chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pregnancy test
Clinical narrative: This is a literature report for the following literature source Vulvar Aphthous Ulcers in an Adolescent After Coronavirus Disease 2019 (COVID-19) Vaccination, Obstetrics and Gynecology. A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "menarche" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: APHTHOUS ULCER (medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "vulvar aphthous ulcers". The event "vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Body temperature: afebrile; Heart rate: 101, notes: isolated; Herpes simplex: negative; Polymerase chain reaction: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Pregnancy test: negative. Therapeutic measures were taken as a result of aphthous ulcer. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003379. A female patient received BNT162b2 (BNT162B2), in 2021 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: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "Had an allergic reaction". Additional information: Adverse event information: On 05Sep2022, it was reported that a patient started treatment on an unspecified date in 2021 with Pfizer BioNTech COVID-19 vaccine at unspecified dose for an unspecified indication. It was reported the patient had an allergic reaction to Pfizer over a year ago. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Illness
Clinical narrative: got really sick; she could barely walk; her body was falling apart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "got really sick"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "she could barely walk"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "her body was falling apart". Additional information: Reporter says she got her first and second shot of the Pfizer COVID-19 vaccine and got really sick - she could barely walk and her body was falling apart. She said she would like to be connected to the legal department because doesn't want to get into a class action lawsuit and wants to be paid the money so she could contain her medical bills since she was sick for 2 years and 2 months.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: i cant say its unquie although it made me sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "unknown", described as "i cant say its unquie although it made me sick".  Additional information: On the question of what makes the Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines, the patient responded i cant say its unquie although it made me sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient experienced redness and swelling at injection site following vaccination with PCV20.; Patient experienced redness and swelling at injection site following vaccination with PCV20.; Patient was fine after pain/swelling subsided after a couple of days.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "Patient experienced redness and swelling at injection site following vaccination with PCV20."; PAIN (non-serious), outcome "recovering", described as "Patient was fine after pain/swelling subsided after a couple of days.".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; The initial case was missing the following minimum criteria: Other-info not qualifying for AE reporting - All other source.Upon receipt of follow-up information on 22Sep2022, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  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: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, Thrombosis
Clinical narrative: blood clots; headaches; diplopia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in 2021 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: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of thrombosis, headache, diplopia. Clinical course: During a routine phone call, the patient described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient is an adult male approximately 40 years old. Patient describes symptoms of headaches, diplopia and blood clots that he recalls following vaccine doses and is actively being treated by his physician. Events took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201184242 same patient/product/event, different dose number;US-PFIZER INC-202201184241 same patient/product/event, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Off label use
Clinical narrative: off label use; Interchange of vaccine product; The last one they got was the Pfizer because she was hoping she wouldn't get sick but did get really really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024492 (Moderna), 149206 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack" (unspecified if ongoing); "stroke" (unspecified if ongoing); "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PRADAXA; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; LATUDA; ASPIRIN [ACETYLSALICYLIC ACID]; SENNA [SENNA ALEXANDRINA LEAF]; COLACE; KLONOPIN; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]. Vaccination history included: coviD-19 vaccine moderna (Dose:01, Lot: 024M20A), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache"; coviD-19 vaccine moderna (Dose:02, Lot: 038A21A), administration date: 13Mar2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "head felt like a ocean", "very very dizzy", "headache"; coviD-19 vaccine moderna (Dose:03, Lot: 0466210), administration date: 24Oct2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache"; coviD-19 vaccine moderna (Dose:04, Lot: 064L21A), administration date: 29Apr2022, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine product"; ILLNESS (non-serious), outcome "unknown", described as "The last one they got was the Pfizer because she was hoping she wouldn't get sick but did get really really sick".  Additional information: Two blood pressure meds  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: sore; red circle; warm to the touch; headache; fatigue; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary immunization series completed., Unknown manufacturer.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore"; RASH MACULAR (non-serious), outcome "unknown", described as "red circle"; FEELING HOT (non-serious), outcome "unknown", described as "warm to the touch"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: On an unknown date, the patient experienced red circle, warm to the touch, sore, headache, fatigue and joint pain which took place after use of product.  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: F
Vaccine: COVID19-2
Symptoms: Rash macular
Clinical narrative: sore; red circle; warm to the touch; headache; fatigue; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary immunization series completed., Unknown manufacturer.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore"; RASH MACULAR (non-serious), outcome "unknown", described as "red circle"; FEELING HOT (non-serious), outcome "unknown", described as "warm to the touch"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: On an unknown date, the patient experienced red circle, warm to the touch, sore, headache, fatigue and joint pain which took place after use of product.  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.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Gait inability, Pyrexia, Vomiting
Clinical narrative: Profound vomiting for 6-8 hours High fever >100°F for 30 hours Extreme dizziness, could not walk without aid or holding wall or other object to avoid falling  for 36 hours post shot  Extreme fatigue  for several days
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave Patient a high dose flu vaccine instead of the regular dose for his age.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bursitis, Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Bursitis-Severe, Additional Details: Patient called and said she can't lift her arm and now has bursitis
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Additional Details: anxiety attack
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Red circle, raised and hard about the size of a kiwi
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Flushing, Hyperhidrosis, Hyperventilation, Nausea
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Additional Details: pt unable to tell if vaccine reaction or anxiety attack
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling on the left arm-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: I gave patient a Cetirizine 10mg and an ice package as she complained of tingling on left arm. I monitored her for 35 minutes and she felt better and left. She said it happened after her second Moderna vaccine as well.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hypocalcaemia, Muscle spasms
Clinical narrative: Patient admitted 9-23-22 to medical center with complaints of generalized muscle cramps and hypocalcemia.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site reaction, Injection site swelling, Muscle mass, Oedema
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Pitting of the skin at injection site.  Chief Complaint of it being visually unappealing-Medium, Additional Details: Patient has what looks like loss of muscle mass in the area of injection.  The skin is pitted in an area of a couple of inches wide.  She stated that she has no additional weakness or loss of range of motion.  No pain or abnormal swelling after injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: 1st dose - nerve twitching in nose lasting for about 3 hours after receiving.  2nd dose - nerve twitching in arms and legs lasting for several hours after receiving.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Tremor
Clinical narrative: 1st dose - nerve twitching in nose lasting for about 3 hours after receiving.  2nd dose - nerve twitching in arms (shaking when resting elbow on table) and legs (thigh area when sitting) lasting for several hours after receiving.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: Systemic: numbing on the tip of the tongue than spread to both sides-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt reported tingling at the tip of the tongue and then spread to both sides. Monitored the pt for an hour and one side of the tingling on the tongue has subsides. Advise pt to seek medical care if experience throat swelling, rash, diffult breathing.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Extra dose administered, Injection site pain, Nausea, Somnolence
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: sleepy the night of injection-Mild, Systemic: Nausea-Mild, Additional Details: pt contacted  to report adverse rxn . pt is familiar and would like to report it.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Flushing, Hyperhidrosis, Staring, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received 2 vaccinations, the moderna bivalent and the fluzone high dose in the left arm.  A few minutes to 5 minutes after the second vaccine the patient still sitting upright froze, staring forward, unresponsive. This lasted for about a minute or so, then he came to and said he fell asleep. He remained upright. We stayed with the patient and called emergency just to make sure he was ok. The paramedics determined that he passed out from vaccine, once recovered he left on his own.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case   dose 1 Janssen  4/9/21  041A21A
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Local AE: Pain at injection site, bad enough to prevent normal movement (rate 6.5/10)  Systemic AE: moderate headache, moderate fatigue, chills I'm taking ibuprofen and it helps with all the side effects.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HOSPITALIZED WITH COVID
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and erythema below injection location.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt  had orders to receive the Rabies Vaccine series. Instead of receiving day 14 dose on 9/9/22, patient received this dose on day 11. (9/5/22)
Sex: U
Vaccine: COVID19-2
Symptoms: Medication error
Clinical narrative: Medication error
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/24/21, 3/25/21. Pfizer 11/19/21. Positive on 9/26/22
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Patient reports headache, body aches, pain, and exhaustion lasting around 36 hours.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 62 years old and received a Fluzone Quad High Dose vaccine. According to CDC:  Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: High dose influenza vaccine given to a patient at age 60 years
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Mobility decreased, Pain
Clinical narrative: Starting the day after receiving the vaccine, I was very tired in the morning and my arms were very sore. It wasn't until the early afternoon that I really felt poorly. I felt extremely tired, my joints were achy and upon awakening from a nap, my joints on the right side of my body were agonizingly painful. It was difficult to move due to the severity of the pain. I called my son (an ER doctor) and asked for advice/medicine. I took some oxycodone (that was already in the house from a previous surgery) and TYLENOL which helped. When I woke up the next morning, I felt much better. I did not need to take any additional dose of oxycodone.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain in extremity
Clinical narrative: Starting the day after receiving the vaccine, I was very tired in the morning and my arms were very sore. It wasn't until the early afternoon that I really felt poorly. I felt extremely tired, my joints were achy and upon awakening from a nap, my joints on the right side of my body were agonizingly painful. It was difficult to move due to the severity of the pain. I called my son (an ER doctor) and asked for advice/medicine. I took some oxycodone (that was already in the house from a previous surgery) and TYLENOL which helped. When I woke up the next morning, I felt much better. I did not need to take any additional dose of oxycodone.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received 5+ years concentration dose of Pfizer COVID vaccine.   No adverse effects or side effects noted over 48 hours after administration.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Rapid, pounding pulse >120 bpm, able to hear heartbeat and rushing of blood  with heart pumps in ears when lying on side.  Resolved after 5 hours, now at 60 bpm.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient stated her vaccine hurt really bad going in and she is still having trouble moving her shoulder without pain.  She has stiffness and limited range of motion without pain.  Since she has had problems with a "frozen shoulder" in the past, she has physical therapy stretches and is taking occasional ibuprofen to help with pain. I explained it may take several weeks to recede with a previous injury in that area and advised her to take vaccines in the right arm from now on when possible as to not irritate the shoulder again.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Upon removal of the needle following injection of the Flucelvax vaccine in the right arm, the patient's arm shot out about a centimeter of blood and then and then it formed a very large bump at least a quarter width in diameter.  It was wider than the width of the Band-Aid requiring two Band-Aids in a cross formation.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt given 2nd dose of HPV too early. No adverse outcome.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse symptoms to report in. Patient received Bivalent Booster as first dose shot
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted to hospital 9/13, tested positive for covid 9/17, and died on 9/26.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Pt develop a rash on the upper left arm, induration on the injection site
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Pt describes severe itching on chest and legs that progressed to hives and reddened scalp the next morning after receiving his vaccination. Symptoms got worse of the next few days
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Incorrect dilution of vaccine
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Cough, Myalgia, Respiratory tract congestion
Clinical narrative: I experienced a breakthrough case of COVID-19 with heavy congestion, coughing, sore muscles and upset stomach.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: I experienced a breakthrough case of COVID-19 with heavy congestion, coughing, sore muscles and upset stomach.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea
Clinical narrative: Patient experienced shortness of breath, seen in ED, seen in cardiology clinic for possible pericarditis
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Fever 6+hrs, severe chills 6+hrs, severe soreness at injection site 72ish hrs., bad headache 96ish hrs.  I took acetaminophen for 4 days and it seemed to help with the fever but not the soreness in the arm which was so bad that I could hardly raise my arm to a horizontal position.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Cough, Headache, Hypoaesthesia
Clinical narrative: Developed headache on the following day from vaccination with numbness present on bilateral face, that is still present 5 days later.  Also reports cough and chest tightness
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Death, Feeling abnormal, Musculoskeletal chest pain, Productive cough
Clinical narrative: Patient called on-call provider on 9/24 stating he thought his asthma was flaring or he had a cold. Had rib pain with coughing, congestion, rhinorrhea, post-nasal drip, and sputum (clear to white). Took at home COVID test and it was negative. Denied shortness of breath, wheezing, chest pain. Was advised to use inhaler and treat symptoms but if he developed shortness of breath/chest pain - go to ER. Wife states he was miserable on 9/24, felt better on 9/25, and was found dead on 9/26 in the morning.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Upper-airway cough syndrome
Clinical narrative: Patient called on-call provider on 9/24 stating he thought his asthma was flaring or he had a cold. Had rib pain with coughing, congestion, rhinorrhea, post-nasal drip, and sputum (clear to white). Took at home COVID test and it was negative. Denied shortness of breath, wheezing, chest pain. Was advised to use inhaler and treat symptoms but if he developed shortness of breath/chest pain - go to ER. Wife states he was miserable on 9/24, felt better on 9/25, and was found dead on 9/26 in the morning.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given bivalent vaccine and is outside the approved age range by 2 weeks.  No adverse reactions reported by parent outside typical side effects seen with routine vaccination. Parent has been informed by our physician on 9/27/22 and told to contact us with any questions or concerns. No further follow-up needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 7 persons received the Pfizer monovalent Covid-19 vaccine and 1 person received the Moderna monovalent Covid-19 vaccine after advice received to only give the bivalent vaccine as a booster.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: "feeling weird and tingly" after receiving unknown influenza vaccination through employer.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac disorder, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: The day after my second vaccine shot, and almost everyday since, I experience arrythmia and palpitations throughout my day. Sometimes as little as  or 6 times a day while other days it happens over 50-70 times a day, especially when walking or walking up or down stairs. I experience shortness of breath and extreme chronic fatigue in addition to these episodes of arrythmia. It has been consistently a challenge to get through the day but the severity of experiencing these episodes has been inconsistent. I have seen numerous medical professionals about this daily problem and I have been given the medical opinion that either the vaccine shot was the cause of this heart condition or a "trigger" to this heart condition becoming the daily problem that it is.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Laboratory test, Palpitations, Scan myocardial perfusion, Ultrasound scan
Clinical narrative: The day after my second vaccine shot, and almost everyday since, I experience arrythmia and palpitations throughout my day. Sometimes as little as  or 6 times a day while other days it happens over 50-70 times a day, especially when walking or walking up or down stairs. I experience shortness of breath and extreme chronic fatigue in addition to these episodes of arrythmia. It has been consistently a challenge to get through the day but the severity of experiencing these episodes has been inconsistent. I have seen numerous medical professionals about this daily problem and I have been given the medical opinion that either the vaccine shot was the cause of this heart condition or a "trigger" to this heart condition becoming the daily problem that it is.
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Computerised tomogram, Hyporesponsive to stimuli, Magnetic resonance imaging
Clinical narrative: weakness and slow to respond after receiving influenza vaccine. Stroke eval performed
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chest X-ray, Computerised tomogram, Dysarthria, Electrocardiogram
Clinical narrative: Pt presented to the ER with slurred speech and weakness after receiving influenza vaccine at pharmacy.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Employee received a flucelvax vaccine and began to wheeze. Had shortness of breath and immediately used her inhaler. She was fine afterwards.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 9/18/2022 Discharge Date: 9/26/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 65 y.o. female with extensive medical conditions including type 2 DM, chronic pain and fibromyalgia on subutex, chronic nausea s/p esophageal surgery, rheumatoid arthritis, who presents today with feeling unwell, shortness of breath, nausea, vomiting, and fatigue for 10-12 days.    Note that patient is independent at baseline; walk independently; not on oxygen; lives with husband.    She was seen by PCP approx 4 days ago, was diagnosed with covid infection, but was not candidate for antiviral as she had symptoms for 6 days. She presented today due to worsening shortness of breath, weakness, nausea and vomiting; generally doesn't feel well. She has not been able to take her home medications due to nausea. Started taking macrobid on Wednesday for UTI.    In ED, oxygen was 85% on room air, was 98% on 3L. BP 230/80 on arrival. Na 131. Cl 86. Cr 1.59 which was baseline. Covid positive again. Her imaging show acute pneumonitis from covid. She is on IV steroid and breathing treatment. She has chronic nausea from history of esophageal surgery. Still feel lightheaded and nausea today, so I kept her and continue with hydration. She can be discharge when her ox sat improved, and electrolytes improved, and tolerating some oral intake.      During hospitalization she did not improve quickly.  A CT scan was performed that revealed obvious bacterial pneumonia.  She was started on ceftriaxone and doxycycline due to her multiple allergies.  Even with this and steroids it occurred 2-3 days to wean off of oxygen.  Her biggest problem was that she would desaturate with minimal activity.  Her diuretics were restarted as well and she diuresed quite well.  By the time she was discharged she was on room air 95% at rest and 92% with any activity.  I did call her primary care physician personally and reviewed the fact that her last chest x-ray did show some decline in her pneumonia.  I did explain she was being discharged with 7 days more of antibiotics, steroids.  I also reviewed her results of her echocardiogram mentioned above.  I also discussed that she had a borderline troponin that never really increased, but had a stress test October 2021 and had really no chest pain and was alreadypositive for COVID.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Electrolyte imbalance, Fatigue
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 9/18/2022 Discharge Date: 9/26/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 65 y.o. female with extensive medical conditions including type 2 DM, chronic pain and fibromyalgia on subutex, chronic nausea s/p esophageal surgery, rheumatoid arthritis, who presents today with feeling unwell, shortness of breath, nausea, vomiting, and fatigue for 10-12 days.    Note that patient is independent at baseline; walk independently; not on oxygen; lives with husband.    She was seen by PCP approx 4 days ago, was diagnosed with covid infection, but was not candidate for antiviral as she had symptoms for 6 days. She presented today due to worsening shortness of breath, weakness, nausea and vomiting; generally doesn't feel well. She has not been able to take her home medications due to nausea. Started taking macrobid on Wednesday for UTI.    In ED, oxygen was 85% on room air, was 98% on 3L. BP 230/80 on arrival. Na 131. Cl 86. Cr 1.59 which was baseline. Covid positive again. Her imaging show acute pneumonitis from covid. She is on IV steroid and breathing treatment. She has chronic nausea from history of esophageal surgery. Still feel lightheaded and nausea today, so I kept her and continue with hydration. She can be discharge when her ox sat improved, and electrolytes improved, and tolerating some oral intake.      During hospitalization she did not improve quickly.  A CT scan was performed that revealed obvious bacterial pneumonia.  She was started on ceftriaxone and doxycycline due to her multiple allergies.  Even with this and steroids it occurred 2-3 days to wean off of oxygen.  Her biggest problem was that she would desaturate with minimal activity.  Her diuretics were restarted as well and she diuresed quite well.  By the time she was discharged she was on room air 95% at rest and 92% with any activity.  I did call her primary care physician personally and reviewed the fact that her last chest x-ray did show some decline in her pneumonia.  I did explain she was being discharged with 7 days more of antibiotics, steroids.  I also reviewed her results of her echocardiogram mentioned above.  I also discussed that she had a borderline troponin that never really increased, but had a stress test October 2021 and had really no chest pain and was alreadypositive for COVID.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oxygen saturation decreased, Pneumonia bacterial, Pneumonitis
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 9/18/2022 Discharge Date: 9/26/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 65 y.o. female with extensive medical conditions including type 2 DM, chronic pain and fibromyalgia on subutex, chronic nausea s/p esophageal surgery, rheumatoid arthritis, who presents today with feeling unwell, shortness of breath, nausea, vomiting, and fatigue for 10-12 days.    Note that patient is independent at baseline; walk independently; not on oxygen; lives with husband.    She was seen by PCP approx 4 days ago, was diagnosed with covid infection, but was not candidate for antiviral as she had symptoms for 6 days. She presented today due to worsening shortness of breath, weakness, nausea and vomiting; generally doesn't feel well. She has not been able to take her home medications due to nausea. Started taking macrobid on Wednesday for UTI.    In ED, oxygen was 85% on room air, was 98% on 3L. BP 230/80 on arrival. Na 131. Cl 86. Cr 1.59 which was baseline. Covid positive again. Her imaging show acute pneumonitis from covid. She is on IV steroid and breathing treatment. She has chronic nausea from history of esophageal surgery. Still feel lightheaded and nausea today, so I kept her and continue with hydration. She can be discharge when her ox sat improved, and electrolytes improved, and tolerating some oral intake.      During hospitalization she did not improve quickly.  A CT scan was performed that revealed obvious bacterial pneumonia.  She was started on ceftriaxone and doxycycline due to her multiple allergies.  Even with this and steroids it occurred 2-3 days to wean off of oxygen.  Her biggest problem was that she would desaturate with minimal activity.  Her diuretics were restarted as well and she diuresed quite well.  By the time she was discharged she was on room air 95% at rest and 92% with any activity.  I did call her primary care physician personally and reviewed the fact that her last chest x-ray did show some decline in her pneumonia.  I did explain she was being discharged with 7 days more of antibiotics, steroids.  I also reviewed her results of her echocardiogram mentioned above.  I also discussed that she had a borderline troponin that never really increased, but had a stress test October 2021 and had really no chest pain and was alreadypositive for COVID.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Polyuria, SARS-CoV-2 test positive, Troponin, Urinary tract infection, Vomiting
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 9/18/2022 Discharge Date: 9/26/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 65 y.o. female with extensive medical conditions including type 2 DM, chronic pain and fibromyalgia on subutex, chronic nausea s/p esophageal surgery, rheumatoid arthritis, who presents today with feeling unwell, shortness of breath, nausea, vomiting, and fatigue for 10-12 days.    Note that patient is independent at baseline; walk independently; not on oxygen; lives with husband.    She was seen by PCP approx 4 days ago, was diagnosed with covid infection, but was not candidate for antiviral as she had symptoms for 6 days. She presented today due to worsening shortness of breath, weakness, nausea and vomiting; generally doesn't feel well. She has not been able to take her home medications due to nausea. Started taking macrobid on Wednesday for UTI.    In ED, oxygen was 85% on room air, was 98% on 3L. BP 230/80 on arrival. Na 131. Cl 86. Cr 1.59 which was baseline. Covid positive again. Her imaging show acute pneumonitis from covid. She is on IV steroid and breathing treatment. She has chronic nausea from history of esophageal surgery. Still feel lightheaded and nausea today, so I kept her and continue with hydration. She can be discharge when her ox sat improved, and electrolytes improved, and tolerating some oral intake.      During hospitalization she did not improve quickly.  A CT scan was performed that revealed obvious bacterial pneumonia.  She was started on ceftriaxone and doxycycline due to her multiple allergies.  Even with this and steroids it occurred 2-3 days to wean off of oxygen.  Her biggest problem was that she would desaturate with minimal activity.  Her diuretics were restarted as well and she diuresed quite well.  By the time she was discharged she was on room air 95% at rest and 92% with any activity.  I did call her primary care physician personally and reviewed the fact that her last chest x-ray did show some decline in her pneumonia.  I did explain she was being discharged with 7 days more of antibiotics, steroids.  I also reviewed her results of her echocardiogram mentioned above.  I also discussed that she had a borderline troponin that never really increased, but had a stress test October 2021 and had really no chest pain and was alreadypositive for COVID.
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Cold sweat, Seizure
Clinical narrative: Patient notified immunizer that she has a personal and family history of experiencing seizures after receiving vaccinations. She received the COVID Pfizer bivalent booster first, and then after the flu vaccine she experienced a mild seizure. Patient was sitting in a chair at the time, and we had a nurse immunizer as well, who was monitoring the patient (noted that patient's skin felt clammy). Patient sat for an extended period of time, and then was picked up by a family member. No other signs or symptoms to report.
Age: 23.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: pt went to get 2nd dose of primary series (1st dose given 8/29/2022)  but was given bivalent booster as 2nd dose of primary series.  no known s/s to note as result of inappropriate dosing.
Age: 23.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: pt went to get 2nd dose of primary series (1st dose given 8/29/2022)  but was given bivalent booster as 2nd dose of primary series.  no known s/s to note as result of inappropriate dosing.