chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypertension" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; METOPROLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: I began treatment same day as positive test result. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 76-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "PVC arrythmia" (unspecified if ongoing), notes: other medical history: PVC arrythmia; "several food" (unspecified if ongoing), notes: known allergies: several food; "seasonal allergies" (unspecified if ongoing); "vaccine dose number:unknown Johnson and Johnson, vaccine dose number:unknown Pfizer" (unspecified if ongoing), notes: vaccine dose number: unknown Johnson and Johnson, vaccine dose number: unknown Pfizer. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other medication Paxlovid in 2 weeks for COVID 19 Treatment. Treatment start date was reported as 06May2022 and stop date was 07May2022 and lot number included FY6859. Reported Event was Allergic reaction. itching swelling in mouth and throat, and asthma like breathing problems. stopped taking after 2 doses. Reaction began 16 hours after first dose. Adverse event start date was 07May2022, 12:00 AM and it was reported that AE resulted in none of the above if patient recovered and adverse event recovered on 08May2022. Treatment received for the adverse event was Benadryl, Alburterol, PepsideAC and Zertec. Device Date was 09May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; sinuse tightness; I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines; I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "low thyroid" (unspecified if ongoing), notes: other medical history: low thyroid; "high cholesterol" (unspecified if ongoing), notes: stopped pravastatin for 6 days. There were no concomitant medications. The following information was reported: RHINORRHOEA (non-serious) with onset Apr2022, outcome "recovering", described as "runny nose"; PARANASAL SINUS DISCOMFORT (non-serious) with onset Apr2022, outcome "recovering", described as "sinuse tightness"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: faint positive; (01May2022) Negative; (05May2022) Negative; (09May2022) Positive, notes: faint positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included treatment for COVID-19 with Paxlovid (lot number fw6343) from 26Apr2022 to 01May2022. On the evening of 08May2022 runny nose began again. This seems beyond the 9 days from onset of symptoms suggested for rebound, and beyond the 2 days post Paxlovid. No other medications the patient received within 2 weeks of vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:00 as dose 1, single (Lot number: EP6955), in left arm, on 03Apr2021 at 13:00 as dose 2, single (Lot number: ER8729), in left arm and on 11Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "genetic hypertrophic cardiomyopathy" (unspecified if ongoing), notes: (take Verapamil for it); "dry eye (Restasis)" (unspecified if ongoing), notes: dry eye (Restasis); "hysterectomy" (unspecified if ongoing), notes: total hysterectomy at age 45 due to fibroids on HRT (Vivelle) for early menopause; "menopause" (unspecified if ongoing), notes: total hysterectomy at age 45 due to fibroids on HRT (Vivelle) for early menopause. Concomitant medication(s) included: VERAPAMIL; VIVELLE [ESTRADIOL]; RESTASIS; FISH OIL Multi-vitamin, turmeric. The following information was reported: PYREXIA (non-serious) with onset 01Apr2022, outcome "recovered" (Apr2022), described as "having a fever"; COUGH (non-serious) with onset Apr2022, outcome "recovered" (15Apr2022), described as "Bad cough"; COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "diagnosed with Covid". The events "diagnosed with covid" and "having a fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative, notes: a week later. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia. Therapeutic measures were not taken as a result of cough included Paxlovid.
Age: 76.0
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 76-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fj9943) at the age of 76 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Known allergies mo, reaction(s): "Known allergies Mo", notes: Known allergies Mo. The following information was reported: COVID-19 (medically significant) with onset 06May2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment received included Amici Clav857.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus, Vulval disorder
Clinical narrative: had vulvar issues and lesions; was diagnosed by biopsy as lichen planus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm and on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: VULVAL DISORDER (non-serious), outcome "unknown", described as "had vulvar issues and lesions"; LICHEN PLANUS (non-serious), outcome "unknown", described as "was diagnosed by biopsy as lichen planus". The event "was diagnosed by biopsy as lichen planus" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: multivitamins, albuterol inhaler prn. Reported Event: I had vulvar issues and lesions which was diagnosed by biopsy as lichen planus, which had flare up after booster. After booster, I had oral lesions also for which I have seen my dentist and still getting workup for lichen planus. Due for my second booster, but worried about flare up. Have seen many case reports regarding this and want to report it. Hospitalization Prolonged: No. Known allergies: No. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. What treatment received for the adverse event? steroids topical, tacrolimus topical, dental visit. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Catheterisation cardiac, Computerised tomogram, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: heart started in CHF from the first two shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm and on 30Mar2021 as dose 2, single (Lot number: ER8732) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; VENLAFAXINE; RESTASIS.  The following information was reported: CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant, life threatening) with onset Mar2021, outcome "recovering", described as "heart started in CHF from the first two shots". The event "heart started in chf from the first two shots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: (unspecified date) normal; Computerised tomogram: (unspecified date) my lungs were filled with fluid; Magnetic resonance imaging: (unspecified date) scarring of the heart; SARS-CoV-2 test: (08Oct2021) Negative, notes: Nasal Swab; Ultrasound scan: (unspecified date) Severe congestive heart, notes: next day; (2019) my heart was normal, notes: I have no risk factors for the CHF. Therapeutic measures were taken as a result of cardiac failure congestive. Clinical course: Patient was a avid cyclist and noticed all last summer her cardio endurance was not very good- think her heart started in CHF from the first two shots.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: heart started in CHF from the first two shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm and on 30Mar2021 as dose 2, single (Lot number: ER8732) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; VENLAFAXINE; RESTASIS.  The following information was reported: CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant, life threatening) with onset Mar2021, outcome "recovering", described as "heart started in CHF from the first two shots". The event "heart started in chf from the first two shots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: (unspecified date) normal; Computerised tomogram: (unspecified date) my lungs were filled with fluid; Magnetic resonance imaging: (unspecified date) scarring of the heart; SARS-CoV-2 test: (08Oct2021) Negative, notes: Nasal Swab; Ultrasound scan: (unspecified date) Severe congestive heart, notes: next day; (2019) my heart was normal, notes: I have no risk factors for the CHF. Therapeutic measures were taken as a result of cardiac failure congestive. Clinical course: Patient was a avid cyclist and noticed all last summer her cardio endurance was not very good- think her heart started in CHF from the first two shots.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: This spontaneous case from was retrieved on 02-May-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2238063-1), reported by other non-healthcare professional (consumer) and concerned a 47-year-old, male patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 23-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as one, route of administration: injection (SYR), anatomical location: right arm and indication:not reported). The batch number reported was 308433.  On the same day, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as three, route of administration: injection (SYR), anatomical location: left arm and indication: not reported). The batch number reported was FJ1620.  On an unspecified date, reported as around December, an unknown amount of time after receiving Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine, the patient noticed tinnitus in both ears got louder, with ringing louder than it used to be.   On 11-Jan-2022, the patient went to audiologist, where the acoustic stimulation tests were performed and resulted in no identified issues, results of hearing test were normal.  At the time of initial reporting, the patient had not recovered from the event 'tinnitus'.  The reporter did not provide a causality assessment. The reporter was not sure that it was a result of the vaccine, but after reading an article on this possibility, thought to report this.   The case was assessed as non-serious.  Company comment: A 47-year-old male patient developed tinnitus after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccines. The acoustic stimulation tests and hearing test were normal. Elapsed time between vaccinations and the onset of the event is unknown. Due to lack of information, causality is unassessable. Sender's Comments: A 47-year-old male patient developed tinnitus after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccines. The acoustic stimulation tests and hearing test were normal. Elapsed time between vaccinations and the onset of the event is unknown. Due to lack of information, causality is unassessable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Injection site pain, Nausea
Clinical narrative: On 5/10, I developed body aches, chills, nausea, headache, and injection site soreness. I was over those symptoms by 5/11.  On 5/11 I developed armpit soreness and swelling, which I still have today on 5/12.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain
Clinical narrative: On 5/10, I developed body aches, chills, nausea, headache, and injection site soreness. I was over those symptoms by 5/11.  On 5/11 I developed armpit soreness and swelling, which I still have today on 5/12.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: swelling on wrist-Medium, Additional Details: pt had pain and swelling of arm. She went to a HCF.  We called to see how pt was that evening.  We will follow up with patient again tomorrow am.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dyspnoea, Pain
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 1.5
Sex: M
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: Pt was due to receive peds Hep A #1, pt instead received the ADULT dose of 1mL Havrix. Provider contacted pts mother who denied any local or systemic reactions.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Flushing, Hyperhidrosis, Hypersensitivity, Mouth swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Swelling face, Swollen tongue, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Fatigue, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: he fell several times a day or two after shot. very dizzy still and weak in legs. had to get a walker to help with walking cannot stand long-Severe, Systemic: Weakness-Severe, Additional Details: was trying to get all the info from wife. she said he went to the doctor and he felt it was not because of the shot but it happened like a day after. wife is conccerned. i asked her to get a neurologist to inspect and check for any clots (ie stroke check d-dymer) and any other neurology issues like guillan barre or etc
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Rash, Walking aid user
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: he fell several times a day or two after shot. very dizzy still and weak in legs. had to get a walker to help with walking cannot stand long-Severe, Systemic: Weakness-Severe, Additional Details: was trying to get all the info from wife. she said he went to the doctor and he felt it was not because of the shot but it happened like a day after. wife is conccerned. i asked her to get a neurologist to inspect and check for any clots (ie stroke check d-dymer) and any other neurology issues like guillan barre or etc
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received expired vaccine on 4-13-22.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Dehydration, Dizziness, Electrocardiogram
Clinical narrative: Rapid heart rate (120 bpm) as measured via smart watch. Steady and would not drop - even when at rest. Went to urgent care - blood pressure was elevated. Urgent care sent me to the ER. ER said it was dehydration and gave fluids; heart rate/blood pressure still did not drop. Followed up with primary care on 11/15/22. She prescribed Lisinopril (5 mg/1x day).  Seemed to help. At the end of January/beginning of April, began to feel lightheaded. Went to primary care on 3/2/22 to see if Lisinopril was still needed. Primary care insisted that it was still needed. Bought a home blood pressure machine - blood pressures were low. Went to cardiologist on 3/23/22. He instructed me to stop taking Lisinopril - did not think I had high blood pressure based on visit and my tracked blood pressure. After I stopped Lisinopril, no more light headedness and blood pressure returned to normal. Did a 24 hour Holter Monitor on 4/6/22 - 4/7/22 - no issues.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory normal, Heart rate increased, Hypotension
Clinical narrative: Rapid heart rate (120 bpm) as measured via smart watch. Steady and would not drop - even when at rest. Went to urgent care - blood pressure was elevated. Urgent care sent me to the ER. ER said it was dehydration and gave fluids; heart rate/blood pressure still did not drop. Followed up with primary care on 11/15/22. She prescribed Lisinopril (5 mg/1x day).  Seemed to help. At the end of January/beginning of April, began to feel lightheaded. Went to primary care on 3/2/22 to see if Lisinopril was still needed. Primary care insisted that it was still needed. Bought a home blood pressure machine - blood pressures were low. Went to cardiologist on 3/23/22. He instructed me to stop taking Lisinopril - did not think I had high blood pressure based on visit and my tracked blood pressure. After I stopped Lisinopril, no more light headedness and blood pressure returned to normal. Did a 24 hour Holter Monitor on 4/6/22 - 4/7/22 - no issues.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 5-3-22.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received expired vaccine on 5-3-22.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 5-4-22.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received expired vaccine on 5-4-22.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Computerised tomogram thorax abnormal, Echocardiogram normal, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Narrative: Bilat PEs. Dx 8/30/21 after 5d hx of acute SOB and tachycardia. Sent to ER for eval, chest CT showed submassive bilateral pulmonary emboli. On that day also found to be in Afib, new onset. COVID testing was negative. He had Neg Doppler US of his legs. ECHO did not reveal any cardiac source of thrombus. He has no known personal or FH of coagulopathy. CT on 10/12 showed no acute PE remaining.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: Narrative: Bilat PEs. Dx 8/30/21 after 5d hx of acute SOB and tachycardia. Sent to ER for eval, chest CT showed submassive bilateral pulmonary emboli. On that day also found to be in Afib, new onset. COVID testing was negative. He had Neg Doppler US of his legs. ECHO did not reveal any cardiac source of thrombus. He has no known personal or FH of coagulopathy. CT on 10/12 showed no acute PE remaining.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received expired vaccine on 5-4-22.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 5-3-22.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received expired vaccine on 5-3-22.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough cases
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 5-3-22
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-26-22.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-13-22
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue
Clinical narrative: Generalized weakness fatigue shortness of breath  Treatment: 2 L of oxygen through NC ; Completed Remdesivir and dexamethasone
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: Vaccine leaked from syringe while in contact with patient , contacted Pharmacist and CDC and Glaxosmith who advised to repeat dose at next visit no harm to patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza A virus test positive, Influenza B virus test positive, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chest X-ray normal, Cor pulmonale, Fibrin D dimer increased
Clinical narrative: Acute respiratory failure with hypoxia (H) This patient with no described history of prior lung disease, and no prior supplemental oxygen need, presented from her skilled nursing facility requiring oxygen at 3 L/min per nasal cannula for the treatment of hypoxemia.  Room air saturation is not recorded.  Etiology of hypoxemia is not certain.  She has tested positive for COVID-19 today, which is a possible etiology, though her lung exam is normal and her admission chest x-ray shows no acute infiltrate.  Initial D-dimer is minimally elevated at 0.56.  I think that we may be seen the patient earlier in her COVID-19 disease course, and that her pulmonary disease and chest x-ray may worsen over the next day or two.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Acute respiratory failure with hypoxia (H) This patient with no described history of prior lung disease, and no prior supplemental oxygen need, presented from her skilled nursing facility requiring oxygen at 3 L/min per nasal cannula for the treatment of hypoxemia.  Room air saturation is not recorded.  Etiology of hypoxemia is not certain.  She has tested positive for COVID-19 today, which is a possible etiology, though her lung exam is normal and her admission chest x-ray shows no acute infiltrate.  Initial D-dimer is minimally elevated at 0.56.  I think that we may be seen the patient earlier in her COVID-19 disease course, and that her pulmonary disease and chest x-ray may worsen over the next day or two.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Discomfort, Dizziness, Ear discomfort
Clinical narrative: I registered and attended the Covid vaccinations at a facility in the spring of 2021. I also responded to all of the texts received by V-safe. On at least one response date (unknown) I included that I was experiencing ringing  and  high pitched hissing in the ears. It did not get worse until the beginning of 2022. I have experienced ringing in both ears increasingly since Early 2022. I saw my specialist at the end of February 2022 due to the fact that I was having hearing difficulty in the workplace with people wearing masks and the increasing tinnitus in both ears. I thought this was very odd to experience ringing in my right ear considering its nearly deaf and I Haven't had any issues with it since I was a young child.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Tinnitus
Clinical narrative: I registered and attended the Covid vaccinations at a facility in the spring of 2021. I also responded to all of the texts received by V-safe. On at least one response date (unknown) I included that I was experiencing ringing  and  high pitched hissing in the ears. It did not get worse until the beginning of 2022. I have experienced ringing in both ears increasingly since Early 2022. I saw my specialist at the end of February 2022 due to the fact that I was having hearing difficulty in the workplace with people wearing masks and the increasing tinnitus in both ears. I thought this was very odd to experience ringing in my right ear considering its nearly deaf and I Haven't had any issues with it since I was a young child.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vomiting
Clinical narrative: vomiting, positive COVID
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-13-22
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-12-22
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Patient presented with cough and shortness of breath. The patient was given steroids and remdesivir and was in the hospital for 2 days
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-12-22
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Dizziness, Lethargy
Clinical narrative: Starting the evening after the vaccination, I experienced malaise, low grade fever (100.2),myalgias and arthralgias that lasted 3 days. The morning after the vaccination, I developed a mild rash on my chest  as well as a small ( approx 2 cm ) lymph node in my left axilla ( I received the injection into the left deltoid muscle ) that was tender to palpation.  The rash resolved in 2 days and the node resolved in 5 days. Over the following 2 weeks I experienced episodes intense sharp left sided chest pain. The episodes were sporadic and of acute onset usually lasting 3 - 5 seconds. I did not experience dyspnea but did feel dizzy. Two weeks post injection , i developed profound lethargy and weakness lasting 3-4 weeks. Always worse in the afternoon I felt the need to sleep  taking frequent naps
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: Starting the evening after the vaccination, I experienced malaise, low grade fever (100.2),myalgias and arthralgias that lasted 3 days. The morning after the vaccination, I developed a mild rash on my chest  as well as a small ( approx 2 cm ) lymph node in my left axilla ( I received the injection into the left deltoid muscle ) that was tender to palpation.  The rash resolved in 2 days and the node resolved in 5 days. Over the following 2 weeks I experienced episodes intense sharp left sided chest pain. The episodes were sporadic and of acute onset usually lasting 3 - 5 seconds. I did not experience dyspnea but did feel dizzy. Two weeks post injection , i developed profound lethargy and weakness lasting 3-4 weeks. Always worse in the afternoon I felt the need to sleep  taking frequent naps
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Somnolence
Clinical narrative: Starting the evening after the vaccination, I experienced malaise, low grade fever (100.2),myalgias and arthralgias that lasted 3 days. The morning after the vaccination, I developed a mild rash on my chest  as well as a small ( approx 2 cm ) lymph node in my left axilla ( I received the injection into the left deltoid muscle ) that was tender to palpation.  The rash resolved in 2 days and the node resolved in 5 days. Over the following 2 weeks I experienced episodes intense sharp left sided chest pain. The episodes were sporadic and of acute onset usually lasting 3 - 5 seconds. I did not experience dyspnea but did feel dizzy. Two weeks post injection , i developed profound lethargy and weakness lasting 3-4 weeks. Always worse in the afternoon I felt the need to sleep  taking frequent naps
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-6-22
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1  4/16/21  Moderna 002C21A dose 2  5/14/21  Moderna 005C21A
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-12-22
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-20-22
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer 2/8/22, 3/3/22. Positive on 5/10/22
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bed sharing, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer 2/8/22, 3/3/22. Positive on 5/10/22
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-27-22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-27-22
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID, weakness
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired vaccine on 4-20-22
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Electromyogram normal, Head discomfort, Hypoaesthesia
Clinical narrative: Terrible nerve pain throughout body.  1. Tingling in head and extreme pressure in head. 2. Tingling/Numbness throughout body (including hands) 3. Internal tremors  4. Burning Feet/Legs
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal, Nerve conduction studies normal, Nerve injury, Neuralgia
Clinical narrative: Terrible nerve pain throughout body.  1. Tingling in head and extreme pressure in head. 2. Tingling/Numbness throughout body (including hands) 3. Internal tremors  4. Burning Feet/Legs
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Tremor
Clinical narrative: Terrible nerve pain throughout body.  1. Tingling in head and extreme pressure in head. 2. Tingling/Numbness throughout body (including hands) 3. Internal tremors  4. Burning Feet/Legs
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna on 4-19-22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complained of pain in her R arm.  After one week pain moved to her shoulder blades.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Nausea, Pyrexia, Vomiting
Clinical narrative: Presents with fever and nausea and vomiting. She was given sotrovimab.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Malaise, Pyrexia, Somnolence
Clinical narrative: On April 18, 2022 I started to have covid like symptoms, very slights chills and a elevated fever 99.4, and very sleepy.  I the symptoms were so slight that I waited around for a few days and I saw an advertisement for Paxlouvid. So I called my doctor, and she stated that I was pass the 5 day window for my symptoms and prescribe me Paxlouvid. I took the Paxlouvid for five days and it really helped me get over covid.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna on 4-19-22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna on 4-19-22
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna on 4-19-22
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Muscle spasms, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I had a runny nose & a sore throat & then I started having chest coughs & then I had to go to ER my muscles were having spasms & i had to go to ER twice because I tested positive for Covid-19
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a runny nose & a sore throat & then I started having chest coughs & then I had to go to ER my muscles were having spasms & i had to go to ER twice because I tested positive for Covid-19
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Improper storage of vaccine, deemed non-viable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna vaccine on 4-20-22
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: I was exposed to COVID. I started getting symptoms of sore throat. I had a positive COVID-19 test. Then my symptoms progressed to congestion, tiredness, and low grade fever. I had an O2 meter that at the lowest was 92. I was having tightness in my chest. I also have a cough as well. I called my doctor and was prescribed Paxlovid. I do have a telehealth visit tomorrow due to the tightness in my chest.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I was exposed to COVID. I started getting symptoms of sore throat. I had a positive COVID-19 test. Then my symptoms progressed to congestion, tiredness, and low grade fever. I had an O2 meter that at the lowest was 92. I was having tightness in my chest. I also have a cough as well. I called my doctor and was prescribed Paxlovid. I do have a telehealth visit tomorrow due to the tightness in my chest.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Photopsia, Visual impairment, Vitreous detachment, Vitreous floaters
Clinical narrative: I had problems in my right eye and it was diagnosed as posterior vitreous detachment. I was having a lot flashing in my eye, sever vision change, and a lot of floaters. I am still dealing with this at this time.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna vaccine on 4-12-22
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received expired moderna vaccine on 4-13-22
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, severe body ache, chills. Did not go to the doctor. Symptoms lasted 2 days.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Nasopharyngitis, Pain, Photopsia
Clinical narrative: I had problems in my left eye and it was diagnosed as posterior vitreous detachment. I was having flashing in my eye and a lot of floaters. I ended up testing positive for Covid  after my 3rd dose on 01/03/2022. I had cold symptoms, slight fever, congestion, back pain, achiness. I had the same thing happen to my right eye after the second dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Retinogram, SARS-CoV-2 test positive, Vitreous detachment
Clinical narrative: I had problems in my left eye and it was diagnosed as posterior vitreous detachment. I was having flashing in my eye and a lot of floaters. I ended up testing positive for Covid  after my 3rd dose on 01/03/2022. I had cold symptoms, slight fever, congestion, back pain, achiness. I had the same thing happen to my right eye after the second dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: I had problems in my left eye and it was diagnosed as posterior vitreous detachment. I was having flashing in my eye and a lot of floaters. I ended up testing positive for Covid  after my 3rd dose on 01/03/2022. I had cold symptoms, slight fever, congestion, back pain, achiness. I had the same thing happen to my right eye after the second dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypersomnia, Mobility decreased, Pain in extremity
Clinical narrative: I felt chills although I did not have a fever. I went to bed with chills and no energy and slept for almost 24 hours. I called my doctor to keep her informed. She advised me to come in if symptoms persisted. I also had the expected arm soreness, but the lack of energy was strong. I just could not get out of bed. The next day though, I was able to get out of bed by mid day to eat and move around. After receiving my first dose of Moderna, I began to experience a ringing in my ears that has persisted ever since. I have spoken to my doctor about the ear ringing and am currently being treated for it.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I felt chills although I did not have a fever. I went to bed with chills and no energy and slept for almost 24 hours. I called my doctor to keep her informed. She advised me to come in if symptoms persisted. I also had the expected arm soreness, but the lack of energy was strong. I just could not get out of bed. The next day though, I was able to get out of bed by mid day to eat and move around. After receiving my first dose of Moderna, I began to experience a ringing in my ears that has persisted ever since. I have spoken to my doctor about the ear ringing and am currently being treated for it.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Joint swelling, Lip swelling
Clinical narrative: Arm and shoulder swelling, rash down back congestion, fever lips swollen and struggling to breathe, possible viral illness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Arm and shoulder swelling, rash down back congestion, fever lips swollen and struggling to breathe, possible viral illness
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Development of maculopapular rash present on  medial thighs and abdomen. Nonpruritic and nonpainful. Developed 9 days following vaccine administration.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to the vaccine. The vaccine is administered, after the deadline of April 1, 2022. Vaccine is not expired.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: My arm started to itch within 1/2 hour. The site became hot and red within 5 hours. The redness and swelling was the size of the palm of my hand withing 8 hours. Site is red, hot, and itchy and swollen.  I have taken loratadine which doesn't seem to help much. I've put ice on the site which gave temporary relief.  On day 3 (today) swelling is slightly down but site remains hot and itchy and area of reaction is same size.