chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details are available; Gardasil 9 improperly stored vaccine administered to patient on 10/7/2020.; This spontaneous report was received from a registered nurse referring to a 11-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.     On 07-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of administration were not reported; lot number S010729 and expiration date 01-DEC-2021) (product storage error). No additional adverse events were reported.     According to the reporter, the temperature excursion was above 9 degrees Celsius (11.3 degrees Celsius) for a time frame of 55 minutes on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA003133:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Caller reporting AE for expired dose of MMR II administered to a patient on 07-OCT-2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-OCT-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 millilters (mL) (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number R027999, which have been verified to be valid, expiration date reported and validated as 01-OCT-2020) as prophylaxis (expired product administered).
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: swelling from his shoulder to his hand; He had pain, redness, and swelling in right arm; had pain, redness, and swelling in right arm; This spontaneous report was received from a certified nursing assistant and refers to a 72 year old male patient. The patient's pertinent medical history was not provided. The patient's historical drugs included simvastatin (ZOCOR) which caused drug allergy (MARRS # 2010USA002785). The patient concurrent conditions included hypertension, Prediabetes, high cholesterol, enlarged prostate and acid reflux. The patient's concomitant therapies included tamsulosin hydrochloride, metformin hydrochloride (GLUCOPHAGE), lisinopril(manufacturer unknown), omeprazole and fluticasone propionate(FLONASE).   On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 mililier, intramuscular lot # T009744, expiration date on 28-JAN-2022 (anatomical location was not provided) for prevention of pneumonia. On the same date, the patient experienced swelling from his right shoulder to his hand (peripheral swelling), right arm pain (pain in extremity) and right arm redness (erythema). The patient did not seek medical attention, however medical treatment with ibuprofen was given to the patient for the events.  The outcome of peripheral swelling was not resolved (reported as the patient still had some swelling). The outcome of pain in extremity and erythema was unknown. The causality between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2010USA002785:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient got the first Shingrix dose a few months ago and had experienced a sore arm. The case has been linked with the case US2020AMR199588 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: low grade fever; severe muscle aches; headache; fatigue; This case was reported by a consumer and described the occurrence of low grade fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain, headache and fatigue. On an unknown date, the outcome of the low grade fever, muscle pain, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, muscle pain, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient was experiencing severe muscle aches, low grade fever, headache and fatigue.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: Exceeded the 6 month window; body aches; fever; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, fever, diarrhea and incomplete course of vaccination. On an unknown date, the outcome of the general body pain, fever and diarrhea were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain, fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed body aches, fever, and diarrhea that took 10 days to recover from after his 1st dose of Shingrix. The patient exceeded the 6 month window for their 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198042:FU1 deleted
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Insomnia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: pain in arm / still experiencing pain; tingling sensation in arm; hands and fingers numb; cannot work or  type on computer; hard time sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) and (batch number 7A799, expiry date 10th December 2021) for prophylaxis.   On 5th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tingling of extremity, numbness in hand, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid.  The patient was not immunocompromised. After receiving Shingrix, the patient experienced pain, tingling sensation in her arm, sometimes to the extent that her hands and fingers were numb. The patient was seen at emergency room and bone and joint practice but was still experiencing pain.  The patient could not work or type on computer.  The pain lasted all day and night and she had a hard time sleeping. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter reported that, his eye doctor had mentioned, his wife was feeling ill after receiving the dose of Shingrix. No further information related to the event was available with the reporter. The reporter did not consent follow up. The case is linked with the case- US2020200799, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200799:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Injection site nerve damage, Mobility decreased
Clinical narrative: patient could not raise her arm for months; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves female patient (age unspecified) who could not raise her arm for months (mobility decreased), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient could not raise her arm for months (mobility decreased) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  It was reported that, vaccination hit a nerve.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was unknown as it was not reported.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quadrivalent and Adacel vaccines which were stored at 27 C were given to 8 patients/ NO AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves 8 patients (unknown demographics) who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5661AA and expiry date: 08-Aug-2021) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (0.5, pre-filled, lot number: UT7006NA and expiry date: 30-Jun-2021)  which was stored at 25 Celsius and those were unsuitable for use since 01-09-2020 for prophylactic vaccination (product storage error).   The patient's medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse event was reported.  Reporter does not have the patient information or AE details with her and asked if patients should be revaccinated.  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 16-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; A 16-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case is linked to case 2020SA262658 (same reporter).  This case involves a 16-year-old female patient who inadvertently received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  The patient had not received any other concomitant vaccination.   On 22-Sep-2020, the patient inadvertently received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: QFA2029 and expiry date was reported as 30-Jun-2021, reporter was not sure about the expiration date] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via an intramuscular route at the deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: at the time of vaccination). Reporter wanted to know about revaccination with Fluzone and efficacy. 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: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: the patient got a partial dose as most of the vaccine leaked out; most of the vaccine leaked out and ran down her arm from the injection; Initial and follow-up information received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.   This case involves a 72-year-old female patient who experienced that the injection site was different like the skin was harder and the patient got a partial dose as during administration, most of the vaccine leaking and running down her arm from the injection (exposure via skin contact and underdose) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.   On 23-Sep-2020, the patient received a partial dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ478AA, expiry date: 30-Jun-2021) via intramuscular route in right arm as prophylactic vaccination.  It was reported that, the patient got partial dose (vaccine underdose) and that most of the vaccine leaked out. The patient's blouse was wet and her fingers were wet. The patient thought that it ran down her arm from the injection site (exposure via skin contact) (latency same day). Reporter was unaware as to how it leaked.  Reporter was requesting a time frame as to when the injection could be repeated safely. She stated in the past she was told to wait 30 days before re-injecting.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 year old female received FLUBLOK QUADRIVALENT instead of FLUZONE QUADRIVALENT/no AE; 16 year old female received FLUBLOK QUADRIVALENT /no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [injection, lot number: UJ446AA and Expiry date: 18-Mar-2021] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 ml once dose via intramuscular route at the right arm, on 24-Sep-2020, for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).    Medical history, medical treatment, concomitant medication and family history were not provided. No other vaccines given.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. (Latency: at the time of vaccination)  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: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient was inadvertently vaccinated with a dose of Adacel 3 years after her previous dose, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from the physician.  This case involves a 15.5 years old female patient who was vaccinated with a 0.5 ml dose vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and other dosing details were not reported)once via an intramuscular route at unknown administration site on an unknown date 3 years after her previous dose for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event reported at the time of reporting.   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.  There will be no information available on the batch number for this case.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received only the liquid portion of the pentacel vaccine, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a four months old male patient who was vaccinated with a second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ29ABA and expiration date  25-APR-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 08-Sep-2020. However the patient received only the liquid portion of the pentacel vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient's concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  It was an actual medication error case due inappropriate reconstitution technique (latency was same day).  The reporter wanted to know if this dose can count as a valid dose.  No adverse event reported to the patient at the time of reporting.  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: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Pentacel vaccine was given to two siblings/ No AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves 2 patients (demographics unknown) who were vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot no:UJ097AAA and expiry date : 19-Sep-2020, strength: standard) once via unknown route in unknown administration site on 30-Sep-2020 for prophylactic vaccination (expired product administered).  The patients medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to expired vaccine used (latency was same day).  An expired doses of Pentacel were given to two siblings by accident. There was no information on the patients other than they were siblings and very young. Only the box was remaining and the vials had been discarded.  At the time of reporting, no adverse event 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: 56.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 56 year old patient that received the Fluzone High-Dose Quadrivalent/no AE; a 56 year-old patient that received the Fluzone High-Dose Quadrivalent/no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 or 56 year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via unknown route in unknown administration site on 01-Oct-2020 prophylactic vaccination (Product administered to patient of inappropriate age and Overdose)  Medical history, concomitant therapy, 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 was same day).  Also, a case of overdose (latency was on same day).  No adverse event was reported to the patient at the time of reporting.  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.  There will be no information available on batch number for this case.
Age: 89.0
Sex: M
Vaccine: FLUX
Symptoms: Death, Device related infection, Paralysis, Pyrexia
Clinical narrative: paralyzed from neck down; fever; an infection related to catheter; Initial information was received on 05-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (caregiver).  This case involves an 89 years old male patient who was paralyzed from his neck down (paralysis), had a fever (pyrexia) and died due to an infection related to catheter (device related infection), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date in Dec-2007, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) once via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was paralyzed from neck down (paralysis) 5 hours following the administration of INFLUENZA VACCINE. He was taken to the hospital for 2 days and got back the use of everything but his legs, and then the hospital discharged him to a rehabilitation center that was more reactive, than preventative. The event paralysis was assessed as medically significant.  Case details: The family (2 nurses in the family) felt that the patient had Guillen's Barre, however this was never officially diagnosed. The patient died in the rehabilitation center within a week due to an infection related to his catheter (device related infection) even though he was not running a fever. At the very end he ran a fever (pyrexia, non-serious event), but they did not put him on the appropriate antibiotics. No autopsy was completed.  The event device related infection was assessed as medically significant and led to death.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of paralysis and pyrexia was unknown while the event device related infection was fatal.  The cause of death was reported as device related infection.  Information on lot number was requested.; Sender's Comments: This case involves an 89 years old male patient who had paralysis, pyrexia and died due to device related infection after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: an infection related to catheter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Chills, fever, nausea, head ache, tired, body aches, joint aches 24 hours
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever, nausea, head ache, tired, body aches, joint aches 24 hours
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye pain, Eye swelling, Feeling cold, Headache, Nausea
Clinical narrative: About 8 hours after injection I started feeling inescapably freezing no matter what I do.. it also came on with severe nausea, and a pounding headache like I?ve never experienced. My eyes feel incredibly sore and swollen these symptoms have persisted for 4 days only getting worse in severity. On the 4th morning I discovered my left leg was covered in peculiar non itchy pussing sores. I have tried to treat the symptoms with Tylenol then I switched to ibuprofen because Tylenol didn?t help.. then the ibuprofen wasn?t helping so I tried excedrin.. I took a dose of Benadryl for the sores. nothing has really helped. I can only describe my last 4 days as an agony far worse than the last time I got the flu
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pustule, Skin ulcer
Clinical narrative: About 8 hours after injection I started feeling inescapably freezing no matter what I do.. it also came on with severe nausea, and a pounding headache like I?ve never experienced. My eyes feel incredibly sore and swollen these symptoms have persisted for 4 days only getting worse in severity. On the 4th morning I discovered my left leg was covered in peculiar non itchy pussing sores. I have tried to treat the symptoms with Tylenol then I switched to ibuprofen because Tylenol didn?t help.. then the ibuprofen wasn?t helping so I tried excedrin.. I took a dose of Benadryl for the sores. nothing has really helped. I can only describe my last 4 days as an agony far worse than the last time I got the flu
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: 24-28 hours after injection, parents noticed blotchy red rash on right thigh, distal to vaccine site.  Hydrocortisone was recommended.   32 hours after, right thigh rash spread medially and superior, slight edema started.   44 hours after, right thigh with moderate to severe edema from knee to inguinal region, ~2x larger than left thigh. Erythema across anterior/medial surface of thigh down to knee.  Zyrtec and Triamcinolone started.   72 hours after, zyrtec and triamcinolone continued, swelling decreased ~25% and erythema fading.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: 24-28 hours after injection, parents noticed blotchy red rash on right thigh, distal to vaccine site.  Hydrocortisone was recommended.   32 hours after, right thigh rash spread medially and superior, slight edema started.   44 hours after, right thigh with moderate to severe edema from knee to inguinal region, ~2x larger than left thigh. Erythema across anterior/medial surface of thigh down to knee.  Zyrtec and Triamcinolone started.   72 hours after, zyrtec and triamcinolone continued, swelling decreased ~25% and erythema fading.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache, Mobility decreased, Muscular weakness, Nausea
Clinical narrative: Afternoon after shot, headache and low fever.  7:00pm Arms and legs dramatic quivering , lasts 30-45 min.  9:00-10:00 2 episodes of vomiting.  9:00pm-3:00am Total, VERY EXTREME muscle weakness in arms and legs, unable to rise from chair, floor or bed using either arms or legs.  somewhere between 3-5:00am was able to rise from bed to pee slept.  9:00am rose to take meds, slept; 11:30 rose to eat, slept rest of afternoon.  Headache and nausea (no vomiting) over next 24 hours.  Following day, slept more and was weaker than usual.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Somnolence, Tremor, Vomiting
Clinical narrative: Afternoon after shot, headache and low fever.  7:00pm Arms and legs dramatic quivering , lasts 30-45 min.  9:00-10:00 2 episodes of vomiting.  9:00pm-3:00am Total, VERY EXTREME muscle weakness in arms and legs, unable to rise from chair, floor or bed using either arms or legs.  somewhere between 3-5:00am was able to rise from bed to pee slept.  9:00am rose to take meds, slept; 11:30 rose to eat, slept rest of afternoon.  Headache and nausea (no vomiting) over next 24 hours.  Following day, slept more and was weaker than usual.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: C-reactive protein increased, Peripheral swelling, Red blood cell sedimentation rate normal, Sensory disturbance, Vaccination site swelling
Clinical narrative: Patient reports within 1 day of administration at outside facility (pharmacy) having expected swelling at deltoid area of vaccine administration but within about 8 days developed marked swelling of the left hand and fingers; did recall sensation of inflammation progressing down along arm but without swelling to degree observed of the hand
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray limb abnormal
Clinical narrative: Patient reports within 1 day of administration at outside facility (pharmacy) having expected swelling at deltoid area of vaccine administration but within about 8 days developed marked swelling of the left hand and fingers; did recall sensation of inflammation progressing down along arm but without swelling to degree observed of the hand
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: shingles to left axilla and left scapula area started 10/8/20 started treatment of Valtrex and prednisone 10/11/20. blisters remain under left axilla with moderate pain, rash to left scapula itching and burning.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: shingles to left axilla and left scapula area started 10/8/20 started treatment of Valtrex and prednisone 10/11/20. blisters remain under left axilla with moderate pain, rash to left scapula itching and burning.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient stated starting the day after her vaccine, she has been unable to lift her arm more than 3-4 inches past her shoulder and it is painful
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Neck pain, Pyrexia
Clinical narrative: Within twelve hours patient reported excessive "burning" pain (9 out of 10) at site of injection radiating to neck and below elbow associated with inability to move arm, denied redness and swelling, within eighteen hours patient reported transient "fever" but did not report recorded temperature, symptoms improved but not resolved within twenty-four hours such that pain reported as 7 out of 10 and some recovery of range of motion
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Customer is not sure if an adult patient received PEDVAX HIB; Circumstance or information capable of leading to medication error; No other AE.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (exact dose, route of administration and anatomical location were not provided) for prophylaxis, therefore experienced product administered to patient of inappropriate age. No adverse event was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Have a temperature; Chills; Achiness; Achiness and soreness and injection site; This case was reported by a consumer via interactive digital media and described the occurrence of high temperature in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date ,refer linked case US2020AMR199556).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix, the patient experienced high temperature, chills, pain and injection site pain. On an unknown date, the outcome of the high temperature, chills, pain and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the high temperature, chills, pain and injection site pain 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 captured as an adult as per vaccine indication.  The reporter had received the second dose on the reporting date and had a temperature, chills, achiness and soreness and injection site. The reporter had also questioned if it was more normal with the second dose. For tolerance to the 1st dose of Shingrix, refer case US2020AMR199556.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199556:Same patient, same suspect, different dose
Age: 67.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the Fluzone Quadrivalent instead of the Fluzone High-Dose Quadrivalent vaccine, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's wife).  This case involves a 67 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], all that his workplace had on hand at the time of his vaccination about 2 weeks ago, instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unspecified date (PT: wrong product administered).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given 0.5ml of the liquid component of Pentacel, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 6 months old male patient who was given 0.5ml of the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6629AA and expiration date:02-May-2021) via unknown route in the left thigh for prophylactic vaccination on 28-Sep-2020 (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE ; PNEUMOCOCCAL VACCINE 13V ; ROTAVIRUS VACCINE and INFLUENZA VACCINE for prophylactic vaccination..  It was an actual medication error case due to inappropriate reconstitution technique (same day latency), as the only the liquid component of the Pentacel vaccine was given and not the powder part.  No adverse event reported at the time of reporting.  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: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported that he woke up Saturday morning (10-10-2020) with a full body rash that caused him a lot of itching.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Pt started with normal muscle soreness post vaccination for about three days.  Muscle pain then began to radiate down the arm and patient also started experiencing numbness an tingling in her forth and fifth finger. Patient was here in the office today and deltoid muscle is still tender to palpation.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain
Clinical narrative: Patient states she began experiencing shooting pain in shoulder about 4 days after vaccination. She states it is not constant pain and only occurs when she moves her arm in certain ways. She believes it is bursitis related to her injection occurring too high in her arm.
Age: 66.0
Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Injected limb mobility decreased, Injection site warmth, Monoplegia
Clinical narrative: Pt. woke up the morning  after flu shot with left arm paralysis. Unable to lift arm past 45 degrees. No pain, swelling or redness at site. Site warm to touch but patients temp was 97.7 on exam.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, nausea, felt like I had a fever but then my forehead was not hot, felt dizzy.  Achy all over my body last night.  That part is better this morning.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: shoulder and upper armed swelled to 1.5 the normal size. large red circle around the injection site with about a 1.5'' diameter. was hard and very warm to the touch. child also complained it was  painful and itchy
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: shoulder and upper armed swelled to 1.5 the normal size. large red circle around the injection site with about a 1.5'' diameter. was hard and very warm to the touch. child also complained it was  painful and itchy
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia
Clinical narrative: chills, muscle aches, stomach pain, headache
Age: 24.0
Sex: F
Vaccine: FLU4, HEPA, TD
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given the pediatric dose of Havrix instead of the adult dose. Per website pt was given another pediatric dose to complete adult dose of hep A vaccine.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Axillary pain, Induration
Clinical narrative: On 10/07/2020 she began feeling pain under her left arm.  She was seen in our office on 10/10/20 and examined. She has 2 to 3 firm lymph nodes in her axilla. They are not reddened.  She was placed on Reflex in case of infection. Pain was improving
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Pain
Clinical narrative: Chills; fever; headache; weak; no appetite achy, all for 24 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills; fever; headache; weak; no appetite achy, all for 24 hours.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: The patient received the vaccines 9/24/20. Later, on 10/9/20 she was hospitalized and diagnosed with Guillain-Barre Syndrome.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Peripheral swelling, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Beginning 10/10, about 4 hours in to the vaccine, arm swollen to 50% larger, vaccine site hot to touch, visibly red, painful.  Low grade fever on 10/11.  Fever gone as of now on 10/12, but arm remains swollen, painful, and hot to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Vomiting
Clinical narrative: 48+ Miserable hours of chills/sweating No appetite- threw up the two apple slices I got down Headache
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Wrong dose of flu vaccine given to my son. The nurse administer the full adult dose 0.5 ml  instead of the pediatric 0.25 ml dose.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that the injection site turned red, swelled up, and itched after receiving the vaccination.  She reported putting ice on the injection site. She returned to the pharmacy two days after receiving the vaccination and reported the reaction.  The swelling had gone down and the arm was only slightly pink, but she was still experiencing itching at the site.  I notified her primary care physician and advised the patient she should avoid further flu vaccinations.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Asthenia, Chills, Hyperhidrosis, Injection site pain
Clinical narrative: 4 hours post injection, arm pain began at injection site. 10 Hours post injection suffered  fever, chills, sweating, pain in all joints which lasted overnight for 10 hours. I was weak all day next day and now OK.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: 4 hours post injection, arm pain began at injection site. 10 Hours post injection suffered  fever, chills, sweating, pain in all joints which lasted overnight for 10 hours. I was weak all day next day and now OK.