chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Death, Dizziness, Dyspnoea, Endotracheal intubation
Clinical narrative: Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia, Hyposmia, Hypotension, Intensive care, Lung opacity
Clinical narrative: Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Muscular weakness, Positive airway pressure therapy, Productive cough, Pulseless electrical activity
Clinical narrative: Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell transfusion, Retroperitoneal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anxiety disorder
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 7/7/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 7/7/2023 ANXIETY DISORDER, OTHER SPECIFIED
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypotension, Respiratory failure
Clinical narrative: I95.9 HYPOTENSION 5/15/2023 ACUTE & CHRONIC RESPIRATORY FAILURE WITH HYPOXIA
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Vascular operation
Clinical narrative: I95.9 HYPOTENSION 5/20/2023 AFTERCARE FOR VASCULAR SURGERY
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Dehydration, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient experience nausea and vomiting and diarrhea.  She became dehydrated and had to go the ER.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Chronic kidney disease, Dementia, Epilepsy, Glomerular filtration rate decreased
Clinical narrative: G40.909 DEMENTIA, UNSPECIFIED SEVERITY, DUE TO EPILEPSY W OTHER BEHAVIORAL DISTURBANCE. 5/13/2023 CKD STAGE 3B (GFR 30-44)
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Angiocardiogram, Arrhythmia, Cardiac stress test, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Pt received dose of Abrysvo RSV vaccine on 9/7/2023 to the L deltoid. On 9/9/23 pt reports experiencing "arrythmias". On Monday 9/11/23, pt reports going to the local urgent care for further evaluation. An EKG was done. On 9/12/23, she visited her PCP for annual visit and to further evaluate arrythmias. She had a stress angiogram done and reports wearing a holter monitor. She is scheduled for a follow up with PCP on 9/19/23. Patient reports that she has had a history of premature ventricular contractions in the past.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate irregular
Clinical narrative: Pt received dose of Abrysvo RSV vaccine on 9/7/2023 to the L deltoid. On 9/9/23 pt reports experiencing "arrythmias". On Monday 9/11/23, pt reports going to the local urgent care for further evaluation. An EKG was done. On 9/12/23, she visited her PCP for annual visit and to further evaluate arrythmias. She had a stress angiogram done and reports wearing a holter monitor. She is scheduled for a follow up with PCP on 9/19/23. Patient reports that she has had a history of premature ventricular contractions in the past.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Was given kinrix and proquad. A few hours later at home the kinrix site became red, warm to the touch and swollen raided area the measures 4.5 " x  5 ". Came into the office on Monday, injection site is looking and feeling better.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode approximately 5 minutes after administration of the vaccines above. The patient was assisted to a lying position, aroused with verbal and tactile stimuli after 3-5 seconds. The patient was anxious prior to vaccine administration, per Mother it had been many years she had immunizations. Cool compress applied to forehead and the patient was given water and cookies, BP: 100/80 Pulse: 88 Resp: 26. The patient was monitored for approximately 15 minutes, till she verbalized she was better. Mother refused EMS transport to ER for evaluation.
Age: 48.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood pressure increased, Dizziness, Headache, Loss of consciousness, Mental status changes
Clinical narrative: About an hour after receiving vaccines, client started to experience headache, dizziness, nausea and vomiting. Vital signs were checked, and client had a HR of 83, O2 of 98% and a BP of 170/110. Patient began to vomit again. Patient next lost consciousness or had altered mental status. Client was taken to ED by staff due to elevated BP and headache.
Age: 48.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: About an hour after receiving vaccines, client started to experience headache, dizziness, nausea and vomiting. Vital signs were checked, and client had a HR of 83, O2 of 98% and a BP of 170/110. Patient began to vomit again. Patient next lost consciousness or had altered mental status. Client was taken to ED by staff due to elevated BP and headache.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given this only after 2 weeks from receiving the Varicella immunization. Should have waited 28 days.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Hypersensitivity, Immunisation reaction, Injection site erythema, Injection site induration
Clinical narrative: A few hours after administration the site where the injection took place was hot, firm, red, itchy. The following day the injection site had slightly worse symptoms as described previously. Then two days post injection, patient work up from his nap with hives all over his body. Legs, trunk, face, arms. Large white, raised, irregular shaped blotches all over. They were red, itchy, and warm. I contacted the doctor and they recommended going to urgent care. They prescribed antibiotics for concerns related to cellulitis and said that he was experiencing a delayed allergic reaction to the vaccine. The hives disappeared almost entirely an hour later and returned about 2 hours later yet again.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site warmth, Pruritus, Rash macular, Skin discolouration
Clinical narrative: A few hours after administration the site where the injection took place was hot, firm, red, itchy. The following day the injection site had slightly worse symptoms as described previously. Then two days post injection, patient work up from his nap with hives all over his body. Legs, trunk, face, arms. Large white, raised, irregular shaped blotches all over. They were red, itchy, and warm. I contacted the doctor and they recommended going to urgent care. They prescribed antibiotics for concerns related to cellulitis and said that he was experiencing a delayed allergic reaction to the vaccine. The hives disappeared almost entirely an hour later and returned about 2 hours later yet again.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Skin warm, Urticaria
Clinical narrative: A few hours after administration the site where the injection took place was hot, firm, red, itchy. The following day the injection site had slightly worse symptoms as described previously. Then two days post injection, patient work up from his nap with hives all over his body. Legs, trunk, face, arms. Large white, raised, irregular shaped blotches all over. They were red, itchy, and warm. I contacted the doctor and they recommended going to urgent care. They prescribed antibiotics for concerns related to cellulitis and said that he was experiencing a delayed allergic reaction to the vaccine. The hives disappeared almost entirely an hour later and returned about 2 hours later yet again.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema
Clinical narrative: . PATIENT WAS SITTING ON THE CHAIR AFTER THE VACCINE AND  STARTED COMPLAINING  SHORTNESS OF BREATH FEW MINUTES AFTER THE VACCINE . PATIENT'S FACE TURNED RED AND WAS ASKED IF SHE WAS FEELING OK. SHE DENIED WHEN ASKED TO CALL THE AMBULANCE. PATIENT STARTED FEELING BETTER AFTER FEW MINUTES. PATIENT WAS ASKED TO SIT IN THE OBSERVATION AREA FOR 30 MINUTES WHERE PHARMACIST KEPT AN EYE OF HER FOR THE  ENTIRE TIME SHE WAS THERE.
Age: 59.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: The patient is 59 years old. He was scheduled to get just a flu shot. His wife was scheduled to get the flu and RSV (she is over 60). The pharmacist administered the RSV and flu to the husband by mistake. There is no adverse effect reported, just administered outside of approved age range.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Cold sweat, Electrocardiogram normal, Pallor, Syncope
Clinical narrative: Vasovagel episode following vaccine injection lasted for under 1 minute. Patient reported chest discomfort following syncope that releaved in 2 minutes. EKG was performed and resulted at normal. Patient's skin was palor and clammy which releived within 10 minutes. Patient and mother reported symptoms were fully resolved at her follow-up PCP visit.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Somnolence
Clinical narrative: Pt reported swelling and itchy at injection site, feel sleepy than usual, reported rash only at injection site, reported no shortness of breath and chest pain. Pt has taken antihistamine at the morning of symptoms started next day. Reported the symptoms has getting better but not much.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypotension, Seizure
Clinical narrative: I95.9 HYPOTENSION 8/6/2023 SEIZURE, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 8/6/2023 SEIZURE, UNSPECIFIED
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: patient received flu shot on 09/16/23 reported to pharmacy on 09/18/23 warm red hard area several inches below where vaccine was given.  Patient contacting md to have evaluated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pruritus, Pyrexia
Clinical narrative: Recieved vaccine 9/15. Developed redness and fever 12 hours later. Followed by heat, induration, swelling over the next two days. Day 3 (9/18) generalized itch without hives presenting on trunk, face, legs and arms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Recieved vaccine 9/15. Developed redness and fever 12 hours later. Followed by heat, induration, swelling over the next two days. Day 3 (9/18) generalized itch without hives presenting on trunk, face, legs and arms.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Angioedema, Chest discomfort, Full blood count, Hypersensitivity, Metabolic function test
Clinical narrative: Allergic reacción, hives, angioedema, chest tightness
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Allergic reacción, hives, angioedema, chest tightness
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Electric shock sensation, Mobility decreased
Clinical narrative: 2 HOURS AFTER VACCINE PATIENT HAD A "RUSH" OF ELECTRICITY STARTING FROM UPPER STOMACH/CHEST TRAVELLING UP TO THE CHEEK.  PATIENT WAS STUNNED, DESCRIBED BEING "FROZEN" FOR A MINUTE OR TWO.  NO FURTHER ISSUES FOLLOWING THIS EPISODE.
Age: 69.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Hypotonia, Muscular weakness
Clinical narrative: patient stated on Sunday on four separate occasions her left hand went flacid (i.e. she was unable to move it). She had gotten RSV and flu shot both in her left arm. RPh had recommended one in each are but pt said she has a lot of "hardware" in other arm so wanted both in left deltoid
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphthous ulcer, Chest X-ray, Condition aggravated, Dairy intolerance
Clinical narrative: Started with a deep cough the next day, the cough has not dissipated 2 years later.  I know have intermediate (I think that's what Dr called it) and have to use ventolin inhaler, montelukast daily.  I take mucinex maximum as needed. Attempted servant discus and symbicort increases canker sores in my mouth had to stop.  Allergies to food I had not been allergic too before I get constant canker sores in my mouth and throat, anaphylaxis reaction from nuts, seeds, nightshade family, strawberries, milk, yogurt, zucchini, eggs and new ones keep coming up.  My seasonal allergies has gotten to point I can't be outside much.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food allergy, Hypersensitivity
Clinical narrative: Started with a deep cough the next day, the cough has not dissipated 2 years later.  I know have intermediate (I think that's what Dr called it) and have to use ventolin inhaler, montelukast daily.  I take mucinex maximum as needed. Attempted servant discus and symbicort increases canker sores in my mouth had to stop.  Allergies to food I had not been allergic too before I get constant canker sores in my mouth and throat, anaphylaxis reaction from nuts, seeds, nightshade family, strawberries, milk, yogurt, zucchini, eggs and new ones keep coming up.  My seasonal allergies has gotten to point I can't be outside much.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect.  High Dose was given when not indicated.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash, Injection site warmth
Clinical narrative: pt arm was very wear,m and rash was spreading from injection site down arm  and towards back of arm.  pt stated she had a knot in her arm at site
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swollen upper lip and cheeks
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Blood glucose normal, Confusional state, Dizziness, Dystonia, Eye movement disorder
Clinical narrative: Patient was administered flu vaccine on left arm first and was well, no reactions after vaccine given. Then I administered Men B vaccine on right arm and shortly after (approx 10 seconds) I had finished giving vaccine to patient, he passed out and he was beginning to fall forward towards me. I grabbed patient and as I was laying him down onto bed his eyes started rolling backwards and he started clenching up his fists and his body began to mildly shake. Patient was unresponsive and would not answer me when I would ask if he was ok. I went and called Dr. to the room. As doctor was coming into the room, patient started to become responsive and responding to me. Patient was pale and was saying he was dizzy and kept trying to sit up but was a bit confused. I told him to lay down and as Dr. was walking into the room, he passed out again and became unresponsive and he began clenching his fists up, eyes started going backwards again, and his body started shaking mildly again. Dr. went out room and told (office manager) to call EMS.  This episode lasted approx. 10-15 seconds. After this episode, patient became responsive and started talking to us and telling us he remembered passing out the first time and woke up to mom hugging him and remembers passing out again.  EMS arrived to clinic and pt was taken to hospital for further evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, Tremor
Clinical narrative: Patient was administered flu vaccine on left arm first and was well, no reactions after vaccine given. Then I administered Men B vaccine on right arm and shortly after (approx 10 seconds) I had finished giving vaccine to patient, he passed out and he was beginning to fall forward towards me. I grabbed patient and as I was laying him down onto bed his eyes started rolling backwards and he started clenching up his fists and his body began to mildly shake. Patient was unresponsive and would not answer me when I would ask if he was ok. I went and called Dr. to the room. As doctor was coming into the room, patient started to become responsive and responding to me. Patient was pale and was saying he was dizzy and kept trying to sit up but was a bit confused. I told him to lay down and as Dr. was walking into the room, he passed out again and became unresponsive and he began clenching his fists up, eyes started going backwards again, and his body started shaking mildly again. Dr. went out room and told (office manager) to call EMS.  This episode lasted approx. 10-15 seconds. After this episode, patient became responsive and started talking to us and telling us he remembered passing out the first time and woke up to mom hugging him and remembers passing out again.  EMS arrived to clinic and pt was taken to hospital for further evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was administered flu vaccine on left arm first and was well, no reactions after vaccine given. Then I administered Men B vaccine on right arm and shortly after (approx 10 seconds) I had finished giving vaccine to patient, he passed out and he was beginning to fall forward towards me. I grabbed patient and as I was laying him down onto bed his eyes started rolling backwards and he started clenching up his fists and his body began to mildly shake. Patient was unresponsive and would not answer me when I would ask if he was ok. I went and called Dr. to the room. As doctor was coming into the room, patient started to become responsive and responding to me. Patient was pale and was saying he was dizzy and kept trying to sit up but was a bit confused. I told him to lay down and as Dr. was walking into the room, he passed out again and became unresponsive and he began clenching his fists up, eyes started going backwards again, and his body started shaking mildly again. Dr. went out room and told (office manager) to call EMS.  This episode lasted approx. 10-15 seconds. After this episode, patient became responsive and started talking to us and telling us he remembered passing out the first time and woke up to mom hugging him and remembers passing out again.  EMS arrived to clinic and pt was taken to hospital for further evaluation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red, swollen, warm to touch, itchy area about 2 to 3 inches below injection site on the day after injection.  Injection site was not involved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 15.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 65+ flu vaccine to 15 year old
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: cdc failed to notify the bivalent was no longer authorized upon authorizing seasonal until the evening of 9/12.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th, so bivalent was given on the 12th.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 17.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave wrong dose, gave 65+ dose to a 17 year old
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Severe Dizziness.  Doctor prescribed Mecline 25 Mg RX Tablets take 1 tab by mouth three times daily
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Administration site bruise, Administration site erythema, Administration site pain, Administration site swelling
Clinical narrative: Per patient, day after vaccine administration their arm at the administration site was very swollen and painful and red. The patient contacted us to tell us that the pain and swelling persisted for a week after vaccination and what appeared to be a bruise appeared at the administration site
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 93.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Asthenia, Blood test, Fatigue, Feeling cold, Tremor
Clinical narrative: I got super cold 2 hours after. I wrapped up. I had a heating pad. I had uncontrollable shaking. I went to the hospital. The shaking stopped. Sunday I was weak and fatigued. I am fine today 9/18.
Age: 1.25
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pt said their arm hurt so much they can barely move it. reccomended tylenol and ibuprofen
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site rash
Clinical narrative: Pt states development of rash/bumps over injection site. States she is not allergic to band-aid used or any adhesives.
Age: 0.75
Sex: U
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: patient was concerned that the evening of the vaccination her arm got really red and swollen. She had swelling up to the neck area and said she was in pain. She also had a fever  and never had any reaction to any vaccines before- explained that redness and swelling at injection site are normal for vaccination but will document for them since they were concerned - not all the way recovered yet still some swelling in the neck
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 1.58
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: I do not know the type of RSV Shot. I have a rash that started on the right arm and has reoccurred in both armpits and between both my thighs and legs.
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 41.0
Sex: U
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 47.0
Sex: U
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Client was standing and stated she felt dizzy at 2:50pm before brief syncopal event. This nurse and MOC caught client and slowly lowered her to the ground and raised her legs. No injury noted by RN or stated by client. Client awake and oriented within seconds. 2nd nurse called in for further assistance. Client had sips of juice while laughing and texting grandmother. Client sitting and standing again by 2:54pm without any dizziness. Client walked out of clinic with MOC by 2:59pm.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lower urinary tract symptoms
Clinical narrative: Date of Admission: 9/11/2023   Date of Discharge: 9/14/2023   Issues to be Addressed at Follow-up: COVID19 and UTI symptoms
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, SARS-CoV-2 test positive
Clinical narrative: Cough, body aches, sore throat
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 87.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; Patient was administered expired VAQTA; This spontaneous report was received from Pharmacist and refers to an unknown patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 21-FEB-2023, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) lot #U021561, expiration date: 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used), it was stated that No Temperature Excursion reported for Affected Product prior the administration of the vaccine. No additional adverse event was reported.  This case was considered as non-valid due to lack of patient identifiers.  Follow-up information has been received from the pharmacist on 11-SEP-2023. The patient's demographic information was updated. The case was regarding a 87-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. The previously reported expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered intramuscularly. It was reported the patient and primary physician were informed of the incident and that the patient had no side effect or adverse reactions from the expired dose administered.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: There are no side effects as of call.; HCP calls to report MMR II administered to a woman who is pregnant.  Patient is 4-6 weeks pregnant.  There are no side effects as of call.  See request case. Urgent Callback Request case.; This spontaneous prospective pregnancy report was received from a physician and refers to a 26-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter.  On an unreported date in 2023 (reported as 4-6 weeks pregnant), the patient became pregnant and the last menstrual period (LMP) was calculated on an unknown date in May 2023.   On 23-JUN-2023, the 4-6 weeks pregnant patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, administered intramuscularly for prophylaxis (strength, anatomical location, lot number, and expiry date were not provided) (exposure during pregnancy).  The pregnancy outcome was not reported at the time of the report (outcome pending) therefore, the fetal outcome was unknown.  It was reported that there were no side effects (no adverse event).
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site hypersensitivity, Pain, Sensitive skin
Clinical narrative: experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; experienced "pain, sensitivity, and hypersensitivity at injection site 18 days after injection; This spontaneous report has been received from a physician via company representative, referring to a 11 years old female patient. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was unknown by reporter.   On 31-JUL-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: 0.5 milliliter, route, strength, lot number and expiration date were unknown by reporter) in the right arm for prophylaxis.         On the same day, the patient experienced pain, sensitivity, and hypersensitivity at injection site 18 days after injection. The patient sought medical attention. It was unknown if the lab diagnostics or studies performed. It was unknown if the treatment was given. Dechallenge was also reported as yes (conflicting information). The outcome of the events was reported as recovering. The causality assessment between the events and suspect vaccine was not reported.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; Nurse called and reported that a dose of PROQUAD was administered to a 15 year old on 8/18/2023.; This spontaneous report was received from a nurse referring to a 15-year-old female  patient. The patient's concurrent conditions, medical history, concomitant therapies and historical drugs were not reported.  On 18-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #X007356, expiration date: 08-SEP-2024, administered subcutaneously for prophylaxis at left arm (strength was not provided) (inappropriate age at vaccine administration). No additional adverse event (no AE).
Age: 52.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; a dose of PROQUAD was administered to an adult today; This spontaneous report was received from a registered nurse and refers to a 52-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-AUG-2023, an adult patient (product administered to patient of inappropriate age) was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 milliliter, lot # reported and confirmed as: W034209, expiration date was reported and confirmed as: 24-APR-2024 (dose number, site and route of administration were not provided) for prophylaxis. The patient needed varicella and measles, mumps, rubella (MMR) vaccination for nursing school. No side effects or symptoms reported. There was no additional adverse event.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion. Excursion occurred on 8/16/2023 which is the date the customer states the products were administered.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml (lot number X006980 and X001000 have been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with expiration dates established as 07-MAR-2025 and 09-JAN-2025, respectively); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml (lot number W038810 has been determined to be valid for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 04-JUN-2024), both administered for prophylaxis after the vaccines had suffered a temperature excursion on that same date (product storage error) (strength, and anatomical site of administration were not provided). Temperature excursion timeframe was 5 minutes at a temperature of -10.2 degree Celsius (C).; Sender Comments: Keywords :
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HCP reporting that PROQUAD was administered after it experienced a supported temperature excursion; This spontaneous report has been received from a medical assistant and refers to a 4-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 25-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at dose of 0.5 milliliter (lot number X002296 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 21-JUL-2024) administered for prophylaxis, after it had experienced a temperature excursion (product storage error) (strength, and anatomical of administration were not provided). The temperature excursion occurred within a timeframe of 1 hour and 36 minutes, at a temperature of -12.6 degree Celsius (C). No adverse events were reported.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; T/E. Improperly stored VARIVAX administered to a patient on 28AUG2023, 0.5mL dose. HCP did not have information (lot number, expiration date) on DILUENT but confirmed it was Merck DILUENT; This spontaneous report was received from a Medical Assistant and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (once), lot #W039294, expiration date: 11-DEC-2024 or lot# U027947, expiration date: 08-SEP-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided); and with sterile diluent (no details reported), and the vaccine was improperly stored: temperature 7.8F (6 F degrees up to 14 F degrees), time frame: 0 hour 30 minutes 0 seconds (no previous temperature excursion). No additional adverse event.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: MA calling to report child received PEDVAXHIB vaccine in addition to PENTCEL on same date.   Caller was difficult to understand and obtain information from. Associaed Req. case # 02460164 and 02460217.  No additional AE.  No PQC.; No additional AE; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2024 (conflicting information since report was received in 2023), the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) for prophylaxis (Overdose). No additional adverse events were reported (No adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Abdominal distension, Erythema, Pain, Pyrexia, Rash
Clinical narrative: pain, redness, swelling, a rash, and fever a week after the injection; pain, redness, swelling, a rash, and fever a week after the injection; pain, redness, swelling, a rash, and fever a week after the injection; pain, redness, swelling, a rash, and fever a week after the injection; pain, redness, swelling, a rash, and fever a week after the injection; This spontaneous report was received from a medical assistant via Company representative concerning a 4-year-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date in August 2023 (also reported within the last 1-2 weeks), the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, administered intramuscularly as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).  Since and unknown date in August 2023 (also reported as a week after the injection), the patient had been experiencing pain, redness, swelling, rash, and fever. The patient did not receive treatment for the events and the symptoms resolved after a day or two. According to the reporter, the family members were sensitive to medications.   Causal relationship between the suspect vaccine and the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE/PQC; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs). No symptoms reported. Obtained consent to contact HCP. AE Filed (Case #02463498). No additional AE/PQC.; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs). No symptoms reported. Obtained consent to contact HCP. AE Filed (Case #02463498). No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The information on patient's medical history, current conditions and concomitant medications were not reported.  On 29-AUG-2023, the patient received a vaccination of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy Type: rHA) 0.5 ml/dose (valid lot# W024972 with expired date 05-FEB-2024) with expired sterile diluent 1 dosage form (lot# U012698 has been verified to be a valid lot number with reported expiration date: 25-AUG-2023) (no prior temperature excursion) as prophylaxis (both strengths and routes of administration were not provided) (Product preparation issue; Expired product administered). There was no symptoms reported (No adverse event).  This was one of both reports from the same reporter.; Sender's Comments:  US-009507513-2309USA000085:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 30-AUG-2023, the patient was vaccinated with and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, lot number U024220 with expiration date 04-AUG-2023, administered as prophylaxis (Expired product administered) (dosage regimen and route of administration were not reported). According to the reporter, the dose was considered as supported based on the Post Expiry Memo, the registered nurse was "happy" with the outcome and did not request. No additional adverse event was reported (No adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion to patient; This spontaneous report has been received from a nurse and refers to a 4-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 02-SEP-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection after it had suffered a temperature excursion (product storage error). (lot number X013909 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 10-NOV-2024) once, administered for prophylaxis (strength, lot #, expiry date, and anatomical site of administration were not provided). Temperature excursion had a timeframe of 20 minutes, at a temperature of 6 degrees Fahrenheit (F). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE and no PQC; HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient.  No symptoms or further details reported.  No other AE and no PQC; This spontaneous report was received from Other Health Professional and refers 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 14-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 14-SEP-2023, HBP called to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient. No symptoms or further details reported. No other AE and no PQC.