chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 03-DEC-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47 Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010204, 1312USA0210205, 1312USA010207 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 05-DEC-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010204, 1312USA010205, 1312USA010206 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to 2 patients who on 21-NOV-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010205, 1312USA010206, 1312USA010207 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown age and gender. On 19-DEC-2013 the patients were vaccinated with a doses of PNEUMOVAX23 (lot # J010396, exp.date: 16-FEB-2015) (reported as 06-FEB-2015), 0.5 ml, intramuscularly), that were opened and left at 70F for 5 hours. No adverse reactions were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: 6VAX-F, HPV4, MEN
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a medical assistant via company representative refers to approximately 11 year old female patient. On 07-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # and dosage regimen unknown), meningococcal vaccine (unspecified) (lot # and dosage regimen unknown) and HEXAVAC (also reported as tdap) (manufacturer unknown) (lot # and dosage regimen unknown). On 07-NOV-2013, a few hours after administration of the vaccines the patient developed rash on her chest. Reportedly the rash resolved after 1 week (approximately 14-NOV-2013). Reporter's causality was not provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a 55 year old female patient. Medical assistant wanted to administer an MMR II on 06-DEC-2013 to the 55 year old unspecified adult female patient however it was unknown if the patient had ever received MMR II in her past and physician was not going to draw titers. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. It was reported that a 1 month old patient was inadvertently administered a dose of VAQTA, 0.5 ml, intramuscular on an unspecified date, instead of the intended RECOMBIVAX. No adverse effects reported. Outcome of medication error was unknown. Causality was assessed as not related. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dose was not reported). After receiving GARDASIL injection, the patient felt faint and dizzy when walking to her car on an unknown date. She was walked back into the office where it was confirmed by HCP (health care professional) that the situation was "not an asthma attack". The outcome of the felt faint and dizzy was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Impaired gastric emptying
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, route, lot# and expiration date unknown). On an unknown date the patient developed gastroparesis after receiving GARDASIL. The outcome of gastroparesis was unknown. This patient was not seen by the physical but by another unspecified pediatrician who in turn talked to the physician. In addition, the patient's mother started a blog, which had "multiple pediatricians commenting". Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pyrexia
Clinical narrative: Fever 100 degrees - 103 degrees started immediately.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date a week after the administration of GARDASIL the patient experienced red erythema a little bigger than a size of quarter that was  hard and warm to touch at the site of the injection. The outcome of red erythema a little bigger than a size of quarter that was hard and warm to touch at the site of the injection and red erythema a little bigger than a size of quarter that was hard and warm to touch at the site of injection was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-DEC-2013 the patient was vaccinated with expired GARDASIL lot # H016960, .5 ml, intramuscular. No adverse effect was reported. The outcome of expired vaccine administered and no adverse effect is unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender (also reported as who were a couple). On an unknown date reporter was informed about two patients were vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). On an unknown date the patients experienced shingles. The outcome of shingles was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant/healthcare worker refers to a 14 year old female patient. On 16-SEP-2013 the patient was vaccinated with first dose of GARDASIL. On 18-NOV-2013, the second dose was administered and third dose on 16-DEC-2013. No adverse effect was reported. The outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: Patient stated she had lymph node swelling in armpit, neck, groin, also significant red, hot spot below shot site, said she can no longer feel bumps (lymph nodes today).
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Local swelling
Clinical narrative: 12/23/2013 Mild. Localized swelling and continued headache.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus. Prednisone.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bursa removal, Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: This 55 year old patient reported receipt of annual influenza vaccination (CSL lot # P59007) on 10/14/2012 to upper posterior left deltoid. He stated he was standing when the shot was given and thought the shot was given further back and higher than past vaccinations. He did not receive any other vaccines and returned to (administrative duties). Later that evening his left shoulder was sore and he took ALEVE for the discomfort. This 6-7/10 dull sore ache persisted over the next week with increasing difficulty lifting his left arm overhead without any other adverse reaction reported (headache, fever, chills, malaise, et al). He denied any redness, swelling or discoloration to vaccine injection site, no recent travel, trauma or injury to left arm/shoulder/neck, and was not lifting at work or home. He had no numbness, tingling or loss of sensation to left arm/fingers and his grip was intact but pain did affect weight of objects picked up and had difficulty putting on his coat. He returned to work first weekend of November (11/2-3/2012) and his command sent him to medical to evaluate this ongoing shoulder pain. Over the next year (11/2012-11/2013) he was seen by Orthopedic providers and treated with oral NSAIDs, steroid injections to left shoulder and physical therapy with temporary relief of pain but no reported improvement in overhead ROM. An MRI completed on 1/31/2013 noted mild supraspinatus impingement with partial tearing of the supraspinatus tendon. Plain film X-ray of left shoulder showed no acute osseous abnormality with minimal degenerative changes to the superolateral aspect of the humeral head and degenerative changes of the AC joint. On 11/18/2013 he had surgery to his left shoulder with providers documenting fraying of superior labrum and full thickness tear of mid-portion of supraspinatus tendon which was repaired including a complete subacromial bursectomy where a rotator cuff tear was visualized and repaired. On 11/22/2013 he contacted the Vaccine Healthcare Center for a causality assessment. He advised he received his 2013 influenza vaccination (SK lot #79GHS) to his right arm by his PCP on 11/4/2013 with no adverse reactions.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Shoulder operation, Tendon injury, X-ray limb abnormal
Clinical narrative: This 55 year old patient reported receipt of annual influenza vaccination (CSL lot # P59007) on 10/14/2012 to upper posterior left deltoid. He stated he was standing when the shot was given and thought the shot was given further back and higher than past vaccinations. He did not receive any other vaccines and returned to (administrative duties). Later that evening his left shoulder was sore and he took ALEVE for the discomfort. This 6-7/10 dull sore ache persisted over the next week with increasing difficulty lifting his left arm overhead without any other adverse reaction reported (headache, fever, chills, malaise, et al). He denied any redness, swelling or discoloration to vaccine injection site, no recent travel, trauma or injury to left arm/shoulder/neck, and was not lifting at work or home. He had no numbness, tingling or loss of sensation to left arm/fingers and his grip was intact but pain did affect weight of objects picked up and had difficulty putting on his coat. He returned to work first weekend of November (11/2-3/2012) and his command sent him to medical to evaluate this ongoing shoulder pain. Over the next year (11/2012-11/2013) he was seen by Orthopedic providers and treated with oral NSAIDs, steroid injections to left shoulder and physical therapy with temporary relief of pain but no reported improvement in overhead ROM. An MRI completed on 1/31/2013 noted mild supraspinatus impingement with partial tearing of the supraspinatus tendon. Plain film X-ray of left shoulder showed no acute osseous abnormality with minimal degenerative changes to the superolateral aspect of the humeral head and degenerative changes of the AC joint. On 11/18/2013 he had surgery to his left shoulder with providers documenting fraying of superior labrum and full thickness tear of mid-portion of supraspinatus tendon which was repaired including a complete subacromial bursectomy where a rotator cuff tear was visualized and repaired. On 11/22/2013 he contacted the Vaccine Healthcare Center for a causality assessment. He advised he received his 2013 influenza vaccination (SK lot #79GHS) to his right arm by his PCP on 11/4/2013 with no adverse reactions.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: 12/12/13 patient appeared with swollen upper arm area, erythema. We followed up 12/15/13 pt said entire trunk region was covered in rash. Patient said will make physician appointment.
Age: 1.58
Sex: F
Vaccine: MMR
Symptoms: Constipation, Muscle strain, Screaming
Clinical narrative: Constipation, daughter was screaming and straining to move her bowels for at least twenty minutes several times over the weekend.
Age: 4.0
Sex: M
Vaccine: RAB
Symptoms: Electroencephalogram normal, Petit mal epilepsy
Clinical narrative: Pt. with several episodes of absent-like seizures lasting 15-30 sec; pt. just this day received Dose#3 (Day#7) of 4 part series for possible exposure to rabid dog (initial testing on head showed positive for rabies but tested by CDC as negative (19Dec13).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Electrocardiogram ambulatory, Electrocardiogram normal, Heart rate increased, Palpitations
Clinical narrative: Began to have heart palpitations.  Heavy heart beat.  Fast pulse.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Began to have heart palpitations.  Heavy heart beat.  Fast pulse.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Muscle spasms, Musculoskeletal stiffness, Neck pain, Nuclear magnetic resonance imaging brain
Clinical narrative: Severe neck pain and headache. Stiffness of neck and muscle spasm. Lasted two weeks before becoming more tolerable.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging spinal
Clinical narrative: Severe neck pain and headache. Stiffness of neck and muscle spasm. Lasted two weeks before becoming more tolerable.
Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Breakout in hives on thighs, back, groin, and back of arms.
Age: 6.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Pneumonia
Clinical narrative: Rigth thigh area with 3cm x 3cm area of erythema, tender to touch. No treatment given. Patient was readmitted with pneumonia and erythema to injection site noted.  Patient then transferred to tertiary care center for further treatment and diagnosis of pneumonia.  Unable to determine if patient would have been hospitalized just for reaction to vaccine.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Bladder catheterisation, Chills, Dysuria, Laboratory test, Micturition disorder
Clinical narrative: 11-3-13 high temp chills for days which caused a urinary problem and emergency ER 11-8-13 catheter had to be put in (11-14-13) hospitalized 11-14 - 11-16-2013 continue now with a urologist 11-19 to present, now not able to urinate like he should - more doctoring ahead.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 11-3-13 high temp chills for days which caused a urinary problem and emergency ER 11-8-13 catheter had to be put in (11-14-13) hospitalized 11-14 - 11-16-2013 continue now with a urologist 11-19 to present, now not able to urinate like he should - more doctoring ahead.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Patient had received flu shot on 9/20/13 and still ended up getting serious flu enough to be hospitalized 3 months after shot. Flu shot did not protect and gave any immunity against flu.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Drug administered at inappropriate site
Clinical narrative: Pt got shot on 9/24/13 and on or around 12/7/13 came back to store where shot was administered and stated to RPH on duty that administering RPH gave flu shot too high on arm, causing discomfort and MD visits since then.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Malaise, Vision blurred
Clinical narrative: Post vaccination employee (patient) called EHS Dept noting she did not feel well. States she felt dizzy, weak and with blurred vision. Recommended she call 911 but declined and had friend stay w/ her. Denied problems w/ other Hep B injections.
Age: 1.53
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flu shot for >3 years given. No adverse reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram normal, Asthenia, Basophil percentage decreased, C-reactive protein increased, Condition aggravated
Clinical narrative: I asked my doctor's office to send this form but when I called to check on it there was no record of it being done so I am following up. Four hours after receiving my "flu shot" in the office I began to have neck and head pain which soon spread to my whole body. It happened so fast and so severely that by 8:30 pm, crying in pain, I went to the ER. I was admitted for two days and sent home with no real diagnosis and still in a lot of pain. During the ER visit my CRP was 148.3 and my WBC was 17,000. The discharge diagnosis was "Leukocytosis". One possible cause was physical and emotional stress, both of which I recently had. (A fall resulting in a fractured foot and a trip to care for my daughter and her family when she had emergency surgery). I was home only one day and decided I could not just endure the pain with no answers any longer and I returned to ER. I had a CT angiogram which was normal. My CRP was down to 89.90 but the WBC was now 19,000. Nothing killed the pain in my head and neck, even Morphine. Although most of the body pain was gone. I was re-admitted and had a consult with a local neurologist who did a lumbar puncture which was also negative. I was given IMITREX which did relieve my head pain some but the severe neck pain continues. The PA who did a very thorough work up in ER the second time was of the opinion that stress had upset my immune system and the flu shot sent it into "overdrive". This makes the most sense to me. I was discharged on Oct 31 being told they did not know what was wrong with me but "It was nothing serious". Since this is the worse thing I ever had to endure, to me it is very serious. I have Parkinson's Disease and my tremor has been out of control ever since. I still feel very weak more days than not. Nearly two months later I am slowly having a few more good days a week. I have moved my appointment with my neurologist up from mid Feb. 2013 to Dec. 20 2013. I have been working with a Chiropractor and Massage Therapist to help my continued neck pain. Labs are all back to normal since Nov. 8, 2013. I forgot to add that I went home on a Prednisone taper that finally relieved the pain. But it blocked the SINEMET.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Headache, Immune system disorder, Leukocytosis, Lumbar puncture normal
Clinical narrative: I asked my doctor's office to send this form but when I called to check on it there was no record of it being done so I am following up. Four hours after receiving my "flu shot" in the office I began to have neck and head pain which soon spread to my whole body. It happened so fast and so severely that by 8:30 pm, crying in pain, I went to the ER. I was admitted for two days and sent home with no real diagnosis and still in a lot of pain. During the ER visit my CRP was 148.3 and my WBC was 17,000. The discharge diagnosis was "Leukocytosis". One possible cause was physical and emotional stress, both of which I recently had. (A fall resulting in a fractured foot and a trip to care for my daughter and her family when she had emergency surgery). I was home only one day and decided I could not just endure the pain with no answers any longer and I returned to ER. I had a CT angiogram which was normal. My CRP was down to 89.90 but the WBC was now 19,000. Nothing killed the pain in my head and neck, even Morphine. Although most of the body pain was gone. I was re-admitted and had a consult with a local neurologist who did a lumbar puncture which was also negative. I was given IMITREX which did relieve my head pain some but the severe neck pain continues. The PA who did a very thorough work up in ER the second time was of the opinion that stress had upset my immune system and the flu shot sent it into "overdrive". This makes the most sense to me. I was discharged on Oct 31 being told they did not know what was wrong with me but "It was nothing serious". Since this is the worse thing I ever had to endure, to me it is very serious. I have Parkinson's Disease and my tremor has been out of control ever since. I still feel very weak more days than not. Nearly two months later I am slowly having a few more good days a week. I have moved my appointment with my neurologist up from mid Feb. 2013 to Dec. 20 2013. I have been working with a Chiropractor and Massage Therapist to help my continued neck pain. Labs are all back to normal since Nov. 8, 2013. I forgot to add that I went home on a Prednisone taper that finally relieved the pain. But it blocked the SINEMET.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Tremor, White blood cell count increased
Clinical narrative: I asked my doctor's office to send this form but when I called to check on it there was no record of it being done so I am following up. Four hours after receiving my "flu shot" in the office I began to have neck and head pain which soon spread to my whole body. It happened so fast and so severely that by 8:30 pm, crying in pain, I went to the ER. I was admitted for two days and sent home with no real diagnosis and still in a lot of pain. During the ER visit my CRP was 148.3 and my WBC was 17,000. The discharge diagnosis was "Leukocytosis". One possible cause was physical and emotional stress, both of which I recently had. (A fall resulting in a fractured foot and a trip to care for my daughter and her family when she had emergency surgery). I was home only one day and decided I could not just endure the pain with no answers any longer and I returned to ER. I had a CT angiogram which was normal. My CRP was down to 89.90 but the WBC was now 19,000. Nothing killed the pain in my head and neck, even Morphine. Although most of the body pain was gone. I was re-admitted and had a consult with a local neurologist who did a lumbar puncture which was also negative. I was given IMITREX which did relieve my head pain some but the severe neck pain continues. The PA who did a very thorough work up in ER the second time was of the opinion that stress had upset my immune system and the flu shot sent it into "overdrive". This makes the most sense to me. I was discharged on Oct 31 being told they did not know what was wrong with me but "It was nothing serious". Since this is the worse thing I ever had to endure, to me it is very serious. I have Parkinson's Disease and my tremor has been out of control ever since. I still feel very weak more days than not. Nearly two months later I am slowly having a few more good days a week. I have moved my appointment with my neurologist up from mid Feb. 2013 to Dec. 20 2013. I have been working with a Chiropractor and Massage Therapist to help my continued neck pain. Labs are all back to normal since Nov. 8, 2013. I forgot to add that I went home on a Prednisone taper that finally relieved the pain. But it blocked the SINEMET.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: 2 days after ZOSTAVAX burning, itching, tingling sensation and waist. Within 1 week numbness, burning tingling from waist to toes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Ultrasound scan
Clinical narrative: 2 days after ZOSTAVAX burning, itching, tingling sensation and waist. Within 1 week numbness, burning tingling from waist to toes.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, X-ray
Clinical narrative: Received flu shot in right deltoid. Very painful. Arm got very stiff as time progressed - could not straighten. Seen by Employee health 11/4/13. Seen by dr several months later.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse reaction. Patient is pregnant and requested a preservative free flu shot and the regular flu shot was given.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt reports random pain in muscle of arm and leg for 3 weeks (Note not site of vaccination).
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Dyskinesia
Clinical narrative: Jerks - started about 1/2 hr after shot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: None stated.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Dyspnoea, Injection site erythema, Injection site warmth, Laboratory test
Clinical narrative: Pt started with redness, at injection site and temp. By the 19th patient was having trouble breathing and swallowing and was taken by ambulance to the ER.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Wheezing
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age (demographics unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route not provided). On an unknown date, after receiving the ZOSTAVAX, the patient experienced coughing and wheezing, and was therefore hospitalized (location and duration unknown). The patient also reported that she has been using many other "unspecified medications" (names/dosages/frequencies/manufacturers unknown). The patient stated she had been using an unspecified "nebulizer" treatment to help her breathe. It was unclear as to when this patient started using the "nebulizer" treatment. There was no mention of a physician in this case. It was reported that the patient sought medical attention. The outcome of coughing and wheezing is unknown. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Induration, Skin warm
Clinical narrative: 10.5 cm x 10 cm area of induration/cellulitis, warmth. Given 7 d of antibiotics and 3 days steroids.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Rash maculo-papular, Urticaria
Clinical narrative: Macropapular rash, urticaria, prickling, onset approximately 2-3 hours after receiving Influenza vaccination.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Infection, Inflammation, Local swelling, Pain in extremity, Type III immune complex mediated reaction
Clinical narrative: Pt reported to me on 12/11/13 that she had reaction w/pain & swelling of right arm, extending from deltoid area (site of Td vaccination down to forearm) following previous immunization. She was subsequently hospitalized, for a period of 10days for "inflammation & infection". Pt's hx is consistent w/ severe Arthus-like reaction to Td.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Febrile convulsion, Pyrexia, Staring, Tremor
Clinical narrative: Shaking staring spell, fever -> febrile seizure.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: 12/12/2013 - client came in with concern about white discoloration on her (rt) deltoid area, states it started after the flu vaccine was admin. and has grown to current size.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising around injection site on right deltoid muscle.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Pt called the day after getting the PNEUMOVAX c/o injection site, swollen size of her fist and pink. She was feeling lightheaded. Pt offered appt. for same day and did take this. Pt instructed to take ADVIL, rest and increase fluids put cool compress on site pt. later in day canceled appt. Stating she wanted to wait 2 days after pt felt there was some improvement, 4 days later pt feels she is better.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt. says immediately after vaccine administration, her arm hurt "pretty bad". She was unable to move her arm the next day so she called the MD and they said "don't worry." It has now been one month and she has no relief yet.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Body temperature increased, Muscular weakness, Myalgia
Clinical narrative: Low back muscle pain, leg weakness and low grade temp lasting 48 hours. Emp still continues to have back pain, some leg pain and weakness (staffs incident report 12/16/13).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat,  congestion and headache 3-4 days after vaccine was given - Mom states this occurred each time GARDASIL was given.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 19-DEC-2013 the patient was vaccinated with expired ZOSTAVAX. The patient experienced no known adverse effect. This ZOSTAVAX had not been exposed to a temperature excursion. The outcome of expired dose of ZOSTAVAX administered and no known adverse effect is unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: States experienced - neck, shoulder and arm pain - hand numbness for 2 days. Denied S.O.B.
Age: 1.23
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Serum sickness-like reaction
Clinical narrative: Serum sickness like reaction-treatment with Benadryl.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt c/o pain at injection site, denies redness or swelling.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysarthria, Flushing
Clinical narrative: Pt. experienced lightheadedness, dizziness, flushing of the face and slurred speech approx. 30 min after receiving the flu vaccine IM. Nurse administered a dose of BENADRYL P.O. and s/s resolved with an hour.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood immunoglobulin E, C-reactive protein, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Patient was seen in ER 11/3/13 and 11/5/13 for bumps on top of head, hives and swelling from face to legs. After testing by allergist it was decided she has been having reaction to flu vaccine also fever 102.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Red blood cell sedimentation rate, Swelling, Urticaria, Vaccination complication
Clinical narrative: Patient was seen in ER 11/3/13 and 11/5/13 for bumps on top of head, hives and swelling from face to legs. After testing by allergist it was decided she has been having reaction to flu vaccine also fever 102.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Headache, Induration, Injection site erythema
Clinical narrative: Patient mom called reporting (L) arm swollen, hard and red. "Pressure in head", fever (worse when standing and bending over). Mild erythema to (L) lat biceps. Dx with cellulitis and vaccine reaction. She was given KEFLEX, instructed to give BENADRYL and ibuprofen.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Local swelling, Pyrexia, Vaccination complication
Clinical narrative: Patient mom called reporting (L) arm swollen, hard and red. "Pressure in head", fever (worse when standing and bending over). Mild erythema to (L) lat biceps. Dx with cellulitis and vaccine reaction. She was given KEFLEX, instructed to give BENADRYL and ibuprofen.
Age: 1.58
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None reported at this time.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema nodosum
Clinical narrative: Initial case was received from a health care professional on 17 December 2013. A 39 years old female patient had no medical history reported, received a dose of Tdap on an unspecified date (Route, Site dose and batch number Not reported). Patient had not reported concomitant medication. It was reported that on unspecified date patient had developed erythema nodosum within 48 hrs after receiving a dose of Tdap vaccine. No laboratory investigation and corrective treatment was reported. At the time of reported the outcome of event was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome, Premature delivery
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131895 and 2013SA131928 (Same vaccine, same reporter). A female patient, whose medical history and concomitant medications were not reported, had received a dose of influenza QIV vaccine (manufacturer: not provided, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. The patient was pregnant at the time of vaccination. Her last menstrual period and estimated delivery date were not reported. On an unspecified date after vaccination, the patient developed Guillain Barre syndrome and had to deliver baby early. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Aborted pregnancy, Exposure during pregnancy, Guillain-Barre syndrome
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131895 and 2013SA131929 (Same vaccine, same reporter). A female patient, whose age, date of birth was not reported, medical history and concomitant medications were not reported, received a dose of INFLUENZA VACCINE (lot number, route manufacturer and site was not reported) on an unspecified date. The patient was pregnant at the time of vaccination. Her last menstrual period and estimated delivery date were not reported. It was reported that the patient had an aborted pregnancy due to Guillain Barre syndrome following administration of QIV flu vaccine. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Age: 0.18
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Cardiac operation, Death neonatal, Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a baby of less than 10 days old. The patient was born with many congenital heart anomalies. Drug reactions/allergies were unspecified by the reported. No demographics were provided for the baby. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (lot#, route, dosage not reported) (routine immunization) shortly after birth. It is unknown whether the baby was given RECOMBIVAX HB or another company's Hepatitis B product. It is also not known when or where the baby received this vaccine. No concomitant medications were reported. It was reported that the baby was born at one unspecified hospital, had heart surgery (fatal, medically significant and hospitalization at another unspecified hospital and then went to a third unspecified hospital, where the baby died (dates unspecified) (fatal and hospitalization. It is not known how long the baby stayed at any of the hospitals. After death, the parents of the baby wanted the organs of this baby to be donated. When tissues from this baby's organs were tested, it was discovered that tissues from the baby's liver were found to be positive for Hepatitis B surface antigens (fatal and hospitalization). The mother of this baby tested as not positive for surface antigens, so they determined that the surface antigens of the baby's liver must have come from the vaccine itself. The liver was rejected as an organ for donation. The physician queried and would like to have phone conversation regarding how it was possible that tissue in an infant's liver could be positive for Hepatitis B surface antigens when infants mother does not have Hepatitis B. Hepatitis B surface antigens were discovered in liver when testing to see if infant could be an organ donor. The company representative states that the infant had multiple health issues requiring surgery and it is assumed that infant had blood transfusions (fatal and hospitalization) but she was not positive (infants antibody were not positive). The outcomes of the reported events were reported as fatal. All the reported events were considered to be serious due to death and hospitalization except the event of heart surgery. The event baby had heart surgery was considered to be medically significant as per internal review in addition to hospitalization and being fatal. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Constipation, Convulsion, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 26 year old female patient with no pertinent medical history. Physician reported that the patient was administered on an unknown date in 2011 with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). Then the patient was administered with a second dose of GARDASIL (dose, route, lot number and expiration date were not reported) on an unspecified date. Later the patient was administered with a third dose of GARDASIL (dose, route, lot number and expiration date were not reported) in April 2012. The physician reported that the patient experienced constipation on an unspecified date after the first dose of GARDASIL and seizures, headaches, nausea, fatigue and autoimmune issues on an unspecified dates after the administration of unspecified doses in the GARDASIL series. The patient present status was reported as not recovered. The patient considered the events as disabling. Upon internal review the seizures were considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 26 year old female patient with no pertinent medical history. Physician reported that the patient was administered on an unknown date in 2011 with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). Then the patient was administered with a second dose of GARDASIL (dose, route, lot number and expiration date were not reported) on an unspecified date. Later the patient was administered with a third dose of GARDASIL (dose, route, lot number and expiration date were not reported) in April 2012. The physician reported that the patient experienced constipation on an unspecified date after the first dose of GARDASIL and seizures, headaches, nausea, fatigue and autoimmune issues on an unspecified dates after the administration of unspecified doses in the GARDASIL series. The patient present status was reported as not recovered. The patient considered the events as disabling. Upon internal review the seizures were considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dyskinesia, Posture abnormal
Clinical narrative: Pt was slumped over and having jerking motions (movements) lasted for about 30 seconds.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Rigth arm swollen, red, warm, and painful. Treatment: Prednisone one tablet by mouth as directed MG UD.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Mom says red spot at injection site and also below site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Asthma, Dyspnoea, Headache, Pain
Clinical narrative: Shortness of breath which precipitated asthma symptoms that continue for 10+ days; fever of 101-- one day; body aches-- one day; head aches-- 36 hours; general lack of energy-- one day.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Shortness of breath which precipitated asthma symptoms that continue for 10+ days; fever of 101-- one day; body aches-- one day; head aches-- 36 hours; general lack of energy-- one day.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Erythema, Feeling hot, Injection site cellulitis
Clinical narrative: Left upper arm stated to get red, swollen and hot. Started at the vaccine administered area but spread and grew all around the arm. Per hospital it created a cellulitis.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling, Ultrasound scan
Clinical narrative: Left upper arm stated to get red, swollen and hot. Started at the vaccine administered area but spread and grew all around the arm. Per hospital it created a cellulitis.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Feeling hot, Hyperaesthesia, Inflammation, Injection site discolouration, Pain
Clinical narrative: Site felt warm and sore to the touch, had inflammation, took Benadryl per provider. Felt feverish a couple days after. Still have 1 in X 1 in discoloration at site of injection on 12/23/2013  (no lingering effects other than slight sensitivity and scarring).
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, Scar
Clinical narrative: Site felt warm and sore to the touch, had inflammation, took Benadryl per provider. Felt feverish a couple days after. Still have 1 in X 1 in discoloration at site of injection on 12/23/2013  (no lingering effects other than slight sensitivity and scarring).
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain, X-ray
Clinical narrative: About 5 hours after vaccine, arm throbbed from shoulder to fingertips. Fingertips went numb. Ability to use (R) arm decreased daily. She would be awakened by pain at night. She still cannot use it normally, but it has improved some. Constant throbbing for first 3 weeks. PCP put her on MEDROL dose pak which decreased pain. Arm felt good for 2 days and then pain gradually increased. She still cannot reach over head to move her arm backward, not can she fasten her bra. She says she takes 1 ALEVE and 1 Extra Strength TYLENOL twice daily for pain. She says she never had anything like this before.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Muscle fatigue, Pain
Clinical narrative: Extreme fatigue onset, headache next am and continued fatigue x approx. 32 hours then body aches head to toe and muscle fatigue that continued for approx 6 more days with intermittent headaches.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Nasal congestion, Oculorespiratory syndrome
Clinical narrative: Swollen eyes, upper respiratory symptoms.  Diagnosed as Ocular respiratory reaction, self-limiting, better in 48 hours
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Sore, red upper arm.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Shingles Injection site became extremely red, swolen, and feverish and, by Saturday, had expanded to cover from elbow to shoulder.  By Saturday, 12/21/13, I was also running a fever of over 100 degrees, with severe body aches.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Monoplegia, Sensory loss
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX23 (Lot # not reported) (dose and route not reported) when the patient was less than 60 years old. No other co suspects were reported. No concomitant therapy was reported. The nurse reported that a co-worker was administered a second dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not reported) less than 5 years later on an unspecified date in 2012. The reporter stated to nurse that could not feel and could not move the arm in which she received the PNEUMOVAX23. The events were described further as her arm was "paralyzed'. Treatment reported was the application of ice to the affected arm. The events resolved within 4 to 6 hours. Upon internal review, the events of the patient could not feel the arm and could not move, was paralyzed was considered to be medically significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection about 3 inches wide. Pt started noticing it today. No pain.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: Patient blacked out for 4-5 seconds after administration of 2nd vaccination at 8:05am. He has high anxiety to needles and held his breath during immunization despite being reminded by father and Medical Assistant to keep breathing. He was in a sitting position leaning on father when incident occurred. We called his name and he began talking to us. We laid him down for 15 min post incident and gave him water and took BP. Pt left happy and alert. Vitals were normal.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: A couple of hours after shot noticed "red bumps" on chest. The next day little red bumps all over. Friday really bad, all over body - size of quarter, some sized pinprick. Went to dermatologist who said "probably hives". Bumps did not itch. Dr gave Triamcinolone acetonide cream.