chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: flare up of hashimotos hypothyroid; Significant and rapid hair loss; including skin and hair issues; including skin and hair issues; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:45 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroid" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMBIEN; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8737, administration time: 04:00 PM , vaccine location: left arm), administration date: 29Mar2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "chills", "fever/low grade fever", "head/body ache", "fatigue", "swelling/redness and pain at injection site", "disrupted menstrual cycle", "heavy/longer than usual menstrual period", "flare up of hashimotos hypothyroid", "skin and hair issues at this time", "hair loss"; Pertussis vaccine, reaction(s): "Known allergies: pertussis vaccine". These occurred after second dose and lasted 6 months. Her hair was starting to regrow and then after booster began to fall out again. She experienced significant and rapid hair loss. Never had hair loss prior, it was sudden significant, and resulted in a thinning across the scalp particularly in the top of head and temple area. Estimate1/4 reduction of volume in this area. Have also experienced flare up of hashimotos hypothyroid including skin and hair issues at this time. Had been stable with medication for more than 5 years prior. The events "booster", "flare up of hashimotos hypothyroid", "significant and rapid hair loss", "including skin and hair issues" and "including skin and hair issues" were evaluated at the physician office visit. Therapeutic measures taken as a result of events included adjustment of thyroid medication. The patient had not recovered from flare up of hashimotos hypothyroid, significant and rapid hair loss, skin and hair issues. No covid prior to vaccination and was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: PCR test: Positive; PCR test: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single and administration date 17Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported SARS-COV-2 TEST POSITIVE after COVID-19 immunization is considered VACCINATION FAILURE of BNT162B2, and the Company cannot exclude the possible causality between the reported event and BNT162B2 administration.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: PCR test: Positive; PCR test: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single and administration date 17Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported SARS-COV-2 TEST POSITIVE after COVID-19 immunization is considered VACCINATION FAILURE of BNT162B2, and the Company cannot exclude the possible causality between the reported event and BNT162B2 administration.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had a COVID breakthrough infection.; I had a COVID breakthrough infection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) 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: COVID-19 (medically significant) with onset 07Jan2022, outcome "recovered" (Jan2022), VACCINATION FAILURE (medically significant) with onset 07Jan2022, outcome "unknown" and all described as "I had a COVID breakthrough infection.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Patient did not receive any other vaccines in four weeks prior to the  COVID vaccine. Patient did not receive any other medications within two weeks of vaccination. Hospitalization prolonged was no.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. No known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Consumer received 2 dose series completion in Feb 2021. She did not receive booster. Tested positive for covid this morning 07Jan2022; Consumer received 2 dose series completion in Feb 2021. She did not receive booster. Tested positive for covid this morning 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (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 07Jan2022, outcome "unknown" and all described as "Consumer received 2 dose series completion in Feb 2021. She did not receive booster. Tested positive for covid this morning 07Jan2022". The patient underwent the following laboratory tests and procedures: body temperature: (07Jan2022) about 101; sars-cov-2 test: (07Jan2022) positive. Clinical information: Consumer received 2 dose series completion in Feb2021. She did not receive booster. Tested positive for covid this morning 07Jan2022. She said she was exposed to covid as her 17-year-old daughter was having fever symptoms on 02Jan2022 who has also tested positive. 17-year-old daughter received 2 dose series (May2021) but not booster. Both experienced fever at about 101 and fatigue from covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: having fever symptoms on 02Jan2022 who has also tested positive; having fever symptoms on 02Jan2022 who has also tested positive/ Both experienced fever at about 101 and fatigue from covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Jan2022, outcome "unknown", described as "having fever symptoms on 02Jan2022 who has also tested positive"; COVID-19 (medically significant) with onset 02Jan2022, outcome "unknown", described as "having fever symptoms on 02Jan2022 who has also tested positive/ Both experienced fever at about 101 and fatigue from covid.". The patient underwent the following laboratory tests and procedures: body temperature: (2022) 101; sars-cov-2 test: (unspecified date) positive. It was reported that, patient did not received booster yet. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Seizure
Clinical narrative: Developed seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 (Lot number: ER8733) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Type 1 Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. There were no known allergies. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The following information was reported: SEIZURE (medically significant) with onset 11Apr2021, outcome "not recovered", described as "Developed seizures". The event "developed seizures" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of seizure. The patient received unspecified treatment for the adverse event.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Pain in extremity
Clinical narrative: booster; arm soreness; Somewhat disruptive during sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2) (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 (Manufacture Unknown.), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; INSOMNIA (non-serious), outcome "unknown", described as "Somewhat disruptive during sleep". Additional Information: The reporter reported that somewhat disruptive during sleep. No other side effects post booster dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: got COVID; got COVID; 1st Dose Johnson Vaccine/ Booster Pfizer; booster; Selected Report Type: Initial Is report related to a study or programme? No Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: mother  Primary / Prescribing Healthcare Professional Info HCP postal address: Regulatory Authority  Dates for got COVID: (From: Unspecified To: Unspecified) Reporter seriousness for got COVID: Unspecified  Is COVID vaccine a Pfizer product? Yes COVID vaccine manufacturer: Pfizer Dates for COVID vaccine: (Start: 11Nov2021 Stop: Unspecified) NDC number of COVID vaccine: Unknown Expiry Date of COVID vaccine: Unknown  Other Products: Not Provided Patient History: Not Provided Investigation Assessment: Not Provided  Additional Context: The report is cross referenced to report ID: (withheld) Warm transfer from withheld with Pfizer Medical Information-(withheld) The caller was fully vaccinated for COVID, and got COVID as well. She just had mild cold symptoms though. The caller got the Johnson Vaccine on 10Mar2021, with lot number 180522. Then, she got the Pfizer COVID booster. She got the booster on 11Nov2021 with lot number TH8030. She just had mild cold symptoms.  She got her vaccines at the health department. She did not have a prescribing doctor.   Is there a Product Complaint: Yes Description of Product Complaint: The caller was fully vaccinated for COVID, and got COVID as well. She just had mild cold symptoms though. The caller got the Johnson Vaccine on 10Mar2021, with lot number 180522. Then, she got the Pfizer COVID booster. She got the booster on 11Nov2021 with lot number TH8030. She just had mild cold symptoms. Patient got her vaccines at the health department. Just had mild cold symptoms though and did not have a prescribing doctor.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: got COVID; got COVID; 1st Dose Johnson Vaccine/ Booster Pfizer; booster; Selected Report Type: Initial Is report related to a study or programme? No Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: mother  Primary / Prescribing Healthcare Professional Info HCP postal address: Regulatory Authority  Dates for got COVID: (From: Unspecified To: Unspecified) Reporter seriousness for got COVID: Unspecified  Is COVID vaccine a Pfizer product? Yes COVID vaccine manufacturer: Pfizer Dates for COVID vaccine: (Start: 11Nov2021 Stop: Unspecified) NDC number of COVID vaccine: Unknown Expiry Date of COVID vaccine: Unknown  Other Products: Not Provided Patient History: Not Provided Investigation Assessment: Not Provided  Additional Context: The report is cross referenced to report ID: (withheld) Warm transfer from withheld with Pfizer Medical Information-(withheld) The caller was fully vaccinated for COVID, and got COVID as well. She just had mild cold symptoms though. The caller got the Johnson Vaccine on 10Mar2021, with lot number 180522. Then, she got the Pfizer COVID booster. She got the booster on 11Nov2021 with lot number TH8030. She just had mild cold symptoms.  She got her vaccines at the health department. She did not have a prescribing doctor.   Is there a Product Complaint: Yes Description of Product Complaint: The caller was fully vaccinated for COVID, and got COVID as well. She just had mild cold symptoms though. The caller got the Johnson Vaccine on 10Mar2021, with lot number 180522. Then, she got the Pfizer COVID booster. She got the booster on 11Nov2021 with lot number TH8030. She just had mild cold symptoms. Patient got her vaccines at the health department. Just had mild cold symptoms though and did not have a prescribing doctor.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nausea, Pain
Clinical narrative: Pfizer BioNTech EAU booster; Body aches; Headache; Nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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 number unknown; manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer BioNTech EAU booster"; PAIN (non-serious), outcome "recovered", described as "Body aches"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "recovered", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Immunisation, Nasopharyngitis
Clinical narrative: allergy like symptoms; She states she has very mild symptoms that she mistaken for a weak cold; Tested positive for covid; Tested positive for covid; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested positive for covid"; HYPERSENSITIVITY (non-serious) with onset 06Jan2022, outcome "unknown", described as "allergy like symptoms"; NASOPHARYNGITIS (non-serious) with onset Jan2022, outcome "unknown", described as "She states she has very mild symptoms that she mistaken for a weak cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: Tested positive for covid.  Clinical course: 'Patient was healthy'. It was also stated that event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: allergy like symptoms; She states she has very mild symptoms that she mistaken for a weak cold; Tested positive for covid; Tested positive for covid; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested positive for covid"; HYPERSENSITIVITY (non-serious) with onset 06Jan2022, outcome "unknown", described as "allergy like symptoms"; NASOPHARYNGITIS (non-serious) with onset Jan2022, outcome "unknown", described as "She states she has very mild symptoms that she mistaken for a weak cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: Tested positive for covid.  Clinical course: 'Patient was healthy'. It was also stated that event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Pharyngeal swelling
Clinical narrative: had an anaphylactic reaction to the Pfizer shot and very short of breath; very short of breath; tongue is swollen; throat is swollen shut like patient can barely swallow; throat is swollen shut like patient can barely swallow; patient can barely swallow; Dizzy; 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) (Lot number: FL3209) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "had an anaphylactic reaction to the Pfizer shot and very short of breath"; DYSPNOEA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "very short of breath"; SWOLLEN TONGUE (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "tongue is swollen"; PHARYNGEAL SWELLING (hospitalization, medically significant), THROAT TIGHTNESS (hospitalization, medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "throat is swollen shut like patient can barely swallow"; DYSPHAGIA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "patient can barely swallow"; DIZZINESS (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "Dizzy". Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, swollen tongue, pharyngeal swelling, throat tightness, dysphagia, dizziness. Patient was given diphenhydramine (BENADRYL), triamcinolone (DERMAZONE), Epinephrine and sent to the hospital. Patient was released after 5 hours. Patient was sent home with mild dose of diphenhydramine (BENADRYL) and Albuterol.
Sex: U
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: had an anaphylactic reaction to the Pfizer shot and very short of breath; very short of breath; tongue is swollen; throat is swollen shut like patient can barely swallow; throat is swollen shut like patient can barely swallow; patient can barely swallow; Dizzy; 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) (Lot number: FL3209) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "had an anaphylactic reaction to the Pfizer shot and very short of breath"; DYSPNOEA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "very short of breath"; SWOLLEN TONGUE (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "tongue is swollen"; PHARYNGEAL SWELLING (hospitalization, medically significant), THROAT TIGHTNESS (hospitalization, medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "throat is swollen shut like patient can barely swallow"; DYSPHAGIA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "patient can barely swallow"; DIZZINESS (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "Dizzy". Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, swollen tongue, pharyngeal swelling, throat tightness, dysphagia, dizziness. Patient was given diphenhydramine (BENADRYL), triamcinolone (DERMAZONE), Epinephrine and sent to the hospital. Patient was released after 5 hours. Patient was sent home with mild dose of diphenhydramine (BENADRYL) and Albuterol.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Nausea, Pain in extremity
Clinical narrative: Booster; Chills; Fever; Headache; Nauseous; Sore arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (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 number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Additional information: Events took place after use of Booster shot of COVID-19 vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Booster; Chills; Fever; Headache; Nauseous; Sore arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (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 number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Additional information: Events took place after use of Booster shot of COVID-19 vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2021, outcome "unknown" and all described as "Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jun2021) positive.  Clinical information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021; Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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), outcome "unknown" and all described as "Patient was fully vaccinated with a booster but tested positive for Covid on 06Jun2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jun2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: 5 days later my husband had COVID; The first Pfizer vaccine we got it on Monday and on Saturday my husband came down with COVID; We were tested and we had COVID; pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 (Lot number: FC3183, Expiration Date: Oct2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset 04Sep2021, outcome "unknown", described as "5 days later my husband had COVID; The first Pfizer vaccine we got it on Monday and on Saturday my husband came down with COVID; We were tested and we had COVID"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "pretty sick". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient is 6 years old. Fully vaccinated on 14Dec2021. Confirmed COVID positive on 06Jan2022; Patient is 6 years old. Fully vaccinated on 14Dec2021. Confirmed COVID positive on 06Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), 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 06Jan2022, outcome "unknown" and all described as "Patient is 6 years old. Fully vaccinated on 14Dec2021. Confirmed COVID positive on 06Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Fatigue, Immunisation, Insomnia
Clinical narrative: Home AG-Positive; dose 3; Home AG-Positive; fatigue; HA congestion; trouble sleeping; tight chest; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "unknown" and all described as "Home AG-Positive"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "fatigue"; UPPER RESPIRATORY TRACT CONGESTION (medically significant) with onset 2021, outcome "unknown", described as "HA congestion"; INSOMNIA (medically significant) with onset 2021, outcome "unknown", described as "trouble sleeping"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "tight chest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of fatigue, upper respiratory tract congestion, insomnia, chest discomfort.  Clinical information: It was reported, + covid exposure 1/1 then sx 1/4 and + Ag test 1/5 sx include fatigue, HA congestion and trouble sleeping and tight chest. Patients did not received any other vaccine in four weeks was unknown. It was unknown patient had covid prior vaccination. Patient tested covid post vaccination. It was unknown did the patient was diagnosed with COVID-19.  Device Date was 07Jan2022.  No follow-up attempts are possible. 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 LOE events , Immunization, fatigue, upper respiratory tract congestion, insomnia, chest discomfort  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper respiratory tract congestion, Vaccination failure
Clinical narrative: Home AG-Positive; dose 3; Home AG-Positive; fatigue; HA congestion; trouble sleeping; tight chest; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "unknown" and all described as "Home AG-Positive"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "fatigue"; UPPER RESPIRATORY TRACT CONGESTION (medically significant) with onset 2021, outcome "unknown", described as "HA congestion"; INSOMNIA (medically significant) with onset 2021, outcome "unknown", described as "trouble sleeping"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "tight chest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of fatigue, upper respiratory tract congestion, insomnia, chest discomfort.  Clinical information: It was reported, + covid exposure 1/1 then sx 1/4 and + Ag test 1/5 sx include fatigue, HA congestion and trouble sleeping and tight chest. Patients did not received any other vaccine in four weeks was unknown. It was unknown patient had covid prior vaccination. Patient tested covid post vaccination. It was unknown did the patient was diagnosed with COVID-19.  Device Date was 07Jan2022.  No follow-up attempts are possible. 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 LOE events , Immunization, fatigue, upper respiratory tract congestion, insomnia, chest discomfort  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: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Positive COVID test on 07Jan2022; Positive COVID test on 07Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) at the age of 10 years as dose 2, single and administration date Nov2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 07Jan2022, outcome "recovering" and all described as "Positive COVID test on 07Jan2022". The event "positive covid test on 07jan2022" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (04Jan2022) negative, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab; (07Jan2022) positive, notes: Nasal Swab; sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient did not receive any other vaccine within four weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed to COVID-19. The patient did not had any known allergies. The patient was treated with ibuprofen for adverse events.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR test Positive; PCR test Positive; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 29 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EL3247) as dose 2, single and administration date 02Mar2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 01Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "PCR test Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Ag test; Test type: Unknown; (05Jan2022) negative, notes: neg AG; Test type: Unknown; (02Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: The seriousness of the case was reported as non serious. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Got worse after the second dose.; Had not been feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 01Mar2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s): "Runny nose", "Congestion", "Inflammation of vocal cords", "Fatigue, so tired, exhaustion", "Shortness of breath/couldn't breathe", "Frozen shoulder/couldn't move her left arm. Clarified left arm was the injection arm", "Heavy in her chest", "Blood pressure was high,220/110", "Flushed face", "Couldn't speak", "Upper respiratory infection". The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "Upper respiratory infection"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Got worse after the second dose."; MALAISE (non-serious), outcome "unknown", described as "Had not been feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not visit with her family during the holiday because since she received the Pfizer vaccine, has been struggling with an upper respiratory infection. Reaction to it started the following week, following the first dose. Got worse after the second dose. They Clarified her reaction is the upper respiratory infection.  Her entire family has had the Pfizer COVID-19 Vaccine, including the booster, and they were infected with the COVID virus. Caller did not know which variant, but they were all positive. Caller did not go to this family gathering because she did not feel well. She had not been feeling well since the second dose of the COVID-19 Vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: had a case of break-through covid, confirmed today via rapid test at home.; had a case of break-through covid, confirmed today via rapid test at home.; fever up to 100 degrees; running nose; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and administration date 05Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "had a case of break-through covid, confirmed today via rapid test at home."; PYREXIA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "fever up to 100 degrees"; RHINORRHOEA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "running nose"; FATIGUE (medically significant) with onset 07Jan2022, outcome "not recovered", described as "exhaustion". The events "had a case of break-through covid, confirmed today via rapid test at home.", "had a case of break-through covid, confirmed today via rapid test at home.", "fever up to 100 degrees", "running nose" and "exhaustion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Jan2022) upto 100 degree; sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, rhinorrhoea, fatigue. Consumer reported that, the patient received any other vaccines within 4 weeks prior to the COVID vaccine and patient received any other medications within 2 weeks of vaccination was unknown. Consumer stated that, the patient did not diagnosed with COVID-19 prior to vaccination and patient had been tested for COVID-19, since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.