chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's alleged wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and postherpetic neuralgia to be disabling events.
Sex: F
Vaccine: HPV4
Symptoms: Clostridium difficile colitis, Fatigue, Feeling abnormal, Feeling cold, Gait disturbance
Clinical narrative: Pneumonia; ended up with CDIFF; symptoms like parkinson's disease; feeling bad kinda like after a flu shot; fatigued; cold; Upper respiratory infection; flu like symptoms; She got mono due to low immune system; She was diagnosed with POTS; Now has chronic nerve damage; a really bad tremor to her hand; Can hardly walk; her health "continues to decline"; This spontaneous report has been received from a consumer referring to a great-niece of her friend of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   The reporter stated that her friend s great-niece could "hardly walk" since an unspecified date and that she had the same exact symptoms as her daughter after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the onset of the events not reported.  Reporter's daughter symptoms included: Pneumonia, ended up with CDIFF (C.difficile colitis), symptoms like Parkinson's disease, feeling bad kinda like after a flu shot, fatigued, cold, upper respiratory infection, flu-like symptoms, got mono due to low immune system, was diagnosed with POTS, Now has chronic nerve damage,  a really bad tremor to her hand, her health "continues to decline" (disease progression).  At the time of the report, the patient's outcome of aforementioned events was unknown.  The causal relationship between the aforementioned event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  was not reported.  Upon internal review, the events of Pneumonia, ended up with CDIFF (C.difficile colitis)and symptoms like Parkinson's disease were considered to be medically significant.  This is one of several reports received from the same reporter.  This is an amended report.  This .safety report report was previously submitted with the incorrect number: US-009507513-2010USA011617. This safety report submission is to provide the correct number: US-009507513-2011USA010344.; Sender's Comments:  US-009507513-2010USA011617: US-009507513-2011USA010224:
Sex: F
Vaccine: HPV4
Symptoms: General physical health deterioration, Immune system disorder, Infectious mononucleosis, Influenza like illness, Nerve injury
Clinical narrative: Pneumonia; ended up with CDIFF; symptoms like parkinson's disease; feeling bad kinda like after a flu shot; fatigued; cold; Upper respiratory infection; flu like symptoms; She got mono due to low immune system; She was diagnosed with POTS; Now has chronic nerve damage; a really bad tremor to her hand; Can hardly walk; her health "continues to decline"; This spontaneous report has been received from a consumer referring to a great-niece of her friend of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   The reporter stated that her friend s great-niece could "hardly walk" since an unspecified date and that she had the same exact symptoms as her daughter after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the onset of the events not reported.  Reporter's daughter symptoms included: Pneumonia, ended up with CDIFF (C.difficile colitis), symptoms like Parkinson's disease, feeling bad kinda like after a flu shot, fatigued, cold, upper respiratory infection, flu-like symptoms, got mono due to low immune system, was diagnosed with POTS, Now has chronic nerve damage,  a really bad tremor to her hand, her health "continues to decline" (disease progression).  At the time of the report, the patient's outcome of aforementioned events was unknown.  The causal relationship between the aforementioned event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  was not reported.  Upon internal review, the events of Pneumonia, ended up with CDIFF (C.difficile colitis)and symptoms like Parkinson's disease were considered to be medically significant.  This is one of several reports received from the same reporter.  This is an amended report.  This .safety report report was previously submitted with the incorrect number: US-009507513-2010USA011617. This safety report submission is to provide the correct number: US-009507513-2011USA010344.; Sender's Comments:  US-009507513-2010USA011617: US-009507513-2011USA010224:
Sex: F
Vaccine: HPV4
Symptoms: Pneumonia, Postural orthostatic tachycardia syndrome, Tremor, Upper respiratory tract infection
Clinical narrative: Pneumonia; ended up with CDIFF; symptoms like parkinson's disease; feeling bad kinda like after a flu shot; fatigued; cold; Upper respiratory infection; flu like symptoms; She got mono due to low immune system; She was diagnosed with POTS; Now has chronic nerve damage; a really bad tremor to her hand; Can hardly walk; her health "continues to decline"; This spontaneous report has been received from a consumer referring to a great-niece of her friend of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   The reporter stated that her friend s great-niece could "hardly walk" since an unspecified date and that she had the same exact symptoms as her daughter after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the onset of the events not reported.  Reporter's daughter symptoms included: Pneumonia, ended up with CDIFF (C.difficile colitis), symptoms like Parkinson's disease, feeling bad kinda like after a flu shot, fatigued, cold, upper respiratory infection, flu-like symptoms, got mono due to low immune system, was diagnosed with POTS, Now has chronic nerve damage,  a really bad tremor to her hand, her health "continues to decline" (disease progression).  At the time of the report, the patient's outcome of aforementioned events was unknown.  The causal relationship between the aforementioned event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  was not reported.  Upon internal review, the events of Pneumonia, ended up with CDIFF (C.difficile colitis)and symptoms like Parkinson's disease were considered to be medically significant.  This is one of several reports received from the same reporter.  This is an amended report.  This .safety report report was previously submitted with the incorrect number: US-009507513-2010USA011617. This safety report submission is to provide the correct number: US-009507513-2011USA010344.; Sender's Comments:  US-009507513-2010USA011617: US-009507513-2011USA010224:
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumococcal polysaccharide PPV23 administered on 01-NOV-2007 and 01-JAN-2009; None adverse reaction or side effects experienced; This spontaneous report was received from a 68 year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 01-NOV-2007, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 01-JAN-2009 another dose of pneumococcal polysaccharide PPV23 (manufacturer unknown) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  1908USA000436:Original Case : 1908USA000436
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: administration of improperly stored GARDASIL 9; This spontaneous report has been received from a consumer of unknown age and unknown gender referring to himself/herself. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On 16-NOV-2020, the reporter inquired temperature stability evaluation and informed agent of administration of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687292, with expiration date 25-AUG-2022, dose, frequency, route of administration was not reported) for prophylaxis (product storage error). The vaccine was exposed to temperature "3" for 3 hours and 30 minutes. Previous temperature excursion was reported as not applicable. Data logger was involved. 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.;  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Arthropod bite, Product prescribing error
Clinical narrative: TICK BITES; PRESCRIBED FLUMIST FOR ADULT PATIENT; UPSET STOMACH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 44 years, height 65 in, weight 138 lb).    No medical history was reported.  Concomitant medication included acetylsalicylic acid.     Patient mentioned successfully being administered Flumist seasonally on a yearly basis and most recent received FluMist Quadrivalent (influenza virus vaccine live, intranasal) 0.2 ml once/single administration, via nasal route, for immunization during OCT-2019. Patient had not received FluMist in 2020.    The patient started treatment with Metoprolol (metoprolol) (batch number(s) unknown) 0.25 mg daily on an unknown date for blood pressure.     The report described a medication error for FluMist Quadrivalent. The reported term was "prescribed FluMist for adult patient" (Preferred term: Product prescribing error).     During JUL-2020, the patient experienced upset stomach (preferred term: Abdominal discomfort). On an unknown date, the patient experienced tick bites (preferred term: Arthropod bite).     Treatment with Metoprolol (metoprolol) was not changed.     At the time of reporting, the event of upset stomach was ongoing. The outcome of the event(s) of tick bites and prescribed flumist for adult patient was unknown.     The events were considered non-serious.     The reporter considered the following event(s) unrelated to treatment with FluMist Quadrivalent (influenza virus vaccine live, intranasal): upset stomach.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: pain in left arm; feeling tired; falling asleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, tiredness and sleepiness. On an unknown date, the outcome of the pain in arm, tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose and experienced pain in left arm and falling asleep due to feeling tired. The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020223065, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223065:2nd dose
Age: 13.0
Sex: U
Vaccine: MEN
Symptoms: Headache
Clinical narrative: suffering severe headaches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 13-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, immediately after receiving Meningococcal B vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 dose vaccination and experienced horrible severe headaches lately.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Fever; Weakness; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received Shingrix. On 10th November 2020, 1 days after receiving Shingrix, the patient experienced fever, weakness and dizziness. On an unknown date, the outcome of the fever, weakness and dizziness were unknown.   It was unknown if the reporter considered the fever, weakness and dizziness 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 adult as per vaccine indication. After receiving dose of Shingrix, the patient experienced fever and weakness some dizziness. The reporter said how long does this last. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever of 102 degrees; received his first dose of Shingrix vaccine 4 weeks ago; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose 4 weeks ago in the left arm intramuscularly, refer case US2020AMR225455). Concurrent medical conditions included type ii diabetes mellitus.   On 10th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th November 2020, less than a day after receiving Shingrix, the patient experienced chills, fever and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills and fever were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm and had fever of 102 degrees F and chills.  The patient reported the fever has gone down but still had chills currently. The patient did not had lot number or expiration date information to provide.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225455:same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 1st dose of shingrix on April 7, 2019 and 2nd dose on August 9, 2019 / Got attack of shingles in November 2020/ suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On 7th April 2019, the patient received the 1st dose of Shingrix. In November 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2 doses of vaccine and got attack of shingles in November 2020. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced pain, aches, fatigue and fever. The patient was treated with aspirin. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR224651.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter US-GLAXOSMITHKLINE-US2020AMR224651:same patient, 1st dose
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Treponema test negative
Clinical narrative: Tested her blood and it came back positive for syphilis / Repeated the test / Came back negative; This case was reported by a other health professional via call center representative and described the occurrence of syphilis test false positive in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included covid-19 (diagnosed in March 2020).   In October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced syphilis test false positive. On an unknown date, the outcome of the syphilis test false positive was unknown.   It was unknown if the reporter considered the syphilis test false positive to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: In early October 2020, the patient received Fluarix Quadrivalent vaccine. Following the vaccination, she provided provided blood and plasma for treatment of COVID patients, and the blood bank tested blood and it came back positive for syphilis.  When the laboratory repeated the test with another test, the test came back negative.  The reporter stated the blood bank told her sometime with the flu vaccine, the lab test gives them a false positive for syphilis. No additional information was provided. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves female patient (age unspecified) who experienced flu (influenza), while she received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication 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 developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for event.   There will be no information available on the batch number for this case.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received HIB portion of Pentacel, DTaP/IPV portion was not given and the HIB  was administered with a solution used for frozen vaccines, maybe sterile water with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information  (reference number: 00317786) was received from a nurse and transmitted to Sanofi 15-Oct-2020.  This case involved a 6 months old female patient who received HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ227AAA, expiry date: 23-Apr-2021), DTap/IPV portion was not given and the Hib was administered with a solution used for frozen vaccines, maybe sterile water via unknown route at an unknown administration site for prophylactic vaccination (product preparation error), on 07-Oct-2020, via intramuscular route in the left thigh for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was a case of actual medication error due to product preparation error.  At the time of report, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: vomiting; dizziness; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist (Reference number- 00322237) and transmitted to Sanofi on 19-Oct-2020.  This case involved 10 patients who experienced vomiting and dizziness, while he/she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ500AB and expiry date: 30-Jun-2021) via intramuscular route, most of them got it in the left arm but a few did not for prophylactic vaccination.  On an unknown date, the patients developed non-serious events vomiting and dizziness (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory test was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events vomiting and dizziness, at the time of reporting.
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: she injected a patient FLUZONE QD NP  subcutaneously instead of intramuscularly on 20 OCT2020 with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional via call center.  This case involves a 16-year-old male patient who was injected with quadrival a-b vaccine [Fluzone Quadrivalent] subcutaneously instead of intramuscularly (incorrect route of product administration).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received on influenza quadrival a-b vaccine (formulation, strength was unknown) (batch number: UT7041JA and expiration date: 30-Jun-2021) at vaccinated with 0.5 ml (once) via subcutaneously instead of intramuscularly (incorrect route of product administration) for prophylactic vaccination.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pharmacist reports 63 year patient inadvertently received FLUZONE HIGH DOSE QUADRIVALENT with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a 63-year-old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (product administered to patient of inappropriate age).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received on influenza quadrival a-b high dose hv vaccine (formulation, strength was unknown) (batch number: UJ546AA and expiration date: 30-Jun-2021) at vaccinated with 0.7 ml (once) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Oct-2020, 3 days after starting the suspect vaccine therapy patient received patient inadvertently received influenza quadrival a-b high dose hv vaccine (product administered to patient of inappropriate age). Patient had not reported any side effects at this time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: This is the second year that I have received the FLUAD (65+) flue vaccine and last year and this year I have experienced left arm pain and weakness in the  left arm.  Last year this lasted 3 months; this year I am in the second month of the symptoms.  This year the pain is worse at night and is disrupting my sleep.  The medication this year is FLUAD (65+) PFS 2020-21 INJ 0.5 ml.  quantity 0.05.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea
Clinical narrative: States she had severe diarrhea 11/14/20 to 11/16/20
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Headache Fever Insomnia Heart pounding/racing Arm ache
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Throat irritation
Clinical narrative: aching and tireness on Tuesday up to Thrusday. Itchy throat starting 11/18th and got worse on 11/19
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypokinesia, Loss of consciousness, Movement disorder
Clinical narrative: Patient received vaccines in our office on 11/18/20 and had no immediate reaction. On 11/19/20 patient went for a walk and came home and was fine, but then was found passed out on floor for a few seconds. She woke and was unable to move any of her extremities. Patient was taken to the ER where she was tested for many things and given IV fluids. All testing was WNL. Over time, movement came back and patient was discharged home and is recovering at home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site cellulitis, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: Fever, plus swelling, inflammation and cellulitis at site of injection.  S/S 2 days.  Patient treated with oral antihistamine, topical steroid, antibiotic and NSAID for pain and fever
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Eye swelling, Ocular hyperaemia, Urticaria
Clinical narrative: Hives around eyes , swelling, and redness  Treated with Benadryl  Went away within 10 minutes
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Same day as vaccine administered:  fever of 101, felt serious chills, abdominal discomfort, headache, serious general weakness.   Next day:  temperature 99.8, general weakness.  Following day: no symptoms.  No treatment aside from bed rest.
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 02-NOV-2020, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 injection, lot # T027110, expiration date 23-MAR-2022; strength and route were not reported) which underwent a temperature excursion for prophylaxis (product storage error). The facility had a power outage due to a storm in the area, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored in their refrigerator when the power went out, and reached a temperature of 56 Fahrenheit degree for 5 hours outside of the recommended storage conditions as outlined in the prescribing information. There was no previous temperature excursion. Data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: I have a small patch of shingles / Got a vaccine 4 weeks ago; This case was reported by another health professional via interactive digital media and described the occurrence of vesicular rash in an adult patient who received Herpes zoster (Shingrix).   In October 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.  It was unknown if the reporter considered the vesicular rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group of patients was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with Shingrix 4 weeks ago from reporting day. The patient thought that, had a small patch of shingles. No further details were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on unknown date, refer case US2020223956) and Aspirin. Concomitant products included acetylsalicylic acid (Aspirin).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received the dose of Shingrix right arm and she experienced fever, aches, pains, and fatigue with a low grade fever. For the second dose, she pretreated with aspirin and yet she had the same reactions. The symptoms lasted 24 hours and then resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter US-GLAXOSMITHKLINE-US2020AMR224583:same reporter US-GLAXOSMITHKLINE-US2020223956:same patient, 1st dose
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: took the flu shot on a Tuesday and dead on Saturday; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 4 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient had received a flu shot on tuesday and was dead on saturday. The reporter was warning people to not take any vaccines in order to be alive. The case is linked with the case- US2020AMR225462, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225462:same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash erythematous
Clinical narrative: swollen with pain at the site of the injection; red patch, swollen with pain at the site of the injection; swollen with pain at the site of the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix).  On 5th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine her left arm. The next day, the patient noticed a red patch, swollen with pain at the site of the injection. The patient took benadryl and used cold patch to relieve the adverse event.  Additional information was not obtained. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: itching and redness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 12th September 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On 3rd November 2020, immediately after receiving Shingrix, the patient experienced injection site itching and injection site erythema. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with dose of Shingrix. The patient had itching and redness at injection site straightway after getting vaccine. The patient took antihistamine to decrease reaction. Till the time of reporting reaction were not recovered. No other information was provided. The reporter consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: itching; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 3rd December 2021).   On 16th September 2020, the patient received the 1st dose of Shingrix. On 26th September 2020, 10 days after receiving Shingrix, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles was recovered/resolved, and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced shingles outbreak and itching, after receiving the 1st dose of Shingrix. The patient had 3 weeks active shingles and still had itching. The reporter consented to follow up.
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: patient had a FLUZONE HD (0.5 ml pfs) from 2019-2020 season, and it was accidentally given to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00317517) received from pharmacist and transmitted to Sanofi 15-Oct-2020.  This case involved a male patient of unknown age who received a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (lot number and expiry date not reported) with pre-filled syringes accidentally via unknown route in unknown administration site, from 2019-2020 season, for prophylactic vaccination (accidental exposure to product).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  It was a case of actual medication error due to accidental exposure to product.  At the time of report, no adverse events were 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 batch number for this case.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was accidentally administered to someone under 65/no AE; Fluzone HD was accidentally administered to someone under 65/no AE; was pregnant/no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involved less than 65 year old female pregnant patient (Exposure during pregnancy) for whom it was reported that quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) was accidentally administered to someone under 65/no AE (adverse event) (Inappropriate age at vaccine administration and overdose).  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. The patient did not receive any other vaccinations or medications   On 19-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) (batch number: UJ491A and expiration date: 30-Jun-2021)  at a dose of 0.7 ml via unlnown route in the left deltoid for prophylactic vaccination.   On 19-Oct-2020, same day after initiation of quadrivalent influenza vaccine, accidentally administration of quadrivalent influenza vaccine to someone under 65 and was pregnant with no adverse event (AE) was reported.   It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  Disclaimer: 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: TDAP
Symptoms: Expired product administered
Clinical narrative: Adacel was given today with an expiration date of 22-Aug-2020/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00322479) was received from consumer and transmitted to Sanofi on 19-Oct-2020.  This case involved an unknown age female patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6043BA, expiry date: 22-Aug-2020), via unknown route in unknown administration site for prophylactic vaccination(Expired product administered).  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.  No adverse event was reported at the time of reporting.  It was a case of actual medical error as expired product administered.  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.