chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: second dose outside of 42 days; diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer COVID vaccine on 15Mar2021 and then diagnosed with COVID-19 on 29Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Mar2021. The reporter was calling on 10May2021 and wanted to find out when could the patient receive the second dose of the Pfizer COVID vaccine. The outcome of the events was unknown.  Information on the  lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and COVID-19 and the suspect drug.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Coombs test, Immune thrombocytopenia
Clinical narrative: autoimmune (Coombs positive) hemolytic anemia; idiopathic thrombocytopenia purpura; This is a spontaneous report from a contactable physician. An 89-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The patient experienced autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura in Mar2021 with outcome of recovered in 2021.  The patient was hospitalized for both events from 2021 to an unknown date. The patient received Prednisone, IVIG as treatment. The events also resulted in Emergency room/department or urgent care and considered as Life threatening illness (immediate risk of death from the event).  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral
Clinical narrative: Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 10:30AM, as 1ST DOSE, SINGLE for covid-19 immunization. Patient did not have medical history and no known allergy. Concomitant medication's included meloxicam and Multivitamins. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02May2021, (reportedly patient stated that, 8 days after the vaccination), his tongue felt fat, and had lips numb. 2 days later symptoms spread. By Wednesday 05May2021 his face was paralyzed. He went to my physician the next morning and was told he have Bell's palsy. Patient states that, my face may never be normal again. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of adverse events as prednisone 20 mg twice a day. Outcome of the events was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Deep vein thrombosis, Laboratory test
Clinical narrative: DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death/natural process
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death/natural process
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: had 2 seizures; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 2nd dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 1st dose, single for COVID-19 immunization. The patient had 2 seizures after receiving his 2nd dose of the Pfizer vaccine. The seizures occurred approximately 15 hours after the vaccine was given. He has no underlying seizure condition. The event was reported as serious for Life-threatening. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient was hospitalized for an episode of A-fib; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via intramuscularly, in Arm Left, on 29Apr2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included that she was diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lurasidone hydrochloride (LATUDA), Metoprolol, Lorazepam, rivaroxaban (XARELTO), Quetiapine, Bupropion, Oxybutynin, Atorvastatin, Diltiazem, Losartan, Gabapentin and Furosemide. Since the vaccination, the patient was not tested for COVID-19. It was reported that on 03May2021, the patient was hospitalized for an episode of A-fib which resulted in emergency room/department or urgent care. The patient was hospitalized due to the event from an unspecified date in May2021 to an unspecified date in May2021. Device date was reported as 11May2021. Outcome of the event was recovered with sequel.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: drug allergy; Initial information was received on 03-May-2021 regarding an unsolicited valid non-serious case received from a consumer or other non-professional (from Novartis Pharmaceuticals Corporation).  This case involves a 66-year-old female patient who had drug allergy (drug hypersensitivity), after receiving TETANUS TOXOID.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious drug allergy (drug hypersensitivity), (unknown latency) following the administration of TETANUS TOXOID.  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 event (drug allergy).  At time of reporting, the outcome was unknown for the event drug hypersensitivity.  Result of assessment was reported as not reported.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: Patient received only received the IPV and DTAP and not the HIB portion, while patient received a first dose of PENTACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via Agency (Reference number- 00577561) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 2 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: U6842BA, expiry date: 05-Jul-2021 and other dosing details were not reported] on 06-Apr-2021 for prophylactic vaccination (product preparation issue).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box.   It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial.   At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not.   Reporter said one option was to do titer but not sure they will be accurate, but the patient was only 2 months old, so reporter prefer not to do a blood draw.   At the time of report, no adverse event was 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.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 11 year and 5 month old patient who was supposed to receive Tdap but was given Daptacel instead with no reported adverse event; a 11 year and 5 month old patient a dose of Daptacel with no reported adverse event; The patient already had 5 previous doses DAPTACEL and received sixth dose of DAPTACEL instead of Tdap  with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00588679) and transmitted to Sanofi on 05-May-2021.  This case involves experienced a 11 year and 5 month old patient (gender unspecified) who was supposed to receive DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [Tdap] [lot number, expiry date and other dosing details were not applicable] but was received sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] [lot number, expiry date and other dosing details were not reported] instead (wrong product administered, product administered to patient of inappropriate age and extra dose administered).  Medical history, medical treatment, family history and concomitant medication were not reported.  It was reported that, the patient already had 5 previous doses of Daptacel vaccine.   It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. (latency: same day)  At the time of report, no adverse event was reported.  At the time of report, reporter would like to know about any safety information and any long-term effect information.    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.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: nurse asks if expired Menactra dose that she administered needs to be repeated with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Medical Information (GMI) (Reference number- 00594513) and transmitted to Sanofi on 10-May-2021.  This case involves a 20-year old female patient for whom nurse asked if expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] dose that she administered needs to be repeated (expired product administered) on 06-May-2021 (lot number: U6576AA and expiration date: 04-Apr-2021] at an 0.5 ml once dose via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported, and concomitant vaccination included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]).  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case from was received on 11-Nov-2020 from other non-health professional (reference number: NVSC2020US019771) and concerned 53-year-old female patient.  The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient developed cough.  The outcome of the event was not reported.   The reporter assessed the event as related to influenza virus vaccine. The reporter stated that the she developed cough and that it was from getting her flu shot.  The case was assessed as non-serious.   The case is linked to the case 202006190 (the same patient).  Company comment: A 53-year-old female patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine, the patient developed cough. The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. More information regarding temporal relationship, diagnostic findings and medical history is needed. With information available, causality cannot be excluded and is assessed as possibly related.; Reporter's Comments: Patient had a cough, states it is from getting her flu shot.; Sender's Comments: A 53-year-old female patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine, the patient developed cough. The patient's historical vaccines included influenza virus vaccines after which the patient always felt like she was coming down with a cold. More information regarding temporal relationship, diagnostic findings and medical history is needed. With information available, causality cannot be excluded and is assessed as possibly related.
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: She always feels like she is coming down with a cold when she gets it; This spontaneous case was received on 11-Nov-2020 from other non-health professional (reference number: NVSC2020US019771) and concerned a female patient of unspecified age. At the time of this report the patient was 53-year-old.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient felt like she was coming down with a cold.  The outcome of the event was not reported.   The reporter assessed the event as related to influenza virus vaccine. The reporter stated that she always felt like she was coming down with a cold when she got the vaccine.  The case was assessed as non-serious.   This case is linked to the case 202006189 (the same patient).  Company comment: The patient experienced nasopharyngitis on an unspecified date after administration of influenza virus vaccine polyvalent. The patient's medical history and concomitant medications were not provided. Causality is unassessable due to lack of reported information.; Reporter's Comments: She always feels like she is coming down with a cold when she gets it.; Sender's Comments: The patient experienced nasopharyngitis on an unspecified date after administration of influenza virus vaccine polyvalent. The patient's medical history and concomitant medications were not provided. Causality is unassessable due to lack of reported information.
Sex: F
Vaccine: FLUX
Symptoms: Local reaction
Clinical narrative: A large local reaction; This spontaneous case was received on 12-Nov-2020 from physician via Communications (reference number: SEQW20-05057) and concerned an adult, female patient. The patient's age at the time of reporting was 24 years.   The patient's medical history and concomitant medications were not reported. The patient reported having a large local reaction to Flucelvax (influenza vaccine, subunit influenza virus vaccine polyvalent) back in 2019.   On unspecified date in 2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specifed, indication, dose, anatomical location and route of administration: not reported). The batch number was not reported. The reporter was unsure if this year's vaccine was even Flucelvax.   On unspecified date in 2020, a few days after receiving influenza virus vaccine polyvalent, the patient was having a large local reaction.   The outcome of the event was not reported.  The reporter assessed the event as not related to influenza virus vaccine polyvalent. The reporter did not think this time it was related to the vaccine.  This case is linked to 202006324 (the same patient).  Company comment:The patient developed local reaction several days after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The reporter did not think this time it was related to the vaccine.; Sender's Comments: The patient developed local reaction several days after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches; Slight fever; This spontaneous case was received on 20-Nov-2020 from other non-health professional via Communication (reference number: SEQW20-05327) with additional document received on 24-Nov-2020 (being processed together) and concerned a male patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2019, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication, anatomical location: not reported) at the pharmacy. The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect varicella zoster vaccine (shingles vaccine) (brand not specified; dose, route of administration, indication, anatomical location: not reported) at the pharmacy. The batch number was not reported.  On an unspecified date in 2019, unknown amount of time after receiving influenza virus vaccine polyvalent and varicella zoster vaccine, the patient developed slight fever and muscle aches for a day or so.  On an unspecified date in 2019, the patient recovered from the events.  The reporter did not provide causality assessment.  Company comment: The events of 'muscle ache' and 'slight fever' are assessed as related to influenza virus vaccine polyvalent.; Sender's Comments: The events of 'muscle ache' and 'slight fever' are assessed as related to influenza virus vaccine polyvalent.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was received on 27-Nov-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-05445) and concerned an adult male patient. At the time of this report, the patient was 83-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date (reported as many years ago), the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed flu like symptoms that lasted for one day.  On an unspecified date, one day after the onset, the patient recovered from the event.  The reporter did not provide a causality assessment.  The reporter assessed this case as non-serious.  This case is linked with the case 202007420 (the same patient).  Company comment:The patient developed influenza like illness on an unspecified date and unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.; Sender's Comments: The patient developed influenza like illness on an unspecified date and unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Injection site warmth
Clinical narrative: Feel like he had flu after injection; Warm feeling at the site; This spontaneous case was received on 03-Dec-2020 via Communications (reference number: SEQW20-05553), reported by other non-health professional (consumer) via and concerned a male patient of an unreported age.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, anatomical location and dose: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced a warm feeling at the site and felt like he had the flu after injection.  The outcome of the events was not reported.  The reporter assessed the event to be related to influenza virus vaccine polyvalent. The reporter has had a reaction in the past with flu vaccines and he was trying to figure out which ingredient could have caused the reaction.  Company comment: A patient of an unreported age was administered influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced vaccination site warmth and influenza like illness. Although chronology needs more clarification, causality is assessed as possibly related for both events.; Reporter's Comments: The reporter has had a reaction in the past with flu vaccines and he was trying to figure out which ingredient could have caused the reaction.; Sender's Comments: A patient of an unreported age was administered influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced vaccination site warmth and influenza like illness. Although chronology needs more clarification, causality is assessed as possibly related for both events.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Her arm had been sore and painful; This spontaneous case was received on 07-Dec-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-05636) and concerned a female patient of unknown age. At the time of reporting, the patient was 84-year-old.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.   On an unknown date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful but not for long period of time as in case 202007547.   On an unknown date, the patient recovered from the event of 'painful arm'.  The reporter did not provide a causality assessment to influenza virus vaccine polyvalent.  This case is linked to case 202007547 (due to the same patient and reporter).  Company comment: A patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful. Causality is assessed as possibly related for pain in extremity.; Sender's Comments: A patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful. Causality is assessed as possibly related for pain in extremity.
Sex: M
Vaccine: FLUX
Symptoms: Ear discomfort, Ear swelling
Clinical narrative: Having issue with my left ear (feel swollen/clogged); Having issue with my left ear (feel swollen/clogged); This spontaneous case was received on 09-Dec-2020 via Communications (reference number: SEQW20-05657), reported by other non-health professional (consumer) and concerned a male patient of an unreported age.  The patient's relevant medical history and concomitant medications were not reported.  On an unreported date in Sep-2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unreported date in 2020, about one week after receiving influenza virus vaccine, the patient experienced issue with his left ear (feel swollen/clogged).  On an unreported date in 2020, the patient went to ear, nose, throat (ENT) doctor who confirmed there was no infection.  At the time of initial reporting on 09-Dec-2020, the patient did not recover from the events, since he was having symptoms for about three months.   The reporter did not provide a causality assessment to influenza virus vaccine.  Company comment: A patient experienced ear discomfort and ear swelling one week after administration of influenza virus vaccine polyvalent. The patient's relevant medical history and concomitant medications were not reported. ENT doctor confirmed there were no presence of infection. Causality is assessed as possibly related to vaccine due to lack of confounding factors.; Sender's Comments: A patient experienced ear discomfort and ear swelling one week after administration of influenza virus vaccine polyvalent. The patient's relevant medical history and concomitant medications were not reported. ENT doctor confirmed there were no presence of infection. Causality is assessed as possibly related to vaccine due to lack of confounding factors.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills, tiredness and achy muscles
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I have noticed a change in my menstrual cycle for 2 cycles post the vaccine 1st and 2nd docse The 2 cycles have had reduced flows, a reduction of approximately 50%.  I will continue to monitor if the change persists.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Profuse menstruale bleeding for a prolonged time.  Not at scheduled menstraul time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT REPORT FEELING LIGHT HEADED AFTER VACCINATION, PATIENT EXPLAINED THAT SHE HAS A HISTORY OF FEELING FAINT WHEN GIVING BLOOD AND OTHER VACCINATION. PATIENT LAID DOWN AND ELEVATED LEGS, AND IMPROVED WITHIN A FEW MIN. PROVIDED PATIENT WITH OJ TO HELP WITH SUGAR. MONITORED FOR 30 MIN. FOLLOW UP CALL WITH PATIENT AT END OF THE DAY, PATIENT REPORT NO SYMP AND BACK TO NORMAL
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: few minutes after shot got warm , then her anxiety kicked in so she had a feeling of faintness---had her lie on floor, put fan on her for cooling & gave cold bottle of water--after a few more minutes felt well enough to sit back in chair--then waited remianing of 30 min & was ok after that to leave
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chest X-ray, Chills, Computerised tomogram, Electrocardiogram
Clinical narrative: Received the 2nd vaccine 4/15/21 I had fever, muscle aches, chills, fatigue, headache for 2 days. On 5/9/2021 I had a Bell?s palsy episode never had any issue like this before. I did go to my local er expressed my concerns this was a reaction to the vaccine but that was blown off.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test, Pain, Pyrexia
Clinical narrative: Received the 2nd vaccine 4/15/21 I had fever, muscle aches, chills, fatigue, headache for 2 days. On 5/9/2021 I had a Bell?s palsy episode never had any issue like this before. I did go to my local er expressed my concerns this was a reaction to the vaccine but that was blown off.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Nausea, tiredness, headache, no appetite. Lasting 36 hours and starting 12 hours after vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Hypertension, Nausea
Clinical narrative: Itchy throat body Body flushed  Chest tightness  Throat tightness  Tachycardia  Hypertension  Nausea SOB
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat irritation, Throat tightness
Clinical narrative: Itchy throat body Body flushed  Chest tightness  Throat tightness  Tachycardia  Hypertension  Nausea SOB
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Itchy throat body Body flushed  Chest tightness  Throat tightness  Tachycardia  Hypertension  Nausea SOB
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Medium
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Tachycardia, Throat tightness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Medium
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: paramedics came to check out patient and he was ok
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypertension, Tremor
Clinical narrative: Systemic: Chills-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Injection site hypoaesthesia, Injection site pain
Clinical narrative: MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen  through 5 days
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Loss of consciousness, Mobility decreased, Neck pain
Clinical narrative: MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen  through 5 days
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen  through 5 days
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Additional Details: Patient began to experience generalized itchiness within 15 minutes post vaccination.  Gave Benadryl 25 mg po at 7:15pm.  Patient began to improve after 15 minutes and was released with directions to return or seek medical care if condition worsened.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Condition aggravated, Headache, Myalgia
Clinical narrative: Headache, muscle pain, weakness, high temp. Drank water continuously.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: Heavy menstrual bleeding, large and excessive menstrual blood clots
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Headache-Mild, Additional Details: Rash presented at injection site to top of shoulder, the size of a deck of cards.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: High fever, chills, shorten breathe, dizziness, fatigue, muscle spasms, joint pain
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: High fever, chills, shorten breathe, dizziness, fatigue, muscle spasms, joint pain
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: while patient was waiting out in the waiting area for their 15 minute monitoring session the patient passed out and fell to the floor. The patient did not injure himself with falling to the floor and woke up immediately after he passed out. We immediately put ice packs on him and had him drink a bottle of water while sitting on the floor and made him stay in the waiting area until his color came back in his face and felt fine to go home. He was extremely nervous about getting the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations made worse when breath is held.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Dizziness, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: cellulitis-Medium, Additional Details: pt ended getting keflex
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Pt. received vaccine around 1930. She stated on 5/12/21 that she did not sit down for the full 15 minutes and left after approximately 5 to 10 minutes. She stated she began to have chest tightness and difficulty breathing. She was brought to an ambulatory care room by pharmacy technician and laid down. I observed her for approximately 10 minutes and took her blood pressure (124/83, pulse 90). She stated that she was able to breathe okay, but her chest was still tight. No known harm.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site haemorrhage, Injection site reaction, Pyrexia
Clinical narrative: First shot: tired, low grade fever Second shot: I bled from vaccine immediately and had blood running down my arm before he could put the bandaid on. I woke up the next day with a big bruise at vaccine site
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: I am experiencing VERY, VERY heavy menstrual bleeding and cramping. My period came 9 days early which is also HIGHLY unusual. My cycle is so regular that you could set your watch by it. I do not experience cramping or this heavy of a blood flow EVER. I am 41 years old, I have had my period since I was 10, so I know my body and my cycle pretty well by now. This is not normal and after consulting  my gynecologist, we feel this is not something that is "wrong" with me, but a side effect from the vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt. began to feel dizzy after receiving the shot. He states that this is a normal reaction for him and he always feels dizzy and anxious after receiving an injection. Pt. laid down on the floor and elevated his legs shortly after announcing he was dizzy. He was given water to drink. He got back up several minutes later and was fine.