chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; 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 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Sep2022 as unk, single (Batch/Lot number: unknown) for 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 Sep2022, outcome "unknown" and all described as "had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: she and her 80 year old husband both tested positive for Covid last Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that, caller was a 78 year old female patient and states that she and her 80 year old husband both tested positive for Covid last Tuesday and started taking Paxlovid yesterday. Caller states that she and her husband have had the Pfizer Covid19 primary series and 1st booster vaccines and had the flu shot last Wednesday.   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-202201198148 Same vaccine/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: tested positive for Covid last Tuesday and started taking Paxlovid yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Proprietary medicinal product name was Paxlovid. Active drug substance was nirmatrelvir tablets, ritonavir tablets. Reporter stated that her 80-year-old husband tested positive for Covid last Tuesday and started taking Paxlovid yesterday. She stated that she and her husband had the Pfizer Covid19 primary series and 1st booster vaccines and had the flu shot last Wednesday. She and her husband had a terrible metallic taste in their mouth after they stop eating. She asked "was this a normal side effect of Paxlovid.  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-202201198146 Same vaccine/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID; Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GH9464), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: FN6205), in left arm, as dose 2, single (Lot number: ER8732), in left arm, as dose 3 (booster), single (Lot number: FE3592), in left arm and as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and I still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Dexamethasone, 4 milligrams that she takes one twice a day and Azithromycin 250 Milligrams. Patient received all the required Pfizer vaccine (Pfizer COVID-19 Vaccine) and the required booster and still got COVID now. Luckily, patient did not have that bad. She just felt funny and went to the (withheld) because she thought she had strep throat she had very bad sore throat (Intent: COVID symptoms) and she caught COVID. She did not know how she got it. She had all the required vaccines and boosters and several months after she got the vaccine and booster. Just one Monday, she had the sore throat and she treated it and then she thought she had strep throat so she went to Medical Express facility and was confirmed with and was tested and the test result came out that patient have COVID. The gentlemen swab my nose and throat and the test result came back that she had COVID and stated she did not understand why.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 21Sep - tested positive on antigen test; 21Sep - tested positive on antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right 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). The patient did not have any known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "21Sep - tested positive on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: Tested positive on antigen test; (27Sep2022) Positive, notes: Faint positive antigen test; (28Sep2022) Negative, notes: Clear negative antigen test; (30Sep2022) Positive, notes: Strong positive antigen test; (22Sep2022) Positive, notes: Tested Positive on PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Sep2022 to 27Sep2022. On 21Sep2022, the patient tested positive on antigen test. On 22Sep2022, the patient tested positive on PCR test. The patient was prescribed Paxlovid and began Paxlovid course. On 26Sep2022, the symptoms had nearly gone with just slight cough remaining. On 27Sep2022, the patient took last Paxlovid dose. On 27Sep2022, the patient had faint positive antigen test, the symptoms were gone. On 28Sep2022, the patient had clear negative antigen test, symptoms were gone. On 29Sep2022, no test was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 15:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 at 17:30 as dose 1, single (Lot number: EN6201), on 13Mar2021 at 17:00 as dose 2, single (Lot number: EN6208), on 05Oct2021 at 16:30 as dose 3 (booster), single (Lot number: 30135BA) and on 15Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history included: "Hyper active airway" (unspecified if ongoing); "reflux" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "known allergies; Rubber" (unspecified if ongoing); "known allergies; latex" (unspecified if ongoing), notes: known allergies; latex; "known allergies; alcohol" (unspecified if ongoing), notes: known allergies; alcohol. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline"; Nickel, reaction(s): "Known allergies: nickel".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (30Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of DRUG INEFFECTIVE and COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Laziness, Malaise
Clinical narrative: I am lazy; I am tired, I want to always go to sleep; I want to always go to sleep; I started getting weaker and sicker; I am not feeling that well; I started getting weaker and sicker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 30Sep2022, outcome "not recovered", described as "I am not feeling that well"; ILLNESS (non-serious), ASTHENIA (non-serious) all with onset 30Sep2022, outcome "not recovered" and all described as "I started getting weaker and sicker"; LAZINESS (non-serious), outcome "not recovered", described as "I am lazy"; FATIGUE (non-serious), outcome "not recovered", described as "I am tired, I want to always go to sleep"; SOMNOLENCE (non-serious), outcome "not recovered", described as "I want to always go to sleep".  Additional information: It was reported that, the patient got the COVID shot, fifth dose of Bivalent. Patient got it Wednesday and patient was not feeling that well. Thursday patient was okay, Friday patient started getting weaker and sicker and now patient just want to know, how long these side effects were going to last? Consumer stated, "It was the 5th dose Bivalent PF12 ERGJ5342 (further clarification unknown) Pfizer." Consumer stated, that was alright, but could you tell me, how long these side effects or when am patient going to start feeling the, better again you know, patient was lazy, was tired, patient want to always go to sleep, could you tell me, when patient was going to start getting back to regular self? Yeah, but you just said you were a pharmacist, you did not know about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I am lazy; I am tired, I want to always go to sleep; I want to always go to sleep; I started getting weaker and sicker; I am not feeling that well; I started getting weaker and sicker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 30Sep2022, outcome "not recovered", described as "I am not feeling that well"; ILLNESS (non-serious), ASTHENIA (non-serious) all with onset 30Sep2022, outcome "not recovered" and all described as "I started getting weaker and sicker"; LAZINESS (non-serious), outcome "not recovered", described as "I am lazy"; FATIGUE (non-serious), outcome "not recovered", described as "I am tired, I want to always go to sleep"; SOMNOLENCE (non-serious), outcome "not recovered", described as "I want to always go to sleep".  Additional information: It was reported that, the patient got the COVID shot, fifth dose of Bivalent. Patient got it Wednesday and patient was not feeling that well. Thursday patient was okay, Friday patient started getting weaker and sicker and now patient just want to know, how long these side effects were going to last? Consumer stated, "It was the 5th dose Bivalent PF12 ERGJ5342 (further clarification unknown) Pfizer." Consumer stated, that was alright, but could you tell me, how long these side effects or when am patient going to start feeling the, better again you know, patient was lazy, was tired, patient want to always go to sleep, could you tell me, when patient was going to start getting back to regular self? Yeah, but you just said you were a pharmacist, you did not know about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: Fj4991) at the age of 63 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DIVIGEL taken for hormone replacement therapy; PROGESTERONE taken for hormone replacement therapy. Past drug history included: Neosporin, reaction(s): "known allergy: Neosporin". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: Poitive, notes: I tested positive; Negative, notes: I tested positive (after previously testing negative once the paxlovid was completed). Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that patient received other medication in  two weeks. Anti-viral details are as follows: Patient was taking Paxlovid from 20Sep2022 to 25Sep2022 to treat covid-19. Covid rebound. On day 7 after completing the paxlovid, Patient became ill again with covid symptoms and tested positive (after previously testing negative once the paxlovid was completed.) Experienced congestion, mild cough, significant fatigue and malaise.
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 47-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (01Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as COVID 19 Treatment, started on 21Sep2022 and stopped on 25Sep2022. Patient tested positive for Covid and Covid Symptoms approximately 6 days after finishing Paxlovid.  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: Maternal exposure timing unspecified, Subchorionic haematoma
Clinical narrative: subchorionic hematoma leading to fetal demise; subchorionic hematoma leading to fetal demise; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (hospitalization, medically significant), SUBCHORIONIC HAEMATOMA (hospitalization, medically significant), outcome "unknown" and all described as "subchorionic hematoma leading to fetal demise". The event "subchorionic hematoma leading to fetal demise" required physician office visit and emergency room visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available reported information, the causal association between the events of "subchorionic hematoma  and Maternal exposure during pregnancy and  the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202201198795 Same vaccine, different patient/event.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 10:00 as dose 7 (booster), single (Lot number: 028k21a) at the age of 69 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "kidney disease" (unspecified if ongoing); "sleep apnia" (unspecified if ongoing); "bladder and prostate" (unspecified if ongoing); "bladder and prostate" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 10Jul2022; ATORVASTATIN, start date: 03Jul2022; LOSARTAN, start date: 13Sep2022; METOPROLOL, start date: 20Jul2022; AMLODIPINE, start date: 01Sep2022; TAMSULIN, start date: 05Jul2022; VITAMIN C & COLLAGEN, start date: 03Jul2022; ASPIRIN (E.C.), start date: 04Jul2022; OMEGA 3 [FISH OIL], start date: 12Jun2022; CENTRUM SILVER +50, start date: 03Jan2021; ZINC, start date: 14Aug2022; SUPER B COMPL, start date: 05Jan2020. 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: product=COVID 19 Treatment, Brand=Pfizer, from 29Sep2022 to 02Oct2022, lot number=Ndc0069108506, Indication=Treatment of COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of 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 male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (28Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 19Sep2022, treatment stop date was 23Sep2022 and indication was treatment of COVID-19. No known allergies were reported.  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: Limb discomfort, Muscular weakness
Clinical narrative: arm syndrome associated with their vaccine; lifting capacity of my arm that I get the vaccine in or booster; It goes drop by the 30 to 50 percent; I cn nrmly lft 120 pnds at my weak arm, straight up&down. It drpd significntly to the point whr 20, 25 pnds cast iron skilet is difficult to manage/I can't lft skilet iron so wel whn I gt the vaccine; 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 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "arm syndrome associated with their vaccine; lifting capacity of my arm that I get the vaccine in or booster; It goes drop by the 30 to 50 percent"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "I cn nrmly lft 120 pnds at my weak arm, straight up&down. It drpd significntly to the point whr 20, 25 pnds cast iron skilet is difficult to manage/I can't lft skilet iron so wel whn I gt the vaccine".  Additional information: Consumer stated, "I was calling for information, so I was wondering if Pfizer has found a solution to use the arm syndrome associated with their vaccine and what I mean by that is the lifting capacity of my arm that I get the vaccine in or booster whenever its done by Pfizer and I have the batch numbers here. It goes drop by the 30 to 50 percent so, if I can normally lift the 120 pounds at my weak arm, straight up and down. It dropped significantly to the point where 20, 25 pounds cast iron skillet is difficult to manage. I am dominantly left hand side. So, anything require glute or strength or coordination is done with my right side, so I need to work the cast iron skillet with the left hand and then I will use the spatula with the right. I can not lift skillet iron so well when I got the vaccine, so have you fixed it?"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Sep2022) Positive, notes: Positive antigen for 7d w symptoms. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 16Sep2022 to 21Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event drug ineffective, COVID19 and bnt162b2 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Decreased appetite, Headache, Migraine
Clinical narrative: splitting headache; Migraine; temperature; decrease the appetite; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Moderna covid-19 vaccine (Dose 1, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 2, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 3, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "splitting headache"; MIGRAINE (non-serious), outcome "unknown"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "temperature"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decrease the appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There is something wrong with that patient have like splitting headache, getting Migraine, temperature, decrease the appetite. patient didn't get this with Moderna. Reason for no lot number: of Unspecified Vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of Unspecified Vaccine: Unknown. Consumer stated,  had the vaccine, the Pfizer the newest one on Thursday. patient had the Moderna the first three were Moderna this one Pfizer. There is something wrong with that patient have like splitting headache, getting Migraine, temperature, decrease the appetite. patient didn't get this with Moderna. Patient meant what's going on. Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Mental disorder, Tinnitus
Clinical narrative: Hearing loss in her left ear; Tinnitus; Losing her mind because of the ringing in her ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent.  A 14-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: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Hearing loss in her left ear"; TINNITUS (non-serious), outcome "unknown"; MENTAL DISORDER (non-serious), outcome "unknown", described as "Losing her mind because of the ringing in her ears". The events "hearing loss in her left ear", "tinnitus" and "losing her mind because of the ringing in her ears" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, tinnitus, mental disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Severe asthmatic reaction; difficulty catching breath; 30 bpm increase in resting heart rate within 12 hrs of dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Covid-19 vaccine (primary immunization series and first booster dose complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 25Sep2022 at 07:00, outcome "recovering", described as "30 bpm increase in resting heart rate within 12 hrs of dose"; ASTHMA (medically significant) with onset 25Sep2022 at 07:00, outcome "recovering", described as "Severe asthmatic reaction"; DYSPNOEA (medically significant) with onset 25Sep2022 at 07:00, outcome "recovering", described as "difficulty catching breath". The events "severe asthmatic reaction", "difficulty catching breath" and "30 bpm increase in resting heart rate within 12 hrs of dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (25Sep2022) 30 bpm increase, notes: 30 bpm increase in resting heart rate within 12 hrs of dose; SARS-CoV-2 test: (28Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of asthma, dyspnea. Clinical course: Patient had severe asthmatic reaction with difficulty catching breath and 30 bpm increase in resting heart rate within 12 hours (as reported) of dose. Patient took three days to improve slightly, but required urgent care doctor visit for nebulizer breathing treatment and prednisone injection, followed by prednisone and albuterol home treatment for another five days. Eight (8) days out and still challenged with "normal" breathing despite treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: testing positive at day 14. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 19Sep2022 to 23Sep2022. The patient's other medical history was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: Ew0161), in right arm, on 11May2021 as dose 2, single (Lot number: Ew0173), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Dec2019, stop date: 21Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201137 same patient, different event, different drug;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Chills; headache; fever; tiredness; runny nose; 5th dose; 5th dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 14:00 as dose 5 (booster), single (Lot number: 59267-0304-02) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (4th dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "5th dose"; CHILLS (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; PYREXIA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; RHINORRHOEA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, pyrexia, fatigue, rhinorrhoea. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, Rhinorrhoea
Clinical narrative: Chills; headache; fever; tiredness; runny nose; 5th dose; 5th dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 14:00 as dose 5 (booster), single (Lot number: 59267-0304-02) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (4th dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "5th dose"; CHILLS (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; PYREXIA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering"; RHINORRHOEA (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 30Sep2022 at 20:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, pyrexia, fatigue, rhinorrhoea. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Off label use
Clinical narrative: terrible pain in my hips; my hip joints; off label; Dose 5; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 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. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: 21Feb2021, for COVID-19 Immunization; coviD-19 vaccine (DOSE 2, SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: 27Feb2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: Apr2022, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Sep2022, outcome "unknown", described as "Dose 5"; OFF LABEL USE (non-serious) with onset 27Sep2022, outcome "unknown", described as "off label"; ARTHRALGIA (non-serious) with onset 28Sep2022, outcome "not recovered", described as "terrible pain in my hips; my hip joints".  Additional information: Patient had the 5th shot which was a booster on Tuesday and by Wednesday, Thursday and Friday and today was having terrible pain in hips. Patient wanted to know if that was normal. Patient stated it was a Pfizer booster, third booster. Patient had the main shot on 21Feb then had a follow up on 27Feb, then first booster on Sep2021 and then had another booster on Apr2022 and the 5th shot on 27Sep2022. It says Bivalent Pfizer, it was stamped on the patient's card. (Captured as Covid-19 vaccine Bivalent). Patient stated that today was Saturday and patient was still in pain. Patient have been in pain for 3 days. Just wanted to know if this was normal or not. Consumer was requested to call or visit the nearest physician in case of emergency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Rash erythematous, Rash pruritic
Clinical narrative: scarlet rash itchy rash all over; scarlet rash itchy rash all over; I couldn't swallow; breathing was difficult; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0183, Anatomical location: Arm Right, Vaccine Administration Date: 15May2021, Vaccine Administration Time: 12:30 PM), administration date: 15May2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FC3182, Anatomical location: Arm Left, Vaccine Administration Date: 21Aug2021, Vaccine Administration Time: 12:30 PM), administration date: 21Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: DYSPHAGIA (life threatening) with onset 01Apr2022 at 15:45, outcome "not recovered", described as "I couldn't swallow"; DYSPNOEA (life threatening) with onset 01Apr2022 at 15:45, outcome "not recovered", described as "breathing was difficult"; RASH ERYTHEMATOUS (life threatening), RASH PRURITIC (life threatening) all with onset 01Apr2022 at 15:45, outcome "not recovered" and all described as "scarlet rash itchy rash all over". The events "scarlet rash itchy rash all over", "i couldn't swallow" and "breathing was difficult" required emergency room visit. Therapeutic measures were taken as a result of rash erythematous, rash pruritic, dysphagia, dyspnoea. Clinical course: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Within an hour, patient developed a scarlet rash, itchy rash all over, then patient couldn't swallow and breathing was difficult.PatientI went to ER and was treated with IV Adrenaline (epinephrine), Steroids, Pepcid, O2 (oxygen), fluids.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 23Sep2022 to 28Sep2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.