chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Neuralgia, Sleep disorder, Vaccination site reaction
Clinical narrative: experiencing ache on the left side of the leg/having some dull ache on the left leg; difficulty walking and sleeping; difficulty walking; difficult to go up and down the stairs; multiple cramps; 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 65-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing ache on the left side of the leg/having some dull ache on the left leg"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty walking and sleeping"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "difficult to go up and down the stairs"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "multiple cramps".  Additional information: The case was reported as non-serious. The patient was experiencing ache on the left side of the leg, it has been three days. She was also having difficulty walking and sleeping. The patient was not in the Patient Assistance Program but she called because and stated that she took the Prevnar and then she was having some dull ache on the left leg. She said she doesn't have a primary doctor because she was referred to one of her primary doctors to go to ask questions. She wanted to know if that's normal or what side effect that was or stuff like that. She got it on her birthday actually. What happened was that everything was fine once she took it, in fact she wanted this one because it was the one undone in suppose to the other two that were you know, the two separate ones (further clarification was not available over the call). What happened was that she felt fine and instead she had a little dull ache on the left side of her leg but it was kind of, it just ached a little bit and she felt there were multiple cramps that could be a side effect and whatever she said ok, that's fine. She would say the past three days it's been pretty bad for her leg, it was achy and hurts, it's difficult to go up and down the stairs and she was concerned because it was even difficult to sleep, to be honest.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Gait disturbance, Insomnia, Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: experiencing ache on the left side of the leg/having some dull ache on the left leg; difficulty walking and sleeping; difficulty walking; difficult to go up and down the stairs; multiple cramps; 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 65-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing ache on the left side of the leg/having some dull ache on the left leg"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty walking and sleeping"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "difficult to go up and down the stairs"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "multiple cramps".  Additional information: The case was reported as non-serious. The patient was experiencing ache on the left side of the leg, it has been three days. She was also having difficulty walking and sleeping. The patient was not in the Patient Assistance Program but she called because and stated that she took the Prevnar and then she was having some dull ache on the left leg. She said she doesn't have a primary doctor because she was referred to one of her primary doctors to go to ask questions. She wanted to know if that's normal or what side effect that was or stuff like that. She got it on her birthday actually. What happened was that everything was fine once she took it, in fact she wanted this one because it was the one undone in suppose to the other two that were you know, the two separate ones (further clarification was not available over the call). What happened was that she felt fine and instead she had a little dull ache on the left side of her leg but it was kind of, it just ached a little bit and she felt there were multiple cramps that could be a side effect and whatever she said ok, that's fine. She would say the past three days it's been pretty bad for her leg, it was achy and hurts, it's difficult to go up and down the stairs and she was concerned because it was even difficult to sleep, to be honest.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site swelling, Lymphadenopathy, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: lymph nodes are swollen in both armpits; injection sites a little swollen and itching really bad; injection sites a little swollen and itching really bad; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 05Sep2023 as dose 1, 0.5ml single (Lot number: GT0538, Expiration Date: Oct2024) at the age of 52 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension takes medication for high blood pressure. Has been under this doctors care since 2021, unknown when diagnosed; "IBS" (unspecified if ongoing), notes: IBS takes medication; "Sleep apnea", start date: 2019 (unspecified if ongoing), notes: Sleep apnea takes medication; "Diabetes", start date: 2022 (unspecified if ongoing), notes: Diabetes takes medication. Concomitant medication(s) included: SHINGRIX intramuscular taken for immunisation, on 05Sep2023 as dose 1, 0.5ml single. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 10Sep2023, outcome "unknown" and all described as "injection sites a little swollen and itching really bad"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes are swollen in both armpits". The events "injection sites a little swollen and itching really bad" and "lymph nodes are swollen in both armpits" required physician office visit. Additional information: The patient had no prior vaccinations within 4 weeks, no relevant family history. The doctor responded with the same response from previous patient of PRIVACY a few times a day, take Zyrtec, Claritin, or Allegra for itching and it can take up to 2 weeks to resolve and if getting worse to contact them. Looks like patient hasn't seen the message yet.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site exfoliation, Vaccination site induration, Vaccination site pruritus
Clinical narrative: injection site was itchy; injection site was hard; injection site was peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL0149) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "concussions", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "contusion", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "She had an accident" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections; "torn rotator cuff" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections. There were no concomitant medications. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "injection site was itchy"; VACCINATION SITE INDURATION (non-serious), outcome "recovered", described as "injection site was hard"; VACCINATION SITE EXFOLIATION (non-serious), outcome "recovered", described as "injection site was peeling". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site induration, vaccination site exfoliation.  Additional information: The patient is asking when the new COVID-19 vaccine will be available. She also asked about tetanus and flu vaccine and agent referred her to the manufacturer since Pfizer does not have a tetanus or flu vaccine. Reports she took all of the Pfizer covid vaccines including the booster. States that when the injection site was healing it was itchy, hard, and peeling; and she took Tylenol. Stated that it took about 3 or 4 days to recover after each dose of the COVID vaccine. The patient was told to exercise and move her arm around.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298937 same patient/product/AE, different dose number;US-PFIZER INC-202300301984 same patient/product/AE, different dose number;US-PFIZER INC-202300301987 same patient/product/AE, different dose number;US-PFIZER INC-202300301985 same patient/product/AE, different dose number;US-PFIZER INC-202300301983 same patient/product/AE, different dose number;US-PFIZER INC-202300301986 same patient/product/AE, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Palpitations, Ventricular extrasystoles
Clinical narrative: high blood pressure/ after the first shot it went up to 159/85; heart palpitations; PVCs; 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 71-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant), outcome "recovering", described as "high blood pressure/ after the first shot it went up to 159/85"; PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown", described as "PVCs". The events "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations" and "pvcs" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 159/85 mmHg, notes: High: after the first shot it went up to 159/85; 100/60 mmHg, notes: usually 100/60.  Clinical course: Caller, female, almost 72 years of age, has had 5 previous shots of the Pfizer COVID vaccines. She is calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85 she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better. She called the Pfizer reaction line and they told her that its happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before. So she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine. When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine and she also was having heart palpitations.  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-202300300611 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300300610 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300300609 same patient/vaccine, different dose/event;US-PFIZER INC-202300300612 Same reporter, patient, product, different dose and event;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I did get the first two shot and the booster last year and then I had Omicron; I did get the first two shot and the booster last year and then I had Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31May2021), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 3030BA) at the age of 75 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I did get the first two shot and the booster last year and then I had Omicron". Clinical course: Patient reported she got the first two shot and the booster last year and then she had Omicron. She had all the symptoms and felt awful. She had other conditions also. She did not undergo investigations. She reported that the Lot number was T.19267 and it was Pfizer, but the printing was so small. Maybe it was not T, maybe it was 1-1or it was L-L.9267. She stated that her card also represented that she got something on 05Mar2021, but she denied and said there were only 3 shot out, first two shot and the booster. She received vaccination at Pharmacy. She did not receive prior vaccinations within 4 weeks. She did not had any lab test for couple of years because she fired her doctor and had an appointment with the new doctor next week.  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: Transient acantholytic dermatosis
Clinical narrative: slight Grovers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), 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) for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Bullous Pemigoid/blistering itching skin reaction/rash". The following information was reported: TRANSIENT ACANTHOLYTIC DERMATOSIS (non-serious), outcome "unknown", described as "slight Grovers".  Additional information: The patient got the first Pfizer booster while  was still taking dupixant and the patient was nervous about getting another booster. The patient also had slight Grovers.  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-PV202300155651 Same patient, different dose and AE;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: nausea; chills; fever; 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 71-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she does have a lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/ Lot number not reported), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: The patient who is a female almost 72 years of age reported for herself that she has had 5 previous shots of the Pfizer COVID vaccines. She is calling about the new one that was just released but nowhere has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85, she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better. She called the Pfizer reaction line, and they told her that it happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before. So, she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine. When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine, and she also was having heart palpitations. The subsequent doses it was always the nausea and the chills and things like that , fever.  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-202300299983 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300612 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300610 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300611 Same patient/ reporter, product, Different dose/ events;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Nausea, Pyrexia
Clinical narrative: nausea; chills; fever; 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 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She does have a lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs"; Bnt162b2 (Dose:2, single), for COVID-19 immunization, reaction(s): "Chills", "Nausea", "fever". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller had AEs to the five previous doses of the Pfizer COVID vaccines, attempted warm transfer to DSU, but accidentally blind transferred due to needing to click several times. She is calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85 she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better.  She called the Pfizer reaction line and they told her that its happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before.  So she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine.  When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine and she also was having heart palpitations. The subsequent doses it was always the nausea and the chills and things like that, fever.   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-202300300612 Same reporter, patient, product,  events different dose;US-PFIZER INC-202300300609 Same patient/ reporter, product, Different dose/ events;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Joint swelling
Clinical narrative: now unable to squat or bend my knee, or stretch my leg. Feels like the back of the knee is puffy; swelling of the back of the both knee; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 26Mar2021 at 14:00 as dose 2, single (Lot number: ER8733) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 04Mar2021, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (non-serious) with onset May2021, outcome "not recovered", described as "swelling of the back of the both knee"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "now unable to squat or bend my knee, or stretch my leg. Feels like the back of the knee is puffy". The events "swelling of the back of the both knee" and "now unable to squat or bend my knee, or stretch my leg. feels like the back of the knee is puffy" required physician office visit. Therapeutic measures were not taken as a result of joint swelling, joint range of motion decreased.  Additional information: One month after second vaccine patient had swelling of the back of the both knee and patient still have today after 2 years with flare ups. patient was perfectly fit, with no knee problem. Patient now unable to squat or bend my knee, or stretch her leg. Feels like the back of the knee is puffy. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300691 same patient/vaccine, different events/suspect doses (LOE);
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3302), on 07Feb2021 as dose 2, single (Lot number: EL9261), on 20Sep2021 as dose 3 (booster), single (Lot number: FF8829), in left arm and on 16Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid; lot number: 00069-1085-30) were taken as a result of vaccination failure, covid-19 from 01Sep2023 to 06Sep2023.  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-202300301020 same patient, different drug, different event;
Age: 43.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-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 (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), 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: "RA" (unspecified if ongoing), notes: Other medical history: RA. 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 "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 included Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Moderna, Dose: 3, 4 / Pfizer, Dose: 1, 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 24Apr2021 as dose 2, single (Lot number: EW0172) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 035C21A), in left arm and on 23Sep2022 as dose 4 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Moderna, Dose: 3, 4 / Pfizer, Dose: 1, 2"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 23Aug2023 to 27Aug2023.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Pyrexia
Clinical narrative: shaking chills; fever; blistering on her feet and hands; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "shaking chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; BLISTER (non-serious), outcome "recovered", described as "blistering on her feet and hands". It was unknown if therapeutic measures were taken as a result of chills, pyrexia, blister. Additional information: Patient experienced shaking chills, fever, and blistering on her feet and hands after receiving the Pfizer Covid vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 5 (booster), single (Lot number: 693274), in right arm and on 09Aug2023 as dose 6 (booster), single (Lot number: GK4974) at the age of 77 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm, on 15Dec2021 as dose 3 (booster), single (Lot number: 303308D), in right arm and on 12Jul2022 as dose 4 (booster), single (Lot number: FP7139), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes B" (unspecified if ongoing); "reflux" (unspecified if ongoing); "unable to metabolize folic acid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: milk protein" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR], start date: 01Jan2017; METANX, start date: 01Jan2019; DEPLIN [LEVOMEFOLIC ACID], start date: 01Jan2019; PANTOPRAZOLE MYLAN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment". Clinical course: Symptoms started 01Sep2023, felt like a chest cold. Felt ill and got tested for Covid and flu on 03Sep2023 at (withheld) (Labor Day weekend). Was prescribed Paxlovid and started taking it that night. The patient underwent the following laboratory tests and procedures: Influenza virus test: (03Sep2023) Positive; (09Sep2023) Negative; SARS-CoV-2 test: (03Sep2023) Positive; (09Sep2023) Negative. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 03Sep2023 to 07Sep2023.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site exfoliation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site was itchy; injection site was hard; injection site was peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), on 27Jan2021 as dose 2, single (Lot number: PAA156051) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "concussions", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "contusion", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "She had an accident" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections; "torn rotator cuff" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections. There were no concomitant medications. Vaccination history included: bnt162b2 (First dose Pfizer Biontech covid 19 vaccine: 05Jan2021, Lot: EL0149 (populated in formal field), Expiration: unknown, NDC: unknown, after all the covid vaccine doses she was given, where the injection site was itchy, hard, and peeling.), administration date: 05Jan2021, when the patient was 51-year-old, for COVID-19 Immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling". The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "injection site was itchy"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "injection site was hard"; VACCINATION SITE EXFOLIATION (non-serious), outcome "recovered", described as "injection site was peeling". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site exfoliation.  Additional information: she took all of the Pfizer covid vaccines including the booster. States that when the injection site was healing it was itchy, hard, and she took a Tylenol. It took about 3 or 4 days to recover after each dose of the covid vaccine. She did not pay attention to it. They told her to exercise and move her arm around. She was in a rehabilitative facility and did not get the doses from her doctor.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298937 same patient/AE, different product;US-PFIZER INC-202300299879 same patient/product/AE, different dose number;
Age: 65.0
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) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Mar2023 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 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), 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: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  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 including Paxlovid from 05Sep2023 to 09Sep2023.  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, 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 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
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) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 70 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Sep2023 to 06Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Mar2022 as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 06Sep2023 to 11Sep2023.   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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: ear ringing/ my husband started complaining of Tinnitus; Dose 3rd was administered 05Oct2022; Dose 4th was administered October it's says but I feel like it was week later than that 2022; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 06Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE), administration date: 27Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot: FF2587), administration date: 05Oct2022, for COVID-19 immunisation, reaction(s): "Wrong vaccine administered". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2022, outcome "unknown", described as "Dose 3rd was administered 05Oct2022; Dose 4th was administered October it's says but I feel like it was week later than that 2022"; TINNITUS (non-serious), outcome "unknown", described as "ear ringing/ my husband started complaining of Tinnitus ". The event "ear ringing/ my husband started complaining of tinnitus " required physician office visit.  Additional Information: Reporter's husband and reporter both had four of the Pfizer COVID-19 Vaccination, Immunizations and she was a very big vaccine protonate. Reporter stated that in January her husband started complaining of Tinnitus. They both had, she no way related it to the immunization at first. They were showing doctor and somebody when she was saying that they had Tinnitus, they were like, got it from shot. Apparently there was small percentage of people that were reporting tinnitus which of course they could not say for sure they said maybe it just a correlation but there was nothing else that could happen. Reporter stated they had all the same series of shot, all of the same lot and everything. Reporter stated, all four were COVID Pfizer 19 mRNA. When asked if husband also received Pfizer COVID-19 Vaccine, reporter stated, they took the exact same thing. Reporter stated, They (Lots) were the exact same as reporter's and like she said when she would call back with her information she would have his ready as well but his were the same because they took one after the other. It was clarified that husband received the same LOT# as FF2587. She would call later for her husband.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302160 Same patient/different dose/AE;US-PFIZER INC-202300302176 Same reporter/drug/AE, different patient;US-PFIZER INC-202300302191 Same reporter/drug/AE, different patient;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 45 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pleva" (unspecified if ongoing); "known allergies: Dairy" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 05Sep2023 to 09Sep2023.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 32-year-old male patient received bnt162b2 (BNT162B2), on 01Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 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: "Anxiety" (unspecified if ongoing); "POTS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "allergy to sulphate" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clyndmycin, reaction(s): "known allergies: Clyndmycin"; Augmentin, reaction(s): "known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 04Sep2023 to 09Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included administration of Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
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) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 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), 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline"; Codeine, reaction(s): "known allergies: Codeine". 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 including Paxlovid from 07Sep2023 to 12Sep2023.