chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Corrective lens user, Eye movement disorder, Magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Strabismus
Clinical narrative: his eyes was turning inward; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose eyes was turning inward (strabismus), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 20-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot HB7L7 and expiration date 31-Aug-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient eyes was turning inward (strabismus) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: VIth nerve paralysis
Clinical narrative: his eyes was turning inward; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose eyes was turning inward (strabismus), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 20-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot HB7L7 and expiration date 31-Aug-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient eyes was turning inward (strabismus) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus
Clinical narrative: his eyes was turning inward; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose eyes was turning inward (strabismus), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 20-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot HB7L7 and expiration date 31-Aug-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient eyes was turning inward (strabismus) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death
Clinical narrative: patient passed away/ died; Initial information received on 19-Nov-2020 regarding an unsolicited valid serious case received from a nurse manager via company representative.  This case involves a 49 years old male patient who passed away/died (death), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Patient had comorbid conditions.  Medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided.   On 17-Nov-2020 at 15:10, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE pre-filled syringe (lot UT7011NAF and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 18-Nov-2020 at 10:30, the patient passed away/died (death), 19 hours 20 minutes (also reported that within 24 hours) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Product used: Used.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported.; Sender's Comments: This case concerns a 49 year old male patient who died, 19 hours 20 minutes after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Patient had comorbid conditions however not specified clearly. Additional information regarding patient's health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient passed away/ died
Age: 4.0
Sex: M
Vaccine: IPV, MMR, UNK, VARCEL, DTAPIPV, MMRV
Symptoms: Blood glucose normal, Dysstasia, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder
Clinical narrative: Patient's parent called into PCP office at 10:00am on 11/18/2020 stating patient had lost consciousness and EMS was called to assess. Was advised to be assessed in the ER. Was then admitted for 1 night to rule out seizure.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, UNK, VARCEL, DTAPIPV, MMRV
Symptoms: Fall, Feeling abnormal, Gait disturbance, Glassy eyes, Grip strength decreased
Clinical narrative: Patient's parent called into PCP office at 10:00am on 11/18/2020 stating patient had lost consciousness and EMS was called to assess. Was advised to be assessed in the ER. Was then admitted for 1 night to rule out seizure.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, UNK, VARCEL, DTAPIPV, MMRV
Symptoms: Hypotonia, Loss of consciousness
Clinical narrative: Patient's parent called into PCP office at 10:00am on 11/18/2020 stating patient had lost consciousness and EMS was called to assess. Was advised to be assessed in the ER. Was then admitted for 1 night to rule out seizure.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, UNK, VARCEL, DTAPIPV, MMRV
Symptoms: Electrocardiogram, Electroencephalogram, Loss of consciousness
Clinical narrative: Patient's parent called into PCP office at 10:00am on 11/18/2020 stating patient had lost consciousness and EMS was called to assess. Was advised to be assessed in the ER. Was then admitted for 1 night to rule out seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as "Shortly"), after receiving the zoster vaccine live (ZOSTAVAX), the patient experienced herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers was still under their care. The outcome of the aforementioned events was unknown. As a result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. The herpes zoster and postherpetic neuralgia were considered as serious events due to they were disabling for the patient. The casuality assessment between the events and the vaccination with zoster vaccine live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: PPV
Symptoms: Ill-defined disorder
Clinical narrative: chronic condition; This spontaneous report has been received from a nurse via a company employee referring to an 80 to 80 plus years old elderly patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date, the patient experienced a chronic condition (ill-defined disorder). It was not provided what the chronic condition is and when the chronic condition occur. The nurse would like to know if she should administer a third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to the patient.      At the time of this report, the outcome of the event was unknown. The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neurological symptom, Pneumonia
Clinical narrative: pneumonia; neurological problems; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.  On an unknown date, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unspecified, after received zoster vaccine live(ZOSTAVAX) the pt suffered from pneumonia and serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had sustained severe and permanent personal injuries, including but not limited to: 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. The pt also had suffered and incurred damages, including medical related expenses, the loss of accumulations; and other economic and non-economic damages as a result of these injuries.  By the time of this report, the pt had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received regarding a case in litigation from a lawyer and the pt on 18-NOV-2020, referring to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in 2012, the pt was vaccinated by a pharmacist in a pharmacy with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: hearing loss (deafness), therefore, the pt was hospitalized and recived treatment. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has 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 costs include 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 suffer such losses, and damages in the future. The outcome of hearing loss was unknown. The causality assessment between hearing loss with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, deafness was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Demyelination, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: balance problems; herpes zoster; demyelinating disease; postherpetic neuralgia; issues with her vision; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after zoster vaccine live (ZOSTAVAX) inoculation), the pt suffered from herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems. The pt was seen and treated by a healthcare provider and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Th pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of 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 zoster vaccine live (ZOSTAVAX), 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 zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems was not recovered.   The reporter considered the events herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems to be disability.     Upon internal review, the event demyelinating disease was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain, Pain in extremity
Clinical narrative: left me sore arm; feel like got run over by a bus; achey everywhere; horrible feeling; This case was reported by a other health professional and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (mild case).   On an unknown date, the patient received the 2nd dose of Shingrix. On 6th June 2020, unknown after receiving Shingrix, the patient experienced malaise, general body pain and feeling abnormal. On an unknown date, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, malaise, general body pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, malaise, general body pain and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had sore arm, achey everywhere and felt run over by a bus.  The patient felt horrible . The patient received Tylenol iced and slept for 2 hrs that afternoon. No fever.  It was reported as this was a nasty vaccine.
Sex: F
Vaccine: RAB
Symptoms: Animal bite, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Flu like symptoms; This case was reported by a physician via licensee and described the occurrence of influenza-like symptoms in a 20-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RABAVERT (received 1st dose on unknown date). Concurrent medical conditions included animal bite.   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, less than a year after receiving RabAvert, the patient experienced influenza-like symptoms. Rechallenge with RabAvert was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Rabvert and developed flu like symptoms. The patient had reactions to vaccine after meeting a bat and developed same kind of symptoms. The patient received 3rd dose and did fine. This case linked with US2020AMR208115, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208115:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm,legs, lower back; slight headache; some fever; I'm sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, headache, fever and general body pain. On an unknown date, the outcome of the pain in arm, headache, fever and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, headache, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and during the night woke up with sore arms ,legs, lower back and a slight headache with some fever this morning sore was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Ear pain, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: flulike symptoms; terrible ringing/hissing in my ears / the hissing and ringing is nonstop,; it feels painful; anxiety.; haven't felt well ever since; feel like / vaccine has permanently ruined me; The patient feel like this vaccine has permanently ruined me and the patient haven't felt well ever since patient's received Shingrix. This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad were unknown.   The reporter considered the influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of the Shingrix vaccine. Within four or five hours developed flu like symptoms and a terrible ringing orb hissing in patient's ears. The flu symptoms went away after 3 days but the hissing in patient's ears had been continuous. The patient was prescribed Medrol dose pack which did not help.  Then the patient went to an audiologist and patient's hearing was fine but he agreed that it was caused by this vaccine. The patient haven't felt normal since patient's gotten the Shingrix, the hissing and ringing is nonstop, sometimes it feels painful and was causing horrible anxiety. The patient's read the side effects on Shingrix and there was no mention of tinnitus but after the patient got the shot the handout said to contact patient's doctor immediately if tinnitus occurred.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: flulike symptoms; terrible ringing/hissing in my ears / the hissing and ringing is nonstop,; it feels painful; anxiety.; haven't felt well ever since; feel like / vaccine has permanently ruined me; The patient feel like this vaccine has permanently ruined me and the patient haven't felt well ever since patient's received Shingrix. This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad were unknown.   The reporter considered the influenza-like symptoms, ear hissing, ear pain, anxiety, unwell and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of the Shingrix vaccine. Within four or five hours developed flu like symptoms and a terrible ringing orb hissing in patient's ears. The flu symptoms went away after 3 days but the hissing in patient's ears had been continuous. The patient was prescribed Medrol dose pack which did not help.  Then the patient went to an audiologist and patient's hearing was fine but he agreed that it was caused by this vaccine. The patient haven't felt normal since patient's gotten the Shingrix, the hissing and ringing is nonstop, sometimes it feels painful and was causing horrible anxiety. The patient's read the side effects on Shingrix and there was no mention of tinnitus but after the patient got the shot the handout said to contact patient's doctor immediately if tinnitus occurred.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got dealy sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.   This case involves patient (unknown demographics) who experienced to got dealy sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a to got dealy sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Decreased immune responsiveness, Malaise
Clinical narrative: Had Bronchitis it was a bad 3 month; Got the normal flu; down immunity wise; Got so sick it lasted close to 2 weeks; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp from social media.  This case involves a 67 years old patient (gender not reported) who got so sick (malaise), down immunity wise (decreased immune responsiveness), had bronchitis (bronchitis) and got the normal flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past 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 VACCINE (produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, on an unknown date, the patient got so sick (malaise) that lasted close to 2 weeks then the patient was down immunity wise (decreased immune responsiveness) and a month later had Bronchitis (latency unknown for all). The patient reported that it was a bad 3 month. The patient had not taken shots since and got the normal flu (influenza) for 4.5 hours (unknown latency) following vaccination.  Additional information: No C19 (probable abbreviation is Covid 19, request for clarification not possible). The patient had been eating right fruits mostly, multiple Vitamins, zinc and eating C Vitamins and minerals.  Laboratory data not reported.  It was not reported if the patient received any corrective treatment or not for reported events.  The patient had recovered from got so sick and normal flu on an unknown date and outcome of other events was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 17.0
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sicker than a dog; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.   This case involves a 17-years-old patient who experienced sicker than a dog (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In 1969, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 1969, the patient developed a non-serious sicker than a dog (illness) three days following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (demographics) who got sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death, Malaise
Clinical narrative: died; sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious case from social media via a consumer or non-health care professional (patient's husband).   This case involves a female patient (age unspecified) who was sick (Illness) and died (Death), after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date in 2016, 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 in 2016, the patient was sick (Illness), 20 minutes following the administration of INFLUENZA VACCINE. On an unknown date in 2016, the patient died (death) 02 days following the administration of INFLUENZA VACCINE. This event was assessed as serious and medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment before death.  At the time of reporting outcome for illness was unknown.  It is unknown if an autopsy was done. Cause of death was not clearly specified.  Information on the batch number was requested.; Sender's Comments: This social media case received involves a female patient (age unspecified) who had illness (latency: 20 minutes) and died (death) 02 days after vaccination with INFLUENZA VACCINE. The time to onset is compatible with role of vaccine. This was poorly document case in which cause of death was not clearly specified. However, information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations, autopsy result and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died
Sex: F
Vaccine: FLUX
Symptoms: Death, Paralysis
Clinical narrative: paralyzed and that led her to early death; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a non-health professional via social media.  This case was linked with the 2020SA333271 (same reporter).  This case involves a female patient (of an unknown age) who was paralyzed and that led to her early death (paralysis), while the she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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 and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was paralyzed and that led to early death (paralysis), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was fatal.  It was unknown if an autopsy was done. The cause of death was reported as paralysis.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from social media involves a female patient (age unspecified) who was died due to paralysis after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations, autopsy result and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: paralyzed and that led to early death
Age: 93.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was administered two doses of FLUZONE High Dose Quadrivalent after 10 days by mistake from 2 different nurses with no AE; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via Medical Information (MI) (Reference number- 00309495).   This case involves a 93 years old male patient who was vaccinated with two 0.7 mL doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ470AB expiry date 30-JUN-2021) via an unknown route and left deltoid administration site on 29-Sep-2020 and left deltoid administration site on 08-Oct-2020 for prophylactic vaccination (extra dose administered) respectively by 2 different nurse.  Medical history, medical treatment, vaccination, family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) in arm.  It was a case of an actual medication error due to extra dose administered (latency unknown).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: during administration of vaccine dose and the fluid leaked right down the patient's arm/no AE; during administration of vaccine dose and the fluid leaked right down the patient's arm/no AE; vaccine was leaking from where the needle connects to syringe/no AE; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case (GMI inquiry number: 00309757) received from a consumer or non-health care professional.  This case involves a 74-year-old female patient who received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and during administration of vaccine, whole time dose and the fluid leaked and dribbled right down the patient's arm (exposure via skin contact and underdose) as vaccine was leaking from where the needle connects to syringe (syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that patient no other vaccine as concomitant medication.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [prefilled syringes,lot UJ478AA, expiry date: 30-Jun-2021] via an intramuscular route at the right arm administration site for prophylactic vaccination.  It was of exposure via skin contact, vaccine underdose and syringe leak.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Disturbance in attention, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: she felt some nausea; while studying for exam, the patient was unable to concentrate or focus, her head is space; vertigo feeling; her head is spacey, fogginess in her head; She state it feels like her equilibrium is off; Arm hurt a little afterwards; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00317693) was received from a consumer and transmitted to Sanofi 15-Oct-2020.  This case involved a 49 year old female patient who experienced she felt some nausea, while studying for exam, the patient was unable to concentrate or focus (disturbance in attention), her head is space, feeling fogginess in her head (feeling abnormal) and had vertigo feeling and stated that it felt like her equilibrium was off (balance disorder) while she received vaccine INFLUENZA VACCINE and her arm hurt a little afterwards (pain in extremity).  Relevant medical history, past medical treatment, vaccination and family history were not provided.   On 14-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot UT7049KA, expiry date: 30-Jun-2021) via intradermal route in the arm not otherwise specified (nos) for prophylactic vaccination and her arm hurt a little afterwards (pain in extremity).  On 15-Oct-2020, the patient nausea, while studying for exam, the patient was unable to concentrate or focus (disturbance in attention), her head is space, feeling fogginess in her head (feeling abnormal) and had vertigo feeling, 1 day following the administration of INFLUENZA VACCINE. She stated that it felt like her equilibrium was off (balance disorder).  The patient said it was different than she ever had before.  Especially when moving quickly.  Relevant tests included No laboratory data was provided.  Final diagnosis was arm hurt a little afterwards, her head is spacey, fogginess in her head, kind of like a vertigo feeling, while studying for exam, the patient was unable to concentrate or focus, her head is space, she stated that it felt like her equilibrium was off and she felt some nausea.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Nurse administered Pentacel to a 2 month old patient without reconstituting it, did not add HIB powder with no adverse event; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a Nurse via call center.  This case involves a 2 months old male patient who administered diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] to a 2 month old patient without reconstituting it, did not add hib powder by a nurse (wrong technique in product usage process), (batch number: UJ160AA and expiration Date: 24-Apr-2021 and batch number: U6395AA and expiration Date: 24-Apr-2021) at a dose of 0.5 ml once via unknown route in left thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong technique in product usage process (latency: unknown).  At the time of reporting, no adverse event was reported.  Action taken and 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. 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: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Wound haemorrhage
Clinical narrative: patient fell and hit her head. Her head started bleeding; patient fell and hit her head. Her head started bleeding; did feel dizzy that she just tripped; Initial information was received on 13-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 86-year-old female patient who was fell and hit her head her head started bleeding (fall and head injury) and did feel dizzy that she just tripped (dizziness)and did feel dizzy that she just tripped (dizziness), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant medication, past medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not received any other vaccines on that day.  On 13-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ517AA, expiry date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 13-Nov-2020, the patient developed non-serious fell and hit her head, her head started bleeding (fall and head injury) and did feel dizzy that she just tripped (dizziness) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported that the patient did not faint.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The outcome was unknown for all the events at the time of reporting.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: itch in whole body  rash
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Autoimmune arthritis, Dizziness, Fatigue, Impaired work ability
Clinical narrative: Shortly after receiving the vaccine I returned to training in computer lab, I was unable to continue with training. I became extremely fatigued, dizzy and weak I was unable to focus on the task at hand. All of my fellow workers were unable to complete the day as well. We were all dismissed for the day. Over the next 24 hrs  I continued to experience fatigue, weakness, shakiness and nausea. To this date I  have nerve pain in the left arm that comes and goes. I have left side nerve pain in my Thigh that is continuous (unsure if this is linked). Also in 2019 I was diagnosed with auto immune arthritis.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Mental impairment, Nausea, Neuralgia, Tremor
Clinical narrative: Shortly after receiving the vaccine I returned to training in computer lab, I was unable to continue with training. I became extremely fatigued, dizzy and weak I was unable to focus on the task at hand. All of my fellow workers were unable to complete the day as well. We were all dismissed for the day. Over the next 24 hrs  I continued to experience fatigue, weakness, shakiness and nausea. To this date I  have nerve pain in the left arm that comes and goes. I have left side nerve pain in my Thigh that is continuous (unsure if this is linked). Also in 2019 I was diagnosed with auto immune arthritis.
Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Lip discolouration
Clinical narrative: Lips turned purple, felt faint
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Severe headache, chills, muscle aches, soreness and redness at site of injection
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Arthralgia
Clinical narrative: Sore shoulder (moderate) , abdominal pain ( mild)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Mobility decreased, Nausea
Clinical narrative: after rec vax. Same day, in evening, started feeling aching and tired. Got into bed at midnight, started having uncontrollable chills, and shivering, temp was normal. By morning, temp is at 101. Body is sore, and can barely move. Nauseaous. Unable to take any meds for it due to nausea. In middle of the night, took peptobismol chewables to help. Now still has body aches, 101 fever, and chills and sweats, along with no sleep. Watering eyes.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: after rec vax. Same day, in evening, started feeling aching and tired. Got into bed at midnight, started having uncontrollable chills, and shivering, temp was normal. By morning, temp is at 101. Body is sore, and can barely move. Nauseaous. Unable to take any meds for it due to nausea. In middle of the night, took peptobismol chewables to help. Now still has body aches, 101 fever, and chills and sweats, along with no sleep. Watering eyes.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Immediately after receiving the high dose flu the patient flared up directly next to the injection sight.  The sight became red, slightly swollen and itchy.  The patient was given an ice pack which allowed the swelling to go down.  He was sent home with Benadryl about 45min-hour the patient was doing better.  Swelling and itchiness had resolved.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Feeling hot, Injection site erythema, Injection site urticaria, Lip pruritus
Clinical narrative: Four minutes after receiving the egg free flu shot patient began to feel a rush of heat.  She started to experience redness at the injection site along with small hives. Her lips began to feel itchy and she began feeling shot of breath.  Patient was given Benadryl in the office - with no improvement.  An ambulance was called and the patient was taken to the hospital.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity
Clinical narrative: deep joint pain in a shoulder; two separate patients that received the Pneumovax 23 from the same lot, and they both had intense arm pain beyond what we expect from vaccines; We sent one for a MRI and have sent her to orthopedics because she was esentially unable to use her arm; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T016159, expiration date not reported but after lot validation established as: 28-FEB-2022 (dose and route of administration were not reported), administered in deltoid, for prophylaxis.    On an unknown date, the patient experienced intense arm pain beyond what was expected from vaccines and deep joint pain in the shoulder. She was sent for a magnetic resonance imaging (MRI), however, the results were not provided. She was also sent for orthopedics, because, as reporter stated, she was essentially unable to use her arm.  The outcome of the events of deep joint pain in shoulder, intense arm pain beyond what was expected from vaccines and decreased mobility of injected limb was unknown. The causal relationship between the reported events and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA010192: