chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: got our flu shots in september and here we are with the flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced got our flu shots in september and here we are with the flu while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a serious got our flu shots in september and here we are with the flu (vaccination failure) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got our flu shots in september and here we are with the flu).  At time of reporting, the outcome was Unknown for the event got our flu shots in september and here we are with the flu.; Sender's Comments: Sanofi company comment dated 30-Nov-2022: This case involves an unknown age female patient who experienced got our flu shots in september and here we are with the flu while receiving vaccine INFLUENZA VACCINE. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, other concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu shots in September and has flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media, non-serious case received from a wife of patient.  This case involves an unknown age male patient who got flu shots in september and had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, administration site, lot number and expiry date was unknown) for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got flu shots in september and has flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 28-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported, "I got the shot and still got the Flu."  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE (form, strength, dose, frequency, site, route, batch number, manufacturer, administration site and expiry date: unknown) for Flu.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "Yes but we are getting the flu! "  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 .
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cough, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: This case involves an unknown age and unknown gender patient who had coughing, sneezing, runny nose and throat scratchy after receiving vaccines MODERNA COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date in Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Flu.  On an unknown date in Oct-2022, the patient received a  dose of suspect MODERNA COVID-19 VACCINE not produced (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2022, the patient developed a non-serious event of coughing (cough), sneezing, runny nose (rhinorrhoea) and throat scratchy (throat irritation) (latency: unknown) following the administration of INFLUENZA VACCINE and (latency: unknown) following the administration of MODERNA COVID-19 VACCINE..  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who still got the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of still got the flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp ( non-health care professional ) .  This case involves an unknown age and unknown gender patient who had flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown   dose of suspect INFLUENZA VACCINE produced by unknown manufacturer ( with unknown strength, form, route, batch number and expiry date ) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of  flu (influenza) (unknown latency)   No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome : Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: the only time i've the flu, is after the shot. nope never again with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who was diagnosed with the only time i've the flu, is after the shot. nope never again with no reported 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 an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (strength, dose, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site.  On an unknown date the patient diagnosed with non-serious the only time i've the flu, is after the shot. nope never again with no reported adverse event (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "Had a flu shot three weeks ago. Came down with a severe case of the flu"  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
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported, "I took one in 1972 got sick for our 11 mouths I swear I will never get one again."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-health care professional ) .  This case involves an unknown age and unknown gender patient who had got the flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer ( with unknown strength, form, rote, batch number and expiration date ) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of got the flu (influenza) (unknown latency)   No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  Outcome : Unknown
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: the door may been left open to long causing IPOL (opened) The highest temperature reached was 48.2F for a total excursion time of 9 minutes with no reported adverse event; A patient was administered IPOL that exceeded extended stability data post temperature excursion with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient and reporter reported that the door may been left open to long causing ipol (opened) the highest temperature reached was 48.2f for a total excursion time of 9 minutes with no reported adverse event and the patient administered IPV (VERO) IPOL that exceeded extended stability data post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Nov-2022, the door may been left open to long causing the highest temperature reached was 48.2f for a total excursion time of 9 minutes with no reported adverse event (product storage error) and the patient received dose 5 of suspect IPV (VERO) at a dose of 0.5 ml (lot U1C571M, expiration date: 17-Jun-2023) via subcutaneous route in the left arm for immunization that exceeded extended stability data post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  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.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Had tenderness in his left arm where the injection was given since it was administered/tiny pain occasionally when moving his arms; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 75 years old male patient who had tenderness in his left arm where the injection was given since it was administered/tiny pain occasionally when moving his arms after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Had vaccine before and experienced soreness for a few days (Pain in extremity). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 16-Nov-2022, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ935AA and expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization.  On 16-Nov-2022 the patient developed a non-serious event of had tenderness in his left arm where the injection was given since it was administered/tiny pain occasionally when moving his arms (vaccination site pain) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  Corrective treatment:  The pharmacist who administered the FLUZONE HD QIV recommended that the patient take two IBUPROFEN (IBUPROFEN) as needed throughout the day for Vaccination site pain.  Outcome: Not recovered
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: only administered the liquid form instead of mixing the diluent with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who experienced only administered the liquid form instead of mixing the diluent with no reported 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 (PNEUMOCOCCAL CONJUGATE VACCINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection at dose pf 0.5ml  lot UJ663AAA via intramuscular route in the right thigh for immunization.  On 28-NOV-2022 the patient developed a non-serious only administered the liquid form instead of mixing the diluent with no reported adverse event (wrong technique in product usage process) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE for Immunization.  It was reported " MA requests to speak with someone about an AE with the PENTACEL that occurred on accident. MA states that a patient needed the PENTACEL but one of the coworkers only administered the liquid form instead of mixing the diluent and Medical assistant reporting that the liquid portion of PENTACEL was given not the lyophilized portion containing ACTHIB".  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event (only administered the liquid form instead of mixing the diluent with no reported adverse event).  At time of reporting, the outcome was Unknown for the event only administered the liquid form instead of mixing the diluent with no reported 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: 6.0
Sex: M
Vaccine: TYP
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: she gave a 6-year-old child a dose of TYPHIM SQ instead of IM with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male child patient who has been given a dose of typhim sq instead of im with no reported adverse event after receiving vaccine typhoid vi polysaccharide vaccine [Typhim Vi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2022, the patient received suspect typhoid vi polysaccharide vaccine solution for injection (batch number: V1A331M) at a dose of 0.5 ML 1X  via subcutaneous route (expiry date, frequency: unknown)  in unknown administration site for Immunization.  On an unknown date the patient diagnosed with a non-serious event of she gave a 6-year-old child a dose of typhim sq instead of im with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of typhoid vi polysaccharide vaccine.  No lab data was reported.  Action taken was 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: 58.0
Sex: M
Vaccine: COVID19-2, PNC13, UNK, UNK, VARZOS
Symptoms: Electromyogram, Gait inability
Clinical narrative: Patient received 4 vaccines on 11/15, Then received HepB on 11/16. Patient was from home self care, independent with all cares, but then on 11/17 patient was unable to walk on his own.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received this vaccine by accident. When I checked in with the patients mom on 11/27 she reported that her daughter was feeling fine and was not experiencing fever, headaches, chills or body aches. She was acting as her usual self
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, headaches, and a slight fever which lasted about 3 days.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Sore with knot feeling at injection site - first day.  2nd day still sore and feeling knot but also hot and red. 3rd day still sore, knot, hot,red and now swollen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Grip strength decreased, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: I got the first vaccine on Sept 6th and over the next month noticed weakness and tingling in my hands that caused me to have to grip things harder to hold them. I like to garden,  mow the lawn, and trim shrubs, and since the vaccine my work became much more difficult. My right hand was affected more, and I am experiencing difficulty straightening two fingers, they get stuck, in the bent position. Since the vaccine both hands get swollen with use of tools in activities that were normally comfortable for me. I saw Dr., thinking it was a sudden onset of arthritis or an injury,  I got blood tests and hand xrays, which indicated it was not the case. I got the second vaccine on November 30th. I logged onto pharmacy site this morning, downloaded my vaccine record, but it downloaded to an unknown location. At the time  both vaccines were visible, I opened the VIS form I had saved to my browser reading list, but upon opening it dissappeared. When I accessed my records again to complete the information for this form, my record of the first vaccine had dissappeared.  Today, my swelling and tingling in my hands is worse than ever. I don't know if physical therapy of my hands will help.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, X-ray limb
Clinical narrative: I got the first vaccine on Sept 6th and over the next month noticed weakness and tingling in my hands that caused me to have to grip things harder to hold them. I like to garden,  mow the lawn, and trim shrubs, and since the vaccine my work became much more difficult. My right hand was affected more, and I am experiencing difficulty straightening two fingers, they get stuck, in the bent position. Since the vaccine both hands get swollen with use of tools in activities that were normally comfortable for me. I saw Dr., thinking it was a sudden onset of arthritis or an injury,  I got blood tests and hand xrays, which indicated it was not the case. I got the second vaccine on November 30th. I logged onto pharmacy site this morning, downloaded my vaccine record, but it downloaded to an unknown location. At the time  both vaccines were visible, I opened the VIS form I had saved to my browser reading list, but upon opening it dissappeared. When I accessed my records again to complete the information for this form, my record of the first vaccine had dissappeared.  Today, my swelling and tingling in my hands is worse than ever. I don't know if physical therapy of my hands will help.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Bradycardia, Chills, Dizziness, Flushing
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient received menactra 3 years prior with no adverse reactions. Received his vaccine in clinic- was fine, walked to the other end of store and passed out- hitting his head. He then came in clinic shaking, vomiting, hypotensive and bradycardic- EMS was called. Pt went to ED
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Head injury, Hyperhidrosis, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient received menactra 3 years prior with no adverse reactions. Received his vaccine in clinic- was fine, walked to the other end of store and passed out- hitting his head. He then came in clinic shaking, vomiting, hypotensive and bradycardic- EMS was called. Pt went to ED
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient received menactra 3 years prior with no adverse reactions. Received his vaccine in clinic- was fine, walked to the other end of store and passed out- hitting his head. He then came in clinic shaking, vomiting, hypotensive and bradycardic- EMS was called. Pt went to ED
Age: 27.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: The patient stated they had previous experiences of 'passing out' from vaccinations. Shortly after receiving both vaccinations ( roughly 5 minutes), the patient stated they felt like they were going to pass out. The patient did pass out, but was breathing and became conscious shortly after. Their blood pressure was taken, and EMS was contacted. EMS did an evaluation of the patient, at which point the patient refused transportation to the emergency room for further evaluation. The patient remained in the pharmacy after the incident for > 30 minutes. A family member was with them and saw that they got home safely. The patient has no prior pertinent PMG; i.e. history of seizure, TBI, etc.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Optic ischaemic neuropathy, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient noticed vision impairment in right eye in September of 2021, was diagnosed with NAION.  Symptoms are stable and have not progressed or improved.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 27.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: patient called stating he has severe pain at site of injection. discovered that patient received a 2nd flu shot a week after his 1st flu shot. counseled patient to take tylenol and apply cold compress to site of injection.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood disorder, Injection site pain, Thrombosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: blood clot in left leg-Mild, Systemic: Weakness-Mild, Additional Details: pt went to er where they found a small blood clot in left leg and put pt on eliquis
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site discharge
Clinical narrative: Error: Leaking from Injection Site-
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac arrest, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis resulting in ventricular arrythmia and cardiac arrest.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular arrhythmia
Clinical narrative: Myocarditis resulting in ventricular arrythmia and cardiac arrest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus.  Kept me up all night and had to cancel plans the next day.  Obviously, I don't know if it is connected to the vaccine.  Just that this is the worst tinnitus I have ever had.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: Headache, nausea, fever, achiness, sleeplessness.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently given Covid 5-11yr pfizer bivalent vaccine instead of Covid 5-11yr pfizer vaccine to complete his 3 dose series.  Patient was 4 years of age when vaccination for covid began.  He received 2 doses of the 6mth-4yrs in September 2022  and then turned 5yrs in October.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Borrelia test, C-reactive protein increased, Dysstasia
Clinical narrative: Arm pain and muscle and joint pain within hours of the shot.  Muscle and joint pain worse at night. Over the next week progressed to pain, and stiffness in knees, hips, pelvis and shoulders.   Whenever I stayed in one position for any length of time (driving, gardening) I was incredibly stiff I could barely get out of the car or stand up.  Over the next few weeks it got worse to the point where getting out of bed and getting dressed became difficult due to stiffness.  Did not know what was going on and lived with it thinking it was related to the vaccine and would go away.  By early July, I called my doctor to see what was going on.  Taking Aleve and Tylenol to try to manage pain and stiffness.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test, Joint stiffness, Laboratory test abnormal, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Arm pain and muscle and joint pain within hours of the shot.  Muscle and joint pain worse at night. Over the next week progressed to pain, and stiffness in knees, hips, pelvis and shoulders.   Whenever I stayed in one position for any length of time (driving, gardening) I was incredibly stiff I could barely get out of the car or stand up.  Over the next few weeks it got worse to the point where getting out of bed and getting dressed became difficult due to stiffness.  Did not know what was going on and lived with it thinking it was related to the vaccine and would go away.  By early July, I called my doctor to see what was going on.  Taking Aleve and Tylenol to try to manage pain and stiffness.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Pelvic pain, Polymyalgia rheumatica
Clinical narrative: Arm pain and muscle and joint pain within hours of the shot.  Muscle and joint pain worse at night. Over the next week progressed to pain, and stiffness in knees, hips, pelvis and shoulders.   Whenever I stayed in one position for any length of time (driving, gardening) I was incredibly stiff I could barely get out of the car or stand up.  Over the next few weeks it got worse to the point where getting out of bed and getting dressed became difficult due to stiffness.  Did not know what was going on and lived with it thinking it was related to the vaccine and would go away.  By early July, I called my doctor to see what was going on.  Taking Aleve and Tylenol to try to manage pain and stiffness.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Arm pain and muscle and joint pain within hours of the shot.  Muscle and joint pain worse at night. Over the next week progressed to pain, and stiffness in knees, hips, pelvis and shoulders.   Whenever I stayed in one position for any length of time (driving, gardening) I was incredibly stiff I could barely get out of the car or stand up.  Over the next few weeks it got worse to the point where getting out of bed and getting dressed became difficult due to stiffness.  Did not know what was going on and lived with it thinking it was related to the vaccine and would go away.  By early July, I called my doctor to see what was going on.  Taking Aleve and Tylenol to try to manage pain and stiffness.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain
Clinical narrative: Continuing  pain and weakness radiating down to elbow. I am unaware of which particular seasonal flu shot I received.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of upper RT  arm became very blotchy red and swollen, painful. Not hives, itchy or blistering or peeling. There had been no previous redness until 12/2/22 that I noticed when I was getting undressed to shower.  I removed the bandaid they applied within  10 min on day of vaccine.  I did experience extreme fatigue on first day after vaccine along with constant dull headache but had read this was normal. I took pics for reference but did not seek any treatment as I am a RN and the symptoms did not progress and I had no respiratory issues, fever, etc.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Site of upper RT  arm became very blotchy red and swollen, painful. Not hives, itchy or blistering or peeling. There had been no previous redness until 12/2/22 that I noticed when I was getting undressed to shower.  I removed the bandaid they applied within  10 min on day of vaccine.  I did experience extreme fatigue on first day after vaccine along with constant dull headache but had read this was normal. I took pics for reference but did not seek any treatment as I am a RN and the symptoms did not progress and I had no respiratory issues, fever, etc.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Pain level 6 headaches, pain level 4 body pains in muscles and joint, pain level 5 at site of the injection, mild elevation in body temperature, nighttime chills and exhaustion.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Pain level 6 headaches, pain level 4 body pains in muscles and joint, pain level 5 at site of the injection, mild elevation in body temperature, nighttime chills and exhaustion.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Pt was administered 0.25ml of a 0.5ml prefilled syringe of Fluzone Quadravalent influenza vaccine. Per program guidelines, this is not a valid dose as the patient should have been given the entirety of the prefilled syringe dose. Per guidelines, pt will still need two doses of influenza vaccine in the same season in order to be considered immunized.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: I have had flu like symptoms since about one day  after the injection.  Very fatigued, chill, lethargic, runny nose, coughing, sneezing, reduced appetite.  Other vaccines did not produce these efffects.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lethargy, Rhinorrhoea, Sneezing
Clinical narrative: I have had flu like symptoms since about one day  after the injection.  Very fatigued, chill, lethargic, runny nose, coughing, sneezing, reduced appetite.  Other vaccines did not produce these efffects.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood test, Dizziness, Hyperhidrosis
Clinical narrative: anaphylaxis, elevated blood pressure, vomiting, sweats, light headed
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: anaphylaxis, elevated blood pressure, vomiting, sweats, light headed
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diplopia
Clinical narrative: Experienced double vision for 5 minutes on 11/26/22 and again for 2 minutes on 11/28/22--no pain, no loss of vision, only present with both eyes open. No other neurologic symptoms such as dizziness, headache, weakness, numbness/tingling. It resolved on its own, no treatment was needed to stop the double vision. I did see my primary care office on 12/1/22 for an physical evaluation with a normal neurologic exam and a recommendation to see ophthalmology for an eye exam. If there is no findings with the eye exam, PCP office is planning brain imaging and blood work.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: PATIENT HAD 2 IMMUNIZATION CARDS AND I WAS PRESENTED ONLY THE SECOND CARD I BELIEVE THAT PREVENTED ME FROM DISCOVERING THE ADDED BOOSTER DOSE AFTER THE FACT
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm ruptured, Brain death, Condition aggravated, Death, Life support
Clinical narrative: Rapid increase of severe migraines after vaccine and lasting until brain aneurysm rupture on 04/29/2021. Patient was put on life support at Hospital on 04/29/2021 and had no brain activity . Patient was pulled from life support and died on 05/03/2021
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Rapid increase of severe migraines after vaccine and lasting until brain aneurysm rupture on 04/29/2021. Patient was put on life support at Hospital on 04/29/2021 and had no brain activity . Patient was pulled from life support and died on 05/03/2021
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: THE PATIENT HAD 2 IMMUNIZATION CARDS AND I WAS PRESENTED ONLY THE SECOND CARD, I BELIEVE THAT I DISCOVERED THE ADDED DOSE ON 3DEC2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough infection
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Breakthrough infection
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: PATIENT HAD 2 IMMUNIZATION CARDS AND WAS PRESENTED THE SECOND CARD THAT DID NOT REFLECT THE ADDED DOSE THAT I ADMINISTERED ON THE ABOVE DATE
Age: 52.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Pruritus
Clinical narrative: Itchy skin and Dermatographia. Still present but has not been as bad as after my first booster.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient reports lip numbness roughly one week after receiving this vaccination.  She does not have any other numbness/tingling in other body parts on the day of report.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer Peds Bivalent dose instead of Pfizer Peds Mono Vaccine as first dose in primary series. No symptoms/issues reported to pharmacy of adverse reactions.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient was given TDAP in right deltoid. following injection patient has pain at site and decreased mobility in the right upper extemity. unable to lift arm above head.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient asked for the 2 nd  dose of moderna in the primary series and was given the bivalen
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Patient fainted approximately 3-5 minutes after receiving the the shot..During the vaccine patient showed no signs of an adverse reaction.  While walking away after the vaccine was administered patient fell onto the floor.  Patient a had two minor injuries to the face.  After being alerted, I rushed to the patient's side to assess the situation.  Upon assessment, patient a had two minor injuries to the face, he was breathing and talking with no issues.  I asked him if he was currently taking any  medications or had any medical conditions, to which he responded no.  I assisted him to his feet and supported his arms while he walked to our clinical services room.  While there, I cleaned his wounds with peroxide and gave him an ice pack for his forehead.  I then sat with him until he was stable and his mother came to pick him up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a primary Pfizer vaccine that expired 11/30/2022. Pt was fine no adverse reactions occured while she was in office for 20-minute observation.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation delayed
Clinical narrative: Period delayed three days.  Very regular 28 day cycles prior to vaccination
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose that was beyond the BUD. No symptoms or reaction following vaccination reported per mother.
Age: 74.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 25 days of multiple itchy red bumpy (but not vesicular) skin eruption on bilateral trunk (worst on abdomen), not improving despite moisturizer creams, calamine lotion, oral steroid course
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Amyotrophic lateral sclerosis, Electromyogram abnormal, Muscle atrophy, Muscle spasms, Peroneal nerve palsy
Clinical narrative: Bad cramping in left leg, drop foot in left foot, lost all muscle mass on left side of body. Went from perfect health to dianosed with ALS or Lou Gehrig disease after the 2nd shot.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Terminal state
Clinical narrative: Bad cramping in left leg, drop foot in left foot, lost all muscle mass on left side of body. Went from perfect health to dianosed with ALS or Lou Gehrig disease after the 2nd shot.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Gave 3rd primary dose rather than first booster dose.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Gave 3rd dose of initial serum rather than a booster
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Magnetic resonance imaging, Ophthalmological examination, VIth nerve paralysis
Clinical narrative: Left eye abducens palsy (6th nerve)
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Gave a 3rd primary dose rather than a booster
Age: 8.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The parents were contacted and made aware of the incorrect dosage.  At the time there were no reported symptoms.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Dad was contacted by the pharmacy stave and given counseling.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiform on both arms, started with left arm and radiated to right arm
Age: 78.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthropathy, Asthenia, Body temperature increased, Laboratory test
Clinical narrative: Massive weakness in joints , temperary temperature, joints continually effected are knees and hands. They are the worst
Age: 78.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Pain, Syncope
Clinical narrative: Massive weakness in joints , temperary temperature, joints continually effected are knees and hands. They are the worst
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Patient said she developed red/swollen eyes a few hours after receiving.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse events
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Chills, Condition aggravated, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: Severe swelling of lymph node in left armpit, sore arm. This was accompanied by worsening COVID-like symptoms over the next 48 hours (tingling mouth/throat sensation, sore tongue, headache, fever, chills, fatigue, and worsening of symptoms associated with my current chronic gastrointestinal conditions). Increasingly prominent periorbital edema that is worse in the mornings (eyelids are so puffy that I do not feel they are fully open)... it's hard to tell but I think all of my lymph nodes are a bit puffy, or there is a noticeable amount of water retention all over my body.  I still do not feel back to normal but have not sought medical treatment.  Currently, my arm soreness has mostly dissipated, and my lymph node is still enlarged but slowly reducing in size every day. Currently struggling with the worsening edema around my eyes and neck, pounding headaches, and fatigue/low stamina/getting winded easily.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Feeling abnormal, Fluid retention, Gastrointestinal disorder, Glossodynia, Headache
Clinical narrative: Severe swelling of lymph node in left armpit, sore arm. This was accompanied by worsening COVID-like symptoms over the next 48 hours (tingling mouth/throat sensation, sore tongue, headache, fever, chills, fatigue, and worsening of symptoms associated with my current chronic gastrointestinal conditions). Increasingly prominent periorbital edema that is worse in the mornings (eyelids are so puffy that I do not feel they are fully open)... it's hard to tell but I think all of my lymph nodes are a bit puffy, or there is a noticeable amount of water retention all over my body.  I still do not feel back to normal but have not sought medical treatment.  Currently, my arm soreness has mostly dissipated, and my lymph node is still enlarged but slowly reducing in size every day. Currently struggling with the worsening edema around my eyes and neck, pounding headaches, and fatigue/low stamina/getting winded easily.