chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: she also had 2 Pfizer COVID boosters; and still got COVID.; she also had 2 Pfizer COVID boosters; and still got COVID.; Caller states she has had 5 Covid Shots, the First 2 were Moderna, and then a mixture of Pfizer Booster doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 006M2014), on 12Mar2021 as dose 2, single (Lot number: 0016219) and on 22Oct2021 as dose 3 (booster), single (Lot number: 047C2114) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing); "Premature atrial contraction" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: DILTIAZEM taken for supraventricular extrasystoles (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); LOSARTAN (ongoing). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Mar2022, outcome "unknown", described as "Caller states she has had 5 Covid Shots, the First 2 were Moderna, and then a mixture of Pfizer Booster doses"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "she also had 2 Pfizer COVID boosters; and still got COVID.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 112/76; Blood test: States her blood work comes out okay; Body temperature: 100.1; Heart rate: 83; SARS-CoV-2 test: negative, notes: Covid test before that and it was negative; positive, notes: The rapid test was positive. Therapeutic measures, Paxlovid,  were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "recovering" and all described as "tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive, notes: Result: Positive; Unit: Not Provided.  Additional information: Caller states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night. Reporter stated that her mom was fully vaccinated and tested positive for Covid 19 on 17Dec2022. Reporter declined to complete the report so no further details were provided. For report # the Covid-19 vaccine Lot number was not provided as the reporter declined the report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
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 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 49 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: "Interstitial cystitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient started Paxlovid from 12Dec2022 to 17Dec2022.
Age: 68.0
Sex: M
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had no other medical history. COVID-19 Treatment start date was 13Dec2022 and stop date was 17Dec2022 via oral route.Adverse event Covid rebound on 21Dec2022, 4 days post last Paxlovid dose with outcome Recovering, and no treatment received.   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 and suspect drug BNT162B2 cannot be excluded.
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 non-contactable reporter(s) (Physician).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 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's relevant medical history and concomitant medications were not reported. 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; Negative, notes: Tested negative on rapid test after completing course of Paxlovid,; Positive, notes: Tested positive for COVID on rapid test again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was unknown if other medication in 2weeks. On 11Dec2022 the patient took Paxlovid for the treatment of event and treatment was stopped on 15Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 its Lack of efficacy cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna / Dose #3: Moderna / Dose #4 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; PRILOSEC [OMEPRAZOLE MAGNESIUM]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna / Dose #3: Moderna / Dose #4 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Then tested negative for three days; (Dec2022) Positive, notes: Then got very sick again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details includes COVID 19 Treatment PAXLOVID, the treatment started on 12Dec2022 and treatment stopped on 17Dec2022. Other medication in 2weeks product were Allopurinol and Prilosec. Rebound COVID. Took Paxlovid for 5 days. Then tested negative for three days. Then got very sick again and tested positive. There was no known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 18Jun2022 as dose 4 (booster), single (Lot number: FM992) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "High Cholesterol" (unspecified if ongoing), notes: other medical history: High Cholesterol. Concomitant medication(s) included: METFORMIN; LANTUS; LOSARTAN; ROSUVASTATIN; FINASTERIDE; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as COVID 19 treatment from 12Dec2022 to 17Dec2022. Patient had no known allergies.
Age: 64.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 08:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Eczema" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2weeks. Received Covid treatment start date on 14Dec2022 and stop date on 19Dec2022 with lot number GE3010, indication for Treatment of COVID-19. It was unknown that the patient had known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Lymphadenopathy, Pain, Pain in extremity, Sleep disorder
Clinical narrative: lymph nodes under her armpits got so swollen; pain down her arm; pain being so sharp; It woke her up in the middle of the night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (ongoing); "Rosacea" (ongoing); "Supraventricular tachycardia History" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EH9899), administration date: 24Dec2020, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL1284), administration date: 12Jan2021, when the patient was 28-year-old, for COVID-19 immunization, reaction(s): "Nausea", "Chills"; flu shot (Vaccine Name: Flu Shot , Manufacturer: Unknown , Lot Number/ Expiry Date: Unknown Route, Anatomical Location: No. of Previous Doses: Right Arm Date: 25Oct2021), administration date: 25Oct2021, when the patient was 28-year-old. The following information was reported: SLEEP DISORDER (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "It woke her up in the middle of the night"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "lymph nodes under her armpits got so swollen"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "pain being so sharp"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "pain down her arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, pain, sleep disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201392289 same reporter/pt, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good; received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good". Clinical course: The patient received all 5 of his Pfizer covid shots and has got covid about 3-4 days ago and is not feeling so good. He said his daughter called and was recommended to try a product that could ease the problems with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Rebound COVID-19 infection 6 days post completion of the complete course of Paxlovid; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 45 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FC3181), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction: "known allergies: Aspirin"; Ibuprofen, reaction: "known allergies: ibuprofen", notes: known allergies: ibuprofen; Naproxen sodium, reaction: "known allergies: Naproxen Sodium". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 21Dec2022, outcome "recovering", described as "Rebound COVID-19 infection 6 days post completion of the complete course of Paxlovid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 as dose 1, single (Lot number: EN6203), in right arm and on 03Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ALK lung cancer" (unspecified if ongoing), notes: Other medical history: ALK lung cancer; "Known allergies: Pennicillan" (unspecified if ongoing), notes: Known allergies: Pennicillan. Concomitant medication(s) included: ALECENSA, start date: 01Oct2017; NP THYROID, start date: 15Dec2020. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Keflex, reaction(s): "Known allergies: Keflex"; Levaquin, reaction(s): "Known allergies: levaquin"; Iv phenegqan, reaction(s): "Known allergies: Phenegqan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Dr. appointment for COVID test, went in on the 09Dec2022, test came back Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within 2 weeks of vaccination. On 07Dec2022, patient had an earache and sinus drip, made a Dr. appointment for COVID test, went in on the 09Dec2022, test came back Positive. Patient was given prescriptions for dexamethasone 4MG tab / azithromycin 500MG tab / Paxlovid. Patient received Paxlovid, from 09Dec2022 to 14Dec2022 for the treatment of 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, COVID19
Symptoms: Vaccination site pain
Clinical narrative: other three vaccines were given and it felt like he hit her bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ANA", start date: Aug2022 (unspecified if ongoing); "left bundle branch block" (unspecified if ongoing), notes: left branch bundle block diagnosed 12 years ago.; "Heart" (unspecified if ongoing). Concomitant medication(s) included: RANOLAZINE oral taken for cardiac disorder; IMMUNETI. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "other three vaccines were given and it felt like he hit her bone".  Additional information: The patient had ANA stands for antinuclear antibodies. It meant her immune system was about gone. She was diagnosed the past summer in Aug. Concomitant medication included Ranolazine one tablet by mouth twice a day when she did not forget it. Product was in a pharmacy bottle and caller did have lot to provide. The patient had been on it for 4 years off and on. Immuneti had vitamin c, zinc, vitamin D3, elderberry. It was an advanced immune defense vitamin. It was reported that the other three vaccines were given at  town and it and it felt like he hit her bone. Caller did not have that much fat on her body  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-202201392160 Same patient, different drug/ AE.;US-PFIZER INC-202201392176 Same patient, different dose/ AE.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: other three vaccines were given and it felt like he hit her bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ANA", start date: Aug2022 (unspecified if ongoing); "left bundle branch block" (unspecified if ongoing), notes: left branch bundle block diagnosed 12 years ago.; "Heart" (unspecified if ongoing). Concomitant medication(s) included: RANOLAZINE oral taken for cardiac disorder; IMMUNETI. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "other three vaccines were given and it felt like he hit her bone".  Additional information: The patient had ANA stands for antinuclear antibodies. It meant her immune system was about gone. She was diagnosed the past summer in Aug. Concomitant medication included Ranolazine one tablet by mouth twice a day when she did not forget it. Product was in a pharmacy bottle and caller did have lot to provide. The patient had been on it for 4 years off and on. Immuneti had vitamin c, zinc, vitamin D3, elderberry. It was an advanced immune defense vitamin. It was reported that the other three vaccines were given at  town and it and it felt like he hit her bone. Caller did not have that much fat on her body  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-202201392160 Same patient, different drug/ AE.;US-PFIZER INC-202201392176 Same patient, different dose/ AE.;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vitamin D
Clinical narrative: chills; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EL1284) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (ongoing); "Rosacea" (ongoing); "Supraventricular tachycardia" (unspecified if ongoing). Concomitant medication(s) included: INTRAUTERINE CONTRACEPTIVE DEVICE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EH9899), administration date: 24Dec2020, when the patient was 28-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021); NAUSEA (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021). Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient also received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: EW0187) in left arm for covid-19 immunisation. Agent stated had caller on the line who received the Purple Cap Formulation of the Pfizer BioNTech Covid Vaccine as a Booster on 02Nov2021 and experienced swelling under arm pit and shooting pain down arm. Caller reported after the second dose, 24 hours later she had chills and nausea that came on and went away quickly.; Sender's Comments: Linked Report(s) : PFIZER INC-202201391914 same reporter/pt, different dose/event;
Age: 37.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, 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's relevant medical history included: "Bmi 30.8 (obese)" (unspecified if ongoing), notes: Bmi 30.8 (obese); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Cipro, reaction(s): "known allergies: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Negative; (16Dec2022) Positive; (21Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: other medication in 2weeks product was LoLoestrin fe and stop date was 09Dec2022. It was reported that on 09Dec: first day of covid. Sore throat, aches (like a flu) 10Dec: first day of paxlovid. Got pax mouth, so gross 14Dec: finished paxlovid, tested negative 16Dec: tested positive. Stopped isolation and went to wearing n95 at all times around others. 17Dec: different symptoms - runny nose, congestion, cough (more like a cold than a flu.) 21Dec: still testing positive, still masking with an N95 and sleeping separate from my spouse Congestion only at night, primary symptom is a dry cough. 27Dec: No moee congestion or symptoms, tested positive.  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: 50.0
Sex: M
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 51-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 04May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right 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) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Paxlovid was used as treatment for COVID-19. Patient received previous covid 19 vaccine. Patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  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
Clinical narrative: If he can "relapse" back into the coronavirus (rebound); If he can "relapse" back into the coronavirus (rebound); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "If he can "relapse" back into the coronavirus (rebound)". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported that they already have 3 doses of the Pfizer COVID-19 vaccine. During the call he mentioned that Pfizer should make a medication more effective and with less adverse effect. If he can "relapse" back into the coronavirus (rebound) after finishing the treatment, and if there are adverse effects reported from stopping the treatment abruptly. Ritonavir is an HIV-1 protease inhibitor but was not active against SARS-CoV-2 Mpro. Ritonavir inhibits the CYP3A-mediated metabolism of Nirmatrelvir, resulting in increased plasma concentrations of Nirmatrelvir.  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
Clinical narrative: if he can "relapse" back into the coronavirus (rebound); if he can "relapse" back into the coronavirus (rebound); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "if he can "relapse" back into the coronavirus (rebound)". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter wanted to know that other adverse effects can he expect with the Paxlovid treatment, he and his son were taking Paxlovid and had experienced some adverse effects such as diarrhea for two days (from the first dose). They already had 3 doses of the Pfizer COVID-19 vaccine. During the call he mentioned that Pfizer should make a medication more effective and with less adverse effect. He also asked if there are deaths reported with Paxlovid, if he can "relapse" back into the coronavirus (rebound) after finishing the treatment, and if there are adverse effects reported from stopping the treatment abruptly. During the call also mentioned that the treatment does not give "the effect you want". Reporter considers that the recommended dose is very high.  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, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; 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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 08Mar2021 as dose 2, single (Lot number: EM9810), in right arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF8641), in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Lot number: 059M21A), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Sulfa Allergy" (unspecified if ongoing). Concomitant medication included: LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 12Dec2022 to 17Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201392435 same patient/drug, different dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, SARS-CoV-2 test
Clinical narrative: fluttering in chest and some slight dizziness; fluttering in chest and some slight dizziness; 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 24Mar2021 at 08:30 as dose 2, single (Lot number: EN6203) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6196; Location of injection: Arm Left; Vaccine Administration Time: 12:00 AM), administration date: 02Mar2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), CHEST DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "fluttering in chest and some slight dizziness". The events "fluttering in chest and some slight dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced a fluttering in chest and some slight dizziness over the past year or so, which patient had attributed to hunger, dehydration etc. Patient had mentioned this to doctor at yearly physical in october. Patient was to monitor and make a return visit should they become more prevalent.
Sex: F
Vaccine: 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 60-year-old female patient received BNT162b2 (BNT162B2), on 07Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Meneires and thyroid" (unspecified if ongoing); "Meneires and thyroid" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received Paxlovid treatment for COVID-19. No products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, Heart rate, Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Premature atrial contraction" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's family history included: "Brother just had COVID" (unspecified if ongoing), notes: Brother just had COVID. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Lot Number: 006M2014), administration date: 12Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 2, SINGLE, Lot Number: 0016219), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 3 (BOOSTER), SINGLE, Lot Number: 047C2114), administration date: 22Oct2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FK9895), administration date: 30Mar2022, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; Flu shot (DOSE NUMBER UNKNOWN: MANUFACTURER UNKNOWN). The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: There were no prior vaccinations within four weeks. She had gotten a cold, so she took a few Tylenol.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Premature atrial contraction" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's family history included: "Brother just had COVID" (unspecified if ongoing), notes: Brother just had COVID. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Lot Number: 006M2014), administration date: 12Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 2, SINGLE, Lot Number: 0016219), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 3 (BOOSTER), SINGLE, Lot Number: 047C2114), administration date: 22Oct2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FK9895), administration date: 30Mar2022, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; Flu shot (DOSE NUMBER UNKNOWN: MANUFACTURER UNKNOWN). The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: There were no prior vaccinations within four weeks. She had gotten a cold, so she took a few Tylenol.
Age: 53.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 53 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. The patient had no known allergies. Concomitant medication(s) included: BUSPIRONE, start date: 01Sep2019. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: I had mild fever for about 3 hours; Developed axillary lymphadenopathy / lymph node about 2 inches under my armpit had swelled up to the size of a golf ball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 3, SINGLE, Lot number: 30135BA,, Anatomical location: Left arm), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 17Dec2022 at 19:00, outcome "unknown", described as "Developed axillary lymphadenopathy / lymph node about 2 inches under my armpit had swelled up to the size of a golf ball"; PYREXIA (non-serious) with onset 17Dec2022 at 19:00, outcome "recovered", described as "I had mild fever for about 3 hours". Therapeutic measures were taken as a result of pyrexia, lymphadenopathy.  Additional information: The patient received treatment of 2 tablespoons of ACV in water. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm where the vaccine was injected; This is a spontaneous report received from a contactable consumer.  An adult male patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2), administration date: 05May2022, for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Dec2022, outcome "unknown", described as "Sore arm where the vaccine was injected". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Dec2022 to 15Dec2022.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.