chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Neuropsychiatric syndrome, Obsessive-compulsive disorder, Red blood cell sedimentation rate, Streptococcus test, Tic
Clinical narrative: Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Vitamin B12, Vitamin B6, Vitamin D
Clinical narrative: Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports the day after she got the shot, her arm was very red and sore, hot to the touch for 6 days. She did not seek medical advice and it resolved on its own
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Loss of personal independence in daily activities, Mobility decreased, Myalgia
Clinical narrative: Pt developed redness, muscle tenderness, pain in extremity, no fever. felt "off" Took Ibuprofen, Asprin cream, benadryl + CBD oil On Thursday 10/8/2020 patient arm was sore without touching it as well as she could not straighten her arm.  The second day 10/9/2020 she started having some redness, which she stated moved inward toward body and  measured about 5" wide and 3-4" long; she also said it slightly raised on the second day. She states it is still faint red today 10/14/2020. Started Thursday 10/8/2020 evening, a few hours her appt here. She still has some faint redness and muscle tenderness to touch.  Never had SOB; Friday 10/9/2020 she was feeling off, no fever, just feeling off, which continued through the weekend and she didn't go to church Sunday.  She has taken Ibprofen, and applied asprin cream. she also applied other lotions. and took benadryl on the second day. She tried CBD oil as well. It is not completely gone; Patient still has muscle tenderness when touched and her arm is still faint red.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt developed redness, muscle tenderness, pain in extremity, no fever. felt "off" Took Ibuprofen, Asprin cream, benadryl + CBD oil On Thursday 10/8/2020 patient arm was sore without touching it as well as she could not straighten her arm.  The second day 10/9/2020 she started having some redness, which she stated moved inward toward body and  measured about 5" wide and 3-4" long; she also said it slightly raised on the second day. She states it is still faint red today 10/14/2020. Started Thursday 10/8/2020 evening, a few hours her appt here. She still has some faint redness and muscle tenderness to touch.  Never had SOB; Friday 10/9/2020 she was feeling off, no fever, just feeling off, which continued through the weekend and she didn't go to church Sunday.  She has taken Ibprofen, and applied asprin cream. she also applied other lotions. and took benadryl on the second day. She tried CBD oil as well. It is not completely gone; Patient still has muscle tenderness when touched and her arm is still faint red.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Vomiting
Clinical narrative: The night after the injection he started feeling chills for a week; The night after the injection he started feeling headaches off-and-one for a month; The night after the injection he  experienced vomiting; The night after the injection he started feeling soreness out the injection site.; Patient received the PNEUMOVAX 23 once "about 14 years ago", another "sometime last year", and just received an booster shot on 29-OCT-2020 .; This spontaneous report was received from a 67 year old male patient reporting on himself, with high blood sugar, and high blood pressure. The patient was allergic to Iodine, and some forms of plastic. Concomitant therapies included insulin and lisinopril. In approximately 2006 (reported as "about 14 years ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  On an unknown date (reported as "sometime last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown). Subsequently, on 29-OCT-2020, the patient received a booster shot of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) because it was recommended (prophylaxis).  The patient reported that the night after the injection, he started feeling chills for a week, headaches off-and-on for a month, vomiting, and soreness out the injection site. The patient did not seek for medical attention.  At the time of the report, the outcome of chills, injection site pain, vomiting and headache was reported as not resolved. The reporter did not mention the causality assessment between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) vaccination.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: the evening after the administration the patient developed a rash on her chest and both arms; This spontaneous report was received from a physician and refers to a 29-year-old female patient. Her concurrent conditions included allergy to sulfonamides (reported as sulfa). The patient's concomitant therapies included levothyroxine sodium (SYNTHROID). There was no information about her medical history provided.  On 03-DEC-2020, the patient was vaccinated with a first dose of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 injection, lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for HPV prophylaxis. On the same day, evening after the administration, the patient developed a rash on her chest and both arms. On 04-DEC-2020, she called the clinic where the vaccine was administrated for medical advice and took diphenhydramine hydrochloride (BENADRYL) for one day. There were no lab diagnostic studies performed. As for 08-DEC-2020, the patient's rash was mostly gone (reported also as recovering, but still has some rash).  Causal relationship between the event and (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT CAME IN12/11/20 SAYING SITE OF INJECTION SWOLLEN AND GETTING BIGGER, ALSO ITCHES AND SLIGHTLY PAINFUL. PATIENT HAS NOT TRIED ANYTHING TO RELIEVE IT
Sex: F
Vaccine: PNC13
Symptoms: Splenectomy, Splenic abscess
Clinical narrative: splenic abscess; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 68-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in Oct2018 and in 2019, both via an unspecified route of administration at single dose for immunization. There were no medical history and concomitant medications. Caller clarified that the patient actually had a splenic abscess in 2018. Caller stated the patient had her spleen removed very recently, Prevnar 13 is part of the recommended vaccinations for post splenectomy. Patient was now asplenic. Outcome of event was unknown.; Sender's Comments: The reported event splenic abscess required spleen removed was most likely an intercurrent diseases, and unlikely causally related to the vaccine of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: She is 63 yo and received HD Fluzone vaccine.  No adverse event occurred.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm "swole -up" for 3 weeks; really bad and painful; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose in arm for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm "swole -up" on 21Oct2019 for 3 weeks, really bad and painful on 21Oct2019. The outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot obtained.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: patient states her left arm has been sore due to the flushot . she has not gone to doctor yet but complains of decreased range of motion. when she tries to move her arm from the front to the back, she states it hurts.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone, CSF test, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram spine
Clinical narrative: Pt received her flu vaccine around 3 pm on 11/30/2020. Later that night she developed a severe headache, fever of 101.6 and neck pain. She called the office the next day around 9 am and based on her symptoms was instructed to go to the nearest Emergency Room. She was diagnosed with meningitis. ( ER note state patient had Nausea and vomiting)
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Headache, Influenza A virus test, Influenza B virus test, Meningitis
Clinical narrative: Pt received her flu vaccine around 3 pm on 11/30/2020. Later that night she developed a severe headache, fever of 101.6 and neck pain. She called the office the next day around 9 am and based on her symptoms was instructed to go to the nearest Emergency Room. She was diagnosed with meningitis. ( ER note state patient had Nausea and vomiting)
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Nausea, Neck pain, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Pt received her flu vaccine around 3 pm on 11/30/2020. Later that night she developed a severe headache, fever of 101.6 and neck pain. She called the office the next day around 9 am and based on her symptoms was instructed to go to the nearest Emergency Room. She was diagnosed with meningitis. ( ER note state patient had Nausea and vomiting)
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Pt received her flu vaccine around 3 pm on 11/30/2020. Later that night she developed a severe headache, fever of 101.6 and neck pain. She called the office the next day around 9 am and based on her symptoms was instructed to go to the nearest Emergency Room. She was diagnosed with meningitis. ( ER note state patient had Nausea and vomiting)
Sex: U
Vaccine: FLUX
Symptoms: Chills, Malaise
Clinical narrative: I got so sick from the flu shot; chills; Initial information regarding an unsolicited valid non-serious case received from a consumer(patient) via social media on 30-Oct-2020.  This case involves a patient of unknown demographics who got so sick from the flu shot (Illness) and chill for 2 days (Chills), while he/she received Influenza Vaccine.  The patient's medical history included as pacemaker user. The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date unknown) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect the patient had got so sick from the flu shot (Illness) and chill for 2 days (Chills).  No laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Age: 30.0
Sex: M
Vaccine: FLUA4
Symptoms: Bursitis
Clinical narrative: Left Arm bursitis, mostly resolved.  Concerned about long term issues.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Condition aggravated, Focal dyscognitive seizures
Clinical narrative: Increased seizure activity since shot.  Neurology prescribed three days of medication to reduce.
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to vaccine; Initial information regarding an unsolicited valid non-serious courtesy case received from a physician assistant on behalf of healthcare professional in the United States of America (USA) via Merck on 03-Nov-2020.  This case involved a patient of an unknown age and gender who experienced allergic reaction to vaccine (Allergy to vaccine), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was asked by reporter if vaccine contains any allergens and further it was reported that patient had an allergic reaction to ADACEL vaccine (Allergy to vaccine).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick every year after getting the Flu Shot; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who got sick (illness) every year after he received INFLUENZA VACCINE.  The patient's medical history, past 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 expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) every year following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome was unknown for illness.  There will be no information on the batch number for this case.
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Bursitis, Magnetic resonance imaging, Pain
Clinical narrative: Pain at sight, bursitis type symptoms afterward
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Bursitis, Exostosis, Magnetic resonance imaging abnormal, Mobility decreased, Pain
Clinical narrative: Pain at sight, bursitis type symptoms afterward
Age: 44.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Pain at sight, bursitis type symptoms afterward
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy skin, Rash pruritic
Clinical narrative: 09/29/2020 Went to dermatologist; head itching.  3 weeks later, Dr. examined; bumps on back. Prescribed prednisone for rash. After medication dose, rash reappeared. 2x Biopsy; inconclusive. 'Dr. didn't accept results and wanted to pursue medication - I declined; 'I'll deal with it''.  Patient still complains of bumps and itchy head.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Edema, warm, and sore to upper arm and elbow area. Today 12/11/2020 it is down to forearm.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Patient received vaccination the morning of 11/11/2020, and the evening of the same day, patient stated he developed fever (101), upset stomach, muscle weakness, muscle aching, and fatigue.  No diarrhea, difficulty breathing or rash was reported.  Patient went to ER the next morning after vaccination due to his symptoms and possible concern about COVID.  COVID test came back negative.  Patient was in ER for about 8 hours and started feeling better and was completely symptom free by the evening of the same day.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient received vaccination the morning of 11/11/2020, and the evening of the same day, patient stated he developed fever (101), upset stomach, muscle weakness, muscle aching, and fatigue.  No diarrhea, difficulty breathing or rash was reported.  Patient went to ER the next morning after vaccination due to his symptoms and possible concern about COVID.  COVID test came back negative.  Patient was in ER for about 8 hours and started feeling better and was completely symptom free by the evening of the same day.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: patient got the flu shot and had bad reactions never again; Initial information was received on 15-Nov-2020 regarding an unsolicited non-valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got the flu shot and had bad reactions never again (unevaluable event), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, patient got the flu shot and had bad reactions never again (unevaluable event).  No laboratory data was 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 regarding batch number in this case.
Age: 45.0
Sex: F
Vaccine: FLUR4, HEP, PPV
Symptoms: Chest pain, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient stated she felt pain immediately after vaccines but thought it was normal.  After she left the pharmacy, around 11am, the pain got worse.  She stated today (12/11) around 1pm that her right arm was in severe pain, with pain traveling to her chest and down her arm.  She stated she could hardly sleep last night and sounded as if she was in tears on the phone.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: There was a burning pain during vaccine injection dissimilar to any prior intramuscular injections (uncharacteristically painful).  Following the 16:30 vaccine administration, patient's entire left arm and shoulder grew increasingly sore and tight.  By about 20:00 the soreness was throughout the arm.   By 21:30 the pain was significant, and throbbing.  Patient self administered 1.5 mg oxycodone (left over from dental surgery) and 1000mg acetaminophen around midnight (12/2/2020) and took another 1.5 mg oxycodone every 3 hours, alternating 600 mg ibuprofen and 650 mg acetaminophen each time.  Throbbing pain was severe even with arm/shoulder immobilized.  Patient could never get shoulder to sit comfortably.  Every position felt like shoulder was trying to dislocate.  Finally throbbing pain subsided (after 5 or 6 mg oxycodone) and according to his Fitbit, patient first fell asleep at 07:10 on 12/2/2020.  Upon waking, lower arm was sore but mobile, but shoulder mobility was limited to around 20-30 degrees in any direction with much pain.  By afternoon, shoulder had loosened up enough to raise arm over the head (slowly, over 2 minutes).  Immobility presented the next morning.  Upon this writing on 12/11/2020, patient continues to feel joint pain and the feeling of inflammation or possible bursitis in the joint.  Soreness extends to the elbow.  There was soreness and difficulty positioning the arm while sleeping.  Symptoms persist daily.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: There was a burning pain during vaccine injection dissimilar to any prior intramuscular injections (uncharacteristically painful).  Following the 16:30 vaccine administration, patient's entire left arm and shoulder grew increasingly sore and tight.  By about 20:00 the soreness was throughout the arm.   By 21:30 the pain was significant, and throbbing.  Patient self administered 1.5 mg oxycodone (left over from dental surgery) and 1000mg acetaminophen around midnight (12/2/2020) and took another 1.5 mg oxycodone every 3 hours, alternating 600 mg ibuprofen and 650 mg acetaminophen each time.  Throbbing pain was severe even with arm/shoulder immobilized.  Patient could never get shoulder to sit comfortably.  Every position felt like shoulder was trying to dislocate.  Finally throbbing pain subsided (after 5 or 6 mg oxycodone) and according to his Fitbit, patient first fell asleep at 07:10 on 12/2/2020.  Upon waking, lower arm was sore but mobile, but shoulder mobility was limited to around 20-30 degrees in any direction with much pain.  By afternoon, shoulder had loosened up enough to raise arm over the head (slowly, over 2 minutes).  Immobility presented the next morning.  Upon this writing on 12/11/2020, patient continues to feel joint pain and the feeling of inflammation or possible bursitis in the joint.  Soreness extends to the elbow.  There was soreness and difficulty positioning the arm while sleeping.  Symptoms persist daily.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: 12/7/2020 started not 'feeling up to par' in the evening; achy, sore, body chills, headache, dizziness. Did not take temperature. Symptoms lasted for approximately later the following evening.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Pain, Pruritus, Skin warm
Clinical narrative: Patient woke up on day 2 with a swollen shoulder that was warm, itchy, and painful.  Pain was radiating.  She was counseled to apply ice to the site, and to contact her primary care provider.
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Antinuclear antibody negative, Joint swelling, Malaise, Myalgia, Peripheral swelling
Clinical narrative: Did not feel well on Saturday, 10/3/2020,low grade fever (99.5)and muscle aches on Sunday 10/4/2020 and Monday 10/5/2020. I had a Covid-19 test on Monday, 10/6/2020; result NEGATIVE on Tuesday, 10/7/2010. Hands and ankles were swollen and rash on forearms developed on Wednesday, 10/7/2020. Saw new doctor, Dr. (previous internist just retired) on Friday, 10/9/2020.. She ordered Nuclear Antibody ANA blood test; result NEGATIVE on Monday, 10/12/2020. Dr. prescribed Prednisone which relieved all symptoms by 5 days later.
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Did not feel well on Saturday, 10/3/2020,low grade fever (99.5)and muscle aches on Sunday 10/4/2020 and Monday 10/5/2020. I had a Covid-19 test on Monday, 10/6/2020; result NEGATIVE on Tuesday, 10/7/2010. Hands and ankles were swollen and rash on forearms developed on Wednesday, 10/7/2020. Saw new doctor, Dr. (previous internist just retired) on Friday, 10/9/2020.. She ordered Nuclear Antibody ANA blood test; result NEGATIVE on Monday, 10/12/2020. Dr. prescribed Prednisone which relieved all symptoms by 5 days later.
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Joint swelling, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Did not feel well on Saturday, 10/3/2020,low grade fever (99.5)and muscle aches on Sunday 10/4/2020 and Monday 10/5/2020. I had a Covid-19 test on Monday, 10/6/2020; result NEGATIVE on Tuesday, 10/7/2010. Hands and ankles were swollen and rash on forearms developed on Wednesday, 10/7/2020. Saw new doctor, Dr. (previous internist just retired) on Friday, 10/9/2020.. She ordered Nuclear Antibody ANA blood test; result NEGATIVE on Monday, 10/12/2020. Dr. prescribed Prednisone which relieved all symptoms by 5 days later.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Experience head ache, body ache, sore right arm on the area where the shot was given and was  red  5"  circumference  where shot was given.
Sex: U
Vaccine: FLUX
Symptoms: Eye infection
Clinical narrative: Four years in a row eye infections after the flu shot; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient of an unknown demography who experienced four years in a row eye infections after the flu shot (eye infection), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, concomitant medications and family history were not provided.  Patient received flu vaccine in past with no side effects, except the last 4 years.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced four years in a row eye infections after the flu shot (eye infection), (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory details reported.  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: U
Vaccine: FLUX
Symptoms: Exposure to communicable disease
Clinical narrative: ended up in a quarantine with a dozen people sick; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) on 05-Nov-2020.  This case involved a patient with unknown age and gender who ended up in a quarantine with a dozen people sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in 1972, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1972 (unknown latency), but in the same year of vaccine administration, it was reported that the patient got a flu shot in a school and the patient ended up in a quarantine with a dozen people sick (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 06-Nov-2020.  This case involves male of an unknown age patient who got the flu (Influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient reported that the only time he got the flu (Influenza) (unknown latency) after getting the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for illness.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: every time had flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who experienced flu (influenza), after he/she received INFLUENZA VACCINE.  The patient's medical history, past 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 expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient only got a flu shot a few times, and every time he/she had flu. The last time was quite severe. He/she had not got flu shot in many years and had no flu. Maybe he/she was just the exception to the rule.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for influenza was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/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 sick (illness) (next day) following the administration of INFLUENZA VACCINE.  It was also reported that a week will never get another flu shot.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, 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: Malaise
Clinical narrative: sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who was sick (illness), after he/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 was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  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 unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: passed out; Initial information was received on 08-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient).  This case involves a patient (demographics unknown) who passed out (loss of consciousness), when received INFLUENZA VACCINE.  Medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of egg allergy. Due to this, the patient could not get flu shot.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed out (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient did not receive vaccine since the event nor got the flu.  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.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient who had loss of consciousness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Concurrent condition included egg allergy. Additional information regarding medical history and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Oral pruritus, Rash macular, Rash papular, Sleep disorder
Clinical narrative: mouth was itchy; lips were swelling; face, shoulder were blotchy, red and few hives, some of these blotches were raised; face, shoulder were blotchy, red, few hives/ blotchy all over his body, including neck, face, eyes, chest, back, some of these blotches were raised and some were not; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional (patient's mother) (Reference number- 00326392) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 19 years old male patient who developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular), lips swelling (lip swelling) and itchy mouth (Oral pruritus), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history included COVID-19 in SEP-2020, patient felt bad for 3 days, and was quarantined for 14 days.  The patient's past vaccination included flu shot late last flu season (reporter did not know which flu shot it was) in FEB-2020 which was tolerated by patient with no problem  Patient's past medical treatments and family history were not provided.  At the time of the event, the patient had ongoing coeliac disease three and half years ago and was completely gluten free now and Food allergy (allergic to melons and some random fruits), which would make his mouth itch.  Patient received no concomitant vaccines.   On 20-Oct-2020 at 3.30pm, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection prefilled syringes (lot number, expiration date was unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  Patient took a shower very late on 20 Oct 2020 or else very early on 21 Oct 2020 after patient got out of the shower the patient developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular) 8 to 9 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported as some of these blotches were raised and some were not.  On 21-Oct-2020 midnight, patient called reporter and stated that he felt like his lips were swelling (lip swelling) and his mouth was itchy (Oral pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Reporter was on the phone with the patient until about 3 am.  Reporter spoke to the pediatric hotline and were advised against taking Benadryl, so the patient did not take it.  Patient was able to go to sleep after 3 am, and when he woke up in the morning, he had recovered.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: mouth was itchy; lips were swelling; face, shoulder were blotchy, red and few hives, some of these blotches were raised; face, shoulder were blotchy, red, few hives/ blotchy all over his body, including neck, face, eyes, chest, back, some of these blotches were raised and some were not; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional (patient's mother) (Reference number- 00326392) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 19 years old male patient who developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular), lips swelling (lip swelling) and itchy mouth (Oral pruritus), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history included COVID-19 in SEP-2020, patient felt bad for 3 days, and was quarantined for 14 days.  The patient's past vaccination included flu shot late last flu season (reporter did not know which flu shot it was) in FEB-2020 which was tolerated by patient with no problem  Patient's past medical treatments and family history were not provided.  At the time of the event, the patient had ongoing coeliac disease three and half years ago and was completely gluten free now and Food allergy (allergic to melons and some random fruits), which would make his mouth itch.  Patient received no concomitant vaccines.   On 20-Oct-2020 at 3.30pm, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection prefilled syringes (lot number, expiration date was unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  Patient took a shower very late on 20 Oct 2020 or else very early on 21 Oct 2020 after patient got out of the shower the patient developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular) 8 to 9 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported as some of these blotches were raised and some were not.  On 21-Oct-2020 midnight, patient called reporter and stated that he felt like his lips were swelling (lip swelling) and his mouth was itchy (Oral pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Reporter was on the phone with the patient until about 3 am.  Reporter spoke to the pediatric hotline and were advised against taking Benadryl, so the patient did not take it.  Patient was able to go to sleep after 3 am, and when he woke up in the morning, he had recovered.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient started to experience AE shortly after; sore, difficulty moving LA.  Referred to PT
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site erythema, Nausea, Pain
Clinical narrative: Flu- like symptoms including  nausea, aches, pains, dizziness but no fever.  Red patch 1"x1&1/2" in size below injection site
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: Patient called today stating that her arm is still sore at the site where she got the vaccination over 1 month ago. The pain isn't severe but she still feels it when she touches the area.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: She is 20 yo and received HD Fluzone vaccine.  No adverse event occurred.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Dysphagia, Fatigue, Headache
Clinical narrative: Approx 2 hours after flu vaccine felt like my throat was swelling, hard to swallow felt like something stuck in my throat.  Started coughing.  The medical clinic called me about something else and suggested I take a Benadryl, which I did.  Later that evening I had a fever of 101 and chills, muscle aches, and fatigue.  Mostly slept.  Woke up with headache took 2 ibuprofen and headache went away.  Next day woke up and besides feeling real tired and achy am otherwise okay.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersomnia, Myalgia, Pharyngeal swelling, Pyrexia
Clinical narrative: Approx 2 hours after flu vaccine felt like my throat was swelling, hard to swallow felt like something stuck in my throat.  Started coughing.  The medical clinic called me about something else and suggested I take a Benadryl, which I did.  Later that evening I had a fever of 101 and chills, muscle aches, and fatigue.  Mostly slept.  Woke up with headache took 2 ibuprofen and headache went away.  Next day woke up and besides feeling real tired and achy am otherwise okay.
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Hypokinesia, Irritability, Pain, Vomiting projectile
Clinical narrative: Mom reports for 24 hours after receiving Fluarix vaccine the following symptoms: complained her body hurt, no fever, projectile vomited 10 times, laid around, and was fussy. After 24 hours she returned to her base line.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: The injection was administered in the Left deltoid area. Two days later I experienced tingling pain in the middle finger of my left hand.  It has progressively gotten worse, to where the pain is sevier, and wakes me up in the middle of the night.  By rubbing the hand for a several minutes, pain may completely go away, or subside to bearable.  Is this GBS?