chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Oedema peripheral, Pain in extremity, Vertigo
Clinical narrative: Patient reported having extreme edema in shoulder and arm, extreme vertigo, sore arm, and extreme tiredness for 6-7 days after vaccination.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Provider ordered Kinrix to catch patient up on vaccines.  Right order was given by medical staff, but Kinrix is not formulated for 2 years old.  Off Label use --- Kinrix is used on 4 years to 6 years.  No adverse events noted.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Condition aggravated, Facial paralysis, Paraesthesia
Clinical narrative: Patient claims left side blistering, slight facial droop, and paresthesia 2 weeks post injection. PMHx of shingles flare several years ago, when initial symptoms started.  Patient states symptoms returned post injection and have lingered.
Age: 59.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Pain
Clinical narrative: pain in the shoulder. pain when left up the arm, get dressed, take a shower, anytime raising the arm.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Computerised tomogram head, Facial paresis, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient noted left sided facial numbness, tingling, left sided facial droop.  Diagnosed with Bell's palsy
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Periarthritis
Clinical narrative: Patient claimed soreness following vaccination.  Patient stated no visual external inflammation present. Used ice and anti-inflammatory per patient.  Then got tried of taking advil and stopped.  Claimed to have pain in same arm 2 months after vaccination when lifting the trunk of her car.  On December 7, 2010, patient sought treatment from Dr..  Patient states to have been diagnosed with frozen should and believes, the vaccine could have the injury.  Patient was prescribed diclofenac 100 mg daily and diclofenac 1% gel to used four times a day.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Absence of immediate treatment response, Rash, Skin irritation, Temperature intolerance
Clinical narrative: Arm, Buttocks, back and leg rash    irritated by heat and will still not go away after treatment. currently taking allegra and benedryl
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: SORE SHOULDER STILL SINCE RECEIVING THE SHOT ON 11/9 (BEEN ABOUT 3 WEEKS)
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site along with chest and back pain on left side which traveled to his right side
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Left arm is continually sore
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: The patient states experiencing on the night of 12/3/2020 (Thursday) a red rash and tenderness to the touch. Over the course of the next few days the rash kept expanding. She states at one point it had a raised edge and felt hard to the touch. There was no itchiness noted or rash noted anywhere else on the body. She came in to see me on 12/7/2020 (the following Monday). The rash expanded the width of her arm. She said it was no longer hot to the touch but over the weekend she could feel the heat coming through her clothes. She also said that the rash appears to have stopped spreading. She had been icing the injection site and taking Tylenol to help with the pain.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, IPV, TDAP
Symptoms: Unevaluable event
Clinical narrative: Pt sat for 15 min, had some water, after 15 minutes pt reported feeling better. BP and HR was checked before discharge.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. said she was unable to lift her arm or move it to her back, had limited range of motion for 2 days. As of 12/7/20 AM when I spoke with patient, she still had pain/limited range of motion to want to follow through with her provider's appointment at 12/7/20 11am.
Age: 42.0
Sex: M
Vaccine: FLU4, IPV, MMR, TYP, VARCEL
Symptoms: Erythema, Injection site pruritus, Rash
Clinical narrative: Patient reports rash on Wednesday/Thursday on back of right arm that has been getting worse, has been taking Zyrtec and Motrin and applying Benadryl cream - recommendations per pharmacist. Reports intermittent mild itchiness at site.  States the redness is getting worse.  Advised that this is a common side effect with any vaccine.  Recommended he continue current regimen and applying ice pack to the area.  Recommended if his symptoms persist or worsen over the next day, advised that he follow-up urgently at urgent care or ER for further evaluation.  States he is currently out of town but advised if he is back in town sooner, we'd be more than happy to take a look at his arm.  He  verbalized understanding.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: pain in arm, fever, chills, warmth at injection site for three days, redness at injection site
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Neuralgia, Pain
Clinical narrative: Pt states that when she got the shot she thought the pharmacist hit a nerve because there was minor nerve pain.  But lately the nerve pain has been traveling up from her left deltoid to her left side of neck and that she has limited mobility of her left arm (can't raise easily above her head).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Nausea
Clinical narrative: general malaise, Nausea, itching at injection site
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Haematochezia, Irritability
Clinical narrative: gross blood noted in stool some irritibility one week following Rotavirus vaccine
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Unresponsive to stimuli
Clinical narrative: Patient went unresponsive + passed out, but felt like vomiting right before that.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Tenderness, Vaccination site reaction
Clinical narrative: the site had induration of 5cmX6cm with redness and tender to palpation; the site had induration of 5cmX6cm with redness and tender to palpation; the site had induration of 5cmX6cm with redness and tender to palpation; the site had induration of 5cmX6cm with redness and tender to palpation; Initial information received on 02-Nov-2017 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 65 years old female patient who had induration of 5cmx6cm with redness and tender to palpation (erythema, vaccination site reaction, tenderness and induration), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 26-Sep-2017, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 12-Oct-2017, the patient developed a non-serious the site had induration of 5cmx6cm with redness and tender to palpation (erythema, vaccination site reaction, tenderness) 17 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 17-Oct-2017, it was improving to 3.5 cm X5 cm patient contacted the CDC (centers for disease control) info line and they advised her to continue same treatment.  It was reporter that, patient was really concerned to seek a biopsy with a general surgeon.  Details of laboratory data not reported.      It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient not recovered from events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Injection site pain, Mobility decreased, Myalgia, Sleep disorder, Ultrasound scan
Clinical narrative: having pain at the injection site, had redness and swelling; having pain at the injection site, had redness and swelling; having pain at the injection site, had redness and swelling; Initial information regarding an unsolicited valid non-serious case received from a consumer via Call Center and transmitted to Sanofi on 09-Nov-2020.  This case involves an unknown age female patient who was having pain at the injection site, had redness and swelling (injection site pain, injection site erythema and injection site swelling), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number Unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was experienced having pain at the injection site, had redness and swelling (injection site pain, injection site erythema and injection site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Final diagnosis was injection site pain, injection site erythema and injection site swelling.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as not resolved for all the events.  There will be no information regarding batch number for the case.
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: having pain at the injection site, had redness and swelling; having pain at the injection site, had redness and swelling; having pain at the injection site, had redness and swelling; Initial information regarding an unsolicited valid non-serious case received from a consumer via Call Center and transmitted to Sanofi on 09-Nov-2020.  This case involves an unknown age female patient who was having pain at the injection site, had redness and swelling (injection site pain, injection site erythema and injection site swelling), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number Unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was experienced having pain at the injection site, had redness and swelling (injection site pain, injection site erythema and injection site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Final diagnosis was injection site pain, injection site erythema and injection site swelling.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as not resolved for all the events.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No adverse effects; patient was administered one dose ofROTATEQ which was improperly stored; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On an unknown date in 2020 (reported as "sometime after at the end of October 2020"), the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and route of administration were unknown; lot number 1660989, which has been verified to be valid, the expiration date was reported and validated as 15-APR-2021) as prophylaxis (product storage error).   The suspect vaccine was exposed to a temperature of 9 degree Celsius (C) for a time frame of 50 minutes, as recorded by digital data logger. Previous temperature excursion was 11 degree C for 1 hour. No adverse effects were reported.  This case was initially considered as a non-valid case due to the lack of patient's identifiers.  Follow-up information has been received from the nurse on 04-DEC-2020. The patient's name was provided. The case becomes valid. Additionally, the reporter stated "the patient was contacted after receiving the vaccine and they are "good" and there was "no adverse event".
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that rotavirus vaccine, live, oral, pentavalent (ROTATEQ), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2012USA002962:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vision blurred
Clinical narrative: Blurred vision; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered herpes zoster and blurred vision. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had 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. Finally, the patient had suffered and incurred damages, including medical expenses, the loss of accumulation, and other economic and non-economic damages. At the time of this report, the patient had not recovered of herpes zoster and vision blurred. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and vision blurred were considered disabling events by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No adverse effects reported; the patient was inadvertently administered a dose of MMRII intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-NOV-2020, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis, intramuscularly rather than subcutaneously (incorrect route of product administration). No adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: no adverse reactions or side effects; vaccination with pneumococal vaccine yearly since 2000-2019; This spontaneous report as received from a lawyer and a consumer via a Plaintiff Fact Sheet regarding a case in litigation (MARRS 2002USA008825) refers to an approximately 61 year old female patient. On an unspecified date in 2001, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and lot # not reported). The patient stated that she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) yearly since 2000. No adverse reactions or side effects were reported.; Sender's Comments:  US-009507513-2002USA008825:
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysphagia, Dysphonia, Dyspnoea, Headache
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 17th October 2019, please refer the case US2020176185.).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of vaccine, the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The complains almost a year later she was still experiencing all of the side effects.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176185:same patient
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 17th October 2019, please refer the case US2020176185.).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of vaccine, the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The complains almost a year later she was still experiencing all of the side effects.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176185:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Erythema, Swelling
Clinical narrative: cellulitis on left lower leg; blisters on 2 toes; redness; swelling; This case was reported by a other health professional and described the occurrence of cellulitis of leg in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cellulitis of leg (serious criteria GSK medically significant), blister, erythema and swelling. On an unknown date, the outcome of the cellulitis of leg, blister, erythema and swelling were unknown.   It was unknown if the reporter considered the cellulitis of leg, blister, erythema and swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 76 or 77 years old. The patient experienced cellulitis on left lower leg within 48 hours with blisters on 2 toes and redness and swelling. The reporter consented to follow up. This case had been linked with US2020AMR239619, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR239619:same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Paraesthesia, Vaccination failure
Clinical narrative: suspected Vaccination failure; shingles blister; Shingles blister; tingling down his left leg; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles since the age of 50 years).   On 13th October 2020, the patient received the 2nd dose of Shingrix. On 11th August 2020, the patient received the 1st dose of Shingrix. On 23rd November 2020, 41 days after receiving Shingrix and 104 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and tingling of extremity. On an unknown date, the outcome of the vaccination failure, shingles, blister and tingling of extremity were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and tingling of extremity to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient stated he started to feel the tingling down his left leg and had a shingles blister, the size of a quarter on his left buttock. This case was considered to be a suspected vaccination failure case, as the details laboratory confirmation for shingles was unknown. Consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: flu like symptoms; sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case is linked to case: 2020SA283027 and 2020SA282902 (same reporter).  This case involves a patient (age and gender unspecified) who had flu like symptoms (influenza like illness) and sickness (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms (influenza like illness) and sickness (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that every time patient have had the flu shot after than got sick with flu like symptoms that were as bad as the flu. Then when the flu came around, consumer got the flu anyway. Consumer stopped getting the vaccine and have only had the flu twice in the last 20 plus years.  No laboratory data was provided.  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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Malaise, Peripheral swelling
Clinical narrative: gotten sick; Swollen arm; felt lousy; Initial information received on 14-Oct-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), swollen arm (peripheral swelling) and felt lousy (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included Every time taken the flu shot in the last 30 years and gotten sick, and every time.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), swollen arm (peripheral swelling) and felt lousy (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that over the years job has pressured me to get one, and every few years give into the pressure, telling them all the time what would happen and it never failed. Now, all these years later, you can't make retired nurse wife take a flu shot. Sometimes, remind her of that first time she talked me into taking one 30 years ago.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: sick; Based on information previously received, the case was coded with correct reference ID.  Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age unspecified) who became sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient became sick every time after receiving the vaccine. The patient stopped taking the vaccine and stopped being sick.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: had one and had four of the five common reactions listed; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient with an unknown demographics who had one and had four of the five common reactions listed (adverse event), while he/she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation (second dose).   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 at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed had one and had four of the five common reactions listed (adverse event) (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 will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: they were all home sick with the flu; They were all home sick with the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves five patients who were all home sick with the flu (illness and influenza), while they received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients were all home sick with the flu (illness and influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients received any corrective treatment or not.  The outcome of the events was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to case 2020SA291942 (same reporter)  This case involves a patient (unknown demographic) who was sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (Unknown latency, non-serious event) after the administration of INFLUENZA VACCINE.  Only 20 percent chance it is the right shot for this flu.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time or reporting, the event was recovered from sickness duration was 2 weeks.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: get a flu symptoms reaction every time; 3 days off home sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA296404 (cluster).  This case involves a patient of unknown demographics who got a flu symptoms reaction (Influenza) and 3 days off home sick (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got a flu symptoms reaction every time (Influenza) and 3 days off home sick every time (Illness) (non serious) (latency-unknown) following administration of Influenza vaccine.  It was reported as the patient didn't want flu shot ever again.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic reactions to it; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA297164 (same reporter).  This case involves a patient of (unknown age and gender) who had allergic reactions (hypersensitivity), while received Influenza Vaccine.  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, patient had allergic reactions (hypersensitivity), (latency: unknown) following vaccination.  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: Malaise
Clinical narrative: get sick every time; Initial information received on 19-Oct-2020 and additional received on 23-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involves a patient of an unknown demographic who got sick every time (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, 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, unknown latency, it was reported that patient got sick every time (illness)when took the influenza vaccine. Stopped taking them over 5 years ago have not been sick in a while.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of Illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: had aches the next day; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social Media.  This case involved a patient of an unknown demographic who had aches (pain), after receiving INFLUENZA VACCINE.  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 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, had aches the next day. This was the first time that has happened. they got the senior dose. patient feel it was just their immune system letting was know it was working.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event pain.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: had worst reaction this year to the flu shot; whole week of misery; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (consumer) via social media.  This case involved a patient of an unknown demographic who had worst reaction this year to the flu shot (Vaccination complication) and whole week of misery (Feeling abnormal), after receiving INFLUENZA VACCINE.  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 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, patient had worst reaction this year to the flu shot (Vaccination complication) and whole week of misery (Feeling abnormal) (latency: unknown) following vaccination.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for both events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Mouth breathing, Rash, Respiration abnormal
Clinical narrative: rash on arm where flu shot given; I got sick; could not breathe out of nose, had to breathe out of mouth; Initial and additional information received on 21-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to cases 2020SA298526 and 2020SA298571.  This case involves a patient of an unknown demographic who experienced rash on arm where flu shot given (rash), got sick (illness) and could not breathe out of nose, had to breathe out of mouth (Mouth breathing), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash on arm where flu shot given (rash), got sick (illness) and could not breathe out of nose, had to breathe out of mouth (Mouth breathing) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: i don't get the flu, but 2- 3 days later, I feel like crap, for 2-3 days; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown demographics who did not get the flu, but 2- 3 days later, felt like crap, for 2-3 days (Feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date unknown) via unknown route at unknown site of administration for prophylactic vaccination.  On an unknown date, the patient did not get the flu, but 2- 3 days later, felt like crap, for 2-3 days (feeling abnormal) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for feeling abnormal.  There will be no information available on the batch number for this case. No further information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: it gives me the worse flu; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involves a patient of unknown demographics who reported that it gives me the worse flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route in unknown administration site unknown) for prophylactic vaccination.  On an unknown date, the patient developed worse flu (influenza) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Sickest ever been; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves patient of unknown age and gender, who was sickest ever been (malaise), while he/she received INFLUENZA VACCINE.  The patient's medical treatment(s), concurrent condition and family history were not provided. Patient had INFLUENZA VACCINE as previous vaccine and was sick.  Concomitant medication was not reported.  On an unknown date, the patient received Influenza Vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, patient was sickest ever been (Malaise) following vaccination. (latency: unknown)   case details- It was reported, patient got the flu shot 2 years in a row back in the 80s, sickest ever been both times and haven't gotten one since and had not been sick since then.  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, event outcome was recovered for feeling sick.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: it gave me the flu both times; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer / non-health care professional.  This case involves a patient of unknown demographics who reported that it gave me the flu (influenza) both times, while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route in unknown administration site unknown) for prophylactic vaccination.  The patient developed the flu both times (influenza) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for gave me the flu both times.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involves a patient of unknown demographics, who reported it gave me the flu (influenza), when received Influenza vaccine.  The patient's medical history, medical treatments, vaccinations, condition medications and family history were not provided.  On an unknown date in 1978, the patient received influenza vaccine (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient stated that it gave the flu (influenza) and haven't had one since.  It was reported haven't had one since  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for flu.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got Flu; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (patient) on 26-Oct-2020.  This case involves patient of unknown demographics who got flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date in 2006 (reported: 14 years ago), the patient got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE and was sicker than a dog. Never again.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Dysstasia, Influenza, Malaise
Clinical narrative: Flu; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (age and gender unknown) who experienced flu (Influenza), while received Influenza Vaccine.  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency-about 2 days), the patient got the flu (Influenza) following administration of INFLUENZA VACCINE. It was reported as event was so bad that the patient was sick for a full 2 weeks, couldn't even get out of bed. The patient never allowed anyone to give a shot and never had flu.  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.