chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia, Insomnia, Irritability, Muscle spasms
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Vaccination site bruising, Vaccination site haematoma
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Blood test normal, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sensory disturbance, Vaccination site haematoma
Clinical narrative: Case number PHEH2014US022638, an initial spontaneous report received from a healthcare professional (clinical director) on 07 Nov 2014, with a follow up report received from a physician on 19 Jan 2015. This report refers to a 44 years old male patient. His medical history was not reported. Concomitant medication included SYNTHROID via oral route at a daily dose of 137 mcg for the treatment of hypothyroidism. The patient received FLUVIRIN in the past on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly at a dose of 0.5 ml in left deltoid on 07 Oct 2014. It was reported that 1 hour after the shot, he started to feel off and then started to feel numbness at the vaccination site on left arm. He started to feel worse over the next few weeks so much that he would have to consciously think about propping his arm up when at the computer. On an unknown date, his leg started going numb. At about 2 and half weeks, he noticed a large red hematoma about 3 inches at the vaccination site. He also experienced queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and,  arm bruise over injection site. On 31 Oct 2014, no focal neurological issue was noticed and bruising at injection site was fine by that day. At 3.5 weeks, he had sort of balance issues, kind of dizzy and off. He got better, but still had sensations in his arm and leg. He went to doctor, had all blood work which was negative. He did not undergo scans yet. The outcome of queasy sensation, unsteady feeling, left leg and arm weakness, less attentive and, arm bruise over injection site was reported as complete recovery. Queasy sensation and unsteady feeling was resolved by Nov 2014. Outcome of sensations in arm and leg was reported as condition unchanged and that of other events was reported as condition improving. Events were reported as non-serious. Causality was not reported. Follow up report received from a physician on 19 Jan 2015: Updated patient demographics, vaccination history, concomitant medication, vaccination details, new events (queasy sensation, left leg and arm weakness, less attentive and arm bruise over injection site), outcome and seriousness.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020968 is a combined initial and follow-up spontaneous report from a health care professional received on 16 Oct 2015. This report refers to a 48-year-old female patient. Historical conditions were not reported. No concomitant medication were reported. The patient was vaccinated with intramuscular dose of FLUVIRIN (batch number: 1515601) at a dose of 1 ml instead of 0.5 ml on 14 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020962 is a combined initial and follow-up spontaneous report from a health care professional received on 16 Oct 2015. This report refers to a 42 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with intramuscular dose of FLUVIRIN (batch number: 1515601) at a dose of 1 ml instead of 0.5 ml on 14 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020970, is an initial spontaneous report from a healthcare professional received on 16 Oct 2015. This report refers to a 44 year old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1515601) 1 ml dose instead of 0.5 ml intramuscular on 14 Oct 2015. No adverse event was reported following the maladministration (overdose).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020971, is an initial spontaneous report from a healthcare professional received on 16 Oct 2015. This report refers to a 32 year old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1515601) 1 ml dose instead of 0.5 ml intramuscular on 14 Oct 2015. No adverse event was reported following the maladministration (overdose).
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Case number PHEH2015US020337, is an initial spontaneous report from a pharmacist received on 08 Oct 2015. This report refers to an adult male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516901, expiry date: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. On the same date, after vaccination he experienced bleeding and swelling at injection site. It was reported that FLUVIRIN was administered to two patients consecutively (vaccine was drawn from the same multidose vial of FLUVIRIN) and they did not experience any anaphylactic or systemic reactions. The outcome of events was reported as unknown. The events seriousness was reported as non-serious and causality of the events was not reported. Following an internal review for the data received on 08-OCT-2015, significant case correction was performed: Changed vaccination site bleeding listed to unlisted.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Case number PHEH2015US020333, is an initial spontaneous report from a pharmacist received on 08 Oct 2015. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516901, expiry date: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. On the same date, after vaccination she experienced bleeding and swelling of injection site. It was reported that FLUVIRIN was administered to two patients consecutively (vaccine was drawn from the same multidose vial of FLUVIRIN) and they did not experience any anaphylactic or systemic reactions. The outcome of events was reported as unknown. The events seriousness was reported as non-serious and causality of the events was not reported. Following an internal review for the data received on 08-OCT-2015, significant case correction was performed: Changed vaccination site bleeding listed to unlisted.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, CSF white blood cell count increased, Culture urine negative, Irritability
Clinical narrative: On 12/12/15 developed fever- CBC and UA reassuring. By 12/14/15 fever persisted and had increasing fussiness- CSF showed over 500 WBCs.  Baby was admitted to hospital and treated with antibiotics and antivirals for meningitis.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Meningitis aseptic, Meningitis viral, Pyrexia, Viral test negative
Clinical narrative: On 12/12/15 developed fever- CBC and UA reassuring. By 12/14/15 fever persisted and had increasing fussiness- CSF showed over 500 WBCs.  Baby was admitted to hospital and treated with antibiotics and antivirals for meningitis.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Headache
Clinical narrative: PAIN IN BOTH SHOULDERS AND BOTH ARMS, AND HEADACHE THAT BEGAN DAY FOLLOWING VACCINATION AND WORSENED DAILY.  PAIN IS ACUTE AT NIGHT AND INTERFERES WITH SLEEP. LOSS OF STRENGTH AND MOBILITY IN BOTH ARMS AND CONTINUOUS PAIN IN JOINTS, MUSCLES, SHOULDERS AND BACK.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: PAIN IN BOTH SHOULDERS AND BOTH ARMS, AND HEADACHE THAT BEGAN DAY FOLLOWING VACCINATION AND WORSENED DAILY.  PAIN IS ACUTE AT NIGHT AND INTERFERES WITH SLEEP. LOSS OF STRENGTH AND MOBILITY IN BOTH ARMS AND CONTINUOUS PAIN IN JOINTS, MUSCLES, SHOULDERS AND BACK.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Sleep disorder, X-ray
Clinical narrative: PAIN IN BOTH SHOULDERS AND BOTH ARMS, AND HEADACHE THAT BEGAN DAY FOLLOWING VACCINATION AND WORSENED DAILY.  PAIN IS ACUTE AT NIGHT AND INTERFERES WITH SLEEP. LOSS OF STRENGTH AND MOBILITY IN BOTH ARMS AND CONTINUOUS PAIN IN JOINTS, MUSCLES, SHOULDERS AND BACK.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 14-Jan-2016. This case involves a female patient (age was not reported) who was vaccinated with a first dose of Fluzone ID (batch number- UT5354BA, expiry date and route were not reported) in the arm on 19-Oct-2015 (her first time with the intradermal). Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient had experienced palpable lump that patient can feel under the area of redness and she stated that it was not painful and just mildly burned when she rubbed it. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from the events (reaction lasted for long (almost 3 months). Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient developed pain, erythema, warmth & induration at site of injection. No fevers. Went to urgent care same day, started on doxycycline to cover for cellulitis. Seen by myself on 2/5/16, induration was about 6x8 cm, with surrounding area 8x10cm of erythema.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Patient stated that shot was higher then normal and hurt very badly going in. She had left the Band-Aid on to show me and it was pretty high on the shoulder but I assured her that it of course was still in the deltoid muscle. She said that when she got home that day that she could not lift her arm and it hurt so badly that she could not lift it for the following 4 days. After that she said that she had a sharp pain in her arm and shoulder that kept her awake at night for the next 13 days. She finally reported sleeping through the night on day 14 after taking Ibuprofen and resting the arm through the entire day. She also reported muscle spasms in the bicep a few days after injection.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Patient stated that shot was higher then normal and hurt very badly going in. She had left the Band-Aid on to show me and it was pretty high on the shoulder but I assured her that it of course was still in the deltoid muscle. She said that when she got home that day that she could not lift her arm and it hurt so badly that she could not lift it for the following 4 days. After that she said that she had a sharp pain in her arm and shoulder that kept her awake at night for the next 13 days. She finally reported sleeping through the night on day 14 after taking Ibuprofen and resting the arm through the entire day. She also reported muscle spasms in the bicep a few days after injection.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Headache, Influenza, Nausea, Pain
Clinical narrative: Flu symptoms. Headache, nausea, fever, chills, aches. Treated as if it were the actual flu (liquids and Tylenol).
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Flu symptoms. Headache, nausea, fever, chills, aches. Treated as if it were the actual flu (liquids and Tylenol).
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLUX
Symptoms: Grip strength decreased, Injection site reaction, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: 4x6 red rash between shot and elbow toward center of arm. Thumb & back of hand swollen & itchy with no grip. Fingers swollen & tingly. Called office but they had already closed.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLUX
Symptoms: Rash erythematous
Clinical narrative: 4x6 red rash between shot and elbow toward center of arm. Thumb & back of hand swollen & itchy with no grip. Fingers swollen & tingly. Called office but they had already closed.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13, FLUX
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: 4x6 red rash between shot and elbow toward center of arm. Thumb & back of hand swollen & itchy with no grip. Fingers swollen & tingly. Called office but they had already closed.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Vaccination complication
Clinical narrative: Information has been received from a physician via company representative referring to a 14 year old female patient who was not pregnant. Medical history and concurrent condition were not reported. On an unspecified date the patient was vaccinated with the first dose of GARDASIL 9 (0.5 ml, route and lot# not reported) and on 09-OCT-2015 the patient was vaccinated with the second dosage (0.5 ml, intramuscular, lot# not reported). It was reported that the patient had adverse reaction to GARDASIL 9. On 09-OCt-2015, the patient developed site injection distress (entire arm). The patient went to Emergency Room and had treatment on the same day. The patient was hospitalized on an unspecified date. The vaccine was continued. At the time of reporting, the patient was recovering from the event. Additional information is not expected as there was no physician's contact information.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Balance disorder, Blood test, Computerised tomogram, Dizziness, Nuclear magnetic resonance imaging
Clinical narrative: WHEN I SAT UP IN BED UPON AWAKENING, I WAS HAVING A SENSATION OF REELING (NOT A SPINNING ROOM-MAYBE LIKE LOOKING OVER A CLIFF OR BEING ON A ROCKING BOAT) I HAD NO CONTROL OVER MY SWAYING BODRY) THIS LASTED PERHAPS 30 SECONDS-1 MINUTE. AGAIN OCCURED THAT MORNING WHILE SITTING ON TNE TOILET. THE EVENT REPEATED ITSELF FOR A WEEK. ON OCTOBER 10, 2015 I NEEDED TO CALL AN AMBULANCE AS THIS REELING AND SWAYING OCCURRED WHILE WALKING. I WAS SENT HOME FROM THE ER WITH NO DIAGNOSIS. (PERHAPS UNRELATED- ON 10/14/2015 HAS AN EPISODE OF SYNCOPE WHEN AT THE ENT OFFICE. DR SENT ME TO ER, UPON WHICH I WAS HOSPITALIZED. AFTER MANY SPECIALISTS (CARDIAC, ENT, NEUROLOGY NO DIAGNOSIS YET) I WAS EXPERIENCING ORTHOSTATIC HYPOTENSION WITH TACHYCARDIA IN THE HOSPITAL.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Orthostatic hypotension, Specialist consultation, Syncope, Tachycardia
Clinical narrative: WHEN I SAT UP IN BED UPON AWAKENING, I WAS HAVING A SENSATION OF REELING (NOT A SPINNING ROOM-MAYBE LIKE LOOKING OVER A CLIFF OR BEING ON A ROCKING BOAT) I HAD NO CONTROL OVER MY SWAYING BODRY) THIS LASTED PERHAPS 30 SECONDS-1 MINUTE. AGAIN OCCURED THAT MORNING WHILE SITTING ON TNE TOILET. THE EVENT REPEATED ITSELF FOR A WEEK. ON OCTOBER 10, 2015 I NEEDED TO CALL AN AMBULANCE AS THIS REELING AND SWAYING OCCURRED WHILE WALKING. I WAS SENT HOME FROM THE ER WITH NO DIAGNOSIS. (PERHAPS UNRELATED- ON 10/14/2015 HAS AN EPISODE OF SYNCOPE WHEN AT THE ENT OFFICE. DR SENT ME TO ER, UPON WHICH I WAS HOSPITALIZED. AFTER MANY SPECIALISTS (CARDIAC, ENT, NEUROLOGY NO DIAGNOSIS YET) I WAS EXPERIENCING ORTHOSTATIC HYPOTENSION WITH TACHYCARDIA IN THE HOSPITAL.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, CSF glucose increased, CSF protein increased, Demyelination, Muscular weakness
Clinical narrative: Leg weakness on 1/29. On 1/30 returned to ER with vomiting and progressive bilateral lower extremity weakness and inability to walk.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Vomiting
Clinical narrative: Leg weakness on 1/29. On 1/30 returned to ER with vomiting and progressive bilateral lower extremity weakness and inability to walk.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: First patient noticed her arm at the injection site was red swollen, sore and warm.  Then the pain started going up her arm and into her neck. She woke about 4am the next morning with some difficulty breathing. She waited until about 7am and went to the store and purchased Benadryl. the Benadryl helped a lot.  She took it for a couple of days.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Neck pain
Clinical narrative: First patient noticed her arm at the injection site was red swollen, sore and warm.  Then the pain started going up her arm and into her neck. She woke about 4am the next morning with some difficulty breathing. She waited until about 7am and went to the store and purchased Benadryl. the Benadryl helped a lot.  She took it for a couple of days.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site dysaesthesia, Injection site pain, Insomnia, Pain
Clinical narrative: Adverse reaction to pneumococcal vaccine, injection 1 day previous.  Patient complains of severe pain 8/10 and dysesthesia on her left arm almost immediately after getting her PPSV yesterday at our clinic. Pain limits patient's ability to move her arm and she was not able to sleep last night.  Location is left upper arm, lateral aspect, at deltoid muscle.  There is no evidence of erythema, edema, or mass, but tenderness on touch. Pain is described as shooting.  Patient prescribed anti-inflammatory and nerve pain medication and requested to return in a week.  Note that patient we provided with VIS in advance of the injection and had reported no prior reactions to vaccines.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to pneumococcal vaccine, injection 1 day previous.  Patient complains of severe pain 8/10 and dysesthesia on her left arm almost immediately after getting her PPSV yesterday at our clinic. Pain limits patient's ability to move her arm and she was not able to sleep last night.  Location is left upper arm, lateral aspect, at deltoid muscle.  There is no evidence of erythema, edema, or mass, but tenderness on touch. Pain is described as shooting.  Patient prescribed anti-inflammatory and nerve pain medication and requested to return in a week.  Note that patient we provided with VIS in advance of the injection and had reported no prior reactions to vaccines.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, headache, myalgia, nausea, chills, decreased appetite within 24 hours of vaccine administration.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Nausea
Clinical narrative: Fatigue, headache, myalgia, nausea, chills, decreased appetite within 24 hours of vaccine administration.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Gait disturbance, Injection site pain, Pain, Screaming, Tremor
Clinical narrative: Mother stated child's legs were trembling and she was screaming in pain and would not let anyone touch her legs especially her rt. leg. No redness or swelling of legs.  No fever. She slept the night and was eating and drinking. The morning post inoculations she was using a small shopping cart to walk.  Mother had administered acetominophen with minimal relief. Mother was going to use Motrin which was recommended by physician.
Age: 15.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Body temperature increased, Hyperaesthesia, Pain
Clinical narrative: Patient has increased temp (99.9), increased sensitivity in skin, mild body aches. Patient rested in health center and encouraged increased PO fluids.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Culture stool negative, Haematochezia, Urine analysis normal, X-ray normal
Clinical narrative: Bloody stools.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea x 5 days, blood in 1 stool on 12/9/15.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: C-reactive protein normal, Condition aggravated, Decreased appetite, Full blood count normal, Haematochezia
Clinical narrative: Stools became more mucous-filled and had streaks of blood the day after vaccination.  Seen in my office where hemoccult was positive.  She was otherwise well-appearing, so was sent home.  The following day she had more blood in stool and was not feeding as well as usual.  Went to ER that night (3/11/15). KUB was negative, CBC and RP were unremarkable, CRP was normal.  Fed well in ER so was discharged home.  She was given a diagnosis of possible viral gastroenteritis vs. milk protein allergy at the time. After her 4-month vaccines (Dtap, Hib, IPV, PCV, Rotarix) were given, she again had bloody stools the following day.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Mucous stools, Occult blood positive, Renal function test normal, Urinary system X-ray, X-ray normal
Clinical narrative: Stools became more mucous-filled and had streaks of blood the day after vaccination.  Seen in my office where hemoccult was positive.  She was otherwise well-appearing, so was sent home.  The following day she had more blood in stool and was not feeding as well as usual.  Went to ER that night (3/11/15). KUB was negative, CBC and RP were unremarkable, CRP was normal.  Fed well in ER so was discharged home.  She was given a diagnosis of possible viral gastroenteritis vs. milk protein allergy at the time. After her 4-month vaccines (Dtap, Hib, IPV, PCV, Rotarix) were given, she again had bloody stools the following day.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Eye movement disorder, Hypersomnia, Irritability, Posture abnormal
Clinical narrative: After receiving vaccine at approximately 8:30 am mom called the office at 4:15 pm stated child slept almost all day from 10 AM - 4 PM. Woke up very cranky and irritable. Mom observed eyes rolling back and noticed child had a hard time holding his head up right. Advice to go to the emergency room. Followed-up next day and mom did not take child to E.R.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Antiphospholipid antibodies negative, Arthralgia, Bone pain, Borrelia test negative
Clinical narrative: Muscle weakness and pain, bone and joint pain - felt arthritic, could not drive because of muscle weakness. Could barely walk for 10 days - chiropractic care, E.R. visit, phys. visit - lab tests.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Hepatitis B antibody positive, Muscular weakness, Myalgia
Clinical narrative: Muscle weakness and pain, bone and joint pain - felt arthritic, could not drive because of muscle weakness. Could barely walk for 10 days - chiropractic care, E.R. visit, phys. visit - lab tests.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: The evening after receiving FLUMIST patient began with sore throat, stuffy nose, headache and body aches. No specific treatment has been needed.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Muscular weakness
Clinical narrative: Flu vaccine given 2/8/16 about 10 AM, about 6 PM - she developed dizziness, difficulty of walking, weakness of both lower extremities. Refer to ER.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling
Clinical narrative: R arm deltoid posterior area is red, raised, hard and warm to the touch, circumference about 4 inches. There is some pink, irritated area also wrapping toward the armpit. Patient's temperature is 98.8. Chills reported the night before.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: R arm deltoid posterior area is red, raised, hard and warm to the touch, circumference about 4 inches. There is some pink, irritated area also wrapping toward the armpit. Patient's temperature is 98.8. Chills reported the night before.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Hep B vaccine was given to the baby.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient started with diffusely worsening hives all over.
Age: 44.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Inflammation, Pain, Pyrexia, Skin warm
Clinical narrative: Huge red, inflamed area, hot to touch, low grade fever, painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: Maternal grandmother describes that skin overlying site of vaccination became red, warm to touch and tender.  After 2-3 days, the overlying 3-4 inch area of redness, warmth and tenderness improved and a knot was felt at the site of vaccination.  Size of knot was initially 2 to 2 1/2 inches but has improved to size of nickel.  Soreness is improving but not resolved completely.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Since getting FLUZONE HIGH DOSE, patient has continued to have low grade fevers, malaise and myalgia (still 4 months out).
Age: 24.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth inferior to (R) deltoid. Started 2/10/16- looks as above 2/12/16. States he feels better.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Significant pain at site of injection requiring visit to ER/Orthopedist.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Fatigue. Heaviness in arms and legs.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient states she received a PREVNAR vaccine and had stiff neck the next day. She said she could not turn left or right.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product physical issue
Clinical narrative: Case number PHEH2015US021588 is an initial spontaneous report received from a health care professional on 21 Oct 2015. This report refers to a 56 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly, whose vial was leaking where the diaphragm and metal ring meet on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported following this medication error.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Headache, Hyperacusis
Clinical narrative: Severe headache, sensitivity to light and noise, extreme fatigue, loss of appetite, high fever, up to 102.7. We missed two days of school as of February 12, 2016.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Photophobia, Pyrexia
Clinical narrative: Severe headache, sensitivity to light and noise, extreme fatigue, loss of appetite, high fever, up to 102.7. We missed two days of school as of February 12, 2016.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPV, VARCEL
Symptoms: Clumsiness, Fatigue, Irritability, Lethargy, Skin warm
Clinical narrative: Since the injections my son has been irritable, and very sleepy. He usually resists afternoon naps, but since the shots, he has been unusually sleepy and slept most afternoons without prodding. Today, he woke up saying he was tired and sleepy, which is unlike him.  He has also been clumsy and running into things and fighting unnecessarily with his older brother. His head feels warm, but he does not have a fever. He just seems lethargic.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPV, VARCEL
Symptoms: Somnolence
Clinical narrative: Since the injections my son has been irritable, and very sleepy. He usually resists afternoon naps, but since the shots, he has been unusually sleepy and slept most afternoons without prodding. Today, he woke up saying he was tired and sleepy, which is unlike him.  He has also been clumsy and running into things and fighting unnecessarily with his older brother. His head feels warm, but he does not have a fever. He just seems lethargic.
Age: 1.29
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Measles, Rash
Clinical narrative: Rash started to develop at home, patient seen in clinic on 2/9/16 and discussed with infection disease attending and thought to be a post-vaccination measles rash.
Age: 16.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Abdominal pain upper, Abnormal behaviour, Headache, Malaise, Pyrexia
Clinical narrative: Patient returned to school after appointment and went to school health, did not feel well.  Nurse/caregiver at school called mother and reported that he seemed "loopy". Pt symptoms progressed to fever, headache, stomach ache and general malaise. Lasted for days and headaches for a week.  At the end of symptoms, patient developed hives the last few days, being sick over one week total.
Age: 16.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Urticaria
Clinical narrative: Patient returned to school after appointment and went to school health, did not feel well.  Nurse/caregiver at school called mother and reported that he seemed "loopy". Pt symptoms progressed to fever, headache, stomach ache and general malaise. Lasted for days and headaches for a week.  At the end of symptoms, patient developed hives the last few days, being sick over one week total.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Was administered an expired shingles vaccine.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Albumin CSF increased, Bowel movement irregularity, CSF immunoglobulin increased, CSF monocyte count decreased, CSF neutrophil count increased
Clinical narrative: Bilateral lower extremity weakness x 4 days approximately 3 weeks after receiving vaccination. Approximately 3 weeks after vaccination she noticed a numb (thick) sensation in her toes. In the ensuing days the numbness ascended to her knees and began to involve the forearms and hands as well as her lips. Concurrent with the numbness  or shortly thereafter, the limbs also became weak. She has also noted some weakness with speaking. She reports having some accidents with urinating and no recent bowel movements. She reports feeling short of breath.  Reduced knee reflexes, subjective loss of sensation in a stocking and glove pattern.Considerable give-way weakness and apparent reduced effort; with encouragement and full effort, she was able to give 5/5 strength in all muscle groups.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: CSF oligoclonal band present, CSF protein increased, CSF red blood cell count positive, Dyspnoea, Exposure during pregnancy
Clinical narrative: Bilateral lower extremity weakness x 4 days approximately 3 weeks after receiving vaccination. Approximately 3 weeks after vaccination she noticed a numb (thick) sensation in her toes. In the ensuing days the numbness ascended to her knees and began to involve the forearms and hands as well as her lips. Concurrent with the numbness  or shortly thereafter, the limbs also became weak. She has also noted some weakness with speaking. She reports having some accidents with urinating and no recent bowel movements. She reports feeling short of breath.  Reduced knee reflexes, subjective loss of sensation in a stocking and glove pattern.Considerable give-way weakness and apparent reduced effort; with encouragement and full effort, she was able to give 5/5 strength in all muscle groups.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Hyporeflexia, Muscular weakness, Sensory loss
Clinical narrative: Bilateral lower extremity weakness x 4 days approximately 3 weeks after receiving vaccination. Approximately 3 weeks after vaccination she noticed a numb (thick) sensation in her toes. In the ensuing days the numbness ascended to her knees and began to involve the forearms and hands as well as her lips. Concurrent with the numbness  or shortly thereafter, the limbs also became weak. She has also noted some weakness with speaking. She reports having some accidents with urinating and no recent bowel movements. She reports feeling short of breath.  Reduced knee reflexes, subjective loss of sensation in a stocking and glove pattern.Considerable give-way weakness and apparent reduced effort; with encouragement and full effort, she was able to give 5/5 strength in all muscle groups.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Urinary incontinence, Urine cannabinoids increased, Urine ketone body present
Clinical narrative: Bilateral lower extremity weakness x 4 days approximately 3 weeks after receiving vaccination. Approximately 3 weeks after vaccination she noticed a numb (thick) sensation in her toes. In the ensuing days the numbness ascended to her knees and began to involve the forearms and hands as well as her lips. Concurrent with the numbness  or shortly thereafter, the limbs also became weak. She has also noted some weakness with speaking. She reports having some accidents with urinating and no recent bowel movements. She reports feeling short of breath.  Reduced knee reflexes, subjective loss of sensation in a stocking and glove pattern.Considerable give-way weakness and apparent reduced effort; with encouragement and full effort, she was able to give 5/5 strength in all muscle groups.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Butterfly rash, Dizziness, Dry eye, Paraesthesia oral, Rash
Clinical narrative: Tingling around lips, butterfly rash on face; 3 weeks later rash extending to backs of hands, dry blurry eyes, dizzy spells. Treated with Cetirizine daily with daily Zantac, equipped with Epi-pen in case of emergency.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Tingling around lips, butterfly rash on face; 3 weeks later rash extending to backs of hands, dry blurry eyes, dizzy spells. Treated with Cetirizine daily with daily Zantac, equipped with Epi-pen in case of emergency.
Age: 0.85
Sex: M
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: 10 month old patient received FluMist, possible chance of increased wheezing. No data available on use under 1 year old.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Chills, Cough, Diarrhoea, Dry skin, Erythema
Clinical narrative: Fever, diarrhea, cough, runny nose, congestion, dry patches of skin on legs, irritabile, sweating, chills/shakes, red cheeks.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Hyperhidrosis, Irritability, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever, diarrhea, cough, runny nose, congestion, dry patches of skin on legs, irritabile, sweating, chills/shakes, red cheeks.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: Fever, diarrhea, cough, runny nose, congestion, dry patches of skin on legs, irritabile, sweating, chills/shakes, red cheeks.
Age: 11.0
Sex: M
Vaccine: FLUX, HPVX, MEN
Symptoms: Pallor, Seizure
Clinical narrative: Seizure, very pale skin, thought he was asleep lasted about 30 seconds.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAPIPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy, widespread hives within 10 minutes of vaccination. Administered diphenhydramine 50 mg/ml Injected 0.25 ml IM x 1. Observation by RN and with NP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAPIPV, MMRV
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Itchy, widespread hives within 10 minutes of vaccination. Administered diphenhydramine 50 mg/ml Injected 0.25 ml IM x 1. Observation by RN and with NP.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Allodynia, Alopecia, Arthralgia, Asthenia, Autonomic nervous system imbalance
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Complex regional pain syndrome, Costochondritis, Disability, Dizziness
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Facial paresis, Fatigue, Fibromyalgia, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.