chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Pain
Clinical narrative: Its gotten worse, to the point of pain; Limited movement; Left shoulder (injection arm) has been sore; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 41-years-old) as a dose 2, single for COVID-19 immunization. Medical history included anxiety, depression, attention deficit disorder (ADD) and asthma. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC), linum usitatissimum seed oil (FLAX OIL) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. Patient took historical vaccine that included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unspecified date as a dose 1, single (UNKNOWN MANUFACTURER) for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the second shot on 25Apr2021, the patient experienced left shoulder (injection arm) soreness. On 16May2021, two weeks before the time of this report, the pain had gotten worse, to the point of pain and limited movement. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left shoulder soreness with worsening pain and limited movement were not resolved at the time of this report.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Arm Pain; Fever; tiredness; body aches; diarrhea; upset stomach; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on an unknown date in May2021 at 18:15 (at the age of 44-years-old) as dose1, single for COVID-19 immunization. Medical history included anemia. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021 at 20:00, the patient experienced arm pain, fever, tiredness, body aches, diarrhea and upset stomach. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm pain, fever, tiredness, body aches, diarrhea and upset stomach was resolved with lasting effects on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm Pain; Fever; tiredness; body aches; diarrhea; upset stomach; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on an unknown date in May2021 at 18:15 (at the age of 44-years-old) as dose1, single for COVID-19 immunization. Medical history included anemia. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021 at 20:00, the patient experienced arm pain, fever, tiredness, body aches, diarrhea and upset stomach. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm pain, fever, tiredness, body aches, diarrhea and upset stomach was resolved with lasting effects on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site swelling
Clinical narrative: Fever; body chills; swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Jun2021 at 18:00 (age at the time of vaccination was 13-year-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of COVID vaccine. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 03Jun2021 at 12:00, the patient experienced fever, body chills and swelling at injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body chills and swelling at injection site were not recovered at the time of this report.  Follow-up attempts completed. lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache
Clinical narrative: serious fatigue; chills; Headache; This is spontaneous report from contactable consumer (patient reported for self). A 47-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: EW0158), via intramuscular route, administered in arm left on 12Apr2021 at 15:30 (at the age of 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included known allergies to pollens and pet dander, COVID tested positive on an unspecified date in Dec2020, tested negative on an unspecified date Jan2021 and allergies. Concomitant medications included CETIRIZINE, route: pill (MANUFACTURER UNKNOWN) for allergies from an unknown date and ongoing. Prior vaccination (within 4 weeks): None. Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: ER2613), via intramuscular route, administered in arm left on 23Mar2021 at 14:15 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced serious fatigue, chills and headache on 23Mar2021 at 07:00. On 13Apr2021 at 07:00, the patient experienced serious fatigue, chills and headache. The patient reported that the day after both shots he had serious fatigue, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. The patient underwent lab tests and procedures which included Covid (COVID-19): positive on an unspecified date in Dec2020 and negative on an unspecified date in Jan2021. The seriousness of the events was reported as non-serious. The outcome of the events was recovered on 14Apr2021.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Constant allergic reactions; Head feels itchy; Hives are seen on face and neck; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced constant allergic reactions, head felt itchy, and hives were seen on face and neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events constant allergic reactions, head feels itchy and hives seen on face and neck was not resolved at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Breath odour, Condition aggravated, Constipation, Inflammation, Influenza
Clinical narrative: Fever/flu; Fever/flu; GI issues - severe constipation; Exacerbation of some underlying issues with autimmune in sleep (insomnia) that get worse when inflammation high.; Exacerbation of some underlying issues with autimmune in sleep (insomnia) that get worse when inflammation high; Generally high levels of inflamation; Smell something 'rotting' in breath/body odor; Smell something 'rotting' in breath/body odor; Large -(3 inches diameter) circular rash raised half centimeter off of my arm at the injection site for 3 days/ now almost pulsing and spreading down my arm; Large -(3 inches diameter) circular rash raised half centimeter off of my arm at the injection site for 3 days/ now almost pulsing and spreading down my arm; This is a spontaneous report from a contactable consumer, the patient.   A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Jun2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune issues and COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021, the patient experienced fever/flu, GI issues - severe constipation, exacerbation of some underlying issues with autoimmune in sleep (insomnia) that get worse when inflammation high, generally high levels of inflammation, smell something 'rotting' in breath/body odour, large -(3 inches diameter) circular rash raised half centimetre off of the arm at the injection site for 3 days, itchy and now almost pulsing and spreading down the arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever/flu, GI issues - severe constipation, exacerbation of some underlying issues with autoimmune in sleep (insomnia) that get worse when inflammation high, generally high levels of inflammation, smell something 'rotting' in breath/body odor, large -(3 inches diameter) circular rash raised half centimetre off of my arm at the injection site for 3 days, itchy and now almost pulsing and spreading down the arm was not recovered at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Pyrexia, Rash papular, Skin odour abnormal
Clinical narrative: Fever/flu; Fever/flu; GI issues - severe constipation; Exacerbation of some underlying issues with autimmune in sleep (insomnia) that get worse when inflammation high.; Exacerbation of some underlying issues with autimmune in sleep (insomnia) that get worse when inflammation high; Generally high levels of inflamation; Smell something 'rotting' in breath/body odor; Smell something 'rotting' in breath/body odor; Large -(3 inches diameter) circular rash raised half centimeter off of my arm at the injection site for 3 days/ now almost pulsing and spreading down my arm; Large -(3 inches diameter) circular rash raised half centimeter off of my arm at the injection site for 3 days/ now almost pulsing and spreading down my arm; This is a spontaneous report from a contactable consumer, the patient.   A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Jun2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune issues and COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021, the patient experienced fever/flu, GI issues - severe constipation, exacerbation of some underlying issues with autoimmune in sleep (insomnia) that get worse when inflammation high, generally high levels of inflammation, smell something 'rotting' in breath/body odour, large -(3 inches diameter) circular rash raised half centimetre off of the arm at the injection site for 3 days, itchy and now almost pulsing and spreading down the arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever/flu, GI issues - severe constipation, exacerbation of some underlying issues with autoimmune in sleep (insomnia) that get worse when inflammation high, generally high levels of inflammation, smell something 'rotting' in breath/body odor, large -(3 inches diameter) circular rash raised half centimetre off of my arm at the injection site for 3 days, itchy and now almost pulsing and spreading down the arm was not recovered at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal Nerve pain; This is a spontaneous report from a contactable consumer, the patient.  A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 23Feb2021 (age at vaccination 47 years) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. On an unknown date in Apr2021, the patient experienced trigeminal nerve pain for 3 weeks. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event trigeminal nerve pain was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: 100.9 temp; vomiting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right (reported as right arm) on 11Jun2021 at 10:00 (at the age of 13-year-old) as dose 2, single for covid-19 immunization. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and women's multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 14May2021 10:00 (at the age of 13-year-old) as dose 1, single for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021 at 02:00, the patient experienced 100.9 temperature and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature resulted as 100.9 (unspecified units) on 12Jun2021. Therapeutic measures were not taken as a result of the events. Outcome of the events 100.9 temperature and vomiting was resolved on an unspecified date in Jun2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Neck pain, Swelling
Clinical narrative: neck is swollen since getting 2nd vaccine.; He says it feels sore; he cannot move his arm as much; This is a spontaneous report from a contactable consumer and his parent. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 12Jun2021 at 11:15 (at the age of 13-year-old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 22May2021 at 11:15 (at the age of 13-year-old) as a dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021 at 12:00, the patient experienced his neck was swollen after getting his second vaccine and he felt that the neck was sore, and he could not move his arm as much. It was unknown whether therapeutic measures were taken as a result of the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was recovering at the time of this report.  Follow-up attempts completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: dose 1: sore arm that gradually worsened; dose 1: sore arm that gradually worsened; immediate fatigue; fever; severe headache; nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 25-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration (at the age of 25 years), administered in left arm on 21May2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient medical history included known allergies with latex. Concomitant medications included paracetamol (TYLENOL), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccinations within 4 weeks. The patient was not tested for covid, post vaccination. It was unknown that the patient had COVID prior vaccination. On 21May2021 at 13:15, the patient experienced dose 1: sore arm that gradually worsened, immediate fatigue, fever, severe headache and nausea. The patient did not receive any treatment for the events. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dose 1: sore arm that gradually worsened; dose 1: sore arm that gradually worsened; immediate fatigue; fever; severe headache; nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 25-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration (at the age of 25 years), administered in left arm on 21May2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient medical history included known allergies with latex. Concomitant medications included paracetamol (TYLENOL), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccinations within 4 weeks. The patient was not tested for covid, post vaccination. It was unknown that the patient had COVID prior vaccination. On 21May2021 at 13:15, the patient experienced dose 1: sore arm that gradually worsened, immediate fatigue, fever, severe headache and nausea. The patient did not receive any treatment for the events. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haematoma, Headache, Nausea, Pain in extremity
Clinical narrative: hematoma; immediate fatigue; light headache; nausea; lesser of a sore arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 11Jun2021 09:00 (at the age of 25-year-old) as dose 2, single for covid-19 immunization. Medical history included known allergies to latex. It was unknown if patient had covid prior vaccination. Concomitant medication(s) included paracetamol (TYLENOL); ibuprofen, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21May2021 01:15 PM (at the age of 25-year-old) for covid-19 immunization and experienced sore arm that gradually worsened, immediate fatigue, fever, severe headache after 24 hours, and nausea. On 11Jun2021, the patient experienced hematoma within 4 hours, lesser of a sore arm, immediate fatigue, a light headache, and nausea. The patient did not receive any treatment for the events. The patient had not tested covid post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 03Mar2021 (at the age of 36 years) as dose 2, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 03Mar2021 at 21:00, evening of the second dose, the patient experienced fever which continued for 18 hours. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if any therapeutic measures were taken as a result of the event. The outcome of the event was resolved on 04Mar2021. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site after administering the vaccine on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: exaggerated cellulitis; painful arm; swollen arm; Initial information was received on 12-Nov-2021 regarding an unsolicited valid serious case from other healthcare professional.  This case is linked to 2021SA387396 (same reporter)  This case involves a 50-year-old male patient who experienced exaggerated cellulitis (cellulitis), painful arm (pain in extremity) and swollen arm (peripheral swelling) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date in between 08-Nov-2021 to 11-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE produced by Sanofi Pasteur (suspension for injection, lot number: C5882AA and expiry date was not reported) via intramuscular route in the arm not otherwise specified (NOS) for prophylactic vaccination.  On an unknown date in Nov-2021, the patient developed a serious exaggerated cellulitis (cellulitis), painful arm (pain in extremity) and swollen arm (peripheral swelling) within 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown; Sender's Comments: This case involves a 50 year old male patient who experienced cellulitis, pain in extremity and peripheral swelling after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The time to onset is compatible. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced runny nose (rhinorrhoea) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious runny nose (rhinorrhoea) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "me too but noe got a runn ie nose."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Amnesia, Coma, Gait disturbance, Guillain-Barre syndrome, Speech disorder
Clinical narrative: Guillain Barre; coma for almost two years; Initial information was received on 18-Nov-2021 regarding an unsolicited valid serious case from a Social Media via a consumer/non-health care professional.  This case involves a female patient (unknown age) who had Guillain Barre (Guillain-Barre syndrome) and coma for almost two years (coma) 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 (in 1992/1993), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed serious Guillain Barre (Guillain-Barre syndrome) and coma for almost two years (coma) (unknown latency) following the administration of INFLUENZA VACCINE.   These events were assessed as medically significant.  The patient had to learn how to walk, talk and remember who was her family.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, after almost 2 years the patient was recovered from coma.  At time of reporting, outcome of the Guillain-Barre syndrome was unknown.  The reporter assessed the Guillain-Barre syndrome as related with suspect and did not report the causality of coma with suspect.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a female patient (unknown age) who had Guillain-Barre syndrome and coma after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Atrial fibrillation, Back pain, Dyspnoea, Gait disturbance, Paranasal sinus hypersecretion
Clinical narrative: afib; lungs plugged up can hardly breathe; prostrate plugged up can barely walk; pain in my back; sinus leaks all day; they had to cut off some of my toes; Initial information was received on 18-Nov-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was 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 (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) (unknown latency) following the administration of INFLUENZA VACCINE.  Atrial fibrillation event was assessed as medically significant.  It was also reported that patient did not get covid (coronavirus disease).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns an Adult (unknown gender) patient who experienced atrial fibrillation, dyspnoea, gait disturbance, back pain, paranasal sinus hypersecretion and toe amputation (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Prostatic disorder, Pulmonary congestion, Toe amputation
Clinical narrative: afib; lungs plugged up can hardly breathe; prostrate plugged up can barely walk; pain in my back; sinus leaks all day; they had to cut off some of my toes; Initial information was received on 18-Nov-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was 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 (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) (unknown latency) following the administration of INFLUENZA VACCINE.  Atrial fibrillation event was assessed as medically significant.  It was also reported that patient did not get covid (coronavirus disease).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns an Adult (unknown gender) patient who experienced atrial fibrillation, dyspnoea, gait disturbance, back pain, paranasal sinus hypersecretion and toe amputation (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Injection site felt like someone punched; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) whose injection site felt like someone punched (vaccination site pain) 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 (in November 2021), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (in November 2021), the patient developed a non-serious injection site felt like someone punched (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: The nurse noticed that while preparing the product was coming out and leaking onto her hand no AE; The product was coming out of the back of barrel of the syringe, past the plunger stopper, and leaking no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00857505) and transmitted to Sanofi on 15-Nov-2021.  This case involves a 63 year old female nurse who noticed that while preparing the RABIES (HDC) VACCINE [IMOVAX RABIES] after reconstituting the product was coming out of the back of barrel of the syringe, past the plunger stopper, and leaking onto her hand (occupational exposure to product and syringe issue).  The nurse's medical history, medical treatment(s), vaccination(s) and family history were not provided.   The nurse had no other concomitant vaccines.  The nurse was not pregnant.  On 12-Nov-2021, the nurse was preparing the product RABIES (HDC) VACCINE (lot T1E943M, expiry: 14-Oct-2022, formulation: pre-filled syringe) after reconstituted the product got onto the skin of her hand product used for unknown indication.  It was a case of occupational exposure while preparing product for administration and syringe leak (latency same day).  It was reported "Nurse states that she was preparing IMOVAX on 12NOV2021; Nurse states she inserted syringe with diluent into the vial with the Sanofi provided needle, she reconstituted the IMOVAX by swirling it around with syringe still inserted into the vial, she then went to pull the IMOVAX back into the syringe. When she was pulling IMOVAX back into syringe, she was trying to get product out of the neck of the vial, as she was pulling back she noticed that IMOVAX was leaking out of the back of the barrel of the syringe, past the plunger stopper, and onto her hand. Nurse asks if there is any possibility a replacement will be sent. Nurse states product is available for return"  The nurse had experienced no side effects after exposure.  The nurse did not require an Emergency Room (ER) or Doctor (Dr) visit after being exposed.   The nurse washed her hands after the exposure.
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product dispensing error
Clinical narrative: Ordered ADACEL SINGLE DOSE VIALS but received ADACEL PRE-FILLED SYRINGES with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00860023) and transmitted to Sanofi on 16-Nov-2021.  This case involves an unknown age female patient who ordered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] single dose vials [0.5 mL (total)] but received ADACEL pre-filled syringes (lot number and expiry date not reported) on an unknown date for prophylactic vaccination (product dispensing error).  It was a case of potential medication error due to product dispensing error (latency was on same day).  It was reported "caller ordered ADACEL SINGLE DOSE VIALS but received ADACEL PRE-FILLED SYRINGES; caller would like to know if she can use VanishPoint needles on pre-filled syringes."  At the time of report, no adverse event reported.  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.  There will be no information available on batch number for this case.
Age: 1.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: received a dose of MENACTRA instead of the MMR vaccine with no reported adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under the reference 00860685).   This case involves a 12 months old male patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of the MMR VACCIN (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) (lot number and expiration date not reported) via unknown route in an unknown administration site for Prophylactic vaccination.  On 15-Nov-2021, the patient received a dose of suspect MENACTRA (0.5 ml, total, once, lot U7140BB and expiration date: 7-Nov-2022) via intramuscular route in the right thigh for Prophylactic vaccination.  It was an actual medication error due to wrong product administered (same day latency).  No adverse event was reported.  It was reported "A 12 month and 9 day old patient received a dose of MENACTRA instead of the measles, mumps, and rubella (MMR vaccine) at their visit on 15Nov2021. Caller stated the patient was mistakenly administered the MENACTRA vaccine and was not sure what to do. Caller did state that the patient has not received any other prior dose of MENACTRA. Caller mentioned that her clinic only administers MENACTRA to patients older than 11 years of age. Agent did inform caller that MENACTRA is approved for ages 9 months to 55 years of age, and that primary vaccination in children 9 through 23 months of age is 2 doses 3 months apart. Caller was provided with the normal adverse effects of MENACTRA on children 9 through 12 months of age."  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.