chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Flu A and B; arm hurt so bad; felt bad; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had flu A and B (influenza), arm was badly hurt (pain in extremity) and felt bad (feeling abnormal) when received vaccine INFLUENZA VACCINE.  The past vaccination(s) included INFLUENZA VACCINE (the patient had been taking it for years).  Past medical treatment(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu A and B (influenza) and about died. Last year, the patient's arm was badly hurt (pain in extremity) and felt bad (feeling abnormal) for a week, following the administration of INFLUENZA VACCINE.  The patient was not willing to take flu shot anymore.   All events assessed as non-serious and latency was unknown for all.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: flu symptoms; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a non-health professional via social media.    This case involves a male patient (of an unknown age) who get flu symptoms within a weeks (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (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 non-serious get flu symptoms within a weeks (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Feels like a month of internal shingles; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.   This case involves a patient (unknown age and gender) who feels like a month of internal shingles (herpes zoster), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to neomycin (Drug hypersensitivity).   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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious internal shingles (herpes zoster) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign was reported, it was assumed that the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, outcome of the event was not reported.  There will be no information available on batch number for this case.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first two doses of Imovax Rabies for pre-exposure prophylaxis received by patient with 10 days interval, no AE; The patient has yet to receive a third dose of Imovax Rabies event if second dose received in 2019, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00313449) and transmitted to Sanofi on 13-Oct-2020  This case involves a 45 year old female patient who was vaccinated with a 1 ml first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] in the left deltoid on 23-Aug-2019 and 1 ml second dose of same vaccine on 03-Sep-2019 in the right deltoid (batch number P1C852M and expiration date 25-SEP-2020 for both the doses) 10 days apart (Inappropriate schedule of product administration) via an unknown route for pre-exposure prophylaxis and yet not received the third dose (Product dose omission issue).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and YELLOW FEVER VACCINE LIVE (17D-204) (STAMARIL) for prophylactic vaccination with the first dose of IMOVAX RABIES.  This was an actual medication error due to drug dose administration interval too long and missed dose. At the time of reporting, the patient yet to receive a third dose. The nurse wanted to know how to proceed with administering the remaining dose.  At the time of reporting, no adverse event was reported to the patient.  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: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: staff mixed the ACTHIB with NACL 0.7% VS NACL 0.4% and administered with no AE; staff mixed the ACTHIB with NACL 0.7% VS NACL 0.4% and administered with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown demographics patient who received a dose of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE[ACT-HIB] (lot: not reported, expiry date: not reported), via unknown route, on 13-Oct-2020 for prophylactic vaccination (product preparation error) and (incorrect product formulation administered).  The patient's past medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to wrong solution used in drug reconstitution and Inappropriate formulation of vaccine administered. It was reported that the acthib was mixed with nacl 0.7% vs nacl 0.4% and administered.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: patient experienced a "quarter sized lump"at the injection site; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case (GMI reference number: US-SANOFI-00314166) received from a pharmacist.  This case involves a 32 year old male patient who experienced a quarter sized lump at the injection site (injection site mass), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication, family history were not provided.   On 12-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7005MA and expiry date 30-June-2021] via an unknown route at right arm site for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious quarter sized lump at the injection site (vaccination site mass) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was injection site mass.  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 reported as not resolved.
Sex: F
Vaccine: FLU3, HIBV, IPV, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: ActHIB(unopened), Fluzone High Dose(unopened), Thyphim(unopened), Ipol(Opened) and unopened) and Tubersol(unopened), lowest temperature was -17C degrees for 63 hour and  45 minutes, did not know the cause of the excursion with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00315997) was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case was linked to cases 2020SA288477, 2020SA290000, 2020SA290005, 2020SA288639 and 2020SA288639.  This case involved 15 months old female patient who was administered with a 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ391AAA, expiry date: 10-Aug-2021), on 07-Oct-2020, via unknown route in left upper thigh for prophylactic vaccination, which had a temperature excursion along with the vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], IPV (VERO) [IPOL], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported for all), at lowest temperature was -17 degrees for 63 hour and  45 minutes. The cause of excursion was unknown.  It was reported that 6- patients received vaccines that were not suitable for use post a temperature excursion. 5 received Fluzone Quadrivalent High Dose and 1 received Act-HIB.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   No adverse event was reported at the time of reporting.  It was a case of actual medical error due to product storage error temperature too low.  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: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Laboratory test, Magnetic resonance imaging
Clinical narrative: Itching, redness and swelling at injection site . Weakness of right leg .
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Itching, redness and swelling at injection site . Weakness of right leg .
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Fatigue, Nasopharyngitis, Pallor, Syncope
Clinical narrative: This patient developed fatigue/pallor and felt cold and shaky a few hours after receiving Bexsero. She did not feel like eating dinner so Mom and Dad were helping her up to bed when she fainted in their arms. She regained consciousness and vomited x1. She felt better the following day.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Vomiting
Clinical narrative: This patient developed fatigue/pallor and felt cold and shaky a few hours after receiving Bexsero. She did not feel like eating dinner so Mom and Dad were helping her up to bed when she fainted in their arms. She regained consciousness and vomited x1. She felt better the following day.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain, Tremor, Urticaria
Clinical narrative: Later in the day on 11/17, patient developed a diffuse urticarial rash.  That evening, had chills/shaking and muscle aches all over.  Felt better the next day,  but then developed a diffuse urticarial rash.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Limb discomfort
Clinical narrative: R arm Shingrix shot. L arm Tetanus/whooping cough shot. R arm almost immediately felt bruised, very uncomfortable. Within 90 minutes Pt felt malaise, body chills, headache, fever, weakness, achy, R leg cramping, and decrease in appetite. R side body affected more the the left. Pt took Tylenol / 1 Tylenol 500 mg on 11/23/2020. Pt hydrating, still achy, limited energy almost 24 hours later.   Pending lab work part of routine physical same day.   Had flu shot October 2, 2020. Taking amoxacillan at this time due to tooth extraction.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: R arm Shingrix shot. L arm Tetanus/whooping cough shot. R arm almost immediately felt bruised, very uncomfortable. Within 90 minutes Pt felt malaise, body chills, headache, fever, weakness, achy, R leg cramping, and decrease in appetite. R side body affected more the the left. Pt took Tylenol / 1 Tylenol 500 mg on 11/23/2020. Pt hydrating, still achy, limited energy almost 24 hours later.   Pending lab work part of routine physical same day.   Had flu shot October 2, 2020. Taking amoxacillan at this time due to tooth extraction.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: vaccine was given at another facility and they do not have the information the day after receiving vaccine patient had pain in the contralateral arm and to a lesser extent in the same arm with weakness in the contralateral arm and muscle pain in both arms she has no fever no chills no other joint pains the pain is been unchanged for approximately 3 weeks she has no pain in her legs examination except for pain weakness is normal
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Chilling, unable to get warm, shivering. This started after going to bed, about 12 hours after administration, and lasted for apporx 4 hours.  Additionally had headache (wicked) when I woke with symptoms. It is now about 24 hours post admin and i still have the headache.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Grip strength decreased, Immediate post-injection reaction, Pain
Clinical narrative: Immediate pain in my shoulder. Pharmacy staff commented that she can't push the syringe in. But when she checked she saw that the fluid was delivered. Pain progressively worse until I could not even hold a fork by 5 pm the same day.
Age: 43.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Feeling abnormal, Halo vision
Clinical narrative: Patient reports she felt a bit "off" almost immediately after receiving her flu and hep a vaccine, however by 6pm she reports symptoms were much worse.  Felt dizzy, halos around lights, felt she couldn't breath, felt nauseous and ended up vomiting and having diarrhea.  Face and lips felt numb.  Reports she took a benadryl OTC and her inhaler and went to bed by 7pm.   2 days later when reporting adverse event, reports that she was feeling improved but still had diarrhea, and her L arm was still tender to the touch.  She declined evaluation by physician.
Age: 43.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction, Nausea, Tenderness
Clinical narrative: Patient reports she felt a bit "off" almost immediately after receiving her flu and hep a vaccine, however by 6pm she reports symptoms were much worse.  Felt dizzy, halos around lights, felt she couldn't breath, felt nauseous and ended up vomiting and having diarrhea.  Face and lips felt numb.  Reports she took a benadryl OTC and her inhaler and went to bed by 7pm.   2 days later when reporting adverse event, reports that she was feeling improved but still had diarrhea, and her L arm was still tender to the touch.  She declined evaluation by physician.
Age: 43.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Vomiting
Clinical narrative: Patient reports she felt a bit "off" almost immediately after receiving her flu and hep a vaccine, however by 6pm she reports symptoms were much worse.  Felt dizzy, halos around lights, felt she couldn't breath, felt nauseous and ended up vomiting and having diarrhea.  Face and lips felt numb.  Reports she took a benadryl OTC and her inhaler and went to bed by 7pm.   2 days later when reporting adverse event, reports that she was feeling improved but still had diarrhea, and her L arm was still tender to the touch.  She declined evaluation by physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Severe soreness in left arm at injection site.  Over all weakness, shivers/chills, muscle aches and pain, headache overnight was the worse  diminished as  time went on the  next day.  I had a similar reaction on  August 25, 2020 when  I took the first dose but I had the  FLUZONE HD INJ PF 20-21 in the right arm on the same day so I wasn't sure which caused the reaction,
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe soreness in left arm at injection site.  Over all weakness, shivers/chills, muscle aches and pain, headache overnight was the worse  diminished as  time went on the  next day.  I had a similar reaction on  August 25, 2020 when  I took the first dose but I had the  FLUZONE HD INJ PF 20-21 in the right arm on the same day so I wasn't sure which caused the reaction,
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain when the flu vaccine was given really high on my left arm then, two days couldn't move my left arm at all without screaming pain.  I still to this day cannot move my left arm to the far left without horrible pain & can't sleep on my left side at all. I can rub my arm really hard then it will relieve some of the pain.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Tremor
Clinical narrative: 5-10 minutes post-flu shot patient fainted with shaking. Patient recuperated quickly and left pharmacy 15 minutes later.
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Myalgia
Clinical narrative: I had severe soreness at injection sites and was weak and in bed for 48 hours after receiving the vaccines I felt muscular aches and pains and a headache as well.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain,swelling ,erythema on the right arm that started from next day acute last for about two weeks.Patient report to the pharmacy on November 23,2020 the adverse event  feeling pain but less severe during one month.Went to emergency room two days after Pneumovax 23 vaccine.Clinical impression celulitis.Received ketorolac injection Rocephin injection and Benadryl injection.She follow up with her primary care physician who prescribed prednisone 20mg for 10 days and instruct her to put ice over the area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: severe red raised circular rash that was hot and painful around the circumference of my bicep and  deltoid  . This swelling lasted 6 days and was quite painful.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: The patients are not having any side effects that I am aware of.; temperature excursion/ the GARDASIL 9 was given to 3 different patients/ Temperature ABOVE 47degrees Farenheit (54.2F) for 0 hours 30 minutes/ Time frame ABOVE 47 degrees F (54.2F) for 0 hours 30 minutes; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-NOV-2020, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # 1637648 with expiration date 19-JUN-2022 (route of administration and anatomical localization was not reported) for prophylaxis. Administered vaccine underwent temperature excursion of 54.2 Fahrenheit degrees for 30 minutes.  Digital data logger was involved. No previous excursions occurred.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-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; Sender's Comments:  US-009507513-2011USA009546: US-009507513-2011USA009052:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients are not having any side effects that I am aware of; temperature excursion/ the GARDASIL 9 was given to 3 different patients./ ABOVE 47 degrees Fahrenheit (54.2F) for 0 hours 30 minutes; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-NOV-2020, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # 1637648 with expiration date 19-JUN-2022 (route of administration and anatomical localization was not reported) for prophylaxis. Administered vaccine underwent temperature excursion of 54.2 Fahrenheit degrees for 30 minutes. Digital data logger was involved. No previous excursions occurred.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-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; Sender's Comments:  US-009507513-2011USA009526: US-009507513-2011USA009052:
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No other AE reported for patient.; RECOMBIVAX HB was administered to one patient on 03Nov2020 after undergoing a temperature excursion; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of thimerosal free hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter, one time, lot # S022584, expiration date 31-OCT-2021 (anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature please move to the previous line excursion of above 47 (49.1) degrees Fahrenheit for 3 hours and 16 minutes. The vaccine was previously exposed to the temperature of 48 degrees Fahrenheit for 30 minutes and to temperature of 47.3 degrees Fahrenheit for 45 minutes. Data logger was involved. There was no adverse effect reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2010, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified)  by a pharmacist for routine long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by nurse practitioner for shingles. As a direct and proximate result of the patient's use of the  vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited  to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event shingles was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ophthalmic herpes zoster
Clinical narrative: herpes zoster keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 29-JUN-2010, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified)  for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). Shortly after receiving vaccine live (ZOSTAVAX) vaccine, the patient suffered sudden and intermittent pain in her eyes and was diagnosed with herpes zoster keratitis. As a direct and proximate result of vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present to prior to using vaccine live (ZOSTAVAX) vaccine. The patient also experienced 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 sale if vaccine live (ZOSTAVAX) vaccine the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, incurable injuries, as well a significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was nor recovered Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event ophthalmic herpes zoster was considered to be medically significant, and was considered to be a disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I have fever from Shingrix; 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 an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient have fever from Shingrix. The patient asked what was normal range.
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test, Exposure during pregnancy, Pertussis, Vaccination failure, Vomiting
Clinical narrative: BOOSTRIX six years ago / recently been experiencing whooping cough'/suspected vaccination failure; experiencing whooping cough / doctors think she has whooping cough/ suspected Whooping cough; vomiting; Vaccine exposure during pregnancy; This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccination failure in an adult female patient who received DTPa (Reduced antigen) (BOOSTRIX) for prophylaxis.   On an unknown date, 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, more than 2 years after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), and vomiting and vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccination failure and vaccine exposure during pregnancy were unknown and the outcome of the whooping cough and vomiting were not recovered/not resolved. The pregnancy outcome was unknown.   It was unknown if the reporter considered the vaccination failure, whooping cough and vomiting to be related to BOOSTRIX.  Additional details were reported as follows: The reporter was patient's friend. The patient's age at vaccination was not reported. The patient received BOOSTRIX during her pregnancy six years ago which leads to vaccine exposure during pregnancy.  The patient had recently been experiencing whooping cough fits with vomiting and had been to the emergency room and to the physician's office several times. The physician thought that patient had whooping cough. The patient had a test to confirm whether or not it was whooping cough but the test results were unknown at the time of reporting. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting. Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229111: same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: flu; was sick as a dog; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.   This case involves a patient with unknown demographics who was sick as a dog (malaise) and had flu (influenza), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date in 1976, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [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 became sick as a dog (malaise) for two weeks and had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. these was assessed as non-serious event.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from malaise and event outcome was unknown for influenza as it was not reported at the time of reporting.   There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: grandmother died from half flu shot; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer or non-healthcare professional.  This case involves a female patient (age was not reported) who died (death), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose (reported as half dose) of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this event was assessed as medically significant.  Details of laboratory data were no reported.  It was not reported if the patient received any corrective treatment before death.  At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: grandmother died from half flu shot
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Eye swelling, Swelling face, Wrong technique in product usage process
Clinical narrative: She was experiencing severe shoulder pain; Face was also really swollen; Both of her eyes are swollen shut; She states that vaccine did not gone into the muscle; Initial information regarding an unsolicited valid non serious case was received from a Consumer/Non-HCP (Healthcare professional) via The Agency (Reference number- 00355124) and transmitted to Sanofi on 11-NOV-2020.  This case involves a female patient (unknown demography) who experienced severe shoulder pain (arthralgia), face was also really swollen (swelling face) and both of her eyes are swollen shut (eye swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. She also states that it did not go into the muscle (wrong technique in product usage process).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non serious severe shoulder pain (arthralgia), 24 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patients face was also really swollen (swelling face), both of her eyes were swollen shut (eye swelling), 24 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient reported that the vaccine did not go into the muscle.  This was also a case of actual medication error due to wrong injection technique (latency: same day).  It was not reported if the patient received any corrective treatment or not.  The outcome of the events arthralgia, swelling face and eye swelling were unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  Batch number has been requested for suspect product for this case.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nasal discomfort, Rhinorrhoea, Sneezing
Clinical narrative: WICKED HEADACHE, BRIDGE OF NOSE FELT LIKE IT WAS PUNCHED, SNEEZY, RUNNY NOSE. NO TREATMENT ADMINISTERED.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain of the left arm from shoulder down to the elbow. For about 24 hours had temperature of 100.9.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Hypersensitivity, Joint range of motion decreased, Malaise
Clinical narrative: Shoulder pain/weakness shortly after injection progressively getting worse now with limited range of motion continuing today 11/24/2020. Body aches/ chills and general not feeling well starting at 5pm on 11/10/2020 and continuing until morning of 11/12/2020.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain
Clinical narrative: Shoulder pain/weakness shortly after injection progressively getting worse now with limited range of motion continuing today 11/24/2020. Body aches/ chills and general not feeling well starting at 5pm on 11/10/2020 and continuing until morning of 11/12/2020.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Insomnia, Musculoskeletal stiffness, Night sweats
Clinical narrative: CLIENT STATED HER ADVERSE REACTIONS BEGAN 24 HOURS AFTER HER INJECTION. SHE EXPERIENCED HEADACHE, SORE THROAT, STIFF NECK, DIZZINESS, NIGHT SWEATS, AND INSOMNIA. AS OF TODAY, SHE STILL COMPLAINS OF INSOMNIA AND DIZZINESS. PRIMARY PHYSICIAN ENCOURAGED HER TO REPORT HER ADVERSE REACTIONS.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: CLIENT STATED HER ADVERSE REACTIONS BEGAN 24 HOURS AFTER HER INJECTION. SHE EXPERIENCED HEADACHE, SORE THROAT, STIFF NECK, DIZZINESS, NIGHT SWEATS, AND INSOMNIA. AS OF TODAY, SHE STILL COMPLAINS OF INSOMNIA AND DIZZINESS. PRIMARY PHYSICIAN ENCOURAGED HER TO REPORT HER ADVERSE REACTIONS.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Did not administer here so unsure of type of flu vaccine. Pt presented to us with dizziness since date administered at doctors office.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body ache fever nausea vomiting diarrhea 11/11/20 to 11/22/20
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Death, Feeding tube user, Nausea, Seizure
Clinical narrative: Patient experienced vomiting, nausea, body weakness, fainting, seizures, unresponsive, needed feeding tube, moved to long term care facility in January before he passed away on 01/13/2019 *Reporter was not sure of vaccine name and details so first flu was chosen
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient experienced vomiting, nausea, body weakness, fainting, seizures, unresponsive, needed feeding tube, moved to long term care facility in January before he passed away on 01/13/2019 *Reporter was not sure of vaccine name and details so first flu was chosen
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Day 1 Approximately 13 hours after injection. Started out with chills and low fever of 99.5F. Fever steadily increased over 12 hours to 101.9F. Had body aches, headache and low energy. Appetite was fine. No stomach issues. After 12 hours fever started to go back down. Fever broke approximately 18 hours after onset of adverse symptoms. Took acetaminophen every 4 hours until max dosage of 10 tablets per 24hour period.    Day 2 Headache and low energy. Diarrhea started approximately 32 hours after initial adverse symptoms. Drank lots of fluids. Small rash broke out on back (both sides near rib cage) that was itchy but did not hurt. Took Benadryl for rash symptoms and acetaminophen for headache. All symptoms had cleared by next morning.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Day 1 Approximately 13 hours after injection. Started out with chills and low fever of 99.5F. Fever steadily increased over 12 hours to 101.9F. Had body aches, headache and low energy. Appetite was fine. No stomach issues. After 12 hours fever started to go back down. Fever broke approximately 18 hours after onset of adverse symptoms. Took acetaminophen every 4 hours until max dosage of 10 tablets per 24hour period.    Day 2 Headache and low energy. Diarrhea started approximately 32 hours after initial adverse symptoms. Drank lots of fluids. Small rash broke out on back (both sides near rib cage) that was itchy but did not hurt. Took Benadryl for rash symptoms and acetaminophen for headache. All symptoms had cleared by next morning.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: Patient advised she is not fully vaccinated, she was inadvertently given Peds dose vs a Adult Dose.  She verbalized good understanding by stating she would schedule in 6months for Adult Hep A when she comes back in 6 months for her 3rd Hep B vaccine.    Dr. and Nursing Director, were notified.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Hypertension, Pyrexia
Clinical narrative: Symptoms feeling cold, headache, low fever, blood pressure high
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Acne, Computerised tomogram normal, Culture negative, Differential white blood cell count normal, Drug hypersensitivity
Clinical narrative: 2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Ear swelling, Erythema, External ear inflammation, Full blood count normal, Gene mutation identification test
Clinical narrative: 2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Inflammation, Pruritus, Scan with contrast normal, Scar, Scratch
Clinical narrative: 2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Skin fissures, Skin irritation, Skin laceration, Skin test negative, Staphylococcus test negative
Clinical narrative: 2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.