chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information had been received on21-OCT-2016 from a nurse regarding a 66 year old female with cerebral palsy, glaucoma, osteoporosis and allergy to penicillin. The nurse reported that the patient received a dose of PNEUMOVAX 23 intramuscular 0.5ml once (lot# M022947, expiration date 12-NOV-2017) on 29-SEP-2016. Concomitant medication included aspirin and TYLENOL. On 30-SEP-2016, the patient developed "warmth, redness, soreness and swelling from the deltoid to the elbow in the same arm that PNEUMOVAX 23 was given" (unspecified arm). The nurse stated that the patient was seen in the office on an unspecified date after receiving the PNEUMOVAX 23, in regards to reaction. When asked present status, the nurse stated, "she is doing better with just a little soreness at the injection site still". No further information was provided. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Entire upper half of arm swollen, red, warm, and itchy.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding patients' pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was provided. On unknown dates, patients were concomitantly vaccinated with doses of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration dates were not provided, along with doses of influenza virus vaccine (unspecified) (dose, formulation, route of administration, lot# and expiration date were not specified). On an unknown dates, patients experienced injection site reaction. The nurse stated, that some of them were injection site cellulitis. The outcome of injection site reactions and injection site cellulitis was not reported. The relatedness between adverse events and the suspect vaccines was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: Cellulitis to site of Varicella vaccine on left posterior arm and not cramps, but cramp-like soreness to lower extremities - mild.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling and hardness at site of injection (swollen area about 3 and 1/2 inches in diameter.  I referred her to call her dr to discuss it.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Rash, Swelling face
Clinical narrative: Patient's mother reported that patient was "breaking out" a little while later patient was being taken to the Emergency Room for swelling in the face and rash.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Eye pruritus, Fatigue, Headache, Ocular hyperaemia, Pain of skin
Clinical narrative: FIRST I BROKE OUT ON FOREHEAD WITH BLEB LIKE, RED, VERY ITCHY BUMPS.  BY THE NEXT DAY, MY LEFT EYE ORBIT, FOREHEAD, HAIR, SKIN AROUND MY LEFT TEMPLE WAS TOO SORE TOO TOUCH.  HURT VERY BADLY.  VERY BAD HEADACHE, PARTICULARLY ON THE LEFT SIDE OF HEAD.  CONTINUED TO HAVE THE RED LESIONS ON FOREHEAD THAT AT TIMES FEEL LIKE PIN PRICKS.  VERY TIRED, FREQUENT HEADACHES, AND SKIN ON AND AROUND FOREHEAD REMAINS SORE TO THE TOUCH. HURTS.  ALSO HAD ITCHY AND REDNESS OF LEFT EYE WHICH I WAS VERY CONCERNED THAT IT MIGHT BE SHINGLES IN MY EYE, THUS I WENT TO MY EYE DOCTOR. MY EYE DOCTOR STATED NO SHINGLES IN MY EYE, BUT DIAGNOSED BREAKOUT OF SAME ON MY FOREHEAD AND PRESCRIBED AN ANTIVIRAL MED.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: FIRST I BROKE OUT ON FOREHEAD WITH BLEB LIKE, RED, VERY ITCHY BUMPS.  BY THE NEXT DAY, MY LEFT EYE ORBIT, FOREHEAD, HAIR, SKIN AROUND MY LEFT TEMPLE WAS TOO SORE TOO TOUCH.  HURT VERY BADLY.  VERY BAD HEADACHE, PARTICULARLY ON THE LEFT SIDE OF HEAD.  CONTINUED TO HAVE THE RED LESIONS ON FOREHEAD THAT AT TIMES FEEL LIKE PIN PRICKS.  VERY TIRED, FREQUENT HEADACHES, AND SKIN ON AND AROUND FOREHEAD REMAINS SORE TO THE TOUCH. HURTS.  ALSO HAD ITCHY AND REDNESS OF LEFT EYE WHICH I WAS VERY CONCERNED THAT IT MIGHT BE SHINGLES IN MY EYE, THUS I WENT TO MY EYE DOCTOR. MY EYE DOCTOR STATED NO SHINGLES IN MY EYE, BUT DIAGNOSED BREAKOUT OF SAME ON MY FOREHEAD AND PRESCRIBED AN ANTIVIRAL MED.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives spread locally near injected shoulder and back. No reaction at injection site.
Age: 0.83
Sex: M
Vaccine: FLU4, HIBV
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from consumer on 02 November 2016. This case involves 10-month-old male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT and dose of ACT HIB (batch number, expiry date, route and site of administration was not reported for both vaccine) on 13 October 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported as unknown. Patient received one other vaccine as a concomitant six weeks prior but patient declined to say what it was. On 20 October 2016, seven day following the vaccination, patient woke up with numbness of right face which persists and was diagnosed with Bell's palsy. On an unspecified date patient was hospitalized. Lab data and corrective treatment was not reported. Patient was not recovered from events. List of documents held by sender: none. Sender's Comments: Bells Palsy is listed with INFLUENZA QUADRIVAL A-B VACCINE but unlisted with HIB (PRP/T) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Hemiparesis
Clinical narrative: Employee c/o weakness to left side of body.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Imaging procedure, Laboratory test, Retching, Seizure
Clinical narrative: After getting flu shot started having headache on 9/25/16 and continue to get worse through 9/27 with then vomiting starting to the point of dry heaves and then went into a seizure and was transported to hospital where another seizure took place and admitted for further observation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: After getting flu shot started having headache on 9/25/16 and continue to get worse through 9/27 with then vomiting starting to the point of dry heaves and then went into a seizure and was transported to hospital where another seizure took place and admitted for further observation.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Peripheral swelling
Clinical narrative: Hematoma - swelling of left arm and bruising. TYLENOL 3/codeine.
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Pt is 5 1/2 months pregnant and received a varicella vaccine.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient state that "her arm got quite swollen and red. The swelling and redness are going down now and there is no sign of infection."
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Clients mother noted headache that occurred 2 hours after immunization that progressed to vomiting the day after. Recommended client seek medical care.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: Patient experienced flu like symptoms, fatigue, and general malaise.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling on outside of left arm (side) and back of arm, around the arm where the IM injection occurred. Swelling started on 11/3/16. Reported on 11/4/16, and patient did acknowledge improvement.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling to injection area, warm to touch, redness and mild tenderness.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. There was no information regarding patient's pertinent medical history, drug reactions and allergies. On 01-NOV-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M004318, expiry; 12-OCT-2017) intramuscular. The patient was using VIAGRA and other multiple unspecified medications concomitantly. The pharmacist reported that, on 02-NOV-2016 the patient was seen at an unspecified walk in clinic (demographics unspecified) because there was a hard nodule at the injection site, the arm was red to elbow and the patient had fever. The patient was diagnosed with cellulitis and treated with cephalexin on an unknown date in November 2016. The pharmacist also reported that patient was admitted to an unspecified hospital (demographics unspecified) on 04-NOV-2016, because the entire arm was red and the fever persisted. On an unknown date in November 2016, the patient's wife called the pharmacy and informed that, the patient's White Blood Cells (WBC) count was 18,000 (units unspecified; from an unspecified lab test). It was reported the patient was not recovered from the event cellulitis at the time of this report. There was no product quality complaint (PQC) involved. Upon internal review the event Cellulitis was considered to be serious due to hospitalization and being medically significant. Additional information has been expected.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. There was no information regarding patient's pertinent medical history, drug reactions and allergies. On 01-NOV-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M004318, expiry; 12-OCT-2017) intramuscular. The patient was using VIAGRA and other multiple unspecified medications concomitantly. The pharmacist reported that, on 02-NOV-2016 the patient was seen at an unspecified walk in clinic (demographics unspecified) because there was a hard nodule at the injection site, the arm was red to elbow and the patient had fever. The patient was diagnosed with cellulitis and treated with cephalexin on an unknown date in November 2016. The pharmacist also reported that patient was admitted to an unspecified hospital (demographics unspecified) on 04-NOV-2016, because the entire arm was red and the fever persisted. On an unknown date in November 2016, the patient's wife called the pharmacy and informed that, the patient's White Blood Cells (WBC) count was 18,000 (units unspecified; from an unspecified lab test). It was reported the patient was not recovered from the event cellulitis at the time of this report. There was no product quality complaint (PQC) involved. Upon internal review the event Cellulitis was considered to be serious due to hospitalization and being medically significant. Additional information has been expected.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. There was no information regarding patient's pertinent medical history, drug reactions and allergies. On 01-NOV-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M004318, expiry; 12-OCT-2017) intramuscular. The patient was using VIAGRA and other multiple unspecified medications concomitantly. The pharmacist reported that, on 02-NOV-2016 the patient was seen at an unspecified walk in clinic (demographics unspecified) because there was a hard nodule at the injection site, the arm was red to elbow and the patient had fever. The patient was diagnosed with cellulitis and treated with cephalexin on an unknown date in November 2016. The pharmacist also reported that patient was admitted to an unspecified hospital (demographics unspecified) on 04-NOV-2016, because the entire arm was red and the fever persisted. On an unknown date in November 2016, the patient's wife called the pharmacy and informed that, the patient's White Blood Cells (WBC) count was 18,000 (units unspecified; from an unspecified lab test). It was reported the patient was not recovered from the event cellulitis at the time of this report. There was no product quality complaint (PQC) involved. Upon internal review the event Cellulitis was considered to be serious due to hospitalization and being medically significant. Additional information has been expected.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, White blood cell count
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. There was no information regarding patient's pertinent medical history, drug reactions and allergies. On 01-NOV-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M004318, expiry; 12-OCT-2017) intramuscular. The patient was using VIAGRA and other multiple unspecified medications concomitantly. The pharmacist reported that, on 02-NOV-2016 the patient was seen at an unspecified walk in clinic (demographics unspecified) because there was a hard nodule at the injection site, the arm was red to elbow and the patient had fever. The patient was diagnosed with cellulitis and treated with cephalexin on an unknown date in November 2016. The pharmacist also reported that patient was admitted to an unspecified hospital (demographics unspecified) on 04-NOV-2016, because the entire arm was red and the fever persisted. On an unknown date in November 2016, the patient's wife called the pharmacy and informed that, the patient's White Blood Cells (WBC) count was 18,000 (units unspecified; from an unspecified lab test). It was reported the patient was not recovered from the event cellulitis at the time of this report. There was no product quality complaint (PQC) involved. Upon internal review the event Cellulitis was considered to be serious due to hospitalization and being medically significant. Additional information has been expected.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Intensive care, Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 year old male patient. The patient's medical history included liver transplant and gastric tube replacement. There was no information about the patient's concurrent conditions or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M004318, expiration date: 12-OCT-2017 (exact dose, route of administration and anatomical location were not provided). On 02-NOV-2016, the patient experienced swelling, fever and body sweats after vaccine administration. The patient was admitted to the hospital on the same date and on 03-NOV-2016, during the night he was transferred to intensive care unit (ICU). At the time of the report, the patient had no lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. The reporter considered the events to be life threatening. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 11/4/16 it was discovered last years' FLUZONE QUADRIVALENT vaccine was administered. The expiration date was 30Jun16. No Known reaction. Vaccine manufacturer was notified.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: On 11-4-16 it was discovered last year's FLUZONE QUADRIVALENT was administered. The expiration date on the vaccine was 30Jun16. No known reaction. Vaccine manufacturer was called.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Hypoaesthesia, Induration, Injection site pain
Clinical narrative: FATIGUE, NAUSEA, PAIN AT SIGHT, ARM NUMBNESS, HARD KNOT, REDNESS ON ARM AND UNDER ARMPIT.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: FATIGUE, NAUSEA, PAIN AT SIGHT, ARM NUMBNESS, HARD KNOT, REDNESS ON ARM AND UNDER ARMPIT.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Numbness of fingers and could not move arm to pick it up.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal discomfort, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: Today at 4 am our exchange student woke feeling dizzy and sick to her stomach.  Her arm is very sore also.  As of 12 noon, her symptoms are not improving.  She also has low-grade fever around 100 F.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Lip swelling, Muscle tightness, Respiratory distress
Clinical narrative: Child with difficulty breathing, swelling to lip and tongue, shaking, red skin, and tight jaw - mother's report. Mother gave Benadryl and took to ER (5 min) and no respiratory distress noted by ER, but given prednisolone and another dose of Benadryl. Tachycardia noted and erythema to skin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swollen tongue, Tachycardia, Tremor
Clinical narrative: Child with difficulty breathing, swelling to lip and tongue, shaking, red skin, and tight jaw - mother's report. Mother gave Benadryl and took to ER (5 min) and no respiratory distress noted by ER, but given prednisolone and another dose of Benadryl. Tachycardia noted and erythema to skin.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: Brachial Plexus Neuropathy.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Discomfort, Dizziness, Erythema, Fall, Induration
Clinical narrative: Patient complained of increased pain in right arm. Noted large area of redness/swelling/warmth to right upper extremity. Patient's skin was taut and area was swollen and painful. Patient's parent administered MOTRIN dosed by weight for pain and discomfort/swelling. Ice also applied to area. Patient also attended dance class per her normal schedule. Patient stated that twice during practice she suddenly became dizzy, blacked out, and fell to the floor. She does not know if she lost consciousness. Her friends around her had to help her up. Mom was instructed to draw a line on the skin to make sure that the redness began to subside and not spread. 36 hours after vaccine and treatment to area as discussed above, patient reported less pain and redness had not spread beyond the line but had not subsided. Right arm continues to be swollen and red area "feels hard" per patient's mom.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Patient complained of increased pain in right arm. Noted large area of redness/swelling/warmth to right upper extremity. Patient's skin was taut and area was swollen and painful. Patient's parent administered MOTRIN dosed by weight for pain and discomfort/swelling. Ice also applied to area. Patient also attended dance class per her normal schedule. Patient stated that twice during practice she suddenly became dizzy, blacked out, and fell to the floor. She does not know if she lost consciousness. Her friends around her had to help her up. Mom was instructed to draw a line on the skin to make sure that the redness began to subside and not spread. 36 hours after vaccine and treatment to area as discussed above, patient reported less pain and redness had not spread beyond the line but had not subsided. Right arm continues to be swollen and red area "feels hard" per patient's mom.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling, redness, warmth below injection site.  Patient also reported having fever on 11/8/16 but subsided as of 11/9/16. Patient took Aspirin after injection.  Advised patient to take Ibuprofen and use cool compress over the area.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Back pain, Blood test, Borrelia test negative, Chest X-ray
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Computerised tomogram, Constipation, Decreased appetite, Dehydration
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Electroencephalogram, Fatigue, Headache, Irritability
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lumbar puncture, Lymphadenopathy, Myalgia, Neck pain, Nuclear magnetic resonance imaging brain
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pelvic pain, Pyrexia, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound pelvis, Unresponsive to stimuli, Urine analysis
Clinical narrative: Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle spasms
Clinical narrative: Patient reports muscle spasms along LT rear deltoid same arm vaccine was administered. Symptoms have lasted a month with consistent occurrence throughout day.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Malaise, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient states she felt ill the night of receiving Pneumovax 23 vaccine. She said she experienced sore throat, congestion, and fever. She went to her primary physician to get treated for a bacterial infection.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Skin warm
Clinical narrative: Pt's mother reporter to us -> pt experienced heat/warmth around head and neck went to MD-got ZPAK/pred/acyclovir, awoke next day w/left ear deafness-is still being followed by MDs.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acoustic stimulation tests, Angiogram, Balance disorder, Computerised tomogram, Deafness unilateral
Clinical narrative: Pt's mother reporter to us -> pt experienced heat/warmth around head and neck went to MD-got ZPAK/pred/acyclovir, awoke next day w/left ear deafness-is still being followed by MDs.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: Pt's mother reporter to us -> pt experienced heat/warmth around head and neck went to MD-got ZPAK/pred/acyclovir, awoke next day w/left ear deafness-is still being followed by MDs.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Cardiac stress test, Cardiac stress test normal, Chest discomfort, Dry mouth
Clinical narrative: Chest tightness, shortness of breath, dry mouth, BP elevated 170/103, neck warm, felt cold, given nitroglycerin in hospital at 930pm, kept overnight for observation.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Feeling cold, Skin warm
Clinical narrative: Chest tightness, shortness of breath, dry mouth, BP elevated 170/103, neck warm, felt cold, given nitroglycerin in hospital at 930pm, kept overnight for observation.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Death
Clinical narrative: Patient seen in ER on 11-4-16 and pronounced dead - possible SIDS. She was seen by us on 10-24-16 and given vaccinations - awaiting ME report.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Vaccination was unusually painful upon administration. Within an hour, I was feeling really faint, nauseated, chest and neck red, and remarkable swelling of right upper arm. Bruise at injection site. Initial treatment: I lied down and put on ice on arm. Could not take pain reliever due to nausea. The next morning, I went to Employee Occupational Health and reported reactions.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Vaccination was unusually painful upon administration. Within an hour, I was feeling really faint, nauseated, chest and neck red, and remarkable swelling of right upper arm. Bruise at injection site. Initial treatment: I lied down and put on ice on arm. Could not take pain reliever due to nausea. The next morning, I went to Employee Occupational Health and reported reactions.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Blindness, Cerebral disorder, Feeding tube user, Laboratory test normal
Clinical narrative: Lost of eyesight, white matter missing from brain, dysphasia, feeding tube, muscle spasms, seizure disorder. No treatment doctors told me he had 6 months to live.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle spasms, Seizure
Clinical narrative: Lost of eyesight, white matter missing from brain, dysphasia, feeding tube, muscle spasms, seizure disorder. No treatment doctors told me he had 6 months to live.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Malaise
Clinical narrative: Patient said he wasn't feeling well since he received his flu shot.  He went to the hospital ER on 10/6/2016 and was admitted and stayed til 10/8/2016.  He was diagnosed with Guillain-Barre syndrome late affect.  He is having extensive follow up outpatient care.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting within 48hrs of receiving vaccines.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Confusional state, Full blood count, Generalised tonic-clonic seizure, Metabolic function test
Clinical narrative: 11/8/16-0530-odd behavior-confusion, then left-sided tonic clonic convulsion. EMS was called, child was seen at hospital ED.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: 11/8/16-0530-odd behavior-confusion, then left-sided tonic clonic convulsion. EMS was called, child was seen at hospital ED.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored PROQUAD (lot # L031600, expiration date 18-FEB-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Soreness in left shoulder/arm tingling in finger.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: 8x10cm redness warm, hot to touch 24hrs after injection-lasted 72hrs.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4Z42R, expiry date 3-th June 2017). Concurrent medical conditions included drug allergy (drug allergy to LEVAQUIN, bee stings and Penicillin). Concomitant products included vitamin D and EVAMIST. On 25th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th October 2016, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced feeling unwell, skin swelling, itchy skin, erythema, swollen tongue and throat constriction. On 26th October 2016, the patient experienced skin irritation, injection site erythema and injection site swelling. The patient was treated with prednisone and antihistamines. In October 2016, the outcome of the swollen tongue and throat constriction were recovered/resolved. On an unknown date, the outcome of the feeling unwell, skin swelling, itchy skin, erythema, skin irritation, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the feeling unwell, skin swelling, itchy skin, erythema, swollen tongue, throat constriction, skin irritation, injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the patient, who was a physican therapist at a hospital. The patient had an allergy to Penicillin, bee stings and LEVAQUIN but the patient had no allergy to eggs. The patient received Influenza vaccine Quadrivalent 2016-2017 season around lunch time on the left upper arm. Within 45 minutes after vaccination, the patient starting feeling sick and then she experienced itchy, swollen and red skin. Her tongue swelled up and she was taken to the emergency room near the physical therapy area. The patient was treated with 60 mg of Prednisone for the next 5 days and an antihistamine Tepcid. On this morning the patient was woke up, and the patient was beat red on her chest, arms and back On same day the patients experienced swollen tongue, throat constriction. On 26th October 2016, the patient experienced skin feels raw and the injection site was all red and puffy. Her throat swelling and closing up was resolved after treatment at the hospital but she had still experiencing her other side effects.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Skin irritation, Skin swelling, Swollen tongue, Throat tightness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4Z42R, expiry date 3-th June 2017). Concurrent medical conditions included drug allergy (drug allergy to LEVAQUIN, bee stings and Penicillin). Concomitant products included vitamin D and EVAMIST. On 25th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th October 2016, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced feeling unwell, skin swelling, itchy skin, erythema, swollen tongue and throat constriction. On 26th October 2016, the patient experienced skin irritation, injection site erythema and injection site swelling. The patient was treated with prednisone and antihistamines. In October 2016, the outcome of the swollen tongue and throat constriction were recovered/resolved. On an unknown date, the outcome of the feeling unwell, skin swelling, itchy skin, erythema, skin irritation, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the feeling unwell, skin swelling, itchy skin, erythema, swollen tongue, throat constriction, skin irritation, injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the patient, who was a physican therapist at a hospital. The patient had an allergy to Penicillin, bee stings and LEVAQUIN but the patient had no allergy to eggs. The patient received Influenza vaccine Quadrivalent 2016-2017 season around lunch time on the left upper arm. Within 45 minutes after vaccination, the patient starting feeling sick and then she experienced itchy, swollen and red skin. Her tongue swelled up and she was taken to the emergency room near the physical therapy area. The patient was treated with 60 mg of Prednisone for the next 5 days and an antihistamine Tepcid. On this morning the patient was woke up, and the patient was beat red on her chest, arms and back On same day the patients experienced swollen tongue, throat constriction. On 26th October 2016, the patient experienced skin feels raw and the injection site was all red and puffy. Her throat swelling and closing up was resolved after treatment at the hospital but she had still experiencing her other side effects.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Contusion, Erythema, Peripheral swelling, Swelling
Clinical narrative: 11/7/16 later in the day after shot were given seen my MD 11/9/16 arm swollen-silver dollar size, bruising, redness, swelling.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Radiating pain down arm. Getting worse each day can barley bend thumb.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a adult female patient who received FLUARIX QUADRIVALENT (batch number B9G34, expiry date May 2017). On 4th February 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles. On an unknown date, the outcome of the general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles were unknown. It was unknown if the reporter considered the general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter was an employee health nurse. The age at vaccination was not reported. The reporter stated that, she received FLUARIX vaccine and experienced full body ache, headache, general fatigue, which were lasted for 2.5 days. The patient also experienced drowsiness, extreme fatigue, throat pain, eye pruritus and body soreness and sniffles. It was reported that, reporter not able to understand vaccine name. This case is one of the 4 cases, reported by the same reporter.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a adult female patient who received FLUARIX QUADRIVALENT (batch number B9G34, expiry date May 2017). On 4th February 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles. On an unknown date, the outcome of the general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles were unknown. It was unknown if the reporter considered the general body pain, headache, fatigue, drowsiness, throat pain, eye pruritus and sniffles to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter was an employee health nurse. The age at vaccination was not reported. The reporter stated that, she received FLUARIX vaccine and experienced full body ache, headache, general fatigue, which were lasted for 2.5 days. The patient also experienced drowsiness, extreme fatigue, throat pain, eye pruritus and body soreness and sniffles. It was reported that, reporter not able to understand vaccine name. This case is one of the 4 cases, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right arm-injection site large red area. -Hot to the touch-swollen. -Difficulty moving-arm up-mobility-red and beginning to itch on Sunday 10/30/16. PS Also redness from flu-shot in other arm. But small areas-multiple.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Injection site induration, Skin warm
Clinical narrative: Flu vaccine given in right thigh on 11/7/16. Parents noticed redness on 11/8/16. Came into office 11/9/16. 8cm of erythematous firmness surrounding injection site with increased warmth. No fever.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient sais arm still sore and kinda difficult to lift arm. Spoke w/ patient on phone 11/8/16.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of stiff neck in a female patient who received FLUARIX QUADRIVALENT (batch number CS979, expiry date 14th June 2017). On 25th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 26th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced stiff neck. On an unknown date, the outcome of the stiff neck was not recovered/not resolved. It was unknown if the reporter considered the stiff neck to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. It was unknown if the patient had any relevant medical history. The patient received FLUARIX QUADRIVALENT on left arm. It was unknown if there were any other suspect or concomitant products involved. This case was not associated with product complaint. There were no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Eye pruritus, Eye swelling
Clinical narrative: This case was reported by a nurse vial call center representative and described the occurrence of swollen eyes in a 63-year-old female patient who received FLUARIX QUADRIVALENT (batch number CD3TF, expiry date 30th June 2017). On 27th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 27th September 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced swollen eyes, itchy eyes and burning in the eyes. The patient was treated with no-drug therapy (Cold Compress). On an unknown date, the outcome of the swollen eyes, itchy eyes and burning in eyes were recovering/resolving. The reporter considered the swollen eyes and burning in eyes to be possibly related to FLUARIX QUADRIVALENT . It was unknown if the reporter considered the itchy eyes to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left deltoid. Beginning of the evening of the vaccinations, the patient experienced swelling an burning of the eyes for approximately 3 days after vaccination. The patient also experienced itchy eyes on the day of intentional vaccination for approximately 3 days after vaccination. The patient was also Health care professional and self-treated with alternating warm and cool compresses for comfort, and reported the event to employee health. Approximately 4 weeks after vaccination date, the symptoms returned.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Pt reports bruising at site of injection.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Lethargy, Nausea
Clinical narrative: About 5 minutes after receiving shot, patient said he was feeling weak and dizzy, began acting lethargic, reported nausea.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: Patient called pharmacy complaining of soreness and nerve pain at the site of injections.
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Syncopic 2 minutes after vaccine injection.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Unusual bruising reported on 11/8/16. Did not seem emotionally affected. Bruise still appeared after 11/8/16. Vaccine administered 10/28/16.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: pt got cellulitis on her arm.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Body temperature increased, Chills, Flushing, Headache, Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a 17-year-old female patient who received BEXSERO. Co-suspect products included FLUARIX QUADRIVALENT.  On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 1st dose of FLUARIX QUADRIVALENT. On an unknown date, 14 hrs after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced headache, tremor, body temperature increased, chills and flushing. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, tremor, body temperature increased, chills and flushing were recovered/resolved. The reporter considered the headache, tremor, body temperature increased and chills to be probably related to BEXSERO and FLUARIX QUADRIVALENT. The reporter considered the flushing to be possibly related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received the BEXSERO vaccine in the right deltoid and the FLUARIX QUADRIVALENT vaccine in the left deltoid at the same time. The nurse reported after receiving the vaccines, the patient reported a mild headache, chills, flushing, 100 or 101 degree F temperature and shakes. The patient required emergency room visit. The patient was treated with ibuprofen and released. The field representative did not have any date of occurrence and lot or expiration information of the vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash erythematous
Clinical narrative: Woke up aching all over - even scalp, jawline to right ear in pain like ear infection, pulsing pain in head above right ear, and red bumps on forehead.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Mother states swelling in tongue, and approx. three small hives on thigh and stomach. Child taken to hospital ER, was given BENADRYL injection. Responded well to treatment and released to follow-up with pediatrician. Hospital physician stated only redness under tongue, not vaccine related. Referred to allergist. Family follow-up visit with pediatrician, told to continue with vaccine schedule, due to reaction not related to vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous, Swelling
Clinical narrative: The Patient Complained of a red raised bump on her arm that hurt and that her arm was swollen and sore for the last 3 days.  She took an anti inflammatory for the pain and was going to call her Dr for an appointment.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: LEFT ARM PAIN WHEN LIFTING ARM UP TO SHOULDER LEVEL.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Right shoulder soreness and pain radiating into upper arm on right.
Age: 31.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Eye pruritus, Eyelid oedema, Lip blister, Lip pain, Lip swelling
Clinical narrative: Puffy itchy eyes. Sore blistering puffy lips.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pruritus, Swelling
Clinical narrative: Swelling and itching now still bruised.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Malaise, Viral infection
Clinical narrative: This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2016154515), license partner for ENBREL. Initial Receipt Date = 02Nov2016. This non-serious spontaneous report (USASP2016154515) was reported to Amgen on 02Nov2016 by a consumer and involves a female patient who felt ill, gives her Enbrel vaccines in her thighs/sometimes they hurt, and got a virus while receiving Enbrel.  No historical medical condition was reported. The patient's current medical condition included Rheumatoid Arthritis. No relevant concomitant medications were provided. Co-suspect medication included Prevnar. The patient began Enbrel on an unknown date. The patient stated that she had been on Enbrel a couple of times. On an unknown date in 2015 last year, the patient had the first installment of the pneumonia vaccine, Prevnar 13, and she felt ill afterwards for about a week. The patient was on Enbrel for about five months when she got the first round of the pneumonia vaccine. On an unknown date in 2015 while on holiday, the patient got a virus that would not go away. Subsequently, the patient discontinued Enbrel for two months. After an unspecified time frame, the patient resumed Enbrel therapy. On an unknown date, the patient stated that her husband gave her Enbrel vaccines in her thighs and sometimes they hurt and sometimes they did not. The patient stated that it was more the stinging of the medication being delivered that hurt. The patient was inquiring if it would be better to give the injection on an area of her thigh that has more fat on it. This time the patient was Enbrel straight through nine months. The patient stated that now she need her second installment of the pneumonia vaccine, the Pneumovax 23. The patient inquired whether she need to stop Enbrel when she receive the vaccine. The patient discussed with her physician about this already and he told her that it was not a live vaccine, but stopping the Enbrel would be optional for her. On an unknown date in 2016 this year, the patient got the flu shot and had no problems. No treatment information was provided. The outcome of the events malaise, injection site pain, and viral infection were reported as unknown. Action taken with Enbrel was reported as unknown for the events malaise and injection site pain. Action taken with Enbrel was temporarily withheld for the event viral infection. The causal relationship between the events malaise, injection site pain, viral infection and the product Enbrel was not provided by the consumer.