chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Tremor
Clinical narrative: She was afraid it's going to kill her, her heart beats fast too; Shaking uncontrollably for a few hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The following information was reported: HEART RATE INCREASED (life threatening), outcome "unknown", described as "She was afraid it's going to kill her, her heart beats fast too"; TREMOR (non-serious), outcome "unknown", described as "Shaking uncontrollably for a few hrs". The patient underwent the following laboratory tests and procedures: Heart rate: increased.  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: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male 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: NEOPLASM MALIGNANT (medically significant) with onset Jan2021, outcome "unknown", described as "cancer".  Description of Event: The patient wife stated that and husband received Pfizer COVID-19 vaccine prior to being diagnosed with cancer in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got Flu shot but still sick; Initial information was received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional via social media.  This case involves an unknown age and  gender patient who got flu shot but still sick , after receiving vaccine Influenza vaccine.  The patient's 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 (formulation, strength, dose , route and lot number :not reported ) in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of got flu shot but still sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, patient got Flu shot but still sick; shots jokes.   It is unknown if there were lab data/results available. Was the company suspect product inappropriately used as per local Marketing authorization? Unknown  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.    Outcome: unknown
Age: 57.0
Sex: U
Vaccine: FLUX
Symptoms: Illness, Impaired work ability
Clinical narrative: was sicker than could ever remember; Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 57-year-old and unknown gender patient who was sicker than could ever remember after 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 in 2004, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date, the patient developed a non-serious event of was sicker than could ever remember (illness) within 2 weeks following the administration of INFLUENZA VACCINE.  It was reported, the patient had to get the flu shot because the patient worked with old people. Missed over 2 weeks of work. Never ever again.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (was sicker than could ever remember).  At time of reporting, the outcome was Unknown for the event was sicker than could ever remember.
Sex: U
Vaccine: FLUX
Symptoms: Conjunctivitis, Illness
Clinical narrative: been seriously ill for 3 weeks; I got sick until I got conjunctivitis; conjunctivitis; Initial information received on 15-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 been seriously ill for 3 weeks; I got sick until I got conjunctivitis and conjunctivitis 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 (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious been seriously ill for 3 weeks; i got sick until i got conjunctivitis (illness) and conjunctivitis (conjunctivitis) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  corrective treatment was not reported for both the events.  Outcome was Unknown for both the events.
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Influenza, Malaise
Clinical narrative: was sick with flu for 14 days; Initial information received on 16-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 was sick with flu for 14 days while receiving vaccines fluarix and 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 (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for Flu. On an unknown date, the patient received a  dose of suspect fluarix not produced by Sanofi Pasteur (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious was sick with flu for 14 days (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Corrective treatment was not reported for the event (was sick with flu for 14 days).  Outcome was Unknown for the event was sick with flu for 14 days.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got flu; Initial information received on 16-Dec-2022 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  still got flu 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 treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient still got flu (influenza) (latency: unknown) following the administration of influenza vaccine.  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 for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: flu; got covid twice!!!; Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves an adult patient of unknown gender who experienced flu and got covid twice after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine for Covid-19.  On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu (influenza).  On an unknown date, the patient developed events flu (influenza) and got covid twice (covid-19) (latency: unknown for both) following the administration of influenza vaccine.  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.  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: Malaise, Vaccination failure
Clinical narrative: Didn't help me a bit; sick; Initial information received on 16-Dec-2022 regarding an unsolicited valid serious case received from a patient (consumer) via social media.  This case involves a patient of unknown age and gender who reported it didn't help me a bit and got sick after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient reported didn't help me a bit (vaccination failure) and got sick (malaise) (unknown latency) following the administration of influenza vaccine.    It was 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 (sick)  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: Medically significant for the event didn't help me a bit (vaccination failure).; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves a patient of unknown age and gender who reported it didn't help me a bit and got sick after receiving influenza vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: don't think it HELPED AT ALL; still got the flu symptoms; Initial information received on 19-Dec-2022 regarding an unsolicited valid serious case received from a Consumer/Non-HCP (non-healthcare professional) via social media.  This case involves a patient of an unknown age and gender who reported still got the flu symptoms and don't think it helped at all after receiving Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown lot number, expiry date, formulation, route, strength) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed events of still got the flu symptoms (influenza) and don't think it helped at all (vaccination failure) (latency: unknown) following the administration of Influenza Vaccine.  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.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown  Seriousness Criteria: Medically significant for don't think it helped at all (vaccination failure).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still ended up with 2 strains of the flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who still ended up with 2 strains of the flu 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, expiry date: Unknown) for flu (influenza).  On an unknown date the patient developed a serious still ended up with 2 strains of the flu (influenza) (unknown latency) following the administration of influenza vaccine.   No lab data reported.  Action taken: unknown.  It was not reported if the patient received a corrective treatment for the event (still ended up with 2 strains of the flu).  Outcome was Unknown for the event still ended up with 2 strains of the flu.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 22-Dec-2022: This case involves an unknown age/gender patient who still ended up with 2 strains of the flu after being vaccinated with influenza vaccine. Furthermore, information regarding concomitants excluding other predisposing etiologies, intervention (if any), medical history, corrective treatment/medical management, family history, 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: Cough, Decreased appetite, Influenza, Rhinorrhoea, Weight decreased
Clinical narrative: cough; runny nose; no appetite; lost over 10 lbs; got the flu anyway for 10 days; Initial information received on 19-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 got the flu anyway for 10 days, cough, runny nose, no appetite and lost over 10 lbs 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 (strength, formulation, dose, expiration date, route, administration site and lot number not reported) for prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu anyway for 10 days (influenza), cough, runny nose (rhinorrhoea), no appetite (decreased appetite), lost over 10 lbs (weight decreased) (unknown latency).  Relevant laboratory test results included: Weight - On an unknown date: [lost over 10 lbs]  Action taken was not applicable.  Corrective treatment not reported for all the events   Outcome was Unknown for all the events.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness; lightheaded; nausea; nauseated; Initial information received on 19-Dec-2022 regarding an non-serious case received from via consumer/non-hcp.  This case involves a 26 years old male patient who was diagnosed with dizziness; lightheaded and nausea; nauseated after receiving influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] and vaccines covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Nov-2022, the patient received a dose suspect influenza quadrival a-b high dose hv vaccine at dose 1 (batch number: UT7701MA) (strength, frequency, formulation, expiry date: unknown) via intramuscular route in the right arm for Influenza immunization.  On 21-Nov-2022, the patient received suspect covid-19 vaccine produced by unknown manufacturer at dose 2 in injection form (batch number: 4302MF023) (strength, expiry date: unknown) via intramuscular route in the left arm for COVID-19 immunisation  On 21-NOV-2022 the patient diagnosed with a non-serious events of dizziness; lightheaded (dizziness), nausea; nauseated (nausea) (same day latency) following the administration of influenza quadrival a-b high dose hv vaccine and following the administration of covid-19 vaccine.  Action taken was not applicable for both suspects.  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 events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient Had the high- dose flu vaccine for people 65 & older, Still got influenza A; Initial information received on 20-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who had the high- dose flu vaccine (INFLUENZA VACCINE (QUADRIVALENT)) for people 65 & older, still got influenza A.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect QUADRIVALENT INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for flu (Influenza).  On an unknown date, the patient developed a non-serious event of patient had the high- dose flu vaccine for people 65 & older, still got influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient Had the high- dose flu vaccine for people 65 & older, Still got influenza A).  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for a week; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves Adult and unknown gender patient who was sick for a week after 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 suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for vaccination.  On an unknown date the patient diagnosed with a non-serious event of sick for a week (malaise) (unknown latency) following the administration of influenza vaccine.  It was reported "Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: My adult son got the flu shot and has the flu according to his doctor. He's been sick for a week. He completed his meds today".  Action taken 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.
Sex: U
Vaccine: FLUX
Symptoms: Frustration tolerance decreased
Clinical narrative: got it anyway, very frustrating; Initial information received on 20-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got it anyway, very frustrating after 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 in early Oct-2022, the patient Got shot of INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of got it anyway, very frustrating (frustration tolerance decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease, or risk factor. It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got it anyway, very frustrating).  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot and for the first time in 50 years got the flu anyway; Initial information received from on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who got the flu shot and for the first time in 50 years got the flu anyway after 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 an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a serious got the flu shot and for the first time in 50 years got the flu anyway (influenza) (unknown latency) following the administration of Influenza Vaccine. The patient was hospitalized for this event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. 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 (got the flu shot and for the first time in 50 years got the flu anyway).  Outcome: Unknown   Seriousness Criteria: The patient was hospitalized for this event for seven days.; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves a patient of unknown demographics who got the flu shot and for the first time in 50 years got the flu anyway after receiving vaccine Influenza 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.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: they have administered 2 doses FLUZONE HIGH DOSE QUADRIVALENT to a patient with no adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old female patient who received 2 doses INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2022 patient received a 0.7 ml dose 1 of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ875AD, expiration date: 30-Jun-2023) via intramuscular route in the left arm. On 16-Dec-2022, the patient again received 0.7 ml dose 2 of suspect same vaccine (lot number: UJ935AC, Expiration date: 23-Jun-2023) via intramuscular route in the left arm with no adverse event (extra dose administered) (unknown latency).   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event they have administered 2 doses fluzone high dose quadrivalent to a patient with no adverse 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: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: child was given expired product with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who was given expired product, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 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 INFLUENZA VACCINE for Prophylactic vaccination and Pneumonia vaccine.  On 20-Dec-2022, the patient received dose 4 (0.5ml total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Strength: standard, formulation: unknown) (lot number: UJ622AAA and expiry date: 07-Dec-2022) via intramuscular route in the left thigh (left leg) for Immunization and on the same day child was given expired product with no reported adverse event (expired product administered).  Reporter wanted to know next steps.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) 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 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: 0.17
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: PENTACEL was given to a patient after it expired with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 months old and unknown gender patient and diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was given after it expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Dec-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (expiry date:05-Dec-2022) (form, strength, dose, frequency, lot number: unknown) via unknown route in unknown administration site for Immunization, after it expired with no reported adverse event (expired product administered) (latency: same day).  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: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Chest pain, Condition aggravated
Clinical narrative: 023H22ot number
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthma, Bronchial hyperreactivity, Bronchitis, COVID-19, Chest X-ray
Clinical narrative: COVID, Paxlovid, COVID rebound, exacerbated asthma and reactive airway infection (bronchitis) followed by more asthma
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Condition aggravated, SARS-CoV-2 test positive
Clinical narrative: COVID, Paxlovid, COVID rebound, exacerbated asthma and reactive airway infection (bronchitis) followed by more asthma
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Vomiting
Clinical narrative: Headache  persistent vomiting
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: I got my first dose of Covid-19 vaccine (Pfizer) in my left arm on Sat 01/30/2021 evening from my workplace. I felt tingling sensation spreading in my left arm right after the shot. The next day, I woke up with a sore arm and the tingling had spread to the whole left side of my body including my left leg, arm, left side of torso, left side of the face and the back left side of my head. The tingling got milder over time. I can barely feel the tingling on other parts of the body except my left arm. It get numbed more easily compared to my right arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Heart rate increased, Metabolic function test
Clinical narrative: Intermittently elevated heart rate 180-200s
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Chest pain, Discomfort, Headache, Hypersomnia, Influenza like illness
Clinical narrative: On the last booster does( number 4) in the first 15 minutes after getting injections everything was a okay. I got home and the injection site started to swell into a bump and it turned red. I instantly fell asleep when arriving home and did not wake up until the afternoon. Upon awakening I realized I was very sick like I had the flu. My body was heavy, nose was stuffed, head was hurting, throat was hurting and injection site was and still is  red and has a bump today.Just yesterday I experienced terrible chest pain that lasted about 20 minutes (I thought I was done lol) . Low key feeling better today but the injection site is still red and has a bump and my body never got over the soreness/heaviness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: On the last booster does( number 4) in the first 15 minutes after getting injections everything was a okay. I got home and the injection site started to swell into a bump and it turned red. I instantly fell asleep when arriving home and did not wake up until the afternoon. Upon awakening I realized I was very sick like I had the flu. My body was heavy, nose was stuffed, head was hurting, throat was hurting and injection site was and still is  red and has a bump today.Just yesterday I experienced terrible chest pain that lasted about 20 minutes (I thought I was done lol) . Low key feeling better today but the injection site is still red and has a bump and my body never got over the soreness/heaviness.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Pain
Clinical narrative: On the last booster does( number 4) in the first 15 minutes after getting injections everything was a okay. I got home and the injection site started to swell into a bump and it turned red. I instantly fell asleep when arriving home and did not wake up until the afternoon. Upon awakening I realized I was very sick like I had the flu. My body was heavy, nose was stuffed, head was hurting, throat was hurting and injection site was and still is  red and has a bump today.Just yesterday I experienced terrible chest pain that lasted about 20 minutes (I thought I was done lol) . Low key feeling better today but the injection site is still red and has a bump and my body never got over the soreness/heaviness.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bladder catheterisation, Bladder disorder, Hypoaesthesia, Laboratory test normal
Clinical narrative: Ending up in the Emergency Room with numbness and tingling in all extremities - hands and feet.   All tests performed at the ER came back normal or negative, but during the stay, my bladder shut down and they had to twice insert a catheter so they could empty the bladder.  Subsequently, I have had persistent and constant joint pain in both shoulders, wrists, hands and knees.  Dr's have taken X-Rays and MRI's of most of the joints but can find nothing.   The joints are in constant and debillatating pain.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Paraesthesia, X-ray normal
Clinical narrative: Ending up in the Emergency Room with numbness and tingling in all extremities - hands and feet.   All tests performed at the ER came back normal or negative, but during the stay, my bladder shut down and they had to twice insert a catheter so they could empty the bladder.  Subsequently, I have had persistent and constant joint pain in both shoulders, wrists, hands and knees.  Dr's have taken X-Rays and MRI's of most of the joints but can find nothing.   The joints are in constant and debillatating pain.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Exposure to SARS-CoV-2, Gastric dilatation
Clinical narrative: We had been quarantined since 10/31/2022 due to my husband?s COVID diagnosis. Patient had a breakthrough case of COVID with initial positive test on 11/04/2022. Patient had severe vomiting and diarrhea that started that night. The diarrhea was intermittent throughout the following weeks but the vomiting did not fully subside until November 25, 2022. On November 15th the vomiting was for 12 hours straight. The other days it was once a night around 7-8 pm. He would vomit up all of his daily food intake. His stomach would hurt and be distended until he vomited, which is out of the ordinary for him. The contents of his stomach would still contain items he ate for breakfast 12 hours prior. Patient was seen by his pediatrician on 11/18/2022 for this condition.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: We had been quarantined since 10/31/2022 due to my husband?s COVID diagnosis. Patient had a breakthrough case of COVID with initial positive test on 11/04/2022. Patient had severe vomiting and diarrhea that started that night. The diarrhea was intermittent throughout the following weeks but the vomiting did not fully subside until November 25, 2022. On November 15th the vomiting was for 12 hours straight. The other days it was once a night around 7-8 pm. He would vomit up all of his daily food intake. His stomach would hurt and be distended until he vomited, which is out of the ordinary for him. The contents of his stomach would still contain items he ate for breakfast 12 hours prior. Patient was seen by his pediatrician on 11/18/2022 for this condition.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: Systemic: see comments vaccine wasnt administered-Mild, Additional Details: this vaccine was NOT administered, child moved once needle was stuck in arm and scrached his arm.  Showed parents full vaccine in syringe before disposing. Parents went to pediatrician after to get vaccine.  opened a report for the sole purpose of documenting the incident
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: patient checked in for a vaccine for flu and pharmacist confirmed flu shot but she said she was not suppose to get the flu she wanted covid she called 12/20/22 2:30pm she said she already recieved the flu shot after researching her she has 2 profiles there is a profile with her name spelled incorrectly which had her covid shot on hold. The patient says she feels completely fine no side effects at all and still wants her covid booster. She was advised to come 2 weeks from 12/15/22
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Panic reaction
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt lightheaded after vaccinations, then panicked, emergency personnel checked her out, all was normal, pt felt better and left.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Severe, Additional Details: pt received vaccine and while in 15 minute waiting period went to front of store to make a purchase.  while at cash register he suffered a seizure, 911 called and responded within a few minutes.  Pt taken to hospital
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pt states silver dollar sized red, swollen, hot, a little itchy spot where vaccine was given, also felt headache, aches, fever, taking advil, wants to see dr just to make sure nothing else going on, told her she needs to do what makes her most comfortable
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pt states silver dollar sized red, swollen, hot, a little itchy spot where vaccine was given, also felt headache, aches, fever, taking advil, wants to see dr just to make sure nothing else going on, told her she needs to do what makes her most comfortable
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Haematoma, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: pain and swelling from hematoma per MD diagnosis-Medium, Additional Details: MD prescribed Keflex for possible infection but request for CT scan if symptoms not improve in a few days.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Unable to move her arm
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, Bronchitis, Chest X-ray, Cough
Clinical narrative: Developed intense deep chest cough that progressed over 8 weeks into severe bronchitis and spasmadic asthma
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast mass, Breast pain, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: I had a painful lump in my right breast, nearish the armpit.  It started as a pea then grew in size as time progressed.  At its largest it was the size of a nickel, if it were a sphere.   I had an inconclusive mammogram and then an ultrasound.  No mass was seen and it was determined to be a stolen lymph node.  Over the last five weeks, the pain has been diminishing but it?s not totally gone.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Headache, Migraine with aura, Sluggishness, Visual field defect
Clinical narrative: Approximately 1 hour after vaccination, I experienced a migraine aura. It began with blind spots in my vision, and progressed to a 20-minute scintillating scotoma. There was a slight headache, and sluggish feeling for hours afterwards. I typically experience migraine aura once or twice yearly. This aura was the same except the blind spots were much worse than before. I did not experience migraine aura with any previous vaccinations.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Appendicitis
Clinical narrative: Appendicitis
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Patient called to report a full body rash that started 7 days after receiving the Shingrix vaccine. The rash is not itchy but is raised.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Coagulation test normal, Magnetic resonance imaging spinal abnormal, Pathology test, Sciatica, Spinal cord injury
Clinical narrative: 9/16/22 Received Flu shot and COVID19 Bivalent booster 9/19/22 Sciatica symptoms started in right calf (I have never had sciatica symptoms in the past) 10/1/22 Sciatica symptoms became more severe in the right calf and right hamstring. 11/22/22 Went to ER, due to severe sciatica symptoms. MRI revealed lesion on spine. Emergency laminectomy surgery to remove spontaneous spinal epidural hematoma. Hematoma contained blood clots.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Spinal epidural haematoma, Spinal laminectomy, Thrombosis
Clinical narrative: 9/16/22 Received Flu shot and COVID19 Bivalent booster 9/19/22 Sciatica symptoms started in right calf (I have never had sciatica symptoms in the past) 10/1/22 Sciatica symptoms became more severe in the right calf and right hamstring. 11/22/22 Went to ER, due to severe sciatica symptoms. MRI revealed lesion on spine. Emergency laminectomy surgery to remove spontaneous spinal epidural hematoma. Hematoma contained blood clots.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received the Pediatric dose of Engerix-B as a first dose.  Patient did not complain of any symptoms.
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Incorrect dose administered
Clinical narrative: Patient got a duplicate flu shot.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Disorientation, Hypertension, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after injection patient was getting out of chair and lost balance; they were caught and sat down to recover. Patient was instructed to either lay down with feet up or sit with head between knees, due to age, patient sat with head between knees. They shortly developed nausea and vomiting. After 15-20 minutes patient continued with symptoms and EMS was called. They evaluated patient and took them to hospital for further evaluation and care. According to patient's son, patient was kept at hospital for a few days for care and recovery. Patient had disorientation and uncontrollable hypertension the following days and nothing further was reported from family. Patient is now at home recovering, still a little disorientated but moving around and back to normal duties.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Immediately after injection patient was getting out of chair and lost balance; they were caught and sat down to recover. Patient was instructed to either lay down with feet up or sit with head between knees, due to age, patient sat with head between knees. They shortly developed nausea and vomiting. After 15-20 minutes patient continued with symptoms and EMS was called. They evaluated patient and took them to hospital for further evaluation and care. According to patient's son, patient was kept at hospital for a few days for care and recovery. Patient had disorientation and uncontrollable hypertension the following days and nothing further was reported from family. Patient is now at home recovering, still a little disorientated but moving around and back to normal duties.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain
Clinical narrative: It Started actually with the 12/17/21  booster shot modern 03H21B. Upper Right Arm Pain. Then this last one. 12?17?22 , Pain all on my Right Side of my body..That has subsided, but My shoulder still hurts
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Contracted Covid-19, probably on 11/24/2022.  Day Zero was 11/19:  sore throat, malaise, "brain fog."   Tested positive on 11/30 and began 5-day treatment.  Ended isolation on 12/9/2022.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chest pain, Computerised tomogram abdomen abnormal, Echocardiogram abnormal
Clinical narrative: Lost of Taste, ongoing. Extreme Fatigue, unable to get out of bed for 2.5 months, full,  strength never returned. Right Renal Artery Stenosis, ongoing,   Hypertension, ongoing, medicated. High Resting Heart Rate > 100, ongoing. Left Ventricular Hypertrophy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glomerular filtration rate decreased, Heart rate increased, Hypertension, Left ventricular hypertrophy
Clinical narrative: Lost of Taste, ongoing. Extreme Fatigue, unable to get out of bed for 2.5 months, full,  strength never returned. Right Renal Artery Stenosis, ongoing,   Hypertension, ongoing, medicated. High Resting Heart Rate > 100, ongoing. Left Ventricular Hypertrophy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Renal artery stenosis
Clinical narrative: Lost of Taste, ongoing. Extreme Fatigue, unable to get out of bed for 2.5 months, full,  strength never returned. Right Renal Artery Stenosis, ongoing,   Hypertension, ongoing, medicated. High Resting Heart Rate > 100, ongoing. Left Ventricular Hypertrophy