chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash macular
Clinical narrative: red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: FLU Shot. Past adverse reactions to the above products included No adverse event with FLU Shot.    On 29-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face). At the time of the report, RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The patient had monovalent dose 1 on 13-FEB-2021 and dose 2 on an unknown date. The patient took monovalent booster dose on unknown date. After 2 to 3 weeks after receiving the Moderna shot in AUG2023, the patient started having red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face. The patient was not on any maintenance medications and does not have a Medical History of any chronic disease. No treatment medication was reported.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine, Drug hypersensitivity, Erythema, Feeling hot, Pain in extremity
Clinical narrative: allergic reaction to vaccine; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very swollen and red; arm is very swollen and red; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 43-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 08Sep2023 as dose number unknown, 0.5ml single (Lot number: GT0538, Expiration Date: Oct2024) at the age of 43 years intramuscular, in right deltoid for immunisation, Device Lot Number: GT0538, Device Expiration Date: Oct2024. The patient's relevant medical history included: "Anxiety", start date: 2022 (unspecified if ongoing); "Depression", start date: 2022 (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: covid-19 vaccine (dose number unknown (booster); Manufacturer unknown), administration date: 04Jan2023, when the patient was 42-year-old, for Covid-19 Immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to vaccine"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "arm is very achy, very warm to touch and itchy"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "arm is very swollen and red". Therapeutic measures were taken as a result of allergy to vaccine, pain in extremity, feeling hot, pruritus, peripheral swelling, erythema.  Additional information: No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Events did not require a visit to the Emergency Room not Physician Office. No family medical history relevant to events. NDC number of Prevnar 20: 0005-2000-01. Reported severe side effect of Prevnar 20. On 11Sep2203, patient sent message stating she was having allergic reaction to vaccine she received Friday. Her arm is very achy, very warm to touch and itchy; arm is very swollen and red. Did not provide when started. Doctor responded "this morning" and recommended patient ice the area a few times a day and take ZYRTEC, CLARITIN, or ALLEGRA daily as needed for the itching. Told her it can take up to 2 weeks for reaction to resolve and let her know if it continues to get worse and mentioned they would report reaction and patient closed case. Patient didn't respond.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: allergic reaction to vaccine; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very swollen and red; arm is very swollen and red; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 43-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 08Sep2023 as dose number unknown, 0.5ml single (Lot number: GT0538, Expiration Date: Oct2024) at the age of 43 years intramuscular, in right deltoid for immunisation, Device Lot Number: GT0538, Device Expiration Date: Oct2024. The patient's relevant medical history included: "Anxiety", start date: 2022 (unspecified if ongoing); "Depression", start date: 2022 (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: covid-19 vaccine (dose number unknown (booster); Manufacturer unknown), administration date: 04Jan2023, when the patient was 42-year-old, for Covid-19 Immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to vaccine"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "arm is very achy, very warm to touch and itchy"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "arm is very swollen and red". Therapeutic measures were taken as a result of allergy to vaccine, pain in extremity, feeling hot, pruritus, peripheral swelling, erythema.  Additional information: No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Events did not require a visit to the Emergency Room not Physician Office. No family medical history relevant to events. NDC number of Prevnar 20: 0005-2000-01. Reported severe side effect of Prevnar 20. On 11Sep2203, patient sent message stating she was having allergic reaction to vaccine she received Friday. Her arm is very achy, very warm to touch and itchy; arm is very swollen and red. Did not provide when started. Doctor responded "this morning" and recommended patient ice the area a few times a day and take ZYRTEC, CLARITIN, or ALLEGRA daily as needed for the itching. Told her it can take up to 2 weeks for reaction to resolve and let her know if it continues to get worse and mentioned they would report reaction and patient closed case. Patient didn't respond.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Cellulitis, Hypersensitivity
Clinical narrative: Cellulitis; they have that as part of her allergic reactions to pneumonia shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), in 2017 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shots, for immunization. The following information was reported: CELLULITIS (hospitalization) with onset 2017, outcome "unknown"; ALLERGY TO VACCINE (hospitalization) with onset 2017, outcome "unknown", described as "they have that as part of her allergic reactions to pneumonia shot". The events "cellulitis" and "they have that as part of her allergic reactions to pneumonia shot" required physician office visit. Clinical course: The patient had reacted Prevnar 13 and put her in the hospital before. The only other shot was for pneumonia, was in hospital. Flu shots were fine, never had reaction until pneumonia shot, the Prevnar 13, when that came out, was the left arm. Cellulitis set in within 20 minutes, almost immediately. Thought that was what caused her to be hospitalized, the cellulitis. That was in 2017, she thought. They only kept her, probably 1 or 2 days. Went to (Hospital name withheld). They have that as part of her allergic reactions to pneumonia shot.    Causality for "cellulitis" and "they have that as part of her allergic reactions to pneumonia shot" was determined associated to device constituent of pneumococcal 13-val conj vac (dipht crm197 protein).  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC13
Symptoms: Device defective, Needle issue, Poor quality device used, Syringe issue
Clinical narrative: After administration of prevnar 13/syringe broke off body; luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe; Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.; Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 13Sep2023 at 10:00 as dose 1, single (Lot number: GH4086), in right thigh for immunisation; for immunisation, Device Lot Number: GH4086. The patient's relevant medical history was not reported. Concomitant medication(s) included: VAXELIS taken for immunisation, on 13Sep2023; ROTARIX PREFILLED taken for immunisation; GRIPE WATER FOR COLIC. The following information was reported: POOR QUALITY DEVICE USED (non-serious) with onset 13Sep2023, described as "After administration of prevnar 13/syringe broke off body"; DEVICE DEFECTIVE (non-serious), DEVICE BREAKAGE (non-serious) all with onset 13Sep2023 and all described as "Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device."; NEEDLE ISSUE (non-serious) with onset 13Sep2023, described as "luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe". Therapeutic measures were not taken as a result of poor quality device used, needle issue, device defective, device breakage. Additional information: The patient was not affected by this adverse event. After administration of PREVNAR 13, once the needle was removed from the patient, the healthcare provider-initiated safety mechanism on attached needle. When this was done, the luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe. Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.     The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein)  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: Paxlovid; Treatment of COVID-19: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). 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 "Treatment of COVID-19: Paxlovid". 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.  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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 3rd time getting Covid-19; 3rd time getting Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Sep2021, stop date: Sep2021; "COVID-19", start date: Aug2022, stop date: Aug2022. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "3rd time getting Covid-19".  The clinical course was reported as follows: The elderly patient was in great health and doesn't take any medications. He has always had the Pfizer vaccine for Covid-19 and stated that he was up to date on the vaccines. In Sep2023, approximately 10-12 days ago he had the third round of Covid-19. He was now negative for Covid-19. He informed that over the last 3-4 years he had Covid-19 three times (he got Covid-19 the 1st time in Sep2021, 2nd time in Aug2022, and 3rd time last week in Sep2023). Every 12 months he has had Covid-19. No treatment was received except resting and tea. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 125/80, notes: normal range; SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300966 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301887 same patient/drug/AE, different dose number/event onset date;
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), on 19Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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). The patient's relevant medical history included: "sulfa drugs." (unspecified if ongoing), notes: Sulfites and sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive, notes: Tested positive for Covid on 28Aug2023; (03Sep2023) Negative, notes: Tested negative on Sunday, 03Sep2023; (07Sep2023) Positive, notes: Tested again on 7Sep2023 and was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was tested positive for Covid on 28Aug2023. Patient  started Paxlovid next day, 29Aug2023. Tested negative on Sunday, 03Sep2023. Started feeling sicker again approx 06Sep2023. Tested again on 07Sep2023 and was positive again. Symptoms of rebound Covid are as bad (if not worse) than first time.  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: 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) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METOPROLOL; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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) all with onset 2023, outcome "unknown" and all described as "COVID". Clinical details: the patient had 4 Pfizer vaccination/boosters and no ill effects. Patient also recently had COVID.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Thinking abnormal
Clinical narrative: complete brain fog, could not think, plan or organize at all; it incapacitated her thought process; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Medical Information Team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), on 25Feb2021 at 08:00 as DOSE 2, SINGLE (Lot number: EN6200) at the age of 73 years, administered in the left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (first dose (Pfizer COVID Vaccine), via an unspecified route of administration (batch/lot number: EL9264) as DOSE 1, SINGLE), administration date: 29Jan2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: BRAIN FOG (non-serious) with onset 25Feb2021 at 14:00, outcome "recovered" described as "complete brain fog, could not think, plan or organize at all"; THINKING ABNORMAL (non-serious) with onset 25Feb2021 at 14:00, outcome "recovered" described as "it incapacitated her thought process." Therapeutic measures were not taken as a result of brain fog, thinking abnormal.  Additional information: Initial inquiry from patient was reported as follows: "I am a believer in vaccines in general. I have had four Pfizer Covid vaccines so far. The second vaccination produced a strong reaction. Now, many months later I am experiencing/have experienced since March, some symptoms of being a long hauler. I would like Pfizer's advice on the safety of me getting the new vaccine this fall. Thank you." Dosage text was reported as "unknown dose injection with a syringe left upper arm." Indication reported as "scared to get Covid." On 19Sep2023 follow-up, patient stated one reaction she had that was finite took place after second vaccination on Friday morning at 8:00 in the morning and by 2:00pm had complete brain fog, could not think, plan or organize at all. Otherwise, she was fine, but it incapacitated her thought process. Since she had reaction that lasted 36 hours had no other reactions after second, third or fourth injection.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304621 same patient and product; different dose and events;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune thyroiditis, Condition aggravated, Epstein-Barr virus infection, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EL3302), in left arm and on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN5318) at the age of 56 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The patient did not had covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300303664 same patient, different vaccine doses and different AE.;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Mycoplasma infection, Pneumonia, SARS-CoV-2 test, Spondylitis
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EL3302), in left arm and on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN5318) at the age of 56 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The patient did not had covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300303664 same patient, different vaccine doses and different AE.;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EL3302), in left arm and on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN5318) at the age of 56 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The patient did not had covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300303664 same patient, different vaccine doses and different AE.;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EL3302), in left arm and on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN5318) at the age of 56 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The patient did not had covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300303664 same patient, different vaccine doses and different AE.;
Age: 80.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Fall, Nausea, Syncope
Clinical narrative: Patient felt nauseous at night and fainted/fell when she got up to get a bowl
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: The patient ended up receiving a regular dose of the Fluzone flu vaccine even though he was qualified to get the high dose since he is over 65 years old. He didn't have any adverse effects of the vaccine before he left the pharmacy.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Dizziness, Impaired work ability, Influenza
Clinical narrative: Flu symptoms. Dizzy, crazy skin(painful) muscles, joints, all painful. Nausea. Had to leave work because of the dizziness. Fever and chills.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Pain of skin, Pyrexia
Clinical narrative: Flu symptoms. Dizzy, crazy skin(painful) muscles, joints, all painful. Nausea. Had to leave work because of the dizziness. Fever and chills.
Age: 20.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Immediately after providing the second vaccine which was the Fluarix Quad the patient fainted. They just slide down in the chair. They regained consciousness within a few seconds.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: Fever for going on 2 weeks now, varies between 100 degrees & went up to 103 degrees last night, headache, nausea, jaw pain, muscle aches, neck pain
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Fever for going on 2 weeks now, varies between 100 degrees & went up to 103 degrees last night, headache, nausea, jaw pain, muscle aches, neck pain
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: red, swollen bump in arm, hot to touch, painful
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: Extreme fatigue developed at approx 1PM  on  09/19/2023   about 24 hours  after the  injection   continued  until  bedtime,  disappeared by morning   09/20/2023..  Fatigue was so severe,  I had  to stay on the  couch... Reddened  area  at  site of  injection,  which enlarged somewhat  on the following  days..and  with increased soreness  on the following days...
Age: 32.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 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 was not reported. Concomitant medication(s) included: CYMBALTA, start date: 01Jan2015. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 recived Paxlovid from 05Sep2023 to 10Sep2023 as COVID-19 treatment.  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-202300303408 same patient, different drug/event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Rash, Skin warm
Clinical narrative: PATIENT RETURNED TO THE PHARMACY WITH REDNESS ADJACENT TO INJECTION SITE; PATIENT ALSO STATED THE RASH WAS WARM TO THE TOUCH
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Contusion, Hypoxia, Peripheral swelling
Clinical narrative: bruising  and swelling of the arm and then radiates to the neck. patient had to go to the emergency room, she was diagnosed with vaccine administration related cellulitis which required antibiotic and oxygen use since she had been hypoxic from it
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arteriogram coronary normal, COVID-19, Cardiac stress test normal, Carditis
Clinical narrative: Heart started hurting really bad after i got covid, the pain increased as if it were on a schedule, i could literally feel inflamation in my heart and it would ramp up in the night and in the mornings, after a year of this it got worse and worse, my heart doctor and specalist can not find anything wrong but the pain is very intense and wrong. the only thing working to stop the pain is Dr vax detox protocol, since i started the protocal, mostly all pain and inflamation has stopped completly, i stil have a cta scheduled to 100% rule out the small blockage causing such pain. This was a bio wepon and people need to know.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal
Clinical narrative: Heart started hurting really bad after i got covid, the pain increased as if it were on a schedule, i could literally feel inflamation in my heart and it would ramp up in the night and in the mornings, after a year of this it got worse and worse, my heart doctor and specalist can not find anything wrong but the pain is very intense and wrong. the only thing working to stop the pain is Dr vax detox protocol, since i started the protocal, mostly all pain and inflamation has stopped completly, i stil have a cta scheduled to 100% rule out the small blockage causing such pain. This was a bio wepon and people need to know.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-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 (Lot number: GH9693) and on 20May2023 at 14:30 as dose 6 (booster), single (Lot number: GJ3268) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EN6201), on 05Mar2021 as dose 2, single (Lot number: EN6198), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 10Feb2022 as dose 4 (booster), single (Lot number: FJ1614) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Autoimmune Hepatitis" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2000; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2005; CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL], start date: Jun2005; MYCOPHENOLATE, start date: Feb2020; NIACINAMIDE, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 07Sep2023 to 12Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303458 same patient/reporter, different drug/event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. 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 14Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Feb2021 at 15:30 as dose 1, single (Lot number: EN6198), in left arm, on 14Mar2021 at 14:45 as dose 2, single (Lot number: EN6206), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: Milk" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient received Paxlovid for COVID-19 Treatment from 15Sep2023 to 18Sep2023. Outcome of the events was unknown.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 61.0
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 consumer. 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 13Sep2022 at 08:15 as dose 6 (booster), single at the age of 61 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single, as dose 3 (booster), single, as dose 4 (booster), single and as dose 5 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "heart issues". The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Negative; (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19/Headache, fever, cough, congestion, aches, diarrhea; COVID-19/Headache, fever, cough, congestion, aches, diarrhea; Moderna: dose#1-4 and Pfizer / BioNTech: dose#5-6; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9693), in left arm and on 20Apr2023 as dose 6 (booster), single (Lot number: GI3268) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 14Feb2021 as dose 2, single (Lot number: 0016M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 012F21A), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) in 2weeks included: AMITRIPTYLINE; CHLORTHALIDONE; OLMESARTAN; ATORVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Moderna: dose#1-4 and Pfizer / BioNTech: dose#5-6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023 at 17:00, outcome "recovering" and all described as "COVID-19/Headache, fever, cough, congestion, aches, diarrhea". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 07Sep2023 to 11Sep2023 for treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Er8727), in left arm, on 16Apr2021 as dose 2, single (Lot number: Er8735), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: Eno173), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: Fka894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Trees allergy" (unspecified if ongoing); "Cats allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid for COVID-19 from 03Sep2023 to 07Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303795 Same patient/different product, different dose/event;US-PFIZER INC-2021549691 Same patient/same product, different dose/event;US-PFIZER INC-2021550466 Same patient/same product, different dose/event;
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: dose#1-2 and Pfizer / BioNTech: dose#3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 017B21A), in left arm and on 21Dec2021 as dose 2, single (Lot number: 029H21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Oct2022, outcome "unknown", described as "Moderna: dose#1-2 and Pfizer / BioNTech: dose#3"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative; (Sep2023) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "One instance of heart rate abnormality on holster test" (unspecified if ongoing), notes: One instance of heart rate abnormality on holster test; "sciatica" (unspecified if ongoing); "obesity" (unspecified if ongoing); "UPI" (unspecified if ongoing), notes: UPI. The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, 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 took Paxlovid for 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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for COVID; testing positive for COVID; 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 NOS), 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 Aug2023, outcome "not recovered" and all described as "testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid the day after testing positive for COVID. Patient have taken all Pfizer vaccines and was grateful to Pfizer as this is the first time with COVID.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.