chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Burns second degree, Electromyogram, Fall, Gait disturbance, Paralysis
Clinical narrative: falling; paralyzed; my gait was extremely abnormal; L4-S1 fusion plus a spinal stimulator which blistered and burnt my back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: BURNS SECOND DEGREE (non-serious) with onset 2023, outcome "unknown", described as "L4-S1 fusion plus a spinal stimulator which blistered and burnt my back"; FALL (hospitalization) with onset 2023, outcome "unknown", described as "falling"; GAIT DISTURBANCE (non-serious) with onset 2023, outcome "unknown", described as "my gait was extremely abnormal"; PARALYSIS (medically significant) with onset 2023, outcome "unknown", described as "paralyzed". The patient underwent the following laboratory tests and procedures: Electromyogram: Unknown results, notes: EMG studies came back and I had to have an L4-S1 fusion plus a spinal stimulator which blistered and burnt my back.  Clinical course: Patient have never seen a Pfizer rep come to office and speak with patient. After having the booster shot for COVID 19, less than a week later, Patient started falling and then graduated from walker to wheelchair to hospital. Patient was paralyzed. About 6 months later gait was extremely abnormal. EMG studies came back and patient had to have an L4-S1 fusion plus a spinal stimulator which blistered and burnt back. All because of that vaccine patient had to have as a health care professional. Patient ended up with COVID anyway.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events  FALL , PARALYSIS  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300321159 same patient, different events after different doses of the vaccine;
Sex: U
Vaccine: UNK
Symptoms: Cardiac failure
Clinical narrative: heart failure; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: forced me to take my ONLY flu shot EVER in 1990 right there at that facility/never have I been so sick as I was directly after; Initial information was received on 29-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Influenza immunisation. The information on batch number was requested.  On an unknown date the patient reported that forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (forced me to take my ONLY flu shot EVER in 1990 right there at that facility/never have I been so sick as I was directly after).  At time of reporting, the outcome was Unknown for the event forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: she had flu shot and got sick from it; Initial information was received on 03-Oct-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 46 years old female patient who experienced she had flu shot and got sick from it after receiving influenza vaccine and treprostinil sodium [Tyvaso].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included alprazolam (xanax); vitamin d3; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (trelegy ellipta); oxygen; erenumab aooe (aimovig); omeprazole (Prilosec); montelukast sodium (singulair); naratriptan hydrochloride (naratriptan); rosuvastatin calcium (crestor); metoprolol succinate (toprol); amlodipine besilate (norvasc); and aspirin [acetylsalicylic acid].  On an unknown date, the patient started taking treprostinil sodium  (Inhalation powder dry) at a dose of 48 ug 4 times a day (QID) via inhalational route (batch number, expiry date, strength: unknown) for Secondary pulmonary arterial hypertension.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Influenza immunization. The information on the batch number will not be available.  On 09-Sep-2023 the patient had flu shot and got sick from it (illness)  (unknown latency) following the first and last dose intake of treprostinil sodium and (unknown latency) following the administration of influenza vaccine.  Action taken with treprostinil sodium (Tyvaso) was unknown and with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria: Hospitalization for event illness. The patient was hospitalized on the same day this event occurred and was discharged on 14-Sep-2023 (Duration: 5 days).; Sender's Comments: Sanofi Company Comment dated 10-Oct-2023: This case involves a 46 years old female patient who experienced she had flu shot and got sick from it after receiving influenza vaccine and treprostinil sodium [Tyvaso].  The patient had ongoing Pulmonary arterial hypertension. Further information on allergy history, family history, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the limited reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Coma, Confusional state, Depressed mood, Dizziness
Clinical narrative: spent 3 days, being comatose; having suicidal thoughts; confused; sad, depressed; weak; tired, fatigued; dizzy; Initial information received on 01-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date, formulation, dosage - not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  In 2023, (latency- few days approximately), the patient spent 3 days, being comatose (coma), having suicidal thoughts (suicidal ideation), confused (confusional state), sad, depressed (depressed mood), weak (asthenia) , tired, fatigued (fatigue) and dizzy (dizziness) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days, being comatose, confused, tired, sad, depressed, having suicidal thoughts, weak, fatigued and dizzy.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: medically significant for the events coma and suicidal ideation.; Sender's Comments: Sanofi company comment dated 07-OCT-2023: This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Sex: U
Vaccine: FLU4
Symptoms: Fatigue, Suicidal ideation
Clinical narrative: spent 3 days, being comatose; having suicidal thoughts; confused; sad, depressed; weak; tired, fatigued; dizzy; Initial information received on 01-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date, formulation, dosage - not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  In 2023, (latency- few days approximately), the patient spent 3 days, being comatose (coma), having suicidal thoughts (suicidal ideation), confused (confusional state), sad, depressed (depressed mood), weak (asthenia) , tired, fatigued (fatigue) and dizzy (dizziness) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days, being comatose, confused, tired, sad, depressed, having suicidal thoughts, weak, fatigued and dizzy.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: medically significant for the events coma and suicidal ideation.; Sender's Comments: Sanofi company comment dated 07-OCT-2023: This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered this to a patient one day shy of their 4th birthday with no adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown gender and 3-year-old (one day before of their 4th birthday) patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization) one day shy / before of their 4th birthday with no adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, reporter queried if there is a grace period for Quadracel to be given? Reporter administered this to a patient one day shy of their 4th birthday. Reporter cannot find anything other than the age is from 4-7 years. Forwarding this information out of an abundance of caution. As you can see below, an office administered a dose of Daptacel one day before the recommended administration at 4-6y for the 4th DTaP and 5th poliovirus vaccine dose. Since Daptacel is approved for use in children 6mo through 6 years, they were not sure whether this qualified as a incident, but after speaking to one of the Directors, they thought it was best to be report, just in case. Reporter was able to provide the requested information, including links to CDC's and state's guidance on dose timing for what is considered a valid dose administration.   It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient was administered with expired TENIVAC with no reported adverse event; Initial information received on 21-Jan-2022 (Non-case) and follow up on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 62 years old female patient where patient was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U6831AA/U7189AA and expiration date- 30-Sep-2023) via intramuscular route in the right arm (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.   Additional information was received on 05-Oct-2023 from Other healthcare professional: Case was updated from Non case to valid case.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023 no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA301830.  This case involves 11 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA B VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Immunisation; POLIO VACCINE (POLIO VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 29-Sep-2023, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for Immunisation.  On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered.   Action taken: not applicable.  Outcome: Unknown   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 the 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.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pentacel was given to a five-year-old with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient for whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was given to a five-year-old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 29-Sep-2023, the five-year-old patient received a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ858AA, expiry date- 29-MAR-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, Caller is asking What is recommendation for this? Do she need further vaccination or would this be her completed dose. This would have been patient last dose.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error, Pyrexia
Clinical narrative: high temperature of 72.7F out of range for 7 weeks with no adverse event; patients were administered post excursion with no adverse event; Initial information was received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases US-SA-2023SA304864 and 2023SA305537.  This case involves a 27 years old male patient who experienced high temperature of 72.7f out of range for 7 weeks and influenza quadrival A-B vaccine [FLUZONE QIV] were administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received a 0.5 ml, once dose of suspect influenza quadrival A-B vaccine (Suspension for injection)  (lot: UT8055JA, expiry date: 30-Jun-2024 , strength: standard) via intramuscular route in unknown administration site for Immunisation.  On an unknown date, high temperature of 72.7f out of range for 7 weeks with no adverse event (product storage error) (unknown Latency)and patients were administered post excursion with no adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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 the Directive and Regulatory Authority 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.
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received the FLUZONE HD QIV post transit duration excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA303907.  This case involves a 87 years old male patient, received the FLUZONE HD QIV post transit duration excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.7 ml dose of suspect Influenza quadrival A-B high dose HV vaccine lot U8138DA via intramuscular route in the deltoid nos for prophylactic vaccination (strength: unknown), received the FLUZONE HD QIV post transit duration excursion with no reported adverse event(poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered   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 the Directive and Regulatory Authority 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.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: injection site reaction as it occurs away from the site but I develop redness about 6-7 inches on the front of my arm; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 77 years old male patient who had injection site reaction as it occurs away from the site but i develop redness about 6-7 inches on the front of my arm after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Immunisation.  On an unknown date, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for influenza (strength, formulation, expiry date: unknown).  On 02-Oct-2023 the patient had injection site reaction as it occurs away from the site but i develop redness about 6-7 inches on the front of my arm (injection site erythema) (unknown latency).  Reportedly, got the shot on Monday and did not develop this redness until 2 days after and don't have any fever, hives, or headache and  would think if  had a reaction to the vaccine that  would have it rather soon after the injection." Consumer stated he may be allergic to the thimerosal use in the multi-dose vials. Caller states this happened last year when he got the flu shot but it was not Fluzone HD it was Fluad Quadrivalent. He states "the redness was not getting worse and maybe a little better and last year the redness lasted a number of weeks until it went away." Consumer states "it may be a little warm but it is not swollen.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (injection site erythema).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event injection site erythema.
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was received on 30-Sep-2023 from other non-health professional (consumer) via Company (reference number SEQW23-02831) with additional information received on 03-Oct-2023 (being processed together) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 24-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) for flu vaccination. The batch number was not reported.  On an unspecified date in Sep-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient felt pain.  The outcome of the event of pain was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202304402 (the same reporter).  Company comment: A female patient of unreported age was vaccinated with Fluad Quadrivalent. In the following six days, patient complained of pain. Patient's medical history and concomitant medications were not reported. Due to plausible temporal relationship, causal role of the suspect vaccine is assessed as possibly related for the reported event.; Sender's Comments: A female patient of unreported age was vaccinated with Fluad Quadrivalent. In the following six days, patient complained of pain. Patient's medical history and concomitant medications were not reported. Due to plausible temporal relationship, causal role of the suspect vaccine is assessed as possibly related for the reported event.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Arteriosclerosis, Computerised tomogram abnormal, Deep vein thrombosis, Goitre
Clinical narrative: Noticed numbness in left calf and had spasms during the night. The next day, [12/22/22] went to Dr.  and was sent to hospital [12/22/22] for an ultrasound to r/o thrombosis. Thrombosis was confirmed and followed with further treatment and work-up at ER [12/22/2]. Additional imaging and laboratory tests were completed [12/22/22]. Discharge diagnosis was Acute deep vein thrombosis (DVT) of tibial vein of left lower extremity. Received loading doses of Eliquis and sent home with Rx for Eliquis with instructions to follow-up with Dr. (vascular surgeon) @ Medical Offices for a 6 month Rx of Eliquis (2 week Rx provided by ER). - in the interim on 12/23/22 with Dr. to receive Rx for additional Eliquis. Saw Dr. on 12/28/22 and was advised that the blood clot was in the best location if one was to have a blood clot and that it should resolve with the Eliquis and no follow-up was necessary. No tests were ordered. Returned with questions for Dr. on 01/11/2023 and was advised there was no need for the anxiety about ther blood clot even though I had not had one before. Dr ordered another ultrasound for 04/21/2023 at Imaging. On 04/27/2023 Eliquis was discontinued by Dr. since the ultrasound showed the blood clot had resolved. Aspirin 81gr. once daily was advised to be taken as a prophylactic measure.   On 9/26/23 after filling out the appropriate form for a Shingles Shot @ Drug Store, Pharmacist inquired about the reaction to the flu vaccine in 2021 and then consulted with 2 of his colleagues. They decided a note from physician was needed in order to get the Shingles vaccine. Called clinic the next day and received several from the MA and a nurse who related that Dr. said I could not have Shingles, RSV or the new Covid shot; info had been relayed incorrectly to the doctor so an in-person appt with CRNP on 10/05/2023. Mr., CRNP confirmed "NO COVID shot could be recommended".  Nurse called later in the day to reiterate not to have any of the vaccines mentioned.   Also had follow-up related to other findings reported on imaging studies in ER including CT Scan for enlarged thyroid (Ct scan done on /2023 confirming enlarged thyroid but no prior imaging was available to compare so follow-up scan was suggested for the future), appt with urologist for suspicious area on kidney which was evaluated with CT scan and found to be insignificant. Also followed up with a cardiologist Dr. - 3/1/23 Telephone appointment  who ordered a nuclear stress test  for 3/15/23 which confirmed mild atherosclerosis.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Imaging procedure, Laboratory test, Muscle spasms, Scan myocardial perfusion abnormal
Clinical narrative: Noticed numbness in left calf and had spasms during the night. The next day, [12/22/22] went to Dr.  and was sent to hospital [12/22/22] for an ultrasound to r/o thrombosis. Thrombosis was confirmed and followed with further treatment and work-up at ER [12/22/2]. Additional imaging and laboratory tests were completed [12/22/22]. Discharge diagnosis was Acute deep vein thrombosis (DVT) of tibial vein of left lower extremity. Received loading doses of Eliquis and sent home with Rx for Eliquis with instructions to follow-up with Dr. (vascular surgeon) @ Medical Offices for a 6 month Rx of Eliquis (2 week Rx provided by ER). - in the interim on 12/23/22 with Dr. to receive Rx for additional Eliquis. Saw Dr. on 12/28/22 and was advised that the blood clot was in the best location if one was to have a blood clot and that it should resolve with the Eliquis and no follow-up was necessary. No tests were ordered. Returned with questions for Dr. on 01/11/2023 and was advised there was no need for the anxiety about ther blood clot even though I had not had one before. Dr ordered another ultrasound for 04/21/2023 at Imaging. On 04/27/2023 Eliquis was discontinued by Dr. since the ultrasound showed the blood clot had resolved. Aspirin 81gr. once daily was advised to be taken as a prophylactic measure.   On 9/26/23 after filling out the appropriate form for a Shingles Shot @ Drug Store, Pharmacist inquired about the reaction to the flu vaccine in 2021 and then consulted with 2 of his colleagues. They decided a note from physician was needed in order to get the Shingles vaccine. Called clinic the next day and received several from the MA and a nurse who related that Dr. said I could not have Shingles, RSV or the new Covid shot; info had been relayed incorrectly to the doctor so an in-person appt with CRNP on 10/05/2023. Mr., CRNP confirmed "NO COVID shot could be recommended".  Nurse called later in the day to reiterate not to have any of the vaccines mentioned.   Also had follow-up related to other findings reported on imaging studies in ER including CT Scan for enlarged thyroid (Ct scan done on /2023 confirming enlarged thyroid but no prior imaging was available to compare so follow-up scan was suggested for the future), appt with urologist for suspicious area on kidney which was evaluated with CT scan and found to be insignificant. Also followed up with a cardiologist Dr. - 3/1/23 Telephone appointment  who ordered a nuclear stress test  for 3/15/23 which confirmed mild atherosclerosis.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Noticed numbness in left calf and had spasms during the night. The next day, [12/22/22] went to Dr.  and was sent to hospital [12/22/22] for an ultrasound to r/o thrombosis. Thrombosis was confirmed and followed with further treatment and work-up at ER [12/22/2]. Additional imaging and laboratory tests were completed [12/22/22]. Discharge diagnosis was Acute deep vein thrombosis (DVT) of tibial vein of left lower extremity. Received loading doses of Eliquis and sent home with Rx for Eliquis with instructions to follow-up with Dr. (vascular surgeon) @ Medical Offices for a 6 month Rx of Eliquis (2 week Rx provided by ER). - in the interim on 12/23/22 with Dr. to receive Rx for additional Eliquis. Saw Dr. on 12/28/22 and was advised that the blood clot was in the best location if one was to have a blood clot and that it should resolve with the Eliquis and no follow-up was necessary. No tests were ordered. Returned with questions for Dr. on 01/11/2023 and was advised there was no need for the anxiety about ther blood clot even though I had not had one before. Dr ordered another ultrasound for 04/21/2023 at Imaging. On 04/27/2023 Eliquis was discontinued by Dr. since the ultrasound showed the blood clot had resolved. Aspirin 81gr. once daily was advised to be taken as a prophylactic measure.   On 9/26/23 after filling out the appropriate form for a Shingles Shot @ Drug Store, Pharmacist inquired about the reaction to the flu vaccine in 2021 and then consulted with 2 of his colleagues. They decided a note from physician was needed in order to get the Shingles vaccine. Called clinic the next day and received several from the MA and a nurse who related that Dr. said I could not have Shingles, RSV or the new Covid shot; info had been relayed incorrectly to the doctor so an in-person appt with CRNP on 10/05/2023. Mr., CRNP confirmed "NO COVID shot could be recommended".  Nurse called later in the day to reiterate not to have any of the vaccines mentioned.   Also had follow-up related to other findings reported on imaging studies in ER including CT Scan for enlarged thyroid (Ct scan done on /2023 confirming enlarged thyroid but no prior imaging was available to compare so follow-up scan was suggested for the future), appt with urologist for suspicious area on kidney which was evaluated with CT scan and found to be insignificant. Also followed up with a cardiologist Dr. - 3/1/23 Telephone appointment  who ordered a nuclear stress test  for 3/15/23 which confirmed mild atherosclerosis.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Myalgia, Urticaria
Clinical narrative: The day of and after there was a headache and muscle aches.  Then around 0200 on 9/23 I woke up covered in hives, I took a benadryl and they did not go away. I tried cold showers and ice and they did not go away.   I went to urgent care on 9/25 and was given IM shots of steroids and benadryl to treat the hives.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: a lump at the injection site; This spontaneous report was received from a dermatologist via a company representative referring to a 29-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis by an obstetrics and gynecology (OBGYN) heath care professional (HCP) (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, after the injection, the patient experienced a lump at the injection site (vaccination site mass). The patient had sought medical attention. The OBGYN HCP recommended for patient to see the dermatologist. The outcome of the event was unknown.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Choking, Cyanosis, Immediate post-injection reaction, Oral administration complication, Wrong technique in product usage process
Clinical narrative: Choked on vaccine; turned blue; This serious case was reported by a nurse via call center representative and described the occurrence of choking in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis.   Concurrent medical conditions included irritability and crying.   On 14-JUL-2023, the patient received Rotarix liquid formulation (oral). On 14-JUL-2023, immediately after receiving Rotarix liquid formulation, the patient experienced choking (Verbatim: Choked on vaccine) (serious criteria GSK medically significant) and cyanosis (Verbatim: turned blue).  The outcome of the choking was resolved and the outcome of the cyanosis was not reported.   It was unknown if the reporter considered the choking and cyanosis to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the choking and cyanosis to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 04-OCT-2023 The reporter was a Certified Nurse Aide. Prior to administration the patient was fussy and crying and during entire administration. The reporter reported that patient choked during administration of Rotarix (liq) and turned blue. The patient started choking during administration, which was done while patient was lying down on table. The reporter reported that babies did not like it. The patient recovered after patting on back and sitting up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The case had been linked to the US2023136407 case, reported by same reporter.; Sender's Comments:  US-GSK-US2023136407:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received dose one of Shingrix in 2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received dose one of Shingrix in 2019). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 04-OCT-2023 The pharmacist reported the patient received dose one of Shingrix. The reporter did not provide patient demographics, lot number, and expiration date.  No exact date of administration of dose one provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Consent to follow-up granted.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever 100.3 less than 24 hours later; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later) in a 52-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 milliliter. On 05-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2023, Body temperature: 100.3 less than 24 hours later.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches) and CHILLS (chills) in a 44-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 3031279) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 31-Aug-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) .5 milliliter. On 01-Sep-2023, the patient experienced PAIN (Body aches) and CHILLS (chills). On 01-Sep-2023, PAIN (Body aches) and CHILLS (chills) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Patient experienced symptom for 24 hours.  It was unknown if the patient experienced any additional symptoms/events. The patient had no concomitant disease, or risk factor. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: tender to the touch; Sore arm at site of injection; feeling tired and rundown; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown) in a 43-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea. Previously administered products included for Product used for unknown indication: Flu shot on 04-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 05-Oct-2023, the patient experienced TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown). At the time of the report, TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Symptoms developed within 16 hours of vaccination. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment information was reported.