chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a positive Covid test; Had a positive Covid test; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), at the age of 76 years, in right arm, on 25Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history included: Degenerative Disc Disease, Known allergies: Penicillin, Known allergies: Sulfa, and Known allergies: adhesive tape, all unspecified if ongoing. Concomitant medications included: SPIRONOLACTONE; ATORVASTATIN. Spironolactone was from Amneal. Atorvastatin was from Apotex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Sep2022, outcome "recovered" (12Sep2022) and all described as "Had a positive Covid test". The patient underwent the following laboratory tests and procedures: Covid test: (03Sep2022) positive; (12Sep2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient began taking Paxlovid for COVID 19 Treatment on 05Sep2022. She had no symptoms by 07Sep2022 but continued to take all doses until 10Sep2022. On 12Sep2022, she tested negative for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter (physician). A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 12Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 69 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "S/P Breast Cancer" (unspecified if ongoing); "Known allergies: Cephalosporin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction: "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid for treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included oral Paxlovid from 01Sep2022 to 05Sep2022. Sender's Comments: Based on available information and possible temporal relationship the causal role of suspect drug cannot be excluded for reported events. Case will be further reviewed on receipt of FU information. 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: 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, notes: COVID 19 Treatment; (15Sep2022) Positive, notes: Rebound 5 days after finishing Paxlovid Return of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Body mass index, Polycystic ovaries
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose 1, Lot: Unknown , ), for COVID-19 immunization, reaction(s): "sharp pain in my stomach", "my Cycle was delayed". The following information was reported: AMENORRHOEA (non-serious) with onset 21Sep2021, outcome "not recovered", described as "cycle completely stopped"; POLYCYSTIC OVARIES (non-serious) with onset 21Sep2021, outcome "not recovered", described as "diagnosed with PCOS". The events "cycle completely stopped" and "diagnosed with pcos" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhea, polycystic ovaries.  Additional information: It was reported that the patient used to have regular menstruation before the Pfizer vaccine after the Pfizer vaccine her Cycle was delayed for the first time in her life. She also experienced a sharp pain in her stomach after the vaccine. Then after she got her second dose a month later her cycle completely stopped and not too long after she was diagnosed with PCOS. She has a low end of normal BMI, and her lifestyle was unchanged before developing menstrual irregularities. She had no covid prior vaccination. She had not covid tested post vaccination. She had no known allergies. She was not received other vaccine in four weeks or other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus anticoagulant disorder" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ENOXAPARIN SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Anti-viral details indicated that COVID 19 Treatment Paxlovid from 06Sep2022 to 11Sep2022 for treatment of COVID-19. On 16Sep2022, symptoms of COVID returned, positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 10:00 as dose 1, single (Lot number: EL9216), in left arm, on 15Mar2021 at 15:00 as dose 2, single (Lot number: EN6283), in left arm, on 20Aug2021 at 17:00 as dose 3 (booster), single (Lot number: SC3181), in left arm and on 09May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Macrodantin, reaction(s): "Known allergies macrodantin", notes: Known allergies macrodantin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Positive, notes: I tested positive again for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: 10 days after her final dose of Paxlovid, Covid-19 symptoms returned in full force and she tested positive again for Covid. This was after 10 days of feeling completely well.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: fk9894), in right 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: COVID-19 (medically significant) with onset Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up (20Sep2022): Follow-up attempts are completed. No further information is expected.
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(s) (Consumer or other non-HCP). The reporter is patient. A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Gout" (unspecified if ongoing), notes: Other medical history: Gout; "BPH" (unspecified if ongoing), notes: Other medical history: BPH. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as: Patient had no known allergies. The patient received Paxlovid (Lot number: 1918535A) from 07Sep2022 to 12Sep2022 for COVID 19 Treatment. Rebound covid infection after completing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Nov2021 as dose 2, single (Batch/Lot number: unknown) and in Apr2022 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), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Paxlovid was given as treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: en6204), in Apr2021 as dose 2, single (Lot number: er8727) and in Apr2022 as dose 3 (booster), single (Lot number: fj5682) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: minor food allergies" (unspecified if ongoing), notes: Known allergies: minor food allergies. Concomitant medication(s) included: OLMESARTAN, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Positive, notes: Tested positive 04Sep; (10Sep2022) Positive, notes: on 10Sep still tested positive (faint line); (12Sep2022) Negative, notes: negative test; (13Sep2022) Positive, notes: test positive with faint line; (14Sep2022) Positive, notes: test positive with solid line (not faint); (16Sep2022) Positive, notes: 16Sep faint line on test for positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
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) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other medication in 2 weeks. Patient had no known allergies. Vaccine lot unknown reason: Misplaced/ discarded. The patient received Paxlovid from 09Sep2022 till 13Sep2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Husband also tested positive and he has received the Pfizer booster; Husband also tested positive and he has received the Pfizer booster; He received Pfizer's two boosters and he got first two dose with Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Husband also tested positive and he has received the Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "He received Pfizer's two boosters and he got first two dose with Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP-6955), in left arm, on 08Apr2021 as dose 2, single (Lot number: EP-6955), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Patient received other medication (Theraflu) in 2 weeks. Patient was treated with oral Paxlovid (lot number: GC4774) from 12Sep2022 to 16Sep2022 for COVID-19. Patient was getting better but began to feel worse upon taking Paxlovid, extreme coughing and congestion occurred although no fever. Orange/bloody mucus after taking Paxlovid also.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose Number: 1 Moderna; Dose Number: 2 Moderna; dose Number: 3 Moderna;Dose Number: 4 Pfizer / BioNTech; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2021 at 12:00 as dose 1, single (Lot number: 027A21A), in left arm, on 06Apr2021 at 12:00 as dose 2, single (Lot number: 028A21A), in left arm and on 28Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 071F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Sep2022, outcome "not recovered" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 2 Moderna; dose Number: 3 Moderna;Dose Number: 4 Pfizer / BioNTech". The patient completed the PAXLOVID treatment on 12Sep2022 after testing positive on 06Sep2022. The medication made mild symptoms disappear. He did a rapid test on 12Sep2022 and tested negative. Late "last night", mild symptoms returned (congestion, runny nose, sneezing and mild coughing). He retested "this morning" (also reported as 16Sep2022, 11:00 AM) and tested positive again. This appears to be a PAXLOVID rebound case. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details stated that COVID 19 Treatment was PAXLOVID (Lot number: 1918530A) from 07Sep2022 to 12Sep2022.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 at 11:00 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 at 15:00 as dose 2, single (Lot number: ER2614), in left arm, on 06Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 05May2022 at 17:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2022; AIRBORNE, start date: 21Aug2022. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Negative; (15Sep2022) Positive; (06Sep2022) Positive; (13Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Began taking Paxlovid same date, 06Sep2022. Symptoms gone by 10Sep2022 and tested negative with rapid test. Finished Paxlovid on 11Sep2022. Tested negative again on 13Sep2022. Symptoms reappeared on 15Sep2022 and tested positive again using two rapid test kits (different manufacturers.) Still have symptoms as of 16Sep2022.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal depression" (unspecified if ongoing); "Extremely drug sensitive, myself and family members" (unspecified if ongoing), notes: Extremely drug sensitive, myself and family members; "menopause" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTERONE; BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Rash; burning at injection site; swelling at the injection site; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FX6073) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site". Additional information included: there are three patients were given Prevnar 20 from the same lot number FX6073 and all three patients had the same adverse events. Rash, burning at injection site, and swelling at the injection site. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200066036 same drug and AE, different patient;US-PFIZER INC-202201170677 same drug and AE, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling at the injection site; Rash; burning at injection site; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FX6073) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site"; RASH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site". Additional information included: there are three patients were given Prevnar 20 from the same lot number FX6073 and all three patients had the same adverse events. Rash, burning at injection site, and swelling at the injection site. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201170676 same drug and AE, different patient; PFIZER INC-PV202200066036 same drug and AE, different patient;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 70 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "post breast cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive other medication in 2 weeks.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound after getting better; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 09Sep2022 to 14Sep2022 for Covid-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Asymptomatic; COVID-19 Asymptomatic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 included: "Asthma" (unspecified if ongoing); "Bowel issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19 Asymptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Positive, notes: after testing negative on Day 11; (Sep2022) Negative, notes: Day 11; (2022) Positive, notes: first positive test. Therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19.  Additional information: No known allergies. Patient received paxlovid as COVID 19 treatment from 06Sep2022 to 10Sep2022. Asymptomatic. Tested positive (17Sep2022) after testing negative on Day 11 after first positive test. He was recovering. Treatment received included Zyrtec.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), on 03Apr2021 as dose 2, single (Lot number: EW0151) and on 03Nov2021 as dose 3 (booster), single (Lot number: FF8028) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing); "Mild asthma" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient received treatment with Paxlovid from 08Sep2022 to 13Sep2022 for Treatment of COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Peripheral swelling
Clinical narrative: my underarm is very swollen; I don't feel good; I don't feel very well; lymph node or swelling under the arm; it's just hurting, it's just very swollen; lymph node or swelling under the arm; it's just hurting, it's just very swollen; 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), in 2022 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), administration date: Aug2022, for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 2022, outcome "unknown", described as "I don't feel good; I don't feel very well"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 2022, outcome "unknown" and all described as "lymph node or swelling under the arm; it's just hurting, it's just very swollen"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "my underarm is very swollen". Additional information: The patient just got the Pfizer Bivalent that is the second booster and the underarm was very swollen and the patient had 1,2, the original shots then had a booster last August and then this was the second booster, the new of the new strain and the patient read on the paper, did not see anything about lymph node or swelling under the arm and the patients was just very, it's just hurting, it's just very swollen.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measure, PAXLOVID,  was taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass
Clinical narrative: Husband had COVID-19 Vaccine last 2021; Now her husband had a quadruple surgery in February; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), (Batch/Lot number: unknown) at 81 mg daily (81 mg, daily [per day]). The patient's relevant medical history included: "blood thinner" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CORONARY ARTERY BYPASS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Husband had COVID-19 Vaccine last 2021; Now her husband had a quadruple surgery in February". The action taken for aspirin [acetylsalicylic acid] was unknown.  Additional information: Reporter called on behalf of her husband. She mentioned that they both had COVID-19 vaccine last 2021 and at the time of report, patient had a quadruple surgery in February. She asked if it would be safe for him to take booster because they had an appointment for the Bivalent booster shot (Confirmed as Pfizer COVID-19 Vaccine) and also she mentioned that patient was taking Aspirin per day and that was 81 milligrams (Further clarification unknown, hence aspirin captured as suspect conservatively) also her husband had a blood thinner.   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.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing). Other medical history included fibromyalgia and patient had no known allergies. The patient took concomitant medications. Patient received the vaccine. Patient received other medications in two weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 12Sep2022 to 17Sep2022 for treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had rash on top of head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A 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: RASH (non-serious), outcome "unknown", described as "Had rash on top of head".  Additional Information: The report was cross referenced to report ID:  Other friends mentioned having rashes associated with unknown Vaccine. Caller declined to complete report regarding other friends. Thought one friend had called Pfizer. The patient is the person who urged caller to contact Pfizer.   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) : PFIZER INC-202201169888 same reporter/drug/event, different patient; PFIZER INC-202201169912 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 13:15 as dose 3 (booster), single (Lot number: ER8727), 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: "Thyroid" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: PREDNISONE, start date: 28Aug2022, stop date: 07Sep2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment received included Paxlovid (Treatment start date - 02Sep2022, Treatment stop date - 06Sep2022).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years 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: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. Concomitant medication(s) included: PRISTIQ; GABAPENTIN; ADVAIR; DUPIXENT. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 02Sep2022 to 08Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 47 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: "high blood pressure" (unspecified if ongoing); "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 "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Sep2022) Negative; (14Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes that the patient was on Paxlovid from 09Sep2022 to 14Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Lot number: fk9729) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2020 as dose 1, single (Lot number: 025J20-2A), in Jan2021 as dose 2, single (Lot number: 029L20A) and in Aug2021 as dose 3 (booster), single (Lot number: c09021A) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "Iodine based dyes" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "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.