chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient said within 2 hours of shot, experienced fever, chills, pain, and arm swelled like the size of a grapefruit.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Pain
Clinical narrative: I was awakened from a sound sleep by intense cramps in my thigh muscles (both legs) so severe I couldn't straighten my legs and had to sit up for almost 2 full minutes before I could move my legs again. It was incredibly painful at the time and I'm still sore today.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: My arm was red and itchy in a cup size circle for 8 days. It was shown to my primary care dr. She thought it was an odd place to have the injection. Left Arm toward the inside. She said I was having an allergic reaction. It is better now. I was visiting my dr the day after the shingles vaccination.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Sinus pain, Swelling face
Clinical narrative: Awakened w/ intense sinus pain. Looked in mirror and facial swelling noted. Treatment: BENADRYL 50mg every 6 hours. CLARITIN x1. I spoke w/ the nurse on Monday 9/18/2017. Symptoms resolved by Tuesday 9/19/2017. I saw Dr. on 11/7/2017 and he recommended not receiving influenza vaccines in the future.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Ear pain, Ear swelling, Erythema, Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 50-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), shingles and localized erythema. On 13th October 2017, the patient experienced enlargement of lymph nodes and ear pain. In October 2017, the patient experienced ear swelling and ringing in ears. On 15th October 2017, the patient experienced sickness, nausea and vomiting. The patient was treated with AUGMENTIN, gabapentin, acyclovir, sulphamethoxazole, SEPTRA DS, codeine, promethazine, PHENERGAN, ULTRAM and LYRICA. On an unknown date, the outcome of the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea and vomiting were recovering/resolving and the outcome of the ringing in ears was not recovered/not resolved. The reporter considered the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea, vomiting and ringing in ears to be unrelated to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was not previously reported to anyone. The patient received FLUARIX QUADRIVALENT in the right deltoid. The patient developed a red spot on his left eye which started to increase and spread up to his forehead. He went to a physician and was diagnosed with cellulitis on the same day. The patient was given antibiotics including AUGMENTIN and SEPTRA DS. On 13th October 2017, 10 days after vaccination, the patient had swollen lymph nodes on his left ear and severe pain as well. The patient went back to his physician and they referred him to an eye doctor who diagnosed him with shingles. They started the patient on Acyclovir 1 gram and Gabapentin 100 mg with ULTRAM 50 mg and LYRICA 50 mg. On 15th October 2017, 12 days after vaccination, the patient was seen in the emergency department because he was so sick with nausea and vomiting. The patient was given PHENERGAN for the nausea and vomiting and he was never admitted overnight. The patient was doing better at the reporting time although he lost two days of work. At the reporting time, the patient still had ringing in the ear but everything else was better including the swelling in his ear and the severe ear pain. The contact details of the eye doctor was provided.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Malaise, Nausea, Tinnitus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 50-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), shingles and localized erythema. On 13th October 2017, the patient experienced enlargement of lymph nodes and ear pain. In October 2017, the patient experienced ear swelling and ringing in ears. On 15th October 2017, the patient experienced sickness, nausea and vomiting. The patient was treated with AUGMENTIN, gabapentin, acyclovir, sulphamethoxazole, SEPTRA DS, codeine, promethazine, PHENERGAN, ULTRAM and LYRICA. On an unknown date, the outcome of the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea and vomiting were recovering/resolving and the outcome of the ringing in ears was not recovered/not resolved. The reporter considered the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea, vomiting and ringing in ears to be unrelated to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was not previously reported to anyone. The patient received FLUARIX QUADRIVALENT in the right deltoid. The patient developed a red spot on his left eye which started to increase and spread up to his forehead. He went to a physician and was diagnosed with cellulitis on the same day. The patient was given antibiotics including AUGMENTIN and SEPTRA DS. On 13th October 2017, 10 days after vaccination, the patient had swollen lymph nodes on his left ear and severe pain as well. The patient went back to his physician and they referred him to an eye doctor who diagnosed him with shingles. They started the patient on Acyclovir 1 gram and Gabapentin 100 mg with ULTRAM 50 mg and LYRICA 50 mg. On 15th October 2017, 12 days after vaccination, the patient was seen in the emergency department because he was so sick with nausea and vomiting. The patient was given PHENERGAN for the nausea and vomiting and he was never admitted overnight. The patient was doing better at the reporting time although he lost two days of work. At the reporting time, the patient still had ringing in the ear but everything else was better including the swelling in his ear and the severe ear pain. The contact details of the eye doctor was provided.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 50-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), shingles and localized erythema. On 13th October 2017, the patient experienced enlargement of lymph nodes and ear pain. In October 2017, the patient experienced ear swelling and ringing in ears. On 15th October 2017, the patient experienced sickness, nausea and vomiting. The patient was treated with AUGMENTIN, gabapentin, acyclovir, sulphamethoxazole, SEPTRA DS, codeine, promethazine, PHENERGAN, ULTRAM and LYRICA. On an unknown date, the outcome of the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea and vomiting were recovering/resolving and the outcome of the ringing in ears was not recovered/not resolved. The reporter considered the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea, vomiting and ringing in ears to be unrelated to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was not previously reported to anyone. The patient received FLUARIX QUADRIVALENT in the right deltoid. The patient developed a red spot on his left eye which started to increase and spread up to his forehead. He went to a physician and was diagnosed with cellulitis on the same day. The patient was given antibiotics including AUGMENTIN and SEPTRA DS. On 13th October 2017, 10 days after vaccination, the patient had swollen lymph nodes on his left ear and severe pain as well. The patient went back to his physician and they referred him to an eye doctor who diagnosed him with shingles. They started the patient on Acyclovir 1 gram and Gabapentin 100 mg with ULTRAM 50 mg and LYRICA 50 mg. On 15th October 2017, 12 days after vaccination, the patient was seen in the emergency department because he was so sick with nausea and vomiting. The patient was given PHENERGAN for the nausea and vomiting and he was never admitted overnight. The patient was doing better at the reporting time although he lost two days of work. At the reporting time, the patient still had ringing in the ear but everything else was better including the swelling in his ear and the severe ear pain. The contact details of the eye doctor was provided.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Rash around injection site small red papules. Does seem to itch. Appeared 2 days after shot. There (seen) 5 hours after shot. Gave BENADRYL orally and triamcinolone topically.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Limb injury, Vaccination complication
Clinical narrative: SIRVA shoulder injury.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Redness, numbness/tingling, swelling.
Age: 21.0
Sex: M
Vaccine: FLUC4, IPV, MMR
Symptoms: Dyskinesia, Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Patient fainted after receiving MMR, polio, and influenza vaccines. Upper extremity jerking and lower extremities drawn to chest. LOC approx. x 10-15 seconds. Was A/O x 3. Patient reports no residual problems/symptoms.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dizziness, Gait disturbance, Injection site erythema, Muscle twitching
Clinical narrative: Had vaccine on 10/30/17 at 1:25 PM and at 11:00 PM that evening vaccine site was very red and swollen, also was dizzy to the point it was difficult to walk, uncontrollable muscle twitching in arm, and temp of 101 w/complete body aches. This was her first ever flu vaccine she received, never had then in the past. Last until 11/2/17 then arm swelling went down but injection site remained red, all other symptoms resolved.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Vaccination site swelling
Clinical narrative: Had vaccine on 10/30/17 at 1:25 PM and at 11:00 PM that evening vaccine site was very red and swollen, also was dizzy to the point it was difficult to walk, uncontrollable muscle twitching in arm, and temp of 101 w/complete body aches. This was her first ever flu vaccine she received, never had then in the past. Last until 11/2/17 then arm swelling went down but injection site remained red, all other symptoms resolved.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture, Blood test, Chest X-ray, Computerised tomogram head, Diplopia
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Dysarthria, Dysphagia, Dysphonia, Endotracheal intubation, Eye inflammation
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Gait inability, Gastrointestinal tube insertion, General physical health deterioration, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Intensive care, Lacrimation increased
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of control of legs, Lumbar puncture, Nasopharyngitis, Nausea, Neck pain
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Ocular hyperaemia, Paraesthesia, Rhinorrhoea
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Scan with contrast, Vision blurred
Clinical narrative: Guillain Barre Syndrome GBS. 10/16/17- I had watery eyes and a runny nose. 10/17/17- My eyes were watering profusely and were extremely red and inflamed. 10/18/17- I woke up with tingling in my hands and feet. I called out of work. It went away but I still had watering eyes. I went to a quick-care facility and was told it was a viral cold. 10/19/17- I woke up feeling worse and called out of work again. I had tingling hands and feet once again, only this time it did not go away. I was unable to climb my stairs and felt like I had a problem controlling my muscles to walk. My voice began sounding strange. I thought I was having a stroke and went to Medical Center ER. I went into observation. I had blood work, CT scan, and MRI. 10/20/17- My physician came in and immediately called a neurologist. When the neurologist came in, he said I should be transferred to another Hospital. That evening I arrived at hospital and admitted into CCU. My symptoms had progressed to being unable to walk, extremely slurred speech, inability to swallow, numbness in hands, feet, and face. No control of my limbs, blurred and double vision, extreme head and neck pain, and nausea. 10/21/17- 4am a lumbar puncture was done. Over the next days, my health declined and I had a feeding tube and was intubated. I was diagnosed with Guillain Barre Syndrome.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: Seen in the ED at MC received ZOFTAN and TYLENOL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lethargy, Local reaction, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever started one hour after the injections. Fever persisted during the day and there was emesis the same evening. Minimal local reaction. Malaise and lethargy lasted for 72 hours, and then resolved abruptly.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Feeling abnormal, Mental status changes, Petit mal epilepsy
Clinical narrative: Patient after the shot would drift off into space with altered mental status and would stare there as well. Likely absence seizures.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Discomfort, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Left arm is sore, lost mobility and strength in arm and hands.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, X-ray
Clinical narrative: Immediate pain in left shoulder after injection. Ongoing pain for 3 weeks now, diagnosed with bursitis based on symptoms.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash, Restlessness
Clinical narrative: Hives/rash, high fever, irritability, restless, decreased appetite.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives/rash, high fever, irritability, restless, decreased appetite.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Large, painful area of redness; intense itching; golf-ball size swelling/hardening.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The nurse injected the vaccine very high up on my arm, close to my arm and shoulder joint. I get the flu shot every year, and I never had any symptoms before, and this year the shot was painful and the pain has persisted since. I can't remove my arm forward at shoulder-level, or lift my arm up over my head without a sharp pain in my upper arm. I went to my family doctor, he prescribe me the Naproxen 500 mg for one month with 1 times refill. It did reduce some pain when I put on my jacket. After taking the medicine for over a month, I am afraid the addiction, and I stop taking the medicine. The pain came back in full force again. I am going to see my primary doctor again, see what can I do to stop the pain.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, induration, swelling at short distance from injection site and 4 days later.
Age: 6.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: KINRIX and MMRV given 11/3/17, noticed red area swelling (R) thigh 11/4/17 increased 11/5/17 seen in ECC large erythema and discoloration Dx with cellulitis, gave Septra single dose, BACTRIM and Mupirocin ordered. Seen by PCP 11/6/17 almost completely resolved.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pain in injection site. Pulses with heart beat. Started at 6p.m. day of injection. Took 2 TYLENOL followed by 2 ALEVE 4 hours later with no relief.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 12-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.75
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 21 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 16-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 5 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 21-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Bedridden, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist, who referred to an 89-year-old male patient. The patient had no drug reactions or allergies. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date in August 2017, the patient was vaccinated with 1 dose of PREVNAR 13 (dose, route of administration, lot# and expiration date were not reported). On 04-NOV-2017, the patient was vaccinated with 1 dose of PNEUMOVAX 23 injection, intramuscularly (dose, lot# and expiration date were not reported) as a prevention of pneumonia. On the same day, after receiving PNEUMOVAX 23, the patient developed a fever of an unknown temperature. The patient's fever was gone on 05-NOV-2017, therefore the outcome of the event was considered as recovered on that day. No laboratory diagnostics or studies were performed. The patient did not seek medical attention and no treatment was given for the adverse event. The relatedness between the event and the suspect therapies was not reported. The pharmacist considered the event of fever to be disabling, because the patient was bedridden for the rest of the day on 04-NOV-2017.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12-month-old patient of unknown gender. The pertinent medical history or concurrent conditions were not reported. On 22-JUL-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 13-year-old patient of unknown age. Pertinent medical history or concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Sex: U
Vaccine: MENB
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable nurse via a Company representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On unspecified date after receiving meningococcal group b rlp2086 the patient experienced cellulitis for which required treatment. The outcome of the event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm, Swelling
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a patient (age and gender not reported), who was vaccinated with FLUZONE QIV (batch number: UI823AB ; expiry date, dose, dose in series not reported) in arm and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in arm (inch apart between two vaccines) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm, Swelling
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a (age and gender not reported), who was vaccinated with FLUZONE QIV (batch number: UT5954LA, expiry date, dose, dose in series not reported) and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test was not reported. Patient was prescribed with antibiotics. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Cellulitis with swelling from shoulder to elbow and feeling hot are unlisted with FLUZONE QIV and PNEUMOVAX. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: 11/2/17 swollen eyes and redness around eyes, shot was administered in the left arm at 11am with left eye being worse. Swelling and redness began within 1 hour of shot to left arm. Took one BENADRYL at 1pm. Swelling progressed called Dr suggested 2 BENADRYL gels. Swelling still evident Friday morning. Still redness around the eyes, Saturday morning swelling lessened but still evident. Redness lessened. Swelling evident Sunday. No redness. Monday morning back to normal.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain, Wrong technique in product usage process
Clinical narrative: Patient states that she has been in pain since the immunization; had missed 1 week of work; and is having mobility issues with her right arm for which she is seeing a doctor for on November 13, 2017. Patient believes that the issues with her right arm are due to the administration technique by the pharmacist and not the vaccine itself.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Paraesthesia
Clinical narrative: Tingling in hands and legs started approximately 12 hrs after vaccine administration. Child also had a temperature of 102.2 axillary. All symptoms subsided within 5-6 hrs.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Breath holding, Crying, Staring
Clinical narrative: As vaccines were being administered pt went from crying to soundless crying holding her breath. Pt's eyes opened with blank stare and open mouth. Took pt, jiggled her in my arms, gave her a squeeze she took a sharp breath. Within 10 min pt was "back to normal" was kept overnight in hospital for observation.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. C/O (R) arm pain at injection site and entire upper arm w/erythema.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Acoustic stimulation tests, Arthralgia, Computerised tomogram, Dizziness, Electrocochleogram
Clinical narrative: Symptoms started in 10/2017 after vaccine. Rash, joint pain, headache, visual disturbance, tinnitus, dizziness, vertigo, hepatitis, cervical dystonia. Tx included steroids, neuro rehabilitation. Currently still taking gabapentin, FLEXERIL, amitriptyline, ZOFRAN PRN, magnesium and ear care supplements.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hepatitis, Lumbar puncture, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Symptoms started in 10/2017 after vaccine. Rash, joint pain, headache, visual disturbance, tinnitus, dizziness, vertigo, hepatitis, cervical dystonia. Tx included steroids, neuro rehabilitation. Currently still taking gabapentin, FLEXERIL, amitriptyline, ZOFRAN PRN, magnesium and ear care supplements.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Tinnitus, Torticollis, Vertigo, Visual impairment
Clinical narrative: Symptoms started in 10/2017 after vaccine. Rash, joint pain, headache, visual disturbance, tinnitus, dizziness, vertigo, hepatitis, cervical dystonia. Tx included steroids, neuro rehabilitation. Currently still taking gabapentin, FLEXERIL, amitriptyline, ZOFRAN PRN, magnesium and ear care supplements.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Left shoulder pain (sharp pain). Loss of range of motion in left arm. Pain in deltoid muscle (L) upon movement (ranges from sharp to dull); no pain on rest. Weakness in left arm; no fever; no rash or redness at injection site.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Itchy at site. Red, warm to touch. Knot, tender.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: 10/30/17-by 3pm itching and burning at injection site that progressed to swelling and redness about size of hand. Patient also noted rash and itching on both inner legs from groin down to knee. Patient treated with SARNA lotion. 11/1-patient states fever occurred. 11/2: fever gone; rash and swelling fading/retreating.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: 10/30/17-by 3pm itching and burning at injection site that progressed to swelling and redness about size of hand. Patient also noted rash and itching on both inner legs from groin down to knee. Patient treated with SARNA lotion. 11/1-patient states fever occurred. 11/2: fever gone; rash and swelling fading/retreating.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Red area, tender and bump under skin.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt. received BOOSTRIX and ZOSTAVAX on 10/11/17. Next pt. day broke out in hives. On 10/14/17 was prescribed prednisone taper - hives worsened and pt. returned to doctor and was prescribed a stronger prednisone taper.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient presented to the pharmacy 2 days after receiving PNEUMOVAX 23 with 3 half dollar size red rash on the upper arm around the injection. The area was red and a little raised. The patient started on BENADRYL and by the next day was much better.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Nuclear magnetic resonance imaging
Clinical narrative: Adhesive capsulitis of left shoulder. Pain, stiffness, loss of range of motion; physical therapy treatment.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis, X-ray
Clinical narrative: Adhesive capsulitis of left shoulder. Pain, stiffness, loss of range of motion; physical therapy treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Drug administered at inappropriate site, Musculoskeletal stiffness, Pain
Clinical narrative: Patient called 10/27/2017 stating that she was still having pain and stiffness from the pneumonia shot. She said she felt that it was getting worse. She also felt that it was getting worse. She also felt that the immunization was given too high on the arm.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Axillary pain, Erythema, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Right upper arm with quarter size purple bruise at injection site. Approx 2" red, warm band below injection site. Tender to touch, pain in right armpit. (red area 12cm x 5cm). Rechecking on 10/23. Placed on antibiotics at appt on 10/20/17.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site warmth
Clinical narrative: Right upper arm with quarter size purple bruise at injection site. Approx 2" red, warm band below injection site. Tender to touch, pain in right armpit. (red area 12cm x 5cm). Rechecking on 10/23. Placed on antibiotics at appt on 10/20/17.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Right upper arm with quarter size purple bruise at injection site. Approx 2" red, warm band below injection site. Tender to touch, pain in right armpit. (red area 12cm x 5cm). Rechecking on 10/23. Placed on antibiotics at appt on 10/20/17.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received just before 1800 10/27/17 - by 1830 local itching at site, erythema, swelling, burning, nausea. 1900 urticaria spreading to torso, neck, scalp. Increased site swelling, erythema, tenderness burning, 2100 - peach sized swelling warmth extending to 3" above elbow.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Nausea, Urticaria
Clinical narrative: Received just before 1800 10/27/17 - by 1830 local itching at site, erythema, swelling, burning, nausea. 1900 urticaria spreading to torso, neck, scalp. Increased site swelling, erythema, tenderness burning, 2100 - peach sized swelling warmth extending to 3" above elbow.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lethargy, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever - swollen lymph nodes under arms and neck - lethargic - over 1 week. Headache - body ache.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented with a swollen arm. There was redness around the site of injection (approx. 1 1/2 - 2" in diameter). It was painful to the touch where vaccine was given and where there was redness. Patient states there is a knot if you press down hard enough at the site. Also painful if pt. lies down on that arm. It has been 3 days since injection. Advised pt. to take MOTRIN and BENADRYL and we will follow up with her.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is hot, red and swollen.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Hypersensitivity, Pain, Swelling
Clinical narrative: Pt. called in middle of the night complaining of red ring, swelling and soreness. MD told pt. this was an allergic reaction. Treating with BENADRYL and warm compresses.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Patient states she experienced: nausea, redness, soreness and bruising at the injection site.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Patient states she experienced: nausea, redness, soreness and bruising at the injection site.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling at site of injection, pain (swelling 3in wide x 7in long).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Gingival pain, Headache
Clinical narrative: Shaking, chills, headache, muscle aches, gums and teeth hurting, joints aching. After 24 hours symptoms receded but joints aching and patient tired.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Polymyalgia rheumatica, Toothache, Tremor
Clinical narrative: Shaking, chills, headache, muscle aches, gums and teeth hurting, joints aching. After 24 hours symptoms receded but joints aching and patient tired.
Age: 22.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Hot flush, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Hives (scalp, elbows, knees) x3 Thursday, Friday, Sat hot flashes redness around injection site body ache ill feeling nausea bump in injection site.
Age: 22.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Pain, Urticaria
Clinical narrative: Hives (scalp, elbows, knees) x3 Thursday, Friday, Sat hot flashes redness around injection site body ache ill feeling nausea bump in injection site.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling hot, Paraesthesia
Clinical narrative: Administered vaccine at 10:15AM. Patient states she started feeling hot and tingly at 10:30AM. Took a BENADRYL at 11:30 and came to check in with me. Had her sit and take the second BENADRYL at 11:45AM. She stated she was feeling better. Went to the bathroom. Reported she threw up at 11:55AM. At 12:10 used her VENTOLIN inhaler. Stated no problems breathing just chest tightness. Awaited call back from MD-But pt stated she was feeling better. Husband picked her up and was going to MD.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Erythema, Fatigue, Hypoaesthesia, Induration
Clinical narrative: The arm is sore, red, itchy, hard, and has a lump. The whole arm per employee feels swollen and tight. Metallic taste that comes and goes. Very tired. Numbness on the left arm.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Limb mass, Pain in extremity, Peripheral swelling, Pruritus, Skin tightness
Clinical narrative: The arm is sore, red, itchy, hard, and has a lump. The whole arm per employee feels swollen and tight. Metallic taste that comes and goes. Very tired. Numbness on the left arm.