chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: I have a brain injury; I had a Covid Booster yesterday and shortly after, I had numbness in my head; my lips were tingling; I have been dizzy, after a couple of hours it went away but I still feel dizzy.; I couldn't like move my eyes and the right side; I can't understand accents; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (booster), single (Lot number: GH9703) 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: BRAIN INJURY (medically significant), outcome "unknown", described as "I have a brain injury"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "I had a Covid Booster yesterday and shortly after, I had numbness in my head"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "my lips were tingling"; DIZZINESS (non-serious), outcome "unknown", described as "I have been dizzy, after a couple of hours it went away but I still feel dizzy."; EYE MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I couldn't like move my eyes and the right side"; AUDITORY DISORDER (non-serious), outcome "unknown", described as "I can't understand accents".   Clinical course: Concern: Consumer stated, "I can't understand anything. Is there somebody that I could talk to that I can understand better? I can't understand you." Consumer stated, "I had a Covid Booster (Clarified as: Pfizer Covid-19 Vaccine) yesterday and shortly after, I had numbness in my head and my lips were tingling, they weren't swollen but they were tingling and it went away. I have been dizzy, after a couple of hours it went away but I still feel dizzy. I am reporting that, after I had the vaccine, I had numbness in my head. I couldn't like move my eyes and the right side, the side that, I had the vaccine (Pfizer Covid-19 Vaccine) on. That's all." Consumer was informed about the role of Pfizer drug safety and when probed to proceed with the questions: Consumer stated, "I have a brain injury and I can't understand accents, So, I heard part of that but I don't, you said is that okay, I don't know what you are asking about? I do not know what you said after file a safety report, after that I don't get what you said, 8 to 10 more minutes? Is that what you said? For what? You have an accent, I am not understanding anything what you are saying. I would rather have somebody call me tomorrow or later." When probed for the Expiration date of Pfizer Covid-19 Vaccine: Consumer stated, "No." Further probing could not be done as consumer was unwilling to complete the report Hence, Limited information was available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Jun2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm, all intramuscular 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), SUSPECTED COVID-19 (medically significant) all with onset 22Oct2022 at 12:30, outcome "recovering" and all described as "got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Negative. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram
Clinical narrative: myocarditis; This is a literature report.  A 17-year-old male 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: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Body temperature: 101 Centigrade; C-reactive protein: elevated; Echocardiogram: LVEF 65 percent, notes: no RWMA, normal diastolic function; LVEF 68 percent, notes: no RWMA, normal diastolic function, follow up; Ejection fraction: 65 %, notes: on presentation; 68 %, notes: follow-up; Electrocardiogram: ST elevation in inferolateral leads; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: Edema, patchy, notes: midmyocardial and sub epicardial late gadolinium enhancement; Resolved edema,, notes: Small patchy low intensity late gadolinium enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event myocarditis  and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Exercise test, Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: myocarditis; This is a literature report.  A 17-year-old male 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: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Body temperature: 101 Centigrade; C-reactive protein: elevated; Echocardiogram: LVEF 65 percent, notes: no RWMA, normal diastolic function; LVEF 68 percent, notes: no RWMA, normal diastolic function, follow up; Ejection fraction: 65 %, notes: on presentation; 68 %, notes: follow-up; Electrocardiogram: ST elevation in inferolateral leads; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: Edema, patchy, notes: midmyocardial and sub epicardial late gadolinium enhancement; Resolved edema,, notes: Small patchy low intensity late gadolinium enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event myocarditis  and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of covid-19; Treatment of covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-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), as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN, start date: 01Sep2020, stop date: 03Oct2022; TRAMADOL, start date: 01Mar2018; ZOMIG, start date: 01Nov2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid from 11Oct2022 to 16Oct2022, as a result of treatment for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 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: "AFIB" (unspecified if ongoing); "HIGH BP" (unspecified if ongoing); "low GFR" (unspecified if ongoing), notes: low GFR 37-39 but steady. Concomitant medication(s) included: LOSARTAN, start date: 01Jan2001; ELIQUIS, start date: 01Jan2001; GLIMEPIRIDE, start date: 01Jan2001. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 71.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: He said he is experiencing some muscle soreness.; Sore throat; Stuffy nose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 24Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for immunisation; varicella zoster vaccine rge (SHINGRIX), on 24Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 24Oct2022, outcome "unknown", described as "He said he is experiencing some muscle soreness."; OROPHARYNGEAL PAIN (non-serious) with onset 24Oct2022, outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 24Oct2022, outcome "unknown", described as "Stuffy nose". Additional information: The patient reported having some muscle soreness after the vaccination. The patient stated that he had muscle soreness, sore throat, and stuffy nose.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: COVID arm red mark was in the shape of a heart; 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), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID arm". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "COVID arm red mark was in the shape of a heart".  Additional information: With the new booster COVID arm red mark was in the shape of a heart. So even body expressed it love. Patient would love to share a picture.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: this is much more likely to be covid than the flu; this is much more likely to be covid than the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ5342) 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: "pre-cancer" (unspecified if ongoing), notes: I have a pre-cancer diagnosis; "mitral valve prolapse" (unspecified if ongoing); "TB exposure" (unspecified if ongoing), notes: recent TB exposure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "this is much more likely to be covid than the flu".  Clinical course: Patient had a second Pfizer vaccine - COVID-19 mRNA LNP-S, bivalent PF 12yrs-adult booster (Pfizer), 30mcg/0.3mL, Lot #: GJ5342 (withheld) - just 3 days after a double flu vaccine (asthma); immediately became ill, was diagnosed with severe bronchitis, and doctors have been back & forth on whether it is bronchitis or covid. Test results variable. Patient started coughing up blood (slightly) yesterday. Patient was fine before the vaccine. (withheld) said this is much more likely to be covid than the flu. Patient had a pre-cancer diagnosis, mitral valve prolapse, recent TB exposure due to County malfeasance - second hand smoke by people after a brief hotel state, which a county nurse later reached out to guests to advise of TB exposure - and severe asthma. patient did not get any warnings for ANY of these conditions prior to the vaccine  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: prior covid infection, as I had in 2021 long covid caused by the vaccines; prior covid infection, as I had in 2021 long covid caused by the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-cancer diagnosis" (unspecified if ongoing); "mitral valve prolapse" (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 "prior covid infection, as I had in 2021 long covid caused by the vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prior covid infection, as I had in 2021 long covid caused by the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (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), 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: "Muscular dystrophy" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of COVID after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 14Oct2022 to 19Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna, Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jul2022 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 02Oct2022 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: Both under control with medications; "High cholesterol" (unspecified if ongoing), notes: Both under control with medications. Concomitant medication(s) included: ATORVASTATIN, start date: 01Apr2021, stop date: 06Oct2022; REMICADE taken for psoriatic arthropathy, stop date: 17Sep2022.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Jul2022 at 13:15, outcome "unknown", described as "Name of Drug as Reported: Moderna, Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, latency 16 days 11 hrs after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (19Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (22Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (23Oct2022) Positive, notes: tested positive for COVID the evening on 23Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks reported as yes. Vaccine lot unknown reason reported as unable to locate or read the details. Patient took Paxlovid on Friday 14Oct2022 and patient started developing cold symptoms on the morning of 23Oct2022 and tested positive for COVID the evening on 23Oct2022. Had very bad head cold the day of 24Oct2022. Patient was on Remicade for psoriatic arthritis. Last dose was on 17Sep2022. Patient was immune compromised from this drug. Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EN6207), on 22Apr2021 as dose 2, single (Lot number: EW1071) and on 17Oct2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Depression" (unspecified if ongoing), notes: General depression/anxiety; "Anxiety" (unspecified if ongoing), notes: General depression/anxiety; "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: PROZAC, start date: Aug2014; ADDERALL, start date: May2016.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: Tested positive for Covid on Saturday 8Oct2022; (16Oct2022) Negative, notes: Tested negative for Covid on Sunday 16Oct; (21Oct2022) Positive, notes: Tested strongly positive for Covid Friday 21Oct; (24Oct2022) Negative, notes: Tested negative by Monday 24Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: It was reported that Patient took Other medication in 2weeks. Patient received Paxlovid for treatment of covid-19, Treatment start date was 08Oct2022,Treatment stop date was 13Oct2022.
Age: 79.0
Sex: U
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.  A 79-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 18Feb2021 as dose 2, single (Lot number: EL1283), on 21Sep2021 as dose 3 (booster), single (Lot number: FF2589) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "atrial fib" (unspecified if ongoing), notes: Other medical history atrial fib; "SSS" (unspecified if ongoing), notes: Other medical history, SSS. The patient's concomitant medications were not reported. Past drug history included: Mobic, reaction(s): "Known allergies mobic", notes: Known allergies mobic; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if patient received other medication in 2 weeks.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 17Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "None known" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 3 days after negative test adverse_event; Positive, notes: COVID 19 Treatment.Covid rebound 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This report is about covid treatment and reported by patient. Patient is not Pregnant and received vaccine. Other medication was not received in 2weeks. Patient received Paxlovid product as anti-viral and indicated for COVID 19 Treatment, treatment started on 13Oct2022 and ended on 18Oct2022. Also, patient received covid vaccine in Left arm and dose number 5 on 17Sep2022 at 01:00 PM. Adverse event was reported as Covid rebound 3 days after negative test. Adverse event started on 23Oct2022 at time: 03:00 PM and patient is recovering. There was no treatment adverse event, none known allergies None and other medical history was none known.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). 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 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Sep2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2, single (Lot number: 32030BD), in right arm for covid-19 immunisation.  The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: 13 yrs ago took tetanus, reaction(s): "Allergy: tetanus", notes: 13 yrs ago took tetanus; Whooping cough shot mix. it reduced my mobility, reaction(s): "reduced my mobility", notes: whooping cough shot mix. It reduced my mobility; Whooping cough shot mix. it reduced my mobility, reaction(s): "Allergy", notes: whooping cough shot mix. It reduced my mobility. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 30155BA, Location of injection: Arm Right), administration date: 03Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: DYSPNOEA (disability), outcome "not recovered", described as "shortness of breath". The event "shortness of breath" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Agency. Therapeutic measures were not taken as a result of dyspnoea. Additional information: No illness other than vaccine reactions. Dose #2 - Vaccine administered at Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks, 5 different Irregular Breathing Issues - My cardiologist classifies it as shortness of breath. The issue started in my sleep the night of my first dose. Each week I experience the issue. It slowly spread throughout the day by Jan. I waited until Jan for the issues to resolve. Since it grew worse I went to visit with my doctor. Since then I've undergone a vast amount of tests with specialist on every level at least 2-3 times a month. Specialist visits includes, Cardiology, Sleep Specialist, Allergist, Neurologist, Pulmonary Medicine, etc. Cardiology/Neurology just confirmed it's vaccine related. No Covid prior vaccination.
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received COVID-19 treatment of Paxlovid from 15Oct2022 to 20Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, 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 (Consumer). The reporter is the patient. A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 19:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing). The patient took concomitant medications. Patient had received other medications in two weeks: Dietary supplements of various brand from 01Jan2022 to 13Oct2022. Patient received Paxlovid from 13Oct2022 to 18Oct2022 for Covid-19 treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Outcome of the events was unknown.   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: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown". 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: Fatigue, Headache
Clinical narrative: normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "normal fatigue", "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown".  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: Pain in extremity, Paraesthesia, Rash macular, Swelling
Clinical narrative: Experienced pins and needles; Swelling; Pain in finger tips; Spots; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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 number unknown (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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Experienced pins and needles"; SWELLING (non-serious), outcome "recovered"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in finger tips"; RASH MACULAR (non-serious), outcome "recovered", described as "Spots".  Additional information: After booster bi valent, experienced pins and needles, swelling, spots, pain in fingertips. All adverse events went away in 2 days.  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: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Skin lesion
Clinical narrative: I had lesions on my body from my neck to my toes; Date 04Jun needed it/ 1st dose date 11Mar2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 2, single (Lot number: EP7533), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. Vaccination history included: BNT162b2 (Dose: 01, Time: Hospital, Anatomical Site of Injection: Arm, Batch/Lot number: EN6207), administration date: 11Mar2021, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Jun2021, outcome "unknown", described as "Date 04Jun needed it/ 1st dose date 11Mar2021"; SKIN LESION (non-serious), outcome "not recovered", described as "I had lesions on my body from my neck to my toes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion.  Additional Information: The patient's life has been destroyed for about 1 year. Had lesions on body from my neck to my toes. Tons of creams burning off, cortisone shots and nothing helps. Just started Dupexent (On 2nd shot). Nothing still happening  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224766 same patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure decreased, Blood pressure measurement, Dizziness, Vaccination site erythema
Clinical narrative: felt like fainting; Blood pressure dropped very low; pain and redness on the injection site; pain and redness on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-027323 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (1st dose (Lot# 011J20A)), administration date: 17Jan2021, for COVID-19 immunization; moderna (2nd dose (lot# 042L20A)), administration date: 19Feb2021, for COVID-19 immunization; moderna (First Booster dose (Lot# 014F21A)), administration date: 21Oct2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt like fainting"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Blood pressure dropped very low"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that after the 2nd primary shot and after the first Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. She also had pain and redness on the injection site. The events were reported non-serious. Prior to the Bivalent vaccine, she had antibody testing done and the result was more than 150. But she did not know what that means. After Bivalent booster (Moderna COVID-19 Vaccine on 19Oct2022 (Lot# 055F22B & MFG Exp. Date 20Oct2022)), she had absolutely no side effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt like fainting; Blood pressure dropped very low; pain and redness on the injection site; pain and redness on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-027323 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (1st dose (Lot# 011J20A)), administration date: 17Jan2021, for COVID-19 immunization; moderna (2nd dose (lot# 042L20A)), administration date: 19Feb2021, for COVID-19 immunization; moderna (First Booster dose (Lot# 014F21A)), administration date: 21Oct2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt like fainting"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Blood pressure dropped very low"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that after the 2nd primary shot and after the first Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. She also had pain and redness on the injection site. The events were reported non-serious. Prior to the Bivalent vaccine, she had antibody testing done and the result was more than 150. But she did not know what that means. After Bivalent booster (Moderna COVID-19 Vaccine on 19Oct2022 (Lot# 055F22B & MFG Exp. Date 20Oct2022)), she had absolutely no side effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 70-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; 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. Patient reported that she and her husband successfully avoided contracting Covid until 15Sep2022 when they both got very sick. While they were taking care of each other and carefully assessing whether or not to take mitigating medication-they both came to the conclusion that without the vaccinations that they both took-they likely would have ended up in the hospital. And that is the purpose of this email. Patient recalled their emotional gratitude when they finally received their first inoculation that was difficult to secure back then. They both were so grateful to have gotten that protection in such a fear-filled time. And now, having gotten very ill this fall after having the first three Pfizer vaccinations and getting to the other side of it, they simply felt how thankful they are for the brilliant scientists at Pfizer for providing them with the protection that enabled them to weather this hideous virus. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Outcome of the events was unknown.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5, BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201250460 Same reporter/vaccine/event, different patients;
Sex: F
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products
Clinical narrative: took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end.; his mother got a little bit sick from it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 01), for COVID-19 Immunization; Moderna (Dose: 02), for COVID-19 Immunization; Moderna (Dose: 03), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end."; ILLNESS (non-serious), outcome "unknown", described as "his mother got a little bit sick from it".  Additional information: The reporter stated that his mother took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end. He stated as well that his mother got a little bit sick from it and he wanted to know if it is normal to have Moderna all three shots and then have a Pfizer Vaccine at the end.  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: Seizure
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset 23Oct2022, outcome "unknown". Clinical course: A patient called in and said she got a primary series of Pfizer covid-19 vaccine and got a Pfizer covid-19 vaccine booster, and she heard on the news that they will start charging on the booster. The caller asked when they would start charging for the booster. The caller also mentioned that she had a seizure last night.  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: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: headache; soreness at injection site; fatigue; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 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 Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 24Oct2022, outcome "unknown"; HEADACHE (non-serious) with onset 24Oct2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2022, outcome "unknown", described as "soreness at injection site".  Additional information: Patient experienced soreness at injection site, fatigue and headache for half a day- 24 hours following Pfizer COVID bivalent booster vaccine on 23Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.