chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site mass
Clinical narrative: About three weeks later I developed 5 cm lump under the arm in which I received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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; Covid-19 vaccine (Booster; Unknown manufacturer). The following information was reported: VACCINATION SITE MASS (non-serious) with onset Oct2022, outcome "unknown", described as "About three weeks later I developed 5 cm lump under the arm in which I received the vaccine". The event "about three weeks later i developed 5 cm lump under the arm in which i received the vaccine" required physician office visit.  Additional information: The patient received the Pfizer second booster on 18Sep2022. About three weeks later the patient developed 5 cm lump under the arm in which the patient received the vaccine. Since then the patient's family physician authorized an ultrasound and a consultation with a surgeon. The surgeon said that it appears the patient had an overreaction to the vaccine. The surgeon said to return in 6 months if the lump hasn't resolved itself and they would do further tests. The patient was questioning if these procedures at all covered if the lump was caused by the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Inhibitory drug interaction
Clinical narrative: I received Botox cosmetic 3 months ago. After 4 attempts every 3 weeks, the doctor said it wasn't working because of the Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; botulinum toxin type a (BOTOX), since Oct2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INHIBITORY DRUG INTERACTION (non-serious), outcome "unknown", described as "I received Botox cosmetic 3 months ago. After 4 attempts every 3 weeks, the doctor said it wasn't working because of the Pfizer vaccines". The action taken for botulinum toxin type a was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: TINNITUS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Bedridden, Fatigue, Feeling abnormal
Clinical narrative: just a little tired; didn't feel good; I was in bed for a couple days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for Covid-19 vaccination; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 vaccination. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "just a little tired"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "didn't feel good"; BEDRIDDEN (non-serious), outcome "recovered", described as "I was in bed for a couple days".  Additional information included Patient called trying to reach Drug safety unit because received two surveys one was for Premarin and another one was for Pantoprazole. Patient explained "I got the Pfizer booster shot the second one not the first one the second one and like a day and a half later I broke out in a sweat and I passed out and that's how I broke my ankle. So I don't know why I got it for these other two things cause like I said I use to take Protonix and Protonix was perfect and I cant afford it now so I have to take something else and Premarin I've been taking since I've been in my 40's" Patient also stated "The first booster that I got it I was just a little tired and I didn't feel good and I was in bed for a couple days but this one reacted different. That's all I can tell you. So I have nothing to feel out because I am okay now. Note: The form of the Premarin was not provided on the phone call but retrieved from the system  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: her allergies and itching has been worse; hives; itching; allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. 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: HYPERSENSITIVITY (non-serious) with onset 18Oct2022, outcome "not recovered", described as "allergies"; URTICARIA (non-serious) with onset 18Oct2022, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset 18Oct2022, outcome "not recovered", described as "itching"; CONDITION AGGRAVATED (non-serious) with onset Dec2022, outcome "not recovered", described as "her allergies and itching has been worse". Therapeutic measures were taken as a result of urticaria, pruritus, hypersensitivity.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Complement factor, DNA antibody, Histone antibody
Clinical narrative: SLE development and COVID-19 vaccination; This is a literature report for the following literature source(s):   A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "SLE development and COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive; Positive; Antinuclear antibody positive: Positive; Complement factor: Unknown result, notes: Hypocomplementemia; DNA antibody: Positive; Histone antibody: Positive. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: M
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: SLE development and COVID-19 vaccination; This is a literature report for the following literature source(s):   A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "SLE development and COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive; Positive; Antinuclear antibody positive: Positive; Complement factor: Unknown result, notes: Hypocomplementemia; DNA antibody: Positive; Histone antibody: Positive. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: F
Vaccine: FLUX
Symptoms: Malaise, Weight decreased
Clinical narrative: feeling ill; 20 pounds decrease from last fill; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via specialty pharmacy.  This case involves an unknown age female patient who experienced feeling ill and 20 pounds decrease from last fill while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site for influenza immunisation.  On an unknown date the patient developed a non-serious feeling ill (malaise) and 20 pounds decrease from last fill (weight decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, pt reported missing over a month of medication due to feeling ill after taking her flu shot. pt also reported a 20 pounds decrease from last fill in october. no indication of md being currently aware and no further information provided.  Relevant laboratory test results included: Weight - On an unknown date:  [20 pounds decrease from last fill].  Action taken with INFLUENZA VACCINE 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 both the events.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: got the flu and it went into pneumonia; got the flu and it went into pneumonia; Initial information regarding an unsolicited valid social media serious case received from a consumer/non-health care professional on 23-Dec-2022.  This case involves female patient of unknown age who got the flu and it went into pneumonia after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA521397(related husband case).   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at unknown (formulation, strength, dose, expiry date, lot number, route, administration site) for prophylactic vaccination.  On an unknown date, the patient developed a serious got the flu and it went into pneumonia (pneumonia, influenza) at unknown latency following the administration of Influenza Vaccine.  Action taken: Not Applicable.  It was not reported if the patient received a corrective treatment for both the events.   At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria : Medically significant for pneumonia; Sender's Comments: Sanofi Company Comment Dated 23-Dec-2022: This case involves female patient of unknown age who got the flu, and it went into pneumonia after receiving vaccine Influenza Vaccine. The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: got flu shot but doesn't protect against type A bummer with no reported adverse event; Initial information regarding an unsolicited valid social media serious case received via consumer/non-Health Care Professional on 26-Dec-2022.  This case involves patient of unknown demographics who received Influenza Vaccine and reports that he / she got flu shot but doesn't protect against type a bummer with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (with lot number, dose, strength, formulation, expiry date: not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date, the patient developed a serious got flu shot but doesn't protect against type a bummer with no reported adverse event (vaccination failure) at unknown latency following the administration of Influenza Vaccine.   No lab data was reported.  Action taken: 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: Medically Significant.; Sender's Comments: Sanofi Company Comment dated 30-Dec-2022: This case involves Adult and unknown gender patient who received Influenza Vaccine and reports that he / she got flu shot but doesn't protect against type a bummer with no reported adverse event. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding past and concomitant medication, any concurrent conditions, lab investigation precludes the comprehensive case assessment.
Sex: U
Vaccine: FLU4
Symptoms: Feeling hot, Injection site erythema, Muscle disorder, Vaccination site rash
Clinical narrative: Reaction to the arm muscle, below shot spot red; Reaction to the arm muscle, below shot spot red; hot arm muscle; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced reaction to the arm muscle, below shot spot red, reaction to the arm muscle, below shot spot red and hot arm muscle while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT WITH PRESERVATIVE. 5ML MULTIDOSE VIAL].  It is unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (strength, formulation, dose, expiry date, batch number, route: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious reaction to the arm muscle, below shot spot red (vaccination site rash), (vaccination site erythema) and hot arm muscle (vaccination site warmth) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken: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 the events.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19 pneumonia, Influenza
Clinical narrative: covid pneumonia; influenza a; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media serious case received from a Consumer/Non-Health Care Professional.  This case involves an unknown age and unknown gender patient who experienced influenza A and covid pneumonia after receiving vaccine Influenza Vaccine.  The patient's past vaccination(s) included 2 shots of COVID-19 Vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (with dose, strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed serious events of Influenza A (Influenza) and COVID pneumonia (covid-19 pneumonia) (unknown latency) following the administration of Influenza Vaccine. The patient was hospitalized for these events.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for both the events.   At time of reporting, the outcome was Unknown for both the events.   Seriousness Criteria: Hospitalization for both events and Medically Significant for covid-19 pneumonia.; Sender's Comments: Sanofi Company Comment dated 30-Dec-2022: This case involves an unknown age and unknown gender patient who experienced influenza A and covid pneumonia after receiving vaccine Influenza Vaccine. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding past and concomitant medication, any concurrent conditions, any family history precludes the comprehensive case assessment. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: two months later got the Flu; very sick; Initial information was received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown demographics who got the flu and very sick after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route and administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient got the flu (influenza) (latency: two months) and very sick (illness) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who still got the flu 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  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Reportedly, I got the shot, still got the flu. lot of good the shot was.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: been home 10 days with the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had been home 10 days with the flu after receiving vaccine Influenza Vaccine.   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 Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, expiry date not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date the patient had been home 10 days with the flu (influenza) (unknown latency) following the administration of  Influenza Vaccine (Flu shot).  It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got My flu shot and got the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who developed got my flu shot and got the flu  after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious i got my flu shot and got the flu  (influenza)  (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: 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.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: cough; Got flu type A; Initial information was received on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves unknown age and gender patient who experienced cough and got flu type a after receiving influenza vaccine.  The patient's past medical history included COVID-19 in september. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date and year in October, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via intramuscular route in unknown administration site for Influenza immunization.  On an unknown date the patient developed a non-serious event of events cough and got flu type a (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: 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 the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: awful flu symptoms even though I've had every shot possible.; still sick; Initial information was received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who experienced awful flu symptoms even though i've had every shot possible and still sick after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route, administration site, formulation, expiration date: Unknown) for Prophylactic vaccination (Immunisation).  On an unknown date the patient developed a non-serious awful flu symptoms even though i've had every shot possible (influenza) and still sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  Outcome: Unknown for the event awful flu symptoms even though i've had every shot possible. and was Not Recovered for the event still sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(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 dose of suspect Influenza Vaccine produced by unknown manufacturer with unknown formulation, strength, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination. Batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency).  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This year it found me! It was a rough 2 weeks but I cant imagine how bad it would have been had I not gotten my flu shot; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported this year it found me! it was a rough 2 weeks but i cant imagine how bad it would have been had i not gotten my flu shot (Influenza Vaccine).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for Flu. Information on batch number was requested.  On an unknown date the patient reported that this year it found me! it was a rough 2 weeks but i cant imagine how bad it would have been had i not gotten my flu shot (influenza) (unknown latency). It was reported that patient always get his flu shot, havent been sick in 25 yrs; This year it found him It was a rough 2 weeks but he cant imagine how bad it would have been he had not got his flu shot! Get your flu shot! This flu is no joke.  Action taken : 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 this year it found me! it was a rough 2 weeks but i cant imagine how bad it would have been had i not gotten my flu shot.
Sex: U
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Illness
Clinical narrative: body aches; fever; stuffy nose; no appetite; headache; sick; runny nose; sleeping all day; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had developed body aches, fever, stuffy nose, no appetite, headache, sick, runny nose and sleeping all day while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) as prophylactic vaccination.  On an unknown date the patient had developed a non-serious body aches (pain),fever (pyrexia), stuffy nose (nasal congestion),no appetite (decreased appetite), headache,sick (illness),runny nose (rhinorrhoea) and sleeping all day (hypersomnia)(unknown latency) following the administration of Influenza vaccine.  It was reported I got mine the beginning of December & I've been sick. I got the Flu body aches fever stuffy nose runny nose. No appetite sleeping all day etc. Now I've been sick for 3 days with funny nose headache body feeling tired etc. And i got the high dose because of my age.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the events (body aches, fever, stuffy nose, no appetite, headache, sick, runny nose, sleeping all day).  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Nasal congestion, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: body aches; fever; stuffy nose; no appetite; headache; sick; runny nose; sleeping all day; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had developed body aches, fever, stuffy nose, no appetite, headache, sick, runny nose and sleeping all day while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) as prophylactic vaccination.  On an unknown date the patient had developed a non-serious body aches (pain),fever (pyrexia), stuffy nose (nasal congestion),no appetite (decreased appetite), headache,sick (illness),runny nose (rhinorrhoea) and sleeping all day (hypersomnia)(unknown latency) following the administration of Influenza vaccine.  It was reported I got mine the beginning of December & I've been sick. I got the Flu body aches fever stuffy nose runny nose. No appetite sleeping all day etc. Now I've been sick for 3 days with funny nose headache body feeling tired etc. And i got the high dose because of my age.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the events (body aches, fever, stuffy nose, no appetite, headache, sick, runny nose, sleeping all day).  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: developed the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who developed the flu after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (developed the flu).  At time of reporting, the outcome was Unknown for the event developed the flu.
Age: 52.0
Sex: M
Vaccine: RAB, UNK
Symptoms: Off label use
Clinical narrative: Off Label Use; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA523303(CLUSTER) and 2022SA523303(CLUSTER).  This case involves a 52 years old male patient who experienced off label use while receiving vaccines RABIES (VERO) VACCINE [VERORAB] and IPV (VERO) [IMOVAX].  The patient's past medical treatment included SHINGRIX on 01-DEC-2022. The patient's past medical history, vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot number not reported. On 20-Dec-2022, the patient received a dose 1  dose of suspect RABIES (VERO) VACCINE lot U1F962V via unknown route in the right arm. On 23-Dec-2022 he also received a dose 2  dose of the same vaccine  lot U1F962V via unknown route in the left arm for dog bite.  On 27-DEC-2022 the patient developed a non-serious off label use (unknown latency) following the administration of IPV (VERO) and 7 days following the administration of RABIES (VERO) VACCINE.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event (Off Label Use).  At time of reporting, the outcome was Unknown for the event off label use.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of PENTACEL was administered today, to a 5 month-old boy,with no reported adverse event; Initial information received on 27-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old male patient for whom  an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered today.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Dec-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (lot number: UJ622AAA, expiry date: 07-Dec-2022) via intramuscular route in unknown administration site for immunization, which is an expired dose of pentacel administered with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was 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 guidelines. 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: 0.08
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: 4-week-old infant was given acthib instead of the hepatitis with no reported adverse event; Initial information was received on 29-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 weeks old female patient who stated that infant was given acthib instead of the hepatitis with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine  (Powder and solvent for solution for injection) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious event 4-week-old infant was given acthib instead of the hepatitis with no reported adverse event (wrong product administered) following the administration of HIB (PRP/T) vaccine.  Action taken: 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 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 guidelines. 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: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Burning in the arm around the injection site. Light-head, fatigue. Heart palpitations that lasted 3 days. Chest pressure, shortness of breath.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Fatigue, Injection site pain, Laboratory test, Palpitations
Clinical narrative: Burning in the arm around the injection site. Light-head, fatigue. Heart palpitations that lasted 3 days. Chest pressure, shortness of breath.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient got very light headed and dizzy and might have passed out.  We called 9-1-1 since she fell to the floor but i dont believe she fully lost conciousness.  She was repsonsvie right away to me. We called 9-1-1 and they responded.  All of Patient's vitals were normal and they said she was ok.  It was the first time she had a flu shot and the first time she recieved 2 vaccines at once. Patient also stated that she had passed out as a child from vaccines and had been fine
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Bacterial infection, Cellulitis
Clinical narrative: Systemic: pt said bacterial cellulitis-Medium, Additional Details: pt said her Dr told her it is a bacterial cellulitis
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 57.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Heart rate increased, Insomnia
Clinical narrative: Swollen arm, tender. Difficulty sleeping - body temperature 1.9 degrees above normal, avg heart rate up 10 points, 2% deep sleep, fatigue and headache.
Age: 57.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Swollen arm, tender. Difficulty sleeping - body temperature 1.9 degrees above normal, avg heart rate up 10 points, 2% deep sleep, fatigue and headache.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Injection site mass, Injection site pruritus
Clinical narrative: After the influenza injection I developed a small lump at the sight that was occasionally itchy.  It seems to have grown bigger and itchier after I had contracted covid-19 in September 2022.  I researched what it could be: and decided I should report it to Vaers.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac function test, Dizziness, Exercise tolerance decreased
Clinical narrative: Weeekness in both legs leading to inability to walk (in wheelchair for 6 weeks). Additionally, when standing up from sitting became light-headed at times collapsing.  Just now being able to start with stretching, exercising at a very low level. Lost significant strength.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Magnetic resonance imaging, Muscular weakness, Neurological examination, Syncope
Clinical narrative: Weeekness in both legs leading to inability to walk (in wheelchair for 6 weeks). Additionally, when standing up from sitting became light-headed at times collapsing.  Just now being able to start with stretching, exercising at a very low level. Lost significant strength.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: Weeekness in both legs leading to inability to walk (in wheelchair for 6 weeks). Additionally, when standing up from sitting became light-headed at times collapsing.  Just now being able to start with stretching, exercising at a very low level. Lost significant strength.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, General physical health deterioration, Insomnia, Laboratory test
Clinical narrative: I have had extreme pain and loss of function in my left arm from shoulder throughout my arm ever since my vaccine.  I?ve had to spend a lot of money out of my pocket for numerous doctor?s visits and physical therapy sessions, and the pain is so bad that I can never go a day without thinking about it or experiencing it.  I have some improved mobility after numerous times physical therapy sessions, but still have weakness and extreme pain in my entire arm and shoulder.  It?s impacted my mental health in addition to my physical health, and I can barely sleep at night.  I filled out reports early on and have had no follow up other than texts about my symptoms.  It now seems like this will be a lifelong issue for me and I want to be contacted and receive compensation.  I am very upset.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: I have had extreme pain and loss of function in my left arm from shoulder throughout my arm ever since my vaccine.  I?ve had to spend a lot of money out of my pocket for numerous doctor?s visits and physical therapy sessions, and the pain is so bad that I can never go a day without thinking about it or experiencing it.  I have some improved mobility after numerous times physical therapy sessions, but still have weakness and extreme pain in my entire arm and shoulder.  It?s impacted my mental health in addition to my physical health, and I can barely sleep at night.  I filled out reports early on and have had no follow up other than texts about my symptoms.  It now seems like this will be a lifelong issue for me and I want to be contacted and receive compensation.  I am very upset.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Cystoscopy normal, Ultrasound kidney normal, Ultrasound urinary system, Urine analysis normal
Clinical narrative: Nothing was identified until 6/2/22 as reported previously. Trace blood was found in urine.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dysphonia, Influenza virus test negative, Productive cough, Pyrexia
Clinical narrative: - Fever (101.9 highest recorded) began morning after vaccination, lasted more than 4 days. Acetaminophen & Ibuprofen reduced temp to 99s, but spiked back to 101 when medicine wore off.  - Cough began morning after vaccination. Began as occasional dry cough. Developed to more frequent productive cough and hoarseness over the next few days.  - At-home COVID-19 test on 12/23/2022 was negative. - Went to facility on 12/24/2022 (day 4 of fever). Lungs good. All vitals good (was using fever reducing medication). RSV and Flu test done (results negative). - Fever continued until 12/25/2022.  - Cough continued through 12/28/2022, but was much improved by 12/26/2022.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: - Fever (101.9 highest recorded) began morning after vaccination, lasted more than 4 days. Acetaminophen & Ibuprofen reduced temp to 99s, but spiked back to 101 when medicine wore off.  - Cough began morning after vaccination. Began as occasional dry cough. Developed to more frequent productive cough and hoarseness over the next few days.  - At-home COVID-19 test on 12/23/2022 was negative. - Went to facility on 12/24/2022 (day 4 of fever). Lungs good. All vitals good (was using fever reducing medication). RSV and Flu test done (results negative). - Fever continued until 12/25/2022.  - Cough continued through 12/28/2022, but was much improved by 12/26/2022.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Severely swollen lymph node
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at the injection site Large circle of redness at injection site Itching Injection site pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Redness, pain at injection site, a lump at injection site.
Age: 58.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Blood test normal, Cardiac function test normal, Catheterisation cardiac abnormal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: Severe chest pain early in morning of Dec 11 2022. Took emergency vehicle to Hospital where I had multiple tests: blood work (no viral infections present); x ray; CT scan; echo cardiogram; heart catheritization. Pain went away during morning in the emergency room but was admitted to hospital and stayed two days for observation.