chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received  FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT.  Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea Vomiting.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nausea, Sedation, Vomiting
Clinical narrative: Symptoms: Headache, sedation, myalgia and nausea vomiting. Treatment: Ibuprofen.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Peripheral swelling, Skin discolouration
Clinical narrative: Arm hard as a rock and swollen. Turned black and blue about a day later. Arm still black and blue as of 10/11/2016 and feels slightly swollen but getting better.
Sex: U
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT.  Additional details were reported as follows: The reporter explained that several staff, about 8, who received FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Pt had elevated, spotty, rash/hives, on lower limbs and trunk, as well as upper back and neck areas. No airway issues.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye discharge, Eye pruritus, Sensation of foreign body, Throat tightness
Clinical narrative: Employee reports that she got itchy eyes, green drainage and it felt like something was in her throat several hours after receiving injection. She stated that she thought her throat was closing up on her. Lasted 2-3 hours. Pt still has hoarse voice today, but not the throat closing feeling. She did not seek medical attention.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia, Sleep disorder
Clinical narrative: I was awakened from sleeping, I broke out in a sweat, fever, nausea, headache, and between 6-7 am I felt weak. Manufacturer: GSK FLUARIX QUADRIVALENT 2016/2017 Formula Exp Date: 6/6/17 Lot number: ZG3S5.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HEPA, HIBV, IPV
Symptoms: Blood culture, Blood test normal, Crying, Erythema, Gait disturbance
Clinical narrative: Knees were swollen, red, warm to the touch, rash with raised bumps, she would flinch and cry in pain when you touched it. She was limping on her right leg and walking on her toes. Took her to the ER. They did blood tests and xrays. Blood tests came back normal and her xrays looked good. Gave her an antibiotic shot and told us to follow up with pediatrician in the morning. Knees looked better this morning, but her left ankle was swollen and red. Pediatrician is thinking it is a viral reaction to the flu shot she received with her 15 month shots.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HEPA, HIBV, IPV
Symptoms: Joint swelling, Pain, Rash, Skin warm, X-ray normal
Clinical narrative: Knees were swollen, red, warm to the touch, rash with raised bumps, she would flinch and cry in pain when you touched it. She was limping on her right leg and walking on her toes. Took her to the ER. They did blood tests and xrays. Blood tests came back normal and her xrays looked good. Gave her an antibiotic shot and told us to follow up with pediatrician in the morning. Knees looked better this morning, but her left ankle was swollen and red. Pediatrician is thinking it is a viral reaction to the flu shot she received with her 15 month shots.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site pain, Pyrexia
Clinical narrative: Patient reports dizziness, pain at injection site (left arm), and fevers.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Influenza like illness, Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: Swollen, tender, erythematous matted axillary lymph nodes same arm as injection site. Arm sore near injection site. Mild flu-like symptoms.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: A expired vaccine was administered to patient.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events - wrong patient received vaccine - unsure of patient identity.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Mom described that child started with a "slight" fever the evening of the day she received her vaccinations followed by vomiting and diarrhea about 12 hours after vaccination. Mom contacted "the doctor" and was instructed that this was normal after vaccinations and to "give it 2 days". The fever, vomiting, and diarrhea continued with a fever as high as 105F, per mom, by the end of day 2. Child was hospitalized on day 3 for 1 day for rehydration therapy. Mom did not state any other cause given by doctors at the hospital other than vaccinations. This was described by mom as she presented for the child's 4 month set of immunizations.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Laboratory test normal, Pain
Clinical narrative: Patient states that she started experiencing chest tightness, pain, and difficulty breathing. Patient got both Fluzone HD and Pneumovax 23 on the same day.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Metabolic function test, Presyncope
Clinical narrative: Client reports she had near syncope episode. At 12:00 PM, Client reported episode to co-worker and was transported via ambulance to ED. IV fluids administered. No medications. Client released to home within a few hours.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Influenza virus test negative, Pyrexia, Urine analysis normal
Clinical narrative: BABY SPIKED A 104.7 TEMP POST VACCINATION ON THE EVENING OF 9/26/16.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Chills, Erythema, Pain, Pruritus
Clinical narrative: Pain, redness, itching, body aches, chills. Pt went to ED and received abx Doxycycline Monohydrate and Benadryl.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash covering much of upper arm starting a few days after vaccine and spreading over next several day. When shown to me was warm to touch. Told patient to see her MD.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain, Peripheral swelling, Skin warm
Clinical narrative: Hurts on left side (side of shot) from elbow to head/neck, swollen arm/hot, dopey feeling.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: Blurry vision in R. eye.  OPthalmologist indicated my reaction likely due to the vaccination, with my corneal transplant performed in 2003.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red raised rash starting around vaccination site and spreading over several day. Covered about half of upper arm starting just below vaccination site and going down from there.  Rash warm to touch.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: Red raised rash starting around vaccine site and spreading downward over a few days.  Warm to touch.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling cold, Headache, Lethargy, Lymphadenopathy
Clinical narrative: Patient awakened with a feeling of fever, chills which then progressed to lethargy, headache, nausea and vomiting in the am.  Then about 24 hours post vaccine she developed enlarged lymph nodes on the same side of her body as the injection.  This swelling and painful enlargement lasted for 2-3 days post emergence.  She was able to return to work on the 4th day but reported neck pain and still feeling tired.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Neck pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Patient awakened with a feeling of fever, chills which then progressed to lethargy, headache, nausea and vomiting in the am.  Then about 24 hours post vaccine she developed enlarged lymph nodes on the same side of her body as the injection.  This swelling and painful enlargement lasted for 2-3 days post emergence.  She was able to return to work on the 4th day but reported neck pain and still feeling tired.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES ALL OVER BODY WITH INTENSE ITCHING. CONTINUED INTO THE NEXT DAY. RECEIVED INJECTION OF ANTIHISTAMINE AND STERIOD.  RECEIVED STEROID DOSE PACK AND CONTINUED TO TAKE ANTIHISTAMINE AROUND THE CLOCK EVERY 4 HOURS.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Induration, Pain, Pruritus
Clinical narrative: Day 1 - redness, warmth and burning  about 2 inches X 2 inches. Day 2- fire red, hard, hot, burning, itching, painful to touch, increasing in size. Day 3-  5 inches X 4 inches fire red hard, itching, burning, painful continuing to spread, tingling to top of arm. Day 4- 7 inches X 5 inches, remains red, hot, hard, swollen and painful, by end of day redness started to decrease. Day 7 slight itching and redness remains, Benadryl, ibuprofen, Claritin and Tylenol taken, no other treatment.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Day 1 - redness, warmth and burning  about 2 inches X 2 inches. Day 2- fire red, hard, hot, burning, itching, painful to touch, increasing in size. Day 3-  5 inches X 4 inches fire red hard, itching, burning, painful continuing to spread, tingling to top of arm. Day 4- 7 inches X 5 inches, remains red, hot, hard, swollen and painful, by end of day redness started to decrease. Day 7 slight itching and redness remains, Benadryl, ibuprofen, Claritin and Tylenol taken, no other treatment.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dyspnoea, Flushing, Throat tightness
Clinical narrative: Within 2 minutes had pharyngeal tightness, sligh difficulty breathing, facial flushing and acute low back pain. Did not use Epipen, sx began to resolve in a few minutes. Took Zantac. All sx resolved when patient came to Occ health.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: My hands have no tactile sensation. every thing i touch is just there. I can not tell if something is hot, cold, soft, hard. the good thing is that they are not hurting me when i beat people up.
Age: 51.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Peripheral swelling, Skin reaction, Vomiting
Clinical narrative: PATIENT ARM SWOLLEN AND RED. PATIENT WAS VOMITING.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pyrexia, Sinus congestion
Clinical narrative: Cough and Sore Throat progressed to severe Sinus Congestion, fever and Fatigue that lasted 7 days. Symptoms unrelieved with decongestant, anti-inflammatory and Combivent Inhaler so that ER visit was made on the 6th day after Flu vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Body Aches, periods of sharp pain. Weakness, fatigue 11/12/2016: pain continues, sweating profusely, weak.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Constant shaking.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Patient reported following in an e-mail to the provider: Two days after the shot, which I had in the buttocks because I cannot have shots in the arm, I had a 4" square rash, hot to the touch and ITCHY!! It took about 4 days to disappear. I've never had any reaction to any previous flu shot, so this was a surprise.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling at injection site.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Mental impairment, Myalgia, Nausea
Clinical narrative: At 4:30PM on Monday the 10th I received a quad dose injection.  12 hours later at 4:30AM I was awakened by an intense headache, intense nausea, muscle soreness and other "flu like" symptoms including severe mental disorientation.  This condition lasted until 4:30PM yesterday the 11th of October.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports a warm, tender, raised, reddened area surrounding the injection site several inches in diameter 24 hours after receiving vaccination. She went to a pharmacy clinic and saw a nurse practitioner who placed her on a course of clindamycin. After 24 hours on the antibiotics she saw no change and wanted to be seen again. She reported to the hotline that she would go to be seen in the ER.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Rash reported at injection site.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 2 Large Areas of redness and inflammation around area of injection site. Site was warm to touch. Patient was recommended to go and see PCP after leaving pharmacy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: L deltoid swollen, pain, feels warm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports painful, red, swollen armpit, no rash and no fever. Patient had taken Advil morning of 10/11/16. Patient reported the reaction started at 2 to 3 pm the afternoon of 10/11/16.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Influenza like illness, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: 3 days fever and very painful arm: onset: 10/11/2016, sore throat with runny nose: onset:  10/12/2016, nausea, no energy, flu like symptoms.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 3 days fever and very painful arm: onset: 10/11/2016, sore throat with runny nose: onset:  10/12/2016, nausea, no energy, flu like symptoms.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea, lethargy, severe abdominal pain.
Age: 31.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Chills, Influenza like illness, Malaise, Tremor
Clinical narrative: Vaccine given 4:07 pm pt at approximately 11:00 pm described severe flu type symptoms - no fever but severe malaise, chills, shaking even though took hot shower.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Influenza virus test, Nausea
Clinical narrative: Terrible chills, high fever that wouldn't go down all night and day, headache, nausea, fatigue.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Terrible chills, high fever that wouldn't go down all night and day, headache, nausea, fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood glucose, Blood pressure measurement, Syncope
Clinical narrative: Syncope, fainting.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Abdominal pain, Aphasia, Arthralgia, Back pain
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Bipolar disorder, Blood test, Cervical radiculopathy, Cognitive disorder, Coordination abnormal
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Dizziness, Dysphagia, Dyspnoea, Ear infection
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Eyelid ptosis, Facial paralysis, Fatigue, Gait disturbance
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Head discomfort, Hemiplegic migraine, Hyperreflexia, Hypokalaemia, Malaise
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Migraine with aura, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Myositis, Nausea, Neck pain, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Orthostatic hypotension, Paraesthesia, Peroneal nerve palsy, Photophobia, Pruritus
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Sciatica, Skin papilloma, Syncope, Tremor
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence, Visual impairment, Vitamin B12 deficiency
Clinical narrative: Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Computerised tomogram normal, Fatigue, Laboratory test, Nuchal rigidity
Clinical narrative: Within 24 hours of receiving Men B #1, c/o weakness, fatigue, neck rigidity. Went to ER - X-ray, CT scan, lab work completed anti-inflammatories provided with IV fluids. Discharge 8-13-16.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Opiates positive, X-ray normal
Clinical narrative: Within 24 hours of receiving Men B #1, c/o weakness, fatigue, neck rigidity. Went to ER - X-ray, CT scan, lab work completed anti-inflammatories provided with IV fluids. Discharge 8-13-16.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Anal incontinence, Hypoaesthesia, Movement disorder, Muscular weakness, Musculoskeletal pain
Clinical narrative: 10/6 and 10/7 sudden weakness of all finger both hands with fingers extended and unable to bend finger. Pain in hands when fingers bent. Numbness tips of all finger. When "shook out hands" then could bend fingers and numbness left. Pain in right shoulder extending to right shoulder blade and right neck if turned head. 10/10 sudden weakness with projectile vomiting and involuntary BM.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Vomiting projectile
Clinical narrative: 10/6 and 10/7 sudden weakness of all finger both hands with fingers extended and unable to bend finger. Pain in hands when fingers bent. Numbness tips of all finger. When "shook out hands" then could bend fingers and numbness left. Pain in right shoulder extending to right shoulder blade and right neck if turned head. 10/10 sudden weakness with projectile vomiting and involuntary BM.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site swelling, Arthralgia, Pain in extremity
Clinical narrative: Patient described severe pain in right arm, some swelling at admin site. The pain after a day travelled towards hip/legs area. Patient called in to inform us of reaction on 10/12/16. MD was informed and patient was seen. They feel reaction may be NOT related to vaccination. However, still can't rule out possibility. Patient doing better.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Cellulitis, Erythema, Musculoskeletal pain, Oedema, Pain
Clinical narrative: Edema, erythema, pain of the (R) arm, shoulder and chest area.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Edema, erythema, pain of the (R) arm, shoulder and chest area.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Swelling, Vaccination site reaction
Clinical narrative: 24 hours after vaccination patient experienced red, blotches approx. 3"x6" vertical from vaccination site. Some swelling but improving. No itching.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin burning sensation, Skin reaction
Clinical narrative: Tuesday morning 10-11-2016 (24-36 hours after vaccine) pt had red, itching, burning skin; left neck and shoulder symptoms dissipate to touch; Wed AM (10/12) burning and redness worse; pt took antihistamine and Wed. pm symptoms were better.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site rash
Clinical narrative: Pain around shoulder/deltoid area. Discoloration/rash around shoulder and deltoid/upper pec area. Pain and rash that last for about almost 2 weeks.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Hypertension
Clinical narrative: Dizziness and hypertension less than 24 hrs.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP, TYP
Symptoms: Abdominal pain upper, Diarrhoea, Feeling cold, Flatulence, Pyrexia
Clinical narrative: 9/30/16 pt. felt chill and feverish. 10/1/16 took oral Typhoid #2 capsule. 10/2/16 cramping in stomach 9 in 0-10 pain scale, last for about 5 sec. 25-30 time in that day, felt like having diarrhea, but just passed some gas 10/3/16 felt fine, took oral typhoid #3. 10/4/16. Same reaction like 10/2/16. Pt. took some PEPTO BISMOL.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Pallor, Skin warm, Staring, Tremor
Clinical narrative: MD was summoned by MA because after giving the 4th vaccine, GARDASIL-9valent, the child slumped and was, for a few brief seconds, started to shake with open eyes staring ahead. Had the child lie down to relax. BP was low at 90/60 with a HR=58/min. Patient was advised to lie down. Patient admits she didn't eat lunch. She was given hard candy to lick after some 10 minutes, her cold, clammy hands became warm and there was a return of color to her pale lips. She was able to sit up and eventually walk to the bathroom on her own after about 25 minutes. She was discharged to return in 1-2 weeks to discuss and likely workup the episode. R/o syncope vs seizures vs postural hypotension vs neurogenic shock.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Urticaria
Clinical narrative: Pt started to feel very nauseous and got hives on her chest, back and shoulders within 2 hrs of receiving flu vaccine on 10/4/16. She took BENADRYL which helped her symptoms.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose improperly stored PROQUAD (lot # M001150 with expiration date 05-JUL-2017; recombinant human albumin (rHA), lot # M019233 with expiration date 17-OCT-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 5.5 degrees Fahrenheit for 4 hours and 45 minutes and 24.8 degrees Fahrenheit for 15 hours and 40 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M000996 with an expiration date: 07-JAN-2018) (dose, and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as there was no consent to contact the reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding an unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was not provided. On unspecified dates since 03-OCT-2016, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M025867 with expiry date 24-MAY-2018, lot # L050956 with expiry date 17-DEC-2017 and lot# M024675 with expiry date 18-MAY-2016) (dosing details not known). The administered doses experienced a temperature excursion of 6.3 Fahrenheit(F) for 1 hour and 50 minutes, 6.6 Fahrenheit(F) for 1 hour and 40 minutes, 40.5 Fahrenheit(F) for 2 hours, 5.2 Fahrenheit(F) for 20 minutes and 6.3 Fahrenheit(F) for 1 hour and 50 minutes. Previous temperature excursions included 13.3 Fahrenheit(F) for 80 minutes, 9 Fahrenheit (F) for 420 minutes. The call was because of a data logger. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to 2 patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On unspecified dates (reported as "between 09-SEP-2016 and 06-OCT-2016), the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose and route were not reported) lot # L016598 and expiry date: 26-JUN-2017. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the 4 reports from the same reporter. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On an unspecified date (reported as "between 09-SEP-2016 and 06-OCT-2016), the patient was vaccinated with improperly stored dose of VAQTA (dose and route were not reported) lot # M012261 and expiry date: 01-FEB-2018. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This case was cross referenced with #1610USA004377, 1610USA003097 and 1610USA004376 (same reporter link). Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to13 patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On unspecified dates (reported as "between 09-SEP-2016 and 06-OCT-2016"), the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (dose and route were not reported). The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This case was cross referenced with # 1610USA003097, 1610USA004376 and 1610USA004378 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, dose #, and route unknown; lot # reported as 36301 (invalid lot #); expiry date: December 2017) that had been exposed to a temperature excursion 32.1 Fahrenheit for 7 hours. The patient did not experience any adverse events. It was not reported, if patient would continue vaccination with GARDASIL 9. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of PEDVAXHIB (dose, and route not reported) from lot # M025192 with expiry date of 21-MAR-2019. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of GARDASIL 9 (dose, and route not reported) from lot # M016193 with expiry date of 24-APR-2018. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was reporting on herself. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient developed a "silver dollar sized, rised" pinkish lump at the injection site. The outcome of the event and relatedness between the event and ZOSTAVAX were not reported. Additional information is not expected as no contact details were provided.
Age: 7.0
Sex: U
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product label confusion, Product preparation error
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 7-year-old patient of unknown gender. No information on the patient's concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated subcutaneously with a dose of PROQUAD injection (albumin status: recombinant human albumin (rHA), lot # M021729, expiration date: 29-OCT-2017; dose not reported), which was reconstituted with a dose of MENACTRA (dose, lot # and expiration date were not reported) in error. There were no concomitant therapies reported. The nurse practitioner stated that the error may had occurred because both the vial of the MENACTRA and the vial of sterile diluent had a white label and their flip-caps looked similar. According to the nurse practitioner, the MENACTRA vial had a white flip-cap and the sterile diluent vial had a grey flip-cap. The patient did not experience an adverse effect. There was no product quality complaint involved. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Rash
Clinical narrative: Myalgia and rash. Pneumococcal vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients had no pertinent medical history, concurrent conditions or concomitant therapies reported. On unspecified dates, the patients received an improperly stored dose of GARDASIL 9 ( lot # M009378; expiration date 23-APR-2018 (dose number and route of administration were not provided). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 34.3 degree F for 1 hour on an unspecified date. Data logger was not involved. There was not product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an a unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concomitant conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dosage and route of administration were not provided; lot number L034736, expiration date 09-DEC-2016). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 22F for 18 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 10F for 14 hours, 28F for 18 hours and 40F for 1 hour on an unspecified dates. A product quality complaint was not involved. Additional information has been requested.