chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Lymphoma, SARS-CoV-2 test, Waldenstrom's macroglobulinaemia
Clinical narrative: approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; This is a spontaneous report from a contactable consumer (patient). A  71-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 24May2021 (Batch/Lot Number: ET6924) at an unspecified dose and  dose 2 via an unspecified route of administration in the left arm on 14Jun2021 (Batch/Lot Number: FC2396) as an unspecified dose for COVID-19 immunisation. Medical history included alpha Thal - HTN (hypertension) from an unknown date and unknown if ongoing , macular degeneration from an unknown date and unknown if ongoing, history of hepatitis B  from an unknown date reported as "50 years ago" and unknown if ongoing. Concomitant medication included candesartan (CANDESARTAN) taken for an unspecified indication, start and stop date were not reported; nebivolol (NEBIVOLOL) taken for an unspecified indication, start and stop date were not reported.  The patient's allergies included sulfa. The patient had received no other vaccines within four weeks. The patient was not diagnosed with COVID-19  prior to vaccination. Approximately 3 months post 2nd vaccination, the patient's hemoglobin dropped  from 12.5 to 6; upon further workup the patient was diagnosed with a lymphoma, Waldenstorm's macroglobulinemia on 28Oct2021 with outcomes of unknown.  The patient was hospitalized for 2 days.  Since the vaccination the patient has been tested for COVID-19; he was rt-pcr: negative on 17Nov2021 via  Nasal Swab.   Treatment for the events was reported as "no." The outcome of the events was reported as unknown.   This may be a duplicate if the reporter also submitted directly to his/her local agency.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Pruritus
Clinical narrative: Itching is been worse than ever; Itching is been worse than ever; I got the last booster shot; 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) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Itching is been worse than ever.), for Covid-19 Immunization, reaction(s): "Itching"; Bnt162b2 (Dose:2, Itching is been worse than ever.), for Covid-19 Immunization, reaction(s): "Itching".  The following information was reported: CONDITION AGGRAVATED (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "Itching is been worse than ever"; IMMUNISATION (non-serious), outcome "unknown", described as "I got the last booster shot".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (06Dec2021): This is a follow up spontaneous report received from a contactable consumer. This consumer reported in response to non-HCP telephonic follow up activity which included that: 1st attempt by phone to consumer to obtain mailing information. Phone answered by a consumer who finished the call abruptly after the introduction of the Pfizer colleague.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angina pectoris, Dizziness, Fatigue, Headache
Clinical narrative: Heart Angina; Vertigo; Dizziness; Achy Muscles; Tired; Queasy; Stomach Uneasy; mild headache; woozy; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 02:45 (Lot number: FF2590) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Pfizer (DOSE 2, SINGLE, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 02:15 AM), administration date: 29May2021, when the patient was 62 years old, for Covid-19 immunization; Pfizer (DOSE 1, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 05Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "recovering", described as "booster dose"; ANGINA PECTORIS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Heart Angina"; VERTIGO (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Vertigo"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Dizziness"; MYALGIA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Achy Muscles"; FATIGUE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Queasy"; ABDOMINAL DISCOMFORT (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Stomach Uneasy"; HEADACHE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "mild headache"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "woozy". Therapeutic measures were not taken as a result of immunisation, angina pectoris, vertigo, dizziness, myalgia, fatigue, nausea, abdominal discomfort, headache, dizziness.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Nausea, Vertigo
Clinical narrative: Heart Angina; Vertigo; Dizziness; Achy Muscles; Tired; Queasy; Stomach Uneasy; mild headache; woozy; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 02:45 (Lot number: FF2590) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Pfizer (DOSE 2, SINGLE, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 02:15 AM), administration date: 29May2021, when the patient was 62 years old, for Covid-19 immunization; Pfizer (DOSE 1, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 05Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "recovering", described as "booster dose"; ANGINA PECTORIS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Heart Angina"; VERTIGO (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Vertigo"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Dizziness"; MYALGIA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Achy Muscles"; FATIGUE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Queasy"; ABDOMINAL DISCOMFORT (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Stomach Uneasy"; HEADACHE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "mild headache"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "woozy". Therapeutic measures were not taken as a result of immunisation, angina pectoris, vertigo, dizziness, myalgia, fatigue, nausea, abdominal discomfort, headache, dizziness.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Break out of a severe Oral Herpes within 3 days of taking COVID Vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 12:00 (Lot number: FF 2593) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have had 1 or 2 oral blisters before" (unspecified if ongoing), notes: not on a frequent basis. Can't even remember the last time I had one. The patient took concomitant medications. Past drug history included: Hydrocodone, reaction(s): "Drug Allergy", notes: known allergies: Yes Hydrocodone. The following information was reported: ORAL HERPES (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Break out of a severe Oral Herpes within 3 days of taking COVID Vaccine.". The event "break out of a severe oral herpes within 3 days of taking covid vaccine." was evaluated at the physician office visit. Therapeutic measures were taken as a result of oral herpes.  Additional information: Unspecified medication given as treatment for the event. The patient did not have Covid-19 prior to vaccination. Patient was not test for Covid-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Muscular weakness, Myalgia, Off label use
Clinical narrative: Acute muscle weakness; muscle pain; moderna 1st&2nd dose, pfizer booster dose; moderna 1st&2nd dose, pfizer booster dose; moderna 1st&2nd dose, pfizer booster dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 88-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 05Nov2021 14:30 (Lot number: unknown) at the age of 88 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bladder infection" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, Lot number: unknown, Location of injection: Arm Left, Vaccine Administration Time: 14:30), administration date: 01Mar2021, when the patient was 87 years old, for Covid-19 immunization; Moderna covid-19 vaccine (Dose 2, Lot number: unknown, Location of injection: Arm Left, Vaccine Administration Time: 14:30), administration date: 01Apr2021, when the patient was 87 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 05Nov2021 14:30, outcome "unknown" and all described as "moderna 1st&2nd dose, pfizer booster dose"; MUSCULAR WEAKNESS (non-serious) with onset 05Nov2021 15:00, outcome "not recovered", described as "Acute muscle weakness"; MYALGIA (non-serious) with onset 05Nov2021 15:00, outcome "not recovered", described as "muscle pain". The events "acute muscle weakness" and "muscle pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of muscular weakness, myalgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccine in four weeks of vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Presyncope
Clinical narrative: heart discomfort during walking; Near fainting at home; Shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 04May2021 11:30 (Lot number: Ew0172) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Apples, peaches allergy" (unspecified if ongoing); "birch tree pollen allergy" (unspecified if ongoing). The patient did not receive other vaccine in four weeks of vaccination. Concomitant medications included: metoprolol; atorvastatin. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0153, Administration time: 11:30, Location: Left arm), administration date: 13Apr2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant), described as "heart discomfort during walking"; PRESYNCOPE (non-serious), described as "Near fainting at home"; DYSPNOEA (non-serious), described as "Shortness of breath"; all with onset 01Jun2021 20:45, outcome "recovered". Therapeutic measures were not taken as a result of angina pectoris, presyncope, dyspnoea.  Follow-up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Immunisation, SARS-CoV-2 test
Clinical narrative: Dizziness; watery diarrhea; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 18:00 (Lot number: FH8028) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE. Past drug history included: Cipeo, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose number: 1, Brand: Pfizer, Lot number: ER8733, Administration time: 03:00 PM, location: Right arm), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Brand: Pfizer, Lot number: EW0162, Administration time: 05:00 PM, location: Right arm), administration date: 16Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:00, outcome "unknown", described as "Booster"; DIARRHOEA (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "watery diarrhea"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "recovering", described as "Dizziness". The events "watery diarrhea" and "dizziness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, dizziness.  Additional Information: Dizziness developed after two days. Severe explosive frequent watery diarrhea beginning 24 hours after the shot. Bright yellow complete liquid diarrhea.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Cough, Eye irritation, Fatigue
Clinical narrative: Fever; chills; severe muscle pains; runny nose; severe migraine; fatigue; sore throat; burning; insomnia; coughing; burning eyes; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 16:30 (Lot number: EW0179) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe muscle pains"; RHINORRHOEA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "runny nose"; MIGRAINE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe migraine"; FATIGUE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "sore throat"; BURNING SENSATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning"; INSOMNIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "insomnia"; COUGH (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "coughing"; EYE IRRITATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning eyes". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, rhinorrhoea, migraine, fatigue, oropharyngeal pain, burning sensation, insomnia, cough, eye irritation.  Additional information: Most recent dose details: Product= COVID 19, brand= Pfizer, lot number=EW0170, administration date=24 May2021, administration time= 04:30 PM, dose number=2, vaccine location= Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: Unknown. If Covid tested post vaccination: Unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; chills; severe muscle pains; runny nose; severe migraine; fatigue; sore throat; burning; insomnia; coughing; burning eyes; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 16:30 (Lot number: EW0179) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe muscle pains"; RHINORRHOEA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "runny nose"; MIGRAINE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe migraine"; FATIGUE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "sore throat"; BURNING SENSATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning"; INSOMNIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "insomnia"; COUGH (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "coughing"; EYE IRRITATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning eyes". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, rhinorrhoea, migraine, fatigue, oropharyngeal pain, burning sensation, insomnia, cough, eye irritation.  Additional information: Most recent dose details: Product= COVID 19, brand= Pfizer, lot number=EW0170, administration date=24 May2021, administration time= 04:30 PM, dose number=2, vaccine location= Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: Unknown. If Covid tested post vaccination: Unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Fever; chills; severe muscle pains; runny nose; severe migraine; fatigue; sore throat; burning; insomnia; coughing; burning eyes; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 16:30 (Lot number: EW0179) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe muscle pains"; RHINORRHOEA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "runny nose"; MIGRAINE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe migraine"; FATIGUE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "sore throat"; BURNING SENSATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning"; INSOMNIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "insomnia"; COUGH (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "coughing"; EYE IRRITATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning eyes". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, rhinorrhoea, migraine, fatigue, oropharyngeal pain, burning sensation, insomnia, cough, eye irritation.  Additional information: Most recent dose details: Product= COVID 19, brand= Pfizer, lot number=EW0170, administration date=24 May2021, administration time= 04:30 PM, dose number=2, vaccine location= Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: Unknown. If Covid tested post vaccination: Unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Asthma, Dyspnoea, SARS-CoV-2 test
Clinical narrative: multiple Hives over entire body; Shortness of breathe; acute asthma attack(s); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:30 (Lot number: 32D308N) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vascular Ehlers-Danlos disease" (unspecified if ongoing); "hypermobility Ehlers danlos disease" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Cardiac syncopy" (unspecified if ongoing); "Bilat renal cell carcinoma" (unspecified if ongoing); "Lesions to skull bones" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: ANGIOEDEMA (medically significant, life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "multiple Hives over entire body"; DYSPNOEA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "Shortness of breathe"; ASTHMA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "acute asthma attack(s)". The events "multiple hives over entire body", "shortness of breathe" and "acute asthma attack(s)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, dyspnoea, asthma. Clinical Course: The patient did not receive any other vaccine in four weeks. The patient had not Covid prior vaccination. The patient had Covid tested post vaccination. The patient had healthcare providers not to receive the vaccine due to co morbidities but was forced to by employer or lose job. The patient had known allergies. The patient received treatment for adverse event. The physicians appt multiple inhalation thereapies.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Angioedema, Dyspnoea, Asthma and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Haematemesis, Immune system disorder, Myalgia
Clinical narrative: Vomiting blood; muscle pain; Dizziness; vomiting; stomach pain; lack of immunity; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:15 (Lot number: EL9269) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EL9269, Dose lot unknown: False, administration time: 14:30, Vaccine location: Left arm, ), administration date: 03Mar2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset 24Mar2021, outcome "not recovered", described as "Vomiting blood"; MYALGIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Dizziness"; VOMITING (non-serious) with onset 24Mar2021, outcome "not recovered", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stomach pain"; IMMUNE SYSTEM DISORDER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "lack of immunity". The events "vomiting blood", "muscle pain", "dizziness", "vomiting", "stomach pain" and "lack of immunity" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of haematemesis, myalgia, dizziness, vomiting, abdominal pain upper, immune system disorder. Clinical course: Ever since patient received 2 dose series she had random moments of dizziness, vomiting, stomach pain, a lack of immunity to other vaccines causing me to get sick easier and for longer. Vomiting blood, and muscle pains. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included medications and follow ups. No other vaccine in four weeks. No other medications in two weeks. The patient had not known allergies. No covid-prior vaccination. Facility type vaccine: Hospital.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting blood; muscle pain; Dizziness; vomiting; stomach pain; lack of immunity; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:15 (Lot number: EL9269) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EL9269, Dose lot unknown: False, administration time: 14:30, Vaccine location: Left arm, ), administration date: 03Mar2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset 24Mar2021, outcome "not recovered", described as "Vomiting blood"; MYALGIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Dizziness"; VOMITING (non-serious) with onset 24Mar2021, outcome "not recovered", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stomach pain"; IMMUNE SYSTEM DISORDER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "lack of immunity". The events "vomiting blood", "muscle pain", "dizziness", "vomiting", "stomach pain" and "lack of immunity" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of haematemesis, myalgia, dizziness, vomiting, abdominal pain upper, immune system disorder. Clinical course: Ever since patient received 2 dose series she had random moments of dizziness, vomiting, stomach pain, a lack of immunity to other vaccines causing me to get sick easier and for longer. Vomiting blood, and muscle pains. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included medications and follow ups. No other vaccine in four weeks. No other medications in two weeks. The patient had not known allergies. No covid-prior vaccination. Facility type vaccine: Hospital.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I have been post menopausal for three years and just had a full on menstrual cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other Non-healthcare professional). The reporter is the patient.  A 51 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170) via unspecified route of administration in arm left on 20Apr2021(age at the vaccination:50 years) as dose 2, single for covid-19 immunization. Patients medical history includes: Post-menopausal for three years from unknown date and month of 2018. Concomitant medication(s) included: WELLBUTRIN (BUPROPION HYDROCHLORIDE). Patient previously received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) via unspecified route of administration in arm left on 30Mar2021(age at the vaccination:50 years) as dose 1, single for Covid-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 22Nov2021, outcome "unknown", described as "I have been post menopausal for three years and just had a full on menstrual cycle.". Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Periorbital swelling
Clinical narrative: severe bags under my eyes; eyes were all puffed up; I felt very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 11:30 (Lot number: 330308D) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "I have aches and pains" (unspecified if ongoing), notes: I have arthritis but otherwise I have aches and pains. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FF2593, Time of Vaccination: 11:30, Anatomical site of injection: left shoulder), administration date: 05Nov2021, when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 26Nov2021, outcome "not recovered", described as "I felt very tired"; PERIORBITAL SWELLING (non-serious) with onset 27Nov2021, outcome "not recovered", described as "severe bags under my eyes; eyes were all puffed up". Therapeutic measures were taken as a result of periorbital swelling.  No follow-up attempts are possible. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Gait inability, Henoch-Schonlein purpura, Pain, Pulmonary pain
Clinical narrative: could not walk; she started to develop pain symptoms; She was diagnosed with HSP; She is now experiencing chest and lung pain; She is now experiencing chest and lung pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date end of Jun2021 (Batch/Lot number: unknown) as dose 1, single (age at vaccination is 18 years old) for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: Had no symptoms. The patient's concomitant medications were not reported. The following information was reported: GAIT INABILITY (medically significant) with onset Oct2021, outcome "unknown", described as "could not walk"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "she started to develop pain symptoms"; HENOCH-SCHONLEIN PURPURA (non-serious) with onset 2021, outcome "unknown", described as "She was diagnosed with HSP"; CHEST PAIN (non-serious), PULMONARY PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "She is now experiencing chest and lung pain". Details were reported as follows: While on an airplane in October, she started to develop pain symptoms and could not walk. She was in a wheelchair for three weeks. She was diagnosed with HSP, an autoimmune disorder that affects small blood vessels. She is now experiencing chest and lung pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Chest pain, Immunisation, Myalgia
Clinical narrative: noticed the large difference in the size of my left breast.Again, there are no lumps or signs of lymph node swelling but my entire breast is larger; experiencing left sided chest pain; felt muscular in nature; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 15:30 (Lot number: FH8028) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: other medical history: Seasonal allergies; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: IBUPROFEN; LARISSIA; LEVOCETIRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "left breast increased in size by 1 cup size. There are no lumps and no signs of lymph node swelling"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right), administration date: 31Mar2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "left breast increased in size by 1 cup size. There are no lumps and no signs of lymph node swelling".  The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 15:30, outcome "unknown", described as "Booster"; CHEST PAIN (non-serious) with onset 24Nov2021 06:00, outcome "recovered" (25Nov2021 18:00), described as "experiencing left sided chest pain"; MYALGIA (non-serious) with onset 24Nov2021 06:00, outcome "recovered" (Nov2021), described as "felt muscular in nature"; BREAST ENLARGEMENT (non-serious) with onset 25Nov2021, outcome "not recovered", described as "noticed the large difference in the size of my left breast.Again, there are no lumps or signs of lymph node swelling but my entire breast is larger". Therapeutic measures were not taken as a result of chest pain, myalgia, breast enlargement.  Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Drug ineffective, Illness
Clinical narrative: booster; do COVID-19 test and I was positive; do COVID-19 test and I was positive; little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs; I could not sleep two nights, waking trying to sit, trying to bed; I got sick; temperature lift little bit over the red line; 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), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus".  The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "do COVID-19 test and I was positive"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs"; INSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "I could not sleep two nights, waking trying to sit, trying to bed"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I got sick"; BODY TEMPERATURE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "temperature lift little bit over the red line". The patient underwent the following laboratory tests and procedures: body temperature: (Nov2021) lift little bit over the red line; sars-cov-2 test: (Nov2021) negative; (Nov2021) negative; (Nov2021) positive, notes: they might be wrong but they said they will send me within 3 days they will send me the correct result.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Pain, SARS-CoV-2 test
Clinical narrative: booster; do COVID-19 test and I was positive; do COVID-19 test and I was positive; little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs; I could not sleep two nights, waking trying to sit, trying to bed; I got sick; temperature lift little bit over the red line; 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), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus".  The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "do COVID-19 test and I was positive"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs"; INSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "I could not sleep two nights, waking trying to sit, trying to bed"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I got sick"; BODY TEMPERATURE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "temperature lift little bit over the red line". The patient underwent the following laboratory tests and procedures: body temperature: (Nov2021) lift little bit over the red line; sars-cov-2 test: (Nov2021) negative; (Nov2021) negative; (Nov2021) positive, notes: they might be wrong but they said they will send me within 3 days they will send me the correct result.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed covid symptoms and tested positive on 26Nov; Developed covid symptoms and tested positive on 26Nov; This is a spontaneous report received from a contactable reporter(s) (Consumer- patient) for a Pfizer sponsored program (005570). A 9 year-old patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single 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 26Nov2021, outcome "unknown" and all described as "Developed covid symptoms and tested positive on 26Nov". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: I feel wiped out; booster; 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), administration date 27Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single 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 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 28Nov2021, outcome "unknown", described as "I feel wiped out".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I had been menstruating when I received my second dose and the day after I received this second dose, I found that I had a period blood clot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), administered in arm left, administration date 26Nov2021 15:00 (Lot number: FH8028) at the age of 16 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefcil, reaction(s): "Known allergies: Cefcil". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fh8028, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 05Nov2021, when the patient was 16 years old, for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. The patient not diagnosed with COVID prior to vaccination and not tested for COVID since the vaccination. The following information was reported: THROMBOSIS (medically significant) with onset 27Nov2021, outcome "unknown", described as "I had been menstruating when I received my second dose and the day after I received this second dose, I found that I had a period blood clot.". Therapeutic measures were not taken as a result of thrombosis.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Syncope, Wrong technique in product usage process
Clinical narrative: I fainted twice; Extreme nausea; Pharmacist jabbed my arm twice; Booster; This is a spontaneous report received from a contactable consumer (patient).  A 64-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration administered in left arm on 26Nov2021 14:30 (at the age of 64-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "allergy"; Toradol, reaction(s): "allergy". Vaccination history included: Bnt162b2 (second dose in left arm at 12:00 p.m.), administration date: 03Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (first dose in left arm at 10:00 a.m.), administration date: 14Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 27Nov2021 06:00, outcome "recovering", described as "I fainted twice"; IMMUNISATION (medically significant) with onset 26Nov2021 14:30, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 27Nov2021 06:00, outcome "recovering", described as "Extreme nausea"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 26Nov2021 14:30, outcome "unknown", described as "Pharmacist jabbed my arm twice". Therapeutic measures were not taken as a result of nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.