chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had a worst Flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had a worst flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 had a worst flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Got very sick; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who was very sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 was very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Pateint  got flu; Initial information was received on 26-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves a 75 years old patient who experienced who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry 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 any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Pateint  got flu; Initial information was received on 29-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves an 80 years old patient who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry 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.  It was reported that, patient got flu 25 years ago.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got flu; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry 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 any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu 3 years in a row; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient (age and gender unspecified) who experienced flu 3 years in a row (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry 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 3 years in a row (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; Initial information regarding an unsolicited valid non-serious case was received from a physician  via the agency (Reference number- 00328036) and transmitted to Sanofi on 22-OCT-2020.  This case involves a 26 year old female patient who had red, hot swollen at injection site and pain down left arm  (vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On 20-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (form :prefilled syringe, lot number and expiry date not reported) via an intramuscular route in the left upper arm for prophylactic vaccination.  On 20-Oct-2020, the patient developed a non-serious patient had red, hot swollen at injection site and pain down left arm (vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site inflammation) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovering from events.  There will be no information available on the lot number for this case.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 4 month old patient received a dose of FLUZONE QUADRIVALENT/no AE; A 4 month old patient received a dose of FLUZONE QUADRIVALENT/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse (other health care professional) via agency (Reference number- 00334499) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 4 months old male patient who received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [prefilled syringe, lot number and expiry date not reported] via intramuscular route in the right thigh for prophylactic vaccination (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL).  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration. It was also case of overdose [Latency: at the same time of vaccination].   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia, Rhinorrhoea
Clinical narrative: Muscle soreness at injection site and same side shoulder Fever 99.3F Chills Fatigue Runny nose
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Headache, Urticaria
Clinical narrative: Next morning: Hives on trunk, flushing on neck and face, dry eyes, headache. No treatment. Resolved on its own in 7 days
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Injection site/muscle soreness up to 1 month following injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Flushing, Headache, Urticaria
Clinical narrative: Next morning: Hives on trunk, flushing on neck and face, dry eyes, headache. No treatment. Expected to Resolve on its own in 7 days, as that was the experience for the previous dose of Shingrix
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Gaze palsy, Pain, Pyrexia
Clinical narrative: Severe headache, fever of 101 and aches all over.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fluid replacement, Hypotension, SARS-CoV-2 test positive, Syncope
Clinical narrative: Syncopal event x 2 the morning after patient received flu vaccine.  Seen in ED and given IVF.  Unclear if EKG was done at that time.  BP was low per patient. Seen by PCP 12/4/2020 and will refer to cardiology
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site movement impairment, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Phone call this morning, 12/4/2020, Pt reports had flu vaccine  and two or three days later had discomfort in left shoulder. Reports discomfort continues till today with stiffness  or freezing up to area of injection site. Plans to see primary care provider.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: patient experienced an injection site reaction; unsure which products were administered intramuscularly and subcutaneous.; This spontaneous report was received from a pharmacist referred to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not provided.      On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, lot# and expiration date were unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot# and expiration date were unknown) for prophylaxis. The reporter was unsure which products were administered intramuscularly and subcutaneously (subcutaneous injection formulation administered by other route).     On an unknown date, the patient experienced injection site reaction.      The outcome of injection site reaction was unknown. The causality between injection site reaction and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: vesicular rash above the right ear to the top of the head/ shingles; another vesicular rash on the right upper eyelid; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 30-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a vesicular rash above the right ear to the top of the head and another vesicular rash on the right upper eyelid (ophthalmic herpes zoster). The patient was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles and ophthalmic herpes zoster to be disability.   Upon internal review, ophthalmic herpes zoster was determined to be medically significant.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: Menactra was given subcutaneously instead of Intramuscularly/no AE; Initial information regarding an unsolicited valid non-serious case was received on 10-Nov-2020 from an other health care professional via The Agency (Reference number- 00353139) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 16-year-old male patient who was vaccinated with first dose 0.5 mL (once) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneously instead of intramuscularly (batch number U6596AA and expiry date 24-May-2021) at left deltoid on 09-Nov-2020 at 16:48 for prophylactic vaccination (Incorrect route of product administration).  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) at left deltoid as prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  At the time of report, patient had not experienced any adverse events.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Hyperhidrosis, Pallor, Vertigo
Clinical narrative: Patient reacted within 30 seconds of vaccination. Patient experienced vertigo, sweating, pale, and left side chest pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia
Clinical narrative: Severe headache, muscle aches and joint pain about 12 hours post dose. Duration for >8 hours, but lessened by naproxen. Also tenderness at injection site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: A few hours after receiving the shot I felt extremely cold, shivering. When I went to bed the cold and shivering was worse, despite many blankets and warm bedclothes. I took a Tylenol and after 20 minutes felt fine. That is all. I am reporting it because this was not listed as a side effect and I believe it should be. It was not serious, I did not contact a medical professional to report because the next day I remained fine.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Headache, Pain
Clinical narrative: Headaches for 4 days Over the counter medicine did not help Overall body aches for four days over the counter medicine did not help with that either
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient stated there were no adverse effects
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Nausea, Pyrexia
Clinical narrative: vomiting and fever of 38.5
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site indentation
Clinical narrative: Discoloration of skin/ indent at site of injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Lethargy, Myalgia
Clinical narrative: Started with extreme chills, shaking, woke up during the night with muscle pain. Next morning woke up with a low grade fever, lethargy, joint and muscle pain, headache. Symptoms lasted about 36 hours
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Started with extreme chills, shaking, woke up during the night with muscle pain. Next morning woke up with a low grade fever, lethargy, joint and muscle pain, headache. Symptoms lasted about 36 hours
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Scab, Scratch
Clinical narrative: Site began itching, then when scratching, bump would scab over, 2 months later, still itching with scabs on arms and chest.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Tendonitis, Wrong technique in product usage process
Clinical narrative: Patient stated that the injection went into the deltoid and not the muscle. Patient stated immediate pain after recieving injection. Pt stated she went to  doctor and  has tendonitis due to vaccine technique and is going to physical therapy
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: After I received the first shingles shot my arm was a little sore. When I got home my arm was still sore around the injection site so I applied a warm compress. A few days after, the injection site started to feel hard to touch and warm. I spoke with the pharmacist and he said when they gave me the injection they must have administered the shot a little low. He also stated the pain would go away with time. I waited for a month for the pain to go away and it did not so contacted pharmacist again and he told me that he would contact the corporate office. A week later they contacted me and told me they would report the reaction. The pain is still constant when I move my arm. It feels like a painful cramp when I move my arm. The pain shoots down my arm to my hands. If i continue to move it the pain gets worse. I have to wait for the pain to stop before I can get any relief. i spoke to my primary care doctor and he stated there was nothing he could do and I would have to speak with the pharmacist again.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Induration, Pain
Clinical narrative: After I received the first shingles shot my arm was a little sore. When I got home my arm was still sore around the injection site so I applied a warm compress. A few days after, the injection site started to feel hard to touch and warm. I spoke with the pharmacist and he said when they gave me the injection they must have administered the shot a little low. He also stated the pain would go away with time. I waited for a month for the pain to go away and it did not so contacted pharmacist again and he told me that he would contact the corporate office. A week later they contacted me and told me they would report the reaction. The pain is still constant when I move my arm. It feels like a painful cramp when I move my arm. The pain shoots down my arm to my hands. If i continue to move it the pain gets worse. I have to wait for the pain to stop before I can get any relief. i spoke to my primary care doctor and he stated there was nothing he could do and I would have to speak with the pharmacist again.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Chills, Diarrhoea, Vomiting
Clinical narrative: Within 1 and 1/2 days pt had chills, vomiting, abd pain, and diarrhea. he was fine by the next day and no residual issues.
Sex: U
Vaccine: FLUX
Symptoms: Impaired work ability, Peripheral swelling
Clinical narrative: arm swelled up; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown age and gender) whose arm swelled up and missed work for a week (peripheral swelling) after he/ she received INFLUENZA VACCINE.  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's arm swelled up (peripheral swelling) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There would be no information available on lot number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Every time patient got a flu shot, he came down with the flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a male patient age not reported who experienced the flu (influenza), while he received INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who developed non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media.   This case is linked to case 2020SA289370 (same reporter).  This case involved an unknown demographic patient who experienced flu (influenza), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(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), (unknown latency) following the administration of INFLUENZA VACCINE.  The patient did not receive another flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event after 3 weeks.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: Feeling bad for 2 weeks; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from consumer (patient) via social media.  This case involves a patient of unknown age who had been feeling bad for 2 weeks (feeling abnormal), while received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was feeling bad (feeling abnormal) (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, event outcome was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from consumer (patient) via social media.  This case involves a 76-year-old patient who got flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, (reported as long time 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.  On an unknown date, the patient got flu (influenza) (non-serious) [about 3 days] following the administration of INFLUENZA VACCINE.  It was reported as patient had not taken Flu shot for last 30 some odd years. Now patient is of 76 years old and have ashma.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that it was the only time patient had flu when he took the shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Influenza, Pain, Pyrexia
Clinical narrative: Flu; chills; body aches; loss of appetite; Fever of 101; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.   This case involves a patient (age and gender unspecified) who experienced flu (influenza), fever 101 (pyrexia), chills, body aches (pain) and loss of appetite (decreased appetite), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry 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) for 12 days, fever of 101 (pyrexia), chills, body aches (pain), loss of appetite (decreased appetite) (less than a week) following the administration of INFLUENZA VACCINE.  It was reported that, patient had not been exposed to anything else.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got very sick; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media.  This case is linked to case 2020SA291942 (same reporter).   This case involves a patient [unspecified demographics] who got very sick (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient took flu shot twice.   Details of laboratory data not reported.    It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sicker than I have ever been; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case id : 2020SA294166, 2020SA294158, 2020SA294157, 2020SA294125 (same reporter).  This case involves a patient of unknown demographics who got sicker than he/she had ever been (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sicker than he/she had ever been (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was not reported for the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: All my flu shot done was make the injection site a bit sore; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via the agency through social media.  This case was linked to cases 2020SA294125, 2020SA294157, 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145.  This case involves a patient of unknown age whose all flu shot done was made the injection site a bit sore (vaccination site reaction), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(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 unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients all flu shot done was made the injection site a bit sore (vaccination site reaction).  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.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: get achey every time; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via Social Media.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294144 , 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who reported of getting achy every time (pain), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, family history and concomitant medications were not provided.   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 who reported of getting achy every time (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: I got a flu shot got sicker than a dog; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social media.  This case is linked to cases 2020SA294125, 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145 (same reporter).  This case involves a patient of unknown age who got a flu shot got sicker than a dog (illness), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(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 unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients got a flu shot got sicker than a dog (illness).  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.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Based on information received on 24-Nov-2020, the report previously considered as non-valid became valid: as the patient had been reported clearly in the description.  Initial information received on 31-Oct-2020 regarding an unsolicited non-valid serious case from a consumer via social media.  This case involves a patient (unknown demography) who was sick (illness), after receiving 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 serious sickness (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  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 illness was not reported.  Information on the batch number was requested.  Follow up information received on 24-Nov-2020 regarding an unsolicited valid serious case from a consumer via social media.  Case became valid from non-valid.; Sender's Comments: Follow up information received on 24-Nov-2020, does not change the previous assessment of this case. This case involves a patient with unknown demography who had illness, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab 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: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever; Initial information was received on 11-Oct-2020 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unspecified age and gender) who had fever (pyrexia), while received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia) next day following the administration of INFLUENZA VACCINE.   No laboratory data was provided.  The patient was treated with IBUPROFEN for pyrexia.  At the time of report, the outcome of event was unknown.  There will be no information available on the lot number for this case.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: I got the shingles vaccine. I had bad headache, low grade fever, and fatigue for 1.5 days after the vaccine. My arm between my elbow and shoulder and injection site were very sore for about a week after the vaccine, to the point that I couldn't touch it at all.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of an unknown demographics who got sick (illness), when received INFLUENZA VACCINE.  The patient's past vaccination included flu shot from which the patient got sick for 4 times.  The patient's medical history, medical treatments, 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 unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness, non-serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that three years no flu shot and no illness. Pretty strange if you ask me. What are those odds. Won't be getting the shot again this year.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the lot number for this case.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: left shoulder swelling redness
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: severe headache, nausea, vomiting once
Age: 37.0
Sex: M
Vaccine: FLUR4
Symptoms: Erythema, Injection site swelling, Swelling, Tenderness
Clinical narrative: swelling, redness, tenderness persisting longer than 48 hours. Swelling developed initially at site of injection and now there is large swelling at the armpit.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: sick; aches; fever; chills; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from the patient via social media.  This case involves a patient of unknown demographics who got sick (illness), with aches (pain), fever (pyrexia) and chills, while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications 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 got sick (illness), with aches (pain), fever (pyrexia) and chills, (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bed rest, Malaise, Respiratory tract infection
Clinical narrative: patient got worst respiratory infection; patient was deathly sick for 12 long weeks; Initial information was received on 23-Nov-2020 regarding an unsolicited valid serious case from a social media via consumer (patient).  This case involves patient of unknown demographics who got worst respiratory infection (respiratory tract infection) and was deathly sick for 12 long weeks (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  The patient had no health issue prior.  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 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 serious worst respiratory infection (respiratory tract infection) unknown latency (within a week) and was deathly sick for 12 long weeks (illness) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  It was reported that, patient was put on three strong different antibiotics that did not work and finally had to be put on complete bed rest to recover. It was the sickest patient had ever been had not been sick again once recovered. Patient did not take another flu shot.  Details of laboratory data not reported.   At the time of reporting, the event outcome was unknown for events.  Information on the batch number was requested.; Sender's Comments: This poorly document case received from social media concerns a patient with unknown demography who experienced illness and respiratory tract infection, after vaccination with INFLUENZA VACCINE (Flu shot), produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.