chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis subacute, Ultrasound scan
Clinical narrative: Illness; subacute thyroiditis; pain in the front of the neck; headaches; fever; general achy-ness; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 10:00 (Lot number: 33B0BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 04Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "Illness"; THYROIDITIS SUBACUTE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "subacute thyroiditis"; NECK PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "pain in the front of the neck"; HEADACHE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "general achy-ness"; FEELING ABNORMAL (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "feeling bad". The events "illness", "subacute thyroiditis", "pain in the front of the neck", "headaches", "fever", "general achy-ness" and "feeling bad" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, thyroiditis subacute, neck pain, headache, pyrexia, pain, feeling abnormal and treated with NSAIDs.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Severe chest pain; racing pulse (103); extreme fatigue; rash; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 13:45 (Lot number: FL3198) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing); "NAFL" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Known allergies: IVP dye" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Demerol, reaction(s): "known allergies: Demerol"; Enbrel, reaction(s): "known allergies: Enbrel"; Xeljanz, reaction(s): "known allergies: Xeljanz"; Cipro, reaction(s): "known allergies: Cipro". Vaccination history included: Moderna vaccine, reaction(s): "known allergies: Moderna vaccine". The following information was reported: CHEST PAIN (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "Severe chest pain"; HEART RATE INCREASED (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "racing pulse (103)"; FATIGUE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "extreme fatigue"; RASH (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "rash"; HEADACHE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, heart rate increased, fatigue, rash, headache.   Additional information: The patient received Pepcid, Zyrtec as treatment for Adverse events. The patient took other medications in two weeks, including Med to offset reaction. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe chest pain; racing pulse (103); extreme fatigue; rash; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 13:45 (Lot number: FL3198) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing); "NAFL" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Known allergies: IVP dye" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Demerol, reaction(s): "known allergies: Demerol"; Enbrel, reaction(s): "known allergies: Enbrel"; Xeljanz, reaction(s): "known allergies: Xeljanz"; Cipro, reaction(s): "known allergies: Cipro". Vaccination history included: Moderna vaccine, reaction(s): "known allergies: Moderna vaccine". The following information was reported: CHEST PAIN (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "Severe chest pain"; HEART RATE INCREASED (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "racing pulse (103)"; FATIGUE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "extreme fatigue"; RASH (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "rash"; HEADACHE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, heart rate increased, fatigue, rash, headache.   Additional information: The patient received Pepcid, Zyrtec as treatment for Adverse events. The patient took other medications in two weeks, including Med to offset reaction. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable reporter (other HCP). A 58-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# FD7218), at the age of 58, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient had pyrexia/fever and nausea, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable reporter (other HCP). A 64-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# FD7218), at the age of 64, on Jan 13, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown/not available/provided), for COVID-19 immunisation. The patient developed pyrexia/fever, and nausea, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neuropathy peripheral
Clinical narrative: Neuropathy; Cant walk after 3rd vax; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Dec2021 12:00 (Batch/Lot number: unknown) at the age of 51-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient has no known allergies. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. There were no concomitant medications. She did not any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: BNT162B2 (administered in left arm as dose 1, single), for COVID-19 immunisation, reaction: "Neuropathy" and BNT162B2 (administered in left arm as dose 2, single), for COVID-19 immunisation, reaction: "Neuropathy." The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Neuropathy" and GAIT INABILITY (non-serious), outcome "not recovered", described as "Cant walk after 3rd vax". The events "neuropathy" and "cant walk after 3rd vax" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral and gait inability.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A 15-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had oropharyngeal pain/sore throat and headache, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Condition aggravated, Vaccination site erythema, Vaccination site mass
Clinical narrative: Booster dose: Has pretty severe pain in right shoulder and clavicle; Booster dose: Has pretty severe pain in right shoulder and clavicle; The whelp is red around it and is worsening; Booster dose: has a very large whelp around injection site; Booster dose: has a very large whelp around injection site/The whelp is red around it and is worsening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 (Lot number: FJ1614) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Dec2020 (ongoing), notes: Verbatim: Anxiety; "Panic attack", start date: Dec2020 (ongoing), notes: Verbatim: panic attacks. Concomitant medication(s) included: CITALOPRAM taken for anxiety, panic attack (ongoing). Vaccination history included: Bnt162b2 (Pfizer Covid 19 Vaccine: , First dose: 24Mar2021 , lot: ER8730, NDC: Unknown , Expiration: Unknown , Route of administration: right arm), administration date: 24Mar2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "First dose: after first dose, both thumbs went numb"; Bnt162b2 (second dose: 15Apr2021 , lot: ER8729, NDC: Unknown , expiration: unknown, Route of administration: right arm), administration date: 15Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Booster dose: has a very large whelp around injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Booster dose: has a very large whelp around injection site/The whelp is red around it and is worsening"; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 16Jan2022, outcome "not recovered" and all described as "Booster dose: Has pretty severe pain in right shoulder and clavicle"; CONDITION AGGRAVATED (non-serious) with onset 15Jan2022, outcome "not recovered", described as "The whelp is red around it and is worsening".  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Sleep disorder
Clinical narrative: falling a lot lately/ fallen; First dose given on 16Jul2021/ Second dose given on 02Sep2021; eyes are so bad; hit her head; She doesn't sleep. If she sleeps for two hours, she is up for 40 hours; blanked out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Lot number: FS2580) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: lot number is handwritten on the card and hard to read. Lot number: EW0186 and it was given on 16Jul2021.), administration date: 16Jul2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: FALL (hospitalization) with onset Sep2021, outcome "unknown", described as "falling a lot lately/ fallen"; LOSS OF CONSCIOUSNESS (medically significant) with onset Sep2021, outcome "unknown", described as "blanked out"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "First dose given on 16Jul2021/ Second dose given on 02Sep2021"; EYE DISORDER (non-serious), outcome "unknown", described as "eyes are so bad"; HEAD INJURY (non-serious) with onset Sep2021, outcome "unknown", described as "hit her head"; SLEEP DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "She doesn't sleep. If she sleeps for two hours, she is up for 40 hours". The events "falling a lot lately/ fallen" and "hit her head" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results.  Additional information: Patient began falling a lot lately in Sep2021, shortly after getting the shots. She has fallen and hit her head maybe 12 times seriously. She has had to go to the emergency room twice. Caller keeps landing on her head. Caller is on oxygen. She her head hits left or right when she falls. She hit the nightstand and the oxygen concentrated. Another time she reached for toilet paper and fell and hit her nose, forehead, and all the way back of her head. She had to go to the hospital and get MRI. She has fallen two other times. One time was out of the chair. She has a chair in there now instead of just a bed. She dozes off. She doesn't sleep. If she sleeps for two hours, she is up for 40 hours. She was in the chair and fell over. She doesn't know what happened. She blanked out. She didn't hit her head that time, but her whole left side. She didn't know where she was or what was going on. There was no call button on that bed. The next thing she knows she was disoriented. She didn't know where her chair was. She got herself up off the floor and the chair was upside down. Caller can't write anymore.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelet count dropped to 0; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PLATELET COUNT DECREASED (medically significant), outcome "unknown", described as "platelet count dropped to 0". The patient underwent the following laboratory tests and procedures: platelet count: dropped to 0. Therapeutic measures were taken as a result of platelet count decreased with I have had infusions twice a week , been on promacta and now EN Plate.  Clinical course: About a week after my first covid shot My platelet count dropped to 0. I have been treated for ITP ever since. I have had infusions twice a week , been on promacta and now EN Plate. So far nothing seems to help. If you have any information that could help I would appreciate it  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: covid she can't shots, she fell down in August when she wasn't taking any mediciation, "my body can't handle injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cimzia, notes: she had reactions from Cimzia, DPT, Humira; Dpt, notes: she had reactions from Cimzia, DPT, Humira; Humira, notes: she had reactions from Cimzia, DPT, Humira; Flu, notes: she had reactions from Cimzia, DPT, Humira react to carrier in all the shot flu. The following information was reported: FALL (non-serious), outcome "unknown", described as "covid she can't shots, she fell down in August when she wasn't taking any mediciation, "my body can't handle injections".  Additional information: During the call the patient stated. "she had reactions from Cimzia, DPT, Humira react to carrier in all the shot flu and covid she can't shots, she fell down in Aug when she wasn't taking any mediciation, "my body can't handle injections, and Her HCP provided her a 2 month sample of Xeljanz XR 11 mg." The patient is prescribed Xeljanz XR extended release 11 mg tablets. Call was not transferred to Pfizer Product Safety.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of rhinorrhoea.  Clinical information: Facility where the most recent COVID-19 vaccine was administered workplace clinic. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, patient was tested for COVID-19. Covid test post vaccination. Covid test type post vaccination was unknown. Covid test name post vaccination was home Ag. Device date was 18Jan2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Vaccination Failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and Vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  An adult male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "covid test result: Positive"; COUGH (medically significant) with onset 12Jan2022, outcome "unknown", described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19, cough.  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 and cough 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan; Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: FF2588) at the age of 34 years as dose 2, single and administration date 24Aug2021 (Lot number: FC3180) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: + covid sx mild nasal congestion 15Jan and home Ag positive 16Jan. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. It was unknown if  patient receive any other vaccines within 4 weeks prior to the COVID vaccine and was the patient diagnosed with COVID-19 Prior to vaccination and has the patient been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: rapid test/ tested positive for Covid 19/ breakthrough case of Covid 19; rapid test/ tested positive for Covid 19/ breakthrough case of Covid 19; cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rapid test/ tested positive for Covid 19/ breakthrough case of Covid 19"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: I took a rapid test I tested positive for Covid 19. Patient stated that, he was fully vaccinated and boostered with the Pfizer BioNTech Covid 19 vaccine. Patient developed cold like symptoms this past weekend and when he took a rapid test he tested positive for Covid 19. While he did not experienced adverse events with the 3 doses of the vaccine, and submitted this report to alert to a breakthrough case of Covid 19. Patient did not had any underlying conditions and dis not take any medications.  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: I did have positive covid four months after my second dose; I did have positive covid four months after my second dose; 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 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 "I did have positive covid four months after my second dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient wanted to know when can they apply the third dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Culture throat, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID virus; Tested positive for COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 (Lot number: EW0180) at the age of 12 years as dose 2, single and administered in arm left, administration date 22May2021 (Lot number: EW0187) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021 13:41, outcome "unknown" and all described as "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: culture throat: (unspecified date) negative; sars-cov-2 test: (22Dec2021) positive.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; 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 91 year-old female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information:  Agent relays he has a patient on the line to get advice, she already had dose 1 and 2 and the booster however she was tested positive for Covid. Agent relays she would like advice if she should take another booster shot. Agent relays the caller did not provide name of product. She would like to get advice on what will be the next step to take. She also mentioned that she came home with Her Daughter who was tested negative (patient mentioned) and also has a Son who is staying at a wondering if He is also positive or not. She also mentioned that she is with 2 other adults in the house.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID infection after completing primary series in May2021; Breakthrough COVID infection after completing primary series in May 2021; his is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2021, outcome "unknown", described as "Breakthrough COVID infection after completing primary series in May2021"; COVID-19 (medically significant) with onset May2021, outcome "unknown", described as "Breakthrough COVID infection after completing primary series in May 2021".  Clinical course: 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test.; Positive COVID test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 16Dec2021 (Lot number: FL3197) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 16Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administration date 26Mar2021 (Lot number: EP6955) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "not recovered" and all described as "Positive COVID test.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: Nasal Swab; (17Jan2022) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis;   A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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 (medically significant), outcome "unknown", described as "anaphylaxis". There was 1 case of anaphylaxis in the Pfizer-BioNTech trial.; Sender's Comments: Based on the limited information currently available, a case of anaphylaxis with bnt162b2 vaccine in this patient cannot be completely excluded
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 06Jul2021 (Lot number: EY0584) at the age of 16 years as dose 2, single and intramuscular, administration date 15Jun2021 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxiclin, reaction(s): "Known allergies: Amoxiclin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The event "tested positive for covid" and "tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical source: No any other Vaccine in four weeks. Tested positive for COVID on 20Jan2022. Congestion and sore throat are only symptoms, which began on 18Jan2022. The patient experienced covid prior vaccination and also tested post vaccination.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I contracted COVID-19; I contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 14:45 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 18Feb2021 14:45 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 27Jan2021 14:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "recovering" and all described as "I contracted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Feb2021 (Lot number: EL3247) at the age of 26 years as dose 2, single and intramuscular, administered in arm right, administration date 20Jan2021 (Lot number: El3247) 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: VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 28Dec2021, outcome "recovered" (Jan2022) and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab; (Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: severe muscle pain; chills; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2022 17:00 (Lot number: FJ1614) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "cad" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "back issues" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; ISOSORB MONO; SIMVASTATIN; METOPROLOL TARTRATE. Past drug history included: Tetanus for Immunisation, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Brand: Pfizer), administration date: 14Aug2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7484, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Brand: Pfizer), administration date: 22Jul2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "severe muscle pain"; CHILLS (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 16Jan2022 16:00, outcome "recovering", described as "nausea".  Additional information: Known allergies were reported for tetanus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tresiba, isosorb mono, simvastatin, metoprolol tar medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Pain in extremity, Uterine spasm
Clinical narrative: Sore arm; Uterine Cramping; moderate to severe menstrual cramping without bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 13:30 (Lot number: FL3198) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Endotrimosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "EDS" (unspecified if ongoing); "hormone replacement therapy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "AS" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 26Jun2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0127, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 03Jun2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "Sore arm"; UTERINE SPASM (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "Uterine Cramping"; DYSMENORRHOEA (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "moderate to severe menstrual cramping without bleeding". Therapeutic measures were not taken as a result of pain in extremity, uterine spasm, dysmenorrhoea. Additional Information: The patient stated that, she had the normal Sore arm, but 30 hours after the covid shot she have begun to have Uterine Cramping, she had not gotten my menstrual cramping in years due to being on Testosterone, however after this shot she had moderate to severe menstrual cramping without bleeding. Prior vaccination within 4 weeks was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation, Pain, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating; Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating.; Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days); Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0179) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "Gluten intolerance" (unspecified if ongoing), notes: known allergies: gluten and "Injury" (unspecified if ongoing), notes: Full body inflammatory response with old injuries (bone and soft tissue). Concomitant medication included unspecified supplements. Past drug history included: Fentanyl, reaction: "Drug allergy", notes: known allergies: fentanyl. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0161; Anatomical Location: Right arm; Route of Administration: unspecified), administration date: 15Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: INFLAMMATION (non-serious), CONDITION AGGRAVATED (non-serious) and PAIN (non-serious), all with onset 26Jun2021, outcome "recovered with sequelae", and all described as "Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating", POLYMENORRHOEA (non-serious) with onset 26Jun2021, outcome "recovered with sequelae" described as "Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days)". The events "Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating" and "Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days)" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, condition aggravated, polymenorrhoea and pain.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no history of abnormal menstrual cycles and has not had any additional abnormal cycles since then. Since the vaccination, the patient had been tested for COVID-19.