chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement
Clinical narrative: Atrial Fibrillation;  This is a solicited report received from contactable reporter(s) (Pharmacist), Program ID: (165487).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 78 years for Covid-19 immunisation; axitinib (INLYTA, NDC: 00069014501), since 26Oct2021 (ongoing) (Lot number: FP9291, Expiration Date: 31Oct2024) at 3 mg 2x/day, oral for renal cancer. The patient's relevant medical history included: "Hypertension" (ongoing). No known drug allergies.  Concomitant medication(s) included: XARELTO; PREDNISONE; HYDRALAZINE; FOLIC ACID; CARVEDILOL; ISOSORBIDE MONONITRATE; OMEPRAZOLE; DILTIAZEM; KEYTRUDA. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, life threatening) with onset 25Jul2022, outcome "unknown". Patient reported Atrial Fibrillation within hours of having his Pfizer booster dose. Hospitalized for cardioversion then released to home. Reported via VAERS.The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. The action taken for axitinib was dosage not changed. Therapeutic measures were taken as a result of atrial fibrillation.  The reporter's assessment of the causal relationship of "atrial fibrillation" with the suspect product(s) BNT162b2 and axitinib was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, there was not a reasonable possibility that the event Atrial Fibrillation was related to the suspect vaccine (BNT162B29) and the suspect drug axitinib. The event was  more likely consistent with an underlying medical condition.
Age: 0.67
Sex: F
Vaccine: HIBV, IPV
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: a temperature excursion involving IPOL and ACTHIB, both of which were administered twice post excursion with no adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old female patient while receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and had temperature excursion involving ipol and acthib, both of which were administered twice post excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jul-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot V1A121M via intramuscular route in the right thigh as Immunization.  On 20-Jul-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the right thigh as Prophylactic vaccination.Lot number was requested.   On 20-JUL-2022 there was a temperature excursion involving ipol and acthib, both of which were administered twice post excursion with no adverse event (poor quality product administered) same day following the administration of all suspect vaccines. The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction (not human error). This situation was reported as a medication error due to vaccines being administered post excursion  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, UNK
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: DTaP-IPV portion of the pentacel was reconstituted with quadracel, instead of the Hib diluent supplied with no reported adverse event; DTaP-IPV portion of the pentacel was reconstituted with quadracel, instead of the Hib diluent supplied, giving the patient an extra dose of the DTaP-IPV with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and it was reported dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied with no reported adverse event and dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied, giving the patient an extra dose of the dtap-ipv with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 28-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot UJ673AA, expiration date: 27-Apr-2023, via intramuscular route in the left thigh as Immunisation On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number not reported in unknown administration site as Immunization. Lot number was requested.  On 28-JUL-2022 the dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied with no reported adverse event (product preparation error) and dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied, giving the patient an extra dose of the dtap-ipv with no reported adverse event (extra dose administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: liquid portion of pentacel was administered without the hib portion with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who had received vaccineDIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and liquid portion of pentacel was administered without the hib portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination  On 14-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  lot UJ590AAA via intramuscular route in left thigh as immunization.  On 14-JUL-2022 the liquid portion of pentacel was administered without the hib portion with no reported adverse event (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (liquid portion of pentacel was administered without the hib portion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received a dose of menactra at 4 months and 3 days old(with no reported adverse event); Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months 3 days  old female patient who  received a dose of menactra with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 02-Aug-2022, the patient received a dose number 1  of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot U7273BB and expiration date: 24-Apr-2023) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On 02-Aug-2022 (latency: same day) , the patient received a dose of menactra with no reported adverse event (product administered to patient of inappropriate age) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event (received a dose of menactra at 4 months and 3 days old(with no reported adverse event)).  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menactra was administered after expiration with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old male patient to whom MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was administered after expiration with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Aug-2022, the patient received as indicated dose 2 (booster)  of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, (frequency: once) ( lot: U6951AA ; expiry date: 06-Jun-2022) via intramuscular route in the deltoid nos for immunization.  It was reported that Menactra was administered after expiration with no reported adverse event (expired product administered) (latency: same day)    Action taken : Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered Menactra after the expiration date with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) after the expiration date with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none    On 03-Aug-2022, the patient received a  dose 2 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, at dose of 0.5 ml once, ( lot: U6952AA ; expiry date: 09-Jun-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that the patient was administered Menactra after the expiration date with no reported adverse event (expired product administered) (onset date: 03-Aug-2022) (latency: same day)  following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Quadracel was mixed with the Pentacel powder which is the Hib component with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] which was mixed with the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] powder which is the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] (formulation, strength, dose, batch number and expiry date not reported) which was mixed with the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] powder (strength, dose, batch number and expiry date not reported) which is the hib component with no reported adverse event (product preparation error).  It was reported, she states that it is not that they were given together but that the Quadracel was mixed with the Pentacel powder which is the Hib component. She states that it is not a problem because they are both a liquid DTaP-IPV and the "same thing just packaged differently". She states that she is calling to make doubly sure it was reported correctly because she was concerned because it said an "extra dose because it wasn't, it was just given a little differently".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event; the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portionthe liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA320954(CLUSTER).  This case involves a 5 months old female patient who experienced gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event and the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portionthe liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 01-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot U7197BA; expiry date: 28-Jan-2024)  via intramuscular route in the right thigh for prophylactic vaccination.  On 01-AUG-2022 the patient reported gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event (single component of a two-component product administered) and (product preparation error)following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.   Action taken: not applicable.    At time of reporting, the outcome was Unknown for the event (single component of a two-component product administered and product preparation error)     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired healing, Injection site reaction
Clinical narrative: had the vaccine over three years ago and the injection site has never healed; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-AUG-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media.  The patient received the vaccine over three years ago and the injection site has never healed. It was not the potential product quality complaint. Additional Supportive Information: The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an Expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5z3x9, expiry date 3rd July 2022) for prophylaxis.   On 12th July 2022, the patient received Boostrix. On 12th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The reporter works at Department of Health. The healthcare professional reported a patient was administered an expired Boostrix (expiry date: 3rd July 2022) dose. The reporter was unable to provide any patient or additional details.  The reporter denied to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of Menveo diluent only; administration of Menveo diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On 4th August 2022, the patient received Menveo. On 4th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-AUG-2022 Reporter's comment: The Medical Assistant(MA) reported administration of Menveo diluent only and not the lyophilized portion of Menveo. The reporter consented to follow-up. Additional supportive information: The patient was given only the Menveo diluent and not the lyophilized portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Expired Rotarix given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 743NB, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th August 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 4th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient was inadvertently given an expired dose of Rotarix. The reporter consented to follow up from safety. Additional Supportive Information: The patient received Rotarix which was already expired, which led to expired vaccine used.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a patient via other company (Pfizer Inc.) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and drug allergy, and other pre-existing medical conditions included: Patient was pregnant at the time of reporting. The patient was gravida 1 and para 0. The date of the patient's last menstrual period was 02-JUN-2022 and expected delivery date was 10-MAR-2023. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 22-MAR-2021 at 12:00 to right arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 32 years old. On 22-MAR-2021, the patient experienced vaccine exposure before pregnancy (Dose number in series 1). On an unspecified date, the pregnancy resulted in an unknown. The patient received dose 2 with non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 22-NOV-2021 at 12:00 to right arm for covid-19 prophylaxis. Concomitant medications included metformin, and metoprolol.  On 15-JUL-2022, at 19:00, the patient experienced confirmed covid-19 infection (Dose number in series 2), and had confirmed clinical vaccine failure (Dose number in series 1). The symptoms were very mild (sore throat and mild cough). The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 15-JUL-2022 to 19-JUL-2022 for treatment of COVID-19 as per her obstetrician-gynecologist. The symptoms disappeared completely by 18-JUL-2022 and reappeared again from 25-JUL-2022. On 26-JUL-2022, Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000245108.; Sender's Comments: V0:20220806607-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Alopecia, Contusion, Cough, Dark circles under eyes
Clinical narrative: Tiredness, hearing disturbance/loss, alteration of taste, hair loss/thinning, nasal/head congestion, runny nose, cough, eyes swelling with discharge and darkening around eyes-resembling bruising, vision disturbance-blurring- mainly right eye, general miserableness. sore itchy scratchy throat, odd smell in nasal cavity/sinuses.  Exaggeration of my seasonal allergy symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Eye swelling, Fatigue, Feeling abnormal, Hypoacusis
Clinical narrative: Tiredness, hearing disturbance/loss, alteration of taste, hair loss/thinning, nasal/head congestion, runny nose, cough, eyes swelling with discharge and darkening around eyes-resembling bruising, vision disturbance-blurring- mainly right eye, general miserableness. sore itchy scratchy throat, odd smell in nasal cavity/sinuses.  Exaggeration of my seasonal allergy symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Parosmia, Rhinorrhoea, Sinus congestion
Clinical narrative: Tiredness, hearing disturbance/loss, alteration of taste, hair loss/thinning, nasal/head congestion, runny nose, cough, eyes swelling with discharge and darkening around eyes-resembling bruising, vision disturbance-blurring- mainly right eye, general miserableness. sore itchy scratchy throat, odd smell in nasal cavity/sinuses.  Exaggeration of my seasonal allergy symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Throat irritation, Vision blurred, Visual impairment
Clinical narrative: Tiredness, hearing disturbance/loss, alteration of taste, hair loss/thinning, nasal/head congestion, runny nose, cough, eyes swelling with discharge and darkening around eyes-resembling bruising, vision disturbance-blurring- mainly right eye, general miserableness. sore itchy scratchy throat, odd smell in nasal cavity/sinuses.  Exaggeration of my seasonal allergy symptoms.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pruritus, Rhinorrhoea
Clinical narrative: After vaccination, 4th dose:  Runny nose, watery eyes, minor itchiness (feels like small insects on skin)
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: pt developed hives one week after TDAP and MMR vaccine
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypertension, Loss of consciousness
Clinical narrative: Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Hypertension-Severe, Additional Details: Patient (and female he came with) were sitting at the vaccination table. Female said he was feeling lightheaded and getting pale. Intern and pharmacist went out to take blood pressure. Patient was talking to us. Pharmacist suggested he sit on floor with back to wall. At that point, he passed-out. Pharmacist had lead tech call 911, while pharmacist and 2 interns gently lowered him to the floor. At this point he regained consciousness. We placed ice packs on patient and took blood pressure.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Hypertension-Severe, Additional Details: Patient (and female he came with) were sitting at the vaccination table. Female said he was feeling lightheaded and getting pale. Intern and pharmacist went out to take blood pressure. Patient was talking to us. Pharmacist suggested he sit on floor with back to wall. At that point, he passed-out. Pharmacist had lead tech call 911, while pharmacist and 2 interns gently lowered him to the floor. At this point he regained consciousness. We placed ice packs on patient and took blood pressure.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Presyncope
Clinical narrative: Patient had vasovagal episode after vaccination. Patient felt dizzy and weak but never lost consciousness. The episode lasted about 10 seconds. Patient was assisted by elevating head, provided ice pack to the nape of neck and was cooled down with fans. Emergency rescue was contacted but patient refused to have them show up. Rescue canceled called themselves after hearing patient refuse service. Patient recovered fairly quickly and expressed fear of needles after the fact.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity, Hypoaesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt said experiencing difficulty swallowing 10min post injection, consulted mom and decided to give benadryl, administered 37.5mg benadryl, mom also had pt use her inhaler, after about 10 more minutes pt said still having difficulty swallowing and now said also little trouble breathing, numbness in arm, and vision changes. Consulted mom and she said to go ahead and call 911. Monitored pt, did not appear in respiratory distress. EMS arrived minutes later, Pt walked out on own with mom and EMS.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt said experiencing difficulty swallowing 10min post injection, consulted mom and decided to give benadryl, administered 37.5mg benadryl, mom also had pt use her inhaler, after about 10 more minutes pt said still having difficulty swallowing and now said also little trouble breathing, numbness in arm, and vision changes. Consulted mom and she said to go ahead and call 911. Monitored pt, did not appear in respiratory distress. EMS arrived minutes later, Pt walked out on own with mom and EMS.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Flushing, Hyperhidrosis, Inflammation
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Unable to Sleep-Medium, Additional Details: After receiving the Pfizer vaccines, patient's face broke-out in acne-like blemishes. Patient's face is red and inflamed. She went to the dermatologist. They diagnosed her with dermatitis.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Unable to Sleep-Medium, Additional Details: After receiving the Pfizer vaccines, patient's face broke-out in acne-like blemishes. Patient's face is red and inflamed. She went to the dermatologist. They diagnosed her with dermatitis.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Dermatitis, Erythema, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Flushed/Sweating-Severe, Additional Details: After receiving the Pfizer vaccines, patient's face broke-out in acne like blemishes. Patient's face is red and inflamed. He went to the dermatologist. They diagnosed him with dermatitis.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Flushed/Sweating-Severe, Additional Details: After receiving the Pfizer vaccines, patient's face broke-out in acne like blemishes. Patient's face is red and inflamed. He went to the dermatologist. They diagnosed him with dermatitis.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Small amount of redness at injection site ~1cm 12hrs Later, then 16 hrs  after injection, 5mm x 5mm area of redness, warmth and mildly tender
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest pain
Clinical narrative: The patient is a 79 y male presenting to the ED via EMS with complaints of shortness of breath for the past week that has worsened today. EMS report the patient was 72% on room air and they placed him on a nonrebreather. He reports a productive cough with chest pain. He denies any radiation of his chest pain to his arm or back. The patient reports previously smoking 3-4 cigarettes daily.  Patient was diagnosed by infectious disease specialist with pneumonia due to COVID-19 with elevated CRP.  Patient's D-dimers are elevated.  Patient's procalcitonin is also elevated.  Patient continues to be very weak lethargic and fatigued as.  Patient continues to have respiratory distress and insufficiency. , placed in isolation. ID consulted and started on IV abx , cefepime, micafungin, and solu medrol, he was also receiving supplemental oxygen, on nasal cannula 6L 1/18 weaned down to 4L NC 1/20.. Pt stable and will be discharged back to AFC.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fibrin D dimer increased, Lethargy, Procalcitonin increased
Clinical narrative: The patient is a 79 y male presenting to the ED via EMS with complaints of shortness of breath for the past week that has worsened today. EMS report the patient was 72% on room air and they placed him on a nonrebreather. He reports a productive cough with chest pain. He denies any radiation of his chest pain to his arm or back. The patient reports previously smoking 3-4 cigarettes daily.  Patient was diagnosed by infectious disease specialist with pneumonia due to COVID-19 with elevated CRP.  Patient's D-dimers are elevated.  Patient's procalcitonin is also elevated.  Patient continues to be very weak lethargic and fatigued as.  Patient continues to have respiratory distress and insufficiency. , placed in isolation. ID consulted and started on IV abx , cefepime, micafungin, and solu medrol, he was also receiving supplemental oxygen, on nasal cannula 6L 1/18 weaned down to 4L NC 1/20.. Pt stable and will be discharged back to AFC.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Respiratory distress, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: The patient is a 79 y male presenting to the ED via EMS with complaints of shortness of breath for the past week that has worsened today. EMS report the patient was 72% on room air and they placed him on a nonrebreather. He reports a productive cough with chest pain. He denies any radiation of his chest pain to his arm or back. The patient reports previously smoking 3-4 cigarettes daily.  Patient was diagnosed by infectious disease specialist with pneumonia due to COVID-19 with elevated CRP.  Patient's D-dimers are elevated.  Patient's procalcitonin is also elevated.  Patient continues to be very weak lethargic and fatigued as.  Patient continues to have respiratory distress and insufficiency. , placed in isolation. ID consulted and started on IV abx , cefepime, micafungin, and solu medrol, he was also receiving supplemental oxygen, on nasal cannula 6L 1/18 weaned down to 4L NC 1/20.. Pt stable and will be discharged back to AFC.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Loss of consciousness, Oxygen saturation decreased
Clinical narrative: During visit patient signed consent form denying any prior reaction or issue with any vaccine. Vaccine administered at 16:30. At approximately 16:45 provider was packing up things to leave and patient states she needs to call her neighbor because she was feeling like she was going to faint. She then got diaphoretic and clammy with ashen appearance. At approximately 16:49 patient became unconscious yet still breathing. O2 sats dropped to 66%. 911 contacted by provider. At 16:50 patient received 0.3mg epinephrine and 16:55 received 50mg diphenhydramine. Patient was in and out of consciousness after receiving medication. Paramedics arrived at 17:05 and patient had regained full consciousness by that time. She was then taken to the nearest hospital for further evaluation.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: During visit patient signed consent form denying any prior reaction or issue with any vaccine. Vaccine administered at 16:30. At approximately 16:45 provider was packing up things to leave and patient states she needs to call her neighbor because she was feeling like she was going to faint. She then got diaphoretic and clammy with ashen appearance. At approximately 16:49 patient became unconscious yet still breathing. O2 sats dropped to 66%. 911 contacted by provider. At 16:50 patient received 0.3mg epinephrine and 16:55 received 50mg diphenhydramine. Patient was in and out of consciousness after receiving medication. Paramedics arrived at 17:05 and patient had regained full consciousness by that time. She was then taken to the nearest hospital for further evaluation.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, admitted and vaccinated
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Softball size bump where shot was given
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase increased, Arteriogram coronary abnormal, Aspartate aminotransferase increased
Clinical narrative: Pt presented to the ED on 1/10 with CC of abdominal pain. Pt was seen in ED a month ago for similar abd pain and had CTA that showed endovascular leak.  Pt was discharged home at that point.     Pt having RUQ pain radiating to his back.  Pain is sharp, stabbing.  He reported it was the worse pain he ever had.  Has had cholecystectomy in 5/2020. He reported some N/V with this.   In ED pt with VS of temp of 98, heart rate 69, respiration rate 18, blood pressure 132/72, and sats 97% on room air.  Labs with hemoglobin low at 12.4, albumin low at 3.0, direct bilirubin elevated at 3.0, total bilirubin elevated at 3.6 alk-phos elevated at 292, AST elevated at 251, ALT elevated at 420, lipase of 36, lactate is 0.7, CRP elevated at 6.67, iron level low at 32, serum ethanol level less than 3, UA negative, COVID-19 PCR positive . Ultrasound abdomen was negative.  MRCP with no evidence of biliary obstruction or compelling evidence of hepatic parenchymal disease.  A left simple renal cysts noted.   Pt was placed in observation.  He got 1 L of normal saline, thiamine IV, Solu-Medrol IV, Dilaudid IV, and IV benadryl.  GI was consulted and ordered MRCP that was negative for any choledocholithiasis.   Recommended follow up in 2-4 weeks to discuss endoscopy.  Felt abdominal pain may be related to COVID as well.   As COVID 19 test came back positive pt was admitted for further workup. Troponin x 3 negative. CXR with no acute process.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bilirubin conjugated increased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased
Clinical narrative: Pt presented to the ED on 1/10 with CC of abdominal pain. Pt was seen in ED a month ago for similar abd pain and had CTA that showed endovascular leak.  Pt was discharged home at that point.     Pt having RUQ pain radiating to his back.  Pain is sharp, stabbing.  He reported it was the worse pain he ever had.  Has had cholecystectomy in 5/2020. He reported some N/V with this.   In ED pt with VS of temp of 98, heart rate 69, respiration rate 18, blood pressure 132/72, and sats 97% on room air.  Labs with hemoglobin low at 12.4, albumin low at 3.0, direct bilirubin elevated at 3.0, total bilirubin elevated at 3.6 alk-phos elevated at 292, AST elevated at 251, ALT elevated at 420, lipase of 36, lactate is 0.7, CRP elevated at 6.67, iron level low at 32, serum ethanol level less than 3, UA negative, COVID-19 PCR positive . Ultrasound abdomen was negative.  MRCP with no evidence of biliary obstruction or compelling evidence of hepatic parenchymal disease.  A left simple renal cysts noted.   Pt was placed in observation.  He got 1 L of normal saline, thiamine IV, Solu-Medrol IV, Dilaudid IV, and IV benadryl.  GI was consulted and ordered MRCP that was negative for any choledocholithiasis.   Recommended follow up in 2-4 weeks to discuss endoscopy.  Felt abdominal pain may be related to COVID as well.   As COVID 19 test came back positive pt was admitted for further workup. Troponin x 3 negative. CXR with no acute process.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood ethanol, Blood iron decreased, Blood lactic acid, C-reactive protein increased, COVID-19
Clinical narrative: Pt presented to the ED on 1/10 with CC of abdominal pain. Pt was seen in ED a month ago for similar abd pain and had CTA that showed endovascular leak.  Pt was discharged home at that point.     Pt having RUQ pain radiating to his back.  Pain is sharp, stabbing.  He reported it was the worse pain he ever had.  Has had cholecystectomy in 5/2020. He reported some N/V with this.   In ED pt with VS of temp of 98, heart rate 69, respiration rate 18, blood pressure 132/72, and sats 97% on room air.  Labs with hemoglobin low at 12.4, albumin low at 3.0, direct bilirubin elevated at 3.0, total bilirubin elevated at 3.6 alk-phos elevated at 292, AST elevated at 251, ALT elevated at 420, lipase of 36, lactate is 0.7, CRP elevated at 6.67, iron level low at 32, serum ethanol level less than 3, UA negative, COVID-19 PCR positive . Ultrasound abdomen was negative.  MRCP with no evidence of biliary obstruction or compelling evidence of hepatic parenchymal disease.  A left simple renal cysts noted.   Pt was placed in observation.  He got 1 L of normal saline, thiamine IV, Solu-Medrol IV, Dilaudid IV, and IV benadryl.  GI was consulted and ordered MRCP that was negative for any choledocholithiasis.   Recommended follow up in 2-4 weeks to discuss endoscopy.  Felt abdominal pain may be related to COVID as well.   As COVID 19 test came back positive pt was admitted for further workup. Troponin x 3 negative. CXR with no acute process.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Haemoglobin decreased, Laboratory test, Lipase normal, Magnetic resonance cholangiopancreatography
Clinical narrative: Pt presented to the ED on 1/10 with CC of abdominal pain. Pt was seen in ED a month ago for similar abd pain and had CTA that showed endovascular leak.  Pt was discharged home at that point.     Pt having RUQ pain radiating to his back.  Pain is sharp, stabbing.  He reported it was the worse pain he ever had.  Has had cholecystectomy in 5/2020. He reported some N/V with this.   In ED pt with VS of temp of 98, heart rate 69, respiration rate 18, blood pressure 132/72, and sats 97% on room air.  Labs with hemoglobin low at 12.4, albumin low at 3.0, direct bilirubin elevated at 3.0, total bilirubin elevated at 3.6 alk-phos elevated at 292, AST elevated at 251, ALT elevated at 420, lipase of 36, lactate is 0.7, CRP elevated at 6.67, iron level low at 32, serum ethanol level less than 3, UA negative, COVID-19 PCR positive . Ultrasound abdomen was negative.  MRCP with no evidence of biliary obstruction or compelling evidence of hepatic parenchymal disease.  A left simple renal cysts noted.   Pt was placed in observation.  He got 1 L of normal saline, thiamine IV, Solu-Medrol IV, Dilaudid IV, and IV benadryl.  GI was consulted and ordered MRCP that was negative for any choledocholithiasis.   Recommended follow up in 2-4 weeks to discuss endoscopy.  Felt abdominal pain may be related to COVID as well.   As COVID 19 test came back positive pt was admitted for further workup. Troponin x 3 negative. CXR with no acute process.