turned all red and her skin was raised, swollen, and the size of the circumference of a softball. It was also reported that on 25-JUN-2014 (reported as yesterday morning) the patient experienced itchiness at the injection site, body aches, headache and nausea after receiving ZOSTAVAX. They visited the local Emergency Room since their physician was unable to see her.  There were no lab diagnostic tests performed. The patient was not admitted. It was also reported that he read at the Internet about several thousands of people who had experienced similar reactions after receiving ZOSTAVAX. At the time of report the patient was recovering from her adverse events. The patient sought medical attention via ER visit. It was reported that the event of swelling was not improved at the time of this report. The relatedness between the patients and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Dysgeusia, Lymphadenopathy, Paraesthesia oral, Rash
Clinical narrative: Tongue felt funny with metallic taste in mouth. Then several hours later developed "bumps" inside mouth with swollen lymph node in jaw line. Self medicated with 50mg Benadryl.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever of 100.9.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Musculoskeletal pain
Clinical narrative: Extreme pain in shoulder. Swelling at injection site.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Blood test, Dysstasia, Hyperaesthesia, Mobility decreased
Clinical narrative: EXCRUCIATING PAIN THROUGH MY WHOLE BODY. COULD NOT BE TOUCHED WITH OUT SCREAMING IN PAIN. COULD NOT LIFT MY ARMS, STAND UP OR WALK  FOR TWO MONTHS. MY CHILDREN PICKED ME UP AND CARRIED ME IN AND OUT OF BED AND TOOK ME TO BATHROOM WAS IN AND OUT OF EMERGENCY ROOM AND URGENT CARE BETWEEN 80 AND 90 TIMES IN 6 MONTHS.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, X-ray
Clinical narrative: EXCRUCIATING PAIN THROUGH MY WHOLE BODY. COULD NOT BE TOUCHED WITH OUT SCREAMING IN PAIN. COULD NOT LIFT MY ARMS, STAND UP OR WALK  FOR TWO MONTHS. MY CHILDREN PICKED ME UP AND CARRIED ME IN AND OUT OF BED AND TOOK ME TO BATHROOM WAS IN AND OUT OF EMERGENCY ROOM AND URGENT CARE BETWEEN 80 AND 90 TIMES IN 6 MONTHS.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity, Injection site rash
Clinical narrative: Varicella (VARIVAX) given on Tuesday 7/22/14. Pt. presented to clinic with hypersensitivity (skin rash) to injection site. Recommended antihistamine, ice, ibuprofen/TYLENOL.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Rash generalised, Rash maculo-papular
Clinical narrative: Broke out in generalized hyperemic maculopapular rash 2 days after receiving DTaP/Hib.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Pt received shots on Monday within two days a rash had formed, by Friday patient diagnosed with varicella.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site pain, Injection site swelling
Clinical narrative: Temp. 100.1. Painful swollen upper left arm - vaccine date 7/17/14.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Blister, Burning sensation, Fibromyalgia, Hepatitis B, Infection
Clinical narrative: Rash on buttock left area had infection oozing out of lower abdomen blisters, burning, itching, inflammation along with neuropathy in left thigh and shooting. Refer to neurologist.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Inflammation, Neck pain, Neuropathy peripheral, Pruritus, Rash
Clinical narrative: Rash on buttock left area had infection oozing out of lower abdomen blisters, burning, itching, inflammation along with neuropathy in left thigh and shooting. Refer to neurologist.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Secretion discharge, Spondylitis
Clinical narrative: Rash on buttock left area had infection oozing out of lower abdomen blisters, burning, itching, inflammation along with neuropathy in left thigh and shooting. Refer to neurologist.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Patient has significant rash, swelling and redness. Affected area stretches from elbow to shoulder.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness and induration on the left arm at site of injection, induration measured 70 x 80 mm, arm warm to touch. Patient reports itchiness and pain at site. Symptoms began after summer school 7/29/14, father applied ice on and off but no change in swelling.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: Redness and induration on the left arm at site of injection, induration measured 70 x 80 mm, arm warm to touch. Patient reports itchiness and pain at site. Symptoms began after summer school 7/29/14, father applied ice on and off but no change in swelling.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Nausea, Pain
Clinical narrative: PATIENT STATED THAT HE STARTED FEELING SICK AFTER LEAVING THE PHARMACY ON HIS WAY HOME WHICH IS 5 MINUTES AWAY. HE REPORTED BEING NAUSEATED AND BODY ACHES. HE REPORTED NOT BEING ABLE TO GET OUT OF BED THE NEXT 24 HOURS.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: 102 degree Fahrenheit fever. Chills and lower back pain. Took 600mg of ibuprofen, within an hour chills stopped.  Fever lasted 17 hours, fluctuating between 100 and 101 Fahrenheit, finally subsiding at 7:30pm.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 8 years old female patient. On 24-APR-2005 the patient was vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml, subcutaneous (lot # was not reported). On 17-JUN-2008 the patient was also vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml, subcutaneous (lot # was not reported). Concomitant medications were not reported. In Dec-2012 the patient developed chicken pox after receiving two doses of (Oka/Merck) VARIVAX. The outcome of patient developed chicken pox was reported as recovered/resolved on unknown date. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On 19-NOV-2007 the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, 0.5ml, subcutaneous (lot # was not provided). On 23-SEP-2011 the patient was also vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml subcutaneous (lot # was not reported). Concomitant medications were not reported. In Dec-2012 the patient developed chicken pox after receiving two doses of (Oka/Merck) VARIVAX. The outcome of patient developed chicken pox was reported as recovered/resolved on unknown date. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose and route not reported). It was reported that 1 to 2 weeks later on an unknown date, the patient experienced itchiness and tingling. The physician did not diagnose the rash as shingles as it had unusual appearance more like poison ivy, unlike what she was familiar with seeing for shingles. The physician prescribed acyclovir. The patient returned in two weeks on an unspecified date, and the rash had spread across the entire trunk area, although the area that had been treated was not pronounced. The patient was recovering. Prior to administering the ZOSTAVAX was inquiry on whether the patient had chickenpox from the physician and the initially answer was yes. Now the patient was not sure. The relatedness for rash like poison ivy, itchiness and tingling and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse refers to a patient of unknown age and gender. Since 02-JUN-2014, one dose of PROQUAD (Merck) was not stored properly. On an unknown date in 2014, the patient was vaccinated with PROQUAD (Merck) (dose, duration and indication were not reported). No adverse effects were noted. Additional information has been requested.
Age: 46.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old patient of unknown gender. On 12-JUL-2014 the patient ws vaccinated with a first dose of (Oka/Merck) VARIVAX (dose, route of administration not provided, lot # 0609AE) which expired on 23-MAR-2014. No adverse reactions were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a 55 year old female nurse, who is the patient, via a company representative. On approximately 03-JUL-2014 the patient was vaccinated with PNEUMOVAX23 (does, route and lot # were not reported). Concomitant medications were not reported. In JUL-2014 the patient experienced all of the lymph nodes in her body swelled up after administration of PNEUMOVAX23. The patient stated she could not put her arms down and could not lie on her side due to the pain. It was also reported that the patient ached all over and had pain while walking. The patient took aspirin due to the adverse events. The patient sought medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patient of an unknown age and gender. Medical history and concurrent conditions were not reported. On 21-JUL-2014, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, lot number, expiration date, and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported an unknown number of patients received improperly stored (Oka/Merck) VARIVAX on 21-JUL-2014. No adverse symptoms reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning to a 12 month old patient, of an unknown gender. Medical history and concurrent conditions were not reported. On 21-JUL-2014, the patient was vaccinated with the fourth dose of liquid PEDVAXHIB (lot number and expiration date were not reported), 0.5ml, intramuscular. Co-suspect and concomitant therapies were not reported. The nurse reported that on 21-JUL-2014, a 12 month old patient inadvertently received a fourth dose of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 15-JUL-2014 the patient was vaccinated with a dose of PROQUAD (lot # K004418, expiration date: 25-SEP-2015), 1 single shot, injection, when the age limit for the product was 12 years old. This was an "other than indicated" adverse event (AE). No side effects reported. 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 6 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. Post 16-JUL-2014, date unspecified, 6 patients were vaccinated with VARIVAX (lot #J014129, expiration date 07-NOV-2015, injection, 0.5ml) subcutaneously. The nurse reported that there were two times temperature excursions affecting these VARIVAX products. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek for medical attention. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a certified medical assistant (C.M.A.) refers to a 26 year old female patient with no pertinent medical history and no drug reactions/allergies. On 21-MAY-2014 the patient was vaccinated with the first dose of GARDASIL injection (lot # H020901, Exp date: 05-JUL-2015, 0.5 ml), intramuscular. No concomitant medication was taken. The patient was pregnant when she received the first dose of GARDASIL, with last menstrual period (LMP) of 25-APR-2014 (also reported as gestation: 7 weeks 1 day on 16-JUN-2014) and estimated due date (EDD) of 30-JAN-2015. Fetal ultrasound was performed. Initial exposure to GARDASIL was at 26 days. The pregnancy outcome was pending. No adverse effect reported. No treatment was given for the event. 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 unspecified patients of unknown age and gender. The nurse initially reported a temperature excursion for (Oka/Merck) VARIVAX (lot#, dose/frequency, route not reported) on 09 JUL-2014, but at which time npo doses of improperly stored (Oka/Merck) VARIVAX had been administered. The nurse called back on 14-JUL-2014 and reported that doses of (Oka/Merck) VARIVAX (lot #, dose/frequency and route were not reported) that were improperly stored on 11-JUN-2013 and 18-JUL-2013 had been administered to unspecified patients on unspecified date since the initial temperature excursion. No adverse events were reported. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route of administration, lot# were not reported). The patient discovered that she was pregnant on unspecified date. The date of last menstrual period (LMP) and estimated delivery date (EDD) was unknown. The outcome of exposure during pregnancy and relatedness between exposure during pregnancy and (Oka/Merck) VARIVAX were not provided. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a field employee refers to a 17 year old patient. On 16-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route unspecified). The patient also received a dose of (Oka/Merck) VARIVAX on an unspecified date before the ZOSTAVAX was administered, and also on an unspecified date after the ZOSTAVAX was administered. No known adverse effects. 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 an healthcare worker refers to some patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot#, strength, dosage, route unknown). On 14-MAR-2014 the reporter reported a temperature excursion. Since the excursion that was reported, S ome of these doses of (Oka/Merck) VARIVAX, (Oka/Merck) PROQUAD (captured in MARRS1407USA010908) and ZOSTAVAX (captured in MARRS1407USA010909) had been administered to patients. The healthcare worker did not report an adverse experience. The outcome of the events was unknown. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies who was 31 weeks pregnant. On 03-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J009788, expiration date: 17-MAR-2016, 0.5 ml/once, intramuscular. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) (Prenatal Vitamin). The nurse stated the GARDASIL dose was "given by mistake, we knew she was pregnant long before 03-JUL-2014, reported as "today", cause she's 31 weeks". The Last Menstrual Period (LMP) was 28-NOV-2013 and Estimated due date (EDD) was 04-SEP-2014. Initial exposure to GARDASIL was at 31 week(s). The outcome of the event was unknown. No laboratory test was done. Additional information is not expected since reporter refused additional contact.
Sex: F
Vaccine: TDAP
Symptoms: Apparent death, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of near death experience in a female subject of unspecified age who was vaccinated with DTPa (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). The last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine at 7 months of pregnancy, during the 3rd trimester. At an unspecified time after vaccination with DTPa (with small D + P), the subject nearly died. This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Consciousness fluctuating, Delusion, Fatigue, Lower respiratory tract infection
Clinical narrative: I felt tired at 3:00 that day and then fatigued/exhausted.  After laying down to a few hours I began to feel feverish and achy.  By 8:00 that evening I was cycling between consciousness and sleep having delusional pre apocolyptic daydreams about people being removed from their homes.  Fever, chills and achiness built through the night, but symptoms gradually diminished through the second day.  On Wednesday morning, 48 hours after being given the TDAP shot, I was back at the doctor.  I still had a 101.2 F fever, and I also had a chest infection.  Now, at just more than 96 hours since I was given the TDAP shot, I still feel tired as well as a bit achy and feverish.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: I felt tired at 3:00 that day and then fatigued/exhausted.  After laying down to a few hours I began to feel feverish and achy.  By 8:00 that evening I was cycling between consciousness and sleep having delusional pre apocolyptic daydreams about people being removed from their homes.  Fever, chills and achiness built through the night, but symptoms gradually diminished through the second day.  On Wednesday morning, 48 hours after being given the TDAP shot, I was back at the doctor.  I still had a 101.2 F fever, and I also had a chest infection.  Now, at just more than 96 hours since I was given the TDAP shot, I still feel tired as well as a bit achy and feverish.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Red, swollen, warm (R) deltoid. Started 7/23/14 knot got worse. Now the size of a golf ball. Called on 7/24/14 advise ibuprofen and BENADRYL and to call if not better. Came into office 7/25/14 knot got bigger. Advise cold compress, Ibu tid and BENADRYL.