chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypothyroidism, Infection, Metabolic syndrome, Painful respiration
Clinical narrative: Hypothyroidism; Palpitations; Anterior Wall chest Pain with respiration; Anterior Wall chest Pain with respiration; Chronic peripheral venous insufficiency; Metabolic syndrome; Pots; Late effect of infectious disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EL9267) at the age of 53 years, in arm right for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SERTRALINE; ZOLOFT. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EL 9262, Location of injection: Arm Left), administration date: 26Jan2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (disability), PAINFUL RESPIRATION (disability) all with onset 17Feb2021 at 20:00, outcome "not recovered" and all described as "Anterior Wall chest Pain with respiration"; PERIPHERAL VENOUS DISEASE (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Chronic peripheral venous insufficiency"; HYPOTHYROIDISM (disability, medically significant) with onset 17Feb2021 at 20:00, outcome "not recovered"; INFECTION (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Late effect of infectious disease"; METABOLIC SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; PALPITATIONS (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Pots". The events "hypothyroidism", "palpitations", "anterior wall chest pain with respiration", "chronic peripheral venous insufficiency", "metabolic syndrome", "pots" and "late effect of infectious disease" required physician office visit. It was reported that AE resulted in Doctor or Other healthcare professional office/clinic visit, Disability or permanent damage.  Therapeutic measures were not taken as a result of hypothyroidism, palpitations, chest pain, painful respiration, peripheral venous disease, metabolic syndrome, postural orthostatic tachycardia syndrome, infection.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral venous disease, Postural orthostatic tachycardia syndrome
Clinical narrative: Hypothyroidism; Palpitations; Anterior Wall chest Pain with respiration; Anterior Wall chest Pain with respiration; Chronic peripheral venous insufficiency; Metabolic syndrome; Pots; Late effect of infectious disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EL9267) at the age of 53 years, in arm right for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SERTRALINE; ZOLOFT. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EL 9262, Location of injection: Arm Left), administration date: 26Jan2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (disability), PAINFUL RESPIRATION (disability) all with onset 17Feb2021 at 20:00, outcome "not recovered" and all described as "Anterior Wall chest Pain with respiration"; PERIPHERAL VENOUS DISEASE (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Chronic peripheral venous insufficiency"; HYPOTHYROIDISM (disability, medically significant) with onset 17Feb2021 at 20:00, outcome "not recovered"; INFECTION (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Late effect of infectious disease"; METABOLIC SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; PALPITATIONS (disability) with onset 17Feb2021 at 20:00, outcome "not recovered"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 17Feb2021 at 20:00, outcome "not recovered", described as "Pots". The events "hypothyroidism", "palpitations", "anterior wall chest pain with respiration", "chronic peripheral venous insufficiency", "metabolic syndrome", "pots" and "late effect of infectious disease" required physician office visit. It was reported that AE resulted in Doctor or Other healthcare professional office/clinic visit, Disability or permanent damage.  Therapeutic measures were not taken as a result of hypothyroidism, palpitations, chest pain, painful respiration, peripheral venous disease, metabolic syndrome, postural orthostatic tachycardia syndrome, infection.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: En6206), on 01Apr2021 as dose 2, single (Lot number: Enr8733), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Uag13725) and on 20May2022 as dose 4 (booster), single (Lot number: Fnol73), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Sulfa antibiotics; "Thyroid Cancer" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment Paxlovid from 07Aug2023 to 12Aug2023. Patient tested positive for covid.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she does have allergies" (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 Jul2023, outcome "recovered" and all described as "had Covid". Clinical course: Patient only received one bivalent vaccine. Caller said she had covid in Jul2023. She had home tests and tested positive but since she recovered, or she assumed she recovered, with the new variant they say it can seem like had allergies and she did not have allergies so she was nervous to take the test again because she knows she could test positive again since you can possibly test positive up to 90 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) positive, notes: home tests. 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-202300278669 similar report from same reporter/different patient;US-PFIZER INC-202300279140 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she does have allergies" (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 Jul2023, outcome "recovered" and all described as "had Covid". Clinical course: Patient only received one bivalent vaccine. Caller said she had covid in Jul2023. She had home tests and tested positive but since she recovered, or she assumed she recovered, with the new variant they say it can seem like had allergies and she did not have allergies so she was nervous to take the test again because she knows she could test positive again since you can possibly test positive up to 90 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) positive, notes: home tests. 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-202300278669 similar report from same reporter/different patient;US-PFIZER INC-202300279140 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mast cell disorder" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Heating loss" (unspecified if ongoing); "Connective tissues disorder" (unspecified if ongoing); "Known allergies: Fibrin glue" (unspecified if ongoing); "Known allergies: Bees" (unspecified if ongoing); "Known allergies: Wasps, fire ants" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Known allergies: oxycodone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (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 Jul2023, outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: her husband they had covid in Jul. Clinical course: Caller said she and her husband they had covid in Jul and wants to know when they will be able to get the booster vaccine. The caller reported that she and her husband both had Covid in Jul2023 and they read you have to wait 3 months after Covid to get another booster and wanted to check if that was correct. They have had two initial vaccines, 3 boosters and one of those was the bivalent vaccine. She stated they had the Pfizer Covid vaccines- the two initial vaccinations and 3 boosters. The last booster being Oct of last year and that one was bivalent. They have only received one bivalent vaccine, all of them Pfizer Covid vaccines. They had Covid in Jul2023. She stated they have home tests and they tested positive but since they recovered, or she assumed they recovered. Her husband is 64 years old and immunocompromised- He has an upcoming appointment with his doctor and they will see if he is eligible for another booster.      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-202300278629 similar report from same reporter/diff patient;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: She had the same stuff on her feet and her hands/blisters and rashes; She had the same stuff on her feet and her hands/blisters and rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: BLISTER (non-serious), RASH (non-serious), outcome "unknown" and all described as "She had the same stuff on her feet and her hands/blisters and rashes".  Additional information: the patient got her 4th vaccination and she had the same stuff on her feet and her hands as the reporter does (blisters and rashes) and she never had anything on her skin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
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 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 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: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) Positive, notes: initial positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: No other medication in 2 weeks. Treatment included Paxlovid from 04Aug2023 to 09Aug2023.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (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), in Sep2022 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 07Aug2023 to 12Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Aug2023, outcome "unknown", described as "low grade fever". It was unknown if therapeutic measures were taken as a result of pyrexia. Additional information: the patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: the first one I just had real bad arm pain; I could not lift my arm for about 3-4 days; 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), on 28Aug2021 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: MOBILITY DECREASED (non-serious) with onset Aug2021, outcome "recovered", described as "I could not lift my arm for about 3-4 days"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "the first one I just had real bad arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278689 Same product, patient, different event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm, Musculoskeletal stiffness, Rash macular, Skin discolouration
Clinical narrative: two aneurysms; getting little red spots all over her body, especially on her legs, that then turn black and blue; getting little red spots all over her body, especially on her legs, that then turn black and blue; stiffness in her neck; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 completed, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: ANEURYSM (medically significant), outcome "unknown", described as "two aneurysms"; RASH MACULAR (non-serious), SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "getting little red spots all over her body, especially on her legs, that then turn black and blue"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness in her neck". Clinical course was as follows: the patient stated she received the Pfizer COVID 19 purple top vaccine and booster when it first came out. She never had a problem with blood clots or anything before but she has since developed two aneurysms and is getting little red spots all over her body, especially on her legs, that then turn black and blue. She also developed stiffness in her neck and the doctor said it was due to the aneurysm and inquired if aneurysms have been reported as side effects of the vaccine.  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: Dysgeusia, Pollakiuria, Rash
Clinical narrative: rash; metallic taste in my mouth; urinated frequently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown"; DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in my mouth"; POLLAKIURIA (non-serious), outcome "unknown", described as "urinated frequently". Additional information: the patient was in excellent health before taking the vaccine.  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: Drug ineffective, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: Not great reactions; long COVID; Not great reactions; long COVID; Not great reactions; long COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001072 (Novavax).  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Apr2022 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), SUSPECTED COVID-19 (medically significant), POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown" and all described as "Not great reactions; long COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fatigue, dizziness, feverish, headache, redness and sore injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, dizziness, feverish, headache, redness and sore injection site
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardioversion, Heart rate abnormal, SARS-CoV-2 test positive
Clinical narrative: Hospital Course: Patient admitted, and cardioverted in ED. And admitted for remdesivir for asymptomatic COVID. After discussion with Cardiologist and ID, final recommendation was to treat fore 3 day course given immune status.  Patient remains asymptomatic, and heart rate improved after cardioversion. Recommendation per cardiology team on the phone was to start metoprolol xl 25mg daily and can be adjusted outpatient.     BP 124/84  | Pulse 110  | Temp 97.7 °F (36.5 °C)  | Resp 18  | Wt 99.7 kg (219 lb 12.8 oz)  | SpO2 95%  | Breastfeeding No  | BMI 32.46
Age: 73.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Syncope
Clinical narrative: PATIENT GOT HIS 2 SHOTS,- PFZIER COVID 19 BIVALENT AND ABRYSVO (RSV) AFTER A COUPLE OF MINUTES AS HE WAS WALKING OUT HE FAINTED.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt received TwinRix dose for Hep A/Hep B Dose. Pt received 1 dose of Vaqta (Hep A) in 2016 and 2 doses of Engerix B (Hep B) in 2017. Guidelines state the series does not need to be restarted but dose should be administered as soon as possible. Engerix B has same dose of Hep B as Twinrix so they can be interchanged. However, the TwinRix dose of Hep A does not equal the dose in Vaqta. Pt needs to receive a dose of Vaqta to finish her Hep A series. Contacted Merck to receive guidance on when her Hep A dose can be administered. They said she can receive the Vaqta dose as soon as possible even though she received the TwinRix dose 8/17/23.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Bivalent vaccine was administered approx. 16 hours after the discard date of 8/17/2023 @ 23:59pm.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past expiration date. Expiration  date; 03/11/2023; administration date 03/13/2023  Called patient to inform her N/A will continue to reach out.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given fourth dose in the series prematurely after incorrect interpretation of the vaccine chart.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Patient in clinic for 12-month-old Well Child, Provider verified MMR, Varicella and Hepatitis A. Vaccines were administered at 3:57pm. In this order Left subcutaneous (Varicella) Left Vastis Lateralis (Hepatitis A) Right subcutaneous (MMR II). I did not notice any reactions immediately. I stepped out of the room at 4:02pm. I was in the hallway when mom opened the door at 4:03pm and told me she noticed a Hive forming on patient's left subcutaneous area. I immediately informed Provider who ordered and verified vaccines and provider went into room to examine patient at 4:04pm. Doctor informed me it was not an allergic reaction but more so an adverse reaction, patient was not having other symptoms at the moment patient was being examined by MD. Provider prescribed Benadryl. Patient left clinic walking with mother.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Head discomfort, Headache, Influenza A virus test negative
Clinical narrative: Pt had Bivalent Pfizer COVID-19 booster on 8/15/23. Pt was fine after injection. Pt reports the next day she had body aches and arm was sore at injection site. Then on  Thursday-8/16/23 morning- fever, chills, head pressure and headache. Pt felt very faint (Pt feels very close to passing out at times).  Pt feels the symptoms are better throughout the day but worse at night. Pt reports she had a Pfizer booster last time and she had similar symptoms with that booster (symptoms at that time lasted 4-5 days).   BP:90/62
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza B virus test, Injection site pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Pt had Bivalent Pfizer COVID-19 booster on 8/15/23. Pt was fine after injection. Pt reports the next day she had body aches and arm was sore at injection site. Then on  Thursday-8/16/23 morning- fever, chills, head pressure and headache. Pt felt very faint (Pt feels very close to passing out at times).  Pt feels the symptoms are better throughout the day but worse at night. Pt reports she had a Pfizer booster last time and she had similar symptoms with that booster (symptoms at that time lasted 4-5 days).   BP:90/62
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: About 12 hrs later, intense shaking/fever began..   Chills, then fever began at 99.6.  Muscle/joint aches/pain, weakness.  Tiny headache.  Into the next day fever fluctuated between 99.6-100.7.  Painful to move.  Feel rotten.  Still having symptoms 30 hrs later.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Tremor
Clinical narrative: About 12 hrs later, intense shaking/fever began..   Chills, then fever began at 99.6.  Muscle/joint aches/pain, weakness.  Tiny headache.  Into the next day fever fluctuated between 99.6-100.7.  Painful to move.  Feel rotten.  Still having symptoms 30 hrs later.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Anal incontinence, Aphasia, Arthralgia, Autopsy, Blood test
Clinical narrative: 8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray, Chest discomfort, Death, Dyspnoea, Electrocardiogram
Clinical narrative: 8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Heart rate irregular, Hyperaesthesia, Hyperhidrosis, Hypertension
Clinical narrative: 8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Incoherent, Malaise, Myocarditis, Pneumonia, Respiratory arrest
Clinical narrative: 8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Troponin, White blood cell count increased
Clinical narrative: 8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash, Skin swelling, Tenderness
Clinical narrative: BASEBALL SIZED RASH PAINFUL TO TOUCH SLIGHTLY ELEVATED AND RED
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Neck pain, Tremor
Clinical narrative: On day of vaccination, about 3-4 hours later, felt Hot/cold, but no fever. The next day, did not feel herself. Complained of head and hands shaking, neck pain, and headaches. Seen at ER on same day.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after  beyond use date.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml im, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis. The caller reported vaccine administered after temperature excursions. Temperature excursion occurred at 18.3F during a time frame of 1 hour and 5 minutes. No previous temperature excursion were reported.  No additional information provided. No additional adverse events or PQC were reported.