chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024301 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024300 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 46 year old female patient.  Past medical history and concomitant medication  were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024289 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 15 year old male patient.  His medical history and concomitant medications were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 22JAN2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024299 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 49 year old female patient. Past medical history was not reported. Concomitant medications were none.  The patient had tolerated vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes.  The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024290, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 15 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024291, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 14 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFs of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the administration (incorrect storage drug). Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024292, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 14 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 15411P, expiry date: MAR2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05NOV 2014. Nurse reported that PFS of FLUVIRN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024298 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 49 year old female patient. Past medical history was not reported. Concomitant medications were none. The patient had tolerated vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from the nurse on 21JAN2015: updated site of vaccination and reporter comment.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024293, is an initial spontaneous report received from a nurse on 02DEC2014 and with a follow up information received from the nurse on 22JAN2015. This report refers to a 26 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml in left deltoid on 03NOV2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up information received from the nurse on 22JAN2015: Updated site of vaccination.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024294, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 34 year old female patient. Her medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with her initial application of FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024295, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up report received from the nurse on 19JAN2015. This report refers to a 29 years old female patient. Her previous vaccinations (unspecified) were well tolerated. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml in left deltoid on 17NOV2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19JAN2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024296, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 51 years old male patient. Past medical history and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated.  The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 12 Nov 2014. The nurse reported that before vaccination, the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024297, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 50 years old male patient. Past medical history was not reported. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Rash pruritic, Rash vesicular
Clinical narrative: Pt states blistery, itchy rash over arms and on face, head and neck that persisted for a week or two.  Lightheadedness also continues to persist (1/8/2016).  MD had no explanation and wasn't sure if it was related to the vaccination or coincidental.
Age: 21.0
Sex: M
Vaccine: FLU4, MMR, MNQ
Symptoms: Dysphagia, Oropharyngeal pain, Speech disorder, Urticaria
Clinical narrative: C/O pain in throat and difficulty swallowing and speaking.  Also hives on wrists.  Sx started a few hours after immunization and stay the same 48 hrs later.  No fever, no dyspnea, no cold sx's.
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cyanosis
Clinical narrative: ACROCYANOSIS OF LEGS & ARMS LASTING LESS THAN 15 MINUTES AT ONE HOUR INTERVALS FOR A FEW HOURS, SPONTANEOUSLY RESOLVING.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Injection site redness/swelling; hives.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Redness/swelling at injection site; hives.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Anal sphincter atony, Angiogram normal, Anorectal disorder, Back pain, Chest pain
Clinical narrative: Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Discomfort, Faecal incontinence, Fatigue, Hypoaesthesia
Clinical narrative: Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Lumbar puncture normal, Mobility decreased, Muscular weakness, Nervous system disorder
Clinical narrative: Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Peroneal nerve palsy
Clinical narrative: Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
Age: 1.1
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 06-JAN-2016, the patient was vaccinated with VARIVAX (Merck) 0.5 ml subcutaneous lot # K001391 and expiry date of 29-JAN-2016 and PROQUAD (Merck) lot # K025760 with expiry date of 08-JUN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 13-AUG-2015, the patent was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 months old patient of unknown gender. On 16-OCT-2015, the patient was vaccinated with improperly stored dose of ROTATEQ lot # K022995 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008996, exp. 01-DEC-2016) (dose and route of administration not provided. No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 554 year old female patient. The patient's pertinent medical history includes sinus infection (Chronic). She had an unspecified drug reaction with Penicillin. On 05-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L027322, expiry date 21-DEC-2016) 0.65 ml, subcutaneous for prevention of shingles. Concomitant therapies included Z-PAK. On an unknown date, the patient was seen by an unspecified physician, after receiving ZOSTAVAX and was prescribed prednisolone 20 mg for 5 days and BACTRIM DS for sinus infection. The outcome of sinus infection (sinusitis) was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of PEDVAXHIB, lot # L030868, expiry date 09-JUN-2018, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9, lot # L016428, expiry date 30-JUL-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of oral ROTATEQ, lot # L020861, expiry date 25-JAN-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of VAQTA lot # L039659, expiry date 15-MAR-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Extreme edema, erythema, pain.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUX
Symptoms: Injection site erythema, Injection site joint pain, Injection site warmth
Clinical narrative: Redness at injection site was first noted. Patient came into the clinic at 4:30 on 1/8/2016 reporting joint tenderness in left shoulder. Has a red/warm area measuring 10.5cm C 13cm. was instructed by provider to take anti-inflammatory medication and to apply ice. Return on Monday 1/11/16 if worsens or no improvement.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUX
Symptoms: Local reaction
Clinical narrative: Redness at injection site was first noted. Patient came into the clinic at 4:30 on 1/8/2016 reporting joint tenderness in left shoulder. Has a red/warm area measuring 10.5cm C 13cm. was instructed by provider to take anti-inflammatory medication and to apply ice. Return on Monday 1/11/16 if worsens or no improvement.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm of injection site causing intense pain and limited mobility.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Coordination abnormal, Decreased appetite, Disorientation
Clinical narrative: Began with fever and muscle aches, escalated to fever over 102, headache, nausea, loss of appetite, muscle weakness, loss of coordination, disorientation, disruptions in short-term memory, disassociation from surroundings, sore joints, insomnia and anxiety. By 48 hours after the vaccine, the symptoms had faded, and he began to recover.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dissociation, Headache, Insomnia, Memory impairment, Muscular weakness
Clinical narrative: Began with fever and muscle aches, escalated to fever over 102, headache, nausea, loss of appetite, muscle weakness, loss of coordination, disorientation, disruptions in short-term memory, disassociation from surroundings, sore joints, insomnia and anxiety. By 48 hours after the vaccine, the symptoms had faded, and he began to recover.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Began with fever and muscle aches, escalated to fever over 102, headache, nausea, loss of appetite, muscle weakness, loss of coordination, disorientation, disruptions in short-term memory, disassociation from surroundings, sore joints, insomnia and anxiety. By 48 hours after the vaccine, the symptoms had faded, and he began to recover.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test negative, Blood test normal, Cardiac function test normal, Influenza, Laboratory test normal
Clinical narrative: Felt I had an extreme case of flu.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Decreased eye contact, Screaming
Clinical narrative: My child cried, napped and went from being a happy, sociable and bubbly baby to screaming for hours and not making eye contact within hours of taking the vaccine. I even have video evidence of her cooing and what sounds like babbling days before her vaccine. I had never heard this scream from my child before or she had never cried that long. After that, it was 10 hours of screaming each day. My child gradually improved. However, to this day, she still has bouts of the same high-pitched screaming out of the blue, though not as often. Her other sibling did not take the vaccine and does not have this problem.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Red, raised circle around injection site, soreness of injection arm, spot of injection hotter than rest of arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications reported. On multiple unspecified dates in 2015 (reported as "since November 2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L025205, expiry date 07-JUL-2016 (dose and route of administration were not specified). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a female patient of unknown age, whose concurrent conditions and medical history were not provided. On 07-MAR-2012 and 09-DEC-2012 the patient was vaccinated respectively with her first and second dose of (Oka/Merck) VARIVAX (dose, site of vaccination, route, lot number and expiration date were not provided). Concomitant therapies were not provided. On 15-DEC-2015, she received a third dose of (Oka/Merck) VARIVAX (dose, site of vaccination, route, lot number and expiration date were not provided) because the doctors office told the patient that the first and second dose were spaced too close together. No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis after vaccine. Has a growing red spot 4-5", on the site of her zoster vaccine from 3 days ago. Bigger than last night. Red and warm. No fever - evaluation by doctor today - treated with: cephalexin 500mg 1 cap 4x/day for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of cellulitis on left arm. I treated it with KEFLEX and told dad to put hydrocortisone on the area. 2 in x 1 3/4 in redness, warmth, swelling.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Malaise
Clinical narrative: 103 temp, chills, very sick, thought I was dying, went for strep throat check.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Oral herpes, Peripheral swelling
Clinical narrative: (R) arm - swollen inflamed red area. Also has fever blister on lower lip.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 months old patient of unknown gender. On 19-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K024700 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L001316, expiry date: 10-NOV-2016). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Localized redness and swelling covering at least 1/2 of posterior arm. Also, exquisite pain and tenderness.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Administered on 1-5-16 at 3:22 PM. Per patient noticed lump on injection site at night. On 1-7-16 noticed swelling and redness. Patient seen by Dr today 1-8-16 for recommendations.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after HPV administration.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Fainted few minutes after immunization given, turned pale for few seconds, recovered without treatment.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiry date: 20-JUL-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Right deltoid with redness, induration, pain, pruritus at injection site beginning day after being vaccinated. Hydrocortisone 1% dispensed for pruritus, encouraged ice QID, TYLENOL for pain. PREVNAR 13 documented as allergy in pt's chart.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site and chills 1 day after receiving injection.
Age: 30.0
Sex: F
Vaccine: DTP
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Rash
Clinical narrative: Developed pain in left shoulder/upper arm, rashes, and myalgias following injection of the vaccine in the left deltoid. This was the first time she received this shot. Methylprednisolone 125 mg once, prednisone 60x3, 50x3, 40x3, 30x3, 20x3, 10x3 mg every day.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Skin rash. Acetaminophen 650 mg TID, hydroxyzine 10 mg BID.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Right arm remains painful.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Myalgia
Clinical narrative: Patients experienced muscle pain and chills for 2 days post vaccination. Symptoms resolved without intervention.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 11-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 months old patient of unknown gender. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K011948 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown dates, the patients have received improperly stored VARIVAX (doses and routes of administration were not reported; lot # L023587, expiration date: 26-JUN-2017; lot# L012038, expiration date: 07-APR-2017; lot# L003774, expiration date: 04-FEB-2017). No symptoms were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Gait disturbance, Hypertension, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 61 year old female consumer reporting on herself with high blood pressure. The patient's medical history included bad reaction with DIAZIDE 30 years ago. On 28-DEC-2015, the patient was vaccinated with PNEUMOVAX 23, one shot subcutaneous in shoulder (lot #, expiration date and dose were not reported). Concomitant therapies included ALDACTAZIDE. On 03-JAN-2016, 7 days after onset of therapy the patient experienced pain on her left shoulder near the injection site, the pain then spread down to her rib cage. It was a throbbing pain that caused difficulty to walk and breathe. Additionally, she experienced shortness of breath. There were no laboratory diagnostics studies performed. No product quality complaint (PQC) was involved. The patient did not seek medical attention and no treatment had been received. At the time of report, the outcome of the events was not recovered. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 months old patient of unknown gender. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K011948 (dose, route and frequency were unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 months old patient of unknown gender. On 19-OCT-2015, the patient was vaccinated with improperly stored dose of ROTATEQ lot # K022995 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, site and route not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001942, 1601USA001944 and 1601USA000936 from the same reporter. Additional information had been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concurrent conditions included high blood pressure. No history of allergies were reported. On 20-OCT-2015, the patient was vaccinated with ZOSTAVAX (strength, frequency, lot number an expiration date not provided) in the left arm. Concomitant therapies included prednisone (manufacturer unknown), NEURONTIN, ZOVIRAX and TOPROL. In October 2015, a few days after receiving the vaccine, the patient experienced pain in extremity (reported as very sore), hypoaesthesia (reported as from the elbow to her wrist it was numb and tingly) and erythema (reported as was very bright red and warm). On an unspecified date, an nuclear magnetic resonance imaging (MRI) was performed to see if the numbness was coming from there but not results were provided. The patient sought for medical attention. She has been treated with many medications, but nothing was working. The patient stated she has been experiencing this for two months and still does not feel any better. The outcome of pain in extremity, hypoaesthesia and erythema was reported as not recovered/not resolved. At the time of this report, the relatedness between pain in extremity, hypoaesthesia and erythema and vaccination with ZOSTAVAX was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (Lot # L029482, expiration date 06-NOV-2016) dose, route and anatomical location were not provided. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 10-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, patient s were vaccinated with GARDASIL (lot # K008931, expiry date 04-MAR-2017) (dose, route and site of administration were not reported) that was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (Batch and Lot No. L013202, exp. 27-JAN-2017) (dose, route and site not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001942, 1601USA001943 and 1601USA000936 from the same reporter. Additional information had been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 79 year old male patient. The patient's concurrent conditions included drug reactions/allergies to penicillin. The patient had no pertinent medical history. On 07-DEC-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot # L032399 with expiration date 26-NOV-2016. The patient was not taking concomitant medication. The reporter stated that, on 14-DEC-2015, the patient developed an itchy rash on the right side of his waist which spread to the left side and then his face. The patient was administered prednisone (manufacturer unknown) on 14-DEC-2015. No lab diagnostics studies were performed. The outcome of rash pruritic was reported as recovered, on an unspecified date. The reporter did not assess the relatedness between rash pruritic and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients received unspecified number of improperly stored doses of VARIVAX (Merck) lot # L026408, expiration date: 15-JUL-2017 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of GARDAIL lot # K010215 (expiration date: 05-MAY-2017) dose 2 (route and site of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 30-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (Lot # L029482, expiration date 06-NOV-2016) dose, route and anatomical location were not provided. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.