chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Inflammation, Influenza like illness, Injection site cellulitis, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 47 years old female patient with asthma, anxiety, codeine allergy and doxycycline allergy. On 04-SEP-2012, the patient was vaccinated intramuscularly in the gluteus maximus, left side with lot # (672673/0492AE; expiration date 22-AUG-2013), first dose of, 0.5 ml PNEUMOVAX23. No other co-suspects were reported. Concomitant medications included influenza virus vaccine (GSK), fluticasone propionate, ADVAIR, XANAX, albuterol (manufacturer unspecified), albuterol sulfate, DUONEB, NEXIUM and ibuprofen. The nurse reported that the patient developed a cellulitis that required hospitalization following vaccination with PNEUMOVAX23. The patient had flu like symptoms, nausea, elevated temperature (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection site of the PNEUMOVAX23 with rigors and limp. The exact development of the flu like symptoms, nausea, elevated temperatures (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection of the PNEUMOVAX23 with rigors and limp was unspecified. The patient went to the office on 06-SEP-2012 and then went to the emergency room and was admitted to the hospital on 06-SEP-2012 for treatment of the cellulitis. The patient was discharged from the hospital on 09-SEP-2012, but went back to the physician office and emergency room on 11-SEP-2012 with symptoms of nausea, increased swelling, pain and tenderness at the injection site. The patient was given a computed tomography (CT) scan of the pelvis and abdomen on 11-SEP-2012 which indicated inflammation, but no abscesses or hematoma. The patient was sent to home after treatment with ZOFRAN, intravenous (IV) fluids generic (KEFLEX) and PERCOCET on 11-SEP-2012. The patient was reported to be recovered on 24-SEP-2012. The patient missed work (unspecified number of days) and could not walk right, limped. The relatedness for the events were unknown for PNEUMOVAX23. This is one report of several reports from the same source. Cellulitis, missed work and could not walk right, limped were considered to be life threatening by the registered nurse. Cellulitis was considered to be disabling by the registered nurse. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Nausea
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 47 years old female patient with asthma, anxiety, codeine allergy and doxycycline allergy. On 04-SEP-2012, the patient was vaccinated intramuscularly in the gluteus maximus, left side with lot # (672673/0492AE; expiration date 22-AUG-2013), first dose of, 0.5 ml PNEUMOVAX23. No other co-suspects were reported. Concomitant medications included influenza virus vaccine (GSK), fluticasone propionate, ADVAIR, XANAX, albuterol (manufacturer unspecified), albuterol sulfate, DUONEB, NEXIUM and ibuprofen. The nurse reported that the patient developed a cellulitis that required hospitalization following vaccination with PNEUMOVAX23. The patient had flu like symptoms, nausea, elevated temperature (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection site of the PNEUMOVAX23 with rigors and limp. The exact development of the flu like symptoms, nausea, elevated temperatures (unspecified) and a swollen, tender and painful area described as a cellulitis at the injection of the PNEUMOVAX23 with rigors and limp was unspecified. The patient went to the office on 06-SEP-2012 and then went to the emergency room and was admitted to the hospital on 06-SEP-2012 for treatment of the cellulitis. The patient was discharged from the hospital on 09-SEP-2012, but went back to the physician office and emergency room on 11-SEP-2012 with symptoms of nausea, increased swelling, pain and tenderness at the injection site. The patient was given a computed tomography (CT) scan of the pelvis and abdomen on 11-SEP-2012 which indicated inflammation, but no abscesses or hematoma. The patient was sent to home after treatment with ZOFRAN, intravenous (IV) fluids generic (KEFLEX) and PERCOCET on 11-SEP-2012. The patient was reported to be recovered on 24-SEP-2012. The patient missed work (unspecified number of days) and could not walk right, limped. The relatedness for the events were unknown for PNEUMOVAX23. This is one report of several reports from the same source. Cellulitis, missed work and could not walk right, limped were considered to be life threatening by the registered nurse. Cellulitis was considered to be disabling by the registered nurse. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Injection site rash, Musculoskeletal stiffness, Nausea
Clinical narrative: The next day patient had rash on site. Rash got worse. On 12/11/12 had rash from elbow to shoulder. N/V, neck stiff, fever, chills all symptoms pt. has with shingles. Pt. has history of 10-11 shingles outbreaks per year even while on VALTREX. Pt. followed protocol for having shot while on VALTREX.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: The next day patient had rash on site. Rash got worse. On 12/11/12 had rash from elbow to shoulder. N/V, neck stiff, fever, chills all symptoms pt. has with shingles. Pt. has history of 10-11 shingles outbreaks per year even while on VALTREX. Pt. followed protocol for having shot while on VALTREX.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Flu vaccination administered in Rotator Cuff, For the last 2 months increased pain, weakness and decreased mobility.
Age: 0.28
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Immediate post-injection reaction, Irritability, Pyrexia
Clinical narrative: Unusual and persistent fussiness and crying (immediately following vaccine), fevers ranging from 100.8 F to 101.4 F (day of and following vaccine).
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site that went from the size of a half dollar to the size of a large orange. Site is hard in the center, approx size of golf ball, with a large amount of redness and swelling around the site and is painful and tender to touch.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: First, intense soreness in entire arm that received injection. Then developed fever (102.5 degrees on 11/22) with general body aches, difficulty breathing, and headache. Dr. prescribed Vicodin on 11/23, which helped with body aches and fever, but not headache, which was non-stop and at a pain level of 9/10. After 5 days of pain, my doctor admitted me to the hospital (11/26-27) for 36 hours to get Dilaudid for the headache pain. After I was released, I had reoccurring headaches for about 2 weeks.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: First, intense soreness in entire arm that received injection. Then developed fever (102.5 degrees on 11/22) with general body aches, difficulty breathing, and headache. Dr. prescribed Vicodin on 11/23, which helped with body aches and fever, but not headache, which was non-stop and at a pain level of 9/10. After 5 days of pain, my doctor admitted me to the hospital (11/26-27) for 36 hours to get Dilaudid for the headache pain. After I was released, I had reoccurring headaches for about 2 weeks.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling with warmth on Left arm.  Hard and raised at the site.  No fever.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus generalised
Clinical narrative: Itching that started in the area of the injection and then itching all over. No rashes, no fever. No other associated symptoms. Given Benadryl with some relief.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Depression, Dysgeusia, Fatigue, Headache
Clinical narrative: Swelling/pain at site of injection. Funny taste in mouth.  Nausea, fatigue, feverish, headache, and depressed went home sick and was sick the next day-12/18/2012.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Malaise, Nausea, Pyrexia
Clinical narrative: Swelling/pain at site of injection. Funny taste in mouth.  Nausea, fatigue, feverish, headache, and depressed went home sick and was sick the next day-12/18/2012.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Fatigue, Influenza virus test negative, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Sore throat, swollen glands, body aches, extreme fatigue, temp 100.9.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Streptococcus test negative
Clinical narrative: Sore throat, swollen glands, body aches, extreme fatigue, temp 100.9.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bilevel positive airway pressure, Cough, Dyspnoea, Intensive care, Paraesthesia
Clinical narrative: This hospital employee received a dose of flu vaccine.  She then presented to our ED with shortness of breath, tingling, coughing, and difficulty breathing.  She received steroids and epi x2 doses.  She was transferred to an adult hospital ICU and placed on BIPAP.     PMH: asthma
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bilevel positive airway pressure, Guillain-Barre syndrome
Clinical narrative: This hospital employee received a dose of flu vaccine.  She then presented to our ED with shortness of breath, tingling, coughing, and difficulty breathing.  She received steroids and epi x2 doses.  She was transferred to an adult hospital ICU and placed on BIPAP.     PMH: asthma
Age: 44.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Throat scratchy, fatigue, redness around site, 101 degrees F fever, congestion, soreness at vaccine site.
Age: 44.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Throat irritation
Clinical narrative: Throat scratchy, fatigue, redness around site, 101 degrees F fever, congestion, soreness at vaccine site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Administered (L) arm IM deltoid - injection site swelled up within 5 second to size of 1 inch x 3 inch raised by 1/2 inch monitored for 15 minutes with no worsening symptoms. MD notified - ok with pt self monitoring; call if worse.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Tinnitus - both ears.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt had redness, swelling below site, fever, and was treated with antibiotic.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: Flu shot 11/29. On 12/8/12 - numbness in toes/feet/legs. Decrease leg strength by 12/2 & numbness in hands. Decreased reflexes. Saw primary care dr 12/12/12. Transferred to medical center on 12/14/12. Test on spinal fluid 12/18/12 (+) for Guillain Barre -> IV.IG started.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy
Clinical narrative: Flu shot 11/29. On 12/8/12 - numbness in toes/feet/legs. Decrease leg strength by 12/2 & numbness in hands. Decreased reflexes. Saw primary care dr 12/12/12. Transferred to medical center on 12/14/12. Test on spinal fluid 12/18/12 (+) for Guillain Barre -> IV.IG started.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster (L) leg.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cardiac arrest, Convulsion, Headache, Hepatic enzyme increased, Hypersensitivity
Clinical narrative: This medically confirmed report (initial receipt 04-Dec-2012) concerns a 20-year-old-female patient. On an unspecified date the patient received influenza vaccine (manufacturer and batch no. not specified) and PNEUMOVAX 23. On 24-Oct-2012, she experienced a bad allergic reaction which resulted in hospitalisation. The patient's heart stopped. She experienced seizures, headaches and had elevated liver enzymes. She remained in hospital for 9 days. The patient requested compensation for her medical expenses. The outcome for the event was not recovered.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Patient is complaining of lower back pain starting left side & spreading after receiving vaccine. Pt has seen chiropractor & found no relief.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Developed a rash, hives and difficulty breathing.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, warmth and edema entire upper arm of injection.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Exercise tolerance decreased, Troponin I increased
Clinical narrative: Patient developed chest pain at rest that was worse while supine and exercise intolerance.  He developed troponin elevation and ST elevations on EKG, but had no effusion or wall motion abnormalities on echocardiogram.  He was treated with activity restriction, colchicine and indomethacin.  Troponins quickly trended downwards and he was discharged to home with activity restrictions and follow-up.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLUN3, HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Gaze palsy, Wheezing
Clinical narrative: Mother states child had a seizure that lasted about 2 minutes.  Pt seen in ER after this happened.  Mother states that child had never had any other previous seizure activity.  Mother states that since the seizure the child's eyes roll back in her head and she has had some wheezing episodes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin infection
Clinical narrative: Patient contracted a skin infection at the injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Dizziness, Erythema, Feeling hot, Headache
Clinical narrative: Soreness, redness and pain in arm around and below injection site. Got worse as evening went on. Up and down all night between pain and urination several times. 12/15 arm swollen and pain increased, cold compress and ibuprofen and rest. Arm swelled more and to elbow. 12/15 PM felt little better, still pain and stiffness. 12/16 continued cold compress, ibuprofen and rest. 12/17 arm still red and swollen and moved below elbow. Called Dr and he prescribed methylprednisolone. Upset stomach, light headed, flu like symptons, mild headache, cheeks blood red hot. 12/18 called Dr waiting for c/b.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Nocturia
Clinical narrative: Soreness, redness and pain in arm around and below injection site. Got worse as evening went on. Up and down all night between pain and urination several times. 12/15 arm swollen and pain increased, cold compress and ibuprofen and rest. Arm swelled more and to elbow. 12/15 PM felt little better, still pain and stiffness. 12/16 continued cold compress, ibuprofen and rest. 12/17 arm still red and swollen and moved below elbow. Called Dr and he prescribed methylprednisolone. Upset stomach, light headed, flu like symptons, mild headache, cheeks blood red hot. 12/18 called Dr waiting for c/b.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Soreness, redness and pain in arm around and below injection site. Got worse as evening went on. Up and down all night between pain and urination several times. 12/15 arm swollen and pain increased, cold compress and ibuprofen and rest. Arm swelled more and to elbow. 12/15 PM felt little better, still pain and stiffness. 12/16 continued cold compress, ibuprofen and rest. 12/17 arm still red and swollen and moved below elbow. Called Dr and he prescribed methylprednisolone. Upset stomach, light headed, flu like symptons, mild headache, cheeks blood red hot. 12/18 called Dr waiting for c/b.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had injection site reaction. MD states size of an orange and raised. Patient told nurse it was hot and itchy.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Blood creatine phosphokinase normal, C-reactive protein increased, Gait disturbance
Clinical narrative: Patient developed hip and shoulder pain three days after vaccination which gradually worsened.  She had weakness to the point of difficulty walking.  Was seen in the ED on 11/18, ESR 32 and was diagnosed with myofascial pain. Was seen in office 12/4 with suspicion for polymyalgia rheumatica.  ESR at that time was 54 and CRP 7.8 with normal CPK.  Started on prednisone 15mg daily with complete resolution in her symptoms by follow up visit 12/19.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myofascial pain syndrome, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed hip and shoulder pain three days after vaccination which gradually worsened.  She had weakness to the point of difficulty walking.  Was seen in the ED on 11/18, ESR 32 and was diagnosed with myofascial pain. Was seen in office 12/4 with suspicion for polymyalgia rheumatica.  ESR at that time was 54 and CRP 7.8 with normal CPK.  Started on prednisone 15mg daily with complete resolution in her symptoms by follow up visit 12/19.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Rash pruritic
Clinical narrative: ITCHY RASH ON ABDOMEN AND BACK SEVERAL HOURS AFTER VACCINE WAS ADMINISTERED.  THIS WAS TREATED WITH BENADRYL AND HAS REMAINED LOCALIZED AND IS CLEARING.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Crying, Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: FEVER AND CRYING UNCONTROLLABLY AND WALKING WITH A LIMP. WITHIN AN HOUR (ABOUT 9PM) WOULD NOT WALK AT ALL AND OR MOVE HIS LEG.  HAS BEEN A FEW DAYS AND IS STILL NOT WALKING WITH A LIMP AND GETTING FEVERS. HAVING TO ALTERNATE WITH MOTRIN AND TYLENOL TO KEEP FEVER DOWN AND PAIN AWAY SO THAT HE CAN FEEL COMFORTABLE, BUT STILL CRIES AND COMPLAINS FOR LEG PAIN WITH A LIMP.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reports pain 8 out of 10 in both shoulders.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Rash
Clinical narrative: Pt had rash and bruising to extremities.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Patient reported labored breathing and wheezing requiring a visit to the emergency department.
Age: 0.17
Sex: F
Vaccine: 6VAX-F
Symptoms: Abdominal pain, Crying, Disturbance in attention, Psychomotor hyperactivity, Restlessness
Clinical narrative: High pitched screaming or persistent crying for hours x 3 plus days.---  Took to Dr. office on Sat after vaccinations et was told it was probably colic!! Extreme sleepiness; Restlessness, hyperactivity or inability to concentrate; Sleep disturbances that change wake/sleep pattern.
Age: 0.17
Sex: F
Vaccine: 6VAX-F
Symptoms: Screaming, Sleep disorder, Somnolence
Clinical narrative: High pitched screaming or persistent crying for hours x 3 plus days.---  Took to Dr. office on Sat after vaccinations et was told it was probably colic!! Extreme sleepiness; Restlessness, hyperactivity or inability to concentrate; Sleep disturbances that change wake/sleep pattern.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PT DEVELOPED SWELLING, REDNESS, TENDERNESS, AND FEVER ON/AROUND SITE OF INJECTION ON RIGHT ARM. AREA MEASURED AROUND 50 MM IN LENGTH. REACTION WAS ON SQ AREA OF RIGHT ARM.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: My arm became very hot, red, hard at the injection site and swollen.  On Monday, 12-17-2012 I went back to the doctors office.  I was given an antibiotic 0 CEPHALEXIN 500mg Sub for Keflex 500mg.  I also started using ice packs on the injection site.  As of Wednesday 12/19/2012 some of the redness has gone away, it's more pink than red but the swelling is still there.  It is also painful to touch and there are some fabrics I am unable to wear at the present time because they hurt the site.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with penicillin allergy, asthma, sinus congestion, sinus infection and hypothyroidism. The patient was vaccinated intramuscularly in the gluteus maximus, with a first dose of 0.5 ml of PNEUMOVAX23 (lot number reported as H016283, exp date 21-FEB-2014) on 07-DEC-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR, albuterol for nebulization, VENTOLIN, FLONASE, ZYRTEC, levothyroxine sodium and PRISTIQ. The nurse reported that a patient developed an injection site reaction described as a cellulitis following vaccination with PNEUMOVAX23 in December 2012. The injection site reaction was described as a swollen, tender, erythematous 5 by 3 inch area at the injection site. The exact development of the swollen, tender, erythematous 5 by 3 inch area at the injection site was unspecified, but the patient contacted the office on 10-DEC-2012. While at the office on 10-DEC-2012 the nurse noted that the patient had a slight limp from the swelling and cellulitis. The patient was given KEFLEX as treatment for the event. The patient also reported that she suffered from muscle cramps in her right knee, hip and buttock region and she also experienced nausea. No lab diagnostic tests were performed. The nurse asked for a lot check. The outcome of the event was unknown. The relatedness for developed an injection site reaction described as a cellulitis following vaccination was not provided for PNEUMOVAX23. The reporting nurse considered the event to be disabling, since the patient could not walk right and limped; she also considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with penicillin allergy, asthma, sinus congestion, sinus infection and hypothyroidism. The patient was vaccinated intramuscularly in the gluteus maximus, with a first dose of 0.5 ml of PNEUMOVAX23 (lot number reported as H016283, exp date 21-FEB-2014) on 07-DEC-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR, albuterol for nebulization, VENTOLIN, FLONASE, ZYRTEC, levothyroxine sodium and PRISTIQ. The nurse reported that a patient developed an injection site reaction described as a cellulitis following vaccination with PNEUMOVAX23 in December 2012. The injection site reaction was described as a swollen, tender, erythematous 5 by 3 inch area at the injection site. The exact development of the swollen, tender, erythematous 5 by 3 inch area at the injection site was unspecified, but the patient contacted the office on 10-DEC-2012. While at the office on 10-DEC-2012 the nurse noted that the patient had a slight limp from the swelling and cellulitis. The patient was given KEFLEX as treatment for the event. The patient also reported that she suffered from muscle cramps in her right knee, hip and buttock region and she also experienced nausea. No lab diagnostic tests were performed. The nurse asked for a lot check. The outcome of the event was unknown. The relatedness for developed an injection site reaction described as a cellulitis following vaccination was not provided for PNEUMOVAX23. The reporting nurse considered the event to be disabling, since the patient could not walk right and limped; she also considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Local reaction, Skin warm, Swelling
Clinical narrative: Thurs noticed large localized reaction, heat, swelling larger than silver dollar, Friday symptoms then intensified, saw dr on Saturday, he prescribed antibiotic which patient started, cellulitis diagnosed.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Incorrect storage of drug
Clinical narrative: Nov 29/12 = patient took 1st dose Nov 31/12 = patient took 2nd dose} unrefriger Dec 3/12 = Patient took 1st dose 2nd pack. Same day had stomach cramps.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient was given flu shot in waiting area of pharmacy and fainted. The paramedics were called, and she was transported to the hospital.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Blood glucose decreased, Facial bones fracture, Fall, Laceration
Clinical narrative: Pt received Hepatitis A & Human Papilloma Virus & flu. Remained seated for 10 min after receiving shots. Then went to bathroom fell & fractured chin & sustained a laceration to chin as well.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Pain
Clinical narrative: Soreness at injection site. Swelling at injection site. Pain on lifting shoulder, seating or sleeping.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient developed redness and tenderness at site of injection. Area grew up a 6" x 3" hard bump. Was treated with hydrocortisone and BENADRYL creams and the area cleared up over 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness (L) thigh from knee to groin and 10 cm wide.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Pt presented with urticarial rash and itching centered primary around site of injection and spreading outward from there. Administered BENADRYL and observed until 1 hour had passed after time of vaccine - urticaria & itching were better.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Oedema, Skin tightness, Skin warm
Clinical narrative: Approx. 10 hours after vacc. given c/o discomfort, redness, & swelling just below injection site on (L) arm; area continued to increase with edema until "all loose skin was tight"; c/o area hot to touch. Much improved after 3 days. (PNEUMOVAX given in left arm).
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Approx. 10 hours after vacc. given c/o discomfort, redness, & swelling just below injection site on (L) arm; area continued to increase with edema until "all loose skin was tight"; c/o area hot to touch. Much improved after 3 days. (PNEUMOVAX given in left arm).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Depressed level of consciousness, Hyporesponsive to stimuli, Lethargy, Pallor
Clinical narrative: Excessive crying at time of event until subsequent lethargy and poor responsiveness. Hard to arouse for about 30 minutes after injection. Pale.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Rash macular, Rash pruritic, Skin discolouration
Clinical narrative: Red, itching blotches entire trunk of body with raised bumps, flesh colored, possible fever, never checked temp.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Bursitis, Drug administered at inappropriate site, Mobility decreased
Clinical narrative: This patient received the DTAP vaccination the day of discharge from the postpartum unit at the clinic on 23 Aug '12. She reports the injection was given high near the right shoulder. She reports that the next day her right arm was sore and 'hurt to move it in any direction'. She denied flu -like or other associated symptoms. 3-4 days after vaccination the pain worsened which necessitated using the left arm for most activities. Systemic symptoms: Currently the pain is constant and severe, partially controlled by ibuprofen 800mg tid which she had been taking for 2 weeks. She states she is unable to lift the arm above the shoulder, is tender to palpation and feels weak. The pain awakens her out of sleep, and she is unable to put pressure on the arm to push self up. Sometimes the pain shoots down the arm to the fingertips and there is pain when she moves the right wrist. She reports there is no visible swelling or redness, no axillary tenderness, no chest wall pain. Diagnosed with adhesive capsulitis by orthopedics. No steroid injection given due to breastfeeding newborn. Undergoing Physical Therapy.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Periarthritis, Postpartum state, Tenderness
Clinical narrative: This patient received the DTAP vaccination the day of discharge from the postpartum unit at the clinic on 23 Aug '12. She reports the injection was given high near the right shoulder. She reports that the next day her right arm was sore and 'hurt to move it in any direction'. She denied flu -like or other associated symptoms. 3-4 days after vaccination the pain worsened which necessitated using the left arm for most activities. Systemic symptoms: Currently the pain is constant and severe, partially controlled by ibuprofen 800mg tid which she had been taking for 2 weeks. She states she is unable to lift the arm above the shoulder, is tender to palpation and feels weak. The pain awakens her out of sleep, and she is unable to put pressure on the arm to push self up. Sometimes the pain shoots down the arm to the fingertips and there is pain when she moves the right wrist. She reports there is no visible swelling or redness, no axillary tenderness, no chest wall pain. Diagnosed with adhesive capsulitis by orthopedics. No steroid injection given due to breastfeeding newborn. Undergoing Physical Therapy.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Tendonitis, X-ray limb abnormal
Clinical narrative: This patient received the DTAP vaccination the day of discharge from the postpartum unit at the clinic on 23 Aug '12. She reports the injection was given high near the right shoulder. She reports that the next day her right arm was sore and 'hurt to move it in any direction'. She denied flu -like or other associated symptoms. 3-4 days after vaccination the pain worsened which necessitated using the left arm for most activities. Systemic symptoms: Currently the pain is constant and severe, partially controlled by ibuprofen 800mg tid which she had been taking for 2 weeks. She states she is unable to lift the arm above the shoulder, is tender to palpation and feels weak. The pain awakens her out of sleep, and she is unable to put pressure on the arm to push self up. Sometimes the pain shoots down the arm to the fingertips and there is pain when she moves the right wrist. She reports there is no visible swelling or redness, no axillary tenderness, no chest wall pain. Diagnosed with adhesive capsulitis by orthopedics. No steroid injection given due to breastfeeding newborn. Undergoing Physical Therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: 75 cm-90 cm swelling - hot to touch and firm. Pt adv to treat with BENADRYL & cold compresses adv to watch for fever, streaking or growing area.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient reported red mark - 2 inch that was warm to the touch and swollen 2 days after administration. No trouble breathing no itching.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Pt got very dizzy & pale. Father escorted son to restroom where pt vomited.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Pt. developed swelling and redness at the site of the injection, within 2-3 hrs of the vaccine adm. The redness and swelling and local warmth progressed over the next 48 hrs.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Loose tooth, Loss of consciousness, Mouth injury, Tooth fracture
Clinical narrative: Patient received vaccination. Sit for a couple of minutes. He stood for a while he passed out and hit floor with mouth. Mom took him to dentist. Had a fractured tooth and one loose tooth from fall.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis 1 week after receiving injection.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Oedema peripheral, Vomiting
Clinical narrative: Patient reported slight arm swelling, sweat/chills, headache, & vomiting night after receiving FLUZONE vaccine & said was feeling better in the morning.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster of upper arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Vaccine administered 11/27/12 started to feel ill 11/28 with fever T 100, chills, HA. Seemed to subside 11/29 however achy joints especially knees. Advised to try Ibuprofen.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling cold, Nausea, Rash macular
Clinical narrative: Arm blotchy all way down to elbow; still present got really cold and sat down in hot tub, felt weak and nauseated. Could hardly raise head due to dizziness, and nausea.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Chills, Dizziness, Dysarthria
Clinical narrative: 8:30 pm. Dizziness, HA, chest pain, chills, labored breathing. 10 pm. Went to ER - lips swollen, slurred speech, increased HR & CP. No treatment given, just monitored.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Heart rate increased, Lip swelling
Clinical narrative: 8:30 pm. Dizziness, HA, chest pain, chills, labored breathing. 10 pm. Went to ER - lips swollen, slurred speech, increased HR & CP. No treatment given, just monitored.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: At 3PM on 12-17-12 patient had fever (103 degrees), chills, & cough. Fever has gone but cough remains.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Patient experienced swelling, hotness in upper arm, tightness from swelling. Advised to get antihistamine.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a few of patients. Specific number of patients was unspecified. The patients was vaccinated with VARIVAX (Merck) (lot number not provided) on an unknown date. No other co-suspects were reported. NO concomitant medications were reported. On an unknown date the patients broke out rash after VARIVAX (Merck) was given. The outcome of adverse event was unknown. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Pruritus, Rash generalised, Rubella antibody negative
Clinical narrative: Information has been received from a registered nurse refers to a current 48 years old female patient with no pertinent medical history. It was reported that the patient who was a nurse came down with rash after receiving M-M-R II(lot number reported as H012142, expiration date 29-JUL-2014) on 28-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient received M-M-R II as a child vaccine however, her titer was negative for rubella and therefore, patient had to receive another dose. On 10-DEC-2012, patient started developing rash all over her body. Rashes were described as little raised and a few spots were clustered together on different parts of her body but on patient's chest, rash looked more generalized. The patient also complained of itching around rash. No treatment was given for adverse event. No diagnostics studies were performed. The patient had sought medical attention via office visit. The outcome of adverse event was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a female patient of unknown age. On 01-DEC-2012 the patient was vaccinated with ZOSTAVAX vial for vaccination (form, dose, frequency and route unknown). No other co-suspects were reported. No concomitant medications were reported. The pharmacy student reported that a patient developed shingles a few days after receiving ZOSTAVAX (exact date unspecified). At the time of report the outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Penile erythema, Penile pain
Clinical narrative: This spontaneous report was received from a 69 years old male patient with high blood pressure and high cholesterol. On 10-DEC-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient explained that he had developed pain and red ring around the head of his penis after having ZOSTAVAX. He was unsure if this was a shingles outbreak of the penis. The reaction began a couple of days ago approximately on 12-DEC-2012. No treatment information was reported. No lab diagnostics studies information was reported. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a 59 years old female patient with aspirin allergy. The patient's medical history included shingles last year. One month ago in November 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient explained that since having ZOSTAVAX about 3 months ago in September 2012, she had developed a rash all over her body. She explained that the rash comes and goes and that she was fine before having this vaccine and at the time of the phone call it was getting worse. The patient was treated with prednisone (manufacturer unknown), topical creams, ALLEGRA, and BENADRYL had been unsuccessful at treating this event. The relatedness for the event was unknown for ZOSTAVAX. It was schedule a blood work. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 89 years old female patient. The patient's medical history included cancer survivor of 2 years. The patient was vaccinated with subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H016765; exp date 12-OCT-2013) on 13-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that for the first 15 minutes after the administration of the dose, her injection site was itching and red. The pharmacist who administered the dose documented that the site was raised and red in a quarter sized perimeter. On 14-DEC-2012 the patient reported to the pharmacist that the injection site was "no longer raised, but it was light pink." No treatment information was reported. The outcome of injection site was itching and red was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. The patient was vaccinated with lot # (671609/1165AA) Exp. date: 19-OCT-2012 ZOSTAVAX (dose and route not reported) on 17-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient received an expired dose of ZOSTAVAX. No adverse effect reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a other health professional (Ph.D)refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX(lot number, expiry date, dose and route was not reported). No concomitant medications were reported. On an unknown date, the patient who never had chicken pox developed shingles after receiving (Merck) VARIVAX. Varicella Zoster Virus (VZV) test done on an unknown date showed positive for shingles. The patient sought medical attention (saw the physician) and the treatment information was unspecified. The outcome of shingles was unknown. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Joint effusion, Joint swelling, Pain
Clinical narrative: This spontaneous report as received from a health care worker refers to an 84 year old female patient. The patient was allergic to FLAGYL, BACTRIM, erythromycin, MACROBID and PEN-VEEK. On 04-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23(lot number reported as H0110916, expiry date 14-feb-2015, route and dose were not reported). On 05-DEC-2012, the patient experienced swelling and intense pain. On 06-DEC-2012, the patients family member called and reported that the patient was feeling tired and weak and the swelling had moved down to anterior and posterior area around elbow, well below injection site and also reported a large pocket of fluid behind elbow. The patient had received PNEUMOVAX23(lot#, expiry not reported) back on an unspecified date in 2000. The patient sought medical attention (called office).Patient was treated with prednisone. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to an 84 year old female patient. The patient was allergic to FLAGYL, BACTRIM, erythromycin, MACROBID and PEN-VEEK. On 04-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23(lot number reported as H0110916, expiry date 14-feb-2015, route and dose were not reported). On 05-DEC-2012, the patient experienced swelling and intense pain. On 06-DEC-2012, the patients family member called and reported that the patient was feeling tired and weak and the swelling had moved down to anterior and posterior area around elbow, well below injection site and also reported a large pocket of fluid behind elbow. The patient had received PNEUMOVAX23(lot#, expiry not reported) back on an unspecified date in 2000. The patient sought medical attention (called office).Patient was treated with prednisone. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 89 years old female patient. The patient's medical history included cancer survivor of 2 years. The patient was vaccinated with subcutaneously with 0.65 ml dose of ZOSTAVAX (lot # H016765; exp date 12-OCT-2013) on 13-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that immediately after injection, the patient reported burning at the injection site and an area of redness and induration that measured about the size of a quarter. On 14-DEC-2012, the patient stated that her injection site was much improved. No treatment information was reported. The relatedness for the reported events was not provided for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 13 year old patient of unknown gender. On 10-DEC-2012, the patient was vaccinated with an adult dose of 1 milliliter (ml) VAQTA (lot number and expiry date unspecified) intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age. The patient has drug allergies with sulfamethoxazole, BACTRIM, acetaminophen, DARVOCET-N and sulfa drugs. The patient's medical history included history of herpes simplex. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date was not reported and route subcutaneous). No concomitant medications were reported. On 10-DEC-2012, the patient breakout of a cold sore after receiving ZOSTAVAX. The patient was prescribed antivirals for the cold sores however she was advised by her unspecified health care professional not to take the antiviral medication since she was just administered the ZOSTAVAX on 27-NOV-2012. The outcome of the event was unknown. It was unspecified if patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a licensed Nurse practitioner refers to a 22 years old (currently 26 years old) female patient. The patient was vaccinated with a first, second dose of, third and fourth dose respectively of VARIVAX (Merck) (dose, route of administration and anatomical location were not reported) on 11-JUN-1987, 13-MAR-1991, 12-AUG-2008 (lot no 1521V, exp. date 19-SEP-2009) and 20-SEP-2012 (lot number [H011553]) is an invalid lot number for VARIVAX (Merck), exp date 11-JUN-2014). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that her daughter received 4 doses VARIVAX (Merck) because her titers were negative. The patient had titers drawn in 2008 and in 2012. No treatment information was reported. the outcome of titers were negative is unknown. The relatedness for titers were negative is unknown for VARIVAX (Merck). Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 17 year old patient of unknown gender. On 10-DEC-2012, the patient was vaccinated with an adult dose of 1 milliliter (ml) VAQTA (lot number and expiry date unspecified) intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.