chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: COVID-19, Malaise, Product dose omission issue
Clinical narrative: the patient then got sick with Covid 5 days after administration resulting in missing the 2nd dose; the patient then got sick with Covid 5 days after administration resulting in missing the 2nd dose; Initial information received from Regulatory Authority on 02-Jan-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 20 years old female patient who got sick with covid 5 days after administration resulting in missing the 2nd dose of Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2023, the patient received 1 ml (Dose 1) of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (lot number: 768914) (Expiry date: 22-Nov-2024) (Strength: Standard) (Frequency: once) via intramuscular route in the left arm for immunization.  On an unknown date, the patient got sick with covid 5 days after administration resulting in missing the 2nd dose of Rabies (Hdc) Vaccine [Imovax Rabies] (covid-19; latency: 5 days) (inappropriate (product dose omission issue; latency: same day).     It was reported, Call received from pharmacist with questions regarding deviating from IMOVAX schedule for pre-exposure dosing. Caller reporting the first dose was administered on 13DEC2023, the patient then got sick with Covid 5 days after administration resulting in missing the 2nd dose. This situation is pre-assessed as a medication error/an inappropriate use due to patient missing 2nd dose in IMOVAX dosing schedule and the patient getting sick with COVID 5 days post receiving dose of IMOVAX. No further information provided by the reporter.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event COVID-19.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the liquid DTAP and IPOL portion was given and they were not able to give the powder Act-HIB with no reported adverse event; Initial information received from country on 03-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient and reporter reported only the liquid dtap and ipol portion of vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was given and they were not able to give the powder act-hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine) For Prophylactic Vaccination; Pneumococcal Vaccine (Pneumococcal Vaccine) For Prophylactic Vaccination; And Rotavirus Vaccine (Rotavirus Vaccine) For Prophylactic vaccination.  On 23-Dec-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ869AA) (Expiry date: 23-Mar-2024) (Strength: Standard) (Frequency: Once) via intramuscular route in the upper left thigh for immunization.  On 23-Dec-2023, the only the liquid dtap and ipol portion of vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was given to patient and they were not able to give the powder act-hib with no reported adverse event (product preparation error) (Latency: same day).  It was reported,  Medical assistant called and reports that PENTACEL was administered incorrectly on 23Dec2023. Authority reports that only the liquid DTAP and IPOL portion was given and they were not able to give the powder Act-HIB. Caller would like to order the diluent for the Act-HIB.   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 and Module of the 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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 68-year old patient received a second dose of fluzone high dose Quadrivalent inadvertently with no reported adverse event; Initial information was received on 04-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68-year old female patient received a second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2023, the patient received a unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, expiry date, lot number not reported) via unknown route in the right arm. On 04-Jan-2024 she also received a dose of the same vaccine  lot UT8137BA via unknown route in the right arm for prophylactic vaccination (Immunization) and 68-year old patient received a second dose of fluzone high dose quadrivalent inadvertently with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 68-year old patient received a second dose of fluzone high dose quadrivalent inadvertently 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Autoimmune disorder, Chest pain, Diplopia, Inflammation
Clinical narrative: ? Within two weeks I had tinnitus ? Within two months I had sharp shooting pains up and down the left side of my body mostly in my arms and legs ? Within three months my feet and hands would swell up and be very painful in the morning ? Within six months I was experiencing quite extreme double vision  ? Within six months I was diagnosed with an indeterminate Auto Immune disorder ? After eight months I wound up in the ER with inflammation and swelling of my chest and chest pains ? To date, I?ve had horrible nerve pain and damage on my left side mostly effecting my neck from upper left back through to behind my ear and side of my neck. I recently spent $2,000 on 10 sessions of acupuncture that did help the neck pain but it is coming back. ? My latest symptom is pins and needles and itching all over
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Neck pain, Nerve injury, Neuralgia, Pain
Clinical narrative: ? Within two weeks I had tinnitus ? Within two months I had sharp shooting pains up and down the left side of my body mostly in my arms and legs ? Within three months my feet and hands would swell up and be very painful in the morning ? Within six months I was experiencing quite extreme double vision  ? Within six months I was diagnosed with an indeterminate Auto Immune disorder ? After eight months I wound up in the ER with inflammation and swelling of my chest and chest pains ? To date, I?ve had horrible nerve pain and damage on my left side mostly effecting my neck from upper left back through to behind my ear and side of my neck. I recently spent $2,000 on 10 sessions of acupuncture that did help the neck pain but it is coming back. ? My latest symptom is pins and needles and itching all over
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus, Swelling
Clinical narrative: ? Within two weeks I had tinnitus ? Within two months I had sharp shooting pains up and down the left side of my body mostly in my arms and legs ? Within three months my feet and hands would swell up and be very painful in the morning ? Within six months I was experiencing quite extreme double vision  ? Within six months I was diagnosed with an indeterminate Auto Immune disorder ? After eight months I wound up in the ER with inflammation and swelling of my chest and chest pains ? To date, I?ve had horrible nerve pain and damage on my left side mostly effecting my neck from upper left back through to behind my ear and side of my neck. I recently spent $2,000 on 10 sessions of acupuncture that did help the neck pain but it is coming back. ? My latest symptom is pins and needles and itching all over
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ? Within two weeks I had tinnitus ? Within two months I had sharp shooting pains up and down the left side of my body mostly in my arms and legs ? Within three months my feet and hands would swell up and be very painful in the morning ? Within six months I was experiencing quite extreme double vision  ? Within six months I was diagnosed with an indeterminate Auto Immune disorder ? After eight months I wound up in the ER with inflammation and swelling of my chest and chest pains ? To date, I?ve had horrible nerve pain and damage on my left side mostly effecting my neck from upper left back through to behind my ear and side of my neck. I recently spent $2,000 on 10 sessions of acupuncture that did help the neck pain but it is coming back. ? My latest symptom is pins and needles and itching all over
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given spikevax after beyond use date
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient received spikevax after beyond use date
Age: 38.0
Sex: M
Vaccine: MNQ, PNC20
Symptoms: Injection site pain
Clinical narrative: Significant left arm pain near site of PCV20 injection, persistent for more than 2 weeks
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Neuralgia, Pain, Pain in extremity, Radiculitis brachial
Clinical narrative: He reports that about 4 days later, or approximately 10-7-23, he woke up with shoulder/elbow pain, and shooting pains in both arms, worse on the left side. He said it is still painful, more so at night, when he gets more of the shooting pains.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Extensive swelling on upper extremity from shoulder to elbow. Hot, read, circumference 4cm larger than opposite arm.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging normal, Mobility decreased, Nerve conduction studies abnormal, Nerve injury
Clinical narrative: On nov 29 I woke up at midnight with severe pain in left shoulder ,  it went on for a week or so  on December 9 I couldn?t lift left arm! Went to urgent care and they referred me to orthopaedic,Dr did mri ; it showed no rotator cuff tear I was referred to Dr for nerve test it showed damaged nerve in neck and he diagnosed me with Parsonage-Turner Syndrome
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy, Sleep disorder
Clinical narrative: On nov 29 I woke up at midnight with severe pain in left shoulder ,  it went on for a week or so  on December 9 I couldn?t lift left arm! Went to urgent care and they referred me to orthopaedic,Dr did mri ; it showed no rotator cuff tear I was referred to Dr for nerve test it showed damaged nerve in neck and he diagnosed me with Parsonage-Turner Syndrome
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given undiluted vaccine
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product substitution error
Clinical narrative: Patient was given VFC dose on 10/6/23. Patient is 19 years old not VFC eligible. No symptoms reactions.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: No immediate adverse events noted. Pt currently hospitalized with COVID-19 infection requiring oxygen despite having received 4 doses of COVID-19 vaccine, last being in 2022.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Fatigue, Migraine, Serum ferritin decreased
Clinical narrative: Severe fatigue, development of anemia, ferritin level dropped to 4, and a large increase in the number of migraine headaches.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash, Skin exfoliation
Clinical narrative: PEALING OF SKIN TO INJECTION SITE WITH SWELLING AND REDNESS, RASH TO NECK AND SHOULDERS.
Age: 64.0
Sex: U
Vaccine: RSV
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: Headache, Red and hot feeling at injection site
Age: 80.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Resident is experiencing hives over extremities, right hand swollen and red, c/o itching. Benadryl 25 mg Q 6 hours PRN for hives and itching. Symptoms started on 1/7/2024.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Guillain - Barre Syndrome; intense pain in right thigh and down the leg
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure decreased, Dizziness, Gait disturbance, Immediate post-injection reaction, Injection site pain
Clinical narrative: This was an RSV vaccine.  As soon as the syringe entered my arm, I felt heat and extreme pain at the injection site.  I sat down and after about 5-10 minutes felt lightheaded, dizzy, and could not walk by myself.  My BP dropped to 80/50.  After another 2-3 minutes, I felt normal.  The pharmacist told me to ask my MD about possible glucose issues; my MD said it was a vasovagel response.  I have had all 5 COVID vaccines and get yearly flu shots and have never responded like this before.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Presyncope
Clinical narrative: This was an RSV vaccine.  As soon as the syringe entered my arm, I felt heat and extreme pain at the injection site.  I sat down and after about 5-10 minutes felt lightheaded, dizzy, and could not walk by myself.  My BP dropped to 80/50.  After another 2-3 minutes, I felt normal.  The pharmacist told me to ask my MD about possible glucose issues; my MD said it was a vasovagel response.  I have had all 5 COVID vaccines and get yearly flu shots and have never responded like this before.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis reaction and allergies; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction and allergies". The patient called to report because she had an anaphylaxis reaction to the original Pfizer COVID vaccine and allergies. She looked at the ingredients in the Pfizer and the 2nd recent booster is safe for her and had no reaction and she was trying to find out if the most current booster has the similar formulation with the 2nd recent booster.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Epistaxis, Petechiae, Platelet count decreased, Skin haemorrhage
Clinical narrative: Bloody nose Bleeding with shaving diffuse petechiae UE, LE face abdomen Platelet count * less than 1 Seen in primary care office -> blood work revealed PLT count <1 to ER
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; I am looking for information on PNEUMOVAX23 and the expiration date and a patient; This spontaneous report has been received from a health care professional and referred to an unidentified patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an expired pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided) (expired product administered). No additional adverse events were reported (no adverse event).  This is a non-valid case due to the lack of patient's identifiers.  Follow-up was received from the nurse (previously reported as a health care professional) referring to the patient on 03-JAN-2024. The patient was vaccinated with the expired pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (lot# W015900, expiration date was 20-OCT-2023) in December 2023.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope, fainted while urinating standing up; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Syncope, fainted while urinating standing up) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SYNCOPE (Syncope, fainted while urinating standing up) (seriousness criterion medically significant). On 21-Dec-2023, SYNCOPE (Syncope, fainted while urinating standing up) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported. Company Comment: This is a spontaneous case concerning a 62-year-old male patient with no reported medical history, who experienced the serious (due to medically significant), event of Syncope, which occurred on the following day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that patient had syncope, fainted while urinating standing up. The outcome of the event was reported as recovered. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 47-year-old female patient (not pregnant) received BNT162b2 omi XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered with sequelae" (Dec2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of events which included nirmatrelvir/ritonavir (PAXLOVID) from 15Dec2023 to 19Dec2023 as antiviral treatment.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 70-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ritonavir (PAXLOVID) from 17Dec2023 to 21Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic myeloid leukaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 12Dec2023 to 17Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective as patient received Paxlovid.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given as treatment from 19Dec2023 to 24Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 26.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: I became extremely ill. 103 fever, body ache, chills. I will never get a flu vaccine again.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; inadvertent administration of expired MMR-II to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-JAN-2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (lot#: U039907, expiration date: 16-DEC-2023; strength and route of administration were not provided) inadvertently by a health professional for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling, Sleep disorder
Clinical narrative: There was initial soreness and minimal swelling. The swelling has resided but arm is still sore even when not using it. I have limited motion. When arm is rotated up and or above head there is a piercing pain in my arm. Also, when performing activities or lifting I have to be careful because if pain strikes may let go with ny left hand due to unexpected pain. I cannot sleep on my left side now due to pain it causes in arm. When getting up from chair or floor my left arm is almost no help at all, as I have to favor it all the time. I am calling my doctor today to see what a resolve will be for this issue.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: RIGHT LYMPH GLANDS IN AXILLA SWELLED AND WERE VERY SORE FOLLOWING FLU VACCINE. SEVERE DISCOMFOT X3 DAYS AND AFFECTED ENTIRE RIGHT ARM.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Neuralgia
Clinical narrative: Patient reports having neuropathic arm pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Headache, Injection site erythema, Insomnia
Clinical narrative: Chills, severe headache, unable to sleep, nausea, felt very disoriented, redness at vaccine location. Lasted 1 full day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Chills, severe headache, unable to sleep, nausea, felt very disoriented, redness at vaccine location. Lasted 1 full day.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Coronary artery disease, Dehydration, Diabetes mellitus inadequate control
Clinical narrative: Hospitalization for pneumonia (COVID-19 positive 10 days later, negative on admission), acute renal failure, dehydration, hypertension, coronary artery disease, uncontrolled diabetes on dates 12/20/2023- 1/3/2024. Treated with dexamethasone.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for pneumonia (COVID-19 positive 10 days later, negative on admission), acute renal failure, dehydration, hypertension, coronary artery disease, uncontrolled diabetes on dates 12/20/2023- 1/3/2024. Treated with dexamethasone.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Goitre, Syncope, Thrombocytopenia
Clinical narrative: Hospitalization for COVID-19 infection with acute hypoxic respiratory failure, syncope, thrombocytopenia, multinodular goiter on dates 1/1/2024- 1/5/2024. Treated with dexamethasone, Remdesivir, vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Chest X-ray abnormal, Fall, Malaise, Pneumonia
Clinical narrative: Patient expressed to physician after injection of Prevnar 20 they had gotten sick and fell. They expressed they had gone to urgent care and had "Traces of pneumonia" on chest x-ray in their urgent care.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Nasal congestion, Pain, Respiratory tract congestion
Clinical narrative: Starting within a week of the vaccination and continuing to present day, pt experiencing nasal congestion, chest congestion, and body aches. Has been treated with amoxicillin starting 12/6/23 without any change in symptoms.
Age: 71.0
Sex: M
Vaccine: FLUR4, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Event: patient was wanting to get Covid vaccine and was given RSV vaccine instead. Treatment: patient did not have any issues with the RSV vaccine. Outcome: patient came in on 1/9/2024 and received the correct vaccine
Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Hep B ordered in chart; Prevnar 20 given. No adverse reaction and no treatment necessary
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry throat, Erythema, Feeling cold, Feeling hot
Clinical narrative: She got her vaccine and she felt a warmth going through her body and felt jittery.  It passed and was fine for the rest of the day Friday and felt fine but did have extreme chills, which has had prior with the COVID vaccines and just felt weak and jittery.  Saturday morning her arm was extreme sore, was cold, and was extremely red, flame red and warm.   Sunday her arm was swollen and red and itched like crazy.  Monday morning she woke up about 6:45 and was on the toilet, her body started sweating, her throat was dry and then she passed out.  She had the shower curtain at that part of the bathtub and fell into the shower curtain and that save her.  She does not know how long she was in and came about and managed to do that.  It has not affected her appetite and has been sleeping good.  She was sitting on the toilet again and felt funny again this morning and while she was walking around her body felt jittery and felt jittery inside.  Today the redness is barely red today, does not itch, and the jitteriness is not real bad but still has it.  She did not call her doctor at all, but did call the pharmacist where she got the shot, and he asked her what her BP was and felt that her lower # was low, and told her to take Tylenol which she did to help with the swelling and soreness, and told her to call back if she had anymore questions.  He also told her to drink a lot of water in case she was dehydrated, which she did yesterday and today as well.  Today it is almost back to normal.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Hyperhidrosis, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: She got her vaccine and she felt a warmth going through her body and felt jittery.  It passed and was fine for the rest of the day Friday and felt fine but did have extreme chills, which has had prior with the COVID vaccines and just felt weak and jittery.  Saturday morning her arm was extreme sore, was cold, and was extremely red, flame red and warm.   Sunday her arm was swollen and red and itched like crazy.  Monday morning she woke up about 6:45 and was on the toilet, her body started sweating, her throat was dry and then she passed out.  She had the shower curtain at that part of the bathtub and fell into the shower curtain and that save her.  She does not know how long she was in and came about and managed to do that.  It has not affected her appetite and has been sleeping good.  She was sitting on the toilet again and felt funny again this morning and while she was walking around her body felt jittery and felt jittery inside.  Today the redness is barely red today, does not itch, and the jitteriness is not real bad but still has it.  She did not call her doctor at all, but did call the pharmacist where she got the shot, and he asked her what her BP was and felt that her lower # was low, and told her to take Tylenol which she did to help with the swelling and soreness, and told her to call back if she had anymore questions.  He also told her to drink a lot of water in case she was dehydrated, which she did yesterday and today as well.  Today it is almost back to normal.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: She got her vaccine and she felt a warmth going through her body and felt jittery.  It passed and was fine for the rest of the day Friday and felt fine but did have extreme chills, which has had prior with the COVID vaccines and just felt weak and jittery.  Saturday morning her arm was extreme sore, was cold, and was extremely red, flame red and warm.   Sunday her arm was swollen and red and itched like crazy.  Monday morning she woke up about 6:45 and was on the toilet, her body started sweating, her throat was dry and then she passed out.  She had the shower curtain at that part of the bathtub and fell into the shower curtain and that save her.  She does not know how long she was in and came about and managed to do that.  It has not affected her appetite and has been sleeping good.  She was sitting on the toilet again and felt funny again this morning and while she was walking around her body felt jittery and felt jittery inside.  Today the redness is barely red today, does not itch, and the jitteriness is not real bad but still has it.  She did not call her doctor at all, but did call the pharmacist where she got the shot, and he asked her what her BP was and felt that her lower # was low, and told her to take Tylenol which she did to help with the swelling and soreness, and told her to call back if she had anymore questions.  He also told her to drink a lot of water in case she was dehydrated, which she did yesterday and today as well.  Today it is almost back to normal.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematochezia, Headache, Nausea
Clinical narrative: The evening of the vaccine patient developed headaches, nausea and hematochezia. This persisted 3 days and then stopped spontaneously.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy
Clinical narrative: Positive pregnancy tests on 1/4, 1/5, and 1/8. Vaccine administered on 1/5.  Miscarriage started 1/9.  Est due date was 09/14.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test, Product administration error
Clinical narrative: Positive pregnancy tests on 1/4, 1/5, and 1/8. Vaccine administered on 1/5.  Miscarriage started 1/9.  Est due date was 09/14.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Dysstasia, Tremor
Clinical narrative: weak, trouble standing up, shakey - went away after 24 hours
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: High level of fatigue, body/muscle aches, tiredness, significant nausea, slight dizziness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Contusion, Diarrhoea, Lymphadenitis
Clinical narrative: Day 1-3 : pain in arm, as well as occasional shooting nerve pains off and on,  shivering off and on.  Diarrhea. No fever. 1/8/24 evening had pain at back of armpit which moved with 2 hours to the armpit with inflamed /swollem lymph node and pain/swelling at armpit and toward front of armpit instead of rear. Two bruises appeared. Will see PC this afternoon.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Neuralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Day 1-3 : pain in arm, as well as occasional shooting nerve pains off and on,  shivering off and on.  Diarrhea. No fever. 1/8/24 evening had pain at back of armpit which moved with 2 hours to the armpit with inflamed /swollem lymph node and pain/swelling at armpit and toward front of armpit instead of rear. Two bruises appeared. Will see PC this afternoon.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Patient reported that she had most recent Moderna Covid vaccine and flu shot at 12:30pm on Sunday 01/07/2024, then spiked a fever a couple of hours after Tymlos was injected at 9:30pm of 102.5 F. She also stated that she had headache and achy joints the next day in addition to a fever of 103.2 F the night of 01/08/24. She states that she has been on Tylenol for symptom relief during the day, yesterday (during the day, body temperature of 100.5 F to 99 F) and today (no fever), and that it has been pretty effective and currently is not having any symptoms. I advised that there is no mention of increased risk of infection and or elevated body temperature with Tymlos per the manufacturer insert but that it may be possible it played a role in her symptom development.
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Underdose
Clinical narrative: No signs or symptoms.  Pt was mistakenly given the pediatric vaccine.  Pt was given 0.5 mL of the moderna covid 19 vaccine for 6m through 11years.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Patient is currently between 32-36 weeks of pregnancy. Date of delivery and birth weight is unknown at this time. Patient was supposed to receive RSV Abrysvo, we correctly billed for the vaccine but unfortunately the incorrect vaccination was pulled and administed, the RSV Arexvy.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Palpitations, Pharyngeal swelling, Pruritus, Swelling
Clinical narrative: Hives on majority of body, itching, heart palpitations, pale skin, swollen face and some on body, swollen throat    .
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives on majority of body, itching, heart palpitations, pale skin, swollen face and some on body, swollen throat    .
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Hypoaesthesia, Skin discolouration
Clinical narrative: Patient experienced chills starting Friday and still has chills today.  Saturday was typing and middle finger of right hand started to turn white and from the tip to 3/4 of the way down the finger and was numb. She rubbed it and ran it under warm water for approx 15 minutes and everything returned to normal. This happened again Sunday once and Monday once.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Condition aggravated, Decreased appetite, Dizziness
Clinical narrative: Pain, redness, swelling at injection site, muschle and joint pain, fever 101 at the highest, then chills, then the nausea, and the reflux, the decreased appetite, then the swelling and sore lymph nodes, headache. I have a history of palpitations, so my heart had palpitations. I got the dizziness. I had the spiking in my blood pressure, and neurological symptoms. I didn't get out of bed. This was great cause I slept a lot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling at injection site, muschle and joint pain, fever 101 at the highest, then chills, then the nausea, and the reflux, the decreased appetite, then the swelling and sore lymph nodes, headache. I have a history of palpitations, so my heart had palpitations. I got the dizziness. I had the spiking in my blood pressure, and neurological symptoms. I didn't get out of bed. This was great cause I slept a lot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Mobility decreased, Myalgia
Clinical narrative: Pain, redness, swelling at injection site, muschle and joint pain, fever 101 at the highest, then chills, then the nausea, and the reflux, the decreased appetite, then the swelling and sore lymph nodes, headache. I have a history of palpitations, so my heart had palpitations. I got the dizziness. I had the spiking in my blood pressure, and neurological symptoms. I didn't get out of bed. This was great cause I slept a lot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neurological symptom, Palpitations, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site, muschle and joint pain, fever 101 at the highest, then chills, then the nausea, and the reflux, the decreased appetite, then the swelling and sore lymph nodes, headache. I have a history of palpitations, so my heart had palpitations. I got the dizziness. I had the spiking in my blood pressure, and neurological symptoms. I didn't get out of bed. This was great cause I slept a lot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mass, Pain in extremity
Clinical narrative: Pt presented to the clinic 1/5/24 with complaints of right arm pain and discomfort affecting ADLs such as pushing since receiving the COVID vaccine on 11/1/23.  There is a lump in the area.  Prescribed oral Celebrex and topical Diclofenac.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Progressive numbness and tingling followed by weakness. Hospitalized on 1/8 and Guillain-Barre Syndrome diagnosed on 1/9
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Mistakenly an extra dose of Flu vaccine administered same day , no reaction has shown during the observation for 15 minutes after vaccination
Age: 13.0
Sex: M
Vaccine: FLUA4, HPV9
Symptoms: Asthenia, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Had an immediate syncopal event-  regained consciousness after about 10 seconds but was pale and diaphoretic.  Vitals were stable, drank juice and took about 15 minutes to feel able to sit up.  Felt very weak after event.
Age: 13.0
Sex: M
Vaccine: FLUA4, HPV9
Symptoms: Syncope
Clinical narrative: Had an immediate syncopal event-  regained consciousness after about 10 seconds but was pale and diaphoretic.  Vitals were stable, drank juice and took about 15 minutes to feel able to sit up.  Felt very weak after event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dermal cyst, Fatigue, Malaise, Pruritus
Clinical narrative: PATIENT REPORTS 1 TO 2 DAYS FOLLOWING VACCINE ADMINISTRATION ITCHY SCALP, DESCRIBED BENIGN CYSTS FORMING ON BACK OF HEAD, NECK, AND SHOULDER BLADES (WARM TO THE TOUCH). ALSO REPORTED COUGH AND FATIGUE/MALAISE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: PATIENT REPORTS 1 TO 2 DAYS FOLLOWING VACCINE ADMINISTRATION ITCHY SCALP, DESCRIBED BENIGN CYSTS FORMING ON BACK OF HEAD, NECK, AND SHOULDER BLADES (WARM TO THE TOUCH). ALSO REPORTED COUGH AND FATIGUE/MALAISE.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore throat, nasal congestion on 1/7/2024 then fever 1/9/2024
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient came in today 01/09/2024 stating she would like to report an adverse reaction as a result of the Shingrix vaccine she received in 06/03/2023. The patient stated that ever since then she has been experiencing muscle pain in the injection site result in pain during backward arm movements.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Erythema, pain, swelling beginning hours after vaccination worsening overnight to include shoulder to elbow pain with limited range of motion, swelling, heat, and scattered erythematous areas.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Erythema, pain, swelling beginning hours after vaccination worsening overnight to include shoulder to elbow pain with limited range of motion, swelling, heat, and scattered erythematous areas.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient called on 1/8/24 to inform me the injection site is hard and hot to the touch. with a rash around the area roughly 2.5 inch in diameter at the time of the call. Site is sore when she presses on it and itches.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Blood test, CSF protein increased, CSF test abnormal, Constipation, Enzyme level increased
Clinical narrative: He got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs.  He called his doctor, that he thought it was a sciatic nerve.  They felt it was something more serious.  His neighbor is a neurosurgeon, who directed him to another hospital ER.  In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40.  He was hospitalized for 16-17 days.  He had 7 treatment of plasmapheresis, and was discharged on 12/29/23 to a rehab center.  The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles.  It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange.  He was in the hospital for 17 days, and now has been in the rehab center since 12/29/23 and is supposed to be there until 1/20/24 where he will be able to go home.  They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging head, Muscular weakness, Plasmapheresis, Sensory loss
Clinical narrative: He got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs.  He called his doctor, that he thought it was a sciatic nerve.  They felt it was something more serious.  His neighbor is a neurosurgeon, who directed him to another hospital ER.  In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40.  He was hospitalized for 16-17 days.  He had 7 treatment of plasmapheresis, and was discharged on 12/29/23 to a rehab center.  The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles.  It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange.  He was in the hospital for 17 days, and now has been in the rehab center since 12/29/23 and is supposed to be there until 1/20/24 where he will be able to go home.  They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.