chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: shingles, loss of hearing, and other zoster-related conditions; other zoster-related conditions; shingles, loss of hearing, and other zoster-related conditions; Information was been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 18-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. At the time of vaccination, the pt relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the pt to be vaccinated; and the pt's pharmacist relied on the warning label affixed to zoster vaccine live (ZOSTAVAX) and believed that it was effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent to the inoculation, the pt was treated by a physician for shingles, loss of hearing, and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Shoulder injury related to vaccine administration, Weight bearing difficulty
Clinical narrative: she started developing severe soreness in her left shoulder ( consumer referred to it as "Sirva") where she received the injection.; This spontaneous report as received from a 72-year-old female patient concerning herself with high blood pressure, asthma, and drug reactions/allergies to fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D), morphine, "NORAVAX", "nutraflurotin", sulfamethoxazole (+) trimethoprim (BACTRIM), and clarithromycin (MACROBID). The consumer  mentioned that she had a similar issue (severe soreness in her shoulder (referred to it as "Sirva") where she received the injection) with her right arm from a flu shot several years ago. Concomitant therapies included losartan potassium (manufacturer unknown), carvedilol, simvastatin (manufacturer unknown), esomeprazole magnesium(NEXIUM), mometasone furoate(NASONEX), and guaifenesin(MUCINEX).  On 20-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot number, and expiration date were not provided) in the left arm for prophylaxis.         On same date, she started developing severe soreness in her left shoulder (consumer referred to it as "Sirva") where she received the injection. Consumer stated that it started as a sharp shooting pain in her shoulder and had consisted to the point that she "could not lift groceries out of her car". On 15-DEC-2020 (reported as Tuesday), the patient was planning on seeing her a doctor to discuss this ongoing issue with her left shoulder. There were no laboratories/studies performed.   The outcome of injection site pain was reported as not resolved. The causality between the event and the suspect vaccine was not provided.  The reporter considered this event to be a disabling event.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased
Clinical narrative: Appearance of a quarter inch red line extending from the outside of the patient´s arm to the patient´s arm pit; Patient was unable to raise affected arm; This spontaneous report was received from a pharmacist concerning a 66-year-old male patient.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 09-DEC-2020 at 11:30, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, route and frequency were not reported) lot # T032003, expiration date: 08-MAY-2022 for prophylaxis.         On 11-DEC-2020 at 11:30, the patient reported the appearance of a quarter inch red line extending from the outside of the patient´s arm to the patient´s arm pit (erythema) and at the event time, patient was unable to raise affected arm (hypokinesia). The pharmacist had extremely limited information at call time.  At the time of reporting, the outcome of erythema and movement disorder was unknown. The relatedness between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: No other AE; Pt received a dose of Pneumovax 23 today (11-DEC-2020) and the expiration date was 28-NOV-2020.; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 11-DEC-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S006778,expiry date 28-NOV-2020,  1 dosage form for prophylaxis (strength, administration route and frequency were not provided). No additional adverse events or prior temperature excursions were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: s006778; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: headache; stomachache; slight fever; fairly significant muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2020239759).   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th November 2020, 2 days after receiving Shingrix, the patient experienced fever (serious criteria other: serious per reporter). On an unknown date, the patient experienced muscle pain (serious criteria other: serious per reporter), headache (serious criteria other: serious per reporter) and stomach pain (serious criteria other: serious per reporter). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, headache, stomach pain and fever were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, stomach pain and fever to be related to Shingrix.  Additional details were reported as follows: The vaccine was given in his upper left arm. The patient experienced fairly significant muscle pain, headache, stomachache and a slight fever. The muscle pain and headache lasted for one day, his stomachache never caused him to throw up and the slight fever started on Monday after injection.  He stated these all lasted up until a day before date of reporting.  The symptoms started to go away on Monday and were reducing each day.  On the day of reporting patient stated that this was the 1st day he was feeling well.  He also experienced the same reactions from the 1st dose of the Shingrix vaccine, but they were not as serious and only lasted one day.  His doctor was aware of the reactions from the 1st dose, but not the 2nd.  The reporter did not consent to follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Abortion threatened, Exposure during pregnancy
Clinical narrative: rushed to the hospital / almost lost my unborn baby; When I was pregnant I was given the tdap vaccine; This prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Tdap Vaccine at an unknown time during the pregnancy. On an unknown date, 5 hrs after receiving Tdap Vaccine, the patient experienced hospitalization (serious criteria hospitalization) and vaccine exposure during pregnancy. On an unknown date, the outcome of the hospitalization and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.   It was unknown if the reporter considered the hospitalization to be related to Tdap Vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. When patient was pregnant was given the tdap vaccine and 5 hours later was rushed to the hospital. The stated she patient almost lost her unborn baby. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury, Pruritus, Rash, Scar
Clinical narrative: Serious reaction / Itching all over my arm; Serious reaction / Scarred all over my arm; Serious reaction / Affected the Nerve in my arm; Serious reaction / Rash; This case was reported by a other health professional via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus (serious criteria other: Serious per reporter), scar (serious criteria other: Serious per reporter), nerve injury (serious criteria other: Serious per reporter) and rash (serious criteria other: Serious per reporter). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pruritus and scar were not recovered/not resolved and the outcome of the nerve injury and rash were unknown.   It was unknown if the reporter considered the pruritus, scar, nerve injury and rash to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient experienced serious reaction with this injection which was still with the pateint over a year later. The patient still had itching all over arm that was injected and the patient now scarred all over arm. The patient gotten several doses of steroids trying to remedy and also tried and antibiotic neck injections to see of it would remedy my symptoms no avail. The patient was healthcare worker and felt like look like a Junkie with all these open itched out scars all over arm. The pateint stated it had affected his/her profession. It affected the nerve in the arm and was creating this rash.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Had cellulitis; This case was reported by a other health professional via other manufacturer and described the occurrence of cellulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and rheumatoid arthritis. Concomitant products included methotrexate.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Previously, the patient had shingles vaccine and experienced cellulitis. The patient was felt terrified and scared with rheumatoid arthritis.  The patient was receiving Xeljanz XR (11mg) for rheumatoid arthritis from 31st October 2020 and the therapy was ongoing.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Cold sweat, Fatigue, Headache
Clinical narrative: could not move; chills; lower back pain; spasm / cramping; can't sit twist or bend without severe pain; severe pain; severe headaches; tiredness; cold sweats; This case was reported by a consumer via patient support programs and described the occurrence of paralysis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat. On an unknown date, the outcome of the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat were unknown.   The reporter considered the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat to be related to Shingrix.  Additional details were provided as follows: On 30th September 2020, the patient received 1st dose of Shingrix.  The patient had side effects from Shingrix vaccine. The patient reported sever lower back pain, spasms, cramping, can't sit twist or bend without severe pain, severe headaches, chills, tiredness.  The patient woke up with cold sweats and could not move.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle spasms, Pain, Paralysis
Clinical narrative: could not move; chills; lower back pain; spasm / cramping; can't sit twist or bend without severe pain; severe pain; severe headaches; tiredness; cold sweats; This case was reported by a consumer via patient support programs and described the occurrence of paralysis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat. On an unknown date, the outcome of the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat were unknown.   The reporter considered the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat to be related to Shingrix.  Additional details were provided as follows: On 30th September 2020, the patient received 1st dose of Shingrix.  The patient had side effects from Shingrix vaccine. The patient reported sever lower back pain, spasms, cramping, can't sit twist or bend without severe pain, severe headaches, chills, tiredness.  The patient woke up with cold sweats and could not move.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died; This case was reported by a consumer via interactive digital media and described the occurrence of death in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 4 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient had died from Flu vaccine after 4 days of receiving vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR240811:same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; breast cancer; outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), breast cancer (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, breast cancer and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, breast cancer and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's daughter. The age at vaccination was not reported.  The patient received shingles shot, possibly Shingrix and experienced outbreak of shingles. The reporter mentioned that, the patient had breast cancer. It was unknown if the breast cancer was prior or post vaccination. This case was considered as suspected vaccination failure as details regarding number of doses, time to onset of target disease and laboratory confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; fairly severe case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mesothelioma.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported the patient received the series of Shingrix in the proper timeframe and had developed a fairly severe case of shingles. As timeframe between the dose and the event was unknwon. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were not reported.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Influenza, Malaise
Clinical narrative: Patient didn't get the flu until recieved the shot; Patient got very ill after flu shot; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA346017, 2020SA346068, 2020SA297294, 2020SA297267 and 2020SA273251 (same reporter).   This case involves patient[ age and gender unspecified] who didn't get the flu until received the shot (Influenza) and got very ill after flu shot (Illness), while patient received vaccines PNEUMOCOCCAL VACCINE [Pneumonia shot] and 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 date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and got very ill after flu shot (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratory data 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 on the batch number for this case.  Follow up information was received on 10-Nov-2020, from a consumer.    New event (ill), suspect PNEUMOCOCCAL shot was updated in field and narrative.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Product administered at inappropriate site
Clinical narrative: patient can not use arm much; They put it in the wrong place; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic)who received INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown and reportedly inappropriate administration site for prophylactic vaccination on an unknown date (product administered at inappropriate site) and cannot use arm much after that (Injected limb mobility decreased).   Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient cannot received INFLUENZA VACCINE via reportedly inappropriate administration site (product administered at inappropriate site) and cannot use arm much after that (Injected limb mobility decreased) (unknown latency). Patient mentioned going to see an orthopedic surgeon. . It was a case of an actual medication error due to vaccine administered at inappropriate site (latency same day).  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  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.  At the time of reporting, the outcome of hypokinesia event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, SARS-CoV-2 test negative
Clinical narrative: patient gotten the flu; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a 60 years old patient gender not reported who gotten the flu (influenza), while he/she 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) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, a month ago patient was told that the patient was around someone who had Coronavirus disease (COVID) due to which the patient had to do mandatory two week quarantine and had to do test. Tested negative and never had any symptoms.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown, at the time of reporting.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu two years in a row while taking the shot.; Initial information received on 15-Nov-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer.   This case involves a patient who got the flu two years in a row while taking the shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu two years in a row while taking the shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: My mother did and she was terribly sick; Initial information was received on 15-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's daughter) via social media.  This case is linked to case 2020SA324588 (same reporter).  This case involves a 93-year-old female patient who was terribly sick (illness), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was terribly sick (illness). She never had a shot again.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: he came down instantly with the flu,both times; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient's wife) via social media and transmitted to Sanofi on 15-Nov-2020.  This case involved male patient of an unknown age for whom it was reported that he came down instantly with the flu, both times (Influenza), while he received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, reporter watched her husband a few years ago get the dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccinations and both the times patient came down instantly with the flu (Influenza).  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for the event Influenza.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: blasted flu; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) on 15-Nov-2020.  This case involved an elderly patient of an unknown gender who blasted in flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history included Streptococcal sore throat on an unknown date in 1990.  Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in the arm not otherwise specified for prophylactic vaccination.  On an unknown date (unknown latency), the patient was blasted in flu (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was resolved on an unknown date after 3 to 4 weeks.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: worst cold; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a social media consumer (patient).  This case involves patient (unknown demographics) who experienced worst cold (nasopharyngitis), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious worst cold (nasopharyngitis), two weeks following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: every time gets a flu shot, get sick; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (parent of patient) via Social media on 17-Nov-2020.  This case involved an adult male patient of an unknown age who every time gets a flu shot, got sick (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that every time patient got a flu shot, patient got sick (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Blood test, Dyspnoea, Erythema, Flushing
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Pulse abnormal, Tunnel vision
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Anaphylactic reaction, Aspartate aminotransferase increased, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Flushing, Full blood count normal
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypokalaemia, Intensive care, Metabolic function test abnormal, Rash erythematous, Thyroxine free normal
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hyperventilation, Respiratory rate increased
Clinical narrative: Anaphylactic reaction onset 10 minutes after injection.  Primary symptoms of diffuse erythematous rash, dyspnea, and dizziness. Patient treated with Diphenhydramine, followed by 0.3mg epinephrine IM w/ improvement of symptoms.  Symptoms recurred/worsened and second dose of epi was given, followed by epinephrine drip.  She has recurrence of symptoms with severe dyspnea and diffuse erythema/flushing within 60 seconds of discontinuation of epinephrine.  Patient remains on epi drip and is currently admitted to Critical Care Unit for ongoing treatment and observation.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: My mother got the flu immediately after getting the flu shot; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's child) via social media.  This case involves a female patient of unknown age who got the flu immediately after getting the flu shot (influenza), while patient was treated with influenza vaccine.  Medical history, 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 an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, reporter's mother got the flu immediately after getting the flu shot (influenza).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient are mistaken the shot had made patient ill many times, doctor's said cant help you; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.    This case involves a female patient of unknown age who was mistaken the shot had made patient ill many times, doctor's said can't help you (illness), while patient was treated with influenza vaccine.  Medical history, 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 an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was mistaken the shot had made patient ill many times, doctor's said can't help you (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Patient experienced aching  and rash the next morning (some the size of marbles).  Patient felt itchy all over especially in the upper inner thighs.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: gotten sick as a dog; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who gotten sick as a dog (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious gotten sick as a dog (illness ) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional .  This case involves patient (unknown demographics) who got the sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the sick (illness) for 4-weeks following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 58.0
Sex: M
Vaccine: FLUR4, PNC13
Symptoms: Syncope
Clinical narrative: Several minutes after vaccination, patient experienced syncope.   Patient laid down and recovered on his own.  No intervention needed and patient was able to drive home.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu every time; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction of Flu.  The patient's medical history, past 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) (14 days) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who experienced got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction of Flu.  The patient's medical history, past 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) (14 days) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea, Neuropathy peripheral, Rash
Clinical narrative: Peripheral neuropathy, rash, difficultly breathing, weakness, dizziness
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: broke in hives; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced broke in hives (urticaria), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious broke in hives (urticaria) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for urticaria.  There will be no information available on the batch number for this case.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  Developed chills, nausea and vomiting beginning at 2 AM the night after receiving the vaccine. Potential fever as well (I don't have a thermometer to check). Symptoms have lasted over 3 hours thus far, still continuing.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dry mouth, Fatigue
Clinical narrative: By 8PM I was feeling extremely tired, went to bed. Woke up at 11:30PM with a fever was cold and shivering, Woke up again at 1:30AM and my mouth was completely dry and my right hand was cramped and could not move. These all my Sjogren's symptoms but more severe than I had ever felt them before. At 4:30AM my fever was 99.3 and I still had all the aforementioned symptoms. I was extremely tired and felt nauseous. By 8AM I had stomach cramping followed by diarrhea. My stomach was too upset to eat at all the entire day of the 14th. I had off and on stomach pains with diarrhea. I was very tired and could not stay awake for very long. My temperature went back down to my normal 97.2 by 10 AM. My right hand is still very hard to move and painful today on the 16TH. My stomach still feels queasy. I have not had a fever again, but still feel horrible. I have not gone to my primary doctor because there is nothing he can do to help.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Malaise, Mobility decreased, Muscle spasms, Nausea
Clinical narrative: By 8PM I was feeling extremely tired, went to bed. Woke up at 11:30PM with a fever was cold and shivering, Woke up again at 1:30AM and my mouth was completely dry and my right hand was cramped and could not move. These all my Sjogren's symptoms but more severe than I had ever felt them before. At 4:30AM my fever was 99.3 and I still had all the aforementioned symptoms. I was extremely tired and felt nauseous. By 8AM I had stomach cramping followed by diarrhea. My stomach was too upset to eat at all the entire day of the 14th. I had off and on stomach pains with diarrhea. I was very tired and could not stay awake for very long. My temperature went back down to my normal 97.2 by 10 AM. My right hand is still very hard to move and painful today on the 16TH. My stomach still feels queasy. I have not had a fever again, but still feel horrible. I have not gone to my primary doctor because there is nothing he can do to help.