chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had not known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 13Feb2024 until 17Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: She clarified that all of her initial vaccines were the Moderna Covid-19 vaccines; Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "She had pneumonia" (unspecified if ongoing). She had pneumonia like 10 or more years ago. She had since been vaccinated with the pneumonia vaccine. The patient's concomitant medications were not reported. Vaccination history included: Pneumonia vaccine, for immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "She clarified that all of her initial vaccines were the Moderna Covid-19 vaccines". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19. She took Paxlovid in 19Sep2022 and also again 09Aug2023. It seemed like she got covid once a year now. She was fully vaccinated and has gotten all of the boosters. She was exposed to a lot of kids and wears a mask sometimes. She felt like she was at risk because she has had pneumonia before. When she got Covid the first time it felt like it was going into her lungs. The second time she took Paxlovid out of precaution. It was very effective and helped with all of the symptoms, but not the fogginess. She clarified that all of her initial vaccines were the Moderna Covid-19 vaccines. Her last 2 booster doses were the Pfizer Covid-19 vaccines.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Bronchitis, Upper-airway cough syndrome
Clinical narrative: bronchitis-cough; postnasal drip; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Vaccine (dose number unknown, Merck), for immunisation.The following information was reported: BRONCHITIS (non-serious) with onset 2023, outcome "not recovered", described as "bronchitis-cough"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 2023, outcome "not recovered", described as "postnasal drip". The events "bronchitis-cough" and "postnasal drip" required physician office visit. Therapeutic measures were taken as a result of bronchitis, upper-airway cough syndrome. Additional information: She stated she did not get a cold and told the agent that. She had a cough and that is it. She waited and didn't go right away (I believe referring to the doctor). Nothing else ever happened. When she overexerts or is laying flat or it just comes on sporadically where you have to cough for a little bit then it stops. They said it was bronchitis and then postnasal drip the next time. She was put on a steroid and cough medicine and no one offered an antibiotic. She went to the doctor again, and her daughter looked up the shot and they said it could be this coughing thing. In regards to the Prevnar 20 vaccine, she stated online it said a chronic cough was in the surveys. She also stated she had one before from Merck and then got this one (Prevnar 20) because she did not want to get pneumonia.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Memory loss; This is a spontaneous report received from a Consumer or other non HCP, Program ID:   A 33-year-old female 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: AMNESIA (non-serious), outcome "unknown", described as "Memory loss".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got your vaccine shots for COVID, got COVID; I got your vaccine shots for COVID, got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got your vaccine shots for COVID, got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Mood altered, Paraesthesia
Clinical narrative: tingling; so moody; the patient felt gradual decline; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (BNT162B2), in 2022 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: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling"; MOOD ALTERED (non-serious), outcome "unknown", described as "so moody"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "the patient felt gradual decline". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: previously was vaccinated; tested positive for covid currently; previously was vaccinated; tested positive for covid currently; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.   A female 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "previously was vaccinated; tested positive for covid currently". The patient mentioned she previously was vaccinated stated possibility of it being a Pfizer vaccine. She had symptoms such as head cold chills and sneezing and body aches. She tested positive for covid currently. Also advised that she consult with her medical provider about positive test. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures taken as a result of drug ineffective, covid-19 was Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Lung disorder
Clinical narrative: heart pain while he sleeps; Lungs are expanded; not being able to breath well/everyday breathing worse; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 25-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DYSPNOEA (medically significant) with onset 2022, outcome "unknown", described as "not being able to breath well/everyday breathing worse"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "heart pain while he sleeps"; LUNG DISORDER (medically significant), outcome "unknown", described as "Lungs are expanded". The events "heart pain while he sleeps", "not being able to breath well/everyday breathing worse" and "lungs are expanded" required physician office visit. The clinical course was reported as follows: The patient was currently 27 years old and got the vaccine when he was 24 and after a year after he got the vaccine, there was a day where he started not being able to breath well in his 25 years of life at the time. He went to a pulmonologist and was told that his lungs are expanded. It looks as though his lungs are of a person that has had asthma in their whole life but he never had problems at breathing but now he has been put on an inhaler and everyday he's breathing worse. He's having heart pain while he sleeps and can't breathe. He also mentioned that he thinks that he doesn't have much time left. Therapeutic measures were taken as a result of dyspnoea, lung disorder.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Muscle spasms
Clinical narrative: muscle spasms that curl up my arm; Initial information received on 17-Feb-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced muscle spasms that curl up my arm after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Autism.   On an unknown date, the patient received suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (lot number, dosage, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious muscle spasms that curl up my arm (muscle spasms) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  It was reported that "I already had autism as a kid but what I experienced at 21, 22 after Tdap shot .The autism of my childhood was genetic but I experienced 21, 22 is from a T DAP shot the meningitis shot the muscle spasms that curl up my arm like that that happens to adults too after stroke. You can see and acknowledge that a vaccine left your child with the disability. After certain vaccines especially dtap TMR especially those other ones too but especially those you'll see that should happen it's cephalopathy that can lead to cerebral palsy and all kinds of brain damage and a lot of the autistic behaviors".  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: tired, sore throat
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Head injury, Hypopnoea, Loss of consciousness, Pallor
Clinical narrative: Patient was fine immediately after injection.  She was asked to stay in Pharmacy area.  She waited about 10 minutes and then stood up to walk to pharmacy window. She could feel her pressure dropping.  She could not speak.  She reached the pharmacist window and blacked out.  She hit her head 3 times, each side of the window and on the counter.  She then blacked out and became white and ashen in her face.  She was rolled to her side and shaken to make her more alert.  She was non responsive and checked for pulse and breathing.  She had shallow breathing and a weak pulse.  I called for EMS to have the staff alert EMS.  Patient took a deep breath and color returned to her face.  She was able to speak.  I asked her if she wanted to sit up and she said no.  She stayed on her back and began breathing regularly.   She denied her head hurting.  Patient was then assisted by EMS.  They found her cognitive, talking and able to make sense.  We had her wait for another 20-30 mins.  Store staff filed appropriate reports for accidents.   Patient was contacted on 2/28/24 to make sure she was doing well.  She said that she was doing fine and had no further issues.  No residual effects
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pulse abnormal, Speech disorder, Unresponsive to stimuli
Clinical narrative: Patient was fine immediately after injection.  She was asked to stay in Pharmacy area.  She waited about 10 minutes and then stood up to walk to pharmacy window. She could feel her pressure dropping.  She could not speak.  She reached the pharmacist window and blacked out.  She hit her head 3 times, each side of the window and on the counter.  She then blacked out and became white and ashen in her face.  She was rolled to her side and shaken to make her more alert.  She was non responsive and checked for pulse and breathing.  She had shallow breathing and a weak pulse.  I called for EMS to have the staff alert EMS.  Patient took a deep breath and color returned to her face.  She was able to speak.  I asked her if she wanted to sit up and she said no.  She stayed on her back and began breathing regularly.   She denied her head hurting.  Patient was then assisted by EMS.  They found her cognitive, talking and able to make sense.  We had her wait for another 20-30 mins.  Store staff filed appropriate reports for accidents.   Patient was contacted on 2/28/24 to make sure she was doing well.  She said that she was doing fine and had no further issues.  No residual effects
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary arterial stent insertion, Coronary artery disease, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, light headed. Ambulance called via 911. (called by unknown assumed associate at private party - Patient was unable to make call) Ambulance EMTs stated the EKG looked like a heart attack. Taken to nearest hospital equipped to treat acute heart attack. Emergency surgery performed same day, with continuing treatment for
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Laboratory test, Percutaneous coronary intervention
Clinical narrative: Shortness of breath, light headed. Ambulance called via 911. (called by unknown assumed associate at private party - Patient was unable to make call) Ambulance EMTs stated the EKG looked like a heart attack. Taken to nearest hospital equipped to treat acute heart attack. Emergency surgery performed same day, with continuing treatment for
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine Administration Error - patient did not receive full dose. No adverse event occurred.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: I administered the incorrect vaccine combination to the patient. DTap and Polio should have been administered seperately due to his age. Instead I administered Quadracel resulting in the patient having to repeat the dose. I informed the PCP and called the patient's parent and spoke to dad and informed him I administered the incorrect vaccine combination and the patient will need a repeat dose on DTap and Polio on or after March 15th. I further explained how this would not negatively affect the patient in any way and reiterated the patient had received the correct vaccines just in the incorrect combination. I also informed the medical director,
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient states she is experiencing severe arm pain starting the same day she received her second dose of Shingrix. It woke her up at night and she was unable to go back to sleep due to the pain.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear congestion, Electrocardiogram, Injection site rash, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Rash from the injection site up the left arm and left side of neck into left ear and behind my ear.  The reaction settled into my ear and the muscle on the left side of my neck creating a "stiff neck" and feeling of my ear and neck being stuffed with cotton.  The condition was finally resolved on 2/19/24 when Dr prescribed a muscle relaxer to be taken at bed time.  When I awoke on 2/20/24, the the stiffness was gone.  Before visiting my PCP, I saw an ENT for possible ear infection and a cardiologist to ensure it was not heart related.  Both doctors advised that they had many senior patients reporting side effects from the Covid 19 booster.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash from the injection site up the left arm and left side of neck into left ear and behind my ear.  The reaction settled into my ear and the muscle on the left side of my neck creating a "stiff neck" and feeling of my ear and neck being stuffed with cotton.  The condition was finally resolved on 2/19/24 when Dr prescribed a muscle relaxer to be taken at bed time.  When I awoke on 2/20/24, the the stiffness was gone.  Before visiting my PCP, I saw an ENT for possible ear infection and a cardiologist to ensure it was not heart related.  Both doctors advised that they had many senior patients reporting side effects from the Covid 19 booster.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Asocial behaviour, Decreased eye contact, Developmental regression, Hyperacusis, Regressive behaviour
Clinical narrative: Within 2.5 to 3 weeks patient quickly regressed with developmental milestones and behaviors.  He lost words.  He stopped pointing to body parts when asked.  He stopped making animal sounds.  He stopped looking at things when parents would point something out to him.  He started playing by himself and not cooperatively with parents.  He stopped responding to his name.  He became very sensitive to everyday noises.  He stopped trying to copy his parents' actions or words.  He stopped trying to see what parents were looking at -- he didn't really seem to notice his parents were there with him.  He was in his own world.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Speech disorder developmental, Unresponsive to stimuli
Clinical narrative: Within 2.5 to 3 weeks patient quickly regressed with developmental milestones and behaviors.  He lost words.  He stopped pointing to body parts when asked.  He stopped making animal sounds.  He stopped looking at things when parents would point something out to him.  He started playing by himself and not cooperatively with parents.  He stopped responding to his name.  He became very sensitive to everyday noises.  He stopped trying to copy his parents' actions or words.  He stopped trying to see what parents were looking at -- he didn't really seem to notice his parents were there with him.  He was in his own world.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal behaviour, Attention deficit hyperactivity disorder, Loss of personal independence in daily activities
Clinical narrative: Substantial disruption of the ability to conduct normal life functions.  During the first semester of my son's first grade year, he did good in academics and behavior.  During the second semester of my son's first grade year, the teacher started to report behavior issues, but he was able to stay in the classroom.  During my son's second grade year, his teacher's and school administrators reported significant behavior issues, and my son was not able to stay in the classroom resulting is lower grades.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in three time recipient of EUA medical countermeasure, Pfizer-Biontech, COVID-19 vaccine. Relative of victim posted a vaccine card online with Dates-Lots for DOSE#1 & DOSE# a screenshot also indicated dead countermeasure recipient received a booster on 10/06/2021. DOSE#1 on 02/14/21 Lot EM9810, DOSE#2 on 03/07/2021 Lot EN6205, DOSE#3 on 10/06/2021 Lot# UNK. On VAX CARD THERE IS PATIENT# DEATH TOOK PLACE IN SPECIFIC STATE
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Online report of death countermeasure recipient that was a highly renowned medical professional. DOSE1 date 02/06/21 Lot EL9269 DOSE2 date 03/02/2021 Lot EN6202
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in countermeasure recipient of Pfizer-Biontech COVID-19 Vaccine. Site of Inoculations listed. DOSE1 date 03/10/21 Lot EN6208 DOSE2 date 04/08/2021 Lot EW0151 Date of Death 09/09/2023
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Resident presenting with cold like symptoms, cough with congestion. Resident experiencing fatigue.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Resident presenting with cold like symptoms, cough with congestion. Resident experiencing fatigue.
Sex: F
Vaccine: HEP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ no negative outcomes; improperly stored VARIVAX; This spontaneous report was received from a clinical supervisor and referred to a 17-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included maxillary sinus cyst, asthma, bee sting, oral contraception, malformation venous, GERD, anxiety state, abdominal cramp, chronic cough, dry mouth, and allergic reaction to bee sting. Concomitant medications included albuterol [salbutamol], ethinylestradiol (+) norgestimate (ORTHO TRI-CYCLEN), triamcinolone and "multivitamin".  On 22-DEC-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x010534, expiration date: 11-APR-2025, administered intramuscularly for prophylaxis (strength, dose were not provided); and the second dose of hepatitis b vaccine (HEPATITIS B [HEPATITIS B VACCINE]), lot# 92D53, expiration date: 03-MAY-2025, administered intramuscularly (strength, dose and indication were not provided).  The administered varicella virus vaccine live (oka/merck) (VARIVAX) had Temperature & Time frame (Product storage error) of -12.9 Celsius degree (C) (-14 C up to -10 C) for 0 hours 21 minutes 0 seconds; -14.4 C (-14 C up to-10 C) for 0 hours 12 minutes 0 seconds. The previous temperature excursion occurred. The previous temperature and time frame were -13.4 C (-14 C up to-10 C) for 0 hours 19 min 0 seconds, -13.5 (-14 C up to-10 C) for 1 hour 59 minutes 0 seconds, -14.8 C (-50 C to -15 C) for 0 hours 5 minutes 0 seconds, -13.8C (-14 C up to-10 C) for 0 hours 38 min 0 seconds, -14.6C (-50 C to -15 C) for 0 hours 9 minutes 0 seconds, -14.6 (-50 C to -15 C) for 0 hours 11 minutes 0 seconds, -14 (-14 C up to-10 C) for 0 hours 17 minutes 0 seconds. No additional AE and no negative outcomes.  The reporter considered the event product storage error as important medical event, require medical/surgical intervention to prevent serious criteria: compliance of standard work for vaccination immunization. Staff who administered vaccine deviated from his practice.  This is one of the 2 cases reported by same reporter.; Sender's Comments:  US-009507513-2402USA000869:MSD
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; intended on administering 1 dose of MMR-II and 1 dose of VARIVAX but accidentally administered 1 dose of MMR-II and 1 dose of VARIVAX but accidentally administered 1 dose of PROQUAD instead of MMR-II.; intended on administering 1 dose of MMR-II and 1 dose of VARIVAX but accidentally administered 1 dose of MMR-II and 1 dose of VARIVAX but accidentally administered 1 dose of PROQUAD instead of MMR-II.; This spontaneous report was received from a medical assistant and refers to a 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 22-FEB-2024, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, albumin status recombinant human albumin (rHA) (lot #X021754, expiration date: 23-FEB-2025, valid lot number per internal review), administered for prophylaxis (strength, and route of administration were not provided); and invertedly one dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml, (lot #X021284, expiration date: 20-AUG-2025, valid lot number per internal review), administered for prophylaxis (strength, and route of administration were not provided) (accidental overdose), since the correct vaccine to administer should have been measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (drug not administered) injection, administered for prophylaxis (dose, strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong dose administered). No additional adverse events were reported.
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC reported; a dose of GARDASIL 9 was accidently administered to a 2-year-old on 2/26/2024; This spontaneous report was received from a medical assistant referring to a 2-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 26-FEB-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (1 dose, lot#: W002614, expiration date: 15-SEP-2024; strength and route of administration was not provided) for prophylaxis accidentally (product administered to patient of inappropriate age). The patient had not had any symptoms. No additional adverse events (AE) were reported (no adverse event).
Age: 1.75
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No further AE details; a single dose of PNUMEOVAX 23 was mistakenly given to a 21 month old patient on 2/26/2024; This spontaneous report was received from a Medical Assistant and referred to a 21-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 26-FEB-2024, the patient was mistakenly given pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), 0.5 milliliter injection, 0.5 milliliter, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (route of administration was not provided) (Product administered to patient of inappropriate age). HCP reports that it was not until after the dose was given to the patient was it realized that the patient was under 2. No further AE details.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: had swelling from shoulder to elbow; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 01-SEP-2023, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: had swelling from shoulder to elbow). The outcome of the swelling arm was resolved.   The reporter considered the swelling arm to be related to Shingrix.     The company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-FEB-2024 The reporter reported that patient received 1st dose of Shingrix and was ized with Shingrix and had swelling from shoulder to elbow. The reporter shared this information did not administer the IZ. Consent to follow up permission was denied.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error, Single component of a two-component product administered
Clinical narrative: received Arexvy adjuvant portion alone without the powder; received Arexvy adjuvant portion alone without the powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Z9R9Y, expiry date 29-JUN-2026) for prophylaxis.   On 19-FEB-2024, the patient received Arexvy. On 19-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received Arexvy adjuvant portion alone without the powder) and inappropriate dose of vaccine administered (Verbatim: received Arexvy adjuvant portion alone without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The pharmacist reported that the patient received Arexvy adjuvant portion alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Guttate psoriasis
Clinical narrative: Developed guttate psoriasis; Severe joint pain; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of GUTTATE PSORIASIS (Developed guttate psoriasis) and ARTHRALGIA (Severe joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced GUTTATE PSORIASIS (Developed guttate psoriasis) and ARTHRALGIA (Severe joint pain). At the time of the report, GUTTATE PSORIASIS (Developed guttate psoriasis) and ARTHRALGIA (Severe joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient took COVID-19 treatment with unspecified drug from 10-Jun-2023 to 15-Jun-2023. Patient took treatment with steroids.   Reporter did not allow further contact
Age: 55.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Cellulitis, Feeling abnormal, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Examinee called the Occupational Health Clinic on 02/28/24 stating he may have experienced a possible adverse vaccine reaction from the Tdap vaccine that was administered in the left deltoid. Examinee received both the influenza and Tdap vaccine on 2/22/24.  Reports on the evening of 2/23/2024 he "just didn't feel right", had mild left arm soreness and felt warm. Reported he did not check his temperature. Reports on the evening of 2/24/2024, he experienced left shoulder and left neck stiffness and noticed swelling, redness, and warmness to touch on his left arm described as,  "4-5 inches in diameter, midway between his left shoulder and left elbow. Reported on 2/26/2024 the redness and swelling had worsened. Reported on 2/26/2024, he went to his allergist office for his routine allergy injection appointment that he has been receiving twice weekly. Reported during his allergy appointment, his left arm was evaluated by the provider, and he was prescribed amoxicillin twice a day for 10 days for "cellulitis". Reported on 2/28/2024, he continued to have mild left shoulder and left neck stiffness with resolution of redness and swelling of the left arm.
Age: 55.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Examinee called the Occupational Health Clinic on 02/28/24 stating he may have experienced a possible adverse vaccine reaction from the Tdap vaccine that was administered in the left deltoid. Examinee received both the influenza and Tdap vaccine on 2/22/24.  Reports on the evening of 2/23/2024 he "just didn't feel right", had mild left arm soreness and felt warm. Reported he did not check his temperature. Reports on the evening of 2/24/2024, he experienced left shoulder and left neck stiffness and noticed swelling, redness, and warmness to touch on his left arm described as,  "4-5 inches in diameter, midway between his left shoulder and left elbow. Reported on 2/26/2024 the redness and swelling had worsened. Reported on 2/26/2024, he went to his allergist office for his routine allergy injection appointment that he has been receiving twice weekly. Reported during his allergy appointment, his left arm was evaluated by the provider, and he was prescribed amoxicillin twice a day for 10 days for "cellulitis". Reported on 2/28/2024, he continued to have mild left shoulder and left neck stiffness with resolution of redness and swelling of the left arm.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia, COVID-19 pneumonia, End stage renal disease, Haemodialysis
Clinical narrative: Hospitalization for sepsis without organ dysfunction secondary to pneumonia, acute hypoxic respiratory failure secondary to COVID-19 pneumonia, ESRD on HE, hyponatremia, insulin-dependent DM, HTN, schizophrenia, anemia on dates 2/19/2024- 2/28/2024. Treated with dexamethasone.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hyponatraemia, Pneumonia, Schizophrenia, Sepsis
Clinical narrative: Hospitalization for sepsis without organ dysfunction secondary to pneumonia, acute hypoxic respiratory failure secondary to COVID-19 pneumonia, ESRD on HE, hyponatremia, insulin-dependent DM, HTN, schizophrenia, anemia on dates 2/19/2024- 2/28/2024. Treated with dexamethasone.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Hospitalization for sepsis without organ dysfunction secondary to pneumonia, acute hypoxic respiratory failure secondary to COVID-19 pneumonia, ESRD on HE, hyponatremia, insulin-dependent DM, HTN, schizophrenia, anemia on dates 2/19/2024- 2/28/2024. Treated with dexamethasone.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 02/17/24
Age: 58.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Asthenia, Joint swelling, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: He got his vaccines, he felt weak, a little drowsy and he went home and laid down, took a nap and felt better until 10:30 that night.  He still was a little sore in the arm area.  His arm was swollen under the arm and noticed it when he was taking a bath.  He went back to the pharmacy where he got the vaccines, and they gave him a claim form and told him to call us.   He still has some swelling under his arm and still in his leg like he has a big bump on his knee.  He tired to go to the doctor yesterday and he was not able to be seen and has to make an appointment to go back.  He is taking some Extra strength Tylenol starting today and hoping that will help.
Age: 41.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Underdose
Clinical narrative: client accidentally given a pediatric dose of Hepatitis A instead of an adult dose of the Hepatitis A vaccine.  no injuries.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Amenorrhoea, Blood testosterone increased, Dysmenorrhoea
Clinical narrative: After Hep B, adolescent or pediatric vaccine - Disruption and lack of menstrual cycle for 8 months. Severe cramps at 8 month mark for several days upon return of cycle.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Tdap and MCV4 per the request of his school nurse and mother.  Review of the record in database prior to the administration indicted that the vaccines had not been given.  The mother was asked to provide records so that historical doses could be entered into database if appropriate.  Upon review of the document after the visit, it was discovered that the child had already received both vaccines in 2021.    Nursing Supervisor, Medical Director, and mother were notified.  Patient did not experience any adverse reactions.
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event, Product expiration date issue
Clinical narrative: discovered 2 days expired after giving vaccine.  We checked the vaccine, date was difficult to see.  No side effects in patient. Will repeat vaccine.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: N/.A
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: GULLAIN BARRE SYNDROME
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Injection site warmth, Throat irritation
Clinical narrative: 14:53 PM About 15 minutes after patient received vaccination, patient c/o scratchy throat. Patient was waiting in lobby and c/o "scratchy throat." Patient was pulled back to exam room. Provider was notified and gave new order for Benadryl 25mg PO now but EPI pen was brought to the exam room on standby. Vitals: 98.1, 126/67, 103, 98% RA. Left arm had some warmth around the injection site but no redness or swelling. 14:58 109/69, 93, 98%RA. 15:10 132/84, 85, 99%RA, 15:23 113/76, 91, 98%RA. 15:15 Patient reported feeling better, throat "less scratchy", vitals continued to be stable. 15:30 Patient okay to leave, stable vital signs, no further reports of scratchy throat, no issues with swallowing, talking without difficulty and no issues with breathing.
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Feeling cold, Impaired work ability, Malaise, Pain, Sensation of foreign body
Clinical narrative: 14:53 PM About 15 minutes after patient received vaccination, patient c/o scratchy throat. Patient was waiting in lobby and c/o "scratchy throat." Patient was pulled back to exam room. Provider was notified and gave new order for Benadryl 25mg PO now but EPI pen was brought to the exam room on standby. Vitals: 98.1, 126/67, 103, 98% RA. Left arm had some warmth around the injection site but no redness or swelling. 14:58 109/69, 93, 98%RA. 15:10 132/84, 85, 99%RA, 15:23 113/76, 91, 98%RA. 15:15 Patient reported feeling better, throat "less scratchy", vitals continued to be stable. 15:30 Patient okay to leave, stable vital signs, no further reports of scratchy throat, no issues with swallowing, talking without difficulty and no issues with breathing.
Age: 41.0
Sex: F
Vaccine: COVID19, HPV9, HPV9
Symptoms: Throat irritation
Clinical narrative: 14:53 PM About 15 minutes after patient received vaccination, patient c/o scratchy throat. Patient was waiting in lobby and c/o "scratchy throat." Patient was pulled back to exam room. Provider was notified and gave new order for Benadryl 25mg PO now but EPI pen was brought to the exam room on standby. Vitals: 98.1, 126/67, 103, 98% RA. Left arm had some warmth around the injection site but no redness or swelling. 14:58 109/69, 93, 98%RA. 15:10 132/84, 85, 99%RA, 15:23 113/76, 91, 98%RA. 15:15 Patient reported feeling better, throat "less scratchy", vitals continued to be stable. 15:30 Patient okay to leave, stable vital signs, no further reports of scratchy throat, no issues with swallowing, talking without difficulty and no issues with breathing.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 1.92
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse effects on the day of the event when Dr. spoke with the mother that afternoon on 02/22/2024.  Treatment solutions is to monitor the patient for one month due to the Varicella vaccination having a delayed side effect on patients per Dr.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient received a Tdap vaccine on 2/15/2024 with lot number 2%A2F and expiration date of 10/19/2026 received in left deltoid.  Patient mistakenly received a second Tdap vaccine dose on 2/29/2024 with the above information.  No site reactions or other adverse reactions noted at time of administration.  -RN
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: High dose flu was given instead of regular dose that patient was due for.
Age: 1.25
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse effects noted and Dr. spoke with the patient mother on 02/22/2024. Treatment solution will be to monitor the patient for one month since the Vaccine Varicella has a delayed reaction on patients per MD.
Age: 0.33
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT GIVEN WRONG VACCINE NO KNOWN REACTION THIS WAS FOUND AT MONTH END COUNT
Age: 0.42
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong patient
Clinical narrative: The Kinrix and the ProQuad vaccines were given to the wrong patient by mistake.  The patient was monitored after the injections, and no adverse reactions were noted.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cardiac disorder, Cardiac pacemaker insertion, Cerebrovascular accident, Myalgia
Clinical narrative: TWO STROKES RIGHT AFTER 1ST AND 2ND  VACCINATIONS WAS GIVEN A HALFHOUR APART. NOW WEAR A PACEMAKER. HAVE MUSCLE AND JOINT PAIN LONG STANDING.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Electrocardiogram ambulatory, Laboratory test, Palpitations
Clinical narrative: Syncopal episode, residual dizziness and heart palpitations
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncopal episode, residual dizziness and heart palpitations
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Myalgia, Pyrexia, Wrong product administered
Clinical narrative: Patient was given a DTAP instead of TDAP. Per CDC it was okay giving DTAP. Patient experienced muscle soreness and fever for less than 24hours.   Patients parents notified
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Death
Clinical narrative: The patient received vaccinations 1 day prior to the unknown cause of death.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injection site rash, Rash erythematous
Clinical narrative: Initially there was no reaction and I had typical 2 day symptoms post injection like prior MODERNA vaccinations  (pain in shoulder, 2 days of weakness) . However on Feb 26 I injected my dose of PRALUENT and I had no noticeable issues. However, that night I noticed a wide rash on my right shoulder near the Moderna injection site. The redness was not acute and I assumed I must have rub the arm against something. On Tuesday I discovered that my abdominal injection site for the PRALUENT, was also red like a rash or abrasion. The rash on both sites still persist to this day
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient called today.  She said her arm was sore until a couple of days ago and then a small red spot appeared yesterday 2 or 3 finger widths below the injection site and it was bigger today. I counselled her to call her doctor and she said she would.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient mistakenly received a MMRV and Varivax instead of the intended MMR and Varivax.  Mother was notified of signs and symptoms to watch for.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hepatitis B instead on an adult dose
Age: 1.25
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC20
Symptoms: Extra dose administered
Clinical narrative: 15 m.o. patient presents for his well child and immunization visit. Patient was due for 3 vaccinations, DTaP, HiB and PCV20. When preparing the vaccinations - Vaxelis, DTaP-HiB-Hep B-IPV was pulled, prepared and administered. Parent and patient were immediately informed. Plan to follow up with parent regarding any adverse side effects, and VIS was provided.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Patient for catch up vaccination. MD ordered KINRIX for DTAP and IPV catch up. Nurse administered. PT 7 y8 m old order should have been Tdap and IPV.
Age: 27.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional Tdap vaccine was given in error.  Patient received the same Tdap with same lot number on 2/11/24 and then received the same vaccine on 2/18/24.  Patient had MMR vaccine on 2/11/24 and then had varicella vaccine 2/18/24.  Has not had any side effects