chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Chest X-ray normal, Dizziness, Electrocardiogram normal, Hypertension, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician, regarding a 16 year old male patient. The patient had no pertinent medical history, concomitant therapies and drug reactions or allergies. On 05-JAN-2018, the patient was vaccinated with a second dose of GARDASIL 9 (dose, lot #, expiration date, route of administration and anatomical location were not reported). After vaccination in January 2018, the patient experienced dizziness, numbness and high blood pressure (Blood pressure 164/90 & Pulse 118 (units not provided)). Subsequently, the patient was sent to the emergency room and an electrocardiogram and a chest x ray were performed which were normal. The patient was discharged from the hospital. The outcome of dizziness, numbness and high blood pressure was unknown. The causal relationship between vaccination and the events was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report, was received from a Respiratory Therapist referring to a Multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N019838, expiration date on 16-FEB-2019 (strength, dose number and route were not provided) for prophylaxis. No adverse events reported. The case was reported due to digital data logger, with a temperature of -0.4 °C during 2 hours, no previous temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2017 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated with ZOSTAVAX (lot# and route unknown) on or about 26-OCT-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAY-2017 the patient was treated at a dermatology center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2017 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated ZOSTAVAX vaccine (lot# and route unknown) on or about 01-NOV-2013, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JAN-2015 the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster inducing migraines. The patient has been prescribed morphine injections, acyclovir, DEMEROL injections, promethazine injection for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 16-JAN-2012, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-AUG-2015, the patient was treated for a blistering vesicular eruption, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX, acyclovir, and ointment for management of her ongoing and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-DEC-2010, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2017, the patient was treated by a nurse practitioner for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 28-MAR-2017, she sought subsequent treatment from the nurse practitioner for ongoing and worsening symptoms of herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 14-MAR-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # L033549 and expiration date of 05-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US--009507513-1801USA006861: US--009507513-1801USA006860.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer referring to a white female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The reporter noted that the patient had serious and life changing effects from GARDASIL. And the reporter claimed would not vaccinate the children until it could be proven with 100% certainty that her side effects were caused by something else. At the reporting time, the outcome of the adverse event was unknown. The causality between the adverse event and GARDASIL was not provided. The reporter considered the event to be serious.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 16-MAR-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # L033549 and expiration date of 05-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 21-MAR-2017 , the patient was vaccinated with a dose of improperly stored ROTATEQ lot # 007307 and expiration date of 30-NOV-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1801USA006247: US-009507513-1801USA006860.
Sex: M
Vaccine: HEP
Symptoms: Adverse event, Hepatitis B antibody negative, Lung disorder
Clinical narrative: This spontaneous report was received from a male patient, who was a pharmacist, referring to himself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2011, the patient completed a series of unspecified number of doses of RECOMBIVAX HB injection (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2017, he had an unspecified tests performed that revealed low titers for hepatitis B antibody. On an unknown date, the patient experienced an unspecified event, which required a treatment with double lung transplant. At the time of the report, the patient was awaiting the transplant and it was not reported when the procedure would be performed. The outcome of the events was unknown. The relatedness between the events and RECOMBIVAX HB was not reported. Upon internal review, the event requiring the treatment with double lung transplant was considered to be medically significant.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram QRS complex, Electrocardiogram QT interval, Electrocardiogram ST segment depression, Electrocardiogram T wave abnormal
Clinical narrative: Initial solicited report received on 12DEC2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. This is a 27 year old male who received immunization with ACAM2000 on 27SEP2017. The patient had no prior cardiac or other relevant medical history. No concomitant medications or vaccines were reported. On 08OCT2017 (12 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (5.69ng/mL) and a normal echocardiogram. On 17OCT2017, he was diagnosed with myocarditis, unspecified. At the time of the report the outcome was unknown. Follow-up information received on 19DEC2017. Diagnostic test results were provided. On 08OCT2017 electrocardiogram results included normal sinus rhythm with RSR or QR pattern in V1 suggestive of right ventricular conduction delay (borderline) with QT/QTc-352/405 ms (notes written: PR depressions and STE consistent with myocarditis); nine days later the electrocardiogram was abnormal with sinus bradycardia and nonspecific t-wave abnormality with QT/QTc=420/408ms; echocardiogram impression was normal but with small pericardial effusion without signs of tamponade. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the subject experienced suspected myocarditis; the information was insufficient to adjudicate for pericarditis; the information did not meet the case definition for subclinical myopericarditis. As a result of the adjudication committee consensus review - there were no changes to the reported events in this case.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Pericardial effusion, Sinus bradycardia, Troponin I increased
Clinical narrative: Initial solicited report received on 12DEC2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. This is a 27 year old male who received immunization with ACAM2000 on 27SEP2017. The patient had no prior cardiac or other relevant medical history. No concomitant medications or vaccines were reported. On 08OCT2017 (12 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (5.69ng/mL) and a normal echocardiogram. On 17OCT2017, he was diagnosed with myocarditis, unspecified. At the time of the report the outcome was unknown. Follow-up information received on 19DEC2017. Diagnostic test results were provided. On 08OCT2017 electrocardiogram results included normal sinus rhythm with RSR or QR pattern in V1 suggestive of right ventricular conduction delay (borderline) with QT/QTc-352/405 ms (notes written: PR depressions and STE consistent with myocarditis); nine days later the electrocardiogram was abnormal with sinus bradycardia and nonspecific t-wave abnormality with QT/QTc=420/408ms; echocardiogram impression was normal but with small pericardial effusion without signs of tamponade. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the subject experienced suspected myocarditis; the information was insufficient to adjudicate for pericarditis; the information did not meet the case definition for subclinical myopericarditis. As a result of the adjudication committee consensus review - there were no changes to the reported events in this case.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This is a Legacy Sanofi Pasteur case previously reported under mfg# 2017SA091146. Initial solicited report received on 17 May 2017 from an investigator (Defense Health Agency) in the trial. A 22-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 VACCINE (lot number and route, site of administration not reported) on 19 October 2016. On 03 November 2016, 15 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 07 November 2016, 19 days post vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. The lab data included within 30 days post vaccination on 30 October 2016, the Troponin I was abnormal (the highest value was recorded as 51.00), ECG was abnormal, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported.  The events outcome was not reported. Relationship to investigational product according to company: associated. Relationship to investigational product according to investigator: not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 22 May 2017: The unit of troponin I was reported as ng/ml. Follow up information received on 21 August 2017: Additional diagnoses/symtoms were reported as 'echocardiogram normal', 'electrocardiogram abnormal' and 'troponin I increased'. Follow-up information received on 29 September 2017: Review date: 21-Sept-2017.  It is reported that initially vaccinated 80 days but no take was observed so subject was revaccinated. Lab data was updated: ECG on 30 October 2016 - STE in leads II, III AVF, V6 with HR palpable at 120 BPM and Troponin T reference range less than 0.03ng/ml on 27 September 2017. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. As a result of the adjudication committee consensus review - the event of pericarditis was removed from this case and the event of subclinical myopericarditis (myocarditis) was added to the case.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Ejection fraction normal, Electrocardiogram PR interval, Electrocardiogram PR shortened, Electrocardiogram ST segment abnormal
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 09 June 2017 and follow up information received on 12 June 2017. A 24-year-old male subject with no significant medical history reported. The subject's concomitant medication were not reported. The subject received a dose of ACAM2000 (lot number and site of administration not reported) on 15 June 2010. On 14 July 2010, 29 days after vaccination the subject was diagnosed with 429.0 non-specific myocarditis, unspecified. The lab data included 14 July 2010, the Troponin I was 02.12 ng/mL (abnormal); on 25 July 2010 electrocardiogram (ECG) was abnormal; on 05 August 2015 Echocardiogram was normal. MRI (heart), MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: associated. Follow up information received on 29 September 2017: Review Date: 11-July-2017. Lab data was updated: ECG on 25 June 2010, which showed that (1) Diffuse ST changes and PR interval depression. ECG on 26 June 2010 which showed that (1) STE 1.0 mm leads II, III, AvF; (2) SB (48BPM) w/varying AV conduction PR interval average 0.198-0.204; and (3) SB (51BPM) with SA otherwise normal. ECHO on 05 August 2010, showed (Normal) EF = 60-65% with normal wall motion and trace mitral regurgitation and Troponin I reference range was listed as greater or equal 5 on 27 September 2017. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. No changes were made to the preferred term(s) of this case based on the adjudication committee decision.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram ST segment elevation, Mitral valve incompetence, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 09 June 2017 and follow up information received on 12 June 2017. A 24-year-old male subject with no significant medical history reported. The subject's concomitant medication were not reported. The subject received a dose of ACAM2000 (lot number and site of administration not reported) on 15 June 2010. On 14 July 2010, 29 days after vaccination the subject was diagnosed with 429.0 non-specific myocarditis, unspecified. The lab data included 14 July 2010, the Troponin I was 02.12 ng/mL (abnormal); on 25 July 2010 electrocardiogram (ECG) was abnormal; on 05 August 2015 Echocardiogram was normal. MRI (heart), MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: associated. Follow up information received on 29 September 2017: Review Date: 11-July-2017. Lab data was updated: ECG on 25 June 2010, which showed that (1) Diffuse ST changes and PR interval depression. ECG on 26 June 2010 which showed that (1) STE 1.0 mm leads II, III, AvF; (2) SB (48BPM) w/varying AV conduction PR interval average 0.198-0.204; and (3) SB (51BPM) with SA otherwise normal. ECHO on 05 August 2010, showed (Normal) EF = 60-65% with normal wall motion and trace mitral regurgitation and Troponin I reference range was listed as greater or equal 5 on 27 September 2017. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. No changes were made to the preferred term(s) of this case based on the adjudication committee decision.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Influenza vaccination was given in left deltoid, and a few hours later, patient had pain radiating down her left side to her hand. this lasted 3 days before resolving.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching/swelling at injection site. Left upper arm swelling. No treatment - will meet/follow up with Dr 02/17/18.
Sex: U
Vaccine: MMR
Symptoms: Drug effect incomplete
Clinical narrative: This literature marketed report refers to an unspecified number of patients of unknown age and gender. In order to better understand individual variations in persistence of neutralizing antibodies following M-M-R II, the authors conducted an expanded analysis of the data set. They identified patterns of seropositivity and antibody persistence following receipt of M-M-R II, compared antibody kinetic patterns across all three M-M-R II antigens, and estimated the rate of decline in antibody titers over time using regression models, accounting for differences between and within subjects. The authors included 313 participants who received on an unknown dates, the first dose of M-M-R II between 12 to 24 months of age for prophylaxis (dose, route, anatomical location, lot number and expiration date were not reported) and the second dose of M-M-R II on an unknown dates between 4 to 6 year of age for prophylaxis (dose, route, anatomical location, lot number and expiration date were not reported). The mean time between the first and second dose was 3.7 years. Serum samples were collected for antibody testing prior to M-M-R II (baseline) and throughout a 12 year follow-up period (post-vaccination at 1 month, 6 months, 2 years, 5 years, 7 years, 10 years, and 12 years). Antibody testing for rubella and mumps was performed at the end of the 12 year study, and specimens from the same individuals were tested in the same run. For measles, specimens collected through the 10 year post - M-M-R II, visit were tested after completion of that visit. The 12 year post - M-M-R II, measles visit samples were tested after completion of that visit using the same reagents and operators as the other tests. Of 313 patients who received the second dose of M-M-R II, 302 had measles antibody data and 296 had mumps and rubella data for the baseline visit, 1 month post-vaccination, and at least 1 additional follow-up visit. On an unknown dates, 5 patients (2%) became and remained seronegative for measles sometime after 6 months post vaccination; 20 patients  (7%) were seronegative converters for mumps, and 11 patients (4%) were seronegative converters for rubella (drug effect incomplete). The outcome of the drug effect incomplete was unknown at the time of reporting. The authors considered drug effect incomplete to be related to M-M-R II as they stated that the rate of antibody decline was associated with M-M-R II response and baseline titer for measles and age at first dose of M-M-R II for rubella.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a 12-year-old female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. In January 2018, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional information was provided as follows: The age at vaccination was not reported. On 18th January 2018, the reporter became aware of the patient who had received 2017-18 seasonal influenza vaccine (manufacturer unknown) at an unknown date before 2018 and was diagnosed with influenza. The patient was confirmed by positive flu test administered in the physician office. The reporter did not have the physician contact information and the patient's parent refused to provide additional details or permission to contact for further follow up. This case was considered as suspected vaccination failure as the time to onset for influenza was not provide at the time of reporting.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Swelling /Itching at site; Shortness of breath, State with 30-40 min after administration. Ambulance Services gave albuterol. ER staff gave patient a steroid and albuterol.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient called this morning and said the right arm where she got the prevnar vaccination has turned bright red and swelled up. She said after the vaccination her muscle hurt like normal but now all of a sudden she was experiencing this. Advised the patient to contact her doctor to report in case needed followup and to monitor reaction for worsening symptoms. Will follow up with patient to see if symptoms resolved or if she saw her doctor.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site erythema, Myalgia, Vaccination site swelling
Clinical narrative: Patient called this morning and said the right arm where she got the prevnar vaccination has turned bright red and swelled up. She said after the vaccination her muscle hurt like normal but now all of a sudden she was experiencing this. Advised the patient to contact her doctor to report in case needed followup and to monitor reaction for worsening symptoms. Will follow up with patient to see if symptoms resolved or if she saw her doctor.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event
Clinical narrative: No adverse event noted. Parent was called as soon as the incident was discovered. Patient's mom called again this morning and she is reporting that patient is doing fine.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Middle insomnia, Pain in extremity, Radiculitis brachial
Clinical narrative: Brachial Neuritis left arm with pain that woke her from sleep the night after receiving the vaccine. Gradually improved over the next week. As of 21 Dec 2017, her symptoms have decreased with the exception of persistent increased sensitivity to touch.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site. Warm to the touch.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: PT SAYS THEY WOKE UP AT 3am with a red face after receiving the flu shot that night. Took benadryl and redness went away.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at site surrounding injection on left arm about 3-4 hours after injection. The swelling worsened and she presented to urgent care on 1/22 and reports she was diagnosed with cellulitis. The patient received antibiotics and symptoms are resolving.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site. Warm to the touch.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Aphasia, Emotional distress, Lethargy, Pyrexia, Tremor
Clinical narrative: Was acting completely normal all day (1/22), then we put him in the bath that evening. Around 7pm, he stopped talking to me, wouldn't answer questions, and was shaking all over. The water was very warm, not cold. We got him out of the bath and in a towel. He shook the whole time we were getting him dressed. Was very emotional. We got him in pajamas and wrapped in a blanket. He finally stopped shaking but was lethargic and not talking much. He woke up the next morning (1/23) with a fever of 100.5. He has been lethargic all morning.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving immunization and felt better and was fully recovered after twenty minutes of monitoring by pharmacist. Patient reported a history of having felt dizzy after receiving an immunization on Immunization Consent Form. Patient requested Advil five minutes after immunization and was advised to take with meal and took the Advil. After full recovery, patient answered no when asked if 911 should be called.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: Patient fainted after receiving immunization and felt better and was fully recovered after twenty minutes of monitoring by pharmacist. Patient reported a history of having felt dizzy after receiving an immunization on Immunization Consent Form. Patient requested Advil five minutes after immunization and was advised to take with meal and took the Advil. After full recovery, patient answered no when asked if 911 should be called.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Muscle tightness, Pain in extremity, Paraesthesia
Clinical narrative: Patient fainted after receiving immunization and felt better and was fully recovered after twenty minutes of monitoring by pharmacist. Patient reported a history of having felt dizzy after receiving an immunization on Immunization Consent Form. Patient requested Advil five minutes after immunization and was advised to take with meal and took the Advil. After full recovery, patient answered no when asked if 911 should be called.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Syncope
Clinical narrative: I felt faint about a minute after shot was administered. The feeling passed, but then after a minute or two, my hands clenched (the tips of my fingers were all pressed together, so not quite a clench) and they felt numb/tingly and I couldnt unclench them. My arms were really heavy and there was severe pain traveling from my upper arm all the way down to my wrist. The feeling lasted about 15 minutes, until i was slowly able to unclench my right  hand and then my left and the severe pain went away. After that, I only felt tenderness by the injection site and my left shoulder.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: I felt faint about a minute after shot was administered. The feeling passed, but then after a minute or two, my hands clenched (the tips of my fingers were all pressed together, so not quite a clench) and they felt numb/tingly and I couldnt unclench them. My arms were really heavy and there was severe pain traveling from my upper arm all the way down to my wrist. The feeling lasted about 15 minutes, until i was slowly able to unclench my right  hand and then my left and the severe pain went away. After that, I only felt tenderness by the injection site and my left shoulder.
Age: 29.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Muscle tightness, Pain in extremity, Paraesthesia
Clinical narrative: I felt faint about a minute after shot was administered. The feeling passed, but then after a minute or two, my hands clenched (the tips of my fingers were all pressed together, so not quite a clench) and they felt numb/tingly and I couldnt unclench them. My arms were really heavy and there was severe pain traveling from my upper arm all the way down to my wrist. The feeling lasted about 15 minutes, until i was slowly able to unclench my right  hand and then my left and the severe pain went away. After that, I only felt tenderness by the injection site and my left shoulder.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site.  Warm to the touch.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Left shoulder pain, decreased range of motion.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Product storage error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 89-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort, incorrect storage of drug and vaccination error. On an unknown date, the outcome of the injection site discomfort, incorrect storage of drug and vaccination error were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX (on left deltoid) after it was stored in the freezer, which led to incorrect storage of drug and vaccination error. The patient experienced no side effects except discomfort at the injection site. The case has been linked with case US2018009454, reported by the same reporter.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Palpitations
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received BEXSERO (batch number 16D301, expiry date February 2019). On 29th November 2017, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 1 day 12 hrs after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and heart racing. On an unknown date, the outcome of the injection site erythema, injection site pain and heart racing were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and heart racing to be related to BEXSERO. Additional information was provided as follows: The healthcare professional reported that the patient developed redness and soreness at injection site along with heart racing about 36 hours after receiving BEXSERO. No further information reported regarding the event.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction. Patient received DTAP instead of TDAP. Verbally spoke with mother and patient was fine with no side effects at all.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction. Verbally spoke with the mother and patient never reacted.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Confusional state, Culture urine negative, Feeling abnormal, Hypopnoea, Pyrexia
Clinical narrative: 1/21/2018 child presented with a fever of 102.5 around 11:00pm. 5ml of TYLENOL given. 1/22/2018 child's fever remained but had no other symptoms. Was taken to pediatric clinic for catheterization and urine sample since there is a history of VUR. 5pm lab called and confirmed urinalysis was clean. 72 hour wait for cultures. 1/22/2018: child bathed and had temperature taken rectally around 7pm. Rectal temperature read 103.5. Child then starting having arm convulsions, staring at the ceiling, would not respond to his name being called and had shallow breathing. Episode lasted less than 30 seconds. Child was given 5ml of TYLENOL which he vomited within minutes. Child seemed dazed, and confused for roughly 30 minutes after episode. Child was taken to the emergency room and presented a 102.9 fever. Was given TYLENOL rectally.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Seizure, Staring, Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: 1/21/2018 child presented with a fever of 102.5 around 11:00pm. 5ml of TYLENOL given. 1/22/2018 child's fever remained but had no other symptoms. Was taken to pediatric clinic for catheterization and urine sample since there is a history of VUR. 5pm lab called and confirmed urinalysis was clean. 72 hour wait for cultures. 1/22/2018: child bathed and had temperature taken rectally around 7pm. Rectal temperature read 103.5. Child then starting having arm convulsions, staring at the ceiling, would not respond to his name being called and had shallow breathing. Episode lasted less than 30 seconds. Child was given 5ml of TYLENOL which he vomited within minutes. Child seemed dazed, and confused for roughly 30 minutes after episode. Child was taken to the emergency room and presented a 102.9 fever. Was given TYLENOL rectally.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site. Warm to the touch.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Erythema, Neck pain, Pyrexia
Clinical narrative: Vaccine was given by MA on 1/12/18, the next day patient reported, while at our office on 1/16/18, that she experienced redness, swelling, warm to touch, fever, pain that radiated into her neck, blurred vision, chest pain and pressure. On 1/16/18 patient reported that day that all symptoms were subsided except the redness, swelling and slight blurred vision. Patient was evaluated by myself, another nurse, and Dr.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling, Vision blurred
Clinical narrative: Vaccine was given by MA on 1/12/18, the next day patient reported, while at our office on 1/16/18, that she experienced redness, swelling, warm to touch, fever, pain that radiated into her neck, blurred vision, chest pain and pressure. On 1/16/18 patient reported that day that all symptoms were subsided except the redness, swelling and slight blurred vision. Patient was evaluated by myself, another nurse, and Dr.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an approximately 8 month old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in 2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number: M044724 (expiration date: 13-JUN-2018), orally, for prophylaxis (strength and dosage schedule were not reported). The storage characteristics were the following: Temperature: 47 F to 77 F for 17 hours. Previous temperature excursion: No. No adverse effects were reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Left upper arm pain and soreness that has persisted >1 month since injection.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV, UNK
Symptoms: Chills, Influenza virus test negative, Pyrexia
Clinical narrative: Patient reported violent shivering and 102 degree fever. He states that the shivering was so bad that he thought he might be having a seizure.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Pyrexia, Rubella antibody positive, Urticaria
Clinical narrative: This spontaneous report has been received from a currently 34 year old female patient who was also a registered nurse concerning herself. The patient's pertinent medical history included gluten intolerance. The patient's drug reactions or allergies included allergy to latex. The patient's concomitant therapies were reported as whatever vaccines they administered to 1 year olds in 1984. On 30-NOV-1984 or early December 1984, when the patient was one year old, she was vaccinated with M-M-R II, 0.5 ml once for prevention of measles, mumps and rubella (dose number, route of administration, anatomical location, lot number and expiration date were not provided). On the same day, she developed fever and hives and it was reported that she was brought back to the doctor. It was unknown if treatment was given for the events or if lab diagnostics or studies were performed. It was also reported that because of those events, she did not get any further doses of M-M-R II, however, the patient stated that she had had multiple titers done since then and she was immune to measles, mumps and rubella. On an unknown date (reported as after stopping the therapy), the patient had recovered from pyrexia and urticaria. The causal relationship between M-M-R II and the events was unknown.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Cough
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist, received via a sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A 72-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose in the arm for immunisation. The patient medical history and concomitant medications were not reported. On unspecified date after vaccination the patient experienced bruising in the arm of injection with outcome of unknown and cough that lasted for a little while. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site reaction, Injection site warmth, Pain of skin, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a sales representative report for a female patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, (Lot # unknown, Expiry Date unknown, NDC # unknown) at single dose in her left arm on 11Jan2018 for immunization. There were no concomitant medications, other medical conditions or relevant investigations to provide. She developed swelling in her left hand on 11Jan2018. She started itching the day after receiving the vaccine, on 12Jan2018. On 13Jan2018, 2 days after the injection, she developed redness and the injection site was extremely hot. She stated her skin felt like it was cooking and was painful on 13Jan2018. There was a 6-9 inch ring around the injection site and it started to spread on an unspecified date. The patient was sent to her physician. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a sales representative report for a female patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, (Lot # unknown, Expiry Date unknown, NDC # unknown) at single dose in her left arm on 11Jan2018 for immunization. There were no concomitant medications, other medical conditions or relevant investigations to provide. She developed swelling in her left hand on 11Jan2018. She started itching the day after receiving the vaccine, on 12Jan2018. On 13Jan2018, 2 days after the injection, she developed redness and the injection site was extremely hot. She stated her skin felt like it was cooking and was painful on 13Jan2018. There was a 6-9 inch ring around the injection site and it started to spread on an unspecified date. The patient was sent to her physician. The outcome of the events was unknown. The information on the batch number has been requested.
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a Spontaneous report from a contactable nurse based on the information received by Pfizer from Merck (Case ID: 00707005). A 70-years-old patient of an unspecified ethnicity and gender received PREVNAR 13, (Lot S74423 Exp 30Nov2019), via an unspecified route of administration in the left arm on 11Dec2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an injection site reaction in the left arm with "erythema 18 cm at the longest point." on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from patient via social media on 31-Dec-2017. This case involves an unknown age female patient was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, 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 patient had the flu. Reported as it sucked. Lab data and corrective treatment were not reported. Event outcome was not reported at the time of reporting. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: Initial unsolicited report received from a health care professional on 11-Jan-2018. This case involves a 55-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL (Batch number: C5220AA, expiry date and dose in series were not reported) via intramuscular route at right arm on 10-Nov-2017. Patient's medical history and concomitant medications were not reported. On an unknown day following the vaccination, the patient had right arm weakness and could not lift his right arm over his shoulder and was seen by doctor today. Laboratory investigations and corrective treatment were not reported. Outcome of both the events were not recovered at time of reporting. Documents held by sender: none.