chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Patient was in lobby and told his mother that he felt funny.  Mother advised that he lost consciousness and hit his head when he fell. Took client to a room to lay down and monitor. Patient recovered without incident.  Released to go home with mother.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain with severe restricted movement of entire arm. This was the arm in which the pneumonia vaccine was administered.
Age: 56.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Asthenia, Chills, Decreased appetite, Excoriation
Clinical narrative: Itching, under neck swollen, chills, extreme weakness, fatgue, ABD cramping, rapid heart beat, head aches, and no appetite. Patient went to the ED that morning and was given Atarax for itching. No swelling observed my medical staff. Only thing objective on exam was excoriations. There was no indication to be admitted to the hospital at that time. She also went to outside ED who gave her something for itching as well, was not admitted.
Age: 56.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Fatigue, Headache, Heart rate increased, Pruritus, Swelling
Clinical narrative: Itching, under neck swollen, chills, extreme weakness, fatgue, ABD cramping, rapid heart beat, head aches, and no appetite. Patient went to the ED that morning and was given Atarax for itching. No swelling observed my medical staff. Only thing objective on exam was excoriations. There was no indication to be admitted to the hospital at that time. She also went to outside ED who gave her something for itching as well, was not admitted.
Age: 56.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: Itching, under neck swollen, chills, extreme weakness, fatgue, ABD cramping, rapid heart beat, head aches, and no appetite. Patient went to the ED that morning and was given Atarax for itching. No swelling observed my medical staff. Only thing objective on exam was excoriations. There was no indication to be admitted to the hospital at that time. She also went to outside ED who gave her something for itching as well, was not admitted.
Age: 56.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Insomnia, Nausea, Pruritus
Clinical narrative: Itching, under neck swollen, chills, extreme weakness, fatgue, ABD cramping, rapid heart beat, head aches, and no appetite. Patient went to the ED that morning and was given Atarax for itching. No swelling observed my medical staff. Only thing objective on exam was excoriations. There was no indication to be admitted to the hospital at that time. She also went to outside ED who gave her something for itching as well, was not admitted.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Significant pain and limited ROM of left arm not improved by supportive measures such as ibuprofen and rest.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Crying, Eye movement disorder, Feeding disorder, Listless
Clinical narrative: Inconsolable crying for 24 hours, eyes rolled back to head. Listlessness (unable to eat food but still nursed).
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chest pain, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Evening of vaccine: great deal of pain near injection site. Following day: more pain starting at elbow and going up arm all the way into the chest, arm is warm to touch and very swollen, Tylenol not relieving pain.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, achiness, headache.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Arthralgia, Asthenia, Astigmatism, Blood test normal
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Complex regional pain syndrome, Constipation, Cough, Ear pain, Electroencephalogram normal
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye pain, Fatigue, Headache, Hemiparesis, Infectious mononucleosis
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Insomnia, Lymphadenopathy, Muscle twitching, Musculoskeletal pain, Nausea
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Neurological decompensation, Nuclear magnetic resonance imaging brain normal, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Viral infection, Vision blurred, Wheelchair user
Clinical narrative: 9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Raised Red Warm area roughly 2 inches wide and 1/2 inches tall on left deltoid.  Continues one week post immunization.  No Pus, streaking noted at site.  Normal Range of Motion, no pain reported with movement.  No fever reported.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test, Eyelid ptosis, Myasthenia gravis
Clinical narrative: Drooping eyelid. Later diagnosed with Myasthenia Gravis.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Dyspnoea, Urticaria
Clinical narrative: HIVES 8/21/16 IN THE EVENING, STILL PRESENT MONDAY AND PT REPORTED SHORTNESS OF BREATH, SEEN OUT OUTSIDE ER 8/22/16, GIVEN PREDNISONE INJECTION AND ORAL PREDNISONE, WHICH HELPED, HIVES LASTED 2 DAYS AND THEN RESOLVED.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Lip swelling
Clinical narrative: Patient's upper lip started swelling the day after HPV #2; associated cough without throat-closing or dyspnea. He previously had lip swelling the day after HPV#1, but was attributed to Amoxicillin prescribed the same day.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperaesthesia, Muscle swelling, Muscle tightness
Clinical narrative: MUSCLE VERY TIGHT AND SWOLLEN, SENSITIVE TO TOUCH.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Headache, itching.  Redness, swelling, hot to touch and hard to touch arm where vaccine was given.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Headache, itching.  Redness, swelling, hot to touch and hard to touch arm where vaccine was given.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Right after MMR vaccine being given pt started scratching at injection site. Site welted up and became very red. Dr. came and accessed pt approx 2 minutes after vaccine was given and pt seemed well. Dr advised to Mom to wait to make sure reaction had stopped and Mom chose to leave AMA.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient came in with a rash from her shoulder going down her arm.  She doesn't know if it is from the shot or the sun.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blister, Skin exfoliation
Clinical narrative: PATIENT SAID THE SURROUNDING AREA AND NOT THE ACTUAL INJECTION SITE WAS BLISTERING. HE CAME TO THE PHARMACIST WHO ADMINISTERED THE VACCINE THE FOLLOWING DAY AND WAS GIVEN ADVIL AND SOME ANTIBIOTIC CREAM. TODAY 8/26/16 PATIENT COMES BACK WITH IS SKIN BEING PEELED LEAST A QUARTER INCH AWAY FROM THE VACCINATION AREA. SUGGESTED TO SEE THE DOCTOR WAS NOT SURE IF ITS IS DUE TO THE VACCINATION ITSELF.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Tremor
Clinical narrative: The pharmacist who spoke to patient on 8/24/16 documented this: "Patient had an adverse reaction to flu HD vaccine, reported uncontrollable shaking and jaw shakes for the entire evening on the date of administration. Patient states the adverse effect only happened that evening, she felt run down for the next day, but no longer having shakes. She has been in contact with her doctor." --- Note that patient received the vaccine on Monday 8/22/16, and she notified our pharmacy 2 days later on Wednesday 8/24/16.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Diarrhoea, Nausea, Tremor
Clinical narrative: The pharmacist who spoke to patient on 8/24/16 documented this: "Patient had an adverse reaction to flu HD vaccine, reported uncontrollable shaking and jaw shakes for the entire evening on the date of administration. Patient states the adverse effect only happened that evening, she felt run down for the next day, but no longer having shakes. She has been in contact with her doctor." --- Note that patient received the vaccine on Monday 8/22/16, and she notified our pharmacy 2 days later on Wednesday 8/24/16.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hypoaesthesia, Swollen tongue
Clinical narrative: Currently being evaluated by provider. Numbness to face, hands, fingers, Swelling of tongue & dizziness, no N/V or fever, Benadryl administered, under observation at this time.
Age: 35.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Incorrect product storage
Clinical narrative: None, due to refrigerator temperature excursion on 8/12/2016, manufacture determined based on drop in temperature that the vaccine is not viable and CDC recommended revaccination.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Bedridden, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Begin feeling ill, became bed ridden, Could not move arm, severe pain in the arm.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient stated that a physician diagnosed him with shingles.
Age: 25.0
Sex: F
Vaccine: JEV1
Symptoms: Dizziness, Influenza like illness, Rash
Clinical narrative: Rash on chest and back. Dizziness, flu like symptoms.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Swollen right leg.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: None, due to refrigerator temperature excursion on 8/12/2016, manufacture determined based on drop in temperature that the vaccine is not viable and CDC recommended revaccination.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: None, due to refrigerator temperature excursion on 8/12/2016, manufacture determined based on drop in temperature that the vaccine is not viable and CDC recommended revaccination.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: None, due to refrigerator temperature excursion on 8/12/2016, manufacture determined based on drop in temperature that the vaccine is not viable and CDC recommended revaccination.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Agitation, Bowel movement irregularity, Crying, Insomnia, Opisthotonus
Clinical narrative: Non stop crying which was uncontrollable. Agitated, arching back, will not sleep. All of which have continued and have not lessened even at 6 months of age. Child still screams 90% of the time, will not sleep. Bowel movements have changed and are not normal.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Screaming
Clinical narrative: Non stop crying which was uncontrollable. Agitated, arching back, will not sleep. All of which have continued and have not lessened even at 6 months of age. Child still screams 90% of the time, will not sleep. Bowel movements have changed and are not normal.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Intensive care, Seizure
Clinical narrative: The patient had several seizures over an hour and a half that lasted anywhere from several seconds to 10 min. long. The patient was subsequently transferred to PICU and then transferred to outside facility for continuous EEG monitoring.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local redness with warmth. 10cm in diameter to the upper right thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: 27-48 Hours after injection patient broke out in hives. Hives lasted 3 days Saw dr on day 4. Given steroids, claritin and benadryl. Child is fine now.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patients left upper arm was sore on Wednesday and was slightly red Thursday and by Friday afternoon the upper arm was red from about an inch below her shoulder extending to about 2 inches above the elbow. She said it is warm to touch. I told her to seek medical care and she said she was getting in touch with her doctor. I suggested taking an antihistamine and then follow her doctors instructions.
Age: 49.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: Localized swelling and redness at vaccine site.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Swelling
Clinical narrative: Arm starting itching and swelling.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse events reported by patient. Due to the refrigerator temperature excursion on 8/12/16, manufacture determine the vaccine is not viable and CDC recommend revaccinate.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse events reported by patient. Due the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Rash erythematous
Clinical narrative: Patient states that 2 days after shingles vaccination that he experienced a rash redness, as well a a fever of over 100 degrees along with chills and joint pain. It only lasted 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site extravasation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient injection site swelled immediately. Injection site was very itchy. Vaccine leaked out of injection site. I removed the syringe from patient's arm and discarded remainder in sharps container.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Myalgia, Myositis, Pain, Urine analysis
Clinical narrative: Myositis - diffuse muscle aches, worst in quads, unable to walk due to pain. Evaluated patient 8/26, exam consistent with myositis. no rhabdomyolysis. no local reaction at site of vaccination.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse events reported by patient. Due the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse events reported by patient. Due the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: PATIENT EXPERIENCED DIZZINES, LIGHTHEADEDNESS AND WEAKNESS ONE MINUTE AFTER ADMINISTRATION OF AFLURIA VACCINE. PATIENT DID NOT GET UNCONSCIOUS AND WAS TALKING AND ANSWERING ALL QUESTIONS.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse events reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Protrusion tongue
Clinical narrative: Tongue protruding, extra fussy.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse event reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Redness, swelling and irritation around injection site.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse event reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was no adverse event reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 65.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Injection site rash
Clinical narrative: Injection site rash.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Rash, warmth in area of injection.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test, Dry eye, Eyelid function disorder, Facial paralysis, Facial paresis
Clinical narrative: Dryness and lacrimation of right eye progressed to inability to close right eye and right sided facial weakness (inability to smile, spit or to puff cheek on right side). Patient was subsequently seen at different provider and diagnosed with Bell's palsy and placed on prednisone (80 mg for 4 days and then tapered) and Valtrex.  Pt has finished meds and reports some improvement at time of this report.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Lacrimation increased
Clinical narrative: Dryness and lacrimation of right eye progressed to inability to close right eye and right sided facial weakness (inability to smile, spit or to puff cheek on right side). Patient was subsequently seen at different provider and diagnosed with Bell's palsy and placed on prednisone (80 mg for 4 days and then tapered) and Valtrex.  Pt has finished meds and reports some improvement at time of this report.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash, Skin warm
Clinical narrative: Redness initially around the site with swelling. Redness spread making the rash bigger and hot to the touch. Swelling increased make the site raised. This occurred over a 12 hour period and woke on August 27, 2016 to the rash being larger, measuring 10cmx8cm. Took to the doctor and they provided prescription for Augmentin. The doctor drew around the rash so I could watch for more movement, which did occurred by another cm around. Augmentin was started at dinner time and will continue for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness initially around the site with swelling. Redness spread making the rash bigger and hot to the touch. Swelling increased make the site raised. This occurred over a 12 hour period and woke on August 27, 2016 to the rash being larger, measuring 10cmx8cm. Took to the doctor and they provided prescription for Augmentin. The doctor drew around the rash so I could watch for more movement, which did occurred by another cm around. Augmentin was started at dinner time and will continue for 10 days.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING ON NECK, BACK, LEGS.  HIVES PRESENT ON NECK.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood magnesium normal, Blood phosphorus normal, Electroencephalogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Seizure like activity.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure like phenomena
Clinical narrative: Seizure like activity.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure like activity.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of his son through a Pfizer employee. A male patient of an unspecified age and ethnicity received TRUMENBA on 16May2016. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever and chills, both on 16May2016, 6-10 hours after the vaccination. Therapeutic measures were taken as a result of the events. The patient woke the reporter up in the middle of night with these symptoms and was then taken to the ER/hospital. The outcome of the events was unknown. Follow-up (17-May-2016): New from the same contactable consumer includes: events considered serious and events clinical course details. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood glucose increased, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Day 1: Evening after administration, swelling and redness through left upper arm. Trouble sleeping. Pt took ibuprofen and put ice on area. Day 2: Swelling, pain, redness, fever, blood glucose levels spiked, site painful to touch. Day 3: Redness spread across upper arm to inner arm and elbow area. Pain continued. Day 4: Office appointment for antibiotic and prednisone. Pt reported slight reduction of swelling but still pain.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Day 1: Evening after administration, swelling and redness through left upper arm. Trouble sleeping. Pt took ibuprofen and put ice on area. Day 2: Swelling, pain, redness, fever, blood glucose levels spiked, site painful to touch. Day 3: Redness spread across upper arm to inner arm and elbow area. Pain continued. Day 4: Office appointment for antibiotic and prednisone. Pt reported slight reduction of swelling but still pain.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin induration
Clinical narrative: Pt received 1 IM and 1 SQ shot in (R) arm, post shot arm got red, hard, swollen. Painful enough to require ER visit, treated/w IM steroid injection and possible follow up for cellulitis per ER MD.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid ptosis, Facial paralysis, Strabismus
Clinical narrative: Right Ptosis and extropia - consistent with Bells Palsy. Prescribed prednisolone for 10day taper.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Inflammation, Peripheral swelling
Clinical narrative: Patients right arm became inflamed, red and swollen. Pt went to clinic - diagnosed w/cellulitis. Given CIPRO.
Age: 19.0
Sex: F
Vaccine: DT, MENB
Symptoms: Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Pink rash to (L) arm both at site of injection (now fading) and also distally to involve areas entire (L) upper arm. Rash is serpiginous with well-demarcated borders and relative central clearing (urticarial).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Rash
Clinical narrative: Pt. phoned in on 8-18-16 with 2" red spot around injection site. Appt on 8-22-16 with Nurse Practic. for shingles rash on lower leg and spot.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dad brought pt in with redness and swelling at injection site. Advised dad to apply warm compress and give TYLENOL for arm pain and to come back or call for worsening symptoms.
Age: 66.0
Sex: M
Vaccine: ANTH
Symptoms: Abnormal dreams, Insomnia, Nervousness
Clinical narrative: Nervous, jump all night time I can't sleep dreaming war time taking.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Contusion, Injection site swelling
Clinical narrative: Pt. reports bruising on (L) hand from fingers to knuckles, swelling to (L) deltoid where shot was given but no bruise to area of shot; bruising to (R) arm, shoulder and side, posterior (R) calf, denies falling or having sxs prior to getting vaccines; no tx received; says an MD she saw at a hospital while visiting a pt told her sxs were probably a result of vaccines given.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 4 days post PREVNAR, pain and erythema at injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness at site of administration (approximately 4 in in diameter) - swelling - hot to touch- itching.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Patient reported extreme redness and irritation at injection site (6 in x 3 in area) red and painful.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine site right deltoid. Treated today w/ prednisone and cephalexin.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: The night after meningococcal B vaccine stated w/fever achiness, headache, fatigue. On day #3 developed vomiting. Slowing improving today 8/26/16.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Pt. was fine after vaccines were given, but passed out and fell out the chair in clinic room and hit his head on the children's chair next to him. Unsure if the vaccine caused the fainting spell or child was very nervous knowing had to receive vaccines and fainted due to this reason? Pt. was out for approx. 30-45 sec or less. Child; pale, clammy and was given peanut butter crackers and a drink. Nurse practitioner examined the child's eyes for PERRLA and for alertness while here at the health dept. that day.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Injection site erythema, Injection site warmth, Swelling, Wheezing
Clinical narrative: Swelling, weakness, wheezing. Area where vaccine given red, hot. Advised ice, TYLENOL. If symptoms worse-ED. Per pt. also taking BENADRYL.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Abdominal pain, Infantile spitting up, Listless, Peripheral coldness, Screaming
Clinical narrative: About 2 hours after vaccines, took formulas feeding, had an episode of screaming 20-30 mins, pulled up legs, spit up, no bile, after spit up was very listless, seemed cold to touch and fell asleep. Slept a little longer than normal/out today 8/26/16. Is afebrile, alert, active, eating/sleeping well.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: About 2 hours after vaccines, took formulas feeding, had an episode of screaming 20-30 mins, pulled up legs, spit up, no bile, after spit up was very listless, seemed cold to touch and fell asleep. Slept a little longer than normal/out today 8/26/16. Is afebrile, alert, active, eating/sleeping well.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: 08/19/16-started to get red circular rash radiating in a circle around where the vaccine was administered. Itchy as well.
Age: 21.0
Sex: U
Vaccine: ANTH, MMR, TYP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: MMR administered IM rather than Sub Q. No sign/symptoms manifest.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: (L) arm pain, redness, swelling.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: 8/24/16 Received VARIVAX left upper arm. She returned to clinic on 8/26/16 to have PPD read and reported to RN that arm was sore. She has erythema 40 mm x 40 mm to left upper arm that is warm to touch. She was evaluated by provider at the Center. Provider advised cold compresses.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient states severe arm pain 3 hours after injection given ice packs/heat PERCOCET.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness 20 mins. after having the vaccine. Advil 400 mg p.o. once.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Local reaction
Clinical narrative: Provider noticed localized reaction/rash on leg where KINRIX was given. Rash did not last long. BENADRYL was given as a treatment and rash was disappearing before BENADRYL was given. No rash was present upon discharge.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Culture throat, Myalgia, Pharyngeal erythema, Pyrexia, Streptococcus test negative
Clinical narrative: Fever and muscle pain (diffuse). No swelling or redness at vaccination site.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Severe urticaria.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Severe urticaria.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccination appt 8/24/2016, DTaP #5 and IPV #4 administered. Redness and warmth with swelling shoulder to elbow, R arm.
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Concussion, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 years old female patient. The patient's medical history and concurrent conditions were not reported. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # M005714, expiry date: 03-OCT-2017) first dose in the series, (route: intramuscular) in the left arm. On the same day after receiving GARDASIL 9, the patient fainted, hit her head and sustained a concussion. The patient was taken by ambulance to the emergency room at hospital. Patient was given a "CAT Scan" while at the hospital. Patient received unspecified treatment for the event. The outcome and causality of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered VAQTA (Lot# M003011, expiration date: 15-NOV-2017, dose, frequency and route were not reported) that were improperly stored at 31.3 Fahrenheit for 124 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered M-M-R II (Lot# L036851, expiration date: 23-SEP-2017, dose, frequency and route were not reported) that were improperly stored at 31.3 Fahrenheit for 124 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was filed. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and genders. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L046319, expiry date: 28-SEP-2017) orally. The vaccine was stored at a temperature of 32 F for 15 minutes and at 31 F for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was filed. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator refers to multiple patients of unknown ages and genders. On an unknown date in 2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L034367, expiry date: 08-SEP-2017, lot #L045954, expiry date: 17-NOV-2017) (route: subcutaneous) throughout the temperature excursion beginning 06-JUL-2016 (incorrect product storage). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of ROTATEQ (lot #L035637 and expiry date 09-JUN-2016) (strength, dosing details, route, anatomical location were unknown). No adverse effects were reported. The vaccine was exposed to the temperature range of 47 degree Fahrenheit to 51 degree Fahrenheit for 1 hour and 15 minutes. The temperature exposure was detected by digital data logger. No previous temperature excursion was involved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # K007977, expiry date: 03-JUN-2016) (route: subcutaneous) (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medication were not provided. On 29-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and expiration date unknown) intramuscular. On 25-MAY-2016 and 28-JUL-2016, the patient was intramuscularly vaccinated with the second dose of GARDASIL (dose, lot# and expiration date unknown) (product use issue). No adverse event was reported. No product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to unspecified number of patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M003439, expiry date: 19-JAN-2018 and lot # M006729, expiry date: 18-FEB-2018). Nurse reported that the vaccine reached 29.92 F for 30.25 hours. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse effects were 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 nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ injection (lot # L020865, Expiration date 09-FEB-2017; lot # M012495, Expiration date 09-OCT-2017; lot # L033548, Expiration date 14-MAY-2017) (exact dose and route of administration were not reported). The administered doses experienced a temperature excursion of 46.8 degree Fahrenheit for 6 hours and 53 minutes and 33.2 degree Fahrenheit for 27 minutes. There was no previous exposures and no data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored dose of VARIVAX, lot # reported as L022868, expiration date: 27-JAN-2017 and lot # L029467, expiration date: 16-AUG-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates between 01-MAY-2016 and 22-AUG-2016 the patient were inadvertently vaccinated with improperly stored PROQUAD (rHA) (dose unknown, lot # M004892, expiration date 25-OCT-2017, subcutaneous). Not adverse effects were reported. Additional information has been requested.