chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to currently 6-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 29-JAN-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) (product storage error) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to currently 9-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 20-FEB-2018, the patient was vaccinated with improperly stored the patient was vaccinated with improperly stored VARIVAX (Lot # N012619 and expiration date 21-APR-2019), (Lot # N025932 and expiration date 19-SEP-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that VARIVAX (lot # N012619) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness at the injection site with some swelling, non-tender, temp of 102.3 on 03/02/2018. Patient seen in the office on 03/03/2018-injection site was warm, swelling, pink to the skin of the outer are blanches but firm. Did not look like a cellulitis. Give TYLENOL and cold compresses to injection site.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 2-year-old female patient who received ENGERIX B (batch number ZD5CA, expiry date 15th February 2020). On 7th February 2018, the patient received the 3rd dose of ENGERIX B .5 ml. On 8th February 2018, 1 days after receiving ENGERIX B, the patient experienced rash, vomiting and fever. On 9th February 2018, the outcome of the rash, vomiting and fever were recovered/resolved. The reporter considered the rash, vomiting and fever to almost certainly related to ENGERIX B. Additional details were provided as follows: The healthcare professional called to report that the patient experienced adverse events 24 hours after vaccination. The patient did not require any intervention and the symptoms were resolved 24 hours after starting. The case was received from vaccine inside sales to the Agency.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a non-health professional and described the occurrence of pain in arm in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced more severe arm soreness after Flu vaccination as compared to arm soreness after SHINGRIX vaccine. This case has been linked to the case US2018GSK032231, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a non-health professional and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK036920). On an unknown date, the patient received SHINGRIX at an unknown dose. In February 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient felt pretty bad in the morning with fever and flu-like symptoms. At the time of reporting, the patient was much better although arm was bit sore but no worse than the flu vaccination. The patient was told to get the 2nd dose between 2 and 6 months, was there a sweet spot or anytime in the range would work equally well.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient came to pharmacy complaining of pain in her left shoulder on 02/10/2018 from an injection given to her by pharmacist on duty on 01/11/2018. Patient asked the pharmacist on duty to have a look at her arm and make sure she was given the correct vaccine. After assessing her arm and checking her profile pharmacist assured patient she had been given the correct vaccine. Patient was concerned of how long the injection site was still hurting. Advised the patient to rub with alcohol and use a warm compress and see if that helps. Patient came in on 3/01/18 and stated she was feeling better.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Patient received SHINGRIX vaccine on 3/1, stopped into pharmacy to report low grade fever and muscle aches on 3/2, wife had called back stating fever and aches continued on 3/3 along with some diarrhea. Follow up on 3/5, wife states adverse reaction has resolved with acetaminophen, ibuprofen, and rest. Patient stopped by pharmacy to note all reactions have resolved.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful prick of needle. Redness area around 3 x 4 inches, hot to the touch, sore, diminishing but still faintly present after 4 days.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site that started about 2 hours after injection.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry skin, Pruritus generalised
Clinical narrative: After an 1 1/2 hour itching started all over the body. I have the itch for 4 days now, skin is drying out on hand and feet. Went to seek medical assistant, coworker said to seek assistance from Occupational health.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Raised rash, erythema, urticaria.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood pressure diastolic decreased, Confusional state, Dizziness, Feeling abnormal, Flushing
Clinical narrative: 10 min after vaccines given -> itchy, dizzy, nausea, pain in thigh/buttocks. Became very flushed. Low diastolic BP, heart rate elevated. On exam, entire body flushed, warm esp over torso, bottom lip slightly swollen, eye injected. Seemed listless and confused. Pt given 25mg of BENADRYL and 10mg of DECADRON with good response. Within hour, flushing gone and pt feeling more like himself.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Heart rate increased, Injection site pain, Lip swelling, Listless, Musculoskeletal pain
Clinical narrative: 10 min after vaccines given -> itchy, dizzy, nausea, pain in thigh/buttocks. Became very flushed. Low diastolic BP, heart rate elevated. On exam, entire body flushed, warm esp over torso, bottom lip slightly swollen, eye injected. Seemed listless and confused. Pt given 25mg of BENADRYL and 10mg of DECADRON with good response. Within hour, flushing gone and pt feeling more like himself.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Nausea, Pruritus, Skin warm
Clinical narrative: 10 min after vaccines given -> itchy, dizzy, nausea, pain in thigh/buttocks. Became very flushed. Low diastolic BP, heart rate elevated. On exam, entire body flushed, warm esp over torso, bottom lip slightly swollen, eye injected. Seemed listless and confused. Pt given 25mg of BENADRYL and 10mg of DECADRON with good response. Within hour, flushing gone and pt feeling more like himself.
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to currently 7-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 29-JAN-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used.  Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 52-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included LYRICA, VICTOZA, cyclobenzaprine, FIORICET, meloxicam and topiramate. On 19th February 2018, the patient received SHINGRIX. On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and nausea. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and nausea to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was not reported previously to anyone. This case was reported by a registered pharmacist. The patient had redness at the injection site which spread from the upper arm to the elbow and also experienced nausea the next day after the injection. The portion of the arm from upper arm to elbow appeared swollen and warm to the touch. The pharmacist reported that the patient did not have fever.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Depressed mood, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX. On 17th February 2018, the patient received SHINGRIX. On 17th February 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On 18th February 2018, the patient experienced feeling down, fever and chills. On an unknown date, the outcome of the swelling arm, feeling down, fever, erythema of extremities and chills were recovered/resolved. The reporter considered the swelling arm, feeling down, fever, erythema of extremities and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm red and arm swelling. On 18th February 2018, 1 day after receiving vaccination, the patient experienced feeling down, fever and chills. About 48 hours after the onset of chills, the patient states that she was better. The patient was in hurry and did not have time to answer additional questions.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Patient reports the following: Within 10-15 minutes after the shot was given pain began that progressed through the day and increased. Next day, felt like he had been punched. Pain continued for next 2 weeks and was not able to lay down and slept in a chair. Saw doctor who prescribed 800 mg Ibuprofen. Worse at night. After 2 - 3 weeks pain subsided and weakness increased. Saw neurologist and was given diagnosis of Parsonage Turner. Could not lift arm and began physical therapy, which improved strength. Had more testing witch indicated nerve damage. Last Dr. was about 2 months ago and Dr. said there was improvement in one nerve and deterioration in the other. He reports now that he he has permanent nerve damage in left arm, ring  and pinky fingers.  Said that he has numbness and desensitization in fingers and arm. Every couple days he has pain in the region the shot was given and near the crease of the elbow. Says he has burning, sharp pain like a lit cigarette is touching his harm.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve injury, Neuralgic amyotrophy, Pain
Clinical narrative: Patient reports the following: Within 10-15 minutes after the shot was given pain began that progressed through the day and increased. Next day, felt like he had been punched. Pain continued for next 2 weeks and was not able to lay down and slept in a chair. Saw doctor who prescribed 800 mg Ibuprofen. Worse at night. After 2 - 3 weeks pain subsided and weakness increased. Saw neurologist and was given diagnosis of Parsonage Turner. Could not lift arm and began physical therapy, which improved strength. Had more testing witch indicated nerve damage. Last Dr. was about 2 months ago and Dr. said there was improvement in one nerve and deterioration in the other. He reports now that he he has permanent nerve damage in left arm, ring  and pinky fingers.  Said that he has numbness and desensitization in fingers and arm. Every couple days he has pain in the region the shot was given and near the crease of the elbow. Says he has burning, sharp pain like a lit cigarette is touching his harm.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain
Clinical narrative: Shooting and throbbing pain in the occipital lobe area that started 6 days after vaccine was administered and persists until today. Patient received the vaccine at doctor's office (02/07/18) and reported the reaction to the pharmacy today (03/05/18).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Acne, Depression, Disturbance in attention, Educational problem, Hair growth abnormal
Clinical narrative: She began to get irregular periods the following fall. By her Junior year in high school she had bad acne, facial hair. Was diagnosed with PCOS in December of 2016. She developed tremors in her hands. Was seen for this mid 2017. She currently is suffering from depression, previously brilliant child, classified as a gifted learner has two D's in her senior year, cannot focus and get her act together.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Menstruation irregular, Polycystic ovaries, Tremor
Clinical narrative: She began to get irregular periods the following fall. By her Junior year in high school she had bad acne, facial hair. Was diagnosed with PCOS in December of 2016. She developed tremors in her hands. Was seen for this mid 2017. She currently is suffering from depression, previously brilliant child, classified as a gifted learner has two D's in her senior year, cannot focus and get her act together.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Patient states reactions started with redness and swelling in lower section of her arm (not at injection site) follwed by itching in the same location on her arm. She states that she still has some swelling in the lower portion of her arm and extreme tenderness here also on 3/5/18 and that vaccine was administered on 2/20/2018. Patient was referred to her primary care provider. Patient states that she was on her way to see the doctor for a further evaluation on 3/5/18.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis, Malaise, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: About 24 hours post injection patient experienced pain in arm grade 3 as well as swelling of the arm and into the neck and shoulder region; also lymphadenitis of the neck and clavicle on left side with visible swelling; difficulty turning head/neck; also had malaise, fatigue; Swelling still visible at 4 days post injection when she reported to me.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: About 24 hours post injection patient experienced pain in arm grade 3 as well as swelling of the arm and into the neck and shoulder region; also lymphadenitis of the neck and clavicle on left side with visible swelling; difficulty turning head/neck; also had malaise, fatigue; Swelling still visible at 4 days post injection when she reported to me.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Balance disorder, Gait disturbance, Laboratory test, Peripheral coldness, Pharyngeal erythema
Clinical narrative: Child refusing to walk, reported poor balance, cold legs (transient) - red throat CSG negative referral to neurology. Injection site normal.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: It has been almost 6 weeks and my arm is STILL very stiff and sore where the vaccine was injected. The pain becomes very bothersome and occasionally affects the usage of my left arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash vesicular
Clinical narrative: Child developed a rash. Rash looked like small blisters on his hands, legs, feet, and diaper area.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient said that when she got home later that night, her left arm had a tingling and numbness sensation. She called the Health Department the next day. I told her to continue to watch it for changes on the skin and to put an ice pack for a few minutes. I followed up with her later in the week. She did not answer the phone after repeated attempts.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old male patient who received SHINGRIX. Concomitant products included Levothyroxine and Mometasone Topical. On 28th February 2018 14:00, the patient received the 1st dose of SHINGRIX. On 28th February 2018 20:00, 6 hrs after receiving SHINGRIX, the patient experienced weakness, chills, fuzzy head and fatigue. The patient was treated with TYLENOL. On an unknown date, the outcome of the weakness, chills, fuzzy head and fatigue were not recovered/not resolved. It was unknown if the reporter considered the weakness, chills, fuzzy head and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient never had a reaction to any vaccine previously. The patient received SHINGRIX in the left deltoid. Three hours before the time of reporting, the patient took TYLENOL and he was feeling better.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Feeling hot, Sneezing
Clinical narrative: 5 minutes after administration of flu vaccine patient started coughing continuously: complained of feeling hot, sneezing and shortness of air.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Abnormal behaviour, Adenovirus test positive, Blood culture negative, Blood glucose, C-reactive protein
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: C-reactive protein increased, CSF culture negative, Chest X-ray normal, Computerised tomogram head normal, Drug screen
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Electroencephalogram normal, Enterovirus test positive, Full blood count, Gaze palsy, Gram stain
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Gram stain negative, Human rhinovirus test positive, Laboratory test, Muscle rigidity, Muscle twitching
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Pyrexia, Seizure, Staring, Tremor, Urine analysis
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Viral test positive, White blood cell count increased
Clinical narrative: 2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site rash, Pruritus, Swelling
Clinical narrative: Patient reports rash at injection site 1 week after receiving vaccine. Patient states site is itchy and swollen/red.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEP, MNQ, TDAP
Symptoms: Dysphagia, Throat tightness
Clinical narrative: After RECEIVING vaccines and the Penicillin injection started complaining of throat difficult swallowing and felt like something grabbing at throat. Family member have history of penicillin allergy, but not self. Patient received 50 mg IM of BENADRYL.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Localized redness, warmth and tenderness.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV9
Symptoms: Abdominal pain upper, Appendicectomy, Cholecystectomy, Computerised tomogram, Decreased immune responsiveness
Clinical narrative: She started having sharp abdominal pains in the upper right quad and had to have her gall bladder removed and 6 months later had to have her appendix removed. Now she vomits regularly and had daily massive headaches. Her immune system is diminished.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV9
Symptoms: Headache, Hepatobiliary scan, Nuclear magnetic resonance imaging, Scan, Vomiting
Clinical narrative: She started having sharp abdominal pains in the upper right quad and had to have her gall bladder removed and 6 months later had to have her appendix removed. Now she vomits regularly and had daily massive headaches. Her immune system is diminished.
Age: 24.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Feeling of body temperature change
Clinical narrative: Stomach distress, feeling hot and cold.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Haematocrit decreased, Haemoglobin decreased, Mean cell volume normal, Oedema peripheral
Clinical narrative: Pt was administered Influenza high dose vaccine, although had already had one 33 days prior at a different facility. The plan was for pt. to receive a pneumococcal vaccination, and medical assistant made error in selecting correct vaccine. Influenza high dose was also given to this patient on 9/29/17 in left deltoid with Lot# UI830AA per State registry information. Pt. developed cellulitis, saw Dr. on 11/02/17 and was prescribed cephalexin 500 mg for 10 days. Pt presented to ER and admitted on 11/04/17 with swelling and cellulitis of right upper extremity, discharged 11/05/17. Was given (in addition to current ciprofloxacin) metronidazole prescription for 10 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Platelet count normal, Platelet disorder, White blood cell count
Clinical narrative: Pt was administered Influenza high dose vaccine, although had already had one 33 days prior at a different facility. The plan was for pt. to receive a pneumococcal vaccination, and medical assistant made error in selecting correct vaccine. Influenza high dose was also given to this patient on 9/29/17 in left deltoid with Lot# UI830AA per State registry information. Pt. developed cellulitis, saw Dr. on 11/02/17 and was prescribed cephalexin 500 mg for 10 days. Pt presented to ER and admitted on 11/04/17 with swelling and cellulitis of right upper extremity, discharged 11/05/17. Was given (in addition to current ciprofloxacin) metronidazole prescription for 10 days.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Dental caries, Dry mouth, Teeth brittle, Tooth discolouration, Tooth fracture
Clinical narrative: Dry mouth, tooth decaying and soreness. Fragile and brittle and breaking off at gum. Rot from inside out of teeth. Turning black, grey and yellow of color.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Toothache
Clinical narrative: Dry mouth, tooth decaying and soreness. Fragile and brittle and breaking off at gum. Rot from inside out of teeth. Turning black, grey and yellow of color.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Vaccination site rash
Clinical narrative: Patient states initial reaction was feeling feverish, pain, and chills that went away shortly but after a few days a rash developed on arm where vaccine was given. Rash started at the site of injection and continued down to elbow.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Muscle spasms, Myalgia
Clinical narrative: Muscle spasms, muscle pain, aching joint pain through-out my body and fatigue.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Patient came in on 3/4/18 stating that she thinks she may have had a reaction to SHINGRIX vaccine. She stated that she had a rash on her arm where the vaccine was given but don't know if it's related to vaccine and it went away quickly after taking BENADRYL.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: HPV 9 given, fever and vomiting for a few weeks after 2nd dose.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Mucous stools, Occult blood
Clinical narrative: Diarrhea and green stools with mucous, occurring 8-12 x a day that began 3 days after getting rotavirus vaccine.
Age: 77.0
Sex: F
Vaccine: HEPAB
Symptoms: Wrong drug administered
Clinical narrative: Patient was given TWINRIX instead of SHINGRIX.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Nodule
Clinical narrative: Patient developed painless red nodule that has not gone away even 4 months after the immunization.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lip swelling, Peripheral swelling, Skin test, Urticaria
Clinical narrative: Right Arm swelling developed the next day after vaccination. The day after that he developed a hive on his left foot. The third day after vaccination he developed hives on left arm and left upper trunk. The fourth day after vaccination, he started to have swelling of his lower lip and his right cheek.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt. came in 4 days after vaccine with swelling, redness, warmth at injection site, fever. Pt. went to Dr. the following day to see if it was cellulitis, Dr. told her she didn't think so and if it didn't get better in a few days to check back. Followed up with patient the following week and she said it was better and she did not go back to Dr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Pain, Pruritus
Clinical narrative: Intense pain and itching throughout shoulders and back, including injection site.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: The patient complained that her arm was painful and numb around the injection site since receiving the second dose of Gardasil 9. This was persistent over a month later. I recommended that she take OTC ibuprofen and follow up with her primary care physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Aspiration bursa, Erythema, Infection, Knee arthroplasty, Pain
Clinical narrative: Dr. saw patient on 2/21/208 for her annual wellness visit and was administered a pneumococcal vaccine in her left deltoid. That same day the patient call back to report redness and significant soreness. Patient was advised to use a warm moist compress and to move the shoulder around to improve absorption of the fluid. Patient then underwent surgery by Dr. on the following day for a total knee replacement. Patient followed up on 2/28 with Dr.'s assistant, PA-C. He accessed her surgical site for infection as the patient was reporting fevers. He then referred her back to Dr. to access for infection of the shoulder related to injection. Dr. examined patient the same day. He consulted with PA-C and they both agreed the area should be imaged with ultrasound and determined whether it needed aspiration for evaluation. The patient was sent to the emergency room of Medical Center. At the ED, the fluid in the patients shoulder (bursa) was collected. The radiologist believed it was infected by appearance and the patient was started on a course of Vancomycin. The patient was admitted to hospital. The patient was in hospital until today 3/5/2018.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Postoperative wound infection, Pyrexia
Clinical narrative: Dr. saw patient on 2/21/208 for her annual wellness visit and was administered a pneumococcal vaccine in her left deltoid. That same day the patient call back to report redness and significant soreness. Patient was advised to use a warm moist compress and to move the shoulder around to improve absorption of the fluid. Patient then underwent surgery by Dr. on the following day for a total knee replacement. Patient followed up on 2/28 with Dr.'s assistant, PA-C. He accessed her surgical site for infection as the patient was reporting fevers. He then referred her back to Dr. to access for infection of the shoulder related to injection. Dr. examined patient the same day. He consulted with PA-C and they both agreed the area should be imaged with ultrasound and determined whether it needed aspiration for evaluation. The patient was sent to the emergency room of Medical Center. At the ED, the fluid in the patients shoulder (bursa) was collected. The radiologist believed it was infected by appearance and the patient was started on a course of Vancomycin. The patient was admitted to hospital. The patient was in hospital until today 3/5/2018.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood count abnormal, Bronchiolitis, Condition aggravated, Cough, Dermatitis atopic
Clinical narrative: 11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Ear infection, Eczema, Failure to thrive, Food intolerance
Clinical narrative: 11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fungal skin infection, Gastrooesophageal reflux disease, Lymphadenopathy, Malabsorption, Milk allergy
Clinical narrative: 11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rhinorrhoea, Staphylococcus test positive, Weight gain poor, Wheezing
Clinical narrative: 11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count increased
Clinical narrative: 11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Generalized muscle aches/joint pains, fatigue and chills/shivering started on 3/1/18 at around 8pm. Started feeling better on 3/3/18 at noontime.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: Left arm very painful; could barely move it - 4 - 5 p.m. Injection site hard and swollen. Severe Chills. Occasional shooting pains down my arm and up into my head. Exhaustion, dizziness and nausea - 8 p.m. Finger joints stiff; middle finger of left hand locking up - this was still happening the next morning. Symptoms improved during the day but fingers locked up overnight and pain was shooting up through left eye. 3/5 2018 - Finger joints of left hand still locking up overnight. Other symptoms have disappeared.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site swelling, Joint lock, Musculoskeletal stiffness
Clinical narrative: Left arm very painful; could barely move it - 4 - 5 p.m. Injection site hard and swollen. Severe Chills. Occasional shooting pains down my arm and up into my head. Exhaustion, dizziness and nausea - 8 p.m. Finger joints stiff; middle finger of left hand locking up - this was still happening the next morning. Symptoms improved during the day but fingers locked up overnight and pain was shooting up through left eye. 3/5 2018 - Finger joints of left hand still locking up overnight. Other symptoms have disappeared.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Left arm very painful; could barely move it - 4 - 5 p.m. Injection site hard and swollen. Severe Chills. Occasional shooting pains down my arm and up into my head. Exhaustion, dizziness and nausea - 8 p.m. Finger joints stiff; middle finger of left hand locking up - this was still happening the next morning. Symptoms improved during the day but fingers locked up overnight and pain was shooting up through left eye. 3/5 2018 - Finger joints of left hand still locking up overnight. Other symptoms have disappeared.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Patient Claims that she had a severe reaction to SHINGRIX Vaccine." Very High fever over 24 hours, dizziness, and just feeling sick." Swollen arm/red from injection site to the top of shoulder.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient Claims that she had a severe reaction to SHINGRIX Vaccine." Very High fever over 24 hours, dizziness, and just feeling sick." Swollen arm/red from injection site to the top of shoulder.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox (1 lesion) on left breast. It's still there as of 3/5/2018. Doesn't seem serious, but it's lasted quite a while and I didn't see this listed as a side effect of SHINGRIX anywhere, so I wanted to report it.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Patient returned to the pharmacy on 3-2-18 to let us know that he had developed reactions to the vaccine - at the site of injection. S/S: Red, Hot, Pain, Swelled (4 inches in diameter).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash to right upper arm at an around injection site. Pt C/O itching that started the morning of 2/28/18. Pt was given prednisolone 15mg/5ml BID for 4 days.