chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Pericardial effusion
Clinical narrative: heart failure; Has fluid build up; has fluid around his heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 32-year-old male patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 2, single (Lot number: 025B21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: PERICARDIAL EFFUSION (hospitalization) with onset 14Jul2022, outcome "unknown", described as "Has fluid build up; has fluid around his heart"; CARDIAC FAILURE (hospitalization, medically significant) with onset 14Jul2022, outcome "unknown", described as "heart failure". The patient was hospitalized for cardiac failure (start date: 14Jul2022); for pericardial effusion (start date: 14Jul2022, hospitalization duration: 2 days). Clinical course: the patient was in the hospital and had heart failure. The patient had fluid buildup, specifically fluid around his heart. Additionally, the reporter stated the patient was in the hospital (further hospitalization details were not available) and had heart failure because of the vaccine. The reporter wanted to know what they had to do to "get on the lawsuit." The patient received two Moderna vaccines and one Pfizer vaccine ("COVID-19 Booster shot").   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 11:00 as dose 1, single (Lot number: HG4677) at the age of 73 years, in left arm for covid-19 immunisation; 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), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from  10Oct2023 to 14Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pcn" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cipro" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 03Oct2023, stop date: 08Oct2023).  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334775 same patient, different drug/events;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: the person reported that she had inflammation in her arm after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset Oct2023, outcome "recovered", described as "the person reported that she had inflammation in her arm after vaccination.". It was unknown if therapeutic measures were taken as a result of vaccination site inflammation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Infection, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient presented to pharmacy on 10/24/23 complaining of redness, swelling and itching that has lasted for a month since her immunization. The redness was localized to the injection site, but her entire hand was swollen. Patient visited doctor and was given antibiotic for infection and a cream to help with itching. Patient was instructed to follow up with PCP if antibiotics do not correct the issue.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Patient presented to the pharmacy on 10/24 to show pharmacist pictures of injection site.  A red rashy, swollen patch of skin was visible an inch or so below the injection site. The issue has resolved, but patient was concerned about effectiveness of vaccine and asked that we report his ADR.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Hot flush, Nausea, Vomiting
Clinical narrative: 5am 10/24/23 vomiting and diarrhea which was frequent and intense until 2pm. Continued nausea and hot flashes
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I am 19 weeks pregnant. My due date is March 16, 2024.  I threw up 7-8 hours after my vaccine, but not sure if that was due to the vaccine.  I suffered a nonstop headache from 8pm 10/21/23 through the early morning of 10/23/23.  My injection site is very sore especially if touched or grazed. On 10/23/23 my injection site swelled up and is visibly protruding red circle about 2-3 inches in diameter. On 10/24/23 it continues to be sore and now itches.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vomiting
Clinical narrative: I am 19 weeks pregnant. My due date is March 16, 2024.  I threw up 7-8 hours after my vaccine, but not sure if that was due to the vaccine.  I suffered a nonstop headache from 8pm 10/21/23 through the early morning of 10/23/23.  My injection site is very sore especially if touched or grazed. On 10/23/23 my injection site swelled up and is visibly protruding red circle about 2-3 inches in diameter. On 10/24/23 it continues to be sore and now itches.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Hallucination, Headache, Nausea, Somnambulism
Clinical narrative: Patient came to pharmacy to inform us that she experienced confusion about an hour after being vaccinated and lost her way on her way back home.  She also had an episode of sleepwalking or walking out of home at night along with hallucination the same night post. She still experience headaches, off and on along with ongoing nausea from her flu shot.  Patient is in the process of seeing her medical doctor for more guidance.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product label confusion
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Condition aggravated, Flushing, Hypertension
Clinical narrative: Became flushed in my face. Took blood pressure and it kept rising went up to 167 over 106.  It usually is around 130 over 8o.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Fever of 101, severe headache, body aches and fatigue. After about 15 minutes after the shot was given she had numbness and tingeling in both arms for about 10 minutes.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever of 101, severe headache, body aches and fatigue. After about 15 minutes after the shot was given she had numbness and tingeling in both arms for about 10 minutes.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: Sudden onset of left kne pain, swelling,, and stiffness within hours of having received the latest moderna Covid vaccine and the seasonal flu vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: The patient states her arm was red and warm to the touch and it has now continued to spread toward her elbow each day
Age: 75.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Condition aggravated, Gait disturbance, Irritable bowel syndrome, Peripheral swelling
Clinical narrative: patient reports swollen right hand and swollen right foot that resolved after a few days.  He also reports his IBS acting up, and and unsteady gait and felt weak walking for a few days after receiving vaccines
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site urticaria, Pain in extremity, Pruritus
Clinical narrative: The day after my arm was sore and red which i thought was normal after a vaccine, however, today is day 5 and it is more red and itchy. It looks like a hives on my right arm where the injection was placed. I have never had a reaction to a vaccine before.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Asthenia, Chest pain, Condition aggravated, Ear pain
Clinical narrative: Working as provider RN, doing phone triage, work with desktop and phone system, clinic RN workstation area.  Received influenza vaccination 10/16/23 after huddle that afternoon. That evening I started to note a change in neuropathy and pain symptoms affecting my neck and upper body; right side. The following day the neuropathy and pain symptoms progressed and by the end of the day I was experiencing stiffness and pain with turning my neck to look over my shoulder. I am noting extreme electric like pain affecting around my right ear, my right facial cheek, my right temple area, the base of my skull on the right side, my neck, going into my chest and right shoulder, and I am not able to move when that happens until the pain passes. I am having weakness and stiffness of my neck. Neuropathy pain affecting the fingers of my right hand has worsened. Wednesday 10/18/23, my symptoms were more significant, I was trying heat therapy which didn't offer relief.  I am noting mild neuropathy symptoms affecting my index finger and thumb of my left hand; intermittently.  Head, Neck. Face  Right  Is seeing her allergist in November. Similar reaction to COVID vaccines in 2020 and 2021. Allergies and neuropathy started. Flu shot seemed to make it worse
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Electric shock sensation, Facial pain, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Working as provider RN, doing phone triage, work with desktop and phone system, clinic RN workstation area.  Received influenza vaccination 10/16/23 after huddle that afternoon. That evening I started to note a change in neuropathy and pain symptoms affecting my neck and upper body; right side. The following day the neuropathy and pain symptoms progressed and by the end of the day I was experiencing stiffness and pain with turning my neck to look over my shoulder. I am noting extreme electric like pain affecting around my right ear, my right facial cheek, my right temple area, the base of my skull on the right side, my neck, going into my chest and right shoulder, and I am not able to move when that happens until the pain passes. I am having weakness and stiffness of my neck. Neuropathy pain affecting the fingers of my right hand has worsened. Wednesday 10/18/23, my symptoms were more significant, I was trying heat therapy which didn't offer relief.  I am noting mild neuropathy symptoms affecting my index finger and thumb of my left hand; intermittently.  Head, Neck. Face  Right  Is seeing her allergist in November. Similar reaction to COVID vaccines in 2020 and 2021. Allergies and neuropathy started. Flu shot seemed to make it worse
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Neck pain, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: Working as provider RN, doing phone triage, work with desktop and phone system, clinic RN workstation area.  Received influenza vaccination 10/16/23 after huddle that afternoon. That evening I started to note a change in neuropathy and pain symptoms affecting my neck and upper body; right side. The following day the neuropathy and pain symptoms progressed and by the end of the day I was experiencing stiffness and pain with turning my neck to look over my shoulder. I am noting extreme electric like pain affecting around my right ear, my right facial cheek, my right temple area, the base of my skull on the right side, my neck, going into my chest and right shoulder, and I am not able to move when that happens until the pain passes. I am having weakness and stiffness of my neck. Neuropathy pain affecting the fingers of my right hand has worsened. Wednesday 10/18/23, my symptoms were more significant, I was trying heat therapy which didn't offer relief.  I am noting mild neuropathy symptoms affecting my index finger and thumb of my left hand; intermittently.  Head, Neck. Face  Right  Is seeing her allergist in November. Similar reaction to COVID vaccines in 2020 and 2021. Allergies and neuropathy started. Flu shot seemed to make it worse
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Lactation insufficiency
Clinical narrative: Breastmilk decreased 2 days after receiving immunization
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Visual impairment
Clinical narrative: Patient reported seeing pitch black around 10 minutes after vaccine administration. Patient reports she almost fell but caught herself on the shopping cart. When patient came to us, she spoke normally and was able to tell us what happened.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Condition aggravated, Intervertebral disc degeneration, Pain
Clinical narrative: I'm a very active 61 year old... played tennis Friday/Saturday/Sunday - Pilates Saturday/Sunday/Monday (all very typical activities) Tuesday walked onto the tennis court for a drill & literally could not swing my racket or turn/bend without pain.. Stomach bloated all afternoon  - my husband felt that was 'flu' like symptom.. Pain was so intense went to the ER on 9/27 & again on 9/28 as the pain meds given were not efficient.. Went to my orthopedic doctor & he confirmed my degenerative disc had worsened? Only thing that I can contribute this to is the vaccine targeted a weak spot in my body?
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle pain, head ache, nausea, stomach pain, abdominal bloating, kidney pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Renal pain
Clinical narrative: Fatigue, muscle pain, head ache, nausea, stomach pain, abdominal bloating, kidney pain
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 3rd dose of the shingrix vaccine even though patient had already gotten the two dose series in 2020-2021. This was discovered on date of report and patient has had no adverse affects.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired MMR administered to patient expired 10-18-23  No adverse reactions noted
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Aphasia, Dysarthria, Full blood count, Impaired work ability, Magnetic resonance imaging head
Clinical narrative: Significant aphasia, difficulty speaking, finding words, thinking a word and a different word comes out. Insidious onset, with significant worsening on 10/24/23. Led to eval in ED. Began resolving while in ED. Workup for stroke was negative. No treatment. Continues to be present but mild, still quite noticeable and interferes with ability to work.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Metabolic function test
Clinical narrative: Significant aphasia, difficulty speaking, finding words, thinking a word and a different word comes out. Insidious onset, with significant worsening on 10/24/23. Led to eval in ED. Began resolving while in ED. Workup for stroke was negative. No treatment. Continues to be present but mild, still quite noticeable and interferes with ability to work.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Aphasia
Clinical narrative: Significant aphasia, difficulty speaking, finding words, thinking a word and a different word comes out. Insidious onset, with significant worsening on 10/24/23. Led to eval in ED. Began resolving while in ED. Workup for stroke was negative. No treatment. Continues to be present but mild, still quite noticeable and interferes with ability to work.
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Per standing order RSV to be given to 60 and older.  The patient was 58 years old. No adverse signs or symptoms observed after injection was given.  Dr. notified and made aware of the deviation to the standing order.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product label issue
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at infection site
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: Patient stated on her left arm where she got the Covid vaccine, she had noticed a lot of swelling underneath her arm. Possibly her lymph nodes. She did not tell us if she had any major health conditions that may cause the swelling of her arm. The pharmacist recommended for the patient to follow-up with her doctor.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Syncope
Clinical narrative: Patient fainted after being given a flu shot at a flu shot clinic at a local church.  Gave patient cold compress after she came to because she said she was feeling warm.  Patient was fine and left about a half hour later with her mother.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: Spikevax was given to patient.  Needle was not secure at the hub.   Vaccine leaked out from the hub and did not enter patient's arm.  A second dose was given with same lot and administered 1 inch from site of first attempt.  Patient did not experience any adverse events.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Vaccine was given under 12
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given under 12 years old
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Skin exfoliation
Clinical narrative: Pityriasis rosea. Symptoms starting to show on chest 2 days after vaccine & spreading throughout body. More scales on trunk. Still present 4 weeks after shot.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Nausea, Syncope
Clinical narrative: About 90 minutes after injection I became a little nauseous and then unexpectedly fainted.  I do have a history of vasovagal syncope but never with such a long delay.  Also I lost a few seconds of memory between the kitchen sink and the room where I woke up.. I don't remember walking into the other room.  I've never had memory loss associated with fainting before this.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Dyspnoea, Fall, Head injury, Syncope
Clinical narrative: After pt's shot,  patient was standing while waiting for family member to get a shot. Patient at first was short of breath and felt faint and dizzy. Eventually fainted and fell. May have hit head on wall. Pt was put in a chair and given a granola bar and apple juice. Seemed to make a recovery after 15 minutes
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Injection site pain, Neck pain, Pain
Clinical narrative: When patient was receiving the injection she said she experienced a "shock-like pain" that radiated from the injection site to her neck. She said it was very, very painful.  She was shaken up so stayed in the injection room for 25 minutes. She stated that she was afraid to leave in case something happened to her. She was given an ice pack and after 15 minutes she said she wasn't in pain put needed to calm down.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Wrong product administered
Clinical narrative: Pt appt made for Novavax, but was administered Moderna (Ped). Based on data it was determined the pt was underdosed and pt was given a dose of Novavax.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is due for Pfizer Pediactric COVID vaccination, however, the immunizer gave patient the Pfizer Toddler COVID vaccine.  Age inappropriate.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain in extremity, Tremor
Clinical narrative: Day after receiving MMR #1 & varicella #1 vaccines patient had brief episode of "head shaking and leg pain". Symptoms self-resolved quickly (<1 min), no further issues.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy per patient report.  Developed on Sunday following vaccination with influenza and COVID on Friday.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG4677) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 28Sep2023, outcome "recovered", described as "exhaustion". Therapeutic measures were not taken as a result of fatigue. Additional information: The vaccine was administered in the pharmacy. The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG4677) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 28Sep2023, outcome "recovered", described as "exhaustion". Therapeutic measures were not taken as a result of fatigue. Additional information: The vaccine was administered in the pharmacy. The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HBP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Patient received PNEUMOVAX 23 on 10/02/2023 with an expiration date of 10/01/2023. No additional AE/PQC.; HBP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Patient received PNEUMOVAX 23 on 10/02/2023 with an expiration date of 10/01/2023. No additional AE/PQC.; Information has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-OCT-2023, the patient was inadvertently vaccinated with an expire dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacsit stated daughter has only recieved 2 doses of GARDASIL 9 at age of 17 and did not complete 3rd dose. Inquring if revaccination is neccssary; No AE/PQC reported.; This spontaneous report has been received from a pharmacist, concerning her/his 17-year-old daughter. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, lot #, expiry date, and route of administration were not provided) administered as prophylaxis. The pharmacist stated that the patient did not complete the 3rd dose (Inappropriate schedule of product administration) and inquired if re-vaccination would be necessary. No adverse event (AE) or product quality complaint (PQC) were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse event (AE); HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 10/20/2023.  Caller confirmed no previous temperature excursions for this product and no symptoms or further details reported.  Caller requested if; This spontaneous report was received from other health professional and refers to a patient with an unknown age of gender.  The patient's pertinent medical history, concomitant medications, drug reaction and allergies were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W019533has been confirmed to be valid for pembrolizumab (KEYTRUDA), expiration date not reported but upon internal reviewed established as 30-SEP-2023) (strength, route of administration, and indication were not provided).  On 20-OCT-2023, the patient received an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (expired vaccine used). No previous temperature excursions for this product and no symptoms or further details reported. No addicional adverse (AE) event was provided.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: Her skin is itchy; The injection site is sore; Her arm is swollen; The injection site is sore. It's red; but there seems to be a bump underneath the skin where it was injected; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected) in a 51-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (She states all her other vaccines were Pfizer. When she had the Pfizer, the arm hurt for two days. Other than being sore and there was no redness and there was nothing that she could feel underneath her skin). Past adverse reactions to the above products included Vaccination site pain with Pfizer.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected). At the time of the report, PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   She states all her other vaccines were Pfizer. She never had Moderna before. She had on 14Oct2023. Her arm was swollen. The injection site was sore. It was red.  She didn't have this with Pfizer, but there seems to be a bump underneath the skin where it was injected. Her skin was itchy. It had been a few days. It was still itchy and sore. She received the Spikevax. It had been a year since she had a COVID vaccine. She does not had her COVID19 vaccine history on hand. She thought the bump reduced in size. When she had the Pfizer, the arm hurt for two days. Other than being sore, there was no redness and there was nothing that she could feel underneath her skin. She does not remember it having an itch either. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Now I have a tendency to have an erratic heartbeat; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat). At the time of the report, HEART RATE IRREGULAR (Now I have a tendency to have an erratic heartbeat) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included blood thinners.  Reporter stated that, this time had a terrible reaction and previously did not have a terrible reaction. Patient did not have any such bad reaction for any of the other shots she had or during the shot. Patient had a tendency to have an erratic heartbeat. Patient did experience this after a shot. Patient had been taking all Moderna and mentioned this was her fifth shot and this time had a terrible reaction with it.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 A°F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Patient was asking does can he take aspirin or ibuprofen. No treatment information was reported.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain, Swelling
Clinical narrative: noticed swelling/my armpit, it is swollen and painful, it happened to me the last time; my armpit, it is swollen and painful, it happened to me the last time; Swollen lymph/ Swollen lymph node; pain went away; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), in Dec2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "not recovered", described as "noticed swelling/my armpit, it is swollen and painful, it happened to me the last time"; AXILLARY PAIN (non-serious), outcome "unknown", described as "my armpit, it is swollen and painful, it happened to me the last time"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph/ Swollen lymph node"; PAIN (non-serious), outcome "recovered", described as "pain went away". The events "noticed swelling/my armpit, it is swollen and painful, it happened to me the last time", "my armpit, it is swollen and painful, it happened to me the last time", "swollen lymph/ swollen lymph node" and "pain went away" required physician office visit. Therapeutic measures were taken as a result of swelling, axillary pain, lymphadenopathy, pain.  Additional information: Patient got the Pfizer vaccine 2 years ago (on her left arm), because it was required since she was a nurse and worked with COVID patients. With this first time she noticed swelling and she took Ibuprofen and pain went away but after some time, the doctors told there was still some swelling in armpit. Her armpit was swollen and painful, it happened to her the last time that she took the COVID Shot. She was asking if it had a long term side effect because the last time she went to do her and they said they saw a swollen lymph and the first time she experienced it was when she got the COVID Shot. Consumer stated, "When she took it the first time she was not suffering from hypertension it was just high cholesterol that was all. 2 years ago." Causality: Consumer stated, "Yes, it just happened every time she got it, she got this shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334668 same patient, different dose/events;
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: it was about 3 days after when her whole face and lips swelled up; it was about 3 days after when her whole face and lips swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20-year-old female patient received bnt162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE oral taken for migraine (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious), all with latency 3 days after the suspect product(s) administration, outcome "unknown" and all described as "it was about 3 days after when her whole face and lips swelled up". The events "it was about 3 days after when her whole face and lips swelled up" required emergency room visit.  Additional information: She started taking topiramate several years ago, like maybe 3-4 years ago. The patient reported that she thinks her 1st booster when you get the 2 series it was about 3 days after when her whole face and lips swelled up and they took her to the emergency room and they called Pfizer. They assumed possibly a reaction and didn't think about it. She thought that it was maybe Oct2021 around then. She doesn't recall and she would have been out of state. She believed she had another about a year ago in Sep2022 with no issues.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333483 same reporter, patient and drug; different dose and events;
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Injuries due to the COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult patient 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: INJURY (non-serious), outcome "unknown", described as "Injuries due to the COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Vaccination failure
Clinical narrative: She just had covid and she has had all the previous covid vaccines.; She just had covid and she has had all the previous covid vaccines.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) and on 22May2023 as dose 6 (booster), single (Lot number: 6J6742) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9264), in right arm, on 10Mar2021 as dose 2, single (Lot number: EN6203) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "She just had covid and she has had all the previous covid vaccines.". The patient underwent the following laboratory tests and procedures: Body height: 5'8''; 5' 6''. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 01:00 as dose 5 (booster), single (Lot number: G16738) at the age of 71 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: continued symptoms and testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from 07Oct2023 to 11Oct2023.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna, Date: 02Oct2021 / Pfizer, Date: 26Sep2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: 6J6739) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: 011L20A), in left arm, on 11Mar2021 as dose 2, single (Lot number: 031a21a), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 047cZ1a), in left arm for immunisation. The patient's relevant medical history included: "Penecillin" (unspecified if ongoing), notes: Known allergies: Penecillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023 at 21:00, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Date: 02Oct2021 / Pfizer, Date: 26Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day 7; Positive, notes: positive this morning 20Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was taken as treatment for COVID-19 from 04Oct2023 to 09Oct2023