chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Epistaxis, Lymphadenopathy, Petechiae, Platelet count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her daughter (age not reported). On an unknown date in 2008 the patient was vaccinated with booster dose of VARIVAX (Merck) subcutaneous (lot #, dose, strength, site and route of administration not reporter). Concomitant therapies included vitamins (unspecified), OMEGA-3 and high doses (not specified) of vitamin d (unspecified). The reporter stated that her twins, boy (captured in MARRS # 1403USA007224) and girl experienced severe reactions after vaccination with booster dose of VARIVAX (Merck). On an unknown date in 2008 the patient experienced generalized lymphadenopathy and very large urticaria on her thigh which covered her almost entire thigh and profuse itching. Her daughter also experienced bruising, petechia and profuse nose bleeds following VARIVAX (Merck) vaccination and these symptoms lasted for several days. About a month after vaccination with VARIVAX (Merck) had another giant urticaria in her arm had similar nose bleeding and bruising issues. Nurse practitioner stated that these bleeding symptoms improved somewhat after several days but her daughter intermittently experienced nosed bleeds and bruising for about a year following vaccination. About a year after VARIVAX (Merck) dose, her daughter was tested and found to have abnormal platelet function and her platelet level dropped. The outcome of generalized lymphadenopathy, platelet level dropped, abnormal platelet function, petechia, profuse itching and very large urticaria on her thigh was not reported. The relatedness between generalized lymphadenopathy, platelet level dropped, abnormal platelet function, petechia, nose bleeding, bruising profuse itching and very large urticaria on her thigh and therapy with VARIVAX (Merck) was unknown. The reporter stated that her children were very sensitive to vaccines and she's been closely working with allergist and immunologist to find the cause for these reactions. This is one of two same patient cases from the same source (second case MARRS # 1403USA007227). This is one of several cases from the same source (other cases MARRS # 1403USA007224, 1403USA007225, 1403USA003195, 1403USA007227, 1403USA007228). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Platelet function test abnormal, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her daughter (age not reported). On an unknown date in 2008 the patient was vaccinated with booster dose of VARIVAX (Merck) subcutaneous (lot #, dose, strength, site and route of administration not reporter). Concomitant therapies included vitamins (unspecified), OMEGA-3 and high doses (not specified) of vitamin d (unspecified). The reporter stated that her twins, boy (captured in MARRS # 1403USA007224) and girl experienced severe reactions after vaccination with booster dose of VARIVAX (Merck). On an unknown date in 2008 the patient experienced generalized lymphadenopathy and very large urticaria on her thigh which covered her almost entire thigh and profuse itching. Her daughter also experienced bruising, petechia and profuse nose bleeds following VARIVAX (Merck) vaccination and these symptoms lasted for several days. About a month after vaccination with VARIVAX (Merck) had another giant urticaria in her arm had similar nose bleeding and bruising issues. Nurse practitioner stated that these bleeding symptoms improved somewhat after several days but her daughter intermittently experienced nosed bleeds and bruising for about a year following vaccination. About a year after VARIVAX (Merck) dose, her daughter was tested and found to have abnormal platelet function and her platelet level dropped. The outcome of generalized lymphadenopathy, platelet level dropped, abnormal platelet function, petechia, profuse itching and very large urticaria on her thigh was not reported. The relatedness between generalized lymphadenopathy, platelet level dropped, abnormal platelet function, petechia, nose bleeding, bruising profuse itching and very large urticaria on her thigh and therapy with VARIVAX (Merck) was unknown. The reporter stated that her children were very sensitive to vaccines and she's been closely working with allergist and immunologist to find the cause for these reactions. This is one of two same patient cases from the same source (second case MARRS # 1403USA007227). This is one of several cases from the same source (other cases MARRS # 1403USA007224, 1403USA007225, 1403USA003195, 1403USA007227, 1403USA007228). Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Anxiety, Bladder disorder, Computerised tomogram normal, Confusional state
Clinical narrative: On October 2, 2013 I received a mandatory flu vaccination. I started to have bouts of jabbing pain in my right eye on October 7th, by October 12th the jabbing pain was more severe and had a burning sensation. This pain became more intense and started to happen more frequently. I saw the dr on October 28th, a retina specialist. He advised me to see my family doctor. I saw dr on October 30th and he diagnosed me with trigeminal neuralgia, he put me on carbamazepine twice a day. The medication did not help the pain. I had an MRI on November 11th and a CT scan on November 14th. Both of these tests came back normal. Dr increased my medication on November 25th to three pills a day. The medication still was not helping the pain so I sought other options. I saw dr who is a DC on December 11 and January 6th, 2014. On January 7th 2014 dr prescribed four pills a day because the three pills were not sufficiently stopping the debilitating pain in my right eye. On February 28 I dr who is a neurologist and he confirmed the diagnosis of trigeminal neuralgia, he suggested I have a gamma knife procedure because six months is a very long time to have trigeminal neuralgia consistently. I wanted another opinion so I went to dr on March 13th, she confirmed trigeminal neuralgia and it was caused by the flu vaccination. Here are all the symptoms: Stabbing and burning in right eye, constant headache, memory loss, confusion, sad, weak bladder, fatigue, anxiety.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed mood, Eye irritation, Eye pain, Fatigue, Headache
Clinical narrative: On October 2, 2013 I received a mandatory flu vaccination. I started to have bouts of jabbing pain in my right eye on October 7th, by October 12th the jabbing pain was more severe and had a burning sensation. This pain became more intense and started to happen more frequently. I saw the dr on October 28th, a retina specialist. He advised me to see my family doctor. I saw dr on October 30th and he diagnosed me with trigeminal neuralgia, he put me on carbamazepine twice a day. The medication did not help the pain. I had an MRI on November 11th and a CT scan on November 14th. Both of these tests came back normal. Dr increased my medication on November 25th to three pills a day. The medication still was not helping the pain so I sought other options. I saw dr who is a DC on December 11 and January 6th, 2014. On January 7th 2014 dr prescribed four pills a day because the three pills were not sufficiently stopping the debilitating pain in my right eye. On February 28 I dr who is a neurologist and he confirmed the diagnosis of trigeminal neuralgia, he suggested I have a gamma knife procedure because six months is a very long time to have trigeminal neuralgia consistently. I wanted another opinion so I went to dr on March 13th, she confirmed trigeminal neuralgia and it was caused by the flu vaccination. Here are all the symptoms: Stabbing and burning in right eye, constant headache, memory loss, confusion, sad, weak bladder, fatigue, anxiety.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Trigeminal neuralgia, Urinary incontinence, Vaccination complication
Clinical narrative: On October 2, 2013 I received a mandatory flu vaccination. I started to have bouts of jabbing pain in my right eye on October 7th, by October 12th the jabbing pain was more severe and had a burning sensation. This pain became more intense and started to happen more frequently. I saw the dr on October 28th, a retina specialist. He advised me to see my family doctor. I saw dr on October 30th and he diagnosed me with trigeminal neuralgia, he put me on carbamazepine twice a day. The medication did not help the pain. I had an MRI on November 11th and a CT scan on November 14th. Both of these tests came back normal. Dr increased my medication on November 25th to three pills a day. The medication still was not helping the pain so I sought other options. I saw dr who is a DC on December 11 and January 6th, 2014. On January 7th 2014 dr prescribed four pills a day because the three pills were not sufficiently stopping the debilitating pain in my right eye. On February 28 I dr who is a neurologist and he confirmed the diagnosis of trigeminal neuralgia, he suggested I have a gamma knife procedure because six months is a very long time to have trigeminal neuralgia consistently. I wanted another opinion so I went to dr on March 13th, she confirmed trigeminal neuralgia and it was caused by the flu vaccination. Here are all the symptoms: Stabbing and burning in right eye, constant headache, memory loss, confusion, sad, weak bladder, fatigue, anxiety.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. The patient's medical history included a drug reaction/allergy to DARVON. On 18-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J011339, 0.65 ml, subcutaneous. Concomitant therapies included finasteride. On an unknown date in March 2014 after receiving ZOSTAVAX, the patient experienced shingles. The patient visited the physician due to the adverse event. The patient received no treatment for the shingles. The physician asked the pharmacist if the patient could receive VALTREX. The outcome of the shingles is unknown. A causality assessment was not provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm around injection, site 6-8 hours after injection. Patient treated with cold pack, BENADRYL. Saw MD and they prescribed an antibiotic.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Dry skin, Pain in extremity, Skin discolouration, Skin exfoliation
Clinical narrative: Arm hurt that afternoon. 2 days after shot developed dry flab/skin (R) lateral arm with brownish dry flaky patches also. No inflammation or itching.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Photophobia, Pyrexia
Clinical narrative: Fever, headache, photophobia 16 hrs after vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Nodule, Skin warm
Clinical narrative: 3-21-14 - Bil arms red swollen and warm to touch. (L) arm - 2 1/2 - 2"" circle and 0.5 cm knot, R - 3 1/2 - 3 1/2 circle area. GM gave antihistamine 3-20-14 and said looks better today. Worse on 3-19 and 3-20-14.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthma, Chest X-ray, Condition aggravated, Dyspnoea
Clinical narrative: Worsening SOB; asthma worse w/in 30-60 min. After several hours, shortness of breath, not responding to albuterol inhaler - by 6:00 PM, SOB severe and told Mom.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Electrocardiogram, Influenza, Nasopharyngitis, Urine analysis
Clinical narrative: Pt. states contracted the flu from the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Redness and pain at site of given vaccine.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Decreased appetite, Full blood count abnormal, Hypersomnia, Immediate post-injection reaction, Viral infection
Clinical narrative: Loss of appetite, slept 24 hrs. straight after vaccines were administered. Starting vomiting the day after. And patient did not went to eat. No fever, patient came in office 3/13/14 and 3/14/14 and is doing fine.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Loss of appetite, slept 24 hrs. straight after vaccines were administered. Starting vomiting the day after. And patient did not went to eat. No fever, patient came in office 3/13/14 and 3/14/14 and is doing fine.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt reports after receiving shot 1/27/14 had fever, took TYLENOL, 1/28, 129-RD very hot to touch, swollen, red, applied icy hot ointment on 1/31 and sx worsened. Came into H. D 2/3 - no redness noted but swelling noted 60 mm areas. Advised cold compress. TYLENOL 2/7/14 arm much better after TYLENOL and ice.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: Approximately 3 hours after vaccination, the patient was noted to have a bright red blotchy rash all over the body (face > trunk). Some, periorbitally, appeared to have small wheals associated with the redness. No respiratory distress. Given BENADRYL, sent to ED for eval/obs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients upper right arm shows swelling and redness. No fever.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness on Proquad vaccine site in arm.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen area with hard core at injection site.  Youth stated "it is itchy".
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Patient complaint of redness qand swelling 5 days after administration of vaccine. Required visit with MD.
Age: 27.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site. Treated with oral steroids and Tylenol. Family questioning if vaccine contained latex, to which the patient had a known allergy.
Age: 1.62
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives to clothing contact areas and at both injection site. Was given HIB and Prevnar at the site right thigh.
Age: 63.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: 30 seconds after HAVRIX injection, pt felt light headed, helped pt to floor, loss of consciousness (approx 30-60 sec.), 3 separate episodes of seizures. BP 190/90, Pulse 68, EMS called.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: After receiving HPV vaccine child passed out in the exam room, then recovered within seconds. Examined by physician.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash, Skin lesion, Skin reaction
Clinical narrative: Pt returned to the office on 3/6/14 following up on local skin reaction/rash, red, raised lesions and fever x2 days. Rash appeared approx 9 days after getting varicella vaccine to lt thigh.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: After receiving the GARDASIL vaccine child passed out for a few seconds then recovered and examined by physician.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Rash pruritic, Urticaria
Clinical narrative: Parent called approx 1 hour after the Hep A vaccine was administered in the (L) arm. States pt had a rash on both arms, base of neck and upper chest. The vaccine was painful at administration. The rash was itchy. Today mom described the rash as hives.
Sex: U
Vaccine: FLU3
Symptoms: Hypotension, Syncope
Clinical narrative: Case number PHEH2014US005577, is an initial spontaneous report from a physician via pharmaceutical company (Merck) received on 19 Mar 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination, patient experienced syncope and hypotension. The outcome, seriousness and causality were not reported. No further information was provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Enlarged area around injection site, very red and warm to the touch, appeared to be about 5 small vesicles in the center of the area.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, FLU3, HPV4, TDAP
Symptoms: Nausea, Retching
Clinical narrative: Patient starts to gag and became nauseous.
Age: 75.0
Sex: M
Vaccine: YF
Symptoms: Cardiac arrest, Death, Endotracheal intubation, Respiratory distress
Clinical narrative: Pt arrived to ED in respiratory distress and was intubated, became asystolic and did not return. Pronounced at 19:05 March 14.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Weight decreased
Clinical narrative: Unexplained weight loss. My daughter indicated that she had lost 5 pounds 'for no reason'.  She was 117 at her most recent doctor visit and was down to 112 in about a month.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: RED, HOT, SWOLLEN STILL 3 DAYS LATER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Rash, Skin warm
Clinical narrative: REDNESS, WARMTH, RASH LOCALIZED FROM UPPER SHOULDER TO ELBOW, FLU LIKE SYMPTOMS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Rash, Skin warm
Clinical narrative: REDNESS, WARMTH, RASH TO UPPER ARM DOWN TO ELBOW, FLU LIKE SYMPTOMS.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash described as "hives" to chest and stomach with itching. No other symptoms reported.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Joint stiffness, Local swelling, Sensation of heaviness
Clinical narrative: Arm swelling, feeling "heavy" and tight fingers. Lump under the L arm pit. No pain.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Haematochezia, Lethargy, Ultrasound abdomen normal, Vomiting
Clinical narrative: Mom states child had bloody stool Feb 27, 2014. 3/19/14 child went to hospital for vomiting and possible intussusception. 3/4/14 lethargic, no appetite, vomiting. Admitted to hospital had multiple ultrasounds to r/o intussusception.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.  Pt also c/o itching and pain at the injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: L deltoid swelling, redness, itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a large knot 3 inches long and 3 inches wide on right deltoid where he recieved his 2nd Varicella vaccine injection.  The area is tender, hot and hard to touch.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Nausea, Vomiting
Clinical narrative: Severe Nausea/ Vomiting awoke me from sleep. By 8:30 AM severe nausea persisted and had severe ache in all muscles- could not get up out of bed by myself. During day severe nausea/ vomiting with serious aches. Difficult to walk.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Pruritus, Upper extremity mass
Clinical narrative: Swollen, red itchy arm with a hard lump approximately 2 inches by 4 inches.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Received TdaP vaccine instead of DtaP that was ordered. Office staff realized the error the next morning.
Age: 1.1
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed with cellulitis 10 days after receiving varicella vaccine. Treated with PO Keflex and resolved.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient was having dyspnea, 102 fever, chills, body aches, FLS.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Symptoms:  Swolen, Red, Hot - shoulder area about 6 inches. Treatment:  Motrin 800.
Age: 45.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Asthenia, Confusional state, Loss of consciousness, Nausea, Pallor
Clinical narrative: Patient recieved a Tdap & Hep-A vaccine Bilat. Deltiods. Approx 10 min later patient had LOC with Petite type Seizure in waiting room. Pt was returned to Izzy Rm with aid of W/C. Patient placed on bed in a supine position with feet elevated. Given cool packs to head & neck. Water & apple jucie provided. Still pale, weak, nauseated. Vital signs Qx10min x3, Q30min x1 WNL. Still confused. Called family member to pick up patient, advised to seek medical evaluation. Left our facility at 3:45PM.
Age: 45.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Petit mal epilepsy
Clinical narrative: Patient recieved a Tdap & Hep-A vaccine Bilat. Deltiods. Approx 10 min later patient had LOC with Petite type Seizure in waiting room. Pt was returned to Izzy Rm with aid of W/C. Patient placed on bed in a supine position with feet elevated. Given cool packs to head & neck. Water & apple jucie provided. Still pale, weak, nauseated. Vital signs Qx10min x3, Q30min x1 WNL. Still confused. Called family member to pick up patient, advised to seek medical evaluation. Left our facility at 3:45PM.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Myalgia, Petit mal epilepsy
Clinical narrative: Patient recieved an Hep-A vaccine. Did well ok'd to go with father to waiting room to wait another 20 minutes. Observed his father with LOC. Patient himself had LOC with petite type seizure, was brought to floor safely by self and assistants from others in waiting room. LOC x30 seconds. He was also sent back to room. Given cool packs & apple juice. Vital sign checked and was WNL. Patient recovered within 10 minutes. Doing better. Had some sore muscle pain to left ankle. He was advised also to seek medical evaluation. Patient stated that he had no breakfast or lunch prior to visit. Family members arrived with a lunch. Left clinic at 3:45 PM with father and a family driver.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Back pain, Injection site discomfort, Injection site mass, Injection site pain
Clinical narrative: Woke up the next day with pain and a lump at injection site.  As the day progressed, it was hard to lift my arm to get in and out of my coat.  At about 1pm,  began with deep muscle aches, mostly back and hips, fatigue, weakness and headache.  By 4pm, fever to 102.7.  Pain and swelling in left arm (injection site) and unable to lay on it or lift it.  Took Advil to bring down fever and relieve symptoms. Fever of 100.8 following day, arm pain.  Took Advil to relieve symptoms.  Fever of 99.0 the next day, less severe arm pain.  Took Advil to relieve symptoms.  By day 4, mostly back to normal, but still some pain in arm.  Now 3/21/2014, mild discomfort on touch of lower left deltoid.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Woke up the next day with pain and a lump at injection site.  As the day progressed, it was hard to lift my arm to get in and out of my coat.  At about 1pm,  began with deep muscle aches, mostly back and hips, fatigue, weakness and headache.  By 4pm, fever to 102.7.  Pain and swelling in left arm (injection site) and unable to lay on it or lift it.  Took Advil to bring down fever and relieve symptoms. Fever of 100.8 following day, arm pain.  Took Advil to relieve symptoms.  Fever of 99.0 the next day, less severe arm pain.  Took Advil to relieve symptoms.  By day 4, mostly back to normal, but still some pain in arm.  Now 3/21/2014, mild discomfort on touch of lower left deltoid.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Aggression, Agitation, Anger, Circadian rhythm sleep disorder, Convulsion
Clinical narrative: By The afternoon following my son receiving his second Dtap and first polio vaccines, his mood had changed to one of significant agitation and anger, which was out of the ordinary. His consistently peaceful sleep pattern was disrupted, and now, 2.5 years later, I am aware that he has not had one night of sleep since those shots during which he hasn't had a night terror type outburst, or several. He had a seizure after the shots as well, only it was about a week after. He exhibits rage and sensory problems, and is constantly covering his ears. He hits his head on the floor very hard and will hit himself with objects. He also seems to have little ability to resist the urge to hit me or my husband, but seems to know he's not supposed to do that. He is very smart in many ways, but I wonder how this will effect his entire life.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Head banging, Hyperacusis, Intentional self-injury, Mood altered, Sensory disturbance
Clinical narrative: By The afternoon following my son receiving his second Dtap and first polio vaccines, his mood had changed to one of significant agitation and anger, which was out of the ordinary. His consistently peaceful sleep pattern was disrupted, and now, 2.5 years later, I am aware that he has not had one night of sleep since those shots during which he hasn't had a night terror type outburst, or several. He had a seizure after the shots as well, only it was about a week after. He exhibits rage and sensory problems, and is constantly covering his ears. He hits his head on the floor very hard and will hit himself with objects. He also seems to have little ability to resist the urge to hit me or my husband, but seems to know he's not supposed to do that. He is very smart in many ways, but I wonder how this will effect his entire life.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Sleep disorder, Sleep terror
Clinical narrative: By The afternoon following my son receiving his second Dtap and first polio vaccines, his mood had changed to one of significant agitation and anger, which was out of the ordinary. His consistently peaceful sleep pattern was disrupted, and now, 2.5 years later, I am aware that he has not had one night of sleep since those shots during which he hasn't had a night terror type outburst, or several. He had a seizure after the shots as well, only it was about a week after. He exhibits rage and sensory problems, and is constantly covering his ears. He hits his head on the floor very hard and will hit himself with objects. He also seems to have little ability to resist the urge to hit me or my husband, but seems to know he's not supposed to do that. He is very smart in many ways, but I wonder how this will effect his entire life.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot, swollen leg at site of vaccination.  Originally, 1" diameter swollen firm site, now stretching to an irregularly shaped red swollen area up to 4.5" in diameter at widest point.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a consumer, mother of the patient, also comes from GlaxoSmithKline (Mfr # A1062194A), refers to a 4 month old male patient. Patient historical drug included DTaP (manufacturer unknown), HepB (manufacturer unknown) and IPV (manufacturer unknown). On 19-FEB-2014 at around 9:00am, the patient was vaccinated with second dose of ROTATEQ, dose 2 (lot # J010139, expiration date: 19-MAR-2015) (route was not reported) unknown. Concomitant vaccines included second dose of PEDIARIX left thigh (lot reported as 99R9E), second dose of ACTHIB (route unknown) (lot reported as UH968AB) and second dose of PREVENAR 13 route was unknown (lot reported as H50603). On 19-FEB-2014, after vaccination with PEDIARIX, ACTHIB, PREVENAR 13 and ROTATEQ the patient experienced possible seizure. The patient was hospitalized. In February 2014, lab studies were performed included MRI (nuclear magnetic resonance imaging) and the EEG (electroencephalogram) and the result showed was fine. The mother reported that "the doctors though her son had a seizure but they could not verify it because he did not have any additional seizures at the hospital." The mother stated that the subject had a "possible reaction to PEDIARIX." The mother reported that the immunization series was not discontinued and it was unknown if the series was delayed. The outcome of possible seizure was unknown. Upon internal review the event of possible seizure was considered as a medically significant. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report as received from a consumer, mother of the patient, also comes from GlaxoSmithKline (Mfr # A1062194A), refers to a 4 month old male patient. Patient historical drug included DTaP (manufacturer unknown), HepB (manufacturer unknown) and IPV (manufacturer unknown). On 19-FEB-2014 at around 9:00am, the patient was vaccinated with second dose of ROTATEQ, dose 2 (lot # J010139, expiration date: 19-MAR-2015) (route was not reported) unknown. Concomitant vaccines included second dose of PEDIARIX left thigh (lot reported as 99R9E), second dose of ACTHIB (route unknown) (lot reported as UH968AB) and second dose of PREVENAR 13 route was unknown (lot reported as H50603). On 19-FEB-2014, after vaccination with PEDIARIX, ACTHIB, PREVENAR 13 and ROTATEQ the patient experienced possible seizure. The patient was hospitalized. In February 2014, lab studies were performed included MRI (nuclear magnetic resonance imaging) and the EEG (electroencephalogram) and the result showed was fine. The mother reported that "the doctors though her son had a seizure but they could not verify it because he did not have any additional seizures at the hospital." The mother stated that the subject had a "possible reaction to PEDIARIX." The mother reported that the immunization series was not discontinued and it was unknown if the series was delayed. The outcome of possible seizure was unknown. Upon internal review the event of possible seizure was considered as a medically significant. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Pt administered VARIVAX #2 sc right deltoid on 3/18/14. Later in evening pt noted redness at site. Had appt here to check this 3/19/14, then again on 3/20/14. As of 3/20/14 erythema present at site 7x8cm pt being treated for cellulitis with KEFLEX.  7 x 8 cm macular erythema at site.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection after 1st dose.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. On an unknown date in September 2012, the patient received dose one of GARDASIL intramuscular injection, dose and frequency unspecified. On 13-MAR-2014, the patient was in office to receive dose two of GARDASIL. Concomitant medication was unspecified. No product quality compliant involved. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Arthralgia, Dizziness, Erythema, Eye pain, Fatigue
Clinical narrative: Symptoms reportedly started the evening after vaccine given/early the following day - symptoms include - fatigue, headache, myalgias, arthralgias (shoulder), nausea, dizziness, tinnitus, eye discomfort (pulse/twitching behind (R) eye), local reaction with redness, tenderness.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Headache, Influenza virus test negative, Local reaction, Muscle twitching, Myalgia
Clinical narrative: Symptoms reportedly started the evening after vaccine given/early the following day - symptoms include - fatigue, headache, myalgias, arthralgias (shoulder), nausea, dizziness, tinnitus, eye discomfort (pulse/twitching behind (R) eye), local reaction with redness, tenderness.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Nausea, Tenderness, Tinnitus
Clinical narrative: Symptoms reportedly started the evening after vaccine given/early the following day - symptoms include - fatigue, headache, myalgias, arthralgias (shoulder), nausea, dizziness, tinnitus, eye discomfort (pulse/twitching behind (R) eye), local reaction with redness, tenderness.
Age: 2.0
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy 1 day after receiving vaccines.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid large area of light redness and swelling size 4 x 5 in.
Age: 0.77
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient reported to pharmacist (3 days after receiving). Revealed slightly swollen and red area to pharmacist. Patient states slightly warm to touch. Advised patient to monitor for improvement.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a physician refers to herself as a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 and dose 2 of GARDASIL (dose, route and frequency were not reported). The physician reported that he had received first two doses of GARDASIL and however, she just found that she was 8 weeks pregnant. The physician was asking whether she has to restart the series after the pregnancy. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-MAR-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as J002646, dose and route were not reported), that had expired on 11-MAR-2014. Concomitant medications were not reported. No adverse effects reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified reporter (Control #54417) concerning a 70 year old female patient. Medical history and concurrent conditions were not reported. Patient had no known allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) Lot # J011651; Expiration date: 22-AUG-2015 (reported as 31-AUG-2014). In 2014, the patient had swelling of the arm, body aches, weak and fever. Patient did not had any trouble breathing and have no known allergies. Once patient was put on antibiotics, patient got better. The outcome of the events was reported as recovering. This is one of 4 reports from the same reporter (1403USA002056, 1403USA007924 and 1403USA007926). Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified reporter (Control #54417) concerning a 90 year old female patient. Medical history and concurrent conditions were not reported. Patient had no known allergies or any trouble breathing. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) Lot # J011651; Expiration date: 22-AUG-2015 (reported as 31-AUG-2014). On 26-FEB-2014 (considering that the 90 year old patient was the last one reported), the patient had swelling of the arm, body aches, weak and fever. Patient did not had any trouble breathing and have no known allergies. Once patient was put on antibiotics, patient got better. The outcome of the events was not reported. This is one of 4 reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified (Control #54417) concerning a 67 year old female patient. Medical history and concurrent conditions were not reported. Patient had no known allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) Lot # J011651; Expiration date: 22-AUG-2015 (reported as 31-AUG-2014). In 2014, the patient had swelling of the arm, body aches, weak and fever. Patient did not had any trouble breathing and have no known allergies. Once patient was put on antibiotics, patient got better. This is one of 4 reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-MAR-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. The pharmacist reported that the patient received ZOSTAVAX that was improperly stored at 27.1F for 30 hours (also reported as stored at 27.1F for 24 hrs). No adverse effects were reported. The outcome of received ZOSTAVAX that was improperly stored at 27.1 F for 30 hrs and no adverse effects were reported as unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an approximately 66 year old male patient. On 14-FEB-2014 the patient was vaccinated with ZOSTAVAX (lot # J011341, expiration date: 13-DEC-2014). Now the patient had a prescription for a MEDROL dosepack and had filled a prescription for amoxicillin (manufacturer unknown) on 11-MAR-2014. The reason the patient was prescribed these medications was not known by the nurse. The nurse stated that the patient also was started on a new medication, tamsulosin (manufacturer unknown) on 05-MAR-2014 for unspecified reason. On an unknown date, the patient experienced adverse event. On unknown date the patient sought medical attention with unknown method. The outcome of adverse event was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: Lightheadedness followed by lapse of consciousness and seizures.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Irritability, Pyrexia, Urine analysis normal
Clinical narrative: Was fussy that night. Spiked temp at 1 am. Had a seizure at 9 am on 03/21/2014.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Pharyngitis streptococcal, Pneumonia, Pyrexia
Clinical narrative: I'm not sure about exact dates of the vaccines. But since his first vaccines he has been nothing but sick with pneumonia, rsv, strep throat, diarrhea, fevers, etc. My son has been beyond sick during his first year of life. I believe the vaccines have compromised his immune system. He is in daycare full time as his brothers have too...and he is by far the most ill of all children I know. Because of his loss of immunity due to vaccines, my child has spent over 80% of his short life very very very sick. We will discontinue vaccinating the children because of the adverse effect the vaccines have imposed on our youngest sons immunity. Also, I cannot say if my son will recover from being sick all the time, but I fully and truly believe that the vaccines compromised his immunity. No child should be sick every 3-4 days. Although this isn't as severe a reaction as some, I am positive he's sick from vaccines.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus generalised, Swollen tongue
Clinical narrative: Itching all over body, swollen tongue and lips.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Round red rash size of 50 cent piece. Symptoms: Itching.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site (left arm) swelling.
Age: 55.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Injection site joint pain, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: From time of injection mild pain that grew every day. Aprox. 30+days later increased pain, dull ache in left shoulder. 10 days after pain in left shoulder joint, weakness and burning in area. This same pain I was feeling in left shoulder, I have in right shoulder. And now has traveled into both forearms. 3/18/2014 Had Xrays R&L shoulders, no sign of injuries, etc. This day I had injection of Cortisone in left shoulder, as pain was more, and constant. 3/22/2014 I still have no relief.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Injection site erythema, Injection site pruritus, Pyrexia, Vaccination site swelling
Clinical narrative: Swelling at vaccine site, redness, itching. Low grade fever, chills.
Age: 1.02
Sex: F
Vaccine: HEPA, MEN, PPV, VARCEL
Symptoms: Gastroenteritis, Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting for 2 weeks, fever spikes on and off for 3 days, gastroenteritis diagnosed. Resulted in child having to be put back on formula for 3 months and wean solid foods back in.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: Staff member received 2nd Hep B vaccine 3/20 - on 3/21 reported to ICN pain in neck, bilat wrists, bilat ankles, numb tingle of hand and feet, difficulty ambulatory due to pain to ER for eval Dx "myalgia",
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Staff member received 2nd Hep B vaccine 3/20 - on 3/21 reported to ICN pain in neck, bilat wrists, bilat ankles, numb tingle of hand and feet, difficulty ambulatory due to pain to ER for eval Dx "myalgia",
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Pt developed a red, warm, swollen arm. Stated it was painful to move. Discovered pt actually had same vaccine in 9/2003 but didn't remember. No problems then but maybe the close proximity of the next shot caused reaction. Told pt to take BENADRYL and ibuprofen and to see dr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 12H of receiving vaccination pt noticed redness and tenderness at inj. site. She called the pharmacy where she was vaccinated 48H after inj. complaining of pain, swelling, heat, redness, and painful to touch at inj site, it seemed to be traveling toward wrist. 96H later pt saw PCP for pain. PCP said the inj. caused a contusion on the muscle.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle contusion
Clinical narrative: Within 12H of receiving vaccination pt noticed redness and tenderness at inj. site. She called the pharmacy where she was vaccinated 48H after inj. complaining of pain, swelling, heat, redness, and painful to touch at inj site, it seemed to be traveling toward wrist. 96H later pt saw PCP for pain. PCP said the inj. caused a contusion on the muscle.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth to R deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LARGE, red, hot to the touch, swollen area on my child's thigh around the injection site.  She says it's painful to the touch.  I did not notice this reaction yesterday or on the day the vaccine was given.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Pain in upper left arm permeating down to elbow.  Very sore at top of left arm.  Definitely sore to the touch.  Trouble sleeping, lifting arm over head and during stretching movements.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Visual impairment, Vitreous detachment, Vitreous floaters
Clinical narrative: All of the sudden my right eye started having "blood strings" going thru it.  I could not see them on the outside but could see them in my vision range.  I called the eye Dr. and left a message.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Blister, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: ELEVATED TEMPERATURE OF 101.3 TREATED WITH TYLENOL. ON 3/21/2014 AT 10:30 AM SHE DEVELOPED SEVERE RASH ON BUTTOCKS WITH BLISTERS ON BACK OF LEGS. BLISTERS SPREAD FURTHER. CHICKENPOX DIAGNOSED ON 3/22/2014 AT 12:30 PM. TREATING WITH OTC CALAMINE LOTION. SHE STILL HAS A FEVER OF 100 AS OF 3/23/2014 AT 4:50 PM.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Agitation, Cellulitis, Chills, Feeling cold, Headache
Clinical narrative: Malaise, cold chills, agitation, headache, swelling, redness and stiffness at the injection site. Unable to lift my forearm.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: Malaise, cold chills, agitation, headache, swelling, redness and stiffness at the injection site. Unable to lift my forearm.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Feeling cold, Injection site erythema, Injection site swelling
Clinical narrative: Malaise, cold chills, agitation, headache, swelling, redness and stiffness at the injection site. Unable to lift my forearm.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Local swelling, Mobility decreased, Pain
Clinical narrative: Malaise, cold chills, agitation, headache, swelling, redness and stiffness at the injection site. Unable to lift my forearm.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Dermatitis, Gingival bleeding, Lip swelling, Nasal congestion
Clinical narrative: 2-21 11am AFLURIA PFS administered, 3pm sore arm, 8pm windburn, clogged nose. 2-22 5am woke up w/ swollen lips and edema, gums were bleeding - pt also notes Hemoglobin C trait, which affects clotting. 2-22 9am swelling stopped but lip still red.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Pain in extremity
Clinical narrative: 2-21 11am AFLURIA PFS administered, 3pm sore arm, 8pm windburn, clogged nose. 2-22 5am woke up w/ swollen lips and edema, gums were bleeding - pt also notes Hemoglobin C trait, which affects clotting. 2-22 9am swelling stopped but lip still red.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt c/o rash on face.