chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: my left hand started to get numb, it has progressed to include left arm, left face and sometimes my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 28Nov2022, outcome "not recovered", described as "my left hand started to get numb, it has progressed to include left arm, left face and sometimes my left leg".  Additional information: Patient had 4th Pfizer COVID-19 vaccine shot on 28Nov2022. That evening patient's left hand started to get numb; it had progressed to include left arm, left face and sometimes left leg. Patient inquired if there was any advice that could be provided as had not subsided at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender 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 10-Nov-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Dec-2022 the patient developed a non-serious event of flu (influenza) (latency: 22 days) following the administration of influenza vaccine.  It was unknown if there were lab data/results available.  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 virus test positive
Clinical narrative: i got my flu shot and now test positive for the flu; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got INFLUENZA VACCINE shot and now test positive for the flu.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient got flu shot and now test positive for the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Relevant laboratory test results included: Influenza virus test - On an unknown date: Positive   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Patient had the flu for 4days and it was not nice at all; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had the flu for 4 days and it was not nice at all after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, frequency, strength, formulation and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient had the flu for 4 days and it was not nice at all (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-healthcare professional.  This case involves a Child female patient who has flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: diagnosed with type A flu.; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case received from a patient via Social Media.  This case involves a patient of unknown age and gender who was diagnosed with type a flu after receiving 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 (dose, strength, formulation, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was diagnosed with type A flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data reported.  Action taken: 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: Illness, Influenza
Clinical narrative: Every time I get the flu shot I get sick for a week; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the flu shot and got sick for a week after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, frequency, strength, formulation and expiry date not reported) via unknown route in unknown administration site for flu (Influenza).  Patient reported that every time when got the flu shot the patient got sick for a week (illness) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  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: Feeling abnormal, Influenza
Clinical narrative: flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-helath care professional.  This case involves an Adult 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 unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(immunization). Information regarding batch number details has been requested.  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" To late. Got my flu shot last month, now have the flu. The worse I have felt in a long time".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got flu shot and still got the flu a month later; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who got flu shot (influenza vaccine) and still got the flu a month later.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient got flu shot and still got the flu a month later (influenza)  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local authorization. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu shot and still got the flu a month later).  At time of reporting, the outcome was Unknown for the event
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Ear congestion, Nausea, Vertigo
Clinical narrative: vertigo; nausea; right ear feels congested or clogged; Initial information received on 01-Dec-2022 regarding an unsolicited valid  non-serious case received from a Patient .  This case involves a 70 years old male patient who experienced vertigo, nausea, right ear feels congested or clogged after receiving 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 06-Nov-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml QY (Lot Number- UJ933AD)(strength, formulation, expiry date: not reported) via unknown route in unknown administration site for Influenza (Influenza immunization).  On 06-Nov-2022 the patient developed a non-serious events vertigo, right ear feels congested or clogged (ear congestion) (Latency- within 15 minutes), nausea(Latency-15-20 minutes), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported Patient states he has an appt with an ENT 10 days from now, also stating the symptoms were severe for the first two days, not as severe now but everything is still there.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events (vertigo, nausea, right ear feels congested or clogged).  At time of reporting, the outcome was recovering for Ear congestion and Not Recovered / Not Resolved for all other events.  Additional information received on 02-Dec-2022 from a patient: dose added for suspect, event outcome updated for ear congestion and latency updated for ear congestion and vertigo. Text amended accordingly.
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Off label use, Product preparation error
Clinical narrative: imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event; imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown age male patient who reported that rabies (HDC) vaccine [IMOVAX RABBIA] series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event.   The patient's past medical history included Animal bite (bit by a dog) on 05-Dec-2022. The patient's past medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine, Powder and solvent for suspension for injection (strength, frequency, lot number, and expiry date: not reported) via unknown route in unknown administration site for bit by dog (Animal bite).  On an unknown date the patient had imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event (product prescribing error) (Inappropriate schedule of product administration) (latency: one day).   It was reported"The caller reported that the consumer was bit by a dog, on 05Dec2022; that the IMOVAX series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure; that the consumer will miss the 19Dec2022 dose due to being out of town, but can make the dose up on 21Dec2022".  Action taken was not applicable.  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 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: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received the product menquadfi 2 times (with no reported adverse event); Initial information was received on 06-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 years old male patient who received the product menquadfi 2 times (with no reported adverse event) after being vaccinated with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination.  On 01-Dec-2022, the patient received a 0.25 Total dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength: standard) (lot number: U7576AB, expiration date: 28-Feb-2025) via intramuscular route in the left arm. On 05-Dec-2022 he also received dose 2 dose of the same vaccine via intramuscular route in the right arm for Immunization (Imunisation).  On 05-DEC-2022 the patient developed a non-serious received the product menquadfi 2 times (with no reported adverse event) (extra dose administered) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event received the product menquadfi 2 times (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 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: 50.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired TENIVAC with no reported adverse event; Initial information received on 06-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old female patient who stated patient was administered expired tenivac with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine; varicella zoster vaccine RGE (CHO) (Shingrix); and influenza vaccine for prophylactic vaccination.  On 05-Dec-2022, the patient received a 0.5 ml dose (1 x) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6831AA, expiry date 08-Aug-2022, strength not reported) via unknown route in unknown administration site for Immunization.  On 05-Dec-2022 the patient was administered expired tenivac with no reported adverse event (expired product administered) (latency: same day)  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered expired tenivac 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.
Sex: M
Vaccine: FLUC3
Symptoms: Condition aggravated, Panic attack
Clinical narrative: Panic attack; This spontaneous case was received on 16-Nov-2022 from other non-healthcare professional (reference number: SEQW22-05847) and concerned a male patient of unknown age.  The patient's concurrent conditions included panic disorder, however, he did not have actual panic attack in years. The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, starting about twelve hours after receiving Flucelvax Quadrivalent, the patient experienced panic attack for the first time in years and was having them constantly ever since. The patient stated nothing else had changed.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  Company comment: A male patient of unknown age experienced panic attack about twelve hours after vaccination with the suspect Flucelvax Quadrivalent vaccine. The patient's concurrent condition included panic disorder. Causality for event is assessed as not related to the suspect vaccine due to implausible temporal relationship.; Sender's Comments: A male patient of unknown age experienced panic attack about twelve hours after vaccination with the suspect Flucelvax Quadrivalent vaccine. The patient's concurrent condition included panic disorder. Causality for event is assessed as not related to the suspect vaccine due to implausible temporal relationship.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Autonomic nervous system imbalance, Condition aggravated, Dysphemia, Facial spasm, Hypoaesthesia
Clinical narrative: Tacchyardia, seizures, syncope, tingling, numbness, paralysis, stutter, spasms, facial spasms,
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Paraesthesia, Paralysis, Postural orthostatic tachycardia syndrome, Seizure
Clinical narrative: Tacchyardia, seizures, syncope, tingling, numbness, paralysis, stutter, spasms, facial spasms,
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tachycardia, Tilt table test
Clinical narrative: Tacchyardia, seizures, syncope, tingling, numbness, paralysis, stutter, spasms, facial spasms,
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness
Clinical narrative: Patient reported hearing loss. Patient had significant decline of hearing ability between 4/21/22 and 11/28/22. He started feeling his hearing loss around June 2022. The condition has persisted with no improvement.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: 2nd dose of original vaccination series administered as Bivalent vaccine instead of monovalent
Age: 49.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Fatigue, Migraine, Nausea, Pain, Pain in extremity
Clinical narrative: Terrible migraines; awful body aches all night, especially ribcage; nausea; exhaustion; and very sore upper arm for over a week after Covid booster shot, just like after previous Covid shots, except symptoms were the worst and the longest-lasting this time.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: None stated.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient Received vaccination at ~10 am on 12/6/22 and complained of severe pain not improved after 30 minutes with ice/heat and ibuprofen at 12:50pm
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: per the pt he feels lightheaded and dizzy still having this problem and he went to pcp he prescribed meclizine , pt also was about to fall couple of times
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pateint is still having pain at the injection.  has been ongoing since first administered and has gotten worse.  informed pt to go see their doctor.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: rash/hives from fingertips to shoulder of left arm
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 1.42
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Vomiting 5 times over the course of two hours
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: A second series of Monovalent, Novavax Vaccine was administered and required only one. First dose 10/15/2022. Second dose not required 11/22/2022.
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: I felt woozy all day after the flu shot but at night I became extremely dizzy. I felt like I had just gotten off a roller coaster. I felt very nauseous. This lasted hours and I finally went to bed.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Mass
Clinical narrative: Swollen lymph nodes.  One floating one on collarbone.  Happy to send a video of the mass.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Breast calcifications, Intraductal proliferative breast lesion, Mammogram abnormal
Clinical narrative: On 1/27/2021 I had a mammogram that did not show any calcifications in my right breast. I had to return for a second mammogram on 2/17/2021 which revealed a group calcifications in my right breast. On 3/17/2021 I had a biopsy which indicated Ductal Carcinoma In Situ.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER, CHILLS
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Atrial fibrillation, Blood test, Dizziness, Electrocardiogram
Clinical narrative: I'm not all sure this is related to the covid vaccine.  On Oct 19, 200 (about 6 weeks after the last covid vaccine dose) I had a total hip replacement at local Hospital.  Surgery went well, but immediately post-op, I was extremely nausea for hours and vomited repeatedly.  I was given meds to manage it and discharged the next day on pain medications.  On Oct 21, 2022 my husband was diagnosed with a blood clot in his left leg and was admitted to the ER.  I could not help because I was recovering from own extensive surgery.  On Oct 22, 2022, I woke with a racing heart, light-headness, dizziness, and feeling weak.  My sister took me to the ER at Medical Center where I was diagnosed with atrial fibrillation.  I was hospitalized for three days to get heart rhythm under control.  I have been in normal sinus rhythm since then.  I reported vaccine status to doctors if asked, but other than that, there was no discussion about it.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Hip arthroplasty, Palpitations, Procedural nausea, Procedural vomiting, X-ray
Clinical narrative: I'm not all sure this is related to the covid vaccine.  On Oct 19, 200 (about 6 weeks after the last covid vaccine dose) I had a total hip replacement at local Hospital.  Surgery went well, but immediately post-op, I was extremely nausea for hours and vomited repeatedly.  I was given meds to manage it and discharged the next day on pain medications.  On Oct 21, 2022 my husband was diagnosed with a blood clot in his left leg and was admitted to the ER.  I could not help because I was recovering from own extensive surgery.  On Oct 22, 2022, I woke with a racing heart, light-headness, dizziness, and feeling weak.  My sister took me to the ER at Medical Center where I was diagnosed with atrial fibrillation.  I was hospitalized for three days to get heart rhythm under control.  I have been in normal sinus rhythm since then.  I reported vaccine status to doctors if asked, but other than that, there was no discussion about it.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: A second series of Monovalent, Novavax Vaccine was administered and required only one. First dose 10/15/2022. Second dose not required 11/22/2022.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myasthenia gravis, Respiratory distress
Clinical narrative: Patient was originally diagnosed with Myasthenia Gravis in November 2022 (not even a month after injection).  Then patient has worsening respiratory distress resulting in hospitalization 12/9/2022.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER, CHILLS
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Bloody discharge, Breast discharge, Breast mass, Magnetic resonance imaging breast abnormal
Clinical narrative: Bloody discharge thru left nipple.  Sonomammography, mammography with Tomosintesis, Biopsy, and MRI with contrast all show solid intraductal mass.   Have bern referred to oncological  surgeon for full removal and confirmatory biopsy.  Continue to bleed ocassionsllyvsnd pain.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram abnormal, Pain, Ultrasound breast abnormal
Clinical narrative: Bloody discharge thru left nipple.  Sonomammography, mammography with Tomosintesis, Biopsy, and MRI with contrast all show solid intraductal mass.   Have bern referred to oncological  surgeon for full removal and confirmatory biopsy.  Continue to bleed ocassionsllyvsnd pain.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Diarrhoea, Respiratory tract congestion
Clinical narrative: LOOSE STOOLS, CONGESTION, COUGH
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Endotracheal intubation, Headache, Intracranial aneurysm, Ruptured cerebral aneurysm
Clinical narrative: Patient was injected with 4th dose of Pfizer on 9/20/22, patient admitted 2 months later on 12/26/2022 with severe headache for days.  Head CT identified R PICA aneurysm rupture.  Patient intubated and EVD drain placed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular drainage
Clinical narrative: Patient was injected with 4th dose of Pfizer on 9/20/22, patient admitted 2 months later on 12/26/2022 with severe headache for days.  Head CT identified R PICA aneurysm rupture.  Patient intubated and EVD drain placed.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus that lasted approximately 1.5 months. Treatment is to monitor.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoacusis, Respiratory tract congestion, SARS-CoV-2 test positive, Tympanic membrane disorder
Clinical narrative: Covid confirmed on Oct 20 with home test.  Congestion impacted hearing severely and tympanic membrane was retracted severely
Age: 39.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Underdose
Clinical narrative: Given Moderna Vaccine booster dose only Pediatric dose - Not Moderna Adult Omnicrom
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss--total loss of hearing in right ear
Sex: U
Vaccine: COVID19-2, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Shot administered roughly 5:25 PM *Continued to keep arm/injection site moving and mobile throughout the night to prevent pain.* 7:00 PM- Noticed unusual itching, upon further inspection the injection site had broken out in a patch of hives (roughly pepperoni-sized) Hives disappeared roughly 45 minutes to 1 hour later. Site remained red, swollen and tender for the rest of the day 8:45 AM on 12/10/2022: Took band-aids off of both influenza shot (no adverse effects) and Moderna vaccine. Moderna vaccine band-aid was significantly bloodier than a standard vaccine bandage (1/3 of the cotton pad was covered in blood).  9:30 AM, current time of writing: Site remains swollen and warm to the touch. Arm remains painful to move, moreso than a standard vaccine injection.
Sex: U
Vaccine: COVID19-2, UNK
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: Shot administered roughly 5:25 PM *Continued to keep arm/injection site moving and mobile throughout the night to prevent pain.* 7:00 PM- Noticed unusual itching, upon further inspection the injection site had broken out in a patch of hives (roughly pepperoni-sized) Hives disappeared roughly 45 minutes to 1 hour later. Site remained red, swollen and tender for the rest of the day 8:45 AM on 12/10/2022: Took band-aids off of both influenza shot (no adverse effects) and Moderna vaccine. Moderna vaccine band-aid was significantly bloodier than a standard vaccine bandage (1/3 of the cotton pad was covered in blood).  9:30 AM, current time of writing: Site remains swollen and warm to the touch. Arm remains painful to move, moreso than a standard vaccine injection.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pruritus, Pyrexia, Rash macular, Sensitive skin
Clinical narrative: Body aches and fever, skin sensitivity, itchy hands and feet that resulted in blotchy red patches. Patches are not raised, different to how my eczema has ever presented so likely not that.
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Cough, Influenza A virus test, Influenza B virus test, Oropharyngeal pain, SARS-CoV-2 RNA
Clinical narrative: Sore throat,  Sinus trouble, cough
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test, Sinus disorder, Streptococcus test
Clinical narrative: Sore throat,  Sinus trouble, cough
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Skin lesion, Skin papilloma
Clinical narrative: I have a huge wart or skin lesion that won't go away due to the vaccine.   Taking cream and ointment for treatment.   Not working.
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that had expired 48 hours prior to injection.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that had expired 48 hours prior to injection.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that had expired 48 hours prior to injection.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that had expired 48 hours prior to injection.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: The adverse effect started at around 11pm on the 9th with my arm getting sore, body getting sore, and starting to get a headache. When I woke up at 8am, my head was hurting at an 8 pain level, my skin hurt everytime something touched it, muscles are sore when I move, I get chills even though I'm sweating, and I feel nauseous constantly.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Pain of skin
Clinical narrative: The adverse effect started at around 11pm on the 9th with my arm getting sore, body getting sore, and starting to get a headache. When I woke up at 8am, my head was hurting at an 8 pain level, my skin hurt everytime something touched it, muscles are sore when I move, I get chills even though I'm sweating, and I feel nauseous constantly.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: PT REPORTS EXTREME PAIN IN ARM SHOULDER AND NECK STARTING EVENING OF RECEIVING SHOT. LASTED APPROXIMATELY 24 HOURS. ONLY OTHER SYMPTOM REPORTED IS FEVER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: mild reaction 2 hours after vaccinations, mmr, varicella, and hep a given, areas of injection was red, hot and swollen.  after 15 - 20 minutes are less redness and swelling advised to follow up 24 hrs.  follow up next day and adverse reaction with swelling and redness in upper thigh are resolved.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that had expired 48 hours prior to injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Patient had dizziness prior to vaccine which got worse after receiving vaccine. Has not tried any treatments. Dizziness is improving.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Arm was immediately tight and sore at injection but no shooting pain. Stiffness developed in arm and then shoulder. In the next few days, the shoulder on the right side became sore with acute pain. Neck on right side also became painful and tender. Then the shoulder improved slightly after one more week but shooting pain continued in right arm.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Skin tightness, Tenderness
Clinical narrative: Arm was immediately tight and sore at injection but no shooting pain. Stiffness developed in arm and then shoulder. In the next few days, the shoulder on the right side became sore with acute pain. Neck on right side also became painful and tender. Then the shoulder improved slightly after one more week but shooting pain continued in right arm.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Fatigue, Pyrexia, Respiratory viral panel, Seizure, Skin warm
Clinical narrative: Vaccines administered in clinic around 9:15AM on 12/8/22 Parents first noted tactile fever at home around 1PM and gave tylenol Grandmother checked axillary temp at home at 5 PM and was noted to be 100.9, second dose of tylenol was given Mother returned from work after and he felt very hot to touch, so was taken to the local ER due to fever and he had a rectal temperature of 103.4 around 9PM.  Received a dose of ibuprofen and within a few minutes began having seizure activity while in the ER and observed by ER staff/RNs.  Seizure was brief, whole body.  Had a period of fatigue after, but was able to awaken and take a bottle before discharge from the ER at 1AM on 12/9/22
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: dad asked for wrong drug , meant flu but said covid , and i gave covid
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling on left side of face.  Symptoms of GBS?.will continue to monitor over the next few days before contacting physician.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: COVID-19, Cough, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Caught covid.  Mild case.  Positive home tests. Congestion, runny nose, sore throat, coughing.  No fever.  Went to urgent care; got Paxlovid.  Symptoms better after about 5 days, tests negative by day 7.  About a week later, rebounded; symptoms and positive tests returned.  Did not treat second time (other than cough drops, acetaminophen).  Better after 5-7 days.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caught covid.  Mild case.  Positive home tests. Congestion, runny nose, sore throat, coughing.  No fever.  Went to urgent care; got Paxlovid.  Symptoms better after about 5 days, tests negative by day 7.  About a week later, rebounded; symptoms and positive tests returned.  Did not treat second time (other than cough drops, acetaminophen).  Better after 5-7 days.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event to report.  Reporting an adminstration error.  Error in dilution. Pfizer Bivalent Orange Cap was diluted with 1.3mL sterile water instead of 1.3ml sodium chloride. Patient was given correct dose (0.2mL).
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was supposed to get the second dose of the Pfizer primary series but patient was given the Pfizer Bivalent Booster.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient received pfizer monovalent vaccine as booster dose instead of bivalent. She is not experiencing any side effects or symptoms at this time.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Vaccination site pain
Clinical narrative: Pt. had shortness of breath and chest pain along with sore arms (left Arm) that's where the vaccine was administered and started around 10 pm.  Pt couldn't lay down due to worsen chest pain.  Around 12:30AM she called EMS. EMS came and gave her EKG and ruled out heart attack. They did not transport her to hospital, but told her to call if symptoms gets any worse. She slept sitting up all night. Her symptoms did not get any better but did not get any worse eiher.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: patient received pfizer monovalent instead of bivalent. No symptoms at this time.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Thrombocytopenia
Clinical narrative: Thrombocytopenia
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Patient is feeling flu like symptoms at this time.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: patient is experiencing flu like symptoms
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Gastrooesophageal reflux disease, Headache, Influenza like illness, Pyrexia
Clinical narrative: Acid reflux, flu-like aches & pains, headache, slight fever for 4 days (so far)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Electroencephalogram normal, Epilepsy, Laboratory test normal
Clinical narrative: Seizures/Epilepsy Fainting Spells
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Seizures/Epilepsy Fainting Spells
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Myocardial injury, Pulmonary thrombosis, Thrombosis
Clinical narrative: Diagnosed with blood clots in both lungs.  Caused damage to heart 3/18/2022.  Took blood thinner for 3 months.  Medical facility refused to scan in order to ensure all clots were gone.  Hosptized August 22, 2022. Large umbrella blood cot covering both lungs along with smaller clots in each lung.   Heart damaged even more.  According to Medical professionals I almost died.  Nothing but cover ups ever since.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Received injection in left upper arm about 10:30am at Pharmacy. About 5:00pm noticed itching on upper left chest. There were whelps and small bumps covering about a four inch square area.  Took a Benadryl and treated with cortisone cream.  Took another Benadryl before bed.  Still itching this am. More Benadryl and cream.  Same issues about noon. Another Benadryl.  Called Pharmacy. They told me if I started having breathing problems to go to emergency and told me to report to VAERS.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Myalgia
Clinical narrative: sore throat, cough, muscular aches & pains, fatigue, headache, slight fever
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: sore throat, cough, muscular aches & pains, fatigue, headache, slight fever
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Chills, Pain
Clinical narrative: patient came to the pharmacy stating that he had received his shingles and pneumonia vaccine 2 days ago and he had been experiencing body aches and chill at night time. He denied any rash, trouble breathing, or any other side effects. Patient stated that he was not taking any medication to treat the body aches or fever. He was advised to take some Tylenol or ibuprofen to help with his symptoms, and if the symptoms were to worsen and not get better to follow up with is provider.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Child was inadvertently given the Pfizer 5-11 bivalent booster at 0.2ml dose.  At her age she should have gotten Pfizer 12+ Bivalent booster.  Multiple members of family getting covid booster.  Both parents made aware of error.  Patient had no adverse reaction, received incorrect product/dose for booster.   No guidance from Pfizer given other than information provided through Pfizer (12/9/22)  Contacted parent to relay information, no return call or reply.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: no symptoms yet.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis, Anti-myelin-associated glycoprotein antibodies positive, Coma, Endotracheal intubation, Malaise
Clinical narrative: Day after vaccination pt reported bodyaches, malaise, mild respiratory symptoms. By 10/25 had blurred vision, urinary retention, then collapsed and required intubation. Became comatose. subsequent evaluation showed evidence of ADEM syndrome, with MOG antibodies. Pt currently in long-term rehab, some improvement but still on vent, little neuromuscular function
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Mechanical ventilation, Myelin oligodendrocyte glycoprotein antibody-associated disease, Neuromyopathy, Pain, Respiratory symptom
Clinical narrative: Day after vaccination pt reported bodyaches, malaise, mild respiratory symptoms. By 10/25 had blurred vision, urinary retention, then collapsed and required intubation. Became comatose. subsequent evaluation showed evidence of ADEM syndrome, with MOG antibodies. Pt currently in long-term rehab, some improvement but still on vent, little neuromuscular function
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope, Urinary retention, Vision blurred
Clinical narrative: Day after vaccination pt reported bodyaches, malaise, mild respiratory symptoms. By 10/25 had blurred vision, urinary retention, then collapsed and required intubation. Became comatose. subsequent evaluation showed evidence of ADEM syndrome, with MOG antibodies. Pt currently in long-term rehab, some improvement but still on vent, little neuromuscular function
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: UPPER ARM PAIN DEVELOPED IN THE MID-AFTERNOON, A FEW HOURS AFTER THE INJECTION, GOT WORSE OVER THE NEXT SEVERAL HOURS AND IS NOW STABLE/UNCHANGING. PATIENT STATES PAIN IS AT SITE OF INJECTION AND IS CURRENTLY LIMITING RANGE OF MOTION.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: My daughter was supposed to receive the updated bivalent booster.  I confirmed the information was correct on the paperwork I signed and also verbally confirmed with the pharmacist administering the shot.  She said she was "absolutely sure" it was the Moderna updated booster.  It was not.  My daughter received the primary Moderna formula.