chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: her husband and she had COVID in June; her husband and she had COVID in June; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "her husband and she had COVID in June".  The reporter stated that she and her husband received the first 2 doses and 1 booster dose last February. The reporter wanted to know if they should receive a fourth and fifth dose of this vaccine. The reporter mentioned that her husband and she had COVID in Jun2022. She declined to be transferred.  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-202201324375 same reporter/product/AE, different patient;
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 07Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthmatic cough after upper respiratory infections" (unspecified if ongoing); "upper respiratory infections" (unspecified if ongoing); "Known allergies: Rash with penicillin" (unspecified if ongoing); "Known allergies: Rash with penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jan2000; HYDROCHLOROTHIAZIDE, start date: 01Jan2000. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: codeine acts as stimulant. 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. Clinical course details: The patient received Andrographis (brand: Planetary Herbald), B-Complex (brand: Natures Bounty), D3 (brand: Nature Made) on 01Oct2022 for unknown indication.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical course:Reporter wanted to know if this had been reported since he didn't find any information on the internet. Then mentioned about how he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine. He added that he's obviously not going to take another booster. When reporter was referred to his HCP, he mentioned that in one of the visits, he was told the booster reacts with immunological system and that his doctor said things that didn't made sense, and that he was actually medical misdiagnosed, which was common to happen to him. Knows people who have heart attacks from the shot. Has heard several people with recent immunization, who got the shot, had heart attacks. Reporter did not have anything like that. Knows people who have heart attacks from the shot. Has heard several people with recent immunization, who got the shot, had heart attacks. Reporter did not have anything like that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
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 (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 28Mar2022 as dose 4 (booster), single (Lot number: FK989S), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia rheumatica" (unspecified if ongoing); "known allergies to Quinolone family of drugs" (unspecified if ongoing). Concomitant medications included: METHYLPREDNISOLONE, start date: 26May2021; METOPROLOL, start date: Jan2016; ATORVASTATIN, start date: Jan1999, stop date: 11Nov2022; OXYBUTYNIN, start date: Jan2019, stop date: 11Nov2022; PRILOSEC [OMEPRAZOLE], start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2022) Rebound of COVID, notes: Rebound of COVID both symptoms and test on 20Nov2022. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 11Nov2022 to 15Nov2022. Clinical course: The patient had rebound of COVID, both symptoms and test on 20Nov2022 at 09:00. Symptoms were mild as of this reporting date, but worse than the first round of COVID on 11Nov2022. The rebound of COVID was treated with cough medicine and had not recovered at the time of the report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325693 same reporter, patient, and product; different dose and event;
Age: 65.0
Sex: M
Vaccine: COVID19, 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:30 as dose 5 (booster), single (Lot number: 97 07) at the age of 65 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: "Hypertension" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was no. Patient had known allergies: Yes
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: Wrong vaccine administered; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2022 as dose 5 (booster), single (Lot number: Fe3592), in left arm for covid-19 immunization; 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 didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Hypothothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. 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"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Sep2022, outcome "unknown", described as "Wrong vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as COVID 19 Treatment, Treatment start date was 13Nov2022, Treatment stop date was 17Nov2022. The patient had 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.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19, wrong product administered and suspect drug BNT162B2, BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). cannot be excluded.
Age: 58.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 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's relevant medical history included: "Asthma" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 Treatment, brand was Paxlovid, treatment start date was 22Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient 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; 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: 6th day came out negative COVID test; (Nov2022) Positive, notes: came positive after 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient had previously received a COVID-19 Vaccine. Patient received Paxlovid as antiviral treatment form 16Nov2022 to 21Nov2022. Rebound on symptom of COVID-19. Patient took 5 days and 6th day came out negative COVID test and came positive after 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 11:00 as dose 5 (booster), single (Lot number: Gh9703) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 at 00:30 as dose 1, single (Lot number: EN6200), in right arm, on 11Mar2021 at 09:00 as dose 2, single (Lot number: EN6206), in right arm, on 01Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: Fk9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "perennial vasomotor rhinitis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL (ongoing); LEVOTHYROXINE (ongoing); QVAR; PROLIA (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive; (19Nov2022) Negative, notes: after completing the pills and stayed negative; (20Nov2022) Negative, notes: after completing the pills and stayed negative; (21Nov2022) Negative, notes: after completing the pills and stayed negative; (22Nov2022) Negative, notes: after completing the pills and stayed negative; (23Nov2022) Positive, notes: until 23Nov when symptoms returned and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 16:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild lupus non organ threatening" (unspecified if ongoing), notes: mild lupus: non organ threatening. Daughter has the same and same thing happened to her.; "Known allergies sulfites, sulfa," (unspecified if ongoing), notes: Known allergies sulfites, sulfa,; "Known allergies walnuts" (unspecified if ongoing), notes: Known allergies walnuts. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, 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) Negative, notes: Tested NEG 2 X; (20Nov2022) Negative, notes: Tested NEG 2 X; (24Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that case was non-serious. No any seriousness criteria was reported. It was reported that vaccine was received. Patient received Allegra via oral route as other medication in 2 weeks. Patient received anti-viral Product for COVID 19 Treatment which brand name as Paxlovid from 15Nov2022 to 19Nov2022, lot number=GF2796, with Oral route. Patient felt great on the Paxlovid except the bitter taste. Mild COVID symptoms fatigue and sore throat. Tested NEG 2 X Sunday 20Nov2022. Worked 3 days then felt fatigued and tested positive again 24Nov2022. Fatigued, Nasal congestion, no fever.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-COVID-19 and Drug Ineffective.
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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's relevant medical history included: "Eczema" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive; (20Nov2022) Negative, notes: testing negative for the past 4 days; (21Nov2022) Negative, notes: testing negative for the past 4 days; (22Nov2022) Negative, notes: testing negative for the past 4 days; (23Nov2022) Negative, notes: testing negative for the past 4 days; (24Nov2022) Positive, notes: today i tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No, the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Patient had COVID-19 Treatment with brand=Paxlovid from 15Nov2022 to 19Nov2022. It was stated as Today she woke up with a sore throat and sinus congestion. She took Paxlovid for 5 days last week and after testing negative for the past 4 days today she tested positive again.  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.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Sialometry
Clinical narrative: Exacerbation of oral lichen planus immediately after receiving Pfizer-BioNTech; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "oral and cutaneous lichen planus" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Steroids for oral and cutaneous lichen planus, notes: topical. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: LICHEN PLANUS (medically significant), 24 hrs after the suspect product(s) administration, outcome "recovering", described as "Exacerbation of oral lichen planus immediately after receiving Pfizer-BioNTech". The patient underwent the following laboratory tests and procedures: Sialometry: 0.3 mg/3 min, notes: resting; 2.1 mg/3 min, notes: was reduced stimulated. Therapeutic measures were taken as a result of lichen planus.  Clinical course: The history of oral and cutaneous lichen planus managed with topical steroids received the Pfizer-BioNTech vaccine in February and March 2021. Twenty-four hours following the second dose, she reported a feeling of "mouth on fire" which continued for 2 weeks. She was seen in July 2021; she had gingival erythema and striations extending into vestibular mucosa Saliva production was reduced (resting 0.3 mg/3 min and stimulated 2.1 mg/3 min). She has prescribed topical clobetasol and bethanechol for dry mouth. At one month follow-up, a significant reduction in erythema was seen.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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-PV202200111251 Same article/ drug/event and different patient:;
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Oral lichenoid reaction
Clinical narrative: Lichen planus; exacerbation of oral lichenoid mucositis; This is a literature report.  A 65-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 included: "carcinoma-in-situ of the left lateral border of tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vitamin a for lichenoid, notes: 0.025% gel, topical; Clobetasol for lichenoid, notes: 0.05% gel twice daily. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LICHEN PLANUS (medically significant), 1 week after the suspect product(s) administration, outcome "recovered"; ORAL LICHENOID REACTION (medically significant), 1 week after the suspect product(s) administration, outcome "recovered", described as "exacerbation of oral lichenoid mucositis". Therapeutic measures were taken as a result of lichen planus, oral lichenoid reaction. Clinical course: Female with a history of carcinoma-in-situ of the left lateral border of tongue, had ongoing follow-up in the oral medicine clinic for lichenoid changes. She had been originally managed with topical vitamin A 0.025% gel and clobetasol 0.05% gel twice daily with excellent response. One week after receiving the second dose of the Pfizer-BioNTech vaccine, she developed sensitivity and ulceration of the buccal mucosa and tongue. Lichenoid striations and ulceration at Buccal mucosa and tongue observed. Oral findings resolved after 4 weeks of the original topical therapy at an increased frequency to 4 times daily.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  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-PV202200111251 Same article/ drug/event and different patient:;
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lichen planus
Clinical narrative: acerbation of oral lichenoid mucositis/oral lichen planus; This is a literature report for the following literature source(s):  A 51-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose  2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Oral lichen planus" (unspecified if ongoing); "oral squamous cell carcinoma of the tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: LICHEN PLANUS (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "acerbation of oral lichenoid mucositis/oral lichen planus". The patient underwent the following laboratory tests and procedures: Clinical findings: include erythema and striations of the posterior, notes: buccal mucosal bilaterally. Therapeutic measures were taken as a result of lichen planus.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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-PV202200111251 Same article/ drug/event and different patient:;
Age: 56.0
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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Back pain, Bone pain, Malaise, Myalgia
Clinical narrative: muscle ache; joint pain; suffering terrible; bones ache; legs hurt; back hurts; 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 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "suffering terrible"; BONE PAIN (non-serious), outcome "unknown", described as "bones ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurt"; BACK PAIN (non-serious), outcome "unknown", described as "back hurts".  Additional Information: She got the Prevnar 20 shot and she was suffering terrible, she had muscle ache and joint pain and stuff, she want to know if this was normal and what can we do about it. She was having a terrible time with side effects  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: muscle ache; joint pain; suffering terrible; bones ache; legs hurt; back hurts; 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 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "suffering terrible"; BONE PAIN (non-serious), outcome "unknown", described as "bones ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurt"; BACK PAIN (non-serious), outcome "unknown", described as "back hurts".  Additional Information: She got the Prevnar 20 shot and she was suffering terrible, she had muscle ache and joint pain and stuff, she want to know if this was normal and what can we do about it. She was having a terrible time with side effects  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ2524), 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. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Nov2022) Negative, notes: Negative test On 23Nov; (25Nov2022) Positive, notes: positive test on 25Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Return of congestion, running nose, slight sore throat, Mild cough, positive test on 25Nov after negative test On 23Nov; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201331809 Same patient, different product and event;
Age: 31.0
Sex: F
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; Janssen Dose Number: 1, Pfizer / BioNTech Dose Number: 2, Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 2 (booster), single (Lot number: 33036BD) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Nasal Allergies" (unspecified if ongoing); "vocal chord dysfunction" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LAMICTAL; SINGULAIR; SPRINTEC; VIT D3; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Janssen Dose Number: 1, Pfizer / BioNTech Dose Number: 2, Moderna Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Covid rebound. Paxlovid was taken as therapeutic measures for drug ineffective, covid-19 from 16Nov2022 to 21Nov2022.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 032330a), on 03Mar2021 as dose 2, single (Lot number: 029A21A), on 21Oct2021 as dose 3 (booster), single (Lot number: o61e21a), in right arm and on 27Apr2022 as dose 4 (booster), single (Lot number: 048l21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing), notes: other medical history: HIV+. Concomitant medication(s) included: JULUCA; SYNTHROID; ROSUVASTATIN; TESTOSTERONE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Sep2022, outcome "unknown"; 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; (Nov2022) Negative; (25Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: Product: COVID 19 Treatment brand: Pfizer treatment from 14Nov2022 to 19Nov2022.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure before pregnancy, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Patient was pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 30 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 had no relevant medical history. No known allergies and no other medical history. Date of last menstrual period: 09Sep2022. The patient is expected to deliver a baby(s) on 16Jun2023. There were no concomitant medications.  The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 09Sep2022, outcome "unknown", described as "Patient was pregnant"; 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.  Clinical course: Covid-19 treatment included Paxlovid from 11Nov2022 to 16Nov2022. Patient was pregnant with Gestational period of 11.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 18:00 as dose 3 (orange cap; booster), single (Lot number: GK1657) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot No: FK9895, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM), administration date: 02Mar2022, when the patient was 5-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE; Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 09Feb2022, when the patient was 5-year-old, for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious), SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 24Nov2022 at 17:00, outcome "not recovered" and all described as "Swollen of left eye as well as face and arms and it is itching". The events "swollen of left eye as well as face and arms and it is itching" required physician office visit. Therapeutic measures were not taken as a result of eye swelling, swelling face, peripheral swelling, pruritus.  Additional information: Patient had not been received any other vaccine within four weeks and any other medications. Patient not experienced covid prior vaccination nor post vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: her arm hurt; She got the booster instead of the first dose of the primary series; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 1 (bivalent), single (Lot number: GH9697) at the age of 34 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Oct2022, outcome "unknown", described as "She got the booster instead of the first dose of the primary series"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt". Additional information: Caller reported she received Pfizer BioNTech COVID-19 Vaccine Bivalent booster on 15Oct2022. Only received the Pfizer BioNTech COVID-19 Vaccine Bivalent Booster and had not received any primary series vaccinations. She was trying to get the second shot and no one was giving this to her; wanted the Moderna Vaccine. She had zero reactions except her arm hurt and that was it.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anaphylactic reaction, Product use issue
Clinical narrative: 02Nov reaction ER day visit 14Nov reaction cephalaxen anafalaxin hospitalization for 3 days; other vaccine same date product=Senior dose flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:00 as dose 1 (bivalent), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation.  The patient's relevant medical history included: "All Penicillin" (unspecified if ongoing); "apples" (unspecified if ongoing); "stone fruits" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; LEVOTHYROXIN; SERTRALINE; ATENOLOL. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 01Nov2022, outcome "unknown", described as "other vaccine same date product=Senior dose flu vaccine"; ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 14Nov2022 at 12:00, outcome "recovering", described as "02Nov reaction ER day visit 14Nov reaction cephalaxen anafalaxin hospitalization for 3 days". The patient was hospitalized for anaphylactic reaction (hospitalization duration: 3 day(s)). The event "02nov reaction er day visit 14nov reaction cephalaxen anafalaxin hospitalization for 3 days" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Additional information: Vaccine administered at pharmacy or drug store. No other vaccine in four weeks. No other medical history. Treatment received for the event anaphylaxis: Benadryl, Pepcid, prednisone, epi -3. No covid prior vaccination. Covid had not tested post vaccination. 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: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Trichorrhexis
Clinical narrative: Hair breakage at crown (top of forehead); FLU VACCINE taken for immunisation on 10Oct2022; FLU VACCINE taken for immunisation on 10Oct2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: Gj5342) at the age of 67 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 10Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Clams" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM9992, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Oct2022, outcome "unknown" and all described as "FLU VACCINE taken for immunisation on 10Oct2022"; TRICHORRHEXIS (non-serious) with onset 01Nov2022, outcome "not recovered", described as "Hair breakage at crown (top of forehead)". Therapeutic measures were not taken as a result of trichorrhexis.  Additional information: The patient received FLU VACCINE within the four weeks prior to vaccination on 10Oct2022. Hair breakage at crown (top of forehead). The patient knows if this was caused by vaccine; but doctor said she has seen a lot if women complaining about the same thing and was just wondering if it was the Covid vaccine. The patient had a long list of other medical history (not specified). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333238 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Pyrexia
Clinical narrative: Coughing 24/7; fever; Cold; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0162) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: NASOPHARYNGITIS (disability) with onset 15Apr2021, outcome "not recovered", described as "Cold"; COUGH (disability) with onset 15Apr2021, outcome "not recovered", described as "Coughing 24/7"; PYREXIA (disability) with onset 15Apr2021, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of cough, pyrexia, nasopharyngitis.   It was reported that patient was coughing 24/7, fever every month, cold, every month or other. Patient did not receive other vaccines in four weeks and did not receive other medication in two weeks. Prior to vaccination, patient has not had COVID-19 and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including  chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.