chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Prostatic specific antigen, Ultrasound scan normal
Clinical narrative: He got his vaccine, he had intense chest pain, he feels like he is being hung up by his pelvis, which is always there with pelvic pain.   He went to UC on 3/9/23 and the doctor said he had a hernia.  The pain goes from just a few inches below his belly button, down his hips, sometimes has pain in his penis, down his lower left leg like he had been shinned.  He also has chest pain on his left side.  most of his pains on the left side and are 7/10 on the left but also show up on the right side of his abdominal area, chest and his legs, but not as intense as the left side.  His feet also tingle a lot.   He had no need for a PCP prior to the vaccine.  Around 3/20/23 he went to his new PCP and at that time and they kept testing him for a hernia, had MRI and CT scan and could not find any objective findings.  He has had US, blood work, testing for caner and nothing is showing up to cause him the symptoms.  He called Moderna after her got his vaccine and he asked if anybody was having pain from the shots, and they asked if he had pelvic pain or why they had pelvic pain and they send him to somewhere else, and they referred him to hospital.  He has been denied by clinic twice and wants to get everything out before applying.  He has an appointment with Urologist, neurologist, and nerve conduction studies and going to see an internal medicine doctor and his PCP in follow up at the end of the month.  He has constant pelvic pain, unable to work as a janitor at the school, he is able to drive some but it is painful to do what he can do.  He is able walk but at a slow pace.  He is falling over sometimes, and it takes him about 30 minutes to get out of bed, has to take his medication and then gets comfortable enough to get up and walk around.  He constant has to roll over a lot to try to get comfortable between the pelvic pain, leg pain and then has to roll over to the left side to get comfortable on that side.  Since the vaccine he is now on Hydromorphone 4 mg, Klonopin 2 mg.  He was put on Ativan at one point and then put on Buspar which he landed in the ER due to heart palpitations.  He also has Narcan Nasal spray but states he will never have to use it, medical marijuana, Tylenol, Ibuprofen.  He was on Gabapentin which put him in the ER.  He did have a CT scan of his head and showed a little cyst but the doctor said it was no big deal.   He is now able to work as his previous job, he used to walk 4-5 miles a day and if he now walks a 1/2 mile or tries to do too much then he cannot do anything for a few days to recover.  He had no issues whatsoever prior to the vaccine.
Sex: F
Vaccine: COVID19, RSV
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Had flu shots, RSV and pneumonia shots, all after Covid vaccinations and boosters/caught Covid even though vaccinated; This is a spontaneous report received from a Consumer or other non HCP, Program ID:  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "erosive gastritis" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 12Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 09Mar2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Aug2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 18Apr2022, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 03Dec2022, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: 15May2023, when the patient was 76-year-old, for COVID-19 immunization; comirnaty omicron xbb.1.5 (DOSE 1, SINGLE), administration date: 20Sep2023, when the patient was 77-year-old, for COVID-19 immunization; Flu shot, for Immunization; Pneumonia shots, for Immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "Had flu shots, RSV and pneumonia shots, all after Covid vaccinations and boosters/caught Covid even though vaccinated". Therapeutic measures were taken as a result of covid-19. Additional information: Patient was prescribed to take Paxlovid as treatment for COVID-19. Patient has no idea how or why she was getting Covid.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, RSV
Symptoms: COVID-19
Clinical narrative: Had flu shots, RSV and pneumonia shots, all after Covid vaccinations and boosters/caught Covid even though vaccinated; This is a spontaneous report received from a Consumer or other non HCP, Program ID:  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "erosive gastritis" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 12Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 09Mar2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Aug2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 18Apr2022, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 03Dec2022, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: 15May2023, when the patient was 76-year-old, for COVID-19 immunization; comirnaty omicron xbb.1.5 (DOSE 1, SINGLE), administration date: 20Sep2023, when the patient was 77-year-old, for COVID-19 immunization; Flu shot, for Immunization; Pneumonia shots, for Immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "Had flu shots, RSV and pneumonia shots, all after Covid vaccinations and boosters/caught Covid even though vaccinated". Therapeutic measures were taken as a result of covid-19. Additional information: Patient was prescribed to take Paxlovid as treatment for COVID-19. Patient has no idea how or why she was getting Covid.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Limb injury
Clinical narrative: BROKEN TOE LEFT LEG; EYES FAR SIDED; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, eczema, neck pain, anxiety, sleep apnea, arthritis, unemployment, and intellectual disability. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 3 ug (dose series 1), administered on 08-FEB-2023 for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced broken toe left leg, and eyes far sided (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the broken toe left leg and eyes far sided was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Limb injury. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Diagnosed with influenza virus infection; This spontaneous case was received on 02-Feb-2024 from other health professional via agency (reference number: SEQW24-00489) and concerned a patient of unreported gender and age.  The patient's medical history and concomitant medication were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand reported as Seqirus; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient was diagnosed with influenza virus infection.  The outcome of event of influenza was not reported.  The reporter did not provide a causality assessment.  The event of influenza was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  Company comment: On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient was diagnosed with influenza virus infection. Causal role of the suspect vaccine is unassessable, due to lack of information regarding chronology and diagnostic findings.; Sender's Comments: On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient was diagnosed with influenza virus infection. Causal role of the suspect vaccine is unassessable, due to lack of information regarding chronology and diagnostic findings.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Disability, Guillain-Barre syndrome, Impaired work ability, Musculoskeletal disorder, Walking aid user
Clinical narrative: The Covid vaccine gave me Guillain-Barre Syndrome.  I was hospitalised for weeks and I was transferred to a rehabilitation facility to learn how to walk again and how to use my hands.  I am no longer able to work.  I am 100% disabled due to my condition.  I have to walk with a walker and/or cane.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure, Cardiac stress test, Chest pain, Electrocardiogram, Neck pain
Clinical narrative: Experienced chest pain, neck and jaw pain, presented to Emergency dept 4 /28/2021. The first question was asked by Triage RN, "are you vaccinated?" I replied yes. Admitted for testing to Hospital for evaluation and further testing. Discharged the next day and follow up with cardiologist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Troponin
Clinical narrative: Experienced chest pain, neck and jaw pain, presented to Emergency dept 4 /28/2021. The first question was asked by Triage RN, "are you vaccinated?" I replied yes. Admitted for testing to Hospital for evaluation and further testing. Discharged the next day and follow up with cardiologist.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Mother reports that pt vomited once when he got home after his vaccination.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Severe pain in right knee, possibly a flare up of arthritis. Improved slowly over 2 weeks.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient received Arexvy vaccine on 2/8/24 and came in 2/10/24 complaining of injection site pain, swelling and redness. Upon further investigation it was determined that the vaccine was incorrectly injected into the arm outside of the deltoid muscle near the elbow.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Pt has not vaccination records for any doses of Dtap, DTP, or Tdap.  He had not yet received a dose of Tdap from our clinic. He received tetanus as his third dose.  He needs to return to clinic to receive and additional dose of Tdap.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: Soreness at vaccine site for 2 days, chills aches, headache
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per recommendations.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Erythema, Headache, Influenza like illness
Clinical narrative: She got her vaccine, no problem immediately.  But yesterday about 3:00 she had fever and chills, her legs felt like lead, achy, kind of flu-like feeling or COVID feeling, headache, eyes are sensitive to the light.  Left side of her nose is clogged.  She is taking Motrin, Flonase for the stuffiness, and Montelukast and her inhaler for her symptoms.  She is also having a heaviness in her chest.  The medicines are helping except for the headache.  Her fever has gone, but had gone to 101.   She did not call her doctor, but she does feel better.  Her arm is red, sore and swollen, the area is hot to touch.  She had her RSV about 2 months ago and she had a similar reaction as far as the arm then as well which eventually went away.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Nasal congestion, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She got her vaccine, no problem immediately.  But yesterday about 3:00 she had fever and chills, her legs felt like lead, achy, kind of flu-like feeling or COVID feeling, headache, eyes are sensitive to the light.  Left side of her nose is clogged.  She is taking Motrin, Flonase for the stuffiness, and Montelukast and her inhaler for her symptoms.  She is also having a heaviness in her chest.  The medicines are helping except for the headache.  Her fever has gone, but had gone to 101.   She did not call her doctor, but she does feel better.  Her arm is red, sore and swollen, the area is hot to touch.  She had her RSV about 2 months ago and she had a similar reaction as far as the arm then as well which eventually went away.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia, Skin warm
Clinical narrative: She got her vaccine, no problem immediately.  But yesterday about 3:00 she had fever and chills, her legs felt like lead, achy, kind of flu-like feeling or COVID feeling, headache, eyes are sensitive to the light.  Left side of her nose is clogged.  She is taking Motrin, Flonase for the stuffiness, and Montelukast and her inhaler for her symptoms.  She is also having a heaviness in her chest.  The medicines are helping except for the headache.  Her fever has gone, but had gone to 101.   She did not call her doctor, but she does feel better.  Her arm is red, sore and swollen, the area is hot to touch.  She had her RSV about 2 months ago and she had a similar reaction as far as the arm then as well which eventually went away.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Patient will be revaccinated per CDC recommendations.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Sharp pain all the time at injection site. Takes hydrocodone/APAP and ibuprofen and helps minimally
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Hypoxia, Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection syndrome and acute on chronic hypoxia 1.5 days after receiving RSV vaccine on 11/28/2023, improving by the time of office visit 12/5/2023
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Anxiety, Palpitations, Suicidal ideation
Clinical narrative: Extreme anxiety during night; heart racing; suicidal ideation.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh is red and swollen.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, lack of mobility
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cognitive disorder, Echocardiogram, Electrocardiogram, Immunisation reaction
Clinical narrative: MODERNA FIRST SHOT 3/4/2021 MODERNA SECOND SHOT 4/01/2021 HAD COVID-19 ILLNESS BEFORE AND AFTER PRIMARY SERIES.   JAN 2022 DEVELOPED MODERATE COGNITIVE DECLINE WITH PARTIAL SEIZURES.  EVALUATED AT THE CLINICA WITH MRI AND SPINAL TAP AND PLACED ON KEPPRA.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging head, Partial seizures
Clinical narrative: MODERNA FIRST SHOT 3/4/2021 MODERNA SECOND SHOT 4/01/2021 HAD COVID-19 ILLNESS BEFORE AND AFTER PRIMARY SERIES.   JAN 2022 DEVELOPED MODERATE COGNITIVE DECLINE WITH PARTIAL SEIZURES.  EVALUATED AT THE CLINICA WITH MRI AND SPINAL TAP AND PLACED ON KEPPRA.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Patient states pain in (right arm) which she stated on 2/12/24 was the arm of administration.  That does not match our records of left arm. Patient today complains of pain in both arms, intense pain, can't lift them properly.  Came "out of nowhere" this weekend.  However, patient has visited MD above several times since October regarding similar complaints of pain and discomfort resulting from the vaccine.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Disorganised speech, Respiratory tract congestion
Clinical narrative: About 5 o'clock. I was driving, and I was trying to talk to my friend. My words were jumbled and I couldnt get the words out. It lasted about 20 mins. I was able to drive, I was fine, it was just the speech. It was about 5:30, and I am ok. But since then, my head has been stuffed. Blowing my nose is terrible. The top of my head is stuffed. No cough of anything, just been blowing my nose. I took a claritin an hour before my shot this morning. So that is the only thing I have taken.
Age: 20.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction occurred. Patient received the incorrect version of the flu vaccine. Provider prescribed the FluVal and patient received the Fluad Quad.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Paraesthesia, Peripheral swelling
Clinical narrative: PER PT/PARENT, AFTER PHYSICAL EXAM/SHOTS ON 01/09/24 PT THE NEXT DAY FELT LEFT FACIAL CHEEK "TINGLE" AND LEFT ARM RED AND SWOLLEN.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus
Clinical narrative: Localized erythema, generalized pruritis without rash ongoing
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient says that she developed hives on her abdomen, back, and back of upper legs starting 9/12/2023, the day after she received vaccines.  She said the hives lasted for 2 days.  She said she had no other symptoms other than the hives and itching.  She did not see a doctor or take any Benadryl or other medications as treatment.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 6.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events noted. Patient was 6 years old at the time of visit and was given a 12 + dose of the Pfizer vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Back pain, Contusion, Erythema, Injected limb mobility decreased, Neck pain
Clinical narrative: When she got up on 2/7/24, pt noticied a little soreness in right arm and by the afternoon  she was unable to lift her arm. Pt. also had pain radiating down right arm and neck radiating over into her back. There was a knot about 3.5 in. wide by 2 in long (going down the arm) with some redness, no fever. Pt took oral Benadryl Thurs night, Fri am and Friday night and the swelling subsided by pain did not decrease. Pt. in office today 2/12/24  and redness and knot are gone, some purple and yellow bruising noted. Pt. still not able to lift arm, neck and back pain are still a problem.  Dexamethasone 6 mg given IM today.
Age: 67.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Nodule, Pain, Pain in extremity, Swelling
Clinical narrative: When she got up on 2/7/24, pt noticied a little soreness in right arm and by the afternoon  she was unable to lift her arm. Pt. also had pain radiating down right arm and neck radiating over into her back. There was a knot about 3.5 in. wide by 2 in long (going down the arm) with some redness, no fever. Pt took oral Benadryl Thurs night, Fri am and Friday night and the swelling subsided by pain did not decrease. Pt. in office today 2/12/24  and redness and knot are gone, some purple and yellow bruising noted. Pt. still not able to lift arm, neck and back pain are still a problem.  Dexamethasone 6 mg given IM today.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Immediate post-injection reaction, Muscle rigidity, X-ray
Clinical narrative: Biceps locked up in both R and L arms.  Underarm pain in L arm. Began right away after my three injections and is still a problem Feb. 12,2023
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired COVID-19 vaccine for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: 9 year 1 month old male presents with c/o Accompanied by mother.  c/o concerns for 1 day since yesterday afternoon, redness left upper arm close to influenza vaccine injection site and spreading distally; influenza vaccine given in that area 2 days ago in the afternoon so 24 hours prior; the redness area spread more this morning. Left arm cellulitis Start Cephalexin Monohydrate powder for reconstitution, 250 mg/5 mL, 11.25 ml, orally, 3 times a day, 10 days, 337.5 ML, Refills 0 .
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient was given a third shot of recombinant zoster
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dtap given instead of Tdap - No complaint from patient
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: PT.  complained of throat feeling like it was closing up about 18- 20 minutes after getting the shot-- she was fine about 10 minutes the shot when i checked on her - her PCP dr was gotten - pt assessed - epipen 0.3 mg/ 0.3 ml given and benedryl 50 mg injection
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram thorax, Dizziness, Electrocardiogram
Clinical narrative: Approximately 44 hours later I developed severe dizziness, blurry vision, and nystagmus with severe nausea and vomiting. I went to the emergency room where stroke and cardiac issues were ruled out. They sent me home with diagnosis of vertigo. I still feel moderately dizzy with mild blurry vision and mild nystagmus. I follow up with my PCP today.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Metabolic function test, Nausea, Nystagmus, Troponin
Clinical narrative: Approximately 44 hours later I developed severe dizziness, blurry vision, and nystagmus with severe nausea and vomiting. I went to the emergency room where stroke and cardiac issues were ruled out. They sent me home with diagnosis of vertigo. I still feel moderately dizzy with mild blurry vision and mild nystagmus. I follow up with my PCP today.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred, Vomiting
Clinical narrative: Approximately 44 hours later I developed severe dizziness, blurry vision, and nystagmus with severe nausea and vomiting. I went to the emergency room where stroke and cardiac issues were ruled out. They sent me home with diagnosis of vertigo. I still feel moderately dizzy with mild blurry vision and mild nystagmus. I follow up with my PCP today.
Age: 0.33
Sex: F
Vaccine: ANTH, PNC20, RV1
Symptoms: Crying, Cyanosis, Eye movement disorder, Pyrexia, Tremor
Clinical narrative: Parent describes pt as crying uncontrollably; eyes rolling, fever, shaking of hands and feet; cyanotic episodes
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: it was not an adverse reaction it was an expired vaccine: expiration date was 1/26/24
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Dtap was ordered and given instead of Tdap.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Vaccine administered as part of a healthcare employee vaccination program. After the vaccine was administered the employee became itchy, localized to the site, and then about 20 minutes after vaccination hives were noted near the site. An anesthesiologist assessed the employee and recommended oral benadryl. The employee then went home, took oral benadryl, and the hives resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Facial paralysis, Lethargy, Pupillary reflex impaired
Clinical narrative: Resident noted to have facial drooping to left side, with unevenness when sticking tongue out. Resident is very lethargic, but is able to follow verbal command. Pupils are very sluggish, with little to no reaction. BP 164/84, respirations 20, o2 96%, temperature 98.4, pulse 123. This nurse spoke with Dr., with verbal orders received to send resident to hospital. Report called in to er.  Resident returned to facility at 6:20am via ambulance with 3 attendants. Report called in to this nurse from RN at ER. Resident has dx of TIA and A-fib and will continue previous orders.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Resident noted to have facial drooping to left side, with unevenness when sticking tongue out. Resident is very lethargic, but is able to follow verbal command. Pupils are very sluggish, with little to no reaction. BP 164/84, respirations 20, o2 96%, temperature 98.4, pulse 123. This nurse spoke with Dr., with verbal orders received to send resident to hospital. Report called in to er.  Resident returned to facility at 6:20am via ambulance with 3 attendants. Report called in to this nurse from RN at ER. Resident has dx of TIA and A-fib and will continue previous orders.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Impaired work ability, Lethargy, Vomiting
Clinical narrative: I had the shot late afternoon 01/10.  The next morning I was awoken at around 4:00 am with a bout of vomiting.  The vomiting was short lived but then I had diarrhea/lethargy for several days after.  I missed two days of work.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram normal, C-reactive protein increased, Computerised tomogram thorax normal, Electrocardiogram normal, Fatigue
Clinical narrative: After receiving the vaccine, I became extremely tired the very next day.  Slept for hours with flu like fatigue.  I was expecting that this could possibly happen but only for a few days.  After that, I progressively became worse with severe fatigue and extremely painful stiff neck and head.  This is still going on three weeks later. I have cancelled activities because of the pain and fatigue.  Pain is probably a 7 on the pain scale when not medicated with ibuprofen.  Fatigue is extreme with need to rest after about 5 minutes of standing upright and doing almost nothing.  Prior to the shingles vaccine, I was playing tennis 2-3 times per week for two hours at a time.  I cross country ski at a vigorous pace for 2-3 hours at a time.  I run, I hike.  It is only since the shingles shot I have been unable to do any of this and even simple things like going to the grocery store.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibrin D dimer, Headache, Hypersomnia, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: After receiving the vaccine, I became extremely tired the very next day.  Slept for hours with flu like fatigue.  I was expecting that this could possibly happen but only for a few days.  After that, I progressively became worse with severe fatigue and extremely painful stiff neck and head.  This is still going on three weeks later. I have cancelled activities because of the pain and fatigue.  Pain is probably a 7 on the pain scale when not medicated with ibuprofen.  Fatigue is extreme with need to rest after about 5 minutes of standing upright and doing almost nothing.  Prior to the shingles vaccine, I was playing tennis 2-3 times per week for two hours at a time.  I cross country ski at a vigorous pace for 2-3 hours at a time.  I run, I hike.  It is only since the shingles shot I have been unable to do any of this and even simple things like going to the grocery store.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: After receiving the vaccine, I became extremely tired the very next day.  Slept for hours with flu like fatigue.  I was expecting that this could possibly happen but only for a few days.  After that, I progressively became worse with severe fatigue and extremely painful stiff neck and head.  This is still going on three weeks later. I have cancelled activities because of the pain and fatigue.  Pain is probably a 7 on the pain scale when not medicated with ibuprofen.  Fatigue is extreme with need to rest after about 5 minutes of standing upright and doing almost nothing.  Prior to the shingles vaccine, I was playing tennis 2-3 times per week for two hours at a time.  I cross country ski at a vigorous pace for 2-3 hours at a time.  I run, I hike.  It is only since the shingles shot I have been unable to do any of this and even simple things like going to the grocery store.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: PATIENT REPORTED THAT SHE HAS PAIN AT THE INJECTION SITE THAT OCCURRED FOR 3 DAYS POST VACCINE ADMINISTRATION AND THAT SHE IS STILL EXPERIENCING 3-MONTHS LATER INTERMITTENTLY.
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, HEP, JEV1, TYP
Symptoms: Blindness transient, Blood glucose normal, Dizziness, Nausea, Pallor
Clinical narrative: At 1052the  patient received all 5 immunizations and while redressing the patient stated he felt dizzy and began to pale. Pt was told to lay down on gurney and remove his blouse. RN was called onto the scene. Pt stated he was nauseas and threw up bile.  Vitals were taken at 1054 and repeated at 1105. Provider was also called to the scene and assessed the pt. POC glucose test was ordered and results were normal. Pt stated he did not eat breakfast that day and was nervous about vaccinations. When asked he did not note losing conscious but did have lose of vision for a moment.. By 1110 the pt was able to tolerate water, sit up without issue, and started to regain color. Pt was able to walk out of clinic without issue and was given a limited duty order to prevent any physical exertion for the day.
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, HEP, JEV1, TYP
Symptoms: Vomiting
Clinical narrative: At 1052the  patient received all 5 immunizations and while redressing the patient stated he felt dizzy and began to pale. Pt was told to lay down on gurney and remove his blouse. RN was called onto the scene. Pt stated he was nauseas and threw up bile.  Vitals were taken at 1054 and repeated at 1105. Provider was also called to the scene and assessed the pt. POC glucose test was ordered and results were normal. Pt stated he did not eat breakfast that day and was nervous about vaccinations. When asked he did not note losing conscious but did have lose of vision for a moment.. By 1110 the pt was able to tolerate water, sit up without issue, and started to regain color. Pt was able to walk out of clinic without issue and was given a limited duty order to prevent any physical exertion for the day.
Age: 43.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness neurosensory
Clinical narrative: Patient with a h/o bilateral SNHL who reports sudden worsening of hearing bilaterally approximately 1 month following second dose of Shingrix vaccine
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Death, Myocardial infarction
Clinical narrative: Patient Died of a sudden heart attack on 01/06/2024. There were no prior symptoms or health conditions
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I got the injection on the 27th of January but about 8-9 days later I started getting a rash., on my back and shoulders. I did go to the ER and the doctor did confirm it was hives. It was itchy, kind look like ring worm. I took Benadryl and put on cortisone. Dexamethasone (steroid) given at ER and 4 to take home. Gone within 2- 3 days after visit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: I R.ph. pulled up the diluent ndc 58160-0829-03 into a syringe and labeled syringe with its label after slowly rolling the vial . After distractions I took diluent only syringe and took it to patient and injected her left arm. then I moved paperwork and saw the other vial with the powder not mixed . I realized what happened and profusely apologized to the patient then I grabbed some more diluent and I let the patient watch me mix it to try to show her what happened then I gave the shot IM into her left arm at least 2 inches apart from the diluent only injection.
Age: 4.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Was given vaccine on 2/72024 and came back next day and saw another provider she had not been able to use her arm until next day.  Large local reaction 4 cm redness.  area some redness and swelling mild discomfort.  No sign of anaphylaxis.  Described by provider as suspected local reaction.    Had Prevnar and flu vaccine left deltoid.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Hypertension
Clinical narrative: Hospitalization for COPD exacerbation, COVID-19 infection, Afib with chronic RVR, and hypertension  on dates 2/4/2024- 2/7/2024. Treated with methylprednisolone and Remdesivir.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Axillary pain, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: Vaccine given Thursday, Friday extreme exhaustion ( slept nearly all day), fever, pain in injection site, nausea, diarrhea  stomach cramps. Saturday continued symptoms and injection site swollen , red, hot and swelling increases until most of the upper arm is involved. Sunday pain in arm pit lymph nodes swelling increases swelling reaches elbow crease. Monday swelling starts to recede. Fevers abate, gastric issues continue . pain in armpit continues feeling less exhausted
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccine given Thursday, Friday extreme exhaustion ( slept nearly all day), fever, pain in injection site, nausea, diarrhea  stomach cramps. Saturday continued symptoms and injection site swollen , red, hot and swelling increases until most of the upper arm is involved. Sunday pain in arm pit lymph nodes swelling increases swelling reaches elbow crease. Monday swelling starts to recede. Fevers abate, gastric issues continue . pain in armpit continues feeling less exhausted
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Vaccine given Thursday, Friday extreme exhaustion ( slept nearly all day), fever, pain in injection site, nausea, diarrhea  stomach cramps. Saturday continued symptoms and injection site swollen , red, hot and swelling increases until most of the upper arm is involved. Sunday pain in arm pit lymph nodes swelling increases swelling reaches elbow crease. Monday swelling starts to recede. Fevers abate, gastric issues continue . pain in armpit continues feeling less exhausted
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accelerated hypertension, COVID-19, Dementia, Metabolic encephalopathy, Physical deconditioning
Clinical narrative: Hospitalization for COVID-19 infection, accelerated hypertension, acute metabolic encephalopathy, physical deconditioning, and dementia on dates 2/8/2024-2/9/2024. Treated with no COVID-19 related medications.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt came in for COVID vaccine on 01/05/24 for 3rd dose. On vial it stated expiration date was 07/24 and sticker expiration date was 01/04/24 for refrigerated period. Was not aware of this expiration date at the time of administration. Reported to manager and provider who contacted CDC and was informed no further dose was needed. Provider contacted family and notified and no adverse reactions noted.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site that is getting bigger
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt came in for COVID vaccine on 01/05/24 for 2nd dose. On vial it stated expiration date of 07/24 and sticker expiration date was 01/04/24 for refrigerated period. Was not aware of this expiration date at the time of administration. Reported to manager and provider who contacted CDC and was informed no repeated dose was necessary.  Provider contacted and notified family and no adverse reactions noted.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Osteoporosis, Renal disorder, Urine calcium
Clinical narrative: My kidney is now releasing calcium and as a result I have osteoporosis
Age: 23.0
Sex: F
Vaccine: COVID19, RAB, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event patient got tdap vaccine 6 month ago. shy signed up to get the typhoid vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Flushing, Foreign body in throat, Malaise
Clinical narrative: Within one minute of giving the shot patient complained of something in her throat.  She became flushed but her breathing remained regular.  BP 180/93 P 89 then she complained of her back hurting.  She was a little dizzy.  Requested that the ambulance be called which was done then wanted to lie down so did.  She was starting to feel better by the time the ambulance arrived so them she didn't want to go.  Then changed her mind and decided to go to the hospital per ambulance.  She left at 10:40 from the health dapartment per ambulance.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: patient reports she experiences itching all over her body for 2-3 days after receiving the COVID vaccines, says she did not seek further care
Age: 0.67
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient has not have any adverse reactions at this time.  Filling out forms due to policy.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient has not reported any symptoms; HCP calling to report accidentally administering a double dose of PROQUAD. Patient was supposed to receive VARIVAX however received PROQUAD. Caller confirmed patient has not reported any symptoms. Permission to contact HCP was granted. No additional; HCP calling to report accidentally administering a double dose of PROQUAD. Patient was supposed to receive VARIVAX however received PROQUAD. Caller confirmed patient has not reported any symptoms. Permission to contact HCP was granted. No additional; This spontaneous report was received from a nurse and refers to a patient of unspecified age or gender. The patient's concurrent conditions, medical history, concomitant medication, drug reactions or allergies were not reported.  On 26-JAN-2024, the patient was accidentally vaccinated with double dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #X021126, expiration date: 12-FEB-2025, albumin status validated as rHA, (strength, route of administration, anatomical location not provided) administered as prophylaxis (extra dose administered); instead of the supposed vaccine to receive varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered). The patient did not report any symptoms.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE/PQC reported.; patient was administered a dose of VARIVAX and MMR II that were reconstituted using STERILE WATER vials,; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JAN-2024, the patient patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA injection (0.5 ml / two dose series, lot #W032493, expiration date: 11-OCT-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 ml / two dose series, lot #X000999, expiration date: 09-JAN-2025), both administered for prophylaxis (strength, and route of administration were not provided ); but the vaccines were reconstituted using STERILE WATER vials, instead of the supplied STERILE DILUENT due to an error in preparation (Vaccine incorrect diluent used).  Medical Assistant confirmed that the patient involved did not report any medical concerns or symptoms related to the administration of the vaccines.