chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Incoherent, Lethargy, Loss of consciousness, Myalgia
Clinical narrative: She got her vaccines, left the doctors office afterwards and went to the grocery store.  Came home, unloaded and put away her groceries and said at the time to her sister who was there, told her that shd did not feel too good and was going to go upstairs and lay down, which she did for about an hour or so.  Her stomach was sort of queazy and did not feel good.  Already had a headache between the time of the vaccine and getting home.  She got up and came down the stairs (3), and walked into the kitchen and she took a bite of some chicken and mid chew she spit it into the sink as she felt really bad, and felt tht it was not right and tried to call out to her sister and fainted.  Her sister was trying to bring her arouaround, and her sister said that before she came to she was mumbling, garbled but her eyes rolled out and felt that she was going to pass out again.  Her sister let her lay there and come conscience.  Probably 1-2 minutes later she said that she was OK, but that she needed something as she was soaking wet from sweating.  She got her a cold wet rag to put around her neck, and she laid on the floor for 15 minutes before she could get her wits to get up.  She has had 2 knee replacements and did not want to kneel and she pulled herself up when she had a thick foam dog bed to get up.  She could not get her legs under her so sat in the chair for 15 minutes.  She does not know if when she fainted her knee overextended or her knee overextended and that she had pain.  Then her sister helped her walk into the living room and sit in her lazy boy.  She then got chills, and then around an hour later she took some Tylenol and went to bed.  She was then in bed for 3 full days.  Her muscles hurt, she was tired and lethargic and thought that her head was going to explode as it hurt so bad.  She did not want to eat as she felt so bad.  She did not call her doctor.  Her knee was doing fine until she fell, she had total knee replacements 2 years and 7 years ago and now they are in severe pain.    Her sister and herself could not figure out what caused her to faint.  She just happened to notice that Shingrix pamphlet and read it and knew that it was due to that vaccine as the literature mentionend it.  It showed all the issues that she had had, and how she felt before and after.  She has regained some of her appetite, but not really hungry.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Speech disorder, Syncope
Clinical narrative: She got her vaccines, left the doctors office afterwards and went to the grocery store.  Came home, unloaded and put away her groceries and said at the time to her sister who was there, told her that shd did not feel too good and was going to go upstairs and lay down, which she did for about an hour or so.  Her stomach was sort of queazy and did not feel good.  Already had a headache between the time of the vaccine and getting home.  She got up and came down the stairs (3), and walked into the kitchen and she took a bite of some chicken and mid chew she spit it into the sink as she felt really bad, and felt tht it was not right and tried to call out to her sister and fainted.  Her sister was trying to bring her arouaround, and her sister said that before she came to she was mumbling, garbled but her eyes rolled out and felt that she was going to pass out again.  Her sister let her lay there and come conscience.  Probably 1-2 minutes later she said that she was OK, but that she needed something as she was soaking wet from sweating.  She got her a cold wet rag to put around her neck, and she laid on the floor for 15 minutes before she could get her wits to get up.  She has had 2 knee replacements and did not want to kneel and she pulled herself up when she had a thick foam dog bed to get up.  She could not get her legs under her so sat in the chair for 15 minutes.  She does not know if when she fainted her knee overextended or her knee overextended and that she had pain.  Then her sister helped her walk into the living room and sit in her lazy boy.  She then got chills, and then around an hour later she took some Tylenol and went to bed.  She was then in bed for 3 full days.  Her muscles hurt, she was tired and lethargic and thought that her head was going to explode as it hurt so bad.  She did not want to eat as she felt so bad.  She did not call her doctor.  Her knee was doing fine until she fell, she had total knee replacements 2 years and 7 years ago and now they are in severe pain.    Her sister and herself could not figure out what caused her to faint.  She just happened to notice that Shingrix pamphlet and read it and knew that it was due to that vaccine as the literature mentionend it.  It showed all the issues that she had had, and how she felt before and after.  She has regained some of her appetite, but not really hungry.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Vaccination itself was into left deltoid, was not eventful, did not notice pain or difficulty, described the site of injection as toward the top of the deltoid, to the lateral side.  Later in the day after the vaccination, he experienced a unilateral tingling on the body on the side of the shot, notably in left arm, left neck and rarely into left leg.  It was more pronounced about 24 hours later, then began to improve.  By 9/22/23 when initially reported, he was noticing intermittent numbness/tingling in his lateral left hand, and then positional peripheral neuropathy in lateral hand for the next week.  By 10/1/23 @ 10 pm he states he has not noticed further symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Localised oedema, Magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: shoulder pain shooting down right arm. still persistent up to today. has seen ortho, had mri which showed fluid in the shoulder. has had steroid shots and pills with no improvement.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Patient came into the work clinic to receive Flu and COVID vaccines.  She was given the Comirnaty new COVID vaccine on her right arm, and she was given fluzone Quad vaccine on her left arm.  Immediately after receiving the vaccines she reported feeling dizzy.  She was asked to stay seated.  Within a minute her head dropped and she appeared to have lost consciousness.  The immunizer quickly grabbed her arms to make sure she did not fall off the chair and called for help.  The second immunizer came over and held her shoulders and head.  Her eyes had rolled back and she was shivering/shaking as if seizing but this lasted less than 30 seconds and she opened her eyes and asked if she had fainted.  The school nurses were present at this point and took her blood pressure while waiting for EMS to arrive.  Her first reading was BP 83/47 and heart rate of 61.  Patient at this point was alert, seated with her legs elevated.  She was talking and expressing concern about the incident.  Her blood pressure was taken again and at this point it was 59/56.  Patient was alert/oriented and reported that she was anxious before the immunization and had been under extreme stress the past couple of weeks.  EMT arrived and checked her blood pressure again, 106/72 and they transported her to the hospital.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: "passed out for 2 hours"  but recovered with no injuries.
Age: 84.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient reported to pharmacy having been to urgent care for cellulitis in the arm which was vaccinated. There was a clear bruise at the injection site, redness and warmth to the touch. She was prescribed a course of antibiotics (bactrim ds 800-160mg) for 10 days. As of return to pharmacy patient was picking up the antibiotic and cellulitis was unresolved. Urgent care also told patient that vaccine had been administered in the wrong spot, but based on bruising, shot looked to have been administered in the deltoid.
Age: 53.0
Sex: F
Vaccine: FLUR4, PNC20, VARZOS
Symptoms: Extra dose administered, Influenza like illness, Pain in extremity
Clinical narrative: PT RECEIVED A 3RD DOSE OF SHINGRIX, THINKING SHE HAD ONLY RECEIVED 1 PREVIOUS DOSE.  SHE HAD A SORE ARM, MILD FLULIKE SYMPTOMS THE NEXT DAY, BUT NO OTHER ISSUES. SHE STATED NO SIGNIFICANT ISSUES
Age: 61.0
Sex: F
Vaccine: 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 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid Disease" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Sep2023 to 25Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311955 Same patient, different drug, different event;
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt had a 4 inch long and 3 inch wide red swollen injection site
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Hospital treatment includes O2, Remdesevir, labs and monitoring.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site swelling, Paraesthesia, Rash
Clinical narrative: SWELLING AT INJECTION SITE - 6 CM BY 6CM, RASH COMES AND GOES ON ARMS, TINGLING IN FINGERS
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: APPROXIMATELY 20 MINUTES AFTER VACCINE ADMINISTRATION, PT REPORTED THAT SHE FELT AS IF HER THROAT WAS TIGHTENING. PT STATED THAT 1 WEEK PRIOR SHE EXPERIENCED THE SAME SYMPTOMS WITH HER COVID-19 VACCINE, REPORTED SHE WAS GIVEN BENADRYL AND SYMPTOMS SUBSIDED. PT HAS EPIPEN AND ALBUTEROL PRESCRIPTION BUT DID NOT HAVE THE MEDS WITH HER. SAT PT DOWN IN CHAIR, ADMINISTERED 50 MG OF ORAL LIQUID BENADRYL AND MONITORED PT. PT REPORTED THAT HER THROAT FELT NORMAL SHORTLY AFTER TAKING BENADRYL. STAY WITH PT FOR 30 MINUTES AFTER ADVERSE EVENT TX WAS GIVEN. LUNG CLEAR TO AUSCULTATION THROUGHOUT. NO SIGNS OF DISTRESS. EDUCATED PT ON STEPS TO TAKE IF SYMPTOMS RETURN/WORSEN.  PT DENIED NEEDING TO SEEK FURTHER TREATMENT FOR SYMPTOMS AT THIS TIME.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: PATIENT CALLED AND SAID HER ARM HURTS SINCE SHE GOT THE VACCINE AND SHE IS GOING TO SEE HER DOCTOR TODAY
Age: 78.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Asthenia, Blood culture negative, Dysstasia, Influenza like illness, Laboratory test
Clinical narrative: Pt arrives via EMS from home due to weakness and not being able to stand. Pt states that he received the COVID and RSV vaccines yesterday. Pt stated feeling fine yesterday prior to vaccines. Patient was closely monitored during hospitalization and given IV fluids. Neurology was consulted during hospital course, and it was thought that patient had a immunization reaction due to the release of interferons and other immune mediated factors following his immunization that caused his flulike symptoms and weakness.
Age: 78.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Neurological symptom
Clinical narrative: Pt arrives via EMS from home due to weakness and not being able to stand. Pt states that he received the COVID and RSV vaccines yesterday. Pt stated feeling fine yesterday prior to vaccines. Patient was closely monitored during hospitalization and given IV fluids. Neurology was consulted during hospital course, and it was thought that patient had a immunization reaction due to the release of interferons and other immune mediated factors following his immunization that caused his flulike symptoms and weakness.
Age: 1.83
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Vaccine Error: Patient was administered an undiluted dose of the pfizer covid booster, therefore receiving 3 times the normal dose. Parent made aware, has not reported any symptoms
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Dysgeusia, Feeling cold
Clinical narrative: First I had the same coffee I drink the last 4 years, and it was bad, then I was cold. I put a blanket over me and went to bed. The next day the coffee tasted normal and I was warmed up as usual.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given 1 full vial that was not reconstituted with diluent. Pt received all 3 doses that were in the vial. Family was notified. No adverse effects reported at this time/
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Atrial flutter, Bloody discharge, C-reactive protein increased
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebral haematoma, Cerebral haemorrhage, Chest X-ray abnormal, Chest pain
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Computerised tomogram thorax abnormal, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fibrin D dimer, Fraction of inspired oxygen, Gastrointestinal tube insertion, Haemoglobin normal
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Lung consolidation, Lung opacity, Mechanical ventilation, Nasal cavity packing
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pneumothorax, Positive airway pressure therapy, Serum ferritin increased, Thrombocytopenia
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vasogenic cerebral oedema
Clinical narrative: Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Catheter placement, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Ferritin 1590; 1/4 On 1 L - but keeps pulling of NC  dry cough.  Cr 6.4.  Last day of azithromycin; 1/5 comfortable on room air.  Patient now agreed to dialysis 1/6 s/p HD.  Daughter noted improving mental status and breathing.   1/7 breathing okay.  Dry coughing.  1/8 no diarrhea, on room air.  1/9 continuing on room air, WBC elevated 13.7 - from line placement, chest x-ray better, blood culture today and monitor WBC.  No phlebitis noted 1/10 in HD today.  WBC 11.6.  Remain on room air, past speech evaluation   1/11 stable on RA, WBC approaching Normal. D/c Airborne plus Isolation at this point. HD placement Pending approval .1/12 last day of Decadron.  Daughters reporting back to baseline mental status
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Haemodialysis, Intentional removal of drug delivery system by patient, Mental status changes, Serum ferritin increased, White blood cell count increased
Clinical narrative: Ferritin 1590; 1/4 On 1 L - but keeps pulling of NC  dry cough.  Cr 6.4.  Last day of azithromycin; 1/5 comfortable on room air.  Patient now agreed to dialysis 1/6 s/p HD.  Daughter noted improving mental status and breathing.   1/7 breathing okay.  Dry coughing.  1/8 no diarrhea, on room air.  1/9 continuing on room air, WBC elevated 13.7 - from line placement, chest x-ray better, blood culture today and monitor WBC.  No phlebitis noted 1/10 in HD today.  WBC 11.6.  Remain on room air, past speech evaluation   1/11 stable on RA, WBC approaching Normal. D/c Airborne plus Isolation at this point. HD placement Pending approval .1/12 last day of Decadron.  Daughters reporting back to baseline mental status
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives on face and trunk approximately 5 minutes after vaccine administration. Doctor was immediately notified and evaluated patient reaction. Administered 12.5mg of PO Benadryl. Patient waited in office and was repeatedly checked on by nursing staff and physician.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given 1 full vial that was not diluted. Patient received all 3 doses contained within in the vial. No adverse events reported at this time
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alpha 1 foetoprotein, Biopsy, Blood lactate dehydrogenase, Bone scan, Chemotherapy
Clinical narrative: Diagnosed with Retroperitoneal Germ Cell Tumor. 4 cycles of BEP given. Possible surgery to remove any remaining mass.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Germ cell neoplasm, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: Diagnosed with Retroperitoneal Germ Cell Tumor. 4 cycles of BEP given. Possible surgery to remove any remaining mass.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Somnolence
Clinical narrative: muscle sore extreme , and at 9pm pt said she felt extreme drowsiness. and sleepy. and feels this is side effect from her vaccine, this am she feels fine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose number unknown, single (Lot number: GH9464) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 19Sep2023, Stop date: 23Sep2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312770 same reporter/patient, different drug/event;
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered 35 days after the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Biopsy skin, Headache, Injection site bruising, Injection site pain
Clinical narrative: She got her vaccine, she had slight pain in injection area, and headache, and that was it.  Then in about June of 2022 she had a skin rash, and has been diagnosed with psoariasis form dermatitis.  She feels it is related to the vaccine as she had no problems with her skin prior to the vaccine.  She also has subcorneal pustular dermitits lechenified, spongiotic psoriasis form dermatitis, as well as atopic dermatitis.  She has been given Clobetasol for treatment of this, and another cream that she was given that was not effective.  She went to see the dermatologist on 7/5/2022.  The medicine is working, but she is started to getting some bad AE from it, and going to see him this month
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash, Skin discolouration, Vein disorder
Clinical narrative: She got her vaccine, she had slight pain in injection area, and headache, and that was it.  Then in about June of 2022 she had a skin rash, and has been diagnosed with psoariasis form dermatitis.  She feels it is related to the vaccine as she had no problems with her skin prior to the vaccine.  She also has subcorneal pustular dermitits lechenified, spongiotic psoriasis form dermatitis, as well as atopic dermatitis.  She has been given Clobetasol for treatment of this, and another cream that she was given that was not effective.  She went to see the dermatologist on 7/5/2022.  The medicine is working, but she is started to getting some bad AE from it, and going to see him this month
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PATIENT RECEIVED COMIRNATY VACCINE ON 9/26/23, WHEN THE PATIENT RETURNED ON 10/3/23 FOR HIS FLU AND PNEUMONIA VACCINATIONS THEY RECEIVED AN ADDITIONAL COMIRNATY  0.3ML DOSE INSTEAD WITH THEIR fluzone HD VACCINATION
Age: 47.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Burning sensation, Dizziness, Vomiting
Clinical narrative: Pt-said she had a burning feeling where she felt she was going to pass out, after a min of sitting she threw up. The EMS came and took her vitals all her numbers were good, at that time her husband came.  EMS walked her outside where she left with her husband.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine that expired 6/30/23
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram normal, Feeling drunk, Headache
Clinical narrative: The patient reports that approximately 1 hour after receiving the vaccine she noticed pain and swelling in her left arm where vaccine was given.  She then noted that she felt "drunk" and had a headache as well.  She went to lunch with her husband and felt a vasovagal response begin to happen when swallowing Pepsi (the patient has these often due to her chronic health conditions above).  She told her husband she was about to pass out and was immediately unconscious.  The fire department and EMS responded and she was found to have a blood pressure of 189/108.  The patient was taken to the emergency department and was evaluated there.  She received a bag of fluids in the ambulance.  The patient states she received no treatment in the ED and was told it was vasovagal syncope.  She states that an EKG was performed but while she was laying down so her results looked normal.  She reports that her blood pressure remained elevated for 3-4 hours after the event and she complains that she still has a headache today (10/3/2023).   She notes that her arm swelling finally went down yesterday (10/2/2023).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Peripheral swelling, Presyncope
Clinical narrative: The patient reports that approximately 1 hour after receiving the vaccine she noticed pain and swelling in her left arm where vaccine was given.  She then noted that she felt "drunk" and had a headache as well.  She went to lunch with her husband and felt a vasovagal response begin to happen when swallowing Pepsi (the patient has these often due to her chronic health conditions above).  She told her husband she was about to pass out and was immediately unconscious.  The fire department and EMS responded and she was found to have a blood pressure of 189/108.  The patient was taken to the emergency department and was evaluated there.  She received a bag of fluids in the ambulance.  The patient states she received no treatment in the ED and was told it was vasovagal syncope.  She states that an EKG was performed but while she was laying down so her results looked normal.  She reports that her blood pressure remained elevated for 3-4 hours after the event and she complains that she still has a headache today (10/3/2023).   She notes that her arm swelling finally went down yesterday (10/2/2023).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: The patient reports that approximately 1 hour after receiving the vaccine she noticed pain and swelling in her left arm where vaccine was given.  She then noted that she felt "drunk" and had a headache as well.  She went to lunch with her husband and felt a vasovagal response begin to happen when swallowing Pepsi (the patient has these often due to her chronic health conditions above).  She told her husband she was about to pass out and was immediately unconscious.  The fire department and EMS responded and she was found to have a blood pressure of 189/108.  The patient was taken to the emergency department and was evaluated there.  She received a bag of fluids in the ambulance.  The patient states she received no treatment in the ED and was told it was vasovagal syncope.  She states that an EKG was performed but while she was laying down so her results looked normal.  She reports that her blood pressure remained elevated for 3-4 hours after the event and she complains that she still has a headache today (10/3/2023).   She notes that her arm swelling finally went down yesterday (10/2/2023).
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered 26 days after the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was given a vaccine that was expired on 6/30/23
Age: 39.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient received a second  Afluria for the year instead of the requested Comirnaty shot. Patient states they do not currently feel any side effects from either shot and is feeling fine.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was given flu shot that was expired on 6/30/23
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: The flu shot formed a sizeable red blotch with pain and itchiness and has lasted 4 days and is finally calming down some.  The blotch was approximately  6" by 4" in size and is located below the injection site.
Age: 74.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Patient received Fluad first. After Shingrix administration, she started to tremble and was unresponsive for a few ~30 seconds. After 2-3 mins she was to keep herself up on her own. She was given glucose gel and seemed to recover. Fire department came and took her away roughly 20-30min following A/E. She came back later to the pharmacy recovered. Said it was vasovagal syncope.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient vaccinated with undiluted dose of COVID pfizer 6m-4yr vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered 40 days past the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions. RN 10/3/23
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Pain, Rash
Clinical narrative: skin rash, naseau, body aches
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: skin rash, naseau, body aches
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Pain, Rash
Clinical narrative: Rash of chest
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: Rash of chest
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery stenosis, Coagulopathy, Hypotension
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/27/2023 BILAT CAROTID ARTERY STENOSIS I95.9 HYPOTENSION 6/28/2023 BILAT CAROTID ARTERY STENOSIS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/27/2023 LEFT CAROTID ARTERY STENOSIS I95.9 HYPOTENSION 6/28/2023 LEFT CAROTID ARTERY STENOSIS
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right 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: "hashimotos" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: TECFIDERA, start date: 01Dec2015. Past drug history included: Gabapentin, reaction(s): "Drug Allergy", notes: Gabapentin causes hives; Gabapentin, reaction(s): "hives". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid (treatment start date: 18Sep2023, treatment stop date: 22Sep2023).  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: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Limb mass, Pain
Clinical narrative: There's a lump in my right arm and it still hurts and if I even move my wrist it hurts all the way up my arm.  I have pain up into my shoulder. I can barely use my arm. I don't sleep on my right side so I am not sure why it is still so swollen with this lump and is painful.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: There's a lump in my right arm and it still hurts and if I even move my wrist it hurts all the way up my arm.  I have pain up into my shoulder. I can barely use my arm. I don't sleep on my right side so I am not sure why it is still so swollen with this lump and is painful.
Age: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Kinrix instead of Infanrix. No harm to patient. No adverse outcomes.
Age: 72.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore shoulder muscle at site of injection and fatigue. Both are mild.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chest pain
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 12/28/2022 CHEST PAIN
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Influenza like illness, Injection site pain, Pain, Peripheral swelling
Clinical narrative: She got her vaccine, it hurt really bad getting it.  Then getting around dinner time she started getting a fever, her arm swelled up, red and she felt like her whole body was in a flu-like state.  She was this way for a week.  Due to her allergies and having a stroke that she can only take Tylenol arthritis.  This medicine does not help much for her.  She is in a lot of pain, has been tried on Gabapentin and was drugged up on it.  She did call her doctor and they said to ice it, rest, fluids, and if it got worse to come in.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: She got her vaccine, it hurt really bad getting it.  Then getting around dinner time she started getting a fever, her arm swelled up, red and she felt like her whole body was in a flu-like state.  She was this way for a week.  Due to her allergies and having a stroke that she can only take Tylenol arthritis.  This medicine does not help much for her.  She is in a lot of pain, has been tried on Gabapentin and was drugged up on it.  She did call her doctor and they said to ice it, rest, fluids, and if it got worse to come in.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Tremor
Clinical narrative: Severe widespread joint paint (9 or 10 out of 10) for 48 hours, tremors when using muslces (holding items, walking, etc.) for 36 hours, fever (101-103) for 48 hours. Rest, hydration, icing.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient received vaccine on 9/28/2023 . Patient developed a rash on his legs and had a rash on his arm as well. Patient went to local emergency department on 10/2/2023 and was prescribed diphenhydramine 25 mg with the directions 1 capsule three times a day as needed for itching.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Dizziness, Loss of consciousness, Pain in extremity, Tenderness
Clinical narrative: Feeling faint. Passed out at home x2. Pain and tenderness in left arm. Feeling weak x4days.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Received vaccine approx 2 pm Friday Sept 29 2023. Woke up with intense dizziness and slight nausea at 4:15 am on Saturday Sept 30 2023. Dizziness persisted for approx 24 hours. Took Tylenol 8hr tablet to ease headache accompanying dizziness
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: GIVEN AT AGE OF 61 YEARS. NO ADVERSE REACTION REPORTED/ASSESSED FROM PATIENT.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: headache
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Known allergies: Yes. Penicillin" (unspecified if ongoing), notes: Known allergies: Yes. Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid from 27Sep2023 for COVID-19.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 62.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at covid booster injection site
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: The wrong vaccine was given for this patient. Instead of the 6 month to 4 year vial, a portion of the 5 to 11 year vial was given. 1.1 mL of sterile water was added to dilute the 5 to 11 year vaccine, and 0.3 mL of this was given to the patient. I calculated this out to be 6.5 mcg of the 2023-2024 COVID vaccine, rather than the 10 mcg recommended amount.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT PRESENTED TO CLINIC WITH COMPLAINTS OF LEFT ARM PAIN AND SWELLING THAT BEGAN TWO DAYS AFTER RECEIVING VACCINATION. PATIENT STATES HE FIRST NOTICED A KNOT UNDER THE SKIN AT INJECTION SITE, AS WELL AS MILD DISCOMFORT. HE STATES THE SWELLING AND PAIN BEGAN TO WORSEN WITH EACH PASSING DAY, AND THE REDNESS AND WARMTH TO THE SKIN STARTED SOON AFTER. TODAY, PATIENT WAS NOTED TO HAVE MILD ERYTHEMA TO LEFT UPPER ARM AND SKIN WAS WARM TO THE TOUCH. RECOMMENDED THAT PATIENT SEEK FURTHER EVALUATION AND TREATMENT AT NEARBY WALK-IN CLINIC. PATIENT VERBALIZED UNDERSTANDING AND STATES HE PLANS TO FOLLOW-UP TODAY WITH WALK-IN CLINIC.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate pain in right upper arm following vaccine administration. Patient reports persistent symptoms of right upper arm and shoulder pain with movement at 4 weeks post-vaccination
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Melaena
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 6/6/2023 MELENA
Age: 32.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Discomfort, Erythema, Product administered at inappropriate site
Clinical narrative: Patient reports redness and discomfort due to vaccines being administered too low on the arm. He states that they were injected midway on the arm between shoulder and elbow. He had to visit a doctor for treatment.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra Flu vaccine. No signs or symptoms reported.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Body temperature increased, Fatigue, Headache, Injection site pain
Clinical narrative: Right arm sore and achy from injection site down to finger tips. No decreased range of motion. Feels drained of energy and tired. Initial temperature was 98.5 F at 10:30 am. Temperature at 12:45 pm was 100.5 F. Also complains of a mild headache. She was given ibuprofen 400mg at 12:50. No improvement at the time this report was written.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Right arm sore and achy from injection site down to finger tips. No decreased range of motion. Feels drained of energy and tired. Initial temperature was 98.5 F at 10:30 am. Temperature at 12:45 pm was 100.5 F. Also complains of a mild headache. She was given ibuprofen 400mg at 12:50. No improvement at the time this report was written.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Loss of consciousness, Subdural haemorrhage, Traumatic intracranial haemorrhage
Clinical narrative: R09.02 HYPOXIA 7/12/2023 TRAUMATIC SUBDURAL HEMORRHAGE W LOC STATUS UNKNOWN, INIT
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: none
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: PEDIATRIC FORMULATION WAS ADMINISTERED INSTEAD OF 12+ FORMULATION.