chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given to a 12 years old patient/ No AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2041, expiry date: 30-Jun-2021) via intramuscular route in left arm on 01-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No  concomitant therapy given to the patient.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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 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: FLUR4
Symptoms: Urticaria
Clinical narrative: experienced  hives starting 12 hours after injection; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographics patient who experienced hives starting 12 hours after injection (urticaria), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history included Mast cell activation syndrome.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE injection lot number not reported for prophylactic vaccination.  On an unknown date, the patient experienced hives starting 12 hours after injection of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (urticaria).  Other relevant tests included no lab data.  Final diagnosis was urticaria.  It was not reported if the patient received a corrective treatment.  The patient was recovered from the event.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 11 years old patient received Flublock vaccine with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from nurse. This case is linked to case: 2020SA287061 (15 years old).  This case involves a 11 years old female patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2009, expiry date: 06-Jun-2021) via unknown route in left arm on 12-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).   The patient's medical history, medical treatments, vaccinations and family history were not provided.  She didn't receive any other vaccinations or medications on that visit.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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 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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of Flublok was given to a 15 years old patient/ No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA, expiry date: 30-Jun-2021) via an unknown route in left arm on 12-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).   The patient's medical history, medical treatments, vaccinations and family history were not provided.  She didn't receive any other vaccinations or medications on that visit.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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 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: 15.0
Sex: M
Vaccine: FLUC3, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the patient was given FLUBLOK  instead of Flucelvax, no AE; Flublok was administered to a 15-year-old patient, no AE; Initial information was received on 15-Oct-2020 regarding an unsolicited valid    This case involves a 15 year old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2010 and expiration date was not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 14-Oct-2020 instead of INFLUENZA VACCINE INACT SAG 3V [FLUCELVAX] (wrong product administered, Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.   This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse reaction reported (unknown to reporter).  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 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: 6.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6 years old patient received a dose of Flublok with no adverse event; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA304264.  This case involved a 6-years-old male patient received a 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2055, Expiration date- 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age) on 20-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration (Latency: Same day).  No relevant laboratory data was reported.  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 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: 7.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old was given Flublok in error with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00327405) and transmitted to Sanofi on 22-Oct-2020.  This case involved a 7 year old patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with the help of prefilled syringes (Lot number and expiry date not reported) via intramuscular route in the shoulder for prophylactic vaccination (product administered to patient of inappropriate age as the patient age was 7 year).  Relevant medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  No other vaccines were administered.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: 1 day).  At the time of report, no adverse event was reported.  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 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: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was given an expired dose of Adacel with no AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 16 years old female patient who received 0.5 mL an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Single-dose vial (lot number: C5519BA, expiry date: 12-Sep-2020) via intramuscular route in the right arm on 21-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was a case of an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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 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: 0.5
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Flublok Quadrivalent vaccine to 6 month old patient/ no AE; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA301262, 2020SA301293, 2020SA301312, 2020SA301272, 2020SA301284, 2020SA301290 and 2020SA301276 (same reporter).  This case involves a six-months-old female patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency-on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: 0.75
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 month old patient received a dose of FLUBLOK instead of Fluzone Quadrivalent/ no AE.; 9 month old patient received a dose of FLUBLOK instead of Fluzone Quadrivalent/ no AE.; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a nine-months-old male patient who was administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ518AA, expiry date- 30-Jun-2021) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via intramuscular route in the left thigh for prophylactic vaccination on 23-Oct-2020 (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications none.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: S: I itching, swelling and redness after flu shot at 11:45 am today.  Left deltoid region, there is no swelling , no erythema, no tenderness. There is  a small injection site.   Local reaction to flu vaccination
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Angiogram abnormal, Atrial fibrillation, Blood bilirubin normal, Blood chloride normal
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatinine increased, Blood culture, Blood glucose normal, Blood lactic acid decreased, Blood potassium normal
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blood sodium normal, Blood urea normal, Brain oedema, Carotid artery occlusion, Central venous catheterisation
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Chest X-ray abnormal, Chills, Coagulation test normal, Computerised tomogram head abnormal
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Electrocardiogram normal, Haemoglobin normal, Haemorrhagic transformation stroke, Hypotension
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Intensive care, Ischaemic stroke, Liver function test normal, Magnetic resonance imaging brain abnormal, Poor quality sleep
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Resuscitation, Troponin increased, Vomiting projectile, White blood cell count increased, White blood cells urine positive
Clinical narrative: Shot was at 6:21pm. Around 8:15pm, patient started to experience upset stomach. She then rapidly was overcome with chills, projectile vomiting, diarrhea. She could not sleep well. she was in and out of the bathroom. I stayed the night with her. She did not have a fever. (97.5),  At 4:27am she rolled out of bed. I was there. I recognized stroke and called 911 at 4:30am. they arrived at 4:35am. We arrived at ER at 5:05am .  Excerpt from medical record ( TOTAL OF 1039 pages for this incident) : " Patient was outside TPA window. Patient was also immediately found to be in atrial fibrillation with rapid ventricular response causing hypotension of apprx 80/50. Patient that was immediately called, the patient required resuscitation prior to going to CAT scan. She was given boluses of lactated Ringer's, digoxin as well as diltiazem pushes which brought her heart rate down to approx 110 and moderate improvement in her BP. CT head revealed no intraparenchymal hemorrhage but was consistent with a right MCA ischemic stroke. CTA of the head and neck revealed no obvious large vessel occlusion may be amenable to interventional removal. There is moderate occlusion of the carotids but nothing requiring emergent intervention.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Tinnitus, Tunnel vision
Clinical narrative: About 5-10 minutes after immunization, patient reported feeling lightheaded, with ringing in her ears and tunnel-vision. Patient returned to the immunization booth and sat down for the next 20 minutes, with ice pack applied to back of neck and bottle of water to drink.  Patient did not lose consciousness, and lightheadedness resolved.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Paraesthesia, Vibration test normal
Clinical narrative: Numbness and tingling in the hands and feet, comes on and off during the days depending on the position, better with movements, no problems at night. He also feels tired with low energy.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Pain from elbow to the shoulder for so far 3 weeks
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX23 that was recalled; Vaccine was  incorrectly stored/Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 08-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX23 that was recalled; Vaccine was incorrectly stored/Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 22-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 08-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Bronchitis, Cardiac disorder, Dyspnoea, Pertussis
Clinical narrative: pneumonia / shortness of breath; atrial fibrillation; whooping cough; acute bronchitis; upper respiratory tract infection; other cardiac complications; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 17-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with pneumonia, acute bronchitis, an upper respiratory tract infection, whooping cough, shortness of breath, atrial fibrillation and other cardiac complications. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. 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, 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, the pt had 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 to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX) (reported as caused by zoster vaccine live (ZOSTAVAX)).  The events of pneumonia/shortness of breath, acute bronchitis, upper respiratory tract infection, whooping cough, atrial fibrillation, and other cardiac complications were considered to be disabling. Upon internal review, the events of pneumonia, atrial fibrillation, and whooping cough were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Upper respiratory tract infection
Clinical narrative: pneumonia / shortness of breath; atrial fibrillation; whooping cough; acute bronchitis; upper respiratory tract infection; other cardiac complications; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 17-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with pneumonia, acute bronchitis, an upper respiratory tract infection, whooping cough, shortness of breath, atrial fibrillation and other cardiac complications. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. 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, 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, the pt had 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 to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX) (reported as caused by zoster vaccine live (ZOSTAVAX)).  The events of pneumonia/shortness of breath, acute bronchitis, upper respiratory tract infection, whooping cough, atrial fibrillation, and other cardiac complications were considered to be disabling. Upon internal review, the events of pneumonia, atrial fibrillation, and whooping cough were determined to be medically significant.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: received / hepatitis B series as an infant / Hepatits B labs / did not have protective antibody titers for Hep B; This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 15-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included vomiting.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her primary hepatitis B series as an infant and recently saw a pediatric gastroenterologist for vomiting.  They drew Hepatitis B labs and noted that she did not have protective antibody titers for Hep B. This case linked with US2020AMR215143, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215143:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter enquired whether it was common to have a rash at the injection site after a Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: have welts around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site wheal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles couple of years ago).   In October 2020, the patient received Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix vaccine three days ago and had welts around the site that look exactly like the beginning of the shingles couple of years ago.  The reporter asked if those were still present and contagious.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Headache, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash / rash presents as large (about 3 by 4 cm) red areas of skin on arms, shoulder and torso; slight headache; feeling warm to the touch; This case was reported by a consumer and described the occurrence of red rash in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5554L, expiry date 8th April 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 28th October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, 30 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Aspirin, the patient experienced red rash, headache and skin warm. The patient was treated with acetylsalicylic acid (Aspirin) and hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the red rash, headache and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the red rash, headache and skin warm to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: This case was reported by patient for himself. About 30 hours after receiving vaccine, the patient experienced slight headache and rash, rash presents as large (about 3 by 4 cm) red areas of skin on arms, shoulder and torso, feeling warm to the touch, no itching or pain. The events were still persisting at about 50 hours after injection. The patient was unresponsive to topical cortisone and headache responsive to aspirin (975 mg). The patient did not seek any other medical assistance so far. The patient's spouse received vaccination from same lot and experienced no adverse events.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Malaise, Migraine, Vertigo
Clinical narrative: "Not feeling well"; freezing (feeling cold); migraines; vertigo; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 20th November 2019, several hours after receiving Shingrix, the patient experienced feeling unwell, feeling cold, migraine and vertigo. On 26th October 2020, the outcome of the feeling unwell, feeling cold, migraine and vertigo were recovered/resolved.   The reporter considered the feeling unwell, feeling cold, migraine and vertigo to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient herself reported that she received the shingrix vaccine on 20th November,2019 and within a matter of hours experienced events like "not feeling well," freezing (feeling cold), migraines and vertigo. She also stated that events lasted for many months but Symptoms are now resolved. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Headache, Injection site pain, Rash, Rash erythematous
Clinical narrative: local injection site pain; rash on her back, torso and/  the inguinal area / was dry / flat circular rash; rash / red; rash was itchy; burning littile bumps; Rash papular; rashes are peeling now; headache; chills; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles, rash and stress.   On 15th October 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills were unknown.   It was unknown if the reporter considered the injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Patient had shingles about 5 years ago and also had history of rashes with increased stress. Physician reported that on 15th  october,2020 patient received the shingrix and flu vaccine and had local injection site pain which resolved in a fewdays. It was reported that a week later patient reported that she had rash on her back, torso and it went down the inguinal area,It was dry, red, itchy, burning littile bumps which progressed to a flat circular rash and the rashes are peeling now. It was also reported that patient had headache and chills after the vaccination. Patient was using Bendryl topically. The reporter consented to follow up
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash papular, Rash pruritic, Skin burning sensation, Skin exfoliation
Clinical narrative: local injection site pain; rash on her back, torso and/  the inguinal area / was dry / flat circular rash; rash / red; rash was itchy; burning littile bumps; Rash papular; rashes are peeling now; headache; chills; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles, rash and stress.   On 15th October 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills were unknown.   It was unknown if the reporter considered the injection site pain, rash, red rash, itchy rash, burning skin, rash papular, skin peeling, headache and chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Patient had shingles about 5 years ago and also had history of rashes with increased stress. Physician reported that on 15th  october,2020 patient received the shingrix and flu vaccine and had local injection site pain which resolved in a fewdays. It was reported that a week later patient reported that she had rash on her back, torso and it went down the inguinal area,It was dry, red, itchy, burning littile bumps which progressed to a flat circular rash and the rashes are peeling now. It was also reported that patient had headache and chills after the vaccination. Patient was using Bendryl topically. The reporter consented to follow up