chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Dehydration, Depressed level of consciousness, Dysphagia, Dyspnoea, General physical health deterioration
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Haemorrhage, Hyponatraemia, Hypophagia, Hypopnoea, Hypoxia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Irregular breathing, Lactic acidosis, Loss of consciousness, Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Painful respiration, Pallor, Pneumonia, Productive cough, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Respiratory rate increased, Sepsis, Sinus tachycardia, Tachypnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Bacterial test positive, Chest X-ray abnormal, Death, Dyspnoea, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Pneumonia, Pyrexia, Sepsis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: Initial unsolicited case received from a physician via other company (Pfizer) under the Manufacturer report number: 2017467169 on 16 Nov 2017. This case involves 66-year-old female patient who was vaccinated with dose one of FLUZONE HIGH DOSE (Batch number: UI877AB, expiry date: 17 May 2018) intramuscularly in left deltoid and 0.5 ml dose of PREVENAR 13 (Manufacturer: Pfizer) (Batch number: T08483 or TO8483, expiry date: 30 Sep 2019, dose in series not reported) intramuscularly in right deltoid on 17 Oct 2017. Patient medical history was reported as history of iron deficiency (it was also reported as due to this patient probably had a B12 deficiency), cervical cancer and patient was in the process of treatment for cancer and bariatric surgery on Nov 2014. The patient had no adverse events following previous vaccinations. Patient concomitant medication was reported as 75 mg Ranitidine twice daily for reflux. The patient was not taking any vaccines within four weeks prior to the suspect vaccine. On 18 Oct 2017, one day following the vaccinations, the patient experienced pain to the right arm from shoulder down, numbness and weakness to third fourth and fifth fingers of right hand. On 26 Oct 2017, nine days after the vaccinations, patient developed Pain across right upper back and shoulder blade area. It was reported as the patient required a visit to physician office. No relevant lab tests were performed. (It was reported as the reporter had ordered some tests, but the tests have not been completed) Patient corrective treatment was not reported. The outcome of the events numbness and weakness to third, fourth and fifth fingers of right hand and pain to right arm from shoulder down was not recovered (it was reported as both events were persisting). The outcome of events Pain across right upper back and shoulder blade area was unknown. The case was considered as serious by the reporter due to medically significant events. The other company assed the causal relationship between the suspect vaccines and with all the events as related. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in right arm, numbness of fingers, upper back pain and shoulder blade pain after vaccination. Time to onset is compatible with the role of vaccine. Additional information regarding patient medical history, infectious history, vaccination technique, immune status at the time of vaccination, concomitant medication and investigation results to rule out the alternative causes are needed for complete assessment of the case. Moreover, as two vaccines were administered, the role of each component cannot be assessed separately.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited case received from a physician via other company (Pfizer) under the Manufacturer report number: 2017467169 on 16 Nov 2017. This case involves 66-year-old female patient who was vaccinated with dose one of FLUZONE HIGH DOSE (Batch number: UI877AB, expiry date: 17 May 2018) intramuscularly in left deltoid and 0.5 ml dose of PREVENAR 13 (Manufacturer: Pfizer) (Batch number: T08483 or TO8483, expiry date: 30 Sep 2019, dose in series not reported) intramuscularly in right deltoid on 17 Oct 2017. Patient medical history was reported as history of iron deficiency (it was also reported as due to this patient probably had a B12 deficiency), cervical cancer and patient was in the process of treatment for cancer and bariatric surgery on Nov 2014. The patient had no adverse events following previous vaccinations. Patient concomitant medication was reported as 75 mg Ranitidine twice daily for reflux. The patient was not taking any vaccines within four weeks prior to the suspect vaccine. On 18 Oct 2017, one day following the vaccinations, the patient experienced pain to the right arm from shoulder down, numbness and weakness to third fourth and fifth fingers of right hand. On 26 Oct 2017, nine days after the vaccinations, patient developed Pain across right upper back and shoulder blade area. It was reported as the patient required a visit to physician office. No relevant lab tests were performed. (It was reported as the reporter had ordered some tests, but the tests have not been completed) Patient corrective treatment was not reported. The outcome of the events numbness and weakness to third, fourth and fifth fingers of right hand and pain to right arm from shoulder down was not recovered (it was reported as both events were persisting). The outcome of events Pain across right upper back and shoulder blade area was unknown. The case was considered as serious by the reporter due to medically significant events. The other company assed the causal relationship between the suspect vaccines and with all the events as related. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in right arm, numbness of fingers, upper back pain and shoulder blade pain after vaccination. Time to onset is compatible with the role of vaccine. Additional information regarding patient medical history, infectious history, vaccination technique, immune status at the time of vaccination, concomitant medication and investigation results to rule out the alternative causes are needed for complete assessment of the case. Moreover, as two vaccines were administered, the role of each component cannot be assessed separately.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Malaise, Presyncope
Clinical narrative: Became lightheaded, felt ill, then had near syncopal event starting about 2 minutes after the vaccination. Did not pass out, then felt better with lying down and drinking water 5 minutes later.
Age: 8.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: He walked out to the waiting room to wait for his mother, and he vomited x 1 and became diaphoretic. He had a winter jacket on and a long sleeve knit top. The waiting room was very warm as was the room where he had his vaccines. I immediately sat him down, and helped him take his jacket off. He immediately began to feel better. I offered water which he drank and had him sit for about 15 minutes. At no time, did he lose consciousness or fall. 13:30 I called his mother to ask how he was doing and mother stated he was doing fine. He has had no emesis episodes, breathing okay and maybe a little rash on his neck, but barely can see it. I told her to call her primary physician or call 911 if there was a medical emergency.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, X-ray
Clinical narrative: Client contacted writer today, Nov. 28, 2017 and reported she has experienced severe pain since getting her flu shot on Oct. 20th. She felt that the pain was more than it should be one week after receiving the vaccine. She had an X-ray today, has gone to a chiropractor 3 times and saw her physician today and he gave her anti-inflammatiry medication. (Mobic) He also ordered P.T.
Sex: U
Vaccine: TDAP
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heaviness in limbs in a patient who received BOOSTRIX. On 18th October 2017, the patient received BOOSTRIX. On 22nd October 2017, 4 days after receiving BOOSTRIX, the patient experienced heaviness in limbs and injection site tenderness. On an unknown date, the outcome of the heaviness in limbs and injection site tenderness were not recovered/not resolved. The reporter considered the heaviness in limbs to be unrelated to BOOSTRIX. It was unknown if the reporter considered the injection site tenderness to be related to BOOSTRIX. Additional details were provided as follow: The age at vaccination was not reported. The healthcare professional stated that, the patient did not have any adverse effects until 4 days.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt.'s mother states child began complaining of left upper arm soreness 2 hours after receiving PPV23 vaccine. Another two hours later, mother noted erythematous ring around left upper arm and shoulder. Child was given acetaminophen and ibuprofen before bed. Pt. unable to sleep from pain and discomfort, waking every hour. That morning, significant swelling had spread down to left anterior antecubital fossa, shoulder, neck and upper back. Avoiding use of left arm, leaving it hanging at his side. Mother denies fever, nausea or vomiting, stomach pain, or headache. Eating and drinking normally. Prescribed 50mg/kg/day cephalexin x 7 days and 250 mg ibuprofen every 6 hours for possible cellulitis.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Swelling
Clinical narrative: Pt.'s mother states child began complaining of left upper arm soreness 2 hours after receiving PPV23 vaccine. Another two hours later, mother noted erythematous ring around left upper arm and shoulder. Child was given acetaminophen and ibuprofen before bed. Pt. unable to sleep from pain and discomfort, waking every hour. That morning, significant swelling had spread down to left anterior antecubital fossa, shoulder, neck and upper back. Avoiding use of left arm, leaving it hanging at his side. Mother denies fever, nausea or vomiting, stomach pain, or headache. Eating and drinking normally. Prescribed 50mg/kg/day cephalexin x 7 days and 250 mg ibuprofen every 6 hours for possible cellulitis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Muscle Weakness in RT Leg.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: Mom reports shortly after getting injection she had a near syncopal episode pale, dizzy but did not pass out/lose consciousness. The next day she was very fatigued, her arm was sore. About 4 days later she experienced tingling "like her arm fell asleep" and numbness below injection site and into fingers. Mom reports her skin was normal colored in arm, pulse was "good" and had no problems with circulation. Mom called Pediatrics with information 11/27/17.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Paraesthesia, Presyncope
Clinical narrative: Mom reports shortly after getting injection she had a near syncopal episode pale, dizzy but did not pass out/lose consciousness. The next day she was very fatigued, her arm was sore. About 4 days later she experienced tingling "like her arm fell asleep" and numbness below injection site and into fingers. Mom reports her skin was normal colored in arm, pulse was "good" and had no problems with circulation. Mom called Pediatrics with information 11/27/17.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives that resolved after given BENADRYL at home.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness and pain at injection site, fever, chills, exhaustion several days.
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Decreased appetite, Malaise
Clinical narrative: Initial unsolicited report received from a Physician on 12-Oct-2017. This case was cross-referenced with 2017SA199339, 2017SA199365, 2017SA199373, 2017SA199386, 2017SA199397 (same reporter). This case involves a female patient of unknown age who was vaccinated with FLUZONE HIGH-DOSE (batch number: UI845AB; expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the ambulatory patient developed malaise and experienced decreased appetite. It was also reported that the patient was bed bound for 6 days. Laboratory tests and corrective treatment were not reported. The events outcome were unknown at the time of reporting. List of documents held by sender: none.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site nodule, Ultrasound scan
Clinical narrative: PENTACEL was administered on 7/21/17 nodule developed at injection site-nodule. Still present months later. Ultra sound ordered. Nodule on side of leg, approximately 6 months ago patient received PENTACEL vaccination to the side of the leg it was given by experienced nurse after that mom noted a nodule 1st evaluated approximately month or 2 afterwards very subcutaneous now appears to be more tabs to the skin this is a little bit more than what I would expect from vaccine reaction under had reported to the VAERS.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Limb discomfort, Tremor
Clinical narrative: Woke up 11/22/17 around 2am T-104.1. Shaking. Took MOTRIN. T-103.7 at 7am. Contacted family physician group-to take MOTRIN every 2 hours alternating with TYLENOL every 2 hours, MEDROL dose pack ordered. Same time in the day noticed that it felt like wrists were bound tight, but it went away. Later same evening, about 7pm felt more normal and much better. No further fevers.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eye swelling, Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: 0815 Flu vaccine administered. 1100 itchy raised hives to torso, bilateral arms, neck. Eyes swollen, red, draining.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Pain, itching, severe swelling in entire back side of forearm, skin discoloration (red at first now skin is darkened in the same area as swelling); symptoms lasted over 7 days. Took BENADRYL with no relief but BENADRYL cream helped with itching. Nothing helped with swelling. Small painful blister at left side of waist lasting 1-3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Pain, itching, severe swelling in entire back side of forearm, skin discoloration (red at first now skin is darkened in the same area as swelling); symptoms lasted over 7 days. Took BENADRYL with no relief but BENADRYL cream helped with itching. Nothing helped with swelling. Small painful blister at left side of waist lasting 1-3 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Aggression, Crying, Culture urine negative, Insomnia, Personality change
Clinical narrative: Child became aggressive, uncontrollable, extended temper tantrum, changed personality, trouble sleeping, waking up during sleep and cries.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Poor quality sleep, Urine analysis normal
Clinical narrative: Child became aggressive, uncontrollable, extended temper tantrum, changed personality, trouble sleeping, waking up during sleep and cries.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Fibula fracture, Hypoaesthesia, Paraesthesia, Road traffic accident, Surgery
Clinical narrative: Developed L to bilateral facial numbness with tingling in hands 1 months post receiving vaccine, * s/p MVA vs bike 2 week post vaccine, surgery for proximal tib/fib fx - also received TD vaccine 2 weeks after (10/10).
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Tibia fracture
Clinical narrative: Developed L to bilateral facial numbness with tingling in hands 1 months post receiving vaccine, * s/p MVA vs bike 2 week post vaccine, surgery for proximal tib/fib fx - also received TD vaccine 2 weeks after (10/10).
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, X-ray limb
Clinical narrative: CT PRESENTED TO THE EMERGENCY DEPARTMENT 5 DAYS AFTER RECEIVING THE INFLUENZA VACCINE WITH PAIN AND REDNESS IN LEFT SHOULDER. CT STATES SHE DEVELOPED PAIN A DAY AFTER GETTING THE INFLUENZA VACCINE. CT REPORTS THE AREA IS ITCHY AND SHE HAD BEEN SCRATCHING AT IT QUITE A BIT. CT WAS DIAGNOSED WITH LEFT ARM CELLULITIS.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiplegia
Clinical narrative: Patient experienced left side paralysis that has since resolved.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: PATIENT SAID THAT SHE HAS ALWAYS HAD AN INJECTION SITE REACTION BUT THIS TIME IT WAS MUCH MORE. SHE ENDED UP WITH PAIN AND WENT TO THE ER AND THEY GAVE HER STEROID SHOT. SHE IS CLAIMING THAT SHE FEELS IT'S SETTLED IN HER JOINT BUT PATIENT HAS A PREVIOUS SHOULDER INJURY.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Decreased eye contact, Exaggerated startle response, Irritability
Clinical narrative: Irritable, decreased self-soothing, decreased eye-contact, increased startling to noises. Symptoms lasted 5 days and then slowly improved over the next few days.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Per Dr.: Mother states patient has a small bubble like bump with redness around it on left thigh. Checked immunization details. Patient received Varicella on left thigh. Reassured that its mild form of chicken pox. Advised to limit contact with little babies and immunocompromised individuals. Keep the area covered and use BENADRYL 3.75ml every 6 hours prn itching.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient has been experience arm soreness and shooting pains since her influenza vaccine. Normally, patient lifts light weights but has been unable to. Sometimes has trouble lifting her arm up also.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: PT STATES THAT THE DISCOMFORT STARTED AS SOON AS SHE GOT THE FLU VACCINATION. PT DESCRIBES THAT HER LEFT SHOULDER IS PERMANENTLY SORE AND THAT SHE CAN BARELY RAISE HER ARM. THAT WHEN SHE TRIES TO RAISE HER ARM, HER ARM HURTS MORE THAN WHEN HER SHOULDER IS IN RESTING POSITION. PT SAYS SHE HAS USED ICE PACKS IN THE PAST AND CURRENTLY TAKES IBUPROFEN 200MG AS NEEDED. PT HAS BEEN TRYING TO DO SOME PHYSICAL THERAPY ON HER OWN. PT SHOWS NO SKIN DAMAGE, SIGN OF BRUISING OR ANY OTHER AT THE SITE OF INJECTION.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Pt states injection given was to close to her shoulder, and feels like that area has been hurting ever since. Pt called pharmacy to state this and that she was going to have an MRI.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Skin discolouration, Syncope
Clinical narrative: Patient with syncopal episode after shots. He turned grey and tightened up with loss of consciousness and eyes rolling back for a few seconds. He lost control of his bladder. No tonic clonic activity. Episode lasted several seconds and then patient recovered spontaneously. HR 70 and Sat 97% at end of event. Patient rested and ate peanut butter cracker with complete resolution of symptoms after several minutes. Mom has history of procedural syncope. Patient had skipped breakfast prior to shots. MD discussed with the family the need to eat before shots and to rest/lay supine for a while afterward.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urinary incontinence
Clinical narrative: Patient with syncopal episode after shots. He turned grey and tightened up with loss of consciousness and eyes rolling back for a few seconds. He lost control of his bladder. No tonic clonic activity. Episode lasted several seconds and then patient recovered spontaneously. HR 70 and Sat 97% at end of event. Patient rested and ate peanut butter cracker with complete resolution of symptoms after several minutes. Mom has history of procedural syncope. Patient had skipped breakfast prior to shots. MD discussed with the family the need to eat before shots and to rest/lay supine for a while afterward.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3rd dose of flu vaccine given to patient. No adverse events except parents made appointment for nurse visit vaccine only for Flu #2, however Flu #2 already given 1 month prior in October 2017.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: BODYACHES ALL OVER BODY FOR 1/2 HOUR.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injected limb mobility decreased, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Muscle aches and fever by 6pm vaccination day. Major soreness in arm that has lasted to date. I have needed to be treated for limited right arm motion and pain by a doctor at least three times since vaccination. Pain subsides to 1-5 scale when I don't use my arm but returns 6-7 when use arm. Very limited strength and range of motion still persists.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Muscle aches and fever by 6pm vaccination day. Major soreness in arm that has lasted to date. I have needed to be treated for limited right arm motion and pain by a doctor at least three times since vaccination. Pain subsides to 1-5 scale when I don't use my arm but returns 6-7 when use arm. Very limited strength and range of motion still persists.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient said since vaccination she has experienced tingling in the arm where she received the flu shot. She said it happens daily and intermittently. She will follow up with her provider at the Medical Clinic immediately.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient concomitant therapies included an unspecified blood pressure (hypertension) and unspecified eye drop medications. The patient had no drug reactions or allergies. On 10-NOV-2017, the patient was vaccinated with ZOSTAVAX (lot # N021170, expiration date 27-OCT-2018) (route of administration and frequency were not reported) in the left arm for prophylaxis diluted with sterile diluent (MERCK STERILE DILUENT). On an unspecified date in November 2017 after receiving ZOSTAVAX, the patient developed a rash at injection site on left arm (injection site rash). The pharmacist instructed her to medicate with diphenhydramine hydrochloride (BENADRYL) and ice. It was reported that no intervention to prevent serious criteria was necessary, that the patient was not hospitalized, and that the patient experience was not significant disability or incapacity or life threatening. At the time of the report, the outcome of injection site rash was reported as not recovered. The relatedness assessment between ZOSTAVAX and injection site rash was not provided.
Age: 18.0
Sex: U
Vaccine: HPV9, MENB
Symptoms: Anxiety, Dizziness, Immediate post-injection reaction
Clinical narrative: This report was received from a Nurse Practitioner referring to an 18 year old patient of unspecified gender. Medical history and concomitant medications were not provided. On 25-OCT-2017, the patient was vaccinated with their first GARDASIL 9 (lot # N017697; expiration 21-JAN-2020) by a physician. It was given with BEXSERO. Immediately after the injection, the patient developed feeling dizzy. The physician reported he believed it may be an anxiety response. The patient returned to the office the next day and all symptoms resolved. The reporter did not provide causality assessment. This is one of several reports from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1710USA007830: US-009507513-1710USA007799.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Soreness/ pain in arm with tingling. Employee states she felt like arm was asleep but sensation wouldn't go away. Couldn't lift arm up and pain/soreness in deltoid region only through November.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre syndrome.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction/anaphylaxis.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site reaction, Pyrexia, Tenderness
Clinical narrative: Pt came into clinic 10 days after injection with redness, fever, and tenderness. Dr prescribed rx cephalexin and recommended BENADRYL for redness and a cold compress for thigh. Possible reaction to MMR or varicella live vaccines. Child's leg has since improved/ resolved reaction.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Head pain and parenthesis at crown of head extending to left side of head. Worse symptoms for 4 days. Lessened on 5th day. Continue to have pain left side of head that increases when lying on left side. Have taken Tylenol, Aleve with minimal relief.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Blood iron normal, C-reactive protein normal, Cough, Fatigue, Full blood count normal
Clinical narrative: 8/12/17, STARTING AT 8:00AM: SORE THROAT. 8/13/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE. 8/14/17- 9/8/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE, COUGH. 9/9/17-9/10/17: SORE THROAT, BODY ACHES, EXTREME FATIGUE, COUGH. 9/11/17-9/15/17: BODY ACHES, FATIGUE. 9/16/17-9/21/17: NORMAL ENERGY, BODY ACHES CONTINUED BUT IMPROVED. 9/22/17: ALL SYMPTOMS RESOLVED.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Laboratory test normal, Metabolic function test normal, Oropharyngeal pain, Pain
Clinical narrative: 8/12/17, STARTING AT 8:00AM: SORE THROAT. 8/13/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE. 8/14/17- 9/8/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE, COUGH. 9/9/17-9/10/17: SORE THROAT, BODY ACHES, EXTREME FATIGUE, COUGH. 9/11/17-9/15/17: BODY ACHES, FATIGUE. 9/16/17-9/21/17: NORMAL ENERGY, BODY ACHES CONTINUED BUT IMPROVED. 9/22/17: ALL SYMPTOMS RESOLVED.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Serum ferritin normal, Streptococcus test, Streptococcus test positive, Thyroid function test normal
Clinical narrative: 8/12/17, STARTING AT 8:00AM: SORE THROAT. 8/13/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE. 8/14/17- 9/8/17: SORE THROAT, HEADACHE, BODY ACHES, EXTREME FATIGUE, COUGH. 9/9/17-9/10/17: SORE THROAT, BODY ACHES, EXTREME FATIGUE, COUGH. 9/11/17-9/15/17: BODY ACHES, FATIGUE. 9/16/17-9/21/17: NORMAL ENERGY, BODY ACHES CONTINUED BUT IMPROVED. 9/22/17: ALL SYMPTOMS RESOLVED.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Pain, Pyrexia, Rash
Clinical narrative: Patient began experiencing body aches and headache last night (same day as vaccines). Patient took some ibuprofen and then went to bed early. Patient had a rash develop today and started having a 101.2 fever.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Client felt dizzy after receiving the HPV vaccine per report.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: Patient reports local swelling and discomfort the night she received the vaccination, followed by chills and subjective fever that resolved by the following morning. Patient reports this several days later on 11/28/17. All symptoms have resolved.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient presented yesterday 11/28/17 to pharmacy to pick up a pain Rx for her arm. She came to consult and informed me that she has been having very bad pain in her arm since getting her flu shot. I asked about previous conditions or any injuries or unusual activity since. Patient stated nothing out of ordinary. She stated that the pain has been waking her up at night and that it is both sharp and dull pain. She has not yet been to see a MD. Advised her to get it looked at. I asked if she could show me where the injection was given. She stated it was very high up on her arm. There is no visible redness or swelling on her arm now. I informed patient it may be due to some injection going into bursa.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: About an hour after he was given the Hep A shot his throat started hurting and it was getting harder to breathe. He took 2 BENADRYL and his inhaler for asthma. Symptoms went away in about an hour after that. The next day he was fine.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Patient stated that she had arm pain, muscle pain, nerve pain.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Breast pain, Breast swelling, Injection site erythema, Injection site pain
Clinical narrative: Patient called pharmacy today 11/28/17 to report that her left arm, hand and elbow to top, including shoulder and part of the back and left breast had swelling and pain a couple of hours after the vaccine. Redness was mainly limited to site of injection. Those symptoms continued for 1 week according to patient. She was advised to report to MD as well. Patient is feeling well now and symptoms have improved.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Patient called pharmacy today 11/28/17 to report that her left arm, hand and elbow to top, including shoulder and part of the back and left breast had swelling and pain a couple of hours after the vaccine. Redness was mainly limited to site of injection. Those symptoms continued for 1 week according to patient. She was advised to report to MD as well. Patient is feeling well now and symptoms have improved.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder a week later.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Today, 11/28/2017, patient called me that she has been having pain in her arm since she got a flu shot on 10/31/2017. I asked her if she can come in so that we may suggest a treatment option for her. She said that she is out of town and that she will be back on December 5th. I left a message on her phone suggesting that she seeks a medical help.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling in right arm, tx BENADRYL, heat and ice.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was noted to have a noticeable bright red area at injection site on left thigh with tenderness and warmth. He also to had a persistent low oral temp 95 to 97 F and became very obstinate which is out of character for him. On exam in the office he was alert and interactive. Upper left thigh had a 5-6 cm area of faint erythema extending from mid outer thigh to inner thigh with a 1 cm subcutaneous area of soft tissue swelling and moderate tenderness to palpation. There was no induration or lesions at the injection site (only erythema). The rest of the exam was normal. No lesions on the right thigh were the other vaccines were given. MMR and DTAP were given in the left thigh. No other rashes or lesions found.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received vaccination without incident, although she now states that her arm hurt from the vaccination. She presented at the Pharmacy on 11/27 stating that she had just come from her MD office and that she is still having difficulty raising her arm and her MD thought the vaccination may have hit a tendon. They prescribed 5 day course of prednisone for the inflammation that may be causing the pain.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Back injury, Fall, Head injury, Syncope
Clinical narrative: Patient fainted twice after vaccination was administered. Patient fell on end cap in store and hit her head and back.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Redness, skin lifted as in a hive, itching, warm area - advised by MD 2 days later to just apply ice to area. Please note the handouts received were for "Meningococcal ACWY Vaccines - MenACWY and MPSV4", "Tdap Vaccine", "Influenza (Flu) Vaccine (Inactivated or Recombinant)" What you Need to Know. The exact type of shot given is unknown to me- above Vaccine selected might be incorrect.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Administered 11/7/2017 and patient complained of arm soreness and couldn't move arm. First time getting FLUZONE HD 2017-2018. It has been 2 weeks and still has pain in arms and can't move arm (pain).
Sex: F
Vaccine: HPV2
Symptoms: Injected limb mobility decreased, Nervousness, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received CERVARIX. On an unknown date, the patient received CERVARIX. On an unknown date, 20 days after receiving CERVARIX, the patient experienced swelling arm, injected limb mobility decreased and nervous. On an unknown date, the outcome of the swelling arm, injected limb mobility decreased and nervous were recovered/resolved. It was unknown if the reporter considered the swelling arm, injected limb mobility decreased and nervous to be related to CERVARIX. Additional details were received as follows: This case was received via hotline. The age at vaccination was not reported. The reporter stated that she searched in the internet and found a patient that developed swelling arm (which was injected) and that arm could not lift up, after receiving CERVARIX. The patient saw a doctor, and the doctor told she was nervous, and no action was taken. The symptoms were resolved by themselves. No other information was provided. The reporter refused to follow up. This case has been linked with case CN2017GSK177485, reported by the same reporter.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.