chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Feeding disorder, Headache, Nausea, Pyrexia
Clinical narrative: unable to eat anything; vomiting; extreme headache; extreme fatigue; nausea; temperature of 101.4 F; This spontaneous report as received from a consumer referring to her daughter a 14 years old patient. Patient's medical history and concomitant medications were reported as none. Information regarding drug allergies or reactions was not provided.   On 24-NOV-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for vaccination against cervical cancer (prophylaxis) (strength, dose, lot number and expiration date were not provided). .         On 26-NOV-2020,  the patient experienced an extreme headache, extreme fatigue, nauseas, vomiting, temperature of 101.4 Fahrenheit (fever) and is unable to eat anything (feeding disorder).  To address the fatigue the patient was resting and she received paracetamol (TYLENOL) and ibuprofen (MOTRIN) to treat the headache and fever.  The outcome of feeding disorder, pyrexia, nausea, fatigue, headache and vomiting was reported as not recovered/not resolved. At the reporting time it was unknown if the patient would follow the vaccination scheme.  The reporter did not assess the causal relationship between the events and the suspect vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: unable to eat anything; vomiting; extreme headache; extreme fatigue; nausea; temperature of 101.4 F; This spontaneous report as received from a consumer referring to her daughter a 14 years old patient. Patient's medical history and concomitant medications were reported as none. Information regarding drug allergies or reactions was not provided.   On 24-NOV-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for vaccination against cervical cancer (prophylaxis) (strength, dose, lot number and expiration date were not provided). .         On 26-NOV-2020,  the patient experienced an extreme headache, extreme fatigue, nauseas, vomiting, temperature of 101.4 Fahrenheit (fever) and is unable to eat anything (feeding disorder).  To address the fatigue the patient was resting and she received paracetamol (TYLENOL) and ibuprofen (MOTRIN) to treat the headache and fever.  The outcome of feeding disorder, pyrexia, nausea, fatigue, headache and vomiting was reported as not recovered/not resolved. At the reporting time it was unknown if the patient would follow the vaccination scheme.  The reporter did not assess the causal relationship between the events and the suspect vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: he gave a dose of VAQTA that had expired on 11/05/2020; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 30-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S031918, expiration date on 05-NOV-2020, 1 mL, for prophylaxis (strength, route of administration and anatomical location were unknown). No previous temperature excursion were reported to product. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031918; expirationdate: 05-NOV-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on: 25-Sep-2020  This report was received from the HEPLISAV-B Registry.  A female patient (age, race and ethnicity not provided) reported to the Registry staff she had received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.   No medical history was reported.   No concomitant medications were reported.  Dosing information of HEPLISAV-B (Lot #, expiration date and NDC #) was not reported.  On 25-Sep-2020, the Registry Staff received an email from the patient stating that she had been vaccinated with the HEPLISAV-B vaccine while pregnant from work. She expressed interest in enrolling in the Registry. Multiple emails were sent to the patient requesting for her phone number or to call the toll-free study number to assess enrollment eligibility but were unsuccessful.   The Registry Staff reported that no further follow-up would be conducted by the Registry and that permission for the company to follow-up with the potential patient was not obtained.  At the time of the report, no adverse events were reported. The action taken with HEPLISAV-B was not reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: had 2 flu shots and the flu both times\suspected vaccination failure; had 2 flu shots and the flu both times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had flu shot and the had flu, he or she was staying away from this shot. This case was considered as suspected vaccination failure as time to onset, laboratory confirmation test were unknown at the time of reporting. This case was linked with case US2020AMR236388, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR236388:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient of unknown age who got sick (illness), while received INFLUENZA VACCINE.  The patient's past vaccination included influenza vaccine as prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant therapy, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency; non-serious) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu within 2 weeks after receiving a flu shot; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.   This case was linked to case 2020SA289370 (same reporter).  This case involved an unknown demographic patient who experienced flu (influenza), after receiving INFLUENZA VACCINE.  The patient had received influenza vaccine in the past for prophylactic vaccination and experienced flu within 2 weeks post vaccination. The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a 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 developed non-serious flu (influenza), within 2 weeks following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: after taking a flu shot twice got the flu both times; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer(patient) via social media.  This case involves a patient (unknown demographics) who had flu both times (Influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received first and second dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu both times (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: got deathly ill due to flu so bad; Initial information was received on 14-Oct-2020 and additional information on 23-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.   This case involves an unknown demographic patient who got deathly ill due to flu so bad (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date (10 or more years ago), the patient received a 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 got deathly ill due to flu so bad (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  After this the patient did not received flu vaccine and no flu experienced since then.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient (age unspecified) who was sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination for 8 years.  Medical history, 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 was sick (illness, non-serious) (hours after) following the administration of INFLUENZA VACCINE.   Last year she just forgot to get it and did not get sick so she won't be getting them anymore.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a couple of weeks; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from consumer (patient) via social media.  This case involves a patient (unknown age and gender) who experienced sore arm for a couple of weeks (pain in extremity), while received INFLUENZA VACCINE.  Patient's vaccination included Influenza vaccine as prophylactic vaccination. Medical history, medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm for a couple of weeks (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Made sick; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare via social media professional.   This case is linked to cases 2020SA294157 and 2020SA294158 (same reporter).  This case involves patient (unknown demograhics) 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 developed a non-serious 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: FLU3
Symptoms: Influenza
Clinical narrative: did cause me to get the flu; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2020SA296074.  This case involves an unknown age female patient who reported did cause me to get the flu (Influenza), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported.  On an unknown date, patient reported that it did cause me to get the flu (influenza) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: some arm soreness; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA340519 and 2020SA346513.  This case involves female patient of an unknown age who experienced some arm soreness (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious some arm soreness (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that he does not know which ones they got. The wife he said got a high dose flu vaccine but he does not know name.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: some arm soreness; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA340519 and 2020SA346488.  This case involves female patient of an unknown age who experienced some arm soreness (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious some arm soreness (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that he does not know which ones they got. The wife he said got a high dose flu vaccine but he does not know name.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: F
Vaccine: FLUR4, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received another flu shot (not sure when or what she was given) but was given FLUBLOK today with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00355246) and transmitted to Sanofi on 11-Nov-2020. This case involves female patient [age unspecified] who received another flu shot (not sure when or what she was given) but was given 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] today [lot number and expiry date not reported] via an unknown route at an unknown administration site on 11-Nov-2020 for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided   It was an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  Product used : Used  Still using product : No  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 87.0
Sex: M
Vaccine: FLUR4
Symptoms: Gait disturbance, Myalgia, Pain in extremity, Pain in jaw
Clinical narrative: still his legs are sore; left jaw is hurting; hardly walk; myalgia; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA346513 and 2020SA346488.  This case involves a 87 years old male patient who experienced still his legs are sore (pain in extremity), left jaw is hurting (pain in jaw), hardly walk (gait disturbance) and myalgia, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Past vaccination included FluBlok (he got the same thing last year and he did not have any side effects).  Medical history, medical treatment, concomitant medication and family history were not provided.  On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route in the left arm site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious still his legs are sore (pain in extremity), left jaw is hurting (pain in jaw), hardly walk (gait disturbance) and myalgia (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was also reported that He consulted a rheumatologist and the rheumatologist said it might last for 2-3 months. The rheumatologist also said he only sees about 1 or 2 cases like this a year so its not common.  Details of laboratory data not reported.   On 10-Oct, the doctor then prescribed prednisone 15 mg (milligram). Couple of weeks ago he cut it to 10mg, and then 5mg. Recently he tried 5mg but that didnt work as he really started hurting again so he is back on 5mg.   The patient was treated with PREDNISONE (PREDNISONE).  At the time of reporting, the outcome of events were reported as unknown.  There will be no information on the batch number to be requested for this case.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gaze palsy, Pain in extremity
Clinical narrative: 2:30pm vaccine. By midnight had chills, couldn't get warm, headache, upper arm muscle ache that worsened through the night then gradually eased over the course of the following day
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Bone marrow oedema, Full blood count normal, Injection site joint movement impairment, Injection site pain, Magnetic resonance imaging abdominal
Clinical narrative: Patient had onset of severe pain in right shoulder following injection. That evening it worsened and had limited Range of motion. This worsened and continued for three weeks before seeking care at my office for evaluation. She continues to be unable to lift arm over head, with severe pain. MRI done. Steroid dosepack given.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Tendon injury, Tendonitis
Clinical narrative: Patient had onset of severe pain in right shoulder following injection. That evening it worsened and had limited Range of motion. This worsened and continued for three weeks before seeking care at my office for evaluation. She continues to be unable to lift arm over head, with severe pain. MRI done. Steroid dosepack given.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, aches, and pain headache nasusea but not throwing up
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient says  a few hours after getting the vaccine he developed a rash. he is still getting episodes of rash. He says the rash started on the Monday and per our records his vaccine was given on a Friday
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Migraine
Clinical narrative: I have pain at the site of injection as well as pain when I lift my arm (side and forward).
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: without any residual effects experienced; the consumer was inadvertently administered 2 PNEUMVAX 23 vaccines/ the first dose was given 23-JUN-2020, and the second dose was given on 05-OCT-2020; This spontaneous report was received from a registered nurse and refers to a 68-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUN-2020, the patient was vaccinated with a 1st dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 time dose (lot # T007790 was confirmed to be valid, expiration date was reported as 03-DEC-2021) (route of administration and anatomical location were not provided) for prophylaxis. On 05-OCT-2020, the patient was inadvertently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 time dose (lot # T007790 was confirmed to be valid, expiration date was reported as 03-DEC-2021) (route of administration and anatomical location were not provided) without any residual effects experienced by the patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-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: Pain
Clinical narrative: persistent soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was selected as an adult, however it was selected as an adult as per vaccine indication. The reporter reported persistent soreness from Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: how long soreness may persist after shingrix vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was selected as an adult, however it was selected as an adult as per vaccine indication. The reporter wanted to know how long soreness might persist after Shingrix vaccination.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Nausea; vomiting; severe headache; leg pain; tingling; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2017, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, vomiting, headache, leg pain and tingling. On an unknown date, the outcome of the nausea, vomiting, headache, leg pain and tingling were unknown.   It was unknown if the reporter considered the nausea, vomiting, headache, leg pain and tingling to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced nausea, vomiting severe headache leg pain and tingling.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: got a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vacination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient got a rash, exactly what Shingrix was supposed to avoid.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: feverhad a 2 degree + fever; for 2 days didn't feel well; 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 and feeling unwell. On an unknown date, the outcome of the fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was selected as an adult, however it was selected as an adult as per vaccine indication. The patient got the Shingrix vaccine, had a 2 degree plus fever for 2 days and did not felt well.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear congestion, Ear pain, Middle ear effusion, Tinnitus, Vertigo
Clinical narrative: Ear fullness; Feels like fluid in ear; Ear is painful; Ear is / ringing; She had vertigo / eyes were not matching up with head; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, 1 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced ear feels clogged, fluid in middle ear, ear pain and ringing in ears. On an unknown date, the outcome of the vertigo was recovered/resolved and the outcome of the ear feels clogged, fluid in middle ear, ear pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, ear feels clogged, fluid in middle ear, ear pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: On 5th October 2020, the patient received the Shingrix shot in left arm then the next morning she had vertigo, her eyes were not matching up with her head. Vertigo had resolved. The patient still had ear fullness, feels like fluid in her ear, ear was painful and ringing. The ear problems had not resolved.  The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Balance disorder, Ear congestion, Ear pain
Clinical narrative: Ear fullness; Feels like fluid in ear; Ear is painful; Ear is / ringing; She had vertigo / eyes were not matching up with head; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, 1 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced ear feels clogged, fluid in middle ear, ear pain and ringing in ears. On an unknown date, the outcome of the vertigo was recovered/resolved and the outcome of the ear feels clogged, fluid in middle ear, ear pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, ear feels clogged, fluid in middle ear, ear pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: On 5th October 2020, the patient received the Shingrix shot in left arm then the next morning she had vertigo, her eyes were not matching up with her head. Vertigo had resolved. The patient still had ear fullness, feels like fluid in her ear, ear was painful and ringing. The ear problems had not resolved.  The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Myalgia, Neck pain, Paraesthesia, Spinal pain
Clinical narrative: Ear fullness; Feels like fluid in ear; Ear is painful; Ear is / ringing; She had vertigo / eyes were not matching up with head; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, 1 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced ear feels clogged, fluid in middle ear, ear pain and ringing in ears. On an unknown date, the outcome of the vertigo was recovered/resolved and the outcome of the ear feels clogged, fluid in middle ear, ear pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, ear feels clogged, fluid in middle ear, ear pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: On 5th October 2020, the patient received the Shingrix shot in left arm then the next morning she had vertigo, her eyes were not matching up with her head. Vertigo had resolved. The patient still had ear fullness, feels like fluid in her ear, ear was painful and ringing. The ear problems had not resolved.  The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus, Vertigo, X-ray normal
Clinical narrative: Ear fullness; Feels like fluid in ear; Ear is painful; Ear is / ringing; She had vertigo / eyes were not matching up with head; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, 1 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced ear feels clogged, fluid in middle ear, ear pain and ringing in ears. On an unknown date, the outcome of the vertigo was recovered/resolved and the outcome of the ear feels clogged, fluid in middle ear, ear pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, ear feels clogged, fluid in middle ear, ear pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: On 5th October 2020, the patient received the Shingrix shot in left arm then the next morning she had vertigo, her eyes were not matching up with her head. Vertigo had resolved. The patient still had ear fullness, feels like fluid in her ear, ear was painful and ringing. The ear problems had not resolved.  The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction, Biopsy skin abnormal, Epistaxis, Nasal discomfort, Oral mucosal exfoliation
Clinical narrative: vasculitis; mouth feeling chapped; nose feeling very sore; skin started peeling from the roof of mouth; nose began to bleed; rash; Initial information received on 24-Nov-2020 regarding an unsolicited valid serious case received from a consumer via Medical Information (Reference number- 00370045).  This case involves female patient of an unknown age who experienced vasculitis, mouth feeling chapped (stomatitis), nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis) and rash, while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIFLUNISAL (DOLOBID).  On an unknown date (years ago), 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.  It was also reported that Flublok has been suggested to her as a good alternative to the regular flu vaccine.   On an unknown date, the patient developed a non-serious mouth feeling chapped (stomatitis) (within a day) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis), rash (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a serious vasculitis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Relevant laboratory test results included: On an unknown date, biopsy skin - [The results came back as vasculitis due to a drug reaction]  Therefore, she doesnt know for sure that it was a reaction to the vaccine, but she has never had a problem taking anti-inflammatories.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient of an unknown age who had vasculitis, stomatitis, nasal discomfort, skin exfoliation, epistaxis and rash, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Concomitant medications included DIFLUNISAL. However, patient's medical condition at time of vaccination, laboratory data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Rash, Stomatitis, Vasculitis
Clinical narrative: vasculitis; mouth feeling chapped; nose feeling very sore; skin started peeling from the roof of mouth; nose began to bleed; rash; Initial information received on 24-Nov-2020 regarding an unsolicited valid serious case received from a consumer via Medical Information (Reference number- 00370045).  This case involves female patient of an unknown age who experienced vasculitis, mouth feeling chapped (stomatitis), nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis) and rash, while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIFLUNISAL (DOLOBID).  On an unknown date (years ago), 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.  It was also reported that Flublok has been suggested to her as a good alternative to the regular flu vaccine.   On an unknown date, the patient developed a non-serious mouth feeling chapped (stomatitis) (within a day) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis), rash (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a serious vasculitis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Relevant laboratory test results included: On an unknown date, biopsy skin - [The results came back as vasculitis due to a drug reaction]  Therefore, she doesnt know for sure that it was a reaction to the vaccine, but she has never had a problem taking anti-inflammatories.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient of an unknown age who had vasculitis, stomatitis, nasal discomfort, skin exfoliation, epistaxis and rash, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Concomitant medications included DIFLUNISAL. However, patient's medical condition at time of vaccination, laboratory data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 40.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Abdominal pain, Back pain, Decreased appetite, Fatigue, Injected limb mobility decreased
Clinical narrative: Right arm-sever pain at injection site, swelling, redness, limited mobility. Body aches, high-grade fever 103.3, vomiting, nausea, fatigue, Decreased appetite, abdominal cramping, low back pain
Age: 40.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Right arm-sever pain at injection site, swelling, redness, limited mobility. Body aches, high-grade fever 103.3, vomiting, nausea, fatigue, Decreased appetite, abdominal cramping, low back pain
Age: 40.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Right arm-sever pain at injection site, swelling, redness, limited mobility. Body aches, high-grade fever 103.3, vomiting, nausea, fatigue, Decreased appetite, abdominal cramping, low back pain
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Injection site swelling, Nausea
Clinical narrative: Injection was administered SQ not IM.  I initially had arm pain, redness, and swelling in the arm at the injection site for three days and then those improved.  On day three I began to have fatigue.  Over the next 10 days the fatigue became progressively worse.  I felt extremely tired and didn't want to get out of bed.  I also had waves of nausea.  There was no vomiting or diarrhea.  I had no fevers.  I also experienced a loss of appetite during that time.  After 10 days I improved and am now back to normal.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Injection was administered SQ not IM.  I initially had arm pain, redness, and swelling in the arm at the injection site for three days and then those improved.  On day three I began to have fatigue.  Over the next 10 days the fatigue became progressively worse.  I felt extremely tired and didn't want to get out of bed.  I also had waves of nausea.  There was no vomiting or diarrhea.  I had no fevers.  I also experienced a loss of appetite during that time.  After 10 days I improved and am now back to normal.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: Woke up in night with chills and nausea and all-over achiness.  The chills lasted for hours.  Finally went back to sleep.  Woke up in the morning with same symptoms plus splitting headache and nasal congestion.  I looked at my phone and tried to read a couple of texts.  I was able to read one word at a time, but couldn't put together the meaning of the sentence.  I could not understand a simple text.  It was quite disturbing.  I went back to sleep for most of the morning.  The headache persisted, but the other symptoms slowly disappeared.  By early evening I was able to work on my laptop and understand sentences again!  The next day, I was back to normal.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Reading disorder
Clinical narrative: Woke up in night with chills and nausea and all-over achiness.  The chills lasted for hours.  Finally went back to sleep.  Woke up in the morning with same symptoms plus splitting headache and nasal congestion.  I looked at my phone and tried to read a couple of texts.  I was able to read one word at a time, but couldn't put together the meaning of the sentence.  I could not understand a simple text.  It was quite disturbing.  I went back to sleep for most of the morning.  The headache persisted, but the other symptoms slowly disappeared.  By early evening I was able to work on my laptop and understand sentences again!  The next day, I was back to normal.
Age: 35.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: 10/7/2019 Patient is a 35 y.o. male evaluated with a video visit on Currently he complains of rash over his whole body. He get a vaccine- flu and Tdap at that time. It is itchy, it started on wrists then moved to armpit, then on upper body.    The symptoms have been present for 1 day(s).  He denies a history of fever, chills, difficulty breathing.  He has tried over-the-counter agents for his symptoms. Zyrtec. ? predniSONE (DELTASONE) 20 MG tablet likely reaction to vaccines. advised if having difficulty breathing, tongue swelling, fever to be seen in person.   Addendum: will cancel prednisone and use vistaril instaed due to recent vaccine
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15yo patient was given flublok. Pt's mother stated on 12/3/2020 that the patient has not experienced any adverse effects from receiving the Flublok vaccine.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Medical observation, Unevaluable event
Clinical narrative: Observation  if patient develop any Flu like symptoms to start Tamiflu ASAP
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swollen to fist size, warm to touch and red
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain in right arm that started 1 day after administration and continued to worsen; pain down right arm, difficulty actively moving arm due to pain
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient stated she received the PPSV23 vaccine around noon on 11/29/2020.  She had pain at the injection site however, later on that day she developed more intense pain, redness was radiating down to elbow, felt hot to touch, and painful.  She woke up  that evening and pain intensified and took some Advil.  Symptoms have now subsided and redness faded as of 10AM 12/03/2020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Severe shivering that lasted 3 hours and low grade fever
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Aggression, Amnesia, Arthralgia, Ear swelling, Hypoaesthesia
Clinical narrative: Reports progressive shoulder pain, numbness and discoloration of L 2nd toe and L external ear. He report loss of memory on two occasions since vaccine administration and 2 episodes of aggressive behavior that are unusual for him.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Skin discolouration, Tenderness
Clinical narrative: Reports progressive shoulder pain, numbness and discoloration of L 2nd toe and L external ear. He report loss of memory on two occasions since vaccine administration and 2 episodes of aggressive behavior that are unusual for him.