chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: patient experienced COVID and considering to take Paxlovid; patient experienced COVID and considering to take Paxlovid; Dose 5 administered with Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient experienced COVID and considering to take Paxlovid"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose 5 administered with Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical information: It was reported that, she explained that she had taken four doses of the Pfizer COVID-19 Vaccine and the original primary series and two booster doses and that every dose made her very sick and each one made more sick then the one before. She suspects that this reaction was caused by gluten or an egg-derived ingredient. In order to take Paxlovid, she wanted to make sure that this medication does not contain any gluten. She described to be already very sick from COVID. She also said that she took a third booster dose (last dose) from Moderna, and that vaccine did not make her sick at all. So, the patient was trying to find a Moderna Bivalent booster to take, and she did find where they are. The patient just didn't have time to get the booster before she came down with COVID.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, SARS-CoV-1 test
Clinical narrative: sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (unspecified if ongoing), notes: tested positive once and the first time was Jan2020; "COVID", start date: Apr2020 (unspecified if ongoing), notes: got delta in late Apr2020 and not yet vaccinated. Lasted until 1st, dose of Pfizer vaccine May2021; "monkey pox" (unspecified if ongoing), notes: Got in this Jun and had monkey pox and felt like getting better after 3 weeks; "Long COVID" (unspecified if ongoing), notes: long Covid and lost sense of smell and all the symptoms with 1st round of Covid and were mild sympts; "Covid-19" (unspecified if ongoing), notes: They had Covid several times; "Hydrocele like a build of lymphatic fluid in the" (unspecified if ongoing), notes: Hydrocele like a build of lymphatic fluid in the scrotum. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; MELATONIN; PEPCID AC; REISHI MUSHROOM; TURKEY TAIL MUSHROOM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM. Vaccination history included: BNT162b2 (Manufacturer: Pfizer, NDC: Unknown, Lot: EW0175, Expiration: Unknown), administration date: 27Apr2021, when the patient was 40-year-old, for Covid-19 immunization, reaction(s): "diarrhea", "Illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sickness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. They got vaccinated in May2021 and got sick between vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204867 similar report from same reporter;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (unspecified if ongoing), notes: tested positive once and the first time was Jan2020; "COVID", start date: Apr2020 (unspecified if ongoing), notes: got delta in late Apr2020 and not yet vaccinated. Lasted until 1st, dose of Pfizer vaccine May2021; "monkey pox" (unspecified if ongoing), notes: Got in this Jun and had monkey pox and felt like getting better after 3 weeks; "Long COVID" (unspecified if ongoing), notes: long Covid and lost sense of smell and all the symptoms with 1st round of Covid and were mild sympts; "Covid-19" (unspecified if ongoing), notes: They had Covid several times; "Hydrocele like a build of lymphatic fluid in the" (unspecified if ongoing), notes: Hydrocele like a build of lymphatic fluid in the scrotum. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; MELATONIN; PEPCID AC; REISHI MUSHROOM; TURKEY TAIL MUSHROOM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM. Vaccination history included: BNT162b2 (Manufacturer: Pfizer, NDC: Unknown, Lot: EW0175, Expiration: Unknown), administration date: 27Apr2021, when the patient was 40-year-old, for Covid-19 immunization, reaction(s): "diarrhea", "Illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sickness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. They got vaccinated in May2021 and got sick between vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204867 similar report from same reporter;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, SARS-CoV-1 test
Clinical narrative: second round of delta and did not get tested and was sick with family; second round of delta and did not get tested and was sick with family; This is a spontaneous report received from a contactable reporter (consumer), Program ID. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 27Apr2021 as dose 1, single (lot number EW0175) and on 19May2021 as dose 2, single (lot number EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "covid", start date: Jan2020 (unspecified if ongoing), notes: several times and only tested positive once; symptoms were extreme fatigue; "long Covid" (unspecified if ongoing), notes: lost sense of smell and all the symptoms with the first round of Covid and were mild symptoms; "got delta", start date: Apr2020 (unspecified if ongoing), notes: fatigue and ongoing body aches; "third time" (unspecified if ongoing), notes: diarrhea for 6 months from Apr2021 and was pretty bad symptoms; "asthma" (unspecified if ongoing), notes: mild and has exacerbated her reaction to the virus; "endocrine disorder/hormonal disorder" (unspecified if ongoing), notes: undiagnosed and she treats herself and she has tried with doctors and no answer; caused by the fact she was overexposed to Benzyl in fabric softener; "overexposed to Benzyl in fabric softener" (unspecified if ongoing), notes: causes severe reaction in newborns and she was 2 weeks and 2 days. There were no concomitant medications. Past drug history included: Tylenol, reaction: "severe hormonal reaction", notes: can't take Tylenol because she will have a severe hormonal reaction. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) both with onset Nov2021, outcome "unknown" and described as "second round of delta and did not get tested and was sick with family". Clinical course information: The patient had Covid several times and only tested positive once and the first time was Jan2020, symptoms were extreme fatigue. She had long Covid and lost sense of smell and all the symptoms with the first round of Covid and were mild symptoms. She got delta in late Apr2020 and not yet vaccinated; fatigue and ongoing body aches. Then third time was diarrhea "for 6 months from Apr2021" (as reported) and was pretty bad symptoms till she got the first shot (as reported) and with first shot went away within a week, was couple of days but will say a week. At the end of Nov2021 and the second round of delta and did not get tested and was sick with family and did not want to wait in line. Among people they did not want to go outside because no one was wearing masks.  Follow-up attempts are completed. No further information is expected.  Follow-up (12Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201205231 same patient/product, different vaccine dose/event;US-PFIZER INC-202201204632 same patient/product/event, different vaccine doses;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: second round of delta and did not get tested and was sick with family; second round of delta and did not get tested and was sick with family; This is a spontaneous report received from a contactable reporter (consumer), Program ID. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 27Apr2021 as dose 1, single (lot number EW0175) and on 19May2021 as dose 2, single (lot number EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "covid", start date: Jan2020 (unspecified if ongoing), notes: several times and only tested positive once; symptoms were extreme fatigue; "long Covid" (unspecified if ongoing), notes: lost sense of smell and all the symptoms with the first round of Covid and were mild symptoms; "got delta", start date: Apr2020 (unspecified if ongoing), notes: fatigue and ongoing body aches; "third time" (unspecified if ongoing), notes: diarrhea for 6 months from Apr2021 and was pretty bad symptoms; "asthma" (unspecified if ongoing), notes: mild and has exacerbated her reaction to the virus; "endocrine disorder/hormonal disorder" (unspecified if ongoing), notes: undiagnosed and she treats herself and she has tried with doctors and no answer; caused by the fact she was overexposed to Benzyl in fabric softener; "overexposed to Benzyl in fabric softener" (unspecified if ongoing), notes: causes severe reaction in newborns and she was 2 weeks and 2 days. There were no concomitant medications. Past drug history included: Tylenol, reaction: "severe hormonal reaction", notes: can't take Tylenol because she will have a severe hormonal reaction. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) both with onset Nov2021, outcome "unknown" and described as "second round of delta and did not get tested and was sick with family". Clinical course information: The patient had Covid several times and only tested positive once and the first time was Jan2020, symptoms were extreme fatigue. She had long Covid and lost sense of smell and all the symptoms with the first round of Covid and were mild symptoms. She got delta in late Apr2020 and not yet vaccinated; fatigue and ongoing body aches. Then third time was diarrhea "for 6 months from Apr2021" (as reported) and was pretty bad symptoms till she got the first shot (as reported) and with first shot went away within a week, was couple of days but will say a week. At the end of Nov2021 and the second round of delta and did not get tested and was sick with family and did not want to wait in line. Among people they did not want to go outside because no one was wearing masks.  Follow-up attempts are completed. No further information is expected.  Follow-up (12Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201205231 same patient/product, different vaccine dose/event;US-PFIZER INC-202201204632 same patient/product/event, different vaccine doses;
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Computerised tomogram, Computerised tomogram thorax, Echocardiogram, Ejection fraction
Clinical narrative: BNT162B2 MRNA booster vaccine related pericarditis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "BNT162B2 MRNA booster vaccine related pericarditis". The event "bnt162b2 mrna booster vaccine related pericarditis" required physician office visit.  CASE PRESENTATION: 72 year old female, previously well, who presented with a 3 day history of central, sticking chest pain associated with exertional dyspnea, cough, palpitations and malaise. She denied any coryzal symptoms. On presentation she was hemodynamically stable but hypoxic and tachycardic. Laboratory investigations revealed leucocytosis and troponinemia of 0.13ng/ml. ECG showed diffuse ST elevations. A transthoracic echo showed a small pericardial effusion with normal LV and RV function, EF 60-65% and a CT Pulmonary Angiogram revealed a small sub-segmental pulmonary embolism with atelectasis and trace effusions. On further questioning she revealed that the symptoms started 3 days after she received her 2nd booster dose of the Pfizer covid vaccine. She was started on colchicine and apixaban and was discharged home with follow- up. Two days after discharge the patient represented to the hospital with worsening chest pain. Investigations revealed worsening leucocytosis and increased inflammatory markers (CRP 303mg/L, ESR 62mm/h). A new finding of a small pericardial effusion and bilateral pleural effusions with consolidations were noted on a repeat CT scan. Decision was made to continue colchicine and commence prednisone. Other infectious and inflammatory causes of pericarditis were ruled out. The COVID spike IgG was negative and the NAAT Cov 2 IgG showed titres >250 (<50).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event of pericarditis and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: COVID19
Symptoms: Electrocardiogram, Inflammatory marker test, Investigation, Nucleic acid test, Pericarditis
Clinical narrative: BNT162B2 MRNA booster vaccine related pericarditis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "BNT162B2 MRNA booster vaccine related pericarditis". The event "bnt162b2 mrna booster vaccine related pericarditis" required physician office visit.  CASE PRESENTATION: 72 year old female, previously well, who presented with a 3 day history of central, sticking chest pain associated with exertional dyspnea, cough, palpitations and malaise. She denied any coryzal symptoms. On presentation she was hemodynamically stable but hypoxic and tachycardic. Laboratory investigations revealed leucocytosis and troponinemia of 0.13ng/ml. ECG showed diffuse ST elevations. A transthoracic echo showed a small pericardial effusion with normal LV and RV function, EF 60-65% and a CT Pulmonary Angiogram revealed a small sub-segmental pulmonary embolism with atelectasis and trace effusions. On further questioning she revealed that the symptoms started 3 days after she received her 2nd booster dose of the Pfizer covid vaccine. She was started on colchicine and apixaban and was discharged home with follow- up. Two days after discharge the patient represented to the hospital with worsening chest pain. Investigations revealed worsening leucocytosis and increased inflammatory markers (CRP 303mg/L, ESR 62mm/h). A new finding of a small pericardial effusion and bilateral pleural effusions with consolidations were noted on a repeat CT scan. Decision was made to continue colchicine and commence prednisone. Other infectious and inflammatory causes of pericarditis were ruled out. The COVID spike IgG was negative and the NAAT Cov 2 IgG showed titres >250 (<50).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event of pericarditis and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Troponin
Clinical narrative: BNT162B2 MRNA booster vaccine related pericarditis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "BNT162B2 MRNA booster vaccine related pericarditis". The event "bnt162b2 mrna booster vaccine related pericarditis" required physician office visit.  CASE PRESENTATION: 72 year old female, previously well, who presented with a 3 day history of central, sticking chest pain associated with exertional dyspnea, cough, palpitations and malaise. She denied any coryzal symptoms. On presentation she was hemodynamically stable but hypoxic and tachycardic. Laboratory investigations revealed leucocytosis and troponinemia of 0.13ng/ml. ECG showed diffuse ST elevations. A transthoracic echo showed a small pericardial effusion with normal LV and RV function, EF 60-65% and a CT Pulmonary Angiogram revealed a small sub-segmental pulmonary embolism with atelectasis and trace effusions. On further questioning she revealed that the symptoms started 3 days after she received her 2nd booster dose of the Pfizer covid vaccine. She was started on colchicine and apixaban and was discharged home with follow- up. Two days after discharge the patient represented to the hospital with worsening chest pain. Investigations revealed worsening leucocytosis and increased inflammatory markers (CRP 303mg/L, ESR 62mm/h). A new finding of a small pericardial effusion and bilateral pleural effusions with consolidations were noted on a repeat CT scan. Decision was made to continue colchicine and commence prednisone. Other infectious and inflammatory causes of pericarditis were ruled out. The COVID spike IgG was negative and the NAAT Cov 2 IgG showed titres >250 (<50).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event of pericarditis and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Fatigue, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: She can be susceptible to seasonal allergies. First 10 years in (withheld) had weekly allergy shot; "sinus problems" (unspecified if ongoing), notes: She had sinus problems; "pituitary cyst" (unspecified if ongoing), notes: Cyst found accidentally and discovered contrast dye to do contrast dye MRI is bad on her kidney. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had 4 years of underwent MRI and no need to do it anymore. That is her decision because she needs her kidneys. That drug was under investigation for kidney problems. She has not done MRI since Dec2020. All previous were Pfizer COVID vaccines. Did all at the same site as well. 1st dose of Pfizer COVID vaccine 13Feb2021, Lot EN6201. She thinks it was right arm because she is left-handed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: sore arm; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: She can be susceptible to seasonal allergies. First 10 years in (withheld) had weekly allergy shot; "sinus problems" (unspecified if ongoing), notes: She had sinus problems; "pituitary cyst" (unspecified if ongoing), notes: Cyst found accidentally and discovered contrast dye to do contrast dye MRI is bad on her kidney. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had 4 years of underwent MRI and no need to do it anymore. That is her decision because she needs her kidneys. That drug was under investigation for kidney problems. She has not done MRI since Dec2020. All previous were Pfizer COVID vaccines. Did all at the same site as well. 1st dose of Pfizer COVID vaccine 13Feb2021, Lot EN6201. She thinks it was right arm because she is left-handed.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Prolonged anaphylaxis to pfizer coronavirus disease 2019 vaccine; This is a literature report.  A 55-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Prolonged anaphylaxis to pfizer coronavirus disease 2019 vaccine".; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Anaphylactic reaction cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasal congestion
Clinical narrative: Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2; second vaccine shot 4 weeks later after dose 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 03 (Booster); first Pfizer booster Sep2021), administration date: Sep2021, for COVID-19 immunization; Bnt162b2 (Dose: 04 (Booster); second booster Mar2022.), administration date: Mar2022, for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown". Additional information: Patient and her husband received the first Pfizer vaccine Jan2021 and second vaccine shot 4 weeks later. They received the first Pfizer booster Sep2021 and the second booster Mar2022. They got the new omicron booster 12Sep2022. They were go happy to remain COVID free until 5 days ago. They looked forward to the new vaccine to protect them from the omicron variant. Their symptoms have been nothing more that nasal congestion, but wanted to pass on the information about the new booster fail.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2; second vaccine shot 4 weeks later after dose 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 03 (Booster); first Pfizer booster Sep2021), administration date: Sep2021, for COVID-19 immunization; Bnt162b2 (Dose: 04 (Booster); second booster Mar2022.), administration date: Mar2022, for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown". Additional information: Patient and her husband received the first Pfizer vaccine Jan2021 and second vaccine shot 4 weeks later. They received the first Pfizer booster Sep2021 and the second booster Mar2022. They got the new omicron booster 12Sep2022. They were go happy to remain COVID free until 5 days ago. They looked forward to the new vaccine to protect them from the omicron variant. Their symptoms have been nothing more that nasal congestion, but wanted to pass on the information about the new booster fail.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Vaccination failure
Clinical narrative: Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2; second vaccine shot 4 weeks later after dose 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 03 (Booster); first Pfizer booster Sep2021), administration date: Sep2021, for COVID-19 immunization; Bnt162b2 (Dose: 04 (Booster); second booster Mar2022.), administration date: Mar2022, for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown". Additional information: Patient and her husband received the first Pfizer vaccine Jan2021 and second vaccine shot 4 weeks later. They received the first Pfizer booster Sep2021 and the second booster Mar2022. They got the new omicron booster 12Sep2022. They were go happy to remain COVID free until 5 days ago. They looked forward to the new vaccine to protect them from the omicron variant. Their symptoms have been nothing more that nasal congestion, but wanted to pass on the information about the new booster fail.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: Patient had the two original vaccinations and one booster for COVID, the last one being Oct2021. Patient experienced nausea and vomiting for all three and really took about three days to recover from each shot. Patient tried the Moderna shot last week and still got sick but not quite as badly. Patient was wondering if suffered an allergic reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: A little redness and itchiness near injection site; A little redness and itchiness near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "A little redness and itchiness near injection site". Additional information: A little redness and itchiness near injection site after COVID vaccine bivalent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Pain, Pain in extremity
Clinical narrative: Body pain; Arm and armpit sore; Arm and armpit sore; Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from a sales representative. A 35-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: Unknown) at the age of 35 years for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete: Unknown manufacturer) for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovering", described as "Body pain", PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), outcome "recovering" and all described as "Arm and armpit sore", BACK PAIN (non-serious), outcome "not recovered".  Additional information: Patient side effects occurred within first 24 hrs and began to diminish the next day. The next day the body pain was better except for the back. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Off label use
Clinical narrative: Tiredness; Mild headache; Chills; Achiness; receiving bivalent booster (5th dose); receiving bivalent booster (5th dose); This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4, SINGLE, UNKNOWN MANUFACTURE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Achiness"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "receiving bivalent booster (5th dose)". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Tiredness; Mild headache; Chills; Achiness; receiving bivalent booster (5th dose); receiving bivalent booster (5th dose); This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4, SINGLE, UNKNOWN MANUFACTURE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Achiness"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "receiving bivalent booster (5th dose)". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Tracheal inflammation, Urticaria
Clinical narrative: swelling of windpipe and lips; hives; swelling of the eyes; swelling of windpipe and lips; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: lsaacs disease (unspecified if ongoing), notes: lsaacs disease; BP (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: TRACHEAL INFLAMMATION (hospitalization), LIP SWELLING (hospitalization), outcome "unknown" and all described as "swelling of windpipe and lips"; URTICARIA (hospitalization), outcome "unknown", described as "hives"; EYE SWELLING (hospitalization), outcome "unknown", described as "swelling of the eyes". The patient was hospitalized for lip swelling, eye swelling (hospitalization duration: 2 day(s)).  Clinical information: In middle of night, patient experienced swelling of windpipe and lips. The second day she had hives and swelling of the eyes. Had to be hospitalized for 2 days. Optional Information includes lsaacs disease, was on 2 BP meds. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling of the face; Rash; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of the face"; RASH (non-serious), outcome "unknown". The events "swelling of the face" and "rash" required physician office visit. Additional information: Patient experienced swelling of the face and rash. Patient has a history of asthma and was sent to an allergist. Event took place after use of product. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Memory loss after vaccination; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "Memory loss after vaccination".  Additional information: Description of Event: Memory loss after vaccination. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient got a positive result to Covid19 virus; patient got a positive result to Covid19 virus; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 21-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "patient got a positive result to Covid19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: On Saturday the patient got a positive result to Covid19 virus.  Clinical course: Last Tuesday the patient received the Bivalent Covid19 vaccine (gray cap) and on Saturday the patient got a positive result to Covid19 virus. Caller would like to know if the patient needs to be revaccinated after 3 months or the vaccine is still on the patient's body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems after getting the vaccine".  Additional information: Event Awareness Date: 09Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Condition aggravated, Fall, Fatigue
Clinical narrative: Unable to walk/couldn't move legs; had to contrite hard just to walk, then I just got worse.; Harder to keep my balance; Weaker; Feeling extremely tired all the time; Kept falling; Hands would ache; I started to drop things and it was difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A 30-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "not recovered", described as "Unable to walk/couldn't move legs"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had to contrite hard just to walk, then I just got worse."; BALANCE DISORDER (non-serious), outcome "unknown", described as "Harder to keep my balance"; ASTHENIA (non-serious), outcome "unknown", described as "Weaker"; FATIGUE (non-serious), outcome "unknown", described as "Feeling extremely tired all the time"; FALL (non-serious), outcome "unknown", described as "Kept falling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hands would ache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I started to drop things and it was difficult".  Additional information Description of Event Outcome: It was started after getting your vaccine. Reporter is 30-year-old. Who has been unable to walk since Mar. Reporter started walking funny start in Nov last year. Reporter started walking width and it was starting for the reporter to be harder to keep the balance. Reporter started getting weaker and feeling extremely tired all the time. Reporter had to contrite hard just to walk, then reporter just got worse. Reporter kept falling and eventually reporter stop walking. Reporter could not move legs and my hands would ache. Reporter started to drop things and it was difficult.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.