chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech dose number: 4; Moderna dose number: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Patient was not pregnant. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2022 at 17:00, outcome "unknown", described as "Pfizer/BioNTech dose number: 4; Moderna dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 11Dec2022 to 16Dec2022 as COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events interchange of vaccine products, drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech/Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 14:00 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fma992) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 at 14:30 as dose 1, single (Lot number: 007M20A), in left arm and on 26Feb2021 at 12:00 as dose 2, single (Lot number: 001a21a), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021 at 14:00, outcome "unknown", described as "Pfizer / BioNTech/Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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 drug ineffective, covid-19.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (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), 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 included: "Fibromyalgia" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had a positive COVID-19 test on an unspecified date and started COVID-19 treatment with Paxlovid from 16Dec2022 to 20Dec2022. After four days of negative tests, the patient had a positive COVID test on 25Dec2022. Outcome of the events was not recovered.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid: tested positive; covid: tested positive; dose 5 (booster) Moderna Bivalent; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 22Feb2021 as dose 1, single (lot number EN6200), on 15Mar2021 as dose 2, single (lot number EN6208), on 04Oct2021 as dose 3 (booster), single (lot number FF2589) and on 06Apr2022 as dose 4 (booster), single (lot number FF9893) at the age of 55 years for covid-19 immunisation; covid-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Sep2022 as dose 5 (booster), single (lot number AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medication(s) were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "dose 5 (booster) Moderna Bivalent"; VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) both with onset 16Dec2022, outcome "not recovered" and described as "covid: tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) positive. Therapeutic measures were taken as a result of vaccination failure and covid-19. Clinical course: Tested positive on 16Dec2022 and started Paxlovid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 48 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FD0809) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 15Dec2022 to 19Dec2022.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Influenza like illness, SARS-CoV-2 test
Clinical narrative: COVID test result Positive; sinus; weak; flu like; decreased appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; LOSARTAN; ALOGLIPTIN. The following information was reported: COVID-19 (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "COVID test result Positive"; DECREASED APPETITE (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "flu like"; SINUS DISORDER (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "sinus"; ASTHENIA (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19, sinus disorder, asthenia, influenza like illness, decreased appetite.  Clinical course: Dose received 1 (bivalent was false), prior to getting the COVID booster on 15Dec2022 I had not had any COVID, Flu, or cold like symptoms. I was feeling fine. One Day later after getting the COVID booster I developed several symptoms coughing, headache, sinus, weak and sore muscles flue like, low grade temp, decreased appetite. No covid prior vaccination. No other vaccine in four weeks. COVID tested post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus disorder
Clinical narrative: COVID test result Positive; sinus; weak; flu like; decreased appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; LOSARTAN; ALOGLIPTIN. The following information was reported: COVID-19 (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "COVID test result Positive"; DECREASED APPETITE (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "flu like"; SINUS DISORDER (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "sinus"; ASTHENIA (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19, sinus disorder, asthenia, influenza like illness, decreased appetite.  Clinical course: Dose received 1 (bivalent was false), prior to getting the COVID booster on 15Dec2022 I had not had any COVID, Flu, or cold like symptoms. I was feeling fine. One Day later after getting the COVID booster I developed several symptoms coughing, headache, sinus, weak and sore muscles flue like, low grade temp, decreased appetite. No covid prior vaccination. No other vaccine in four weeks. COVID tested post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history or no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) 17Dec2022 to 21Dec2022. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulum" (unspecified if ongoing); "hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: COMBIPATCH taken for hormone replacement therapy, start date: 15Oct2010. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient received PAXLOVID for treatment of Covid-19 from 09Dec2022 to 13Dec2022.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: when his daughter (60 years old) had covid; when his daughter (60 years old) had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A 60-year-old female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "when his daughter (60 years old) had covid".  Clinical course: Caller said received all the five shots of the Pfizer covid-19 vaccine and couldn't believe he got covid 3 to 4 days ago. Caller mentioned that when his daughter (60 years old) had covid, she called Pfizer and Pfizer recommended something and she got it and it helped her tremendously.   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: 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). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing). There were no concomitant medications. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Dec2022 to 17Dec2022.  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: Body height, Pain in extremity, Poor quality product administered, Product administration error
Clinical narrative: Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.; Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose number unknown, 0.3 ml single (Lot number: GJ6796, Expiration Date: 31Jan2024), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "unknown", described as "Sore arm"; PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 23Dec2022, outcome "unknown" and all described as "Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of product administration error, poor quality product administered, pain in extremity.  Additional information: The pharmacist reported that the patient received a dose of Pfizer Covid19 vaccine, Bivalent, Gray cap that was "open for 18 hours" and left at room temperature, in the vial. This happened on Friday, the patient was stable and ok. Created an AE Form because a vaccine was administered 6 hours past the 12 hour period time allowed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (27Dec2022): New information was reported from a contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Reporter mailing address and institution, lab test, dosage regimen details and new event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 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. Vaccination history included: Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown".  Additional information: Refers getting the primary series experiencing only soreness and after that a first booster dose on 06Dec2022. Eight hours after getting the Pfizer BioNTech COVID-19 booster, she experienced tinnitus. The caller wants to know if there is any information available regarding patients who received the PFizer BioNTech COVID-19 bivalent booster and experienced tinnitus. She refers wanting to get the bivalent booster but she has already cancelled three appointments to get it out of fear that the tinnitus would come back. Caller is an audiologist. Caller states she was looking for more information about Tinnitus, and research on the new bivalent vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201398398 same patient, different vaccine dose/AE.;US-PFIZER INC-202201398399 same patient, different vaccine dose/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness; Sore arm after primary Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm after primary Covid vaccine".  Additional information: Refers getting the primary series experiencing only soreness. Caller is an audiologist.  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-202201398251 same patient, different vaccine dose/AE.;US-PFIZER INC-202201398399 same patient, different vaccine dose/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm after primary Covid vaccine; primary series experiencing only soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "soreness", "Sore arm after primary Covid vaccine". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm after primary Covid vaccine"; PAIN (non-serious), outcome "unknown", described as "primary series experiencing only soreness".         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-202201398398 same patient, different vaccine dose/AE.;US-PFIZER INC-202201398251 same patient, different vaccine dose/AE.;
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough is a lot worse; 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), on 27Dec2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had a cough yesterday", start date: 26Dec2022 (ongoing), notes: Calling about the Pfizer COVID shot, had a cough yesterday. The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "cough is a lot worse".  Additional information: It was reported that, calling about the Pfizer COVID shot, had a cough yesterday and then got the shot this morning at 10 and now cough is a lot worse. Has test kits, would the test kit give a false positive since caller had the shot this morning. Not related to a study or programme.   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: She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive; She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: She is a cancer survivor 10 years back.; "Blood pressure" (unspecified if ongoing), notes: Indication for Use in Case: Blood pressure. Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; BENAZEPRIL taken for blood pressure abnormal; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She was a Pfizer trial for Vaccine/Caller had the Pfizer COVID-19 Vaccines and tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: had to take because COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She takes a Probiotic every day for her stomach. She was a Pfizer trial for Vaccine. She was on trial for Vaccine and vaccine didn't create any side effects. She got her COVID-19 Vaccines through Pfizer. Caller had the Pfizer COVID-19 Vaccines and tested COVID positive. Caller declines to provide details regarding her vaccinations. She states she never had any side effects with the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: the arm just being a little sore for 24 hours; 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 male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9264) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "the arm just being a little sore for 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Additional information included He has tested positive for covid and went in and got his test; he just scooted up in his seat and ran into it and hit his head and glasses and is bald headed and has taken more skin off of the top of his head because he does not wear a hat and is bald so does not feel anything and that got his skin. They were all in the left arm and the time of administration varied from 10:00am to 2:30-3:00pm and his were at the same facilities as his wife's vaccines. Card does not have handwritten the expiry dates or NDC numbers for his vaccine doses. They had no adverse effects other than the arm just being a little sore for 24 hours and they did not get sick themselves after the pfizer covid vaccines; the sore arm was pretty much with all of the Pfizer covid vaccines where the arm was a little sore but it was nothing like being killer sore and it was not as bad as the tetanus shot which hurts usually pretty good after you get it and not at the time you get it because they use a small needle but then it gets pretty sore; has no manufacturer, lot, expiry date or NDC for his tetanus shots as his last one was 10 years ago and he does not have that information. Prior Vaccinations (within 4 weeks):Vaccines 4 weeks prior: got the flu shot he thinks somewhere around the time he got the Pfizer Covid vaccine 3rd dose and the flu shot may have been within a week of the covid vaccine 3rd dose so the flu shot may have been on 21Sep2021; has no manufacturer, lot, expiry date or NDC for the flu shot to provide.      ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399436 same reporter/ patient, same drug, different AE.;US-PFIZER INC-202201399615 same reporter/patient, same drug/different dose, same AE (dose 2);US-PFIZER INC-202201399616 same reporter/patient, same drug/different dose, same AE (dose 3);US-PFIZER INC-202201399617 same reporter/patient, same drug/different dose, same AE (dose 4);US-PFIZER INC-202201399618 same reporter/patient, same drug/different dose, same AE (dose 5);
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Soreness in left arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:30 as dose 4 (booster), single (Lot number: GJ6742) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS; "Cervical Focal Dystonia" (unspecified if ongoing), notes: Cervical Focal Dystonia; "Diverticulosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "covid" (unspecified if ongoing), notes: if covid prior vaccination reported as yes. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; TIZANIDINE; LEVOTHYROXIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: known allergies: Codeine; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "Soreness in left arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. if covid tested post vaccination reported as no.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Wrong product administered
Clinical narrative: rash started to cover my limbs, my buttocks, and my torso; It is terribly itchy.; Pfizer Bivalent; Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 at 15:00 as dose 1, single (Lot number: GH9702) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Dec2022 at 15:00, outcome "unknown", described as "Pfizer Bivalent; Dose Number: 1"; RASH PRURITIC (non-serious) with onset 24Dec2022 at 15:00, outcome "not recovered", described as "It is terribly itchy."; RASH (non-serious) with onset 24Dec2022 at 15:00, outcome "not recovered", described as "rash started to cover my limbs, my buttocks, and my torso". Therapeutic measures were not taken as a result of rash, rash pruritic.  Additional information: On 24Dec2022 a rash started to cover patient limbs, buttocks and torso. It was terribly itchy. No other vaccine in four weeks. No covid tested prior and post vaccination. No Known allergies.  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: Chills, Fatigue
Clinical narrative: tired; chills; 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 79-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: she also takes cholesterol meds but pretty healthy otherwise.; "High blood pressure" (unspecified if ongoing), notes: she has high blood pressure that she takes meds for. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary series completed with unknown manufacturer), for Covid-19 immunization; Flu vaccine (Caller also states she already got a flu shot without egg and had no problem with it.), for Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; CHILLS (non-serious), outcome "unknown".  Additional information: The caller stated that after her booster last year in Nov she was tired and little bit of chills, therefore she enquired if it will be alright to receive the bivalent booster Pfizer BioNTech covid 19 vaccine. Caller also stated she already got a flu shot without egg and had no problem with it. Caller reported that she had high blood pressure that she takes meds for, she also takes cholesterol meds but pretty healthy otherwise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; nausea; headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:30 as dose 3 (booster), single (Lot number: GJ6742) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Peanuts" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; VITAMIN D [COLECALCIFEROL]; STRATTERA. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Pfizer BioNTech, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Aug2021, when the patient was 15-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Pfizer BioNTech, Batch/Lot No: FA6780, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Jul2021, when the patient was 15-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "Soreness at injection site"; PYREXIA (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, nausea, headache, pyrexia.  Additional information: Location of injection for vaccine received same date: Influenza-Left arm. The most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient been had not tested for COVID-19, since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Fibromyalgia
Clinical narrative: experienced a wide range inflammatory response in all joints/experienced same side effects; it exacerbated her fibromyalgia/experienced same side effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced a wide range inflammatory response in all joints/experienced same side effects"; FIBROMYALGIA (non-serious) with onset 2022, outcome "unknown", described as "it exacerbated her fibromyalgia/experienced same side effects".  Clinical information: Caller received the Pfizer COVID booster in Jan2022 and experienced a wide range inflammatory response in all joints. Caller said it exacerbated her fibromyalgia, which developed as a result of Lyme's disease she contracted several years ago. Caller mentioned spouse also received Pfizer COVID booster at the same time and experienced same side effects.  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-PV202200132898 same reporter/drug/event, different patients;
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngitis
Clinical narrative: a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign Prostatic enlargement" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "a cold".  Additional information: Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. The patient did not received any other medications the patient received within 2 weeks of vaccination. Patient had a cold before catching Covid, so the symptoms have been confusing as to which was which.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201400118 same patient, different dose and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Laboratory test
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 at 08:00 as dose 1, single (Lot number: EL9231) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Received all 3 doses at [hospital name withheld]. Hair loss started to [Illegible] bad and worse in Feb2022.
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 17Dec2022 to 21Dec2022 for COVID-19 treatment. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Decreased appetite, Emphysema, Headache, Insomnia, Productive cough
Clinical narrative: Emphysema; His arm "turned black and blue six inches around"; I couldn't sleep; I couldn't eat; headache; fever of 99; threw up a couple times; couldn't stop coughing and was producing phlegm; 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 male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pravastatin (PRAVASTATIN), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Cholesterol" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Immunization, reaction(s): "never reacted to flu vaccines". The following information was reported: EMPHYSEMA (non-serious), outcome "unknown"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "His arm "turned black and blue six inches around""; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't sleep"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I couldn't eat"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever of 99"; VOMITING (non-serious), outcome "unknown", described as "threw up a couple times"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "couldn't stop coughing and was producing phlegm". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for pravastatin was unknown. Therapeutic measures were taken as a result of emphysema.  Additional information: The patient was not allergic to anything. The patient mentioned that he had a bad reaction to the medication Prevnar 20 and was asking if he could take a blood test to see how much of the vaccine he received. He's pretty sure the nurse gave him "too much of it since it comes in a vial right". "I had every side effect". It was bad for like two weeks. The patient had emphysema and used an inhaler. "Do you think it mixed with that inhaler I'm taking? Atmosphere HFA Aerosole inhaler." He also wondered if his reaction was from the pravastatin he took for cholesterol.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia, Skin discolouration, Vomiting
Clinical narrative: Emphysema; His arm "turned black and blue six inches around"; I couldn't sleep; I couldn't eat; headache; fever of 99; threw up a couple times; couldn't stop coughing and was producing phlegm; 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 male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pravastatin (PRAVASTATIN), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Cholesterol" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Immunization, reaction(s): "never reacted to flu vaccines". The following information was reported: EMPHYSEMA (non-serious), outcome "unknown"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "His arm "turned black and blue six inches around""; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't sleep"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I couldn't eat"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever of 99"; VOMITING (non-serious), outcome "unknown", described as "threw up a couple times"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "couldn't stop coughing and was producing phlegm". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for pravastatin was unknown. Therapeutic measures were taken as a result of emphysema.  Additional information: The patient was not allergic to anything. The patient mentioned that he had a bad reaction to the medication Prevnar 20 and was asking if he could take a blood test to see how much of the vaccine he received. He's pretty sure the nurse gave him "too much of it since it comes in a vial right". "I had every side effect". It was bad for like two weeks. The patient had emphysema and used an inhaler. "Do you think it mixed with that inhaler I'm taking? Atmosphere HFA Aerosole inhaler." He also wondered if his reaction was from the pravastatin he took for cholesterol.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got covid 3 to 4 days ago; he got covid 3 to 4 days ago; 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 male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "he got covid 3 to 4 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) he got covid 3 to 4 days ago.  Clinical course: Caller said received all the five shots of the Pfizer covid-19 vaccine and couldn't believe he got covid 3 to 4 days ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.