chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Incontinence, Intervertebral disc degeneration, Mobility decreased, Motor dysfunction
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nerve conduction studies abnormal, Nerve root compression, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: First felt a hot electrical shock run down arm to finger tips approximately 2-5 minutes after the shot was completed, then arm became painful and by night numb and hard to lift. Later that night hives and itching at site, the next day started to be able to use arm again, day 3 painful arm and some redness/itching on upper arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: First felt a hot electrical shock run down arm to finger tips approximately 2-5 minutes after the shot was completed, then arm became painful and by night numb and hard to lift. Later that night hives and itching at site, the next day started to be able to use arm again, day 3 painful arm and some redness/itching on upper arm.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Itching and redness all over. 50mg oral Benadryl given@ 10:13 AM.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Cold sweat
Clinical narrative: Chills, cold sweat, whole body shivers, then felt like I was burning up. No fever recorded.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat, aches, fatigue, fever, dizziness, weakness, chills and shivering.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Sore throat, aches, fatigue, fever, dizziness, weakness, chills and shivering.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fever/chills, headache, muscle aches, fatigue, nausea.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever/chills, headache, muscle aches, fatigue, nausea.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, Full blood count, Heart rate decreased
Clinical narrative: Extreme Myalgia, Myositis, hypotension, vertigo, "pins and needles", uncontrolled yawning, low heartrate.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hypotension, Myalgia, Myositis, Paraesthesia, Thyroid function test
Clinical narrative: Extreme Myalgia, Myositis, hypotension, vertigo, "pins and needles", uncontrolled yawning, low heartrate.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vertigo, Yawning
Clinical narrative: Extreme Myalgia, Myositis, hypotension, vertigo, "pins and needles", uncontrolled yawning, low heartrate.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Very painful initial shot followed by continued pain in the arm/shoulder for 3 weeks at the current time ... pain is less now, but still ongoing.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Influenza like illness, Malaise, Nausea, Rash
Clinical narrative: UPON WAKING ON 10/3/15 HAD RASH ON LEFT ARM, FACE AND NECK.  RASH IS RED, RAISED, VERY ITCHY, EYES ITCH.  AS OF 10/9/15 PATIENT SEEN BY NP IN PCP OFFICE.  NOTES STATE FLU LIKE SYMPTOMS THE DAY AFTER RECEIVING THE SHOT TO INCLUDE MALAISE AND MILD NAUSEA.  NEXT DAY DEVELOPED A WIDESPREAD MACULAR PAPULAR RASH ON FACE, NECK, CHEST, ARMS AND ABDOMEN.  NOTES SUSPECT REACTION TO FLU SHOT AS IN PREVIOUS YEARS WHEN SHE RECEIVED THE VACCINATION SHE DEVELOPED RASH, ALTHOUGH NOT AS EXTENSIVE.  PER CCRNP. PATIENT WAS REFERRED TO ALLERGIST, PATIENT HAS APPOINTMENT SCHEDULED FOR 10/22/15.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: UPON WAKING ON 10/3/15 HAD RASH ON LEFT ARM, FACE AND NECK.  RASH IS RED, RAISED, VERY ITCHY, EYES ITCH.  AS OF 10/9/15 PATIENT SEEN BY NP IN PCP OFFICE.  NOTES STATE FLU LIKE SYMPTOMS THE DAY AFTER RECEIVING THE SHOT TO INCLUDE MALAISE AND MILD NAUSEA.  NEXT DAY DEVELOPED A WIDESPREAD MACULAR PAPULAR RASH ON FACE, NECK, CHEST, ARMS AND ABDOMEN.  NOTES SUSPECT REACTION TO FLU SHOT AS IN PREVIOUS YEARS WHEN SHE RECEIVED THE VACCINATION SHE DEVELOPED RASH, ALTHOUGH NOT AS EXTENSIVE.  PER CCRNP. PATIENT WAS REFERRED TO ALLERGIST, PATIENT HAS APPOINTMENT SCHEDULED FOR 10/22/15.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Sleep disorder
Clinical narrative: Within 5-6 hrs difficulty lifting. It's been ongoing pain. Getting less, but still bothering patient. Left arm shoulder. Still difficulty to sleep on that side.
Age: 46.0
Sex: U
Vaccine: FLUC3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Developed stiff neck 48 hours after receiving flu vaccine.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right upper arm w/ 4.5 cm x 4.5 cm w/erythematous patch slightly warm.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Drug administered to patient of inappropriate age, Neck pain, Pain
Clinical narrative: Went into pharmacy and pharmacist never asked about current meds. I had no literature presented to me before shot. I asked her questions and then she mentioned that TYLENOL has a drug interaction with vaccine. I told her I took LORTAB which has TYLENOL but she did not know what to say as to whether there will be an interaction.  I also asked her whether to take Flu and Pneumonia vaccine together or separately; she did not provide a good response. I decided to take the 2 of them. I had a prescription to receive the over 65 years pneumonia however I'm not sure whether I received the correct one since when I got home I reviewed the paperwork and it specified it was for the pneumonia vaccine for 65 and under. I called another pharmacy to ask about the interaction between LORTAB/TYLENOL and the vaccines but the staff specified they did not know. At night the pain began I and tried to take deep breaths to help control the pain but it did not work. Did not have problems with the Flu but had problems with the pneumonia vaccine. Patient usually goes to the bathroom often at one but at one point had sharp pain in the left part of the neck but ignored it and went to sleep. 90 minutes later got up to the bathroom and had shooting pain in the whole back all the way to the buttocks. Patient put blanket on and lay flat which helped back a little. I had to take LORTAB by midnight and some more by 6am. Right now still has pain but not as severe. She also had a soft stomach with these issues. At this point not sure when can start taking LORTAB again but is following up with doctor.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Left arm 4.5 x 5 cm erythematous, warmth.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient stated that her left arm began to turn red and warm to touch.  It then began to spread through the entire arm.  She placed cool compresses on the areas, which decreased the redness and pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal chest pain, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: PATIENT SAID SHE WOKE UP WITH BODY ACHES IN LEGS, BACK, NECK, AND RIBS ACCOMPANIED BY A FEVER.
Age: 6.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria at injection site spreading across torso to RUE and subsequently to LEs throughout 24 hour period.
Age: 6.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria at injection site spreading across torso to RUE and subsequently to LEs throughout 24 hour period.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash papular, Vaccination site induration
Clinical narrative: First induration at vaccination site, then fine papular eruptions over upper arms, chest, back and bilateral breasts.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: RASH.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Employee had hives to bilateral arms.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left deltoid pain like someone punching her since flu shot. Constant even when not sleeping on the arm.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Headache, bodyaches, chills, fever, hives/rash, pain at injection site.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Headache, bodyaches, chills, fever, hives/rash, pain at injection site.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray abnormal, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Acute onset spiking fever, shaking chills, fatigue, dyspnea, non-productive cough.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Acute onset spiking fever, shaking chills, fatigue, dyspnea, non-productive cough.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Fine bumps on face, under both eyes on both sides of the face. Looks like fading wepts or fading hives. Benadryl 50mg p.o given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Haemoglobin decreased, Lethargy, Vomiting
Clinical narrative: Lethargy and emesis upon arrival at home.  Parent notified the office and returned arriving at 11:51 AM.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain on site of injection.
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Wheezing
Clinical narrative: Abrupt onset of wheezing, treated with albuterol and required Emergency Room visit.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Burning sensation, Dizziness, Erythema, Nausea, Peripheral swelling
Clinical narrative: Patient experienced burning and redness, followed by nausea and dizziness, followed by swelling of the arm.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Spreading rash that hurts and itches.
Age: 1.65
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given Flu vaccine 0.50ml instead of 0.25ml that is recommended for children 3 years and under.
Age: 1.01
Sex: M
Vaccine: MMR, MMR
Symptoms: Urticaria
Clinical narrative: Child developed urticaria on right arm 10 min after administering MMR vaccine. No other symptoms. Given Benadryl and observed in office.
Age: 1.01
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash
Clinical narrative: Child developed urticaria on right arm 10 min after administering MMR vaccine. No other symptoms. Given Benadryl and observed in office.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received another flu shot at local pharmacy.  She did not have any adverse events but we felt this warranted reporting.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Mom is reporting the School Nurse noticed "hives" today. Pt. has not had any other noted adverse reactions, no new meds, foods, etc.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Pharyngeal erythema, Pharyngeal oedema, Tachycardia
Clinical narrative: 10:00 AM: FACE FLUSHED, THROAT MODERATELY SWOLLEN & RED. 3:40 PM: DIZZINESS; TACHYCARDIA.
Age: 56.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Deltoid muscle felt real sore where flu shot was given.  This soreness has continued until present.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Paranasal sinus discomfort
Clinical narrative: Patient started feeling sinus pressure, followed by uncontrollable sneezing and copious nasal discharge. Patient then had trouble breathing (chest tightness) and used 4 doses of Ventolin, which helped somewhat. This was followed by "painful throbbing" in the head. When patient woke up next morning, patient felt better, but still fatigued.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Patient started feeling sinus pressure, followed by uncontrollable sneezing and copious nasal discharge. Patient then had trouble breathing (chest tightness) and used 4 doses of Ventolin, which helped somewhat. This was followed by "painful throbbing" in the head. When patient woke up next morning, patient felt better, but still fatigued.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Solid red rash around injection site. Pt was given Fluzone PFS which does not contain latex.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising at injection site.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: INJECT SITE REACTION (SWELLING, REDNESS, HEAT, ITCHING).
Age: 40.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Lip swelling
Clinical narrative: Dizzy, lightheaded, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Muscular weakness, Oral discomfort, Oral pruritus, Paraesthesia
Clinical narrative: Dizzy, lightheaded, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Dizzy, lightheaded, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting x 1 episode, unclear time of event.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Patient had severe arm pain, not only at injection site, but entire arm. She was not able to lift her arm or use her arm for everyday activities. There was no visible swelling or redness at injection site. She was not able to sleep at night. She did not have a headache. The extreme arm pain lasted 2 days, then she felt fatigued for the next 2 days, by the 5th day she felt fine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient had severe arm pain, not only at injection site, but entire arm. She was not able to lift her arm or use her arm for everyday activities. There was no visible swelling or redness at injection site. She was not able to sleep at night. She did not have a headache. The extreme arm pain lasted 2 days, then she felt fatigued for the next 2 days, by the 5th day she felt fine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Hives and welts; burning and itching sensation.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Mom noticed diffuse red, raised clusters of bumps around, but away from injection site on 10/13/2015 after she changed the Band-Aid.  On 10/14/2015 the clusters had come together forming large red, raised areas.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pain in arm "like I had been punched" with continued pain in are followed by numbness and tingling in hands and fingers (ongoing).
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Hives & welts on face, around mouth and nose red and swollen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Throat irritation
Clinical narrative: Difficulty swallowing, itch/scratchy throat.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient is a volunteer at the hospital, complained of numbness of tongue and mouth about 10 minutes post administration of vaccine. Patient denied having difficulty breathing or itching, recommended patient to go to the ER if symptoms worsened or difficulty breathing developed. Patient refused to go to the ER and left with friend.
Age: 87.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Blood glucose increased, Blood pressure increased, Feeling cold
Clinical narrative: Patient felt cold and very weak. His wife called 911 and was taken to the hospital. Blood pressure and blood glucose were elevated.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site reaction, Pallor
Clinical narrative: Employee developed itching on inside of arm vaccinated from wrist to shoulder with blanching of skin and redness. Patient took a Claritin with no relief, 1 hour later took Benadryl with resolution of symptoms.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Employee developed itching on inside of arm vaccinated from wrist to shoulder with blanching of skin and redness. Patient took a Claritin with no relief, 1 hour later took Benadryl with resolution of symptoms.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Hypersensitivity, Nausea
Clinical narrative: SEVERE ALLERGY REACTION, FEVERE, HEADACHE, NAUSEA AND VOMIT, DROWSINESS, FATIGUE AND JOINT PAIN, SHOCKING AND FAINT.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Shock, Somnolence, Syncope, Vomiting
Clinical narrative: SEVERE ALLERGY REACTION, FEVERE, HEADACHE, NAUSEA AND VOMIT, DROWSINESS, FATIGUE AND JOINT PAIN, SHOCKING AND FAINT.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Insomnia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Pain in left shoulder, difficulty sleeping, onset 10/06/2015 evening. On 10/08/2015 patient was in clinic for administration of son's flu shot, and relays clinic nurse said her flu shot had been administered high. On 10/12/2015 patient spoke with PHN re: left shoulder pain, no swelling or redness, was advised to come back if experiences tingling. Last night 10/13/15 patient states numbness & tingling started, down left arm to hand/fingers. This morning 10/14/15 patient saw another PHN- ice was applied for swelling of left shoulder; advised to see doctor. Patient saw doctor today (10/14/15) afternoon, was prescribed Flexeril, Neurontin, Tylenol-Codeine. To return to doctor Monday, 10/19/15 if no improvement. Note: I have it documented that patient's flu shot was administered in Right Deltoid on 10/06/2015.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Rash and persistent soreness that continued for 15 days.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Middle insomnia, Pruritus, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Started to itch last night, woke up in the middle of the night with a slight rash on the neck. This am noticed rash on back and sides, right thigh, stomach. No pus, it is not raised and is just red and itchy. Pt has not taken any meds and was advised by rph to take an antihistamine and to call 911/go to ER if symptoms worsen or if there is difficulty breathing.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Injection site pain, Pain, Pollakiuria
Clinical narrative: Arm pain at site of injections (left and right). Generalized weakness and aching. Possible low-grade fever overnight with increased urinary frequency. Generalized weakness and aching on day 2.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Chills, Pain, Pain in extremity
Clinical narrative: Deltoid swelling and pain, pain with arm movement (much more significant than any other vaccine received), chills. Next morning and throughout day, joint pain in hips and knees as well as low back pain. Treatment--acetaminophen and heating pad.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Deltoid swelling and pain, pain with arm movement (much more significant than any other vaccine received), chills. Next morning and throughout day, joint pain in hips and knees as well as low back pain. Treatment--acetaminophen and heating pad.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Tonic clonic movements
Clinical narrative: After I gave patient her flu shot she passed out and exhibited tonic clonic like symptoms.  This lasted less than 15 seconds.  She came to and sat up and passed out again exhibiting the same tonic clonic like symptoms lasting less than 15 seconds.  She came to again and I had her stay on her back with her legs up for about 5 minutes and then she slowly sat up and I gave her some juice. She walked to the office and the school called her mother and she went home.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on abdomen and back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Redness, swelling, soreness, no itching, no pus, a little hard on surface, no tenderness.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting.
Age: 51.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Pain, hard to raise arm, lack of sleep.
Age: 20.0
Sex: M
Vaccine: FLUN4, TYP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood chloride increased, Blood creatine phosphokinase increased
Clinical narrative: Symptoms began within 1 hour of vaccine administration.  Soreness/Tenderness of Right shoulder, progressivley worsened throughout remainder of day. Upon awakening next day, swollen eyelids, R shoulder pain progressed to Left shoulder.  Pt saw someone who administered Benadryl which alleviated symptoms.  Next day, pain worsened, decreased range of motion to both arms.  Noted urine dark and a rash ocurred across the body.  No other S&S reported.
Age: 20.0
Sex: M
Vaccine: FLUN4, TYP
Symptoms: Blood glucose normal, Blood urine present, Chromaturia, Eyelid oedema, Injected limb mobility decreased
Clinical narrative: Symptoms began within 1 hour of vaccine administration.  Soreness/Tenderness of Right shoulder, progressivley worsened throughout remainder of day. Upon awakening next day, swollen eyelids, R shoulder pain progressed to Left shoulder.  Pt saw someone who administered Benadryl which alleviated symptoms.  Next day, pain worsened, decreased range of motion to both arms.  Noted urine dark and a rash ocurred across the body.  No other S&S reported.
Age: 20.0
Sex: M
Vaccine: FLUN4, TYP
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Protein total decreased, Rash generalised
Clinical narrative: Symptoms began within 1 hour of vaccine administration.  Soreness/Tenderness of Right shoulder, progressivley worsened throughout remainder of day. Upon awakening next day, swollen eyelids, R shoulder pain progressed to Left shoulder.  Pt saw someone who administered Benadryl which alleviated symptoms.  Next day, pain worsened, decreased range of motion to both arms.  Noted urine dark and a rash ocurred across the body.  No other S&S reported.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nervousness
Clinical narrative: Pt reports feeling shaky, fatigued and has a headache.
Age: 61.0
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: RASH/ HIVES/ITCHING.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site bruising, Injection site pain, Injection site pruritus, Ocular hyperaemia
Clinical narrative: Patient reported bruise/sore/itchy at injection site on left arm and itchy/red left eye that started appearing about an hour after receiving the vaccine. Patient stated on 10/13/15 that the bruise/sore/itchy injection site and left itchy/red eye is slowly improving.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site become swollen and "hot". Patient was on a trip at the time and was told by a nurse to watch it carefully and see her doctor when she returned home.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT IS UNABLE TO LIFT THE ARM IN WHICH THE VACCINE WAS GIVEN DUE TO GREAT PAIN. SHE STATES THAT IT IS NOT GETTING ANY BETTER DESPITE WAITING SEVERAL DAYS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after receiving Zostavax vaccine, patient noticed the site was red, swollen and hot.  She circled the site and waited until the next morning.  When she saw it expanded beyond the circle she proceeded to the emergency room.  According to the patient she was diagnosed with cellulitis and treated with a 7 day course of clindamycin.  The swelling is gone and guest has no symptoms at this time.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site erythema, Injection site reaction, Pain in extremity
Clinical narrative: Limited range of motion of left arm.  Unable to sleep on left side.  Red welt - 6" x 2" about 2" below injection site for 3 days.  Moderate joint pain, even in toes and fingers. Took Aleve to relieve pain and iced red area.  10/14/2015 redness was gone and pain in arm and joints finally subsided.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Sleep disorder, Urticaria
Clinical narrative: Limited range of motion of left arm.  Unable to sleep on left side.  Red welt - 6" x 2" about 2" below injection site for 3 days.  Moderate joint pain, even in toes and fingers. Took Aleve to relieve pain and iced red area.  10/14/2015 redness was gone and pain in arm and joints finally subsided.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain, Pyrexia, Swelling
Clinical narrative: 3/4" Swelling, very hard & red, painful, hard for 3 days. after 3 days fever of 100, day 4 better with some swelling and achiness, by Day 5 resolved.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Mouth swelling, Pharyngeal oedema
Clinical narrative: Patient received Prevnar 13 on 10-8.  The next day redness started at site on right arm and continued to get larger.  Came to pharmacy on 10/14 and redness was from shoulder to elbow.  Saw Dr and was prescribed doxycycline and Medrol DP and was advised to also get some Benadryl. Patient also stated there was previously some feeling of swelling in the mouth and throat area but that had subsided.
Age: 32.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Vomiting, Nausea, Fever (102.5) Chills, given 1000mg Tylenol every 6 hours for 2 days.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, X-ray normal
Clinical narrative: Frozen shoulder.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Joint swelling, Laboratory test, Peripheral swelling
Clinical narrative: Hives and swelling of bilateral feet, ankles, lower legs, and hands. Pain to joints including the ankles, knees, hips, back, wrists, and elbows. Hospitalized on Monday 10/12/15 @ 08:15 was given IM prednisone, Oral prednisone, 25 mg Benadryl, and Pepcid. Diagnosed with urticaria and joint inflammation.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives and swelling of bilateral feet, ankles, lower legs, and hands. Pain to joints including the ankles, knees, hips, back, wrists, and elbows. Hospitalized on Monday 10/12/15 @ 08:15 was given IM prednisone, Oral prednisone, 25 mg Benadryl, and Pepcid. Diagnosed with urticaria and joint inflammation.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Dyspnoea, Pyrexia, Respiratory distress
Clinical narrative: Fever, chills, tried to compromised breathing and respiratory distress.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Oropharyngeal pain, Respiration abnormal, Swollen tongue
Clinical narrative: Started with throat hurting and by around 9 AM the next morning her tongue was swollen about 4 times the normal size. So large that she could not keep her tongue in her mouth and her breathing was affected.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Generalised tonic-clonic seizure, Rash
Clinical narrative: 10 Grand Mal seizures over 10 days after vaccinations, recurring rash on face. Treatment for seizures with Keppra.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Pt presented to the pharmacy 8 hours later with two red eyes.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient had high dose last year with no reaction. Patient had high dose flu shot and was ok for about 3 days, then started to show sign of bruises and then there was a bump around the area where the shot was administered. Patient patient to take Benadryl and Tylenol. Patient did not realize the bruise was there until she saw it in the mirror. It is not painful but if she presses it, the pain occurs. She was ok, just to let us know. We gave patient a box of #24 generic allergy relief Benadryl and a box of cold compresses. Told patient to come back to see us in a few days for us to follow up. She was fine with us handling the situation.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy around 4:15pm and said that her arm was really sore. She described it as her entire arm being sore. Vaccine administrator recommended that the patient take some OTC pain reliever and to follow up with us on 10/15/15 if the pain continued.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Menstruation delayed
Clinical narrative: I do not know the exact date and time of her hair loss.  She had the shot on 8/17/15 and by 9/01/15 we started seeing her hair fall out. She has realy long straight hair. You can see hair spiked up near the scalp - meaning it's noticeable. I assumed that this is because her hormones are changing, however, I have never seen an 11 year old with hair falling out like this. Two days after the shot, she had a brief period and hasn't started her period since that time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Spreading redness, and swelling in left upper arm, fever. Dr. has diagnosed cellulitis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site joint pain, Injection site pain
Clinical narrative: Patient said shot given in joint. Right arm deltoid region. Felt pain immediately. Still have joint, shoulder pain currently.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Shoulder hurt initially. About a day later couldn't lift shoulder or arm. Cannot sleep on left side. Still pain and stiffness in shoulder.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular, Skin warm
Clinical narrative: Warm, maculopapular rash, non-pruritic. Advised treatment with ibuprofen and cool compresses to area. Rash noticed approximately 48 hours after vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Left arm redness warm to touch. Diagnosis: Cellulitis Tx with Cephalexin 250 mg/5 mL bid x 10 days.
Age: 22.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Upper extremity mass
Clinical narrative: Pt. called on 10/12/15 states she received GARDASIL 9 one week ago and c/o quarter size lump on left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Eye swelling, Injection site pain, Injection site swelling
Clinical narrative: Swollen eyes. Swollen/sore (R) deltoid.
Age: 39.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Local swelling/redness/itching achyness.
Age: 62.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Arthralgia-al joints. Myalgia-below back, (legs).
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Erythema multiforme
Clinical narrative: 3 days past FLUMIST noted erythema multiforme extremities.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Fall, Hyperhidrosis, Pallor
Clinical narrative: After injection, pt became diaphoretic and pale and dizzy. Pt lost balance and fell to ground. No loss of consciousness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: He felt "tingly" after vaccines. Resolved after a few minutes.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Rash erythematous, Skin exfoliation
Clinical narrative: Diffuse erythematous rash on lateral (L) upper arm with central clearing. Mild scaling at border. Hydrocortisone apply twice a day prn.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Throat irritation
Clinical narrative: Aprox 30-45 min after receiving my flu shot my lip and throat became itchy and my lip were slightly swollen. Took BENADRYL 50 mg all symptoms resolved.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Per triage RN: Positive for widespread hive; widespread itching or facial swelling and no other serious symptoms and no serious allergic reaction in the past.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Day after administration, patient had a half-dollar size welt. We reported to her physician on 10-8-15.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus
Clinical narrative: Day after administration, patient had a half-dollar size welt. We reported to her physician on 10-8-15.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Knee arthroplasty, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Pt reports 101 fever, body ache, arm/shoulder/neck pain/immobility to raise arm/also b/L knee pain (s/p knee replacement). Also reported to PCP.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt reports 101 fever, body ache, arm/shoulder/neck pain/immobility to raise arm/also b/L knee pain (s/p knee replacement). Also reported to PCP.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea
Clinical narrative: Patient report adverse reaction to vaccination FLUZONE-HD and PREVNAR 13. Pt said she had severe diarrhea following the vaccine administration.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Back pain, Fatigue, Headache, Laboratory test normal, Psychiatric symptom
Clinical narrative: Syncope, fatigue, chronic headaches, psychiatric changes, back pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope, fatigue, chronic headaches, psychiatric changes, back pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Palpitations, Peripheral swelling
Clinical narrative: Pt had swelling in arm felt dizzy and heart racing and nausea.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Pain
Clinical narrative: Difficult breathing. Chest pains. Aches in whole body. Difficult sleeping had to use oxygen continuously for 2 weeks.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed big rash at the injection site and was referred to MD. She was prescribed Cephalexin.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. ON 23-JUN-2015 the patient was vaccinated with ROTATEQ (Oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. On 23-JUN-2015 the patient was vaccinated with oral, ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 161, 162, 163 and 164). Background: Since June 2015, there had been 1645 times (30 times each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 03-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 165, 166 and 167). Background: Since June 2015, there had been 1645 times (30 minutes each time+ 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 Minutes each time= 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 04-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 168 and 169). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 05-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via company representative referring to a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date (reported as a few years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot# and expiration date not reported). On an unknown date the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention in an unspecified way and acyclovir was given as treatment on an unknown date. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a 9 week old patient of unknown gender. On 11-AUG-2015 the patient was vaccinated with ROTATEQ (oral, lot # K022990, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.