chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram ST segment depression, Endotracheal intubation, Fasciotomy, Gastrointestinal sounds abnormal
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperammonaemia, Hyperhidrosis, Iliac artery occlusion, Intensive care, Laboratory test abnormal
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lactic acidosis, Left ventricular dysfunction, Lung opacity, Pericardial effusion, Peripheral artery occlusion
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Procalcitonin, Pulse absent, Pupil fixed, Renal infarct
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory rate decreased, SARS-CoV-2 test negative, Shock, Skin discolouration, Thromboembolectomy
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Toxicologic test normal, Troponin increased, Ultrasound Doppler abnormal, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Patient received a COVID 2nd booster and ~40 minutes later began to cough, became unresponsive, and was barely breathing in his cart. EMS was called and patient was transported to Medical Center ED where we was intubated. Prior to ED arrival, he was noted to be diaphoretic and having involuntary movements, suggestive of decorticate posturing. CTA did not show PE, CVA or significant dissection flap in the aortic arch, but did show renal infarct. Left leg below the knee was also found to be cold, dusky, pulseless and ultrasound showed intraluminal thrombus with associated near complete occlusion of the external iliac artery, extends through and includes posterior tibial, peroneal, anterior tibial arteries. Emergent embolectomy and fasciotomy was performed followed by heparin drip. Pt was transferred to the ICU, where he was acidotic and in shock, started on bicarb and vasopressors. Worsening labs noted along with anuria and no bowel sounds, right pupil fixed and dilated, EKG with later ST depressions and RBBB, increased troponins. CTA was repeated, showing type A dissection extending up to the carotids and down to renals ? not amenable to surgery and patient transitioned to CMO.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: No further adverse events; HCP reporting administered dose of expired PEDVAX HIB.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug allergies or reactions, concurrent conditions, and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with an expired haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 1 dose, lot number S030964, expiration date reported and validated as 01-APR-2022, (strength, vaccination schedule, anatomical location of injection, and route of administration were not provided) for prophylaxis (expired product administered). It was stated that no history of prior excursions on products, no further adverse events were reported/ no product quality complaints.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Dose of improperly stored product was administered to a patient.; No additional adverse events reported; This spontaneous report has been received from a nurse prescriber concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions drug reactions or allergies and concomitant therapies were not provided.  On 06-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T029550, expiration date not reported, but upon internal review was established as 01-SEP-2022), that underwent a temperature excursion of 55.0 Fahrenheit grades in 2 hours and 24 minutes (product storage error). No additional adverse events were reported.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information; adult patient received ENGERIX-B 12OCT2021 and did not receive second dose of RECOMBIVAX HB until today 11APR2022; This spontaneous report was received from a nurse and refers to an adult female patient. On 12-OCT-2021, the patient received HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B). The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The patient did not receive second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1ml/once, reported lot # T0035865 was evaluated and changed to the valid Lot # T035865, expiration date: 28-APR-2023 (strength and route of administration were not provided) until 11-APR-2022 for prophylaxis (Inappropriate schedule of vaccine administered). The patient's titers were good and she was fine. The patient doesn't need any further doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB). No adverse event occurred.
Sex: M
Vaccine: VARZOS
Symptoms: Eye operation, Hypoacusis, Rash, Retinal disorder, Visual impairment
Clinical narrative: retinal issues; affect hearing; severe rash; Information has been received regarding a case in litigation from a lawyer and referred to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On or around 14-MAY-2016, the pt received the zoster vaccine live (ZOSTAVAX) (route, strength, dose, lot number and expiration date were unknown) from a pharmacy for its intended purpose: the prevention of shingles. On unknown date (reported as shortly thereafter), the pt suffered severe side effects affecting his vision and hearing in addition to a severe rash. The pt presented to physician and was diagnosed with retinal issues and had eye surgery. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX). The outcome of the events was considered as not recovered. The causality was related.   The reporter considered the events to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (route, strength, dose, lot number and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster, and postherpetic neuralgia. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality was related.  The reporter considered the events to be disability.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN AFTER VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 18-FEB-2022) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced pain after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain after vaccine was not reported. This report was non-serious.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at the injection site for a few days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild soreness at the injection site for a few days) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products).  Patient had no COVID positive test or diagnosis in the past. Patient had not taken other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included APIXABAN (ELIQUIS), PAROXETINE, MEMANTINE, BIMATOPROST (LUMIGAN), DORZOLAMIDE, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site for a few days). On 22-Feb-2021, VACCINATION SITE PAIN (Mild soreness at the injection site for a few days) had resolved.            No treatment medication was reported.   This case was linked to MOD-2022-558945, MOD-2022-559005.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered more than 42 days after the first dose; Expired 2nd dose administered to patient/patient received expired 2nd dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 42 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered to patient/patient received expired 2nd dose of Moderna) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 012F21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 42 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered to patient/patient received expired 2nd dose of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 42 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered to patient/patient received expired 2nd dose of Moderna) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter stated that the expiration date was from CDC. According to CDC expiration date 19 Mar 2022 was the last updated on this lot.  No treatment medications was reported.   Reporter did not allow further contact
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple temprature excursion with no adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced multiple temprature excursion with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Mar-2022, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (strength and formulation: unknown) (lot UJ578AAA, Expiration Date:09-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date it was reported multiple temprature excursion with no adverse event (intercepted product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event multiple temprature excursion with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Excursion information: total time out of range is 2 days with a minimum 9.2C and maximum 28.3 C with no adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 month old and unknown gender patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] which was involved in excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3c with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot number not reported and expiry date: 10-Sep-2022) via unknown route in unknown administration site as prophylactic vaccination. There will be no information on batch number for this case.  On an unknown date the patient developed a non-serious "excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3 c with no adverse event (product storage error)".   It was reported "HCP emailed patient information in regards to a previous temperature excursion case, see case 01078729 for additional details. Excursion information is listed below: 17Oct2021: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported. 19Oct2021 @ 1:15pm: total time out of range is 30 minutes with a minimum of 12.3C and maximum of 15.6C reported. 19Oct2021 @ 2:25pm: total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported. Additional Description of event Adverse events: Administered. No additional information provided."  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3 c with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received  via other health professional.  This case involves a 1 years old and unknown gender patient who was administered vaccine with reported total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine with lot UJ578AAA and expiry date: 10-Sep-2022 (dose, route and administration site: unknown) for Immunization.  On 17-Oct-2021, It was reported that temperature excursion of Pentacel vaccine occurred with total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, on 19-Oct-2021,  temperature excursion occurred with 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event (product temperature excursion issue).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event out of range for 2 days with a minimum of 9.2c and maximum of 28.3c with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C total time out of reported  total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child and unknown gender patient who experienced total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c total time out of reported  total time out of range is 1 hour with a minimum of negative 1.8c and maximum of 1.8c reported with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c total time out of reported  total time out of range is 1 hour with a minimum of negative 1.8c and maximum of 1.8c reported with no reported adverse event (product storage error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C total time out of reported  total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported with no reported adverse event).  At time of reporting, the outcome was Unknown for the event total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c total time out of reported  total time out of range is 1 hour with a minimum of negative 1.8c and maximum of 1.8c reported with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product administration error, Product storage error
Clinical narrative: excursions reached 52.6 F and the total amount of time out of range was 32.25 hours with no other reported adverse event; seven patients had been administered vaccines post excursion with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp received on 26-Apr-2022.  This case involves 7 patients of unknown age and gender who experienced excursions reached 52.6 f and the total amount of time out of range was 32.25 hours with no other reported adverse event and seven patients had been administered vaccines post excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL].  This case is linked to case 2022SA152239(CLUSTER).  The past medical history, medical treatment(s), vaccination(s) and family history of the patients were not provided.   Reportedly, temperature excursions reached 52.6 F and the total amount of time out of range was 32.25 hours with no other reported adverse event (product storage error). On an unknown date, the patients received suspect IPV (VERO) at unknown dose, formulation, frequency, route (lot T1E871M, expiry date: Oct-2022) in unknown administration site as prophylactic vaccination (Product administration error).  It was reported "Caller states that she called previously to report a temperature excursion. States that she needs to update time of the temperature excursion from 3420 minutes (57 hours) to 32.25 hours. Caller also reports that seven patients had been administered vaccines post excursion. Caller did not clarify which vaccines the patients received. This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 29-Apr-2022 from a consumer: Case updated from a non-valid case to a valid case. Event verbatim updated for product storage error. Event of product administration error added, Text updated accordingly.; Sender's Comments:  01078543:Please see inquiry #01078543 for General Vaccine information
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: 18 month old got Pentacel, including the polio, that was not due with no reported adverse event; Initial information  was received on 04-May-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 18 months old female patient who got pentacel, including the polio, that was not due with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included:  Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 03-May-2022, the patient received 4th dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel] 0.5 ml  (Batch number: U6971AA, expiration date: 11-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 03-May-2022 the patient got pentacel, including the polio, that was not due with no reported adverse event (wrong product administered) (latency: on the same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  Action taken: Not applicable. Corrective treatment: Not reported. Outcome:  Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient was treated with expired doses of pentacel with no reported adverse event; Initial information was received on 05-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 2 months old female patient who experienced patient was treated with expired doses of pentacel with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and rotavirus vaccine for Immunisation.  On 25-Mar-2022, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, and strength: unknown) (batch number: UJ414AAA Expiry date- 12-MAR-2022) via Intramuscular route in left thigh for immunization.  On an unknown date the patient developed a non-serious patient was treated with expired doses of pentacel with no reported adverse event (expired product administered) (latency same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.    Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was treated with expired doses of pentacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: patient had a suspected stroke
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Impaired work ability, Vertigo
Clinical narrative: Vertigo starting 11/4  for 1-2 weeks,  mostly lightheadedness and feeling "off-balance".  Only one time did I feel it strongly in my head that I was unable to work.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: She got tinnitus after each of her two Covid vaccines. The first time lasted  about a week and then thankfully went away. After the second one, she once again got tinnitus. This time lasted about a week and a half. Mosty in the right ear both times, but occasional in the left, as well. Thankfully it went away again as a more full-time thing, but she does still get twinges of it.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no AE; a patient received less than recommended dose of PROQUAD; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #U029325 verified as valid and expiration date: 19-MAR-2023, albumin status: rHA) (dose, route of administration, injection site were not provided) for prophylaxis. The patient received less than recommended dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Incorrect dose administered). No additional adverse events were reported (No adverse event).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient had a reaction to lipitor). Concomitant products included ETANERCEPT (ENBREL), ATENOLOL and TAMSULOSIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021) outcome was unknown.            The patient had not tested COVID positive test or diagnosis ever. Patient had also mentioned that they took concomitant medications but does not specified the same for what. No treatment information was reported.   This case was linked to MOD-2022-558782, MOD-2022-558245 (Patient Link).
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient had no allergies for medications, food and other products. The patient never had COVID positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included APIXABAN (ELIQUIS), PAROXETINE, MEMANTINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], BIMATOPROST (LUMIGAN) and DORZOLAMIDE for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 07-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was reported that, after 1st dose the patient experienced soreness at the injection site that lasted between 1 and 2 weeks. No treatment details were reported.   This case was linked to MOD-2022-559004, MOD-2022-559005 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my whole body hurt for an entire day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my whole body hurt for an entire day) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 7758 and 19337) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (my whole body hurt for an entire day). At the time of the report, MYALGIA (my whole body hurt for an entire day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up received and contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19; My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 27Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19".  Additional information: Description of Potential AE/PC: The patient and his wife were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet both contracted COVID-19? (Him first, 27Apr2022, even after receiving his second booster on 15Apr2022). The patient's wife was symptomatic 30Apr2022, yet tested negative that day and 01May2022, but then positive 02May2022.She had been separated as best as possible from her (21-year-old) daughter, but curious to know if she'd qualify to participate?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Gait disturbance, Lymph node pain, Paraesthesia, Peripheral swelling
Clinical narrative: Developed migratory angioedema. Swelling started approx 5 days after Moderna COVID booster.  Developed painful lymph node in armpit (near injection site) for 5 days, then developed swelling in feet. Could not walk for 24 hours d/t pain.  The swelling migrated around body approx every 48 to 72 hours. Starts as a "tingling" sensation  To date the following areas of body involved: feet, knees, hands, tongue, cheeks, lips, genitals, left side of my face Seen by allergist.  Now on 3 Allegra daily at 180 mg each. Takes lasix and prednisone 10-20mg prn for swelling Seen by cardiologist and medical conceirge physician.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Developed migratory angioedema. Swelling started approx 5 days after Moderna COVID booster.  Developed painful lymph node in armpit (near injection site) for 5 days, then developed swelling in feet. Could not walk for 24 hours d/t pain.  The swelling migrated around body approx every 48 to 72 hours. Starts as a "tingling" sensation  To date the following areas of body involved: feet, knees, hands, tongue, cheeks, lips, genitals, left side of my face Seen by allergist.  Now on 3 Allegra daily at 180 mg each. Takes lasix and prednisone 10-20mg prn for swelling Seen by cardiologist and medical conceirge physician.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Shakiness-Medium, Additional Details: patient's wife called to report he was having some shakiness the day after his vaccine. General shakiness of the body. Arm was "a little" sore. No previous history of this with previous covid shots
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Lethargy
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: pt was lightheaded, felt warm, and had chills after vaccine w/in 15 min.-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt experienced sympotoms within the 15 min observation period.  Was monitored and vitals checked.  Pt was placed in a supine position with feet elevated until symptoms passed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Visual impairment
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: pt was lightheaded, felt warm, and had chills after vaccine w/in 15 min.-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt experienced sympotoms within the 15 min observation period.  Was monitored and vitals checked.  Pt was placed in a supine position with feet elevated until symptoms passed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: PATIENT THINKS VACCINE WAS GIVEN TOO HIGH IN THE ARM
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID breakthrough case