chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: May 4th - chills, site extremely hot, headache, and felt like I was coming down with the flu. I could not raise my arm more than half way up and by the 5th, I could not raise it at all without terrific pain. By the morning of the 5th the area of the shot was very swollen, hot, and got worse as the day went on.  In the evening, I went to Pharmacy and saw a pharmacist. She said I was having an Allergic reaction and she wanted me to get to urgent care the next morning. OD, took a marker and drew a circle around the swelling and redness which was at that time 4 inches around. He said if it spread past that drawing I was to see my doctor which I did a few days later.  Dr. said I had an allergic reaction and she does not feel I should have the second shot. On the 10th, it was still spreading but since the swelling was subsiding I did nothing else. After the swelling starting going down, I could raise my arm. Conclusion today, you still see the faint red 4 inch circle on my arm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT DEVELOPED ACTIVE SHINGLES.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Blood urine present, Chest X-ray normal, Crying, Differential white blood cell count normal
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Electroencephalogram normal, Eye movement disorder, Full blood count normal, Glucose urine absent
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hepatic enzyme increased, Liver function test normal, Nitrite urine absent, Nuclear magnetic resonance imaging normal, Protein urine absent
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Seizure like phenomena, Specific gravity urine normal, Speech disorder developmental, Tremor
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urobilinogen urine decreased, White blood cell count increased, White blood cells urine negative
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray normal, pH urine normal
Clinical narrative: Patient was seen in the ER 05 at 0100 following an episode of shortness of breath. She had been crying for 3-4 minutes, very hard per parents, and then seemed to have trouble catching her breath. Parents denied seizure activity. They report she has had similar events in the past with crying fits. Patient had received vaccines the day before so they were giving her TYLENOL every four hours. Temp max was 100F rectally in the ER. Exam was benign and she was discharged home with BRUE. Patient returned to the ER at 0900 with concerns for seizure-like episode. Parents reported 3-4" episode of shaking and eyes rolling back in her head. The felt she had difficulty catching her breath. Seen in our office 05/04/18. Patient was admitted overnight for observation. With seizure precautions in place, no further seizures were observed while the patient was admitted. Laboratory workup however as remarkable for elevated WBC and liver enzymes (ALT and AST). She maintained normal feeding, voiding, and stooling. An EEG was performed and no abnormalities or epileptiform activity was seen during the recording. Due to concern of parent's observation that patient has ceased making sounds since onset of seizures (including cooing and other sounds), speech therapy evaluated the patient and concluded patient is high risk for speech/language delay and will benefit from early intervention ST to monitor early speech/language development and provide parent education, appropriate for outpatient therapy. There were no concerns for feeding expressed, as patient takes 6oz every 3-4 hours with occasional breast feeding. Occupational therapy evaluated the patient and further recommended close monitoring of development with early intervention as indicated. Patient was discharged with instruction for close follow up with PCP. Further outpatient workup of unprovoked seizures may include MRI of the brain. I spoke with Dr. via phone last week to discuss follow up. Mom reports no further seizure activity. Mom denies concerns regarding development. She does not feel patient has lost any previously achieved milestones. Follow up appt. 05/15/18 labs done. Hepatic function panel CBC with auto diff. Results normal. Patient had MRI and repeat labs all normal results. Started on KEPPRA. Seen for follow up here 05/22/18 and stable at that time.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 80-year-old patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were unknown. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The pharmacy student reported this case during click to chat forum. The age at vaccination was not reported but could be 79 or 80 years. The reporter reported the patient had been getting a lot of redness and pain. The reporter reported that they had very limited information regarding the adverse reaction. No further information was reported regarding the event.
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine Administered at 3:30 PM 5/23/18 approximately 12 hours later patient developed a painful and swollen upper right arm in the tricep area.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The patient received SHINGRIX vaccine 5 days before the date of reporting and at the time of reporting the patient still had a large area of red, swelling and heat at injection site. The reporter did not have the lot number or expiration date of the vaccine and declined to provide further contact details. Chat was transferred to Response Center.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 84-year-old male patient who received SHINGRIX. Concomitant products included terazosin. On 3rd May 2018 16:00, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site rash were recovered/resolved. The reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness and swelling at the injection site the day after receiving the vaccine. The patient stated the rash extended for about 5 inches at the injection site. The symptoms lasted for about 5 days and then disappeared. The patient had denied permission to contact their physician.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: The day of vaccination - Symptoms were: "Insolvable crying for more than 3 hours - High Fever - extremely high tactile, ete ? 104 and lower T (with simultaneous acetaminophen and Ibuprofen) was 101 degrees F - Not eating -No appetite - (L) Thigh - excessive Redness-Swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a adult patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue and appetite lost. On an unknown date, the outcome of the fatigue and appetite lost were unknown. It was unknown if the reporter considered the fatigue and appetite lost to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that SHINGRIX was given to a patient 5 days ago time of reporting. The patient was experiencing extreme fatigue and loss of appetite. The healthcare professional could not access any patient or vaccine information at time of chat.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th May 2018, several hours after receiving SHINGRIX, the patient experienced injection site rash, headache, injection site pain, injection site swelling and nausea. The patient was treated with NORCO. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the headache, injection site pain, injection site swelling and nausea were recovered/resolved. The reporter considered the injection site rash, headache, injection site pain, injection site swelling and nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced rash, bumps, and swelling 1 and 1/2 inches below the injection site after receiving SHINGRIX. The patient also experienced headache, nausea, and pain where the rash was located and there was swelling at the injection site. The patient started to experience these effects a few hours after receiving the dose of SHINGRIX. The patient did not have a doctor visit but did take NORCO for the pain because it was so bad. Most of the adverse affects had resolved except the rash and bumps below the injection site.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Papular rash on arm, torso. BENADRYL and topical steroid.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 103 after vaccine.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever of 100.8, body aches, nausea. Advised to go to ER but Pt declined.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Rash from head to torso and fever of 101.0 started the night vaccines were given (5/22/18).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received SHINGRIX vaccine 5/21/18 and broke out in rash on full torso, chest, neck, arms on 5/22/18.
Sex: M
Vaccine: TYP
Symptoms: Cold sweat, Feeling hot, Nausea, Tinnitus
Clinical narrative: After about 5 minutes felt: hot/clammy -nausea -Ringing in Ear, after approximately 10 minutes after EMS arrived symptoms improved and pt and mother refused to go to ER.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient experiencing rashes on her lower and upper extremities, torso and face. She noticed pruritis on 5/20/18 then rashes on 5/22/18. Primary care provider referred patient to urgent care on 5/24/18.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: Pt. received SHINGRIX shot at 11:30 AM. Within 5-10 min pt. stated dizziness and warm flushing feeling. We called 911 and I sat by pt. with EPIPEN in hand if needed. Ambulance arrived within 5 mins and took pt. to hospital.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Hot flush, Hypersensitivity
Clinical narrative: Pt. received SHINGRIX shot at 11:30 AM. Within 5-10 min pt. stated dizziness and warm flushing feeling. We called 911 and I sat by pt. with EPIPEN in hand if needed. Ambulance arrived within 5 mins and took pt. to hospital.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Skin reaction
Clinical narrative: Pt. received SHINGRIX shot at 11:30 AM. Within 5-10 min pt. stated dizziness and warm flushing feeling. We called 911 and I sat by pt. with EPIPEN in hand if needed. Ambulance arrived within 5 mins and took pt. to hospital.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pain, Urticaria
Clinical narrative: Patient presented to the pharmacy with a rash on his buttocks- showed a picture of it covering both cheeks. Recommended that the patient report to Urgent Care Center across the street for further evaluation. Unable to diagnose at pharmacy true cause of rash which is why he was referred for treatment. Patient was not having difficulty breathing. He stated rash happened over night.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Urticaria
Clinical narrative: Patient presented to the pharmacy with a rash on his buttocks- showed a picture of it covering both cheeks. Recommended that the patient report to Urgent Care Center across the street for further evaluation. Unable to diagnose at pharmacy true cause of rash which is why he was referred for treatment. Patient was not having difficulty breathing. He stated rash happened over night.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient presented to the pharmacy with a rash on his buttocks- showed a picture of it covering both cheeks. Recommended that the patient report to Urgent Care Center across the street for further evaluation. Unable to diagnose at pharmacy true cause of rash which is why he was referred for treatment. Patient was not having difficulty breathing. He stated rash happened over night.
Age: 24.0
Sex: F
Vaccine: HPV9, FLU4, HEPA, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was seen in office on 4/18/2018, Patient was offered the Hepatitis A, Influenza and HPV9 vaccine and accepted. Patient stated she was on birth control pills and that her last period was on 2/20/2018, patient stated that her periods were not regular and that it was normal for her to not have a period every month due to being on the birth control. I gave patient the immunizations before the Doctor went in to see the patient. The doctor saw the patient and ordered a pregnancy test due to missed periods. Patients test came back positive.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site pain, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 64-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included Fluticasone, LEVOXYL, loratadine and trazodone. On 12th May 2018, the patient received SHINGRIX .5 ml. On 12th May 2018, several hours after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injected site pain, injection site erythema, injection site swelling, fever and generalized pruritus. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling and generalized pruritus were not recovered/not resolved and the outcome of the fever was recovered/resolved. The reporter considered the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling, fever and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX around noon in left arm and experienced that same night a fever that lasted 24 hours with an itchy body, injection site soreness which hurt and difficulty lifting her arm. Less than a day after receiving SHINGRIX, the patient experienced injection site redness, swollen in that area with a big circle that was raised.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 64-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included Fluticasone, LEVOXYL, loratadine and trazodone. On 12th May 2018, the patient received SHINGRIX .5 ml. On 12th May 2018, several hours after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injected site pain, injection site erythema, injection site swelling, fever and generalized pruritus. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling and generalized pruritus were not recovered/not resolved and the outcome of the fever was recovered/resolved. The reporter considered the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling, fever and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX around noon in left arm and experienced that same night a fever that lasted 24 hours with an itchy body, injection site soreness which hurt and difficulty lifting her arm. Less than a day after receiving SHINGRIX, the patient experienced injection site redness, swollen in that area with a big circle that was raised.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 64-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included Fluticasone, LEVOXYL, loratadine and trazodone. On 12th May 2018, the patient received SHINGRIX .5 ml. On 12th May 2018, several hours after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injected site pain, injection site erythema, injection site swelling, fever and generalized pruritus. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling and generalized pruritus were not recovered/not resolved and the outcome of the fever was recovered/resolved. The reporter considered the injected limb mobility decreased, injection site pain, injection site erythema, injection site swelling, fever and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX around noon in left arm and experienced that same night a fever that lasted 24 hours with an itchy body, injection site soreness which hurt and difficulty lifting her arm. Less than a day after receiving SHINGRIX, the patient experienced injection site redness, swollen in that area with a big circle that was raised.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Headache
Clinical narrative: This spontaneous report as received from a physician refers to a currently 9 year old male patient. The patient's concurrent conditions included asthma. There was no information about the patient's medical history or concomitant medications. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # N022727 with expiration date of 12-JUN-2010, route of administration reported as injection, for prevention of Human papilloma virus (HPV) (dose was not reported). On 21-MAY-2018, according to the physician, the patient had an adverse experience, after receiving the second dose of GARDASIL 9, as he stiffened up and his eyes rolled back. According to the physician, the patient might have had "some type of seizure" and it lasted "about 30 seconds. The patient was referred to a neurologist and it was also informed that the patient complained of having asthma and allergies (unknown start date) when he went into the office. No treatment was given for the adverse events and no laboratory tests were performed. The patient was back to normal at that time. The causal relationship between the seizures and allergies and therapy with GARDASIL 9 was not reported. Upon internal review the event of seizure was considered to be medically significant.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthma, Eye movement disorder, Hypersensitivity, Musculoskeletal stiffness, Seizure
Clinical narrative: This spontaneous report as received from a physician refers to a currently 9 year old male patient. The patient's concurrent conditions included asthma. There was no information about the patient's medical history or concomitant medications. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # N022727 with expiration date of 12-JUN-2010, route of administration reported as injection, for prevention of Human papilloma virus (HPV) (dose was not reported). On 21-MAY-2018, according to the physician, the patient had an adverse experience, after receiving the second dose of GARDASIL 9, as he stiffened up and his eyes rolled back. According to the physician, the patient might have had "some type of seizure" and it lasted "about 30 seconds. The patient was referred to a neurologist and it was also informed that the patient complained of having asthma and allergies (unknown start date) when he went into the office. No treatment was given for the adverse events and no laboratory tests were performed. The patient was back to normal at that time. The causal relationship between the seizures and allergies and therapy with GARDASIL 9 was not reported. Upon internal review the event of seizure was considered to be medically significant.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: The patient had pain in the left arm on the first day. The next day, the are became red and swollen, with increased pain. It was also itchy. By the 2nd day, the redness and swelling was from the top of his shoulder to his elbow. No fever, chills, induration or fluctuation.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Health service technician erroneously administered HEP A vs HEP B. Patient was informed of the error and educated on possible side effects. Patient experienced no side effects or complications.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Diarrhoea, Fatigue, Frequent bowel movements, Myalgia
Clinical narrative: Temp to 101.4 F, myalgia, fatigue, local pain, DIARRHEA with frequent liquid stools beginning with a few episodes 6 hours post injection, but then progressing to q60-90 minutesfor the next 24 hours.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Temp to 101.4 F, myalgia, fatigue, local pain, DIARRHEA with frequent liquid stools beginning with a few episodes 6 hours post injection, but then progressing to q60-90 minutesfor the next 24 hours.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles eruption, R T10/11.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a boy patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported. On 27-OCT-2017, the patient was vaccinated with improperly stored Oka/Merck VARIVAX (dose, route unknown, lot # N017396 with expiration date 07-JUN-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA011819: US-009507513-1805USA011818: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1805USA011822.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Angioedema, Arthralgia, Blood test, Chest discomfort, Fatigue
Clinical narrative: This spontaneous report was received from a non-pregnant female patient of unknown age, concerning herself. The patient had no medical history, concurrent conditions, concomitant medications, historical drugs, drug reactions nor allergies reported. The patient reported that she received 3 doses of an unspecified hepatitis b vaccine (manufacturer unknown) injection in arm (not specify), 0, 1, 6 month schedule (route, lot # and expiration date were unknown) first dose was administered on 09-NOV-2016 and second dose on 13-DEC-2016 for Prevention of Hepatitis B. On an unknown date approximately mid December 2016, after receiving the first two doses, she felt a heaviness in her chest, fatigue and joint pain in her wrists, knees and hips. Subsequently, on 06-JUN-2017, the patient was vaccinated with her third dose, and after it on an unknown date in July 2017, she felt like she was hit by a truck, with brain fog and vision difficulties along with a rash and hives. On and unknown date, the patient also reported that she had been diagnosed with chronic urticaria and angiodemia. The patient sought for medical attention and received treatment for the adverse events, and also unspecified blood tests were performed without results provided. At the time of the report, the patient was recovering from the angioedema, arthralgia, fatigue, feeling abnormal, chest discomfort, visual impairment and urticaria chronic. The patient did not mention the causality assessment between the events and unspecified hepatitis b vaccine (manufacturer unknown). Upon internal review, angioedema was determined to be a medically significant event.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Rash, Urticaria, Urticaria chronic, Visual impairment
Clinical narrative: This spontaneous report was received from a non-pregnant female patient of unknown age, concerning herself. The patient had no medical history, concurrent conditions, concomitant medications, historical drugs, drug reactions nor allergies reported. The patient reported that she received 3 doses of an unspecified hepatitis b vaccine (manufacturer unknown) injection in arm (not specify), 0, 1, 6 month schedule (route, lot # and expiration date were unknown) first dose was administered on 09-NOV-2016 and second dose on 13-DEC-2016 for Prevention of Hepatitis B. On an unknown date approximately mid December 2016, after receiving the first two doses, she felt a heaviness in her chest, fatigue and joint pain in her wrists, knees and hips. Subsequently, on 06-JUN-2017, the patient was vaccinated with her third dose, and after it on an unknown date in July 2017, she felt like she was hit by a truck, with brain fog and vision difficulties along with a rash and hives. On and unknown date, the patient also reported that she had been diagnosed with chronic urticaria and angiodemia. The patient sought for medical attention and received treatment for the adverse events, and also unspecified blood tests were performed without results provided. At the time of the report, the patient was recovering from the angioedema, arthralgia, fatigue, feeling abnormal, chest discomfort, visual impairment and urticaria chronic. The patient did not mention the causality assessment between the events and unspecified hepatitis b vaccine (manufacturer unknown). Upon internal review, angioedema was determined to be a medically significant event.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 17 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an adult formulation of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019) , (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929 , Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of (MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.  Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT)(no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.