chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Limb discomfort, Pain, Pain in extremity, Pyrexia
Clinical narrative: Per patient, within an hour of being vaccinated, her arm was in pain and felt very heavy. Shortly thereafter, a low grade fever developed in addition to body aches and pains. This was accompanied by headache. The symptoms resolved with rest and an NSAID.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Heart rate increased, Seizure like phenomena
Clinical narrative: After administering the shot, the patient closed his eyes and went into symptoms what seem to be seizure for about 10-15 seconds.  The pt slide on to the floor and then open up his eyes and said "I had a dream". Seem as his heart rate was high, the ambulance was immediately called.  They came over in about 10 minutes and the pt seem fine.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autism, Crying, Decreased eye contact, Developmental delay, Lethargy
Clinical narrative: Seizure like activity, not responsive to verbal stimulus, loss of eye contact, lethargic, uncontrollably crying, diagnosis of global developmental delay and autism at 18 months.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Seizure like activity, not responsive to verbal stimulus, loss of eye contact, lethargic, uncontrollably crying, diagnosis of global developmental delay and autism at 18 months.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness, no itching, no pain. Not at injection site but approximately 3 inches from bottom of deltoid. Patient doesn't know if redness is related to immunization. Unable to tell. Just wants to take proper precautions.
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Aphasia, Autism, Crying, Developmental delay
Clinical narrative: Seizure like activity, uncontrollably crying, no response to verbal communication or when calling him to get his attention, loss of previous spoken words, no longer social or wanting to be held.
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure like phenomena, Social avoidant behaviour, Unresponsive to stimuli
Clinical narrative: Seizure like activity, uncontrollably crying, no response to verbal communication or when calling him to get his attention, loss of previous spoken words, no longer social or wanting to be held.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Paraesthesia oral
Clinical narrative: Tingling on tongue; shortness of breath.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection became very warm, swollen and erythematous. The central area was 27 mm in diameter. The erythematous area that extended outward measured 60 mm across and 75 mm vertically. Hydrocortisone cream was applied, followed by an ice pack.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Patients allergist reported anaphylaxis.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles within 10 days of getting the shot.   I have never had shingles before.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash generalised, Urticaria
Clinical narrative: PATIENT CLAIMED THEY BROKE OUT IN FULL BODY RASH AND HIVES.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Periarthritis
Clinical narrative: Pain at site immediately.  Severe stabbing pains at injection site about 1-2 weeks later that lasted for 8+ months.  Frozen shoulder developed after 2 months. Did physical therapy 3x per week for 2 weeks with no improvement.  Still pain at injection and frozen shoulder to date (11 months later).
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt came into pharmacy on 11/11/15 with an injection site reaction on her right arm where her Zostavax rx was given of a significant area raised, red and feverish.  The area also had a small bruise on the edge of it.  Pt stated that she thinks it is starting to get better but wanted a second opinion.  Also stated that her armpit was itching every once in a while no signs of swollen lymph nodes.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Tremor
Clinical narrative: Diarrhea, nausea, shaking, chills for about 12 hours, total time feeling tired - 2 days.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Tendonitis
Clinical narrative: Extreme pain in deltoid area at the site of injection on left arm. Unable to lift arm to shoulder height without extreme pain. Although I have had some relief, I am still not able to exercise or leverage my left arm, 7 months later.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: X-ray limb normal
Clinical narrative: Extreme pain in deltoid area at the site of injection on left arm. Unable to lift arm to shoulder height without extreme pain. Although I have had some relief, I am still not able to exercise or leverage my left arm, 7 months later.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Patient complain that she has pain on left shoulder that radiates to neck after injection. It comes and goes but some times she can not use her arm. It is very painful. She is not sure if vaccine caused it since she has arthritis.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Injection site swelling, Musculoskeletal pain, Pain
Clinical narrative: Patient said she still has pain after 10 days. She has little swelling at injection site. It does not bother her for entire day but at night when she put on lotion she feels pain and it radiates to shoulder.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient woke up on 11/11/15 with a swollen and painful injection site. Patient said it was swollen to the size of an egg and tender and painful. Patient said the site was not red. She thinks it has gotten bigger during the day (only called the pharmacy around 6pm).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2-3 days after receiving the vaccine, patient had a 3x3 in red swollen area which appeared around the shot. It was sore, hurt, pain score 7 (scale 1-10). On 10/23, the area was still visibly red and still could see the 3x3 in circle.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that her arm has been hurting ever since and the pain is very intense sometimes and she thought it would go away but after 3 weeks she is still having the pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Musculoskeletal chest pain, Neck pain, Pain in extremity
Clinical narrative: Left rib area sharp pain, left hand and fingers sharp pain, left shoulder and neck sharp pain, shortness of breath and itching throughout Friday evening to and currently. Visit doctor's office Wednesday 11/11/15. I was prescribed HFA inhaler, 2 poofs twice/day, Prednisone 10mg, and hydroxyzine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Left rib area sharp pain, left hand and fingers sharp pain, left shoulder and neck sharp pain, shortness of breath and itching throughout Friday evening to and currently. Visit doctor's office Wednesday 11/11/15. I was prescribed HFA inhaler, 2 poofs twice/day, Prednisone 10mg, and hydroxyzine.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Ocular hyperaemia, Pyrexia, Rhinorrhoea
Clinical narrative: Chills, fever, runny nose, red eyes.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood pressure increased, Chills, Eye discharge, Ocular hyperaemia
Clinical narrative: Chills, fever, runny nose, red eyes.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Chills, fever, runny nose, red eyes.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Sore, warm and red arm at injection site. Shoulder pain bilaterally. Neck pain. Leg and muscle aches.  Headaches. Dizziness.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Sore, warm and red arm at injection site. Shoulder pain bilaterally. Neck pain. Leg and muscle aches.  Headaches. Dizziness.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient experienced a sharp, shooting pain beginning Sunday evening. The pain was located in the arm that the Pneumococcal vaccine was administered (left arm).
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Dry skin, Rash
Clinical narrative: Rash presented on left hand in two small spots. The skin was dry.  Patient washed dishes on 11/10/15 and it caused the spots two blister and dryout/crack.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient claimed she experience rash and itching after be immunized.  Patient reported the adverse event on 11/11/2015.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Not sure of time and day of onset. May be 11/3/15. Circular red silver dollar sized "welt" at site of injection which felt hard and hot and itched in the very center.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Not sure of time and day of onset. May be 11/3/15. Circular red silver dollar sized "welt" at site of injection which felt hard and hot and itched in the very center.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Throat irritation
Clinical narrative: Feeling of throat scratchiness and difficulty swallowing when eating.  Symptoms felt similar to how I feel if there is something with corn in my food or medicines.  I treated with OTC Benadryl 25mg with resolution of symptoms in 2 hours.  Recommended dose of 50mg was not taken due to need to drive vehicle.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: WAS UNABLE TO MOVE ARM ON SUNDAY MORNING AND WAS RED AND SWOLLEN, SO HE WENT TO THE DOCTOR'S OFFICE AND THEY DIAGNOSED IT AS CELLULITIS AND GAVE HIM DOXYCYCLINE.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain first 9pm on 11/10 then burning, itching, redness, warmth at site. Temperature 100 at 10am 11/11. Used cool compress and took Benadryl in pm of 11/11. States area less red.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Herpes zoster, Influenza like illness, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: On 11/06 suddenly was hit with severe flu-like symptoms, minus a fever. I also had a very swollen lymph node on my neck. By the next morning, the flu-like symptoms were suddenly gone but I continued to get more swollen lymph nodes, all on the left side of my body. By Saturday night, a large area on the back, left side of my head began hurting. It started as an odd tingled, then began to feel like someone was pulling my hair, and then finally just became a very sharp pain. On Wednesday 11/11, I was diagnosed with shingles. I am a very healthy 31 year old and have never had shingles before.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: Guillain-Barre syndrome. Week after flu shot developed fever/sore throat which lasted about week then developed numbness in fingertips - progressed to neuromuscular weakness, respiratory SOB.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Oropharyngeal pain, Pyrexia
Clinical narrative: Guillain-Barre syndrome. Week after flu shot developed fever/sore throat which lasted about week then developed numbness in fingertips - progressed to neuromuscular weakness, respiratory SOB.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Within 5 hours of vaccine administration, I developed significant pain in the left shoulder. The pain has not subsided. Over the counter pain medications, ice packs, heat pack, and exercise have not improved pain. Difficult to sleep. Limited range of motion and strength in left arm continue. No prior issues.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Pyrexia, Rash
Clinical narrative: Rash, fever, chest tightness. Pt reported this to us on 11/10/15.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm, swollen.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There were no pertinent medical history and concurrent conditions and concomitant medications reported. On 03-NOV-2015 the patient was vaccinated with expired dose of PROQUAD (Merck) lot # K006218, expired on 29-OCT-2015, dose 1 (route, dose not reported). No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperventilation, Pyrexia
Clinical narrative: Patient c/o fever, chills, hyperventilating within a few hours of injection which lasted a few days.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Incorrect product storage, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 14 year old female patient with an unspecified food allergy. The patient's medical history included tonsils removed on an unspecified date. On 03-NOV-2015, prior to successful vaccination, a dose of VARIVAX (Merck) lot # K015992 and expiration date 23-SEP-2016, was tried to be administered, but the vaccine was frozen. The reporter stated that the vaccine was reconstituted and placed syringe in the freeze. The patient skin was pierced not vaccine flowed through since it was frozen. Subsequently, the patient was vaccinated with a correctly reconstituted and stored second dose of VARIVAX (Merck) lot # K015992 and expiration date 23-SEP-2016, 0.5 ml, subcutaneous in the right arm. Concomitant therapies included "MONOVA", GARDASIL, administered in the left arm and HAVRIX also administered in the right deltoid, but different site. On 04-NOV-2015, reported as "within 24 hours", the patient experienced injection site located where the VARIVAX (Merck) was injected. The injection site was red, puffy and itchy. On 04-NOV-2015, the patient went to the medical assistant office for medical attention and lidocaine cream was given as treatment. There was product quality issue involved. The reporter stated that if the reaction got worse and did not improve, they may call back for lot check. The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as not recovered/not resolved. The reporter considered injection site erythema, injection site pruritus and injection site swelling to be related to VARIVAX (Merck). Additional information is not expected since the reporter did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a subcutaneous dose of ZOSTAVAX, (lot number and expiration date were not provided). Concomitant medications were not provided. On an unknown date, the patient experienced some form of shingles. At the time of the report, the patient's outcome was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of ROTATEQ, oral, lot # K023532 and expiration date 21-JUN-2016, which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Shooting pain in right deltoid area for 6 days that resulted in limited mobility.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: None. Dr gave pt PREVNAR 13 in July and we gave in October. Did not know pt had already gotten in Dr office.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: P got pneumonia shot on 11/4/15. The arm got red, swelled, painful at injection site swelling was there until 11/9/15, Pt went to see MD about it.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender.  The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of COMVAX, injection, lot # J013884 and expiration date 19-AUG-2016, (route of administration and anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Patient phones pharmacy about an hour after receiving flu shot. Experiencing tingling of the tongue and some swelling of the tongue. Recommend taking diphenhydramine which resolved the symptoms. Follow up patient had no further complications or treatment required.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Headache, Injection site pain, Nausea
Clinical narrative: Day after vaccine - nausea, fever, chills, body aches, headaches, intense pain in arm where shot was given. Illness lasted 3 days. arm still swollen, red and painful at 1 week out.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Day after vaccine - nausea, fever, chills, body aches, headaches, intense pain in arm where shot was given. Illness lasted 3 days. arm still swollen, red and painful at 1 week out.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of GARDASIL 9 lot # L016428 and expiration date 30-JUL-2017, (route of administration an anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Induration, Upper extremity mass
Clinical narrative: Large, hard lump with significant bruising over entire upper arm down through to elbow.
Age: 14.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 09-NOV-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 lot # L014458 with expiration date 11-FEB-2017, (dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RVX
Symptoms: Gastroenteritis, Interchange of vaccine products, Rotavirus test positive
Clinical narrative: Information has been received from a published literature article. Rotavirus remains the leading cause of severe diarrhea in children under 5 years worldwide. ROTARIX (RV1) an ROTATEQ (RV5) have been associated with reductions in and severity of rotavirus disease. Studies have evaluated the impact of RV1 or RV5 but little is known about the impact of incomplete or mixed vaccination upon vaccine effectiveness. This is a case control study to examine association of combined RV1 and RV5 and rotavirus acute gastroenteritis, factoring severity of diarrheal disease. Children born after March 1, 2009 with acute gastroenteritis from three hospitals were approached for enrollment. Survey was administered, stool specimen was collected, and vaccination records were obtained. 89 of 1127 children with acute gastroenteritis were enrolled. Stool specimens were collected from 708 for rotavirus testing; 215 stool samples tested positively for rotavirus. Among the 215 patients, 7 patients received complete mixed dose of rotavirus vaccination, which was defined as receiving one dose of RV1 and two doses of RV5 by 8 months 0 days or one dose of RV1 and one dose of RV5 before 8 months of 0 days of age; 5 patients received incomplete mixed dose of rotavirus vaccination, which was defined as receiving only one dose of RV5 and one dose of RV1 after 8 months 0 days of age. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received FLUCELVAX vaccination for influenza for 2015-2016 year and experience paraesthesia in the form of numbness, tingling in left arm and leg a few hours after vaccination, but was transient and didn't require further medical care.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt rcv PCV13 on 10-21-15, RTC on 10-26-15 with redness and pain to inj site with some itching. Pt treated with KEFLEX 500 mg 1 TID x10 days and prednisone 10 mg 1 QD x 5days, pt RTC on 10-28-15 redness and itching had spread. Pt given 1 gram ROCEPHIN and clindamycin 300 mg TID x 10 days and BACTROBAN. Pt f/u with dr on 10-30-15 and admitted to hospital x 2 days.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm swollen, hot. Red, itchy swelling 8" in diameter.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Per pt experienced hives on 2 occasions on leg and all over. Her MD stated she could be allergic to the egg components. Pt confirmed she eats eggs and has received flu vaccine in past.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Rash, Swelling face
Clinical narrative: Swelling and rash at the site of injection on right deltoid region. Also mild rash/swelling below eyes on both cheeks.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: She came Wednesday (11-4-15) for PREVAR 13 (reconstituted) by her dr.) and by Friday she started having swelling redness and itching, she came to the pharmacy to check the site of injection and she was referred to the dr. Today (11-11-15) she come with rx for SEPTRA DS and hydroxyzine tabs.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt received Flu vaccine on 11/9/15 and around 12 noon pt experienced swelling at injection pain and the swelling and pain has spread down left arm around tricep area.
Age: 41.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, TYP
Symptoms: Blindness unilateral, Computerised tomogram head normal, Loss of consciousness, Night sweats, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Loss of vision in one eye, loss of consciousness, report of seizure activity by husband, night sweats.
Age: 41.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, TYP
Symptoms: Seizure
Clinical narrative: Loss of vision in one eye, loss of consciousness, report of seizure activity by husband, night sweats.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a consumer referring to her mother, a 87 year old female patient. The patient's relevant medical history was not reported. On an unknown date of 2014, the patient was vaccinated with ZOSTAVAX intramuscularly (dose and lot# were not reported) (Incorrect route of drug administration). Information regarding concomitant medication was not reported. Three months later in 2014 (also reported half years after vaccination), the patient experienced shingles after receiving ZOSTAVAX. The reporter stated that the case was mild and felt it would have been worse without the vaccine. The shingles was recovered on an unknown date of October 2014. The reporter considered the shingles to be non-serious and not related to ZOSTAVAX. Additional information is not expected as the reporter refused to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to the patients of unknown age and sex. On an unspecified date, between August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB lot # J014855 expiry date 16-APR-2015. Concomitant medications were not reported. No symptoms were reported. No PQC were involved and no further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates between 25-OCT-2015 and 02-NOV-2015, the patients received unspecified doses in the immunization series of RECOMBIVAX HB lot # L004754, expiration date 10-NOV-2016, 1 dose (route and dose were not reported) that were improperly stored. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reaction/allergies were not reported. On unknown dates between 25-OCT-2015 and 02-NOV02015, the patients received unspecified doses in the immunization series of M-M-R II lot # L008684, expiration date 13-MAY-2017, 1 dose (therapy type, route and dose were not reported) that were improperly stored. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatoin has been received from a physician assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates between 25-OCT-2015 and 02-NOV-2015, the patients received doses of PNEUMOVAX23 lot # L008664, expiration date 03-NOV-2016, 1 dose, (route and dose were not reported) that were improperly stored. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On 04-NOV-2015, the 9 week pregnant patient was vaccinated with GARDASIL lot # 1010596 and expiry date of 06-APR-2017 inadvertently, when she was indicated to receive a influenza vaccine. The last month period of the patient was approximately 02-SEP-2015 and expected date of delivery was 08-JUN-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to the patients of unknown age and sex. On an unspecified date between August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored oral, ROTATEQ (lot # K004795 and expiry date 11-FEB-2016). Concomitant medications were not reported. No symptoms were reported. No PQC were involved and No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # K004948 Expiration date: 04-APR-2016) (dose, route and anatomical location of administration were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L003227 Expiration date: 13-OCT-2016) (dose, route and anatomical location of administration were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 06-NOV-2015, the patient was vaccinated and an expired dose of PNEUMOVAX 23 (lot # K007824, expiration date 05-NOV-2015) intramuscular (dose was not provided). Concomitant medication was not reported. No known adverse effects. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 27-OCT-2015 from a registered nurse. The nurse reported that the patient might have received GARDASIL 4 after 26 years of age at an unspecified time in the past. The patient is not exhibiting any adverse effects. No other information was provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHEH2015US017996 is an initial spontaneous report received from a consumer on 11 Sep 2015. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of flu vaccine (manufacturer and batch number: not reported) in 2014 and experienced flu (see case: PHHY2015US115608). The patient was again vaccinated with flu vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 Aug 2015. On 06 Sep 2015, she got flu. On 08 Sep 2015, she experienced scratchy throat and on 09 Sep 2015 she experienced fever. On an unknown date, she had nausea. The reporter stated that the vaccine did not work in 2014 and 2015. The outcome of the events reported as recovering. The seriousness and causality of the events were not reported. Seriousness assessment of the event flu upgraded based on the available information in the source document and event vaccination failure based on the NVx key event list. Follow-up information from consumer received on 30 Oct 2015: Reporter's comment (vaccine did not work) was updated.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza, Nausea, Pyrexia, Throat irritation, Vaccination failure
Clinical narrative: Case number PHEH2015US017996 is an initial spontaneous report received from a consumer on 11 Sep 2015. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of flu vaccine (manufacturer and batch number: not reported) in 2014 and experienced flu (see case: PHHY2015US115608). The patient was again vaccinated with flu vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 Aug 2015. On 06 Sep 2015, she got flu. On 08 Sep 2015, she experienced scratchy throat and on 09 Sep 2015 she experienced fever. On an unknown date, she had nausea. The reporter stated that the vaccine did not work in 2014 and 2015. The outcome of the events reported as recovering. The seriousness and causality of the events were not reported. Seriousness assessment of the event flu upgraded based on the available information in the source document and event vaccination failure based on the NVx key event list. Follow-up information from consumer received on 30 Oct 2015: Reporter's comment (vaccine did not work) was updated.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Insomnia, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pain in shoulder, by the end of the day he could not move his whole arm, could not even open a bottle, he felt paralyzed in his right arm, pain is continuous, could not sleep and cried for 4 days the pain in still there, however the intensity has been reduced, went to PCP they gave pain meds that he states did not help, states he is 80% better but pain is still there.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Crying, Insomnia, Mobility decreased, Musculoskeletal pain, Paralysis
Clinical narrative: Pain in shoulder, by the end of the day he could not move his whole arm, could not even open a bottle, he felt paralyzed in his right arm, pain is continuous, could not sleep and cried for 4 days the pain in still there, however the intensity has been reduced, went to PCP they gave pain meds that he states did not help, states he is 80% better but pain is still there.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Cancer surgery, Insomnia, Pain, Renal failure, Vaccination error
Clinical narrative: Pain in shoulder, by the end of the day he could not move his whole arm, could not even open a bottle, he felt paralyzed in his right arm, pain is continuous, could not sleep and cried for 4 days the pain in still there, however the intensity has been reduced, went to PCP they gave pain meds that he states did not help, states he is 80% better but pain is still there.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt- 28-Oct-2015) concerns a 56 year old male patient. The patient had medical history of diabetes. On 10-Oct-2015, the patient received unspecified dose of influenza vaccine (influenza virus vaccine, manufacturer and batch number not reported) and Pneumovax 23 (pneumococccal vaccine, batch number not reported).  On the night of 10-Oct-2015, the patient developed body aches, chills and a fever at 99.9 degree Celsius.  The outcome was not reported. Reporter's Comments: Reporter's comments: The reporter assessed the case as serious (fatal). Sender's Comments: Company comments: Seriousness criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of vaccine not provided. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, body aches is unlisted; fever and chills are also unlisted due to fatal outcome. Causality: Unassessable. Time to event onset and fatal outcome is same day of vaccination. However patient's past medical history, concomitant medication, concurrent illness and sequence of events leading to death was not provided. Patient was not of advanced age and the reported events are consistent with the safety profile for Afluria and not serious enough to cause fatal outcome. Concomitant Pneumovax is considered co-suspect. Insufficient information including absence of autopsy report to causally assess the case.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Information has been received from a physician referring to a 62 year old female patient. Information concerning medical history and concurrent condition was not reported. On 07-NOV-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and route not unknown). There was no concomitant therapy reported. On 08-NOV-2015, the patient developed a rash, a blister, redness, warm and pain at the injection site following the administration of ZOSTAVAX. A pharmacist mentioned the rash was spreading down the patient's arm. Ice and BENADRYL were given as treatment for the events. Lab diagnostics studies were not performed. The patient had sought medical attention via office visit. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a physician referring to a 62 year old female patient. Information concerning medical history and concurrent condition was not reported. On 07-NOV-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and route not unknown). There was no concomitant therapy reported. On 08-NOV-2015, the patient developed a rash, a blister, redness, warm and pain at the injection site following the administration of ZOSTAVAX. A pharmacist mentioned the rash was spreading down the patient's arm. Ice and BENADRYL were given as treatment for the events. Lab diagnostics studies were not performed. The patient had sought medical attention via office visit. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Balance disorder, Chills, Headache, Hypoaesthesia
Clinical narrative: Headache, nausea, vomiting, fever, chills, loss of balance, blurred vision, numbness or tingling of legs, shoulder pain, stomach pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Nausea, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: Headache, nausea, vomiting, fever, chills, loss of balance, blurred vision, numbness or tingling of legs, shoulder pain, stomach pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Headache, nausea, vomiting, fever, chills, loss of balance, blurred vision, numbness or tingling of legs, shoulder pain, stomach pain.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Axillary mass, Burning sensation, Dizziness, Fatigue
Clinical narrative: Vertigo, neck painful to touch, constant unrelenting headache, irritability, difficulty forming sentences, large lump under right arm (shot arm), dizziness, burning feet, insomnia, systemic pain and inflammation, right hand and wrist pain, foot neuropathy, very poor word recall, fatigue, radiating and unrelenting shoulder and arm pain, which has become severe. Patient has not recovered from last item.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Inflammation, Insomnia, Irritability, Musculoskeletal pain
Clinical narrative: Vertigo, neck painful to touch, constant unrelenting headache, irritability, difficulty forming sentences, large lump under right arm (shot arm), dizziness, burning feet, insomnia, systemic pain and inflammation, right hand and wrist pain, foot neuropathy, very poor word recall, fatigue, radiating and unrelenting shoulder and arm pain, which has become severe. Patient has not recovered from last item.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Neuropathy peripheral, Pain in extremity, Speech disorder, Tenderness, Vertigo
Clinical narrative: Vertigo, neck painful to touch, constant unrelenting headache, irritability, difficulty forming sentences, large lump under right arm (shot arm), dizziness, burning feet, insomnia, systemic pain and inflammation, right hand and wrist pain, foot neuropathy, very poor word recall, fatigue, radiating and unrelenting shoulder and arm pain, which has become severe. Patient has not recovered from last item.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Cough, Croup infectious
Clinical narrative: Sudden, severe croup coughing with elevated body temperature (2 degrees above normal 97 F for her).
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm. Can't lift arm by itself over head. Can only move arm in certain directions.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Feeling hot, Hyperhidrosis
Clinical narrative: While waiting for the mandated 15 min rest period post influenza mist vaccination, patient developed extreme diaphoresis, felt hot in an air-conditioned room.  Patient vital signs were ok, had chills later but all symptoms resolved after 60 mins post administration.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: Very rapid heart beat, trouble catching my breath, high fever 102.0 headache and body aches. I took Aleve and Mucinex and a left over anti biotic. I finally felt better and could move around approximately 4 days later.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noted swelling, redness and tenderness of left deltoid area evening of injection.  Erythema measures 9 cm X 13 cm.  No improvement since onset on reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No drug reactions or allergies were reported. On 10-NOV-2015 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (strength, dose frequency and route were not reported) lot # J014229 with expiry date of 08-NOV-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain and decreased range of motion of arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, CSF pressure increased, CSF volume increased, Dizziness, Intracranial pressure increased
Clinical narrative: She experienced nausea and dizziness.  She has now had severe dizziness for 5 weeks with no relief.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture abnormal, Nausea, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Venogram
Clinical narrative: She experienced nausea and dizziness.  She has now had severe dizziness for 5 weeks with no relief.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose normal, Blood pressure increased, Dry mouth, Dysgeusia, Dysphagia
Clinical narrative: Diaphoresis, Dry mouth, Metallic taste in mouth, increased blood pressure, throat felt odd - a bit hard to swallow, pale. Symptoms never progressed and lasted for approx. 45 minutes - 1 hour. Supportive measures. Check blood pressure and glucose. EMS called but patient refused transport.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Diaphoresis, Dry mouth, Metallic taste in mouth, increased blood pressure, throat felt odd - a bit hard to swallow, pale. Symptoms never progressed and lasted for approx. 45 minutes - 1 hour. Supportive measures. Check blood pressure and glucose. EMS called but patient refused transport.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 7 days after vaccine developed itching at site, when seen 11/11 had at 5 cm indurated tender erythematous area, no fever or generalized symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen/redness/warm - told by ER physician to apply ice and take ibuprofen.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: 10/20 15 min after injection - redness, swelling of site - Ice packs applied, BENADRYL 25 mg po. 10/21 - Called on day off - said she was much better. Redness and swelling subsided. 10/22 - Swollen lymph node (L) side of neck. Saw primary care Dr. - SOLU-MEDROL, Clindamycin, BENADRYL and PEPSID ordered.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash generalised
Clinical narrative: On 10-28-2015, around 3PM, feet were itching - also arm pits - body covered in rash. Called the nurse hotline. My Dr. was on call - he informed the nurse to tell me to take CLARITIN and PEPCID. Come in Monday, if still broken out. Rash went away, but reoccurred on Tues (11-3) But very light - continued CLARITIN and PEPCID - still breaking out today (11-6).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pain
Clinical narrative: Severe chills, took 2 200 mg. ADVILS and symptoms subsided in 30 minutes. Injection site arm with pain and redness which lasted 4-5 days.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness over entire arm length - slight pain. Received cortisone injection from doctor. Symptoms subsided after 2 days.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, MMR, MNQ
Symptoms: Rash
Clinical narrative: Rash to (B) arms. Dx rash following immunizations. BENADRYL given. Strict ER warning also given.