chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion of punctured IPOL was 8.7C for 10 minutes due to unknown causes and administered with no reported adverse event; temperature excursion of punctured IPOL was 8.7C for 10 minutes due to unknown causes and administered with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid non-serious case received from a health professional. GMI Inquiry Number: 01281017  This case involves a 6-year-old female patient to whom post-excursion administration after temperature excursion of punctured IPV (VERO) [IPOL] was 8.7c for 10 minutes due to unknown causes and administered 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 onset, it was reported that temperature excursion of punctured ipol was 8.7c for 10 minutes due to unknown causes with no reported adverse event (product storage error).  On 19-Aug-2022, the patient was administered punctured IPOL post-excursion at dose 0.5ml once via intramuscular route in the left thigh (lot: T1E872M, expiry date: 10-Oct-2022) for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  This situation is reported as a medication error due to administration post excursion and temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.    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: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who experienced medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 15-Sep-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE once ( lot UJ583AB; expiry date: 15-Oct-2022) via unknown route in unknown administration site for immunization.  On 15-SEP-2022 the patient reported a non-serious event medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event extra dose administered.   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: 20.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administer the High Dose 65+ vaccine to someone 20 years old with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received  via consumer/non-hcp on 15-Sep-2022. Agency number: 01281079  This case involves a 20-year-old and unknown gender patient to whom Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] the high dose 65+ vaccine was administered 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 20-year-old patient was administered suspect the high dose 65+ vaccine at (formulation, strength, dose, route, lot number, administration site) for prophylactic vaccination with no reported adverse event (wrong product administered).  Action taken: Not applicable.  At time of reporting, the outcome was Not Recovered.     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: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue
Clinical narrative: immunization techs gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 75 years old female patient and reported that immunization techs gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event , it involved  vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , once (formulation: injection) (lot number and expiry date: not reported ) via intramuscular route in the left arm for immunization.  On 07-Sep-2022 the patient developed a non-serious event of " immunization techs  gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event " (accidental exposure to product) (latency: same day) .  It was reported " One of the immunization techs gave a patient the vaccine and it was dripping down patient's arm, as patient felt it go down their arm. Pharmacist stated that it was dripping out the side of the needle where you put the syringe. Pharmacist states she was not there the day it happened and doesn't know if the needle was not on tight enough or if the product had a crack in it but the product dripped out of the side of the needle."  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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired DAPTACEL with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired daptacel with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength, dose, route, administration site and lot number not) for immunization.  On an unknown date, the patient received an expired daptacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  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 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: 0.5
Sex: F
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 6 months old female patient who was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] without being reconstituted with the powder component (lyophilized acthib vaccine), 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 CONJ 7V (CRM197) (Prevnar); rotavirus vaccine live reassort oral 5V (Rotateq) and influenza vaccine (INFLUENZA VACCINE) all for Immunisation.  On 13-Sep-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the thigh nos for immunisation.  On 13-Sep-2022 the patient was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine without being reconstituted with the powder component (lyophilized acthib vaccine), with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day for both). Reporter also wanted to know where to find the 0.4% NaCL diluent to mix with the ACTHIB portion.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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: 0.58
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion at 30.6 fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction with no reported adverse event; IPOL was administered post temperature excursion with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA388426.  This case involves a 7 months old female patient who was administered IPV (VERO) [IPOL] post temperature excursion at 30.6 Fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction 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 CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On an unknown date, the suspect IPV (VERO) was exposed to a temperature excursion at 30.6 Fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction with no reported adverse event (product storage error).  On 22-Aug-2022, the patient received 0.5 mL dose 3 of suspect IPV (VERO) (formulation and strength not reported; lot T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the left thigh for prophylactic immunization.  On 22-Aug-2022, (latency: same day) the patient was administered post temperature excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  It was reported, The temperature excursion was caused by a refrigerator malfunction. Max/low temperature reached: 30.6 F Duration out of labelled range: 2 hours 46 minutes. IPOL was administered to a patient post temperature excursion after it was not suitable to use.  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. ; Sender's Comments:  01282755: 01282765: 01282682:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: QUADRACEL was administered to a patient post temperature excursion after it was not suitable to use with no reported AE; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old female patient to whom experienced Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered post temperature excursion after it was not suitable to use with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller was reported a temperature excursion. The temperature excursion was caused by a refrigerator malfunction. 1 dose of QUADRACEL, 1 dose of IPOL and 1 dose of DAPTACEL were administered to patients after the excursion (Max/low temperature reached: 30.6 F Duration out of labelled range: 2 hours 46 minutes Human error: No) (Total of 3 patients). This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  On 23-Aug-2022, the patient received 0.5 ml, 1st dose of suspect Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine lot T5970AA via intramuscular route in the left deltoid for immunisation. QUADRACEL was administered to a patient post temperature excursion after it was not suitable to use (poor quality product administered) (latency: same day).    Action taken: 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of PENTACEL was administered to a patient today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case  via health professional on 16-Sep-2022. Agency number: 01282761  This case involves a 4-month-old female patient to whom expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] was administered to a patient today 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 CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) for Prophylactic vaccination.  On 16-Sep-2022, the patient received expired 2nd dose of suspect Pentacel at dose 0.5ml once via intramuscular route in the left thigh (lot: UJ571AAA, expiry date: 11-Sep-2022) for Immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was 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.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: refrigerator malfunction Max/low temperature reached: 30.6 F for 2 hours 46 minutes with no reported adverse event; DAPTACEL was administered to a patient post temperature excursion after it was not suitable to use with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA388282(CLUSTER) and 2022SA388426(CLUSTER).  This case involves 18 months old female patient who was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post temperature excursion after it was not suitable to use with no reported adverse event and refrigerator malfunction max/low temperature reached: 30.6 f for 2 hours 46 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 10-Aug-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C583AA, expiry date: 11-May-2023) via intramuscular route in the left thigh for immunisation.  On an unknown date there was refrigerator malfunction max/low temperature reached: 30.6 f for 2 hours 46 minutes with no reported adverse event (product storage error) for diphtheria-15/tetanus/5 AC pertussis vaccine. On 10-Aug-2022 the patient was administered diphtheria-15/tetanus/5 AC pertussis vaccine post temperature excursion after it was not suitable to use with no reported adverse event (poor quality product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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: F
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had the flu shot by Sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event; Initial information  was received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 10-Sep-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for immunization.    On 10-SEP-2022 the patient developed a non-serious patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse event (expired product administered) (latency same day) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event patient had the flu shot by sanofi on 9/10/ paper work indicates the expiration date as 6/22/ expiration date (yyy-mm-dd): 2022-06-30 with no adverse 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA
Clinical narrative: COVID-19 positive; This spontaneous case from the United States was retrieved on 29-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2006126-1), reported by other healthcare professional and concerned a 43-year-old, female patient.  The patient's concurrent conditions included chronic low back pain, restless leg syndrome, depression, cyclical vomiting, gastrooesophageal reflux disease (GERD), penicillin, tramadol, codeine, morphine, tylenol with codeine allergy and lactose intolerance. The patient's concomitant medications included Voltaren gel (diclofenac), fluoxetine, gabapentin, iron, Vyvanse (lisdexamfetamine), Icy Hot patches, pantoprazole and pramipexole, all used for an unreported indication.   On 27-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose: reported as 'one', and indication: not reported). The batch number reported was P100355694 (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same day, the patient was vaccinated with non-company co-suspect Covid-19 Janssen (COVID-19 vaccine NRVV Ad26 (JNJ 78436735); route of administration: intramuscular (IM), anatomical location: right arm (RA), dose: reported as 'one', and indication: not reported). The batch number reported was 1822811.  On 29-Dec-2021, two months and two days after receiving Afluria Quadrivalent and co-suspect Covid-19 Janssen, the patient had a SARS-CoV-2 RNA NAAT test, and the result was positive.  On an unspecified date, the patient visited the physician's office, but no further information was provided.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: Two months and two days after receiving Afluria Quadrivalent and co-suspect Covid-19 vaccine, the patient had a SARS-CoV-2 RNA NAAT test, and the result was positive. However, causality is assessed as not related due to biological implausibility.; Sender's Comments: Two months and two days after receiving Afluria Quadrivalent and co-suspect Covid-19 vaccine, the patient had a SARS-CoV-2 RNA NAAT test, and the result was positive. However, causality is assessed as not related due to biological implausibility.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Dizziness, Dysphagia, Fatigue, Flushing
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine and within minutes felt light headed and a lump in throat - given water & benadryl at store.  Light headedness decreased but later in afternoon patient had rapid heartrate and went to ER for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Hyperhidrosis, Hypersensitivity, Hypertension, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine and within minutes felt light headed and a lump in throat - given water & benadryl at store.  Light headedness decreased but later in afternoon patient had rapid heartrate and went to ER for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Nausea, Pyrexia, Sensation of foreign body, Tachycardia
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine and within minutes felt light headed and a lump in throat - given water & benadryl at store.  Light headedness decreased but later in afternoon patient had rapid heartrate and went to ER for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat tightness
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine and within minutes felt light headed and a lump in throat - given water & benadryl at store.  Light headedness decreased but later in afternoon patient had rapid heartrate and went to ER for treatment.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Neck pain, Pain in extremity, Trismus
Clinical narrative: Muscle Pain in right vaccinated arm and left arm Unable to open mouth wide Neck Pain
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: pain,sswelling and itching at site-Mild, Additional Details: just swelling at njection site,,,was given too low
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: pain,sswelling and itching at site-Mild, Additional Details: just swelling at njection site,,,was given too low
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient has fainted after a flu and bivalent COVID shots give. patient recovered in a minute. 911 was called and showed up about 20 minutes later. patient has filled better and does not want to check out. tried to contact patient today 9/19/22 but no response.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Localized reaction, improvement noted in pain, redness and swelling with ice and tylenol
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: Systemic: syringe malfunctioned-Mild, Additional Details: administered vaccine, syringe malfunctioned and vaccine contents leaked out. patient did not get full dose, revaccinated patient
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Discomfort, Oropharyngeal pain, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: sore throat-Medium.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: Systemic: intermittent ringing in the ear 6 hours after the vaccine given-Mild
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted while getting the COVID bivalent shot. She was unresponsive for few minutes and than woke up and was fine. Said this happens when she receives vaccinations.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.25ml instead of 0.5ml.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient given 0.25ml instead of 0.5ml.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Flushing, Pruritus, Urticaria
Clinical narrative: felt hot, flushed, had redness to face, developed hives to arms, stomach, back, neck, and face, itching resolved with Benadryl and Pepcid
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Pyrexia, Rash, Swelling
Clinical narrative: Systemic rash and swelling (chest, stomach, neck, head- 3 days so far), allover muscle soreness (1 day), feverish (a few hours on the night of the shot)
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient given 0.25ml instead of 0.5ml.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Urinary tract infection
Clinical narrative: Hospitalization for UTI on dates 8/15/2022- 8/20/2022.  Treated with no medications for COVID-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracted COVID-19 infection that lead to hospitalization after receiving Pfizer vaccine.  Patient received at least one dose, unknown if she completed series and received booster doses.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: I had small red bumps on my abdomen below the breast line that went around to underneath my arm in like an equator line and on my back. There was no pus or nothing coming out but it was itchy. I applied remedy for itching as needed and it went away.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effects or side effects were noted by parent after two days post vaccination.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypoxia
Clinical narrative: Hospitalization for hypoxia due to COVID-19 on dates 8/17/2022- 8/23/2022.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, zinc 50 mg PO daily.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Bacteraemia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for bacteremia (also COVID-19 positive) on dates  8/17/2022-8/23/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cough, Diarrhoea, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient developed tingling sensation immediately after Fluzone injection. Felt generally unwell within 2 hours and progressively developed upper respiratory symptoms described below. Took surface temp daily and ranged from 98.0-98.8 degrees Fahrenheit using infrared thermometer. Beginning on day 2, developed nasal congestion and unremitting cough, and moderately painful arm at site of Fluzone injection. Little or no redness. Illness progressed to unremitting cough, nasal and chest congestion lasting 7 days. URI symptoms accompanied by fatigue, body aches, and diarrhea (loose, brown stools; no blood). Confusing situation because she received 2 vaccines at once and granddaughter was sick with URI too (last exposure was 3 days prior to vax).
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Malaise, Nasal congestion, Pain, Paraesthesia, Respiratory symptom
Clinical narrative: Patient developed tingling sensation immediately after Fluzone injection. Felt generally unwell within 2 hours and progressively developed upper respiratory symptoms described below. Took surface temp daily and ranged from 98.0-98.8 degrees Fahrenheit using infrared thermometer. Beginning on day 2, developed nasal congestion and unremitting cough, and moderately painful arm at site of Fluzone injection. Little or no redness. Illness progressed to unremitting cough, nasal and chest congestion lasting 7 days. URI symptoms accompanied by fatigue, body aches, and diarrhea (loose, brown stools; no blood). Confusing situation because she received 2 vaccines at once and granddaughter was sick with URI too (last exposure was 3 days prior to vax).
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Patient developed tingling sensation immediately after Fluzone injection. Felt generally unwell within 2 hours and progressively developed upper respiratory symptoms described below. Took surface temp daily and ranged from 98.0-98.8 degrees Fahrenheit using infrared thermometer. Beginning on day 2, developed nasal congestion and unremitting cough, and moderately painful arm at site of Fluzone injection. Little or no redness. Illness progressed to unremitting cough, nasal and chest congestion lasting 7 days. URI symptoms accompanied by fatigue, body aches, and diarrhea (loose, brown stools; no blood). Confusing situation because she received 2 vaccines at once and granddaughter was sick with URI too (last exposure was 3 days prior to vax).
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient injected 0.25ml instead of 0.5ml
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Diarrhoea, Full blood count, Headache
Clinical narrative: High fever for 3-4 days of 101-103, severe chills and body aches, headache and severe diarrhea for 3-4 days, fever and chills resolved in 3 days, still with slight loose stools on 9/22/2022 when seen in clinic. Patient c/o when vaccine given, felt like her muscles in her arm were separating in two. Patient treated herself at home, but states that on day 3 after the vaccine thought she was going to have to go to ER for severe weakness and possible dehydration.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Metabolic function test, Muscle discomfort, Pain, Pyrexia
Clinical narrative: High fever for 3-4 days of 101-103, severe chills and body aches, headache and severe diarrhea for 3-4 days, fever and chills resolved in 3 days, still with slight loose stools on 9/22/2022 when seen in clinic. Patient c/o when vaccine given, felt like her muscles in her arm were separating in two. Patient treated herself at home, but states that on day 3 after the vaccine thought she was going to have to go to ER for severe weakness and possible dehydration.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, C-reactive protein increased, Cardioversion, Dyspnoea, Dyspnoea exertional
Clinical narrative: 12 hours after vaccine had expected headache, aches, pains and fever 100.2 which last 48 hours but developed residual shortness of breathe with exertion and at night.  FOur days later symptoms of headache resturn but worsening SOB on exterion and night sweats.  COVID tested negative several times. No diarhea and no one ill at time at home.   Symptoms persisted now for one past vaccine admin, went to Urgent care.  COvid PCR negative and FLu negative.  d dimer normal , CRP sligh;lty elevated.  I was in atrial fibrillation.  I was unable to me medically converted to normal sinus over the next 48 hours and got electro cardio converted  successfully on September 22.  Echo showed no clots.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram normal, Fibrin D dimer normal, Headache, Influenza virus test negative, Night sweats
Clinical narrative: 12 hours after vaccine had expected headache, aches, pains and fever 100.2 which last 48 hours but developed residual shortness of breathe with exertion and at night.  FOur days later symptoms of headache resturn but worsening SOB on exterion and night sweats.  COVID tested negative several times. No diarhea and no one ill at time at home.   Symptoms persisted now for one past vaccine admin, went to Urgent care.  COvid PCR negative and FLu negative.  d dimer normal , CRP sligh;lty elevated.  I was in atrial fibrillation.  I was unable to me medically converted to normal sinus over the next 48 hours and got electro cardio converted  successfully on September 22.  Echo showed no clots.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 12 hours after vaccine had expected headache, aches, pains and fever 100.2 which last 48 hours but developed residual shortness of breathe with exertion and at night.  FOur days later symptoms of headache resturn but worsening SOB on exterion and night sweats.  COVID tested negative several times. No diarhea and no one ill at time at home.   Symptoms persisted now for one past vaccine admin, went to Urgent care.  COvid PCR negative and FLu negative.  d dimer normal , CRP sligh;lty elevated.  I was in atrial fibrillation.  I was unable to me medically converted to normal sinus over the next 48 hours and got electro cardio converted  successfully on September 22.  Echo showed no clots.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Cold sweat, Diarrhoea, Fatigue, Headache
Clinical narrative: 4th day of: severe Soaking night sweats, aches at joints, headache, fatigue, clammy, diarrhea,
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Night sweats
Clinical narrative: 4th day of: severe Soaking night sweats, aches at joints, headache, fatigue, clammy, diarrhea,
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test in symptomatic fully vaccinated pt
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Agitation, Anxiety, Arthralgia, Autoscopy
Clinical narrative: She got her vaccine, she had some pain, but did not feel too bad just tired and had done some yard work earlier in the week and hurt her hand, had gone to the doctor and had an X-ray of her hand.  She later went and got her vaccine.  She woke up at 3:00 AM and had dizziness and did not feel right, scary feeling (Out of body experience),  had pain  in her chest and across her shoulders, under her right arm (lymph note) that woke her up and that would not go away.   The lymph node swells up from time to time due to sickness.  She was feeling really agitated.  She got up and saw that her stomach was bothering her too, and made something to eat and took 2 Tylenol, and she tried to get back to sleep but she was not able to.  When she got up again she had real anxiety and depression, and felt like she did not want to be alive.  This is the feeling that she had years ago when she was put on steroids.  She felt that she could have killed herself at that point.  She could not think, and kept trying to get her mind on something other than how bad she felt.  Someone called her later and she talked to them and tried to tell them how she felt.  She was supposed to have a foot doctor APT at 10:00 AM and she was on the phone and forgot about the appointment and could not function mentally.  For most of the day she felt the depression state (what's going on with my body type thing).  She sings in a chorus in a nursing home, and felt that she should go to be around people which may help it to go away.  She went and not feeling well, down most of the day, but was putting on a face.  In the middle of the event about an hour, she felt a terrible agitated feeling all over her body, did not know what was going on.  She was trying to stand up and left and got in her car and went home.  She had terrible chills and was freezing, was wrapped up in blankets, also pains all over, pains in her head and her stomach was gnarling.  She felt like she needed to feed it, but that did not  help those symptoms.  She watches carefully what she eats, eats what helps her stomach.  She started eating things that were mild things.  She took some Tylenol and did eat something, and counted the hours between the Tylenol.    Each day she has felt better and today is the first time that she felt well enough to call and report it.  She is still feeling tired as she has not been able to sleep very well.    States that this is different from any other vaccine that she has had and wants it to be rechecked some more.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Depression, Dizziness, Fatigue
Clinical narrative: She got her vaccine, she had some pain, but did not feel too bad just tired and had done some yard work earlier in the week and hurt her hand, had gone to the doctor and had an X-ray of her hand.  She later went and got her vaccine.  She woke up at 3:00 AM and had dizziness and did not feel right, scary feeling (Out of body experience),  had pain  in her chest and across her shoulders, under her right arm (lymph note) that woke her up and that would not go away.   The lymph node swells up from time to time due to sickness.  She was feeling really agitated.  She got up and saw that her stomach was bothering her too, and made something to eat and took 2 Tylenol, and she tried to get back to sleep but she was not able to.  When she got up again she had real anxiety and depression, and felt like she did not want to be alive.  This is the feeling that she had years ago when she was put on steroids.  She felt that she could have killed herself at that point.  She could not think, and kept trying to get her mind on something other than how bad she felt.  Someone called her later and she talked to them and tried to tell them how she felt.  She was supposed to have a foot doctor APT at 10:00 AM and she was on the phone and forgot about the appointment and could not function mentally.  For most of the day she felt the depression state (what's going on with my body type thing).  She sings in a chorus in a nursing home, and felt that she should go to be around people which may help it to go away.  She went and not feeling well, down most of the day, but was putting on a face.  In the middle of the event about an hour, she felt a terrible agitated feeling all over her body, did not know what was going on.  She was trying to stand up and left and got in her car and went home.  She had terrible chills and was freezing, was wrapped up in blankets, also pains all over, pains in her head and her stomach was gnarling.  She felt like she needed to feed it, but that did not  help those symptoms.  She watches carefully what she eats, eats what helps her stomach.  She started eating things that were mild things.  She took some Tylenol and did eat something, and counted the hours between the Tylenol.    Each day she has felt better and today is the first time that she felt well enough to call and report it.  She is still feeling tired as she has not been able to sleep very well.    States that this is different from any other vaccine that she has had and wants it to be rechecked some more.