chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR; PLAVIX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID". Clinical course: The caller stated last year he took the first two Pfizer Covid vaccines- the first one and then, what was it 3 days later or something like that the second one, and then he also received the Pfizer Covid vaccine booster dose and he was fine. He just came back from country on Sunday, the 11th and this is when he started to have pain in his chest and thought it was his heart but he went to the emergency room and was there for 5 hours they found out he had Covid and they gave him Paxlovid. Before he took Paxlovid they told him to hold Crestor and Plavix, and he also takes colchicine for gout. So, per the MD so he did not take any of the Plavix or Crestor. He took Paxlovid in the morning and evening and then the next morning (yesterday), so he only took it for a day and a half. He started having bleeding, nose bleed, and diarrhea yesterday and then stopped taking the Paxlovid because he did not want it to get worse. He stated he put cotton in his nose and 20 minutes later he took the cotton out and it was stopped, so it stopped about half an hour after it started. Regarding the diarrhea he stated he had it last night and he has not gone anywhere so he does not know if it stopped also. He did not take any Paxlovid pills last night, he just took them that morning and he did not take any today- because of the bleeding and diarrhea.  The called the hospital and the hospital told him to come on down to be seen but he stated it was originally a doctor in the hospital that treated him (it sounded like he was saying he did not want to go back). He is supposed to take for 3 and a half more days but thinks nothing will happen if he stops, he will just quarantine. He stated last time he had Covid he did not take anything and he was fine (did not give date on the last time he had Covid).  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5 and BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300224009 same patient/drug, different dose and events;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Hypertension
Clinical narrative: T78.3XXA ANGIOEDEMA, INIT 4/13/2023 HTN (HYPERTENSION)
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Patient reported dizziness and Light headed after 15 minute window. Offered water and/or popsicle. Patient refused. Alerted provider  Checked back in 10 minutes, patient reported symptoms were gone. Released patient and advised to call if any other reaction or if needed.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cheilitis, Lip swelling
Clinical narrative: Swelling in lower lip and several sores on inside of lower lip
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Epistaxis, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 3/31/2023 ACUTE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/28/2023 ACUTE PULMONARY EMBOLISM ACUTE DVT OF BILAT FEMORAL VEINS 3/31/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 3/31/2023 EPISTAXIS ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/28/2023 EPISTAXIS ACUTE DVT OF BILAT FEMORAL VEINS 3/31/2023 EPISTAXIS
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic arteriosclerosis, Deep vein thrombosis, Hypoxia
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/27/2023 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 3/27/2023 ACUTE RESPIRATORY FAILURE HYPOXIA 4/10/2023 ACUTE RESPIRATORY FAILURE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/27/2023 ATHEROSCLEROSIS OF AORTA ACUTE RESPIRATORY FAILURE 3/27/2023 ATHEROSCLEROSIS OF AORTA HYPOXIA 4/10/2023 ATHEROSCLEROSIS OF AORTA
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebellar stroke, Cerebrovascular accident, Computerised tomogram, Laboratory test
Clinical narrative: Multiple debilitating strokes in the cerebellum and cerebrum.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Multiple debilitating strokes in the cerebellum and cerebrum.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Moderna Bivalent expired date was 6/12/23 and was administered on 6/19/23
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental poisoning, Acute respiratory failure, Respiratory failure, Toxicity to various agents
Clinical narrative: ACUTE RESPIRATORY FAILURE 3/15/2023 POISONING BY OTHER OPIOIDS ACCIDENTAL INIT ENC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/13/2023 POISONING BY OTHER OPIOIDS ACCIDENTAL INIT ENC
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: We could not get a hold of the patient. We have tried calling several times, but the patient is not answering.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Addison's Disease" (unspecified if ongoing); "hypopituitarism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Reglan, reaction(s): "Known allergies: reglan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223980 Same patient differnt drugs and events;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Partial seizures
Clinical narrative: FOCAL MOTOR SEIZURE ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Transient ischaemic attack
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE TRANSIENT CEREBRAL ISCHEMIA
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypoxia
Clinical narrative: R09.02 HYPOXIA 4/24/2023 ASTHMA, UNSPECIFIED
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: PCP office notified of deceased patient on 5/18/2023. Per ED documents, patient was brought in unresponsive, CPR in progress. Also noted, 2-year-old found lying on top of the patient and patient was not breathing. PCP office instructed by Risk Management department to file VAERS report on 6/19/2023.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypercholesterolaemia
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/10/2023 HYPERCHOLESTEROLEMIA
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Very painful lower back and knees/ hips pain
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Chronic respiratory failure, Left ventricular failure, Respiratory failure
Clinical narrative: J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/16/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Endometrial thickening, Heavy menstrual bleeding, Menstrual clots, Menstrual disorder
Clinical narrative: Per patient report- For the vacation adverse effects report, I've had excessively heavy, long periods with clotted blood coming out since early 2022, so it corresponds with the third dose of the Covid vaccine I received in January 2022. The heavy periods are not monthly, some months they are light and more like spotting. However, when I get heavy periods, the bleeding continues for two weeks or more and some days it's so heavy that I'm constantly in the bathroom changing pads, washing and changing underwear & clothes, and even needing to put something underneath me where I sit to prevent blood staining things. The latest one that started on May 23rd has not stopped yet (3 weeks and counting!) and I'm getting dizzy and feel palpitations because of all the bleeding and heavy clots that come out continuously.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Ultrasound pelvis abnormal
Clinical narrative: Per patient report- For the vacation adverse effects report, I've had excessively heavy, long periods with clotted blood coming out since early 2022, so it corresponds with the third dose of the Covid vaccine I received in January 2022. The heavy periods are not monthly, some months they are light and more like spotting. However, when I get heavy periods, the bleeding continues for two weeks or more and some days it's so heavy that I'm constantly in the bathroom changing pads, washing and changing underwear & clothes, and even needing to put something underneath me where I sit to prevent blood staining things. The latest one that started on May 23rd has not stopped yet (3 weeks and counting!) and I'm getting dizzy and feel palpitations because of all the bleeding and heavy clots that come out continuously.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 12/12/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD HYPOTENSION 12/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: please above, pt is diagnosed with zoster outbreak 9 days after receiving the vaccine.  Course, currently 15 days with increasing dermatome involvement.
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received monovalent covid vaccine on 3/23/23. Received bivalent covid vaccine on 5/22/23 and 6/19/23. Bivalent covid vaccine administered on 6/19/23 was administered too early per current guidelines.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epilepsy
Clinical narrative: EPILEPSY, UNSPECIFIED
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Crying, Muscle tightness, Palpitations, Panic attack
Clinical narrative: 35-year-old female with anxiety, possible vaccine reaction however at this time I suspect she more likely had a panic attack.  Patient was crying and reported that she felt as though she was having palpitations, and that her face was tight.  Heart rate was within normal limits, with no palpitations noted, no angioedema or erythema noted to the face.  Posterior oropharynx was clear and patent.  Patient was given initial dose of 50 mg of Benadryl orally.  Vital signs assessed every 5 minutes for 15 minutes.  Patient is now calm.  Offered to call 911 for ambulance for patient to be monitored in the emergency room.  However patient declined at this time.  I do not suspect that the patient is having a anaphylactic reaction to the vaccine and rather an anxiety or panic attack related to the COVID-vaccine.  Patient's husband was notified of the reaction, and he is on his way to come and pick her up.  Patient vital signs remained stable.  No further symptoms noted.  Instructed patient to follow-up with her primary care provider, and return to the urgent care for any new, persistent, or worsening concerns.  Instructed patient that if she was to start feeling the symptoms again that she proceed proceed to the emergency room.  Discussed signs and symptoms of anaphylaxis such as swelling of the throat, face, eyes, urticaria, palpitations, wheezing, or difficulty breathing.  Patient verbalized understanding of these.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: after receiving vaccine the patient's arm was swollen and painful and tender to touch for the following week, (06/12/23-6/18/23) and currently it is red and itchy at the site of injection. (06/19/23)
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thrombocytopenia" (unspecified if ongoing); "enlarged spleen" (unspecified if ongoing); "littoral cell angioma" (unspecified if ongoing); "Prostate cancer", start date: 2010 (unspecified if ongoing). Concomitant medication(s) included: BENEFIBER FIBER SUPPLEMENT, start date: 19Aug2021; PRESERVISION AREDS 2, start date: 08Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 01Jun2023 to 05Jun2023 for treatment of COVID-19. Brand of concomitant medication PreservisionAreds2 was Bausch & Lomb. Patient got mild Covid rebound symptoms on 15Jun2023 at 08:00 PM with outcome of not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223853 same patient, different drugs and events;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Tenderness, Varicella
Clinical narrative: I broke out with a mild case of Chicken Pox,  first on side of leg, then a day later 12 spots on my belly, a few on the neck, one in my ear, a couple on my arm. no pain unless I touch them, they did not itch much.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angina unstable, Smear cervix abnormal
Clinical narrative: UNSTABLE ANGINA 3/21/2023 ABNL CERVICAL PAP
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Barium enema abnormal, Decreased appetite, Diet refusal, Flatulence
Clinical narrative: Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Gastrointestinal oedema, Ileocaecal resection, Imaging procedure abnormal, Infant irritability, Infantile vomiting
Clinical narrative: Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intestinal dilatation, Intestinal mass, Intestinal obstruction, Intussusception, Laparotomy
Clinical narrative: Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Mass excision, Pathology test, Poor feeding infant, Procedural failure, Small intestinal intussusception reduction
Clinical narrative: Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Small intestinal obstruction, Soft tissue disorder, Soft tissue mass, Ultrasound abdomen abnormal, X-ray
Clinical narrative: Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 1/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Hypoxia
Clinical narrative: R09.02 HYPOXIA 3/26/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Age: 0.17
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Injection site discolouration
Clinical narrative: silver splinter looking spot on both thighs. One on left thigh was from 2 month old shots and one on right thigh from 4 month old shots.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Condition aggravated, Generalised oedema, Hypotension
Clinical narrative: PERIPHERAL NEUROPATHY 4/13/2023 CHRONIC ATRIAL FIBRILLATIONHYPOTENSION 4/20/2023 CHRONIC ATRIAL FIBRILLATION PERIPHERAL NEUROPATHY 4/13/2023 CHF EXACERBATION, UNSPECIFIED HYPOTENSION 4/20/2023 CHF EXACERBATION, UNSPECIFIED PERIPHERAL NEUROPATHY 4/13/2023 ANASARCA HYPOTENSION 4/20/2023 ANASARCA
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY 4/13/2023 CHRONIC ATRIAL FIBRILLATIONHYPOTENSION 4/20/2023 CHRONIC ATRIAL FIBRILLATION PERIPHERAL NEUROPATHY 4/13/2023 CHF EXACERBATION, UNSPECIFIED HYPOTENSION 4/20/2023 CHF EXACERBATION, UNSPECIFIED PERIPHERAL NEUROPATHY 4/13/2023 ANASARCA HYPOTENSION 4/20/2023 ANASARCA
Age: 31.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Angiogram cerebral normal, Arteriogram carotid, Magnetic resonance imaging head normal, Migraine, Muscle twitching
Clinical narrative: Pulsatile tinnitus in right ear has persisted since early October. Started with migraines and facial twitching within a week of receiving the booster shot before shifting primarily to pulsatile tinnitus.
Age: 31.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Superior semicircular canal dehiscence, Tinnitus
Clinical narrative: Pulsatile tinnitus in right ear has persisted since early October. Started with migraines and facial twitching within a week of receiving the booster shot before shifting primarily to pulsatile tinnitus.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Subclavian steal syndrome, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE LEFT SUBCLAVIAN STEAL SYNDROME 2/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Second Shingrix vaccine administered was expired on date of administration. Administered 2/17/2023, expired 11/7/2022. Discovered thru internal audit. Primary care physician has been notified, incident has been submitted, and patient has been notified and will stop in this week to receive re-administration of 2nd dose (as per CDC guidelines)
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Got COVID in 5 months last year; Got COVID in 5 months last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (ongoing), notes: irregular heart break; "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Got COVID in 5 months last year". The patient underwent the following laboratory tests and procedures: Body temperature: 130.7, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; 103.7, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; 104, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; SARS-CoV-2 test: very much light, notes: strep throat but it was very much light. Clinical course: Reporter also wanted to add under issue when she had the COVID for the first of time she had two very large abscess white abscess in her throat she also had Pharyngitis with it and she had Laryngitis with it and she had 130.7 fever and it went from 103.7 to 104 for about 5 days and within she had the strep test done because may be she had the strep test in urgent care, strep throat but it was very much light Diphtheria look very much like Diphtheria and they did not know what it was but she did not want to be admitted to the hospital because they will keep on ventilator and die like her uncle (further not clarified) had so but yeah but she was very sick she had laryngitis pharyngitis those big passed balls in back of her throat and she could not hardly swallow. yeah she was pretty much miserable and then the heart problem so she had two, so the second time it wasn't newly as bad like a bad cold but yeah even though she had two Pfizer vaccine and the booster did nothing for her.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223692 same patient, different doses and events;
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Second Shingrix vaccine administered was expired on date of administration. Administered 01/20/2023, expired 11/7/2022. Discovered thru internal audit. Primary care physician has been notified, incident has been submitted, and patient has been notified. Patient will stop in this week to receive re-administration of 2nd dose (as per CDC guidelines)
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pericarditis
Clinical narrative: ACUTE PERICARDITIS, UNSPECIFIED 12/12/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event, Product administration error
Clinical narrative: Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 10/22/2022,  10/24/2022,  11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia
Clinical narrative: NUMB LEFT FACE AND ARM, STARTED DAY OF VACCINE
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Angina unstable, Hypersensitivity
Clinical narrative: UNSTABLE ANGINA ALLERGIC REACTION, INIT
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 6/16/2023.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Neck pain, Nodule, Pain, Pain in extremity
Clinical narrative: Pain after immediately after injection that radiated up into neck and down into arm continued for several months.  Had "a knot" half grapefruit size that started the day after and continued for 4 months.  Pain 6 months.  Improving with massage, chiropractic benefit.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Computerised tomogram, Condition aggravated, Gait disturbance, Hypoaesthesia
Clinical narrative: Long tremors on different parts of the body, first the tremors started in the lower extremities, then it started to move to the torso, and then to the upper extremities, arms and head, and eyes. I experience long periods of brain fog, no walking properly, and numbness in the lower and sometimes up extremities. I have gone to the neurologists multiple times and have done CT scans, MRIs, and other tests. They acknowledge my symptoms but do not know what it is. The first time I went to the doctors, they thought I suffered a stroke.  So they requested I go to the emergency room.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Tremor
Clinical narrative: Long tremors on different parts of the body, first the tremors started in the lower extremities, then it started to move to the torso, and then to the upper extremities, arms and head, and eyes. I experience long periods of brain fog, no walking properly, and numbness in the lower and sometimes up extremities. I have gone to the neurologists multiple times and have done CT scans, MRIs, and other tests. They acknowledge my symptoms but do not know what it is. The first time I went to the doctors, they thought I suffered a stroke.  So they requested I go to the emergency room.
Age: 82.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: no symptoms, no reactions
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt had rash, itching, swelling, lump around injection area. Started day after injection and all symptoms resolved except swelling by following day.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: DTAP given, but expired 06/10/2023. Spoke with parent. No adverse events at this time, but will continue to follow.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient experienced vasovagal syncope following administration of Trumenba (Meningococcal Serogroup B) vaccination into his right deltoid. After lying with his feet in the air and taking sips of water, the patient was able to leave.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: syncope, no treatment required. Patient ambulated to PV independently.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Small intestinal obstruction
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 4/28/2023 PARTIAL SMALL BOWEL OBSTRUCTION
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------- OBSTRUCTIVE SLEEP APNEA 12/14/2022 HX OF ABNL UTERINE BLEEDING
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bell's palsy, Presyncope
Clinical narrative: LEFT BELLS PALSY 3/20/2023 NEAR SYNCOPE LEFT BELLS PALSY 3/20/2023 ABDOMINAL PAIN
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 4/12/2023 ATRIAL FLUTTER, UNSPECIFIED
Age: 75.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product use issue
Clinical narrative: Vaccine administered on 4/5/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus
Clinical narrative: Diabetic reaction after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "recovered", described as "Diabetic reaction after COVID vaccine". The patient underwent the following laboratory tests and procedures: Blood glucose: High, notes: Diabetic reaction after COVID vaccine. Clinical course: High blood sugar after COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This patient was given a Kinrix injection by mistake.  He should have been given a Pediarix due to his age.
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 4/19/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 4/24/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 5/22/23 and 6/19/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 06/01/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product use issue
Clinical narrative: Vaccine administered on 06/02/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatty liver alcoholic, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 4/15/2023 ALCOHOLIC FATTY LIVER
Age: 0.75
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: No signs of adverse effects post administration.
Age: 66.0
Sex: F
Vaccine: PNC15
Symptoms: Pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: PATIENT STATES SHE WAS SORE ON WEDNESDAY - ON FRIDAY BELOW VACCINATION SITE THERE WAS REDNESS, HOT TO TOUCH, "HIVE" AREA, ITCHY.  PATIENT HAS TAKEN BENADRYL. PATIENT STILL EXPERIENCING THESE SYMPTOMS AS OF 6/19/23.  UPON SPEAKING WITH PATIENT ON 6/19, I RECOMMENDED TO ICE AREA, CONTINUE ON BENADRYL AND TO FOLLOW UP WITH MD.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Obstructive sleep apnoea syndrome
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/10/2023 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Vaccine not reconstituted, sterile diluent given only
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Biliary colic, Cholelithiasis, Neuropathy peripheral
Clinical narrative: G62.9 NEUROPATHY 4/24/2023 BILIARY COLIC G62.9 NEUROPATHY 4/24/2023 CHOLELITHIASIS
Age: 26.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: patient fainted after giving last vaccination -Adacel. Patient was quickly revived in a few seconds.  We checked his blood pressure 102/67-pulse92. We had patient remain in pharmacy for 30 minutes to monitor him. He said he was fine and went home.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Allergy to vaccine, Computerised tomogram thorax, Rash, Urticaria
Clinical narrative: Mother returned to clinic after receiving Hep A, noted hives on his face  and arm 40 minutes after leaving office.  Urticarial rash as noted on left cheek, right arm & a few on his legs.  Lungs CTA bilat.; no lip or tongue swelling or resp distress noted.  RR 32. 5 mls of benedryl and prednisone administered at office. Observed for an hour, rash did resolve., Allergist was informed and did confirm that it was a probable allergic reaction to vaccine. Allergist did recommend patient stay on treatment with prednisone and benadryl for 5 days.
Sex: U
Vaccine: COVID19
Symptoms: Scan, Thrombosis
Clinical narrative: I ended up with 2 blood clots in my upper right above my elbow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "I ended up with 2 blood clots in my upper right above my elbow". The event "i ended up with 2 blood clots in my upper right above my elbow" required physician office visit. The patient underwent the following laboratory tests and procedures: Scan: One was where stated above my elbow, notes: and the 2nd had moved up and was stuck under my highest rib on my right side. Clinical course: After taking the first 2 shots, a booster was available and patient had that also. In a short period of time patient ended up with 2 blood clots in upper right above elbow. Knew the symptoms of a possible blood clot and made an appointment with doctor. He immediately sent patient to get a scan to see their exact location. One was where stated above elbow and the 2nd had moved up and was stuck under highest rib on right side. Patient was told the clots were in an unusual area. Within a short.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: extra dose of ACTHIB was administered with no reported adverse event; Initial information received on 14-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 months old male patient who was administered an extra dose of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B Vaccine RHBSAG (YEAST), HIB VACCINE CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Vaxelis) for Prophylactic vaccination; pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination.  On 13-Jun-2023, the patient received a Standard dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 mL  total (lot UJ836AA, expiry date- 28-OCT-2023) via intramuscular route in the right thigh for Immunization.  On 13-Jun-2023, (latency- same day), the patient developed a non-serious event of extra dose was administered with no reported adverse event (extra dose administered) following the administration of haemophilus type B (HIB) (PRP/T) vaccine.  Reportedly, HCP called to inform that a medical assistant gave an extra dose of ACTHIB. As per the caller, the medical assistant thought that the VAXELIS did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: administered Tdap intradermally in the forearm and the patient was having a reaction; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves Elderly and unknown gender patient who was administered diphtheria, tetanus and acellular pertussis vaccine intradermally in the forearm and the patient was having a reaction.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (lot number, strength, expiry date, dosage, formulation- not reported) via intradermal route in the forearm NOS (not otherwise specified) for Prophylactic vaccination (Immunisation). Information on the batch number was requested  On an unknown date the patient was administered tdap intradermally in the forearm and the patient is having a reaction (immunisation reaction) (unknown latency) following the administration of diphtheria, tetanus and acellular pertussis vaccine  Reportedly, medical assistant administered Tdap to an elderly patient intradermally in the forearm and the patient is having a reaction. "Is there anything to be advised of?  Action taken was 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: 6.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received the diluent because the pharmacist failed to dissolve the vaccine and just gave the diluent with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA185167.  This case involves a 6 years old male patient who received the diluent because the pharmacist failed to dissolve the Yellow Fever Vaccine [YF-VAX] vaccine and just gave the diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2023, it was reported that 0.5ml dose of suspect Yellow Fever Vaccine Solution for injection (lot number and expiry: not reported) was not reconstituted and the patient received the diluent because the pharmacist failed to dissolve the vaccine and just gave the diluent with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.