chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: a day after testing negative I now test positive; Positive, notes: a day after testing negative I now test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection Site Pain; This is a spontaneous report received from a contactable reporter(s), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection Site Pain".  Additional information: Reporter calling on behalf of herself that said she received the Pfizer Covid Bivalent Vaccine, and she was asking how long the injection site pain was supposed to last. Caller stated it was day 3 of the injection site pain and declined to complete a report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme tiredness within 6 hours of injection. Still present 36 hours later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. Concomitant medication(s) included: GABAPENTIN; LEVOTHYROXINE; CRESTOR. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 14Sep2022 at 12:00, outcome "not recovered", described as "Extreme tiredness within 6 hours of injection. Still present 36 hours later.". Therapeutic measures were not taken as a result of fatigue.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat; Great Fatigue; Whole body intensely hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis", start date: 2008 (ongoing); "Graves' disease", start date: 2005 (ongoing); "chemically sensitive" (ongoing), notes: Caller states that she is chemically sensitive to many things, she cannot even name them all. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot Number: FJ6369), administration date: 08Mar2022, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot Number: FJ6369), administration date: 29Mar2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13Sep2022, outcome "recovering", described as "Great Fatigue"; HEART RATE INCREASED (non-serious) with onset 13Sep2022, outcome "recovering", described as "Rapid heartbeat"; FEELING HOT (non-serious) with onset 13Sep2022, outcome "recovering", described as "Whole body intensely hot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, fatigue, feeling hot.  Additional information: The patient took no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. NDC number of Covid Booster, Comirnaty, Omicron Booster: Unknown. Caller (patient) stated that she had an adverse event with this booster dose that she did not expect. She had her first Covid Vaccines in Mar2022, prior to that she had none. States that with this booster dose she had a rapid heartbeat, great fatigue, and her whole body was intensely hot. States that she is feeling better now but wanted to report it. Says that she does not blame Pfizer, she blames her own body; she is a chemically sensitive person. The patient stated that Rapid heartbeat has improved, Great fatigue (started several hours after she received the vaccine) has gotten slightly better, Whole body intensely hot; she feels a bit heated now, but not as much as before and all these events began the same day that she got the booster vaccine. Caller stated that she did not want to go to a hospital and figured the symptoms would alleviate in time, which they seem to have done. She requested the Pfizer vaccines because she trusts Pfizer more than the other companies since she uses other unspecified Pfizer Products. Follow-up attempts are completed. No further information is expected.; Reporter's Comments:
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: I am experiencing a big jump in my Glucose range after receiving that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "I am experiencing a big jump in my Glucose range after receiving that". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, "Me and my wife received the Bivalent BA.4, 5 booster shot (Confirmed as Pfizer COVID-19 Vaccine and suspect captured as Covid-19 Bivalent Vaccine) on 08Sep2022 okay and I am experiencing a big jump in my Glucose range after receiving that, is that a known side effects?" Consumer was informed about role of Pfizer Drug Safety. Consumer was informed about Pfizer Medical Information and asked to provide the number. Consumer stated, "No, now I am looking online under the Pfizer and this was the number that, I was supposed to call, to report." Consumer was informed about filing safety report and again informed about the role of Pfizer Drug Safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 34 years, in left arm for covid-19 immunization. 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: had not experienced rebound (negative on rapid antigen and PCR tests); (06Sep2022) Positive, notes: I first tested positive on 06Sep when I had a fever (on an rapid antigen test and on a PCR test); (unspecified date) not positive, notes: tested myself every day after that with rapid antigen tests and was not positive for the coronavirus; (unspecified date) Negative, notes: had not experienced rebound (negative on rapid antigen and PCR tests); (unspecified date) Positive, notes: Product=COVID 19 Treatment; (Jul2022) Positive, notes: I had previously tested positive for with the coronavirus in late Jul, taken Paxlovid; (05Sep2022) Negative, notes: tested negative on at home rapid antigen test; (06Sep2022) Positive, notes: I first tested positive on 06Sep when I had a fever (on an rapid antigen test and on a PCR test); (11Sep2022) Negative, notes: I tested negative for the coronavirus on an at-home rapid antigen test on Day 6 on 11Sep2022; (15Sep2022) Positive, notes: back positive with a faint line on 15Sep; (16Sep2022) positive line showed up almost immediately. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product administration error
Clinical narrative: diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature; diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature; Expired vaccine used/Expiration Date: 22Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Sep2022 at 15:49 as dose number unknown (maroon cap), 3 ug single (Lot number: FT9142, Expiration Date: 22Jan2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 15Sep2022 at 15:49, outcome "unknown", described as "Expired vaccine used/Expiration Date: 22Jan2022"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 15Sep2022 at 15:49, outcome "unknown" and all described as "diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature".  Additional information: The case reported as non-serious. Dose/Dosage Form: Maroon cap, Original(Monovalent)6 months to 4 years-3 mcg/dose, Dilute before use. RN asking about stability of pizer-BioNTech COVID-19 Vaccine per caller (burgundy cap) Maroon cap, 6 months to up to 05-years, diluted vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3;49 pm, product was at room temperature, what to do in this situation Next steps also, on the vial expiry date is 22Jan2022 but expiry date. 31Dec2022 is noted in the chart, reporter wanted to know if we had any clear guidance on that Lot# FT9142 per safety reporter had a question regarding that as well but when reporter came on the line she stated that she had figured it out, no need to address that question, mentioned that NDC # on the box and actual vial were different last two digits were different that is why she was confused but she had figure it out ( per reporter she shared that with safety us well) no question to medical information about that either as per reporter he had figured it out as well. The only difference was the last two numbers one is the box is 04 and the vial is 01.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 at 11:00 as dose 1, single (Lot number: EL9265), in left arm, on 22Feb2021 at 11:15 as dose 2, single (Lot number: EN6205), in left arm, on 05Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 11Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing), notes: Other medical history: Chronic asthma. Concomitant medication(s) included: NEBIVOLOL, start date: 20Apr2022; LISINOPRIL, start date: 14Jul2020; PANTOPRAZOLE SODIUM, start date: 14Jul2020; ELIQUIS, start date: 03Mar2021; TADALAFIL, start date: 29Oct2021; ASPIRIN LOW, start date: 03Mar2021; ADVAIR, start date: 14Jul2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 16:15 as dose 5 (booster), single (Lot number: 6H6964) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PEPCID [FAMOTIDINE]; SINGULAIR. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Nasal Swab . Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Vascular Carotid Surgery", start date: Nov2021 (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL, start date: 2021; LISINOPRIL taken for hypertension, start date: 2021; LASIX [FUROSEMIDE], start date: 2021; LIPITOR, start date: 2021; ASPIRIN 81, start date: 2021. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0191), administration date: 07Jun2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EW0217), administration date: 01Jul2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Nosebleed", "Vascular Carotid Surgery". The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Nosebleed". Therapeutic measures were taken as a result of epistaxis.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to vaccinations. The patient received the first, second, and booster doses of the vaccine. After the second dose and the booster dose the patient had nosebleeds. The reporter wanted to know the information related to the vaccine and blood thinners. It was reported that nosebleed occurred after the patients second dose and booster dose of the vaccine. Stated that it was not severe. The patient would feel something in nose and then when she would blow it there would be blood. Adverse event treatment included Vitamin C, so the patient increased her Vitamin C at that time and the nosebleed went away after several days. It was reported that nosebleed was more after the second dose of the vaccine than the booster dose of the vaccine. When the reporter realized she will probably need a second booster and was thinking somewhat surprised that it happened with the patients booster dose. The patient was on several medications. Initially reported that the patients question was related to Lipitor, which she states she thinks it was a blood thinner. It was reported that blood thinner was Plavix, Clopidogrel; not Lipitor. Clopidogrel was in a pharmacy vial. The reported that Lipitor was an Aspirin, then stated no, maybe it was a Calcium. The reporter reported no further information related to her Lipitor.
Age: 76.0
Sex: U
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: injection site pain; headache; fatigue; muscle ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered"; HEADACHE (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered", described as "injection site pain"; MYALGIA (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered", described as "muscle ache". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia.  Additional Information: Patient had not received any other vaccine in four weeks. It was reported that the patient had not tested for COVID prior and post vaccination.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS". There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Sep2022, outcome "unknown", COVID-19 (medically significant) with onset 13Sep2022, outcome "not recovered" and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive. Therapeutic measures were taken as a result of covid-19. 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies to opioid pain medication" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (10Sep2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 06Sep2022 to 10Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm 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), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: "a little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "suspected nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as ""a little sore at the site" after receiving those previous doses".  Additional information: Caller asked about the ingredients for the Pfizer-Covid19 vaccine, GRAY cap, Bivalent formula.  She reported a suspected nickel allergy, noting that "sometimes the earrings that have nickel irritate my skin" but her dermatologist never tested her for an allergy. She noted that the consent form at (name withheld) asked about allergies and "it did not have that before" so she wrote in 'Nickel'.  Because of this, her pharmacist was not sure whether she could get the new booster when she "went 3 days ago".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: head to toe rash x 5 weeks head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (hospitalization), outcome "unknown", described as "head to toe rash x 5 weeks head to toe". The event "head to toe rash x 5 weeks head to toe" required emergency room visit. Additional information: Patient was having a head to toe rash x 5 weeks. Reporter has talked to a few friends who possibly have had rashes associated with the Pfizer Covid vaccine. He also was seen in a hospital ER and the doctor suggested the possibility. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had the Pfizer both the vaccines, then I had a booster. Then I got COVID; I had the Pfizer both the vaccines, then I had a booster. Then I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), Suspected COVID-19 (medically significant), outcome "unknown" and all described as "I had the Pfizer both the vaccines, then I had a booster. Then I got COVID".  Additional Context: It was mentioned that yesterday, on 15Sep2022, patient got the second booster (Pfizer Covid 19 second booster shot) and at the same time they got the unspecified flu shot, one in one arm, one in the other. The patient asked if that was acceptable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: Shaking with the chills; Shaking with the chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 09:30 as dose 2, single (Lot number: PF7140) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: PF7140, Location of injection: Arm Left, Administration time: 09:30 Am), administration date: 24Aug2022, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Headache", "Chills". The following information was reported: HEADACHE (non-serious) with onset 14Sep2022 at 21:30, outcome "not recovered"; TREMOR (non-serious), CHILLS (non-serious) all with onset 14Sep2022 at 21:30, outcome "recovering" and all described as "Shaking with the chills". Therapeutic measures were taken as a result of tremor, chills, headache. Additional information: No other vaccine in four weeks. No Other medications in two weeks. 12 Hours after the shot he started having Chills and the worst headache he had ever had. They lasted for about 3 days. After the second shot the same thing 12 hours after the shot he started shaking with the chills and the headache was there again also in 2 days into the 2nd shot and still have a terrible headache. treatment included Pharmacy told him to take Advil or Tylenol. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. No Hospitalization Prolonged.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Dyspnoea, Off label use, Product use issue, Urticaria
Clinical narrative: Broke out in hives from head to toe; Difficulty breathing at night; Got both COVID 19 updated booster and Flucelvax shot the same day; Got both COVID 19 updated booster and Flucelvax shot the same day; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 61 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 14Sep2022 as dose 1, single (Lot number: 942404) intramuscular for immunisation. The patient's relevant medical history included: "Known allergy: Latex" (unspecified if ongoing); "Known allergy: Preservatives" (unspecified if ongoing), notes: Known allergy: Preservatives. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2022 at 11:00, outcome "unknown" and all described as "Got both COVID 19 updated booster and Flucelvax shot the same day"; URTICARIA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Broke out in hives from head to toe"; DYSPNOEA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Difficulty breathing at night". It was unknown if therapeutic measures were taken as a result of urticaria, dyspnoea. Additional information: Patient got both COVID 19 updated booster and Flucelvax shot the same day at the pharmacy, on Wednesday 14Sep2022. She said she broke out in hives from head to toe and had difficulty breathing at night on 15Sep2022. Events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: The patient was scheduled to receive the bivalent vaccine next Tuesday. He stated that he and his wife were taking Keytruda for cancer. His doctor said because they had received booster doses of the Pfizer COVID-19 Vaccine before and done well, this one should not cause a problem as it is similar and a combination of mRNA from the original vaccine. The patient was also asking if there are any interactions between Keytruda and the new formulation of the COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170301 same reporter, drug, and event; different patient;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Investigation, Lymphoproliferative disorder
Clinical narrative: A cyst appeared on my right breast; primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 2, single (Lot number: FK4554) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies Sulfa" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot number: FK9895), administration date: 19Mar2022, when the patient was 31-year-old, for COVID-19 immunization. No other vaccine in four weeks. The following information was reported: BREAST CYST (medically significant) with onset 14May2022, outcome "unknown", described as "A cyst appeared on my right breast"; LYMPHOPROLIFERATIVE DISORDER (medically significant) with onset 14May2022, outcome "unknown", described as "primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder". The events "a cyst appeared on my right breast" and "primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder" required physician office visit. A cyst appeared on right breast that was tested at various labs and ultimately determined to be primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder. Dermatology journal found indicated, "This case series found cutaneous T-cell-rich lymphoid infiltrates to be rare but potential complications after Pfizer/BioNTech COVID-19 mRNA vaccination." Therapeutic measures were taken as a result of breast cyst, lymphoproliferative disorder. Adverse events treatment included surgical removal of cyst, oncologist visit and labs. The patient was not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hodgkin's disease, Pericardial effusion
Clinical narrative: Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.; Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 3 (booster), single (Lot number: En6204), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; LASIX [FUROSEMIDE]; BUSPAR; NEURONTIN. Past drug history included: Benzoyl peroxide, reaction(s): "known allergies: Benzoyl peroxide", notes: known allergies: Benzoyl peroxide. Vaccination history included: pfizer/biontech (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Right), administration date: 29Mar2021, for COVID-19 immunization, reaction(s): "COVID-19"; covid19 vaccine (Dose 1, Batch/lot number=Fj1714,, Location of injection=Arm left), administration date: 08Mar2021, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PERICARDIAL EFFUSION (medically significant) with onset 16Jul2022, outcome "not recovered", described as "Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma."; HODGKIN'S DISEASE (medically significant) with onset 22Jul2022, outcome "not recovered", described as "Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.". The events "diffuse large b cell non hodgkin's lymphoma 22jul2022." and "heart pericardial effusion 16jul2022 fluid treated positive for lymphoma." required emergency room visit. Therapeutic measures were taken as a result of hodgkin's disease, pericardial effusion.; Sender's Comments: Based on the available information  the causal association of suspect drug BNT162B2 and the serious events PERICARDIAL EFFUSION and HODGKIN'S DISEASE cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.; Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 3 (booster), single (Lot number: En6204), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; LASIX [FUROSEMIDE]; BUSPAR; NEURONTIN. Past drug history included: Benzoyl peroxide, reaction(s): "known allergies: Benzoyl peroxide", notes: known allergies: Benzoyl peroxide. Vaccination history included: pfizer/biontech (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Right), administration date: 29Mar2021, for COVID-19 immunization, reaction(s): "COVID-19"; covid19 vaccine (Dose 1, Batch/lot number=Fj1714,, Location of injection=Arm left), administration date: 08Mar2021, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PERICARDIAL EFFUSION (medically significant) with onset 16Jul2022, outcome "not recovered", described as "Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma."; HODGKIN'S DISEASE (medically significant) with onset 22Jul2022, outcome "not recovered", described as "Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.". The events "diffuse large b cell non hodgkin's lymphoma 22jul2022." and "heart pericardial effusion 16jul2022 fluid treated positive for lymphoma." required emergency room visit. Therapeutic measures were taken as a result of hodgkin's disease, pericardial effusion.; Sender's Comments: Based on the available information  the causal association of suspect drug BNT162B2 and the serious events PERICARDIAL EFFUSION and HODGKIN'S DISEASE cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hodgkin's disease, Pericardial effusion
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: En6204), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7533), in right arm and on 22Jan2022 as dose 3 (booster), single (Lot number: Fj1714), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis". Concomitant medication(s) included: BUSPAR; CYMBALTA; LASIX [FUROSEMIDE SODIUM]; NEURONTIN. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: Benzoyl peroxide". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Nasal Swab.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: En6204), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7533), in right arm and on 22Jan2022 as dose 3 (booster), single (Lot number: Fj1714), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis". Concomitant medication(s) included: BUSPAR; CYMBALTA; LASIX [FUROSEMIDE SODIUM]; NEURONTIN. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: Benzoyl peroxide". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Nasal Swab.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort; Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE; lot Number: Unknown, Anatomical location: Arm Left), administration date: 18Jan2021, when the patient was 21-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 2,  SINGLE; Lot Number: Unknown), administration date: 18Feb2021, when the patient was 21-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 3 (BOOSTER),SINGLE;  Lot Number: Unknown), administration date: 26Oct2021, when the patient was 22-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious) all with onset 17Sep2022, outcome "unknown" and all described as "Swollen lymph node in armpit of arm where vaccination was administered, causing moderate discomfort". Therapeutic measures were not taken as a result of lymphadenopathy, discomfort.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. This report is not serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Headache, Menstruation irregular
Clinical narrative: headaches; menstrual cycle has been extremely irregular; lost a lot of my hair; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 at 12:00 as dose 2, single (Lot number: 32030BD) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO. Vaccination history included: BNT162b2 (dose 1, lot number FE3590, on 22Oct2021,02:15 PM, vaccine location Right arm), administration date: 22Oct2021, when the patient was 41-year-old, for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "headaches"; ALOPECIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "lost a lot of my hair"; MENSTRUATION IRREGULAR (non-serious) with onset 29Dec2021, outcome "not recovered", described as "menstrual cycle has been extremely irregular". Therapeutic measures were not taken as a result of headache, menstruation irregular, alopecia.  Additional information: The patient had received no other vaccine in four weeks and had no known allergies. Since getting second vaccine in Nov2021 her menstrual cycle has been extremely irregular, after decades of being the same day every month. She has also lost a lot of hair and developed weekly headaches where she never had headaches before. No Covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.