chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; Information has been received from a lawyer referring to a 72 years old female patient. Information about concurrent condition, history condition and concomitant medication was not reported. On 21-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Bell's palsy on or about 12-FEB-2015 including any and all of it sequelae. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s defective design, the patient suffered severe and permanent physical injuries, including but not limited to Bell's palsy, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event Bell's palsy was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events Bell's palsy to be disability.   Upon internal review, Bell's palsy was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Pneumovax23 was administered first and the Prevnar 13 dose has been delayed and has not been given to the patient al this time; This spontaneous report was received from a pharmacist via Pfizer and refers to a 59-year-old male patient. The patient's concurrent condition included being immunocompromised. The patient's medical history included recent heart transplant. His concomitant therapies were not reported.  On 21-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, intramuscularly in the left arm, frequency was reported as once, lot # S029265, expiry date 31-MAR-2021, for prophylaxis. It was reported that he used pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because of post heart transplant vaccination check list.  The patient was prescribed with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and then a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was supposed to be administered 8 weeks later. However, the vaccines were administered backwards and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given first. The dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) was delayed and was not given to the patient at the time of the report. Action taken with both suspect vaccines was reported as unknown.  The pharmacist considered the event to be medically significant as it had the potential to be very significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029265; expirationdate: 31-MAR-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
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered to a patient; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 27-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # s021092, for prophylaxis, which had expired on 18-MAY-2020 (expired product administered) (dose, route and site of administration were not reported).  The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: s021092; expirationdate: 18-MAY-2020; 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 meet the criteria for Reportability
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Currently the patient is not experiencing any side effects. No additional AE; HCP states a 13-monlh-old male patient was given PROQUAD and VARIVAX instead of VARIVAX and MMR II.; HCP states a 13-monlh-old male patient was given PROQUAD and VARIVAX instead of VARIVAX and MMR II.; This spontaneous report was received from a medical assistant, referring to a 13-months-old male patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 14-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), also; it was prescribed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), however; instead of this, it was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T010092, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021) (inappropriate schedule of product administration and wrong product administered). At the time of this report the patient was not experienced any side effects, no additional adverse events were reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: A patient who has missed their third dose of GARDASIL 9; No other adverse event; This spontaneous report was received from the administrator on behalf of the costumer concerning a child patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 09-JUN-2017, at age 11, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 17-AUG-2017, the the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) both vaccines for prophylaxis. The frequency was planned as 3 doses: 0, 2 and 6 months (dose, route of administration, anatomical location, lot number and expiration date were not provided for none of the vaccines). The patient did not came back in for third dose. No other adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: herpes labialis; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 24-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered from multiple outbreaks of herpes zoster and herpes labialis. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and herpes labialis were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events herpes zoster and herpes labialis to be disability.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature range 6°F to 14°F Time frame 80 hours; This spontaneous report was received from an office manager, referring to a 5-year-old patient of unknown gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.    On 08-SEP-2020, at the age of 5-year-old, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S027464 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis. The vaccine administered, experienced a temperature range from 6 degrees Fahrenheit (F) to 14F, for 80 hours, as recorded by a data logger (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007316:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature range 6°F to 14°F Time frame 80 hours; This spontaneous report was received from an office manager, referring to a 13-month-old patient of unknown age. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.    On 19-AUG-2020, at the age of 13-month-old, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S004554 which has been verified to be valid, expiration date reported and validated as 14-FEB-2021) as prophylaxis. The vaccine administered experienced a temperature range from 6 degrees Fahrenheit (F) to 14F, for 80 hours, as recorded by a data logger (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007316: US-009507513-2009USA007304:
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain; This case was reported by a other health professional via other manufacturer and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back injury, back surgery, chronic back pain, weakness left or right side, graves' disease, hypothyroidism, achalasia (surgery) and multiple sclerosis. Concurrent medical conditions included back pain (Severe back pain) and achalasia. Concomitant products included levothyroxine sodium (Synthroid), hydromorphone hydrochloride (Dilaudid), oxycodone hydrochloride (Oxycontin) and fenofibrate.   In September 2019, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that female patient received the shingrix vaccine and then experienced nerve pain. Patient past medical history was mentioned that patient had Back injury, Back surgery, Hardware failure, Chronic back pain, MS hugging, Left sided weakness, Left leg smaller, Graves disease, Hypothyroidism, Achalasia, Achalasia surgery, Aspirated. The patient's concomitant medications included Synthroid, Dilaudid, Oxycontin, Vitamin D, Protonix, Fenofibrate The reporter did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site bruising
Clinical narrative: bruise at injection site; when she was pregnant in 2018 she received Boostrix; This retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In 2018, the patient received Boostrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Boostrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Boostrix, the patient experienced injection site bruising and vaccine exposure during pregnancy. On an unknown date, the outcome of the injection site bruising and vaccine exposure during pregnancy were unknown. The pregnancy outcome was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Boostrix.  Additional details were provided as follows: The age vaccination was not reported. The patient received Boostrix when she was pregnat in 2018 (vaccine exposure during pregnancy) and experinced 2 cm small bruise at injection site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182599:same reporter US-GLAXOSMITHKLINE-US2020182602:same reporter
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Swelling in left arm and left leg; This case was reported by a other health professional via call center representative and described the occurrence of peripheral swelling in a 52-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2014-2015 season) (batch number DL352, expiry date 30th June 2015) for prophylaxis.   In December 2014, the patient received Fluarix 2014-2015 season (intramuscular). In December 2014, 12 hrs after receiving Fluarix 2014-2015 season, the patient experienced peripheral swelling. On an unknown date, the outcome of the peripheral swelling was recovered/resolved.   It was unknown if the reporter considered the peripheral swelling to be related to Fluarix 2014-2015 season.  Additional details were provided as follows: The patient received Fluarix 2014-2015 season in left arm and had Swelling in left arm and left leg. The reporter stated the Swelling was gone in twenty-four hours. The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel components were not mixed together and patient was called back to received the Act-HIB portion, no AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.   This case involves a two months old male patient who received a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ260AA, expiry date: 14-May-2021) via an intramuscular route in the left thigh on 17-Aug-2020 as prophylactic vaccination and components of Pentacel were not mixed together and patient was called back to received the ACT-HIB portion (Product preparation issue).  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination .  It was an actual medication error due to inappropriate reconstitution technique on same day.  At the time of reporting, 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: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: injection site reaction of warmth; injection site reaction of raised lump; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a female patient who experienced injection site reaction of warmth (vaccination site warmth) and injection site reaction of raised lump (vaccination site mass), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ432AB) via an intramuscular route in the deltoid (not specified) as prophylactic vaccination.   On 24-Aug-2020, the patient developed non-serious injection site reaction of warmth (vaccination site warmth) and injection site reaction of raised lump (vaccination site mass) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting for both the events.  There will be no information available on batch number for this case.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: A 17 years old patient received third dose of MENACTRA vaccine in 2020 was previously vaccinated with the same vaccine in 2014 and 2019/No AE; Initial information was received on 26-Aug-2020 and additional information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 17 years old male patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on an unknown date in 2014, 2019 and third dose on  26-Aug-2020 (batch number, expiry date and dosing details not reported) for prophylactic vaccination respectively.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication if any, not reported.  It was a case of actual medication error due to extra dose administered. (Latency: at the same time of vaccination).  It was reported that an immunosuppressant drug was taken by the patient when he received Menactra vaccine in 2019.  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.  There will be no information available on the batch number for this case.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discharge, Injection site haemorrhage
Clinical narrative: Bleeding, wetness at the injection site drainage lighter than blood color; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 93-year-old female patient who experienced bleeding, wetness at the injection site drainage lighter than blood color (vaccination site haemorrhage), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Medical history, past medical treatment, vaccinations and family history were not provided.  Concomitant medications included WARFARIN SODIUM (COUMADIN) used as blood thinner.  On 28-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ461AA, expiry date 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 28-Aug-2020, the patient had bleeding, wetness at the injection site drainage lighter than blood color (vaccination site haemorrhage) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   Other laboratory data not reported.  It was not reported if the patient received any corrective treatment or not.  On an unknown date, the patient recovered from vaccination site haemorrhage.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired IPOL MDV was given to the patient, no AE; Initial information was received on 31-Aug-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 9 month old female patient who was administered an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was unknown whether patient received concomitant medications or other vaccines.   On 28-Aug-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1A251M, expiry date: 02-May-2020, form: injection (multi dose vial)) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day)  At the time of report, the patient had no adverse event symptoms.  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: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of Quadracel administered to a 4 month old patient, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from the physician (pediatrician).  This case involves a four month old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (vial, lot C5655AA and expiration date 26-Nov-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 20-Aug-2020 (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had concomitantly vaccinated with a dose of HIB VACCINE (HIB) for prophylactic vaccination on 20-Aug-2020.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  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 and Module VI of the 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: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired dose of Fluzone High Dose, no AE; a 64-years-old patient was given Fluzone High Dose, No AE; A 64-years-old patient was given Fluzone High Dose, no AE; Initial information received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 64-years-old female patient who received a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AA, expiry date not reported) via an intramuscular route in the right deltoid on 01-Sep-2020 that had already expired on 20-Jun-2020 (expired product administered  product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant medications   It was an actual medication error case due to expired vaccine used, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  At the time of reporting, 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: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Fluzone High Dose Trivalent was given to a patient, no AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from the pharmacist via web enquiry.  This case is linked to cases 2020SA241782 and 2020SA241783 (same reporter).  This case involves a 81 year old male patient who was vaccinated with a 0.5 ml dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe, lot UJ299AA and expiration date 30-Jun-2020) via an intramuscular route at an unknown administration site on 01-Sep-2020 for prophylactic vaccination (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant therapy were not provided.   It was an actual medication error case due to expired vaccine used (latency was same day).  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: 8.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 8 years old patient was given Fluzone High Dose by mistake/no AE; A 8 years old patient was given Fluzone High Dose by mistake/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with cases 2020SA242184, 2020SA242185, 2020SA242186, 2020SA242187 (same reporter).  This case involves a 8-years-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy received by the patient.   On 31-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ450AB and expiry date 30-Jun-2021) via intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and it was also a case of overdose (latency: on same day).  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.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: flu shot took the patient for a loop; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 72-years-old female patient.  The flu shoot took the patient for a loop (unevaluable event), while she received INFLUENZA VACCINE.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing medical history of four Autoimmune disorder, Thyroid disorder, Arthritis and Raynaud's phenomenon.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the flu shoot took the patient for a loop (unevaluable event) unknown latency following the administration of INFLUENZA VACCINE.   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for the event.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient was given FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE, No AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of above 65 years of age who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ441AA, Expiry date 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   It was reported that patient had no concomitant medications and may have pre-existing medical conditions.  It was an actual medication error case due to wrong vaccine administered.   At the time of reporting, 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.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a female patient who got the flu (influenza), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's, past medical treatment, vaccination, concomitant medication and family history were not provided.  The patient mentioned that she had taken the Fluzone Trivalent in the past and had been immunocompromised due to cancer.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  Other details: reporter wanted to know about availability of FLUZONE HIGH-DOSE TRIVALENT in the country this year, and asked whether FLUZONE HIGH-DOSE QUADRIVALENT is adjuvant-free. Reporter had been taking Fluzone high-dose trivalent since years.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of report outcome of the event was unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: A elderly female patient who presented with influenza following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is not clearly defined. Patient also had ongoing immunodeficiency and cancer, and information on concomitant medication, and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublok that was frozen was administered in error, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 33-year-old female patient who received 0.5 (unit not reported) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006, Expiry date 22-May-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 14-Sep-2020, that was frozen (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  This was an actual medication error case due to product storage error temperature too low.  At the time of reporting, 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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: 68 year old female patient Fluzone HD that was frozen was administered, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA258066 (same reporter).  This case involves a 68 year old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ462AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product storage error.  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: 40.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublok that was frozen was administered in error, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with case 2020SA253162 (same reporter).  This case involves a 40 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was frozen in error (product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2020, the patient received 0.5 (unit not specified) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2006 and expiry date 22-May-2021) via unknown route in unknown administration site for prophylactic vaccination.  This was an actual medication error case due to product storage error temperature too low.  At the time of reporting, 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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site mass, Injection site pain, Pain
Clinical narrative: Developed immediate pain at site of injection and a lump in area the same day.  Has had ongoing pain in that area since injection. Lump still present.  Has lost some range of motion (especially overhead extension of left arm). Continues to have pain in areas when she uses it.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Itchy splotches on legs
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Neuralgia
Clinical narrative: patient came in on 9/22 and stated she had pain in left arm where PPSV was given, "sharp pain, nerve pinching, redness, inflammation" - she has a scar on that arm from previous burn, she had about quarter-size bruising around the injection site - we think there is additional scar tissue under the skin that may have been it causing the pain. she is taking naproxen and will continue to take, counseled her to call MD if pain gets worse
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Scar
Clinical narrative: patient came in on 9/22 and stated she had pain in left arm where PPSV was given, "sharp pain, nerve pinching, redness, inflammation" - she has a scar on that arm from previous burn, she had about quarter-size bruising around the injection site - we think there is additional scar tissue under the skin that may have been it causing the pain. she is taking naproxen and will continue to take, counseled her to call MD if pain gets worse
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Note    Patient called and said that she received a flu and pneumonia shot about 3.5 weeks ago. She said that arm that she got the pneumonia shot in is feeling fine but the one she got the flu shot in, is really sore. She said that she can barely even use that arm. She's been alternating heat and ice to relieve the pain, she's been taking ibuprofen and the pain isn't letting up. She said she gets a flu shot every year and she's never reacted to it like this. She's wanting to know if you have any other suggestions?
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fall, Loss of consciousness, Nausea
Clinical narrative: Patient received vaccines in clinic. Stayed sitting for 5-7 minutes with no reaction. Offered for patient to wait in waiting room for mother to return but wanted to go find her in the grocery store (clinic is inside grocery store). Advised if and concerns or feeling off needs to come back. Was told from customer patient passed out after getting vaccine. Mother reported patient said he felt sick to stomach and then fell straight forward and was "out of it" for 1 min. Patient was examined by provider and EMS and was sent home. No further issues when checked on later in the day.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Patient's daughter called to inform the pharmacy that the patient was experiencing severing pain in the arm that she had received the flu shot in a day prior. She stated that there was slight redness at the sight of the injection and the patient was running a slight fever. She also mentioned that the patient was unable to move her arm in which she had received the flu shot - patient was advised to take otc pain medication and ice the area- patient was told that if it does not get better - she was to contact her primary care physician
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Developed mild arm soreness shortly after immunization near injection site.  Most of upper arm, outer aspect was moderately to severely sore within a few hours and remained so for several days.   Mild headache experience in the evening after receiving the vaccine but was not experienced after that -- no other symptoms besides arm soreness was experienced.  The left arm ached and was sensitive to pressure (sleeping on that side) for about 4 days and moderated after that.  Raising arm out to side or over head also exacerbated pain.  Pain/ache resolved fully within about 1 week.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Lip swelling, Pyrexia, Rash
Clinical narrative: Swollen face, swollen lips, extreme, fever, extreme fatigue, headache that lasted 3-5 days, splotchy red cheeks also
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Swelling face
Clinical narrative: Swollen face, swollen lips, extreme, fever, extreme fatigue, headache that lasted 3-5 days, splotchy red cheeks also
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: 9/22/2020 9:33:04 AM > pt states he Recieved Shingles shot 3 days ago, dose 2/2, states no issues with first shot. Experiencing chicken pox like rash through out body, bilateral arms, wrist and up, and bilateral legs and neck. Denies itching. States it's not bothersome, just there. Noticed it today, did not see it yesterday. Took a BENEDRYL.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: expired PNEUMOVAX was administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown gender and age (age reported as 7 (age units not provided)). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 21-AUG-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (expiration date: June 2020; lot#, route of administration and anatomical location were not reported); dose/frequency reported as 1 (not specified); for prophylaxis. Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) had no previous temperature excursion.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient inadvertently received a dose of PROQUAD and a dose of VARIVAX at the same office visit.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 14-SEP-2020, the patient was inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: T006838, expiration date: 24-AUG-2021; route and dose details were unknown) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S021322, expiration date: 09-JUL-2021; route and dose details were unknown) for prophylaxis at the same office visit (inappropriate schedule of product administration).