chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she thought she was going to die; her mind went totally blank; shortness of breath; couldn't move or do anything; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "kidney damage" (unspecified if ongoing), notes: most recent GFR of 52; "Blood pressure high" (ongoing), notes: well controlled. Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose 1, Lot number: EN5318), administration date: 29Jan2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EL9266), administration date: 22Feb2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Lot number: 30130BA), administration date: 26Sep2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose 4 (Booster), Lot number: FK9896), administration date: 30Mar2022, when the patient was 76-year-old, for Covid-19 Immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset Sep2022, outcome "recovering", described as "couldn't move or do anything"; MENTAL IMPAIRMENT (non-serious) with onset Sep2022, outcome "recovering", described as "her mind went totally blank"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "shortness of breath"; NEAR DEATH EXPERIENCE (medically significant) with onset 19Sep2022, outcome "recovering", described as "she thought she was going to die". The patient received her 5th dose, the Bivalent, was just a week ago on 12Sep2022, so they didn't have the 2-3 week time to fully build immunity. Confirmed she tested positive for Covid-19 on 19Sep2022. Patient stated with the Covid-19 her mind went totally blank for 24 hours and she hadn't been eating with the Covid. She mentioned that she had shortness of breath. She coughs while on the phone. She also reported that she had a runny nose. For 24 hours she couldn't move or do anything on Sunday (18sep2022) or Monday (19Sep2022) and on Monday (19Sep2022) she thought she was going to die. She states after 2 doses of Paxlovid, she feels better than she did and she was able to walk her dog 1 mile today. Seriousness Criteria: patient stated being 77 with reactive airway, she would consider it to be Moderate, but certainly not disabling. The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 52, notes: most recent; SARS-CoV-2 test: (19Sep2022) Positive.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Experienced shingles with it; 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 female patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune hypothyroid" (ongoing), notes: current medical condition; "COVID" (unspecified if ongoing), notes: COVID twice and that the last time she got the new variant. The patient's concomitant medications were not reported. Past drug history included: Polysorbate 80, reaction(s): "allergic to polysorbate 80", notes: allergic to polysorbate 80. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: HERPES ZOSTER (non-serious) with onset 2022, outcome "unknown", described as "Experienced shingles with it".  Additional information: Caller asked whether the new flu shot came out this year was from Pfizer. Caller stated that she just got her last booster dose on 13Jul2022 and that she experienced shingles with it. Caller also mentioned that she is allergic to polysorbate 80, so she wanted to make sure if the new formulation has any polysorbate 80 in it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had Covid; Patient had Covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; IBUPROFEN; FOLIC ACID; LEVOTHYROXINE; LORATADINE; METHOTREXATE; OMEPRAZOLE; VITAMIN C ACID; VITAMIN D3; TIZANIDINE; TYLENOL. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "recovering" and all described as "Patient had Covid". Clinical course: In Aug2022 (3 weeks ago) patient had COVID. Symptoms are Cough, upper respiratory symptoms, fatigue, headache, brain fog, difficulty with smelling and cramps. brain fog, fatigue and cough persist (covid). The reporter did not considered that event caused by suspect product. The reporter stated that adverse event was not serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product cannot be fully excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen left axillary area (lymphadenopathy); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX; ACYCLOVIR [ACICLOVIR SODIUM]; SEASONALE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Sep2022 at 16:00, outcome "unknown", described as "Swollen left axillary area (lymphadenopathy)". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional information: Patient was not tested for covid post vaccination. No vaccines in four weeks. Patient received vaccine at pharmacy or drug store.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I contacted COVID last Monday; I contacted COVID last Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old patient received 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 included: "Blood pressure high" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 19Sep2022, outcome "unknown" and all described as "I contacted COVID last Monday". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 97.7, notes: my temperature has always been 97.7; SARS-CoV-2 test: (19Sep2022) unknown results.  Clinical course: Patient had some muscle pains and had very few symptoms, my symptoms were light. Patient stated, "I don't needed to have anything right now. Patient stated, "I contacted COVID last Monday. I had very few symptoms, my temperature has always been 97.7, I had a sense of taste and smell. Patient had some muscle pains but nothing (further not clarified hence, event captured conservatively) because I am old. I am 78. So, that's normal for me to have muscle pain and my friends have been telling me that I need to take Paxlovid and I am not sure that I need to take it. I do Have High Blood pressure (Intent: Medical History) and I take the Simvastatin (Intent: Concomitant product) and I also take, it is not Lisinopril but it is one those other meds that I do take for High blood pressure and so because my symptoms are light. I am very hesitant about taking any other meds like Paxlovid."  When probed to clarify after receiving which shot consumer was having symptoms: Patient stated, "I told you what my symptoms were. Should I repeat them". When clarifeid the concern: Patient had the very first two shots and no booster." When paraphrased the medication name as Pfizer COVID-19 Vaccine shots: Patient stated as Yes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm, as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rhuematoid arthritus" (unspecified if ongoing), notes: Other medical history: Rhuematoid arthritus; "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details included COVID 19 Treatment with Paxlovid. Treatment start date was reported as 12Sep2022 and treatment stop date was reported as 16Sep2022, Lot number:GE5197. Got Covid took Paxlovid at about third day took for 5 days, felt much better, like it was over. Then about a day or two later started having symptoms again, each day now symptoms are getting worse and she was sick again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria near left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 07Sep2022, stop date: 07Sep2022; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (Primary immunization completed., Manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (Dose number 3, Manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (Dose number 4, Manufacturer unknown.), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 21Sep2022, outcome "not recovered", described as "Urticaria near left armpit". Therapeutic measures were taken as a result of urticaria.  Additional information: It was reported that the patient had received treatment for the adverse event with hydrocortisone 2.5 percent. The patient had not tested for covid post vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID; got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP7543), in left arm and in Apr2021 as dose 2, single (Lot number: EW0150) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (ongoing); "High cholesterol" (ongoing); "high blood pressure" (ongoing); "muscle aches" (ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol increased (ongoing). Past drug history included: Lisinopril for high blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "unknown" and all described as "got the first 2 doses of the Pfizer COVID 19 vaccine/tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive. Clinical course: It was reported that the patient's symptoms are extremely light and that her doctor doesn't recommend that she take PAXLOVID.    No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 14:30 as dose 1, single (Lot number: ER8735), in left arm and on 05May2021 at 13:30 as dose 2, single (Lot number: EWD175) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 024021A), in left arm and on 18May2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACICLOVIR, start date: Dec2010, stop date: 12Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Sep2022) Negative; (20Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event: Anti-viral details: product COVID 19 Treatment, Paxlovid, Treatment start date 13Sep2022, Treatment stop date 18Sep2022, Indication Treatment of COVID-19. Rebound: After feeling better (only fatigue remained and that was improving) and testing negative with rapid antigen tests on 18Sep and 20, I started to have sinus/throat symptoms and congestion, and extreme fatigue again on 21Sep afternoon, and tested positive on rapid antigen test again on 21Sep at 7:30 pm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Right arm pain; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 18:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 43 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; LINZESS. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster), Single), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering", described as "Right arm pain"; FATIGUE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering"; HEADACHE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Additional information: No known allergies. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Other medical history: HTN, IBS. Other medication in two weeks: lisinopril, omeprazole, linzess and MVI. Facility type vaccine was pharmacy or Drug Store.
Age: 75.0
Sex: M
Vaccine: COVID19, 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 75-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 at 10:00 as dose 4 (booster), single (Lot number: G75342) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: MIRTAZAPINE; ZOLOFT; CONCERTA; OMEPRAZOLE. Past drug history included: Known allergies: cypro, reaction(s): "Known allergies: cypro"; Known allergies: epinephrine, reaction(s): "Known allergies: epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The current age of the patient was 76 years. The other medications which patient received in 2weeks were mirtazapine, zoloft, concerta, omeprazole, concerta.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 at 10:00 as dose 4 (booster), single (Lot number: G75342) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: MIRTAZAPINE; ZOLOFT; CONCERTA; OMEPRAZOLE. Past drug history included: Known allergies: cypro, reaction(s): "Known allergies: cypro"; Known allergies: epinephrine, reaction(s): "Known allergies: epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The current age of the patient was 76 years. The other medications which patient received in 2weeks were mirtazapine, zoloft, concerta, omeprazole, concerta.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hepatic pain, Pain in extremity
Clinical narrative: Pain in liver area; fatigue; Arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 10:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL; LOSARTAN; AMLODIPINE; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: EP6955), administration date: 18Mar2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: ER8731), administration date: 15Apr2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Single, Batch/Lot No: FE3594), administration date: 16Dec2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2022, outcome "unknown", described as "Arm pain"; HEPATIC PAIN (non-serious) with onset 22Sep2022, outcome "unknown", described as "Pain in liver area"; FATIGUE (non-serious) with onset 22Sep2022, outcome "unknown". Therapeutic measures were not taken as a result of hepatic pain, fatigue, pain in extremity.  Additional information: Facility type of vaccine was reported as Pharmacy or Drug Store. Patient did not received any other medication within four weeks. Other medications in two weeks included: Metoprolol, Losartan, Amlodapine, Pantoprazole, Si. Patient did not had Covid-19 prior to vaccination. Patient did not tested for Covid-19 since vaccination. Patient does not have any known allergy. Treatment was not received.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in my arms and upper part of my legs; 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 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in my arms and upper part of my legs".  Additional Information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), > 12 years - 15/15 mcg per dos. Question: There were no clinical trials for the vaccine (BA4/BA5), why not. Question: Caller has been using Premarin vaginal cream since age 61 and she is currently 73-year-old. '' Before I got my last tube, I had to make several calls to my insurance since it has to be refilled too early. I use 0.5 twice a week on the applicator. I squeeze from the bottom slowly, carefully. When I take the applicator off, more cream comes out on its own, I can't get the cream back in the tube. How can you make this tube more efficient. When I take the applicator off, I'm holding it sideways.Caller adds later during the call AE on Pfizers covid vaccine is I got the two original Pfizers, and the booster by Pfizer. I noticed. tingling in my arms and upper part of my legs that lasted a day. 24 hours at the most but not within the 1st 15 minutes. Mostly the lower extremity of my arm. The pharmacist says maybe it is my body's reaction to it. Caller like suggestions to avoid more of the PREMARIN vaginal cream from squirting out of the tube after taking the applicator off. Question: Do you have any information on this variant with regards to Comirnaty/Pfizer-BioNTech COVID-19 Vaccine. When will the clinical trials for the vaccine (BA4/BA5) be released. Request Name: REQ-927800. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent.  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: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient 01Sep2022 when manufacture date on bottle was Sep2021. One day after expiration date; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (005570).  A 7-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 7 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 11Nov2021, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "AE(s) following prior vaccinations: None"; BNT162b2 (DOSE 2, SINGLE), administration date: 03Dec2021, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "AE(s) following prior vaccinations: None". The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 01Sep2022, outcome "unknown", described as "patient 01Sep2022 when manufacture date on bottle was Sep2021. One day after expiration date".  Additional information: NDC number of Covid-19 monovalent 5 to 11 vaccine: 59267-1055-4. rIt was reported that Pfizer covid vaccine (orange cap) with the manufacture date Sep2021. Technically, was given 1 day past expiration that was given. No relevant tests was conducted. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with any AE(s). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Two days ago I contracted Covid, and I have had three Moderna shots, one Pfizer shot on 31Jul; Two days ago I contracted Covid, and I have had three Moderna shots, one Pfizer shot on 31Jul; 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 79-year-old male patient received BNT162b2 (BNT162B2), on 31Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Caller has diabetes and "other prior conditions". The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2022, outcome "unknown" and all described as "Two days ago I contracted Covid, and I have had three Moderna shots, one Pfizer shot on 31Jul". 79-year-old male is calling to report his "recent Covid condition, I am a stockholder of many years, two days before (20Sep2022) I contracted Covid, and I have had three Moderna shots, one Pfizer shot on 31Jul2022, and I have prior health conditions, and I just thought that I was pretty bulletproof with four shots and taking precautions, but contracting Covid was a shock to me, I want to alert Pfizer". Caller has diabetes and "other prior conditions". Caller states "I can't say I contracted Covid two days before, on Sunday (18Sep2022) I came down with some symptoms, tested Tuesday" and was positive for Covid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site for booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 18:15 as dose 3 (booster), single (Lot number: GH9694) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Sep2022 at 21:30, outcome "recovering", described as "Pain at the injection site for booster shot". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Site of vaccine has pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 68-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 and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Site of vaccine has pain".  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-202201182250 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Site of vaccine has pain; 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 68-year-old female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Site of vaccine has no pain, unlike previous 3 Pfizer"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Site of vaccine has no pain, unlike previous 3 Pfizer". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Site of vaccine has pain".  Additional information: It was reported that the site of vaccine had no pain, unlike previous 3 Pfizer and one Moderna vaccine or booster. The patient had a reaction every single time before.  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-202201182250 Similar report from same reporter (Pfizer bivalent booster);US-PFIZER INC-202201182345 Similar report from same reporter (1st dose);US-PFIZER INC-202201182346 Similar report from same reporter (2nd dose);
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). Concomitant medication(s) included: TURMERIC [CURCUMA LONGA RHIZOME]; QUERCETIN; ESTROGEN; MAGNESIUM; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has taken Pfizer antiviral drug for the treatment of COVID-19 from 13Sep2022 to 17Sep2022.  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, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 18Mar2022 as dose 4 (booster), single (Lot number: 039f21a), in left arm and on 05Aug2022 as dose 5 (booster), single (Lot number: 064a22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "mood disorder" (unspecified if ongoing), notes: Other medical history: mood disorder,; "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "obese" (unspecified if ongoing), notes: Other medical history: obese. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: no known allergies.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Feeling hot, Pain in extremity, Vaccination site erythema, Vaccination site mass
Clinical narrative: arm started itching, with a raised red bump where needle went in; raised red bump where needle went in; raised red bump where needle went in; arm feels warm to touch; burning; soreness mid upper arm; This is a spontaneous report received from a 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 08Sep2022 at 11:00 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: High BP; "Known allergies: Sulphur" (unspecified if ongoing), notes: Known allergies: Sulphur. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN; METOPROLOL; METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset Sep2022, outcome "not recovered", described as "arm feels warm to touch"; BURNING SENSATION (non-serious) with onset Sep2022, outcome "not recovered", described as "burning"; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "not recovered", described as "soreness mid upper arm"; VACCINATION SITE PRURITUS (non-serious) with onset 17Sep2022, outcome "not recovered", described as "arm started itching, with a raised red bump where needle went in"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious) all with onset 17Sep2022, outcome "not recovered" and all described as "raised red bump where needle went in". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site mass, feeling hot, burning sensation, pain in extremity.  Additional information: Patient was not pregnant at time of vaccination. One week after the injection, arm started itching, with a raised red bump where needle went in. This week, 2 weeks after injection, arm feels warm to touch, burning, and a lump and soreness mid upper arm. If other vaccine in four weeks reported as No. AE resulted in none of the above. If covid prior vaccination and if covid tested post vaccination reported as No.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pruritus
Clinical narrative: arm started itching, with a raised red bump where needle went in; raised red bump where needle went in; raised red bump where needle went in; arm feels warm to touch; burning; soreness mid upper arm; This is a spontaneous report received from a 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 08Sep2022 at 11:00 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: High BP; "Known allergies: Sulphur" (unspecified if ongoing), notes: Known allergies: Sulphur. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN; METOPROLOL; METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset Sep2022, outcome "not recovered", described as "arm feels warm to touch"; BURNING SENSATION (non-serious) with onset Sep2022, outcome "not recovered", described as "burning"; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "not recovered", described as "soreness mid upper arm"; VACCINATION SITE PRURITUS (non-serious) with onset 17Sep2022, outcome "not recovered", described as "arm started itching, with a raised red bump where needle went in"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious) all with onset 17Sep2022, outcome "not recovered" and all described as "raised red bump where needle went in". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site mass, feeling hot, burning sensation, pain in extremity.  Additional information: Patient was not pregnant at time of vaccination. One week after the injection, arm started itching, with a raised red bump where needle went in. This week, 2 weeks after injection, arm feels warm to touch, burning, and a lump and soreness mid upper arm. If other vaccine in four weeks reported as No. AE resulted in none of the above. If covid prior vaccination and if covid tested post vaccination reported as No.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes arm pit became swollen; 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 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Sep2022, outcome "recovering", described as "Lymph nodes arm pit became swollen".  Additional Information: Dose/ Dosage Form: Gray cap, Original/ Omicron BA.4/BA.5 (Bivalent), greater than 12 years - 15/15 mcg per dos. Question: Received booster dose of Pfizer COVID 19 Vaccine Monday, bivalent product. Patient experienced side effects that she had questioned about. The caller declined speaking to file a safety report she stated and only wanted to ask a question. Went to (Pharmacy name withheld) Monday took shot and had a bad reaction. Lymph nodes arm pit became swollen and she want to know if that was normal. She tried to ask the pharmacy what she should do because her primary care provider had nothing to do with that she said. Caller noted that the pharmacy told her it should resolve. "It had gone down some. Asked to wait for few more days. She will see what happens from there." E-transmitting as the patient stated she did not want to file a report. 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: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: 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 11Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient previously received a COVID-19 Vaccine. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 12Sep2022 to 16Sep2022. Rebound of symptoms and positive COVID test on day 11 days after initial diagnosis, 6 days after finishing nirmatrelvir; ritonavir, 4 days after testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated and tested positive for Covid on 22Sep2022.; Patient was fully vaccinated and tested positive for Covid on 22Sep2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) 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; 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 22Sep2022, outcome "recovering" and all described as "Patient was fully vaccinated and tested positive for Covid on 22Sep2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was fully vaccinated and tested positive for Covid on 22Sep2022. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for 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.