chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: reported that an expired acthib was administered to a child, with no reported adverse event; Initial information received  on 29-Mar-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 3 years old male patient and reporter reported that an expired HIB (PRP/T) Vaccine [ACT-HIB] was administered to a child, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for Immunisation; and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) for Immunisation.  On 29-Mar-2023, the patient received 0.3 ml (Dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ648ABA, Expiry date: 16-Mar-2023) (Strength- Standard) via intramuscular route in the left thigh for immunization.  On 29-Mar-2023, the reporter reported that an expired HIB (PRP/T) Vaccine was administered to a child, with no reported adverse event (expired product administered) (Latency: same day).  It was reported, She wanted to know what her next step will be. Frequency: 3 times ( 1st dose- 2 months old, 2nd dose- 4 months old, and 3rd dose- today.  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Head discomfort, Muscular weakness
Clinical narrative: Fel't like I was hit over the head and ruffed up my legs are very wobbly, never again. Feels like covid without the coughing.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Flushing
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: cold extremities, low bp, anxiety reported by pt, nausea numbness and tingling in fingers, got shot at 10:14am, pt complained of feelinng dizzy, pt layed down with feet elevated at 10:20am and atempted to get BP but pt was moving around and wasnt able to get readings, called EMS, fire dept arrived at 10:30am and ran bp of 108/60, with hr=55 at 10:33am and took patient outside on gerny for further tests, no brusing at injection site, wont let me complete without choosignan option
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Hypotension, Injection site bruising, Nausea
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: cold extremities, low bp, anxiety reported by pt, nausea numbness and tingling in fingers, got shot at 10:14am, pt complained of feelinng dizzy, pt layed down with feet elevated at 10:20am and atempted to get BP but pt was moving around and wasnt able to get readings, called EMS, fire dept arrived at 10:30am and ran bp of 108/60, with hr=55 at 10:33am and took patient outside on gerny for further tests, no brusing at injection site, wont let me complete without choosignan option
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: cold extremities, low bp, anxiety reported by pt, nausea numbness and tingling in fingers, got shot at 10:14am, pt complained of feelinng dizzy, pt layed down with feet elevated at 10:20am and atempted to get BP but pt was moving around and wasnt able to get readings, called EMS, fire dept arrived at 10:30am and ran bp of 108/60, with hr=55 at 10:33am and took patient outside on gerny for further tests, no brusing at injection site, wont let me complete without choosignan option
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Upper arm very swollen, red, large red hot spot immediately below injection site.  Resolved by 4/1/2023 9:00 AM.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient informed me on 03/30/2022 that her arm was still hurting from a Shingles vaccine I gave her in November 2022. I called her today, April 1, 2023 @ 8:50 a.m.,  to get more information, so I could fill out this form.  I asked her if it was still hurting. She said not as bad. I recommended Ice, Aleve, and Lidocaine gel. I verified which arm. She replied, it is the right arm that hurts. The Shingles vaccine was given into the left arm.  She claims it is the right arm that is sore.  Then she changed the date  to  September 10th, 2022. She received a TDAP and Flu vaccines. Both in the left arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain, Pyrexia
Clinical narrative: Fever 101*F and higher  Extreme body aches  No energy  Nauseated
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Malaise, Respiratory tract congestion
Clinical narrative: Tested positive for COVID with home test on 1/5/23.  Husband tested positive on 1/2/23.  I had a negative PCR test on 1/2/23, but some mild symptoms appeared 1/4/23.  Temperature about 100. Fatigue, cough, congestion.  Had Zoom visit with healthcare professional at PCP's practice on 1/5/23.  Started Paxlovid 1/5/23 twice a day.  Symptoms subsided within 2-3 days, but then recurred3-5 days after the 5-day Paxlovid regimen was completed.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID with home test on 1/5/23.  Husband tested positive on 1/2/23.  I had a negative PCR test on 1/2/23, but some mild symptoms appeared 1/4/23.  Temperature about 100. Fatigue, cough, congestion.  Had Zoom visit with healthcare professional at PCP's practice on 1/5/23.  Started Paxlovid 1/5/23 twice a day.  Symptoms subsided within 2-3 days, but then recurred3-5 days after the 5-day Paxlovid regimen was completed.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient already received the Moderna Bivalent Covid booster in October of 2022. As of right now patient has not reported any symptoms or side effects.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: RECEIVED A SECOND BIVALENT DOSE.  FIRST DOSE OF MODERNA BIVALENT 50 MCG/0.5MLS WAS GIVEN 11-12-22.  SECOND DOSE OF PFIZER BIVALENT 30MCG/0.3MLS WAS GIVEN 4-1-23.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arrhythmia, Atrial fibrillation, Cardiac disorder, Cerebrovascular accident, Chest discomfort
Clinical narrative: Don't know which flu shot I got. Got both at same time. Each arm. That night, I had unique coughing fit as it was 5th booster. Deep hard dry cough and would not stop. Could not drink water nor desired it. 9 min of this, during, felt heart beat faster. Then 1 final deepest cough ever, and felt heart stop beat. Sat down as I was standing to deal with cough.  Caught my breath and cough stopped,  just like that. Sipped some water after. My chest felt different. When cough started, I was in bed, lying down to sleep. No other symptoms before. A couple weeks later, went to general exam, diagnosed with a fib, then later, hospital emergency room.  Heart attach, and no one would believe me so MONA delayed, 11/16/ 23. 20% heart damage, waiting 7 months for cardiac rehab! Not avail until this June.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Contrast media allergy, Cough, Fluid intake reduced, Heart rate increased, Laboratory test
Clinical narrative: Don't know which flu shot I got. Got both at same time. Each arm. That night, I had unique coughing fit as it was 5th booster. Deep hard dry cough and would not stop. Could not drink water nor desired it. 9 min of this, during, felt heart beat faster. Then 1 final deepest cough ever, and felt heart stop beat. Sat down as I was standing to deal with cough.  Caught my breath and cough stopped,  just like that. Sipped some water after. My chest felt different. When cough started, I was in bed, lying down to sleep. No other symptoms before. A couple weeks later, went to general exam, diagnosed with a fib, then later, hospital emergency room.  Heart attach, and no one would believe me so MONA delayed, 11/16/ 23. 20% heart damage, waiting 7 months for cardiac rehab! Not avail until this June.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Myocardial infarction, Weight decreased
Clinical narrative: Don't know which flu shot I got. Got both at same time. Each arm. That night, I had unique coughing fit as it was 5th booster. Deep hard dry cough and would not stop. Could not drink water nor desired it. 9 min of this, during, felt heart beat faster. Then 1 final deepest cough ever, and felt heart stop beat. Sat down as I was standing to deal with cough.  Caught my breath and cough stopped,  just like that. Sipped some water after. My chest felt different. When cough started, I was in bed, lying down to sleep. No other symptoms before. A couple weeks later, went to general exam, diagnosed with a fib, then later, hospital emergency room.  Heart attach, and no one would believe me so MONA delayed, 11/16/ 23. 20% heart damage, waiting 7 months for cardiac rehab! Not avail until this June.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Epistaxis, Full blood count, Heavy menstrual bleeding, Immune thrombocytopenia
Clinical narrative: Bruising, petichiae, heavy bleeding with menstrual period, bloody nose.  We got blood drawn on March 29 and again March 31.  Her blood platelet count was 40 on March 29 and 71 on March 31.  She was diagnosed with idiopathic thrombocytopenia purpura.  No treatment needed at this time since her platelet count is on its way up.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: Bruising, petichiae, heavy bleeding with menstrual period, bloody nose.  We got blood drawn on March 29 and again March 31.  Her blood platelet count was 40 on March 29 and 71 on March 31.  She was diagnosed with idiopathic thrombocytopenia purpura.  No treatment needed at this time since her platelet count is on its way up.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: On Thursday, I became ill and slept for 5 hours.  I think on the next day, I called and asked for the Paxlovid, which was great. In terms of question 21, I never actually went into the clinic but contacted the Nurses line. Then, the knowledgeable nurses would call back and check on me.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis, Dyspnoea, Heart rate increased
Clinical narrative: Three days following my second vaccination, I started to develop chest pains, shortness of breath, and a dangerously high heart rate (confirmed by hospital and EMS). I was diagnosed with costochondritis and was instructed to take ibuprofen regularly. I still have flare ups and chest pains.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Skin discolouration
Clinical narrative: PATIENT HAS A BLISTER THE SIZE OF QUARTER. THE PATIENT COMPLAINS ABOUT PAIN AND THE ARM IS RED/DARK BROWN
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Lethargy, Pallor
Clinical narrative: Pt is here for follow-up after a vaccine reaction yesterday. He was in his usual state of health. At his 2 month well check he received pentacel, prevnar, and rotateq. After the rotateq he developed gross pallor and lethargy without LOC. No choking. He had no anaphylactic sx. Vital signs were normal. Patient was observed for total of 30 minutes with slow but spontaneous return to baseline.  He did well yesterday at home and had been feeding well.  This morning he had another pallor episode lasting about 15 mins. His muscle tone seemed decreased. He gradually returned back to baseline.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Immunizations received 3/29/23; both Tdap and MCV give in left deltoid.  Next day 3/30/23 at school developed raised red patch with some tenderness to left arm.  No fever or other systemic symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: PATIENT REPORTS GETTING DIZZY AND HAVING A HEADACHE 24 HOURS AFTER VACCINE, WENT TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH VERTIGO, STATES DR STATED IT WAS BROUGHT ON BY THE VACCINE
Age: 42.0
Sex: M
Vaccine: HEP, MMR, PNC20, TDAP, VARCEL
Symptoms: Cold sweat, Syncope, Vision blurred
Clinical narrative: After all the vaccines were administered the patient started to have blurred vision and cold sweats, a few minutes after he faint. We monitor his pulse and call EMS. when paramedics arrived, patient was alert, and all vital signs were normal.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Not sure if the vaccine caused this but I noticed my period changed. I would have spotting around the second or third week of my period every month. My doctor would change the birth control but the same issue occurred. I stopped taking the pill in April of 2022 and it took 11 months to get my period back.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac telemetry, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: Presented on 2/24/23 for fast HR after 12hrs of vomiting & diarrhea.  was found to be in a-fib.  Treated with 2L IVF.   Had CT chest & abdomen &CXR.  Started on a heparin drip & rec'd a bolus of Cardizem, did not convert to SR, given a 2nd bolus of cardizem & continuous drip started..  Admitted to telemetry unit.  on 2/25/23, cardizem drip adjusted.  was in & out of SR.  started on po metoprolol 50mg bid & eliquis 5mg bid. on 2/26,  cardizem stopped.  rec'd a bolus of amiodarone & then drip started.  converted to SR.  on 2/27/23, amiodarone drip stopped & started on po amiodarone tid.  discharged to home later that day.  Norvasc was dc'd.  New meds were amiodarone 200mg x15day the 200mg daily, ASA EC 81mg daily & Eliquis 5mg q12hr, Metoprolol 50mg q12hr
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax, Diarrhoea, Heart rate increased, Sinus rhythm, Vomiting
Clinical narrative: Presented on 2/24/23 for fast HR after 12hrs of vomiting & diarrhea.  was found to be in a-fib.  Treated with 2L IVF.   Had CT chest & abdomen &CXR.  Started on a heparin drip & rec'd a bolus of Cardizem, did not convert to SR, given a 2nd bolus of cardizem & continuous drip started..  Admitted to telemetry unit.  on 2/25/23, cardizem drip adjusted.  was in & out of SR.  started on po metoprolol 50mg bid & eliquis 5mg bid. on 2/26,  cardizem stopped.  rec'd a bolus of amiodarone & then drip started.  converted to SR.  on 2/27/23, amiodarone drip stopped & started on po amiodarone tid.  discharged to home later that day.  Norvasc was dc'd.  New meds were amiodarone 200mg x15day the 200mg daily, ASA EC 81mg daily & Eliquis 5mg q12hr, Metoprolol 50mg q12hr
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray normal, Chest discomfort, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: The night of the shot he ran a fever of 102, body shakes,  and couldn't breathe like an elephant was sitting on his chest. Convulsions then followed. Fever started about 6pm and all of the symptoms followed. At 1 am 8/15 symtpoms were so bad ambulance was called
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Tremor
Clinical narrative: The night of the shot he ran a fever of 102, body shakes,  and couldn't breathe like an elephant was sitting on his chest. Convulsions then followed. Fever started about 6pm and all of the symptoms followed. At 1 am 8/15 symtpoms were so bad ambulance was called
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (the patient and his wife had received two bivalent moderna Covid-19 booster doses since September 3, 2022. The first dose was in September 3, 2022 and the second dose was on December 20, 2022).    No concomitant medications was provided. No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717565 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717565:patient(husband)case
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Depressed level of consciousness, Lethargy, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Error: Expired Product Administered-
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Peripheral swelling
Clinical narrative: Sore swollen arm, shivering for 24 hrs, body aches, headache
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever, headache
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Asthenia, Atrial septal defect, Cardiomegaly, Cholecystitis
Clinical narrative: I had labral replacement surgery on 10/18/2022. On 10/20/2022, I began exhibiting psychotic symptoms and struggling to eat. I continued getting weaker and weaker and more psychotic. We tried changing my opiate prescription and taking me off opiates, but I did not improve. On 10/27/2022, I had a panic attack due to hallucinations and called 911. I was transported to hopsital, who then transported me to hospital liver transplant floor.  The hospital found: bilateral PE?s, right femoral DVT, shock liver, inflamed gallbladder, acute kidney injury, pneumonia, psychosis, metabolic encephalopathy, enlarged heart, PFO. I was discharged on 10/31/2022. On 11/15/2022, I had to return to my PCP for an IV due to increasing weakness and dehydration.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Dehydration, Eating disorder, Echocardiogram
Clinical narrative: I had labral replacement surgery on 10/18/2022. On 10/20/2022, I began exhibiting psychotic symptoms and struggling to eat. I continued getting weaker and weaker and more psychotic. We tried changing my opiate prescription and taking me off opiates, but I did not improve. On 10/27/2022, I had a panic attack due to hallucinations and called 911. I was transported to hopsital, who then transported me to hospital liver transplant floor.  The hospital found: bilateral PE?s, right femoral DVT, shock liver, inflamed gallbladder, acute kidney injury, pneumonia, psychosis, metabolic encephalopathy, enlarged heart, PFO. I was discharged on 10/31/2022. On 11/15/2022, I had to return to my PCP for an IV due to increasing weakness and dehydration.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hallucination, Hip arthroplasty, Ischaemic hepatitis, Metabolic encephalopathy, Panic attack
Clinical narrative: I had labral replacement surgery on 10/18/2022. On 10/20/2022, I began exhibiting psychotic symptoms and struggling to eat. I continued getting weaker and weaker and more psychotic. We tried changing my opiate prescription and taking me off opiates, but I did not improve. On 10/27/2022, I had a panic attack due to hallucinations and called 911. I was transported to hopsital, who then transported me to hospital liver transplant floor.  The hospital found: bilateral PE?s, right femoral DVT, shock liver, inflamed gallbladder, acute kidney injury, pneumonia, psychosis, metabolic encephalopathy, enlarged heart, PFO. I was discharged on 10/31/2022. On 11/15/2022, I had to return to my PCP for an IV due to increasing weakness and dehydration.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia, Psychotic disorder, Psychotic symptom, Ultrasound scan
Clinical narrative: I had labral replacement surgery on 10/18/2022. On 10/20/2022, I began exhibiting psychotic symptoms and struggling to eat. I continued getting weaker and weaker and more psychotic. We tried changing my opiate prescription and taking me off opiates, but I did not improve. On 10/27/2022, I had a panic attack due to hallucinations and called 911. I was transported to hopsital, who then transported me to hospital liver transplant floor.  The hospital found: bilateral PE?s, right femoral DVT, shock liver, inflamed gallbladder, acute kidney injury, pneumonia, psychosis, metabolic encephalopathy, enlarged heart, PFO. I was discharged on 10/31/2022. On 11/15/2022, I had to return to my PCP for an IV due to increasing weakness and dehydration.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event occured but vaccine was administered after beyond use date in error
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haemangioma of skin
Clinical narrative: About a week after vaccination I developed a sudden onset of small cherry angiomas on my face, scalp, and trunk of my body.. I have never had them, not even one, in my entire life. No one else in my family has had them, even in old age. After going to a dermatology appt she recommended that I submit a report because it seemed to be an under reported reaction.  They are harmless, but it's a reported side effect and likely under reported - so I'm filing the report as suggested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event occured but vaccine was administered after beyond use date in error
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event occured but vaccine was administered after beyond use date in error
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Asthenia, Bile duct stent insertion, Biopsy liver, Coeliac plexus block
Clinical narrative: She was diagnosed with metastatic pancreatic cancer at the end of January 2023 and opted for no treatment in follow-up with oncology.  3/7 she saw a pain specialist in the plan clinic and is scheduled for a celiac plexus block 3/27 for pain control.  3/13 she had an ERCP with a covered metal stent placed in the CBD.  3/23 - 3/21 she was admitted to the hospitalist service for pain control.  She was started on a fentanyl patch in addition to Norco.  CT at that time showed rapidly progressive malignancy.  She declined both hospice and home health at that time and opted to discharge home.  3/23 she returns to the emergency room with audio and visual hallucinations, paranoia, weakness, fatigue, severe right abdominal pain, constipation.  She discharged 3/27 on hospice.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen abnormal, Constipation, Endoscopic retrograde cholangiopancreatography, Fatigue, Hallucinations, mixed
Clinical narrative: She was diagnosed with metastatic pancreatic cancer at the end of January 2023 and opted for no treatment in follow-up with oncology.  3/7 she saw a pain specialist in the plan clinic and is scheduled for a celiac plexus block 3/27 for pain control.  3/13 she had an ERCP with a covered metal stent placed in the CBD.  3/23 - 3/21 she was admitted to the hospitalist service for pain control.  She was started on a fentanyl patch in addition to Norco.  CT at that time showed rapidly progressive malignancy.  She declined both hospice and home health at that time and opted to discharge home.  3/23 she returns to the emergency room with audio and visual hallucinations, paranoia, weakness, fatigue, severe right abdominal pain, constipation.  She discharged 3/27 on hospice.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test, Pain, Pancreatic carcinoma metastatic, Paranoia, Positron emission tomogram
Clinical narrative: She was diagnosed with metastatic pancreatic cancer at the end of January 2023 and opted for no treatment in follow-up with oncology.  3/7 she saw a pain specialist in the plan clinic and is scheduled for a celiac plexus block 3/27 for pain control.  3/13 she had an ERCP with a covered metal stent placed in the CBD.  3/23 - 3/21 she was admitted to the hospitalist service for pain control.  She was started on a fentanyl patch in addition to Norco.  CT at that time showed rapidly progressive malignancy.  She declined both hospice and home health at that time and opted to discharge home.  3/23 she returns to the emergency room with audio and visual hallucinations, paranoia, weakness, fatigue, severe right abdominal pain, constipation.  She discharged 3/27 on hospice.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray
Clinical narrative: She was diagnosed with metastatic pancreatic cancer at the end of January 2023 and opted for no treatment in follow-up with oncology.  3/7 she saw a pain specialist in the plan clinic and is scheduled for a celiac plexus block 3/27 for pain control.  3/13 she had an ERCP with a covered metal stent placed in the CBD.  3/23 - 3/21 she was admitted to the hospitalist service for pain control.  She was started on a fentanyl patch in addition to Norco.  CT at that time showed rapidly progressive malignancy.  She declined both hospice and home health at that time and opted to discharge home.  3/23 she returns to the emergency room with audio and visual hallucinations, paranoia, weakness, fatigue, severe right abdominal pain, constipation.  She discharged 3/27 on hospice.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain in extremity, X-ray
Clinical narrative: had intense pain in left hip and upper leg. Had x-rays and saw NP at facility. Was told that the problem was muscular. Was given pain medicine and told to exercise the area. The pain ceased in two weeks in my hip but persisted in my upper leg. Pain was focused in the muscle on front of my leg so not thought to be nerves. Pain decreased over time and moved to lower leg.  Now I have little pain and some numbness in lower shin area.  Not sure if this at all related to the vaccination
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Dyspepsia, Dysstasia
Clinical narrative: *NOTE: Unsure of which seasonal influenza vaccine received  Day 1, around 3pm: experienced stomach pain; around 1am, vomited and could not lay flat in bed; vomited a second time during the night and stayed on couch propped up; difficulty standing up fully due to stomach pain; chills and body aches/headache Days 2 and 3: severe stomach pain, chills, body aches/headache continued; lack of appetite; ate jello and chicken broth Day 4: stomach pain started to subside, but ingestion of any food lead to stomach pain For about one week (days 1-7 or 8), diet of only jello and chicken broth For about an additional 3 weeks, diet slowly expanded to include toast, other soups, meats, etc.
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Gastroenteritis viral, Headache, Mobility decreased, Pain, SARS-CoV-2 test negative
Clinical narrative: *NOTE: Unsure of which seasonal influenza vaccine received  Day 1, around 3pm: experienced stomach pain; around 1am, vomited and could not lay flat in bed; vomited a second time during the night and stayed on couch propped up; difficulty standing up fully due to stomach pain; chills and body aches/headache Days 2 and 3: severe stomach pain, chills, body aches/headache continued; lack of appetite; ate jello and chicken broth Day 4: stomach pain started to subside, but ingestion of any food lead to stomach pain For about one week (days 1-7 or 8), diet of only jello and chicken broth For about an additional 3 weeks, diet slowly expanded to include toast, other soups, meats, etc.
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Vomiting
Clinical narrative: *NOTE: Unsure of which seasonal influenza vaccine received  Day 1, around 3pm: experienced stomach pain; around 1am, vomited and could not lay flat in bed; vomited a second time during the night and stayed on couch propped up; difficulty standing up fully due to stomach pain; chills and body aches/headache Days 2 and 3: severe stomach pain, chills, body aches/headache continued; lack of appetite; ate jello and chicken broth Day 4: stomach pain started to subside, but ingestion of any food lead to stomach pain For about one week (days 1-7 or 8), diet of only jello and chicken broth For about an additional 3 weeks, diet slowly expanded to include toast, other soups, meats, etc.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Lip disorder, Pruritus, Rash, Urticaria
Clinical narrative: About an hour and a half after the vaccine the patient started having itching, with raised bumps on their neck and back that continue to this time when Benadryl is not taken. They had welts that formed on their face that only lasted the evening of the vaccine. They now have a sensation of raised rough areas on the inside of their lips.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Dry tickly cough and tiredness began 12/31/2022. Positive home test for Covid 19 on 1/1/2023.Went to Urgent Care on 1/2/2023, where positive test was confirmed.  Started paxlovid and benzonate on 1/2/2023.  Symptoms lessened by 1/5/2023 and resolved by 1/10/23. Negative home test on 1/8/2023.  Overall symptoms were mild.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Ill-defined disorder
Clinical narrative: Spike Protein in the Base of my neck.  I am receiving prescription medicine to help but it is really taking a toll on my body.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature fluctuation, Chills, Dizziness, Injection site pain, Nausea
Clinical narrative: On day 1 (Mar. 31), very sore right arm, and gradual onset of chills, temp fluctuation, body aches. These effects somewhat dampened by acetaminophen. Increasing chills, nausea and pains during the night, disrupting sleep. Next morning, extremely nauseated, lightheaded.  Nearly fainted when walking in house. Could not eat due to nausea.  However, did drink lots of water. Temp fluctuations continued all day, swinging from 96.2 to 99.2, all while taking acetaminophen. Right arm still extremely sore. On day 3 (Apr 2), temp is more stable.  Still slightly queasy when walking around house.  Today I removed bandaid over injection site and discovered the extremely sore part of my arm was actually NOT the injection site, but a red, slightly raised patch about 3 inches below the injection site. The patch is slightly warmer than surrounding skin, is an irregular circle about 2-3 inches in diameter, and is very tender to the touch, while the injection site is only very mildly sore. I have had no medical treatment other than self-administered acetaminophen. I am monitoring the red patch on my right arm and will call my doctor if it gets worse or lasts too long. FYI, my normal temp is around 97.8.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: On day 1 (Mar. 31), very sore right arm, and gradual onset of chills, temp fluctuation, body aches. These effects somewhat dampened by acetaminophen. Increasing chills, nausea and pains during the night, disrupting sleep. Next morning, extremely nauseated, lightheaded.  Nearly fainted when walking in house. Could not eat due to nausea.  However, did drink lots of water. Temp fluctuations continued all day, swinging from 96.2 to 99.2, all while taking acetaminophen. Right arm still extremely sore. On day 3 (Apr 2), temp is more stable.  Still slightly queasy when walking around house.  Today I removed bandaid over injection site and discovered the extremely sore part of my arm was actually NOT the injection site, but a red, slightly raised patch about 3 inches below the injection site. The patch is slightly warmer than surrounding skin, is an irregular circle about 2-3 inches in diameter, and is very tender to the touch, while the injection site is only very mildly sore. I have had no medical treatment other than self-administered acetaminophen. I am monitoring the red patch on my right arm and will call my doctor if it gets worse or lasts too long. FYI, my normal temp is around 97.8.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial thrombosis, Autoimmune disorder, Biopsy muscle abnormal, Biopsy peripheral nerve abnormal, Dermatomyositis
Clinical narrative: January 2022: Neuropathy in right foot.  April 2022: had to use a cane. June 2022 began testing.  October 2022 diagnosed with MDA5 autoimmune disease, which caused dermatomyositis in my leg with muscle inflammation. It has progressed to my entire leg and I am have to get a wheelchair. I have had 2 infusions of IVHGH and I infusion if Ruxton. No signs of re-leaf. November 2022 had a heart attach. A blood clot in an artery that could not be stinted and heart attacks do not run in my family
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Myocardial infarction, Myositis, Neuropathy peripheral, Walking aid user
Clinical narrative: January 2022: Neuropathy in right foot.  April 2022: had to use a cane. June 2022 began testing.  October 2022 diagnosed with MDA5 autoimmune disease, which caused dermatomyositis in my leg with muscle inflammation. It has progressed to my entire leg and I am have to get a wheelchair. I have had 2 infusions of IVHGH and I infusion if Ruxton. No signs of re-leaf. November 2022 had a heart attach. A blood clot in an artery that could not be stinted and heart attacks do not run in my family
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: January 2022: Neuropathy in right foot.  April 2022: had to use a cane. June 2022 began testing.  October 2022 diagnosed with MDA5 autoimmune disease, which caused dermatomyositis in my leg with muscle inflammation. It has progressed to my entire leg and I am have to get a wheelchair. I have had 2 infusions of IVHGH and I infusion if Ruxton. No signs of re-leaf. November 2022 had a heart attach. A blood clot in an artery that could not be stinted and heart attacks do not run in my family
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epistaxis, Eye pruritus, Nasal inflammation, Pruritus
Clinical narrative: Skin itching, eye itching and nose bleeding/ inflammation since the day of vaccination till today.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Local reaction
Clinical narrative: Local reaction on arm. Cold compress applied
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired 3/24/2023
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired 3/24/2023
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm is swollen and red
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear pain, Extrasystoles, Hallucination, Neck pain
Clinical narrative: Per patient, neck pain, fever of 100-101, hallucinations at night, leg wiggling, pain in the deep ear, jaw, and back, dizziness, and heart beat skipping
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Per patient, neck pain, fever of 100-101, hallucinations at night, leg wiggling, pain in the deep ear, jaw, and back, dizziness, and heart beat skipping
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: The female that injected me in the Right arm. Injected me directly in my Bursa at the top of my shoulder. It was very painful at the injection site and within 2 hours I could not lift my arm and I have been in severe pain for several months.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb abnormal
Clinical narrative: The female that injected me in the Right arm. Injected me directly in my Bursa at the top of my shoulder. It was very painful at the injection site and within 2 hours I could not lift my arm and I have been in severe pain for several months.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Brief resolved unexplained event, Crying, Cyanosis, Diarrhoea, Unresponsive to stimuli
Clinical narrative: Per Mom, later that day started wtih ongoing explosive diarrhea, then suddenly became nonresponsive, had blue lips, but then did become responsive again and restart crying. Mom called EMS, states pulse ox was 70s when EMTs arrived, went via ambulance to hospital. Being evaluated in ED, vitals are good, no more diarrhea, feeding well. Initial dx is BRUE, possibly related to vaccines she had earlier today.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Ear pruritus, Fatigue, Headache, Influenza like illness, Pruritus
Clinical narrative: Patient reported itching at the ears, palms of hand and hairline. No rash, just itching. Onset Saturday, 4/1/2023. Also had Flu-like symptoms, headache, fatigue
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Labour induction, Premature rupture of membranes
Clinical narrative: Premature rupture of membranes in otherwise uncomplicated pregnancy - membranes ruptured on 11/23, child delivered via vaginal induction, original due date 11/29/23. Child later went on to develop partial seizures at 4 months of age and infantile spasms at 6 months of age. Cause of seizures has not been determined to date despite extensive workup.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/14/21 Lot# 037K20A;  Moderna 2/11/21 Lot# 037K20A;
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/14/21 Lot# 037K20A;  Moderna 2/11/21 Lot# 037K20A
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 6/25/21 Lot# 051C21A;  Moderna 7/23/21 Lot# 052C21A;  Moderna 9/9/21 Lot# 058E21A;  Moderna 3/18/22 Lot# 026L21A
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Erythema
Clinical narrative: Red patches developed on face and L thigh; Red patches developed on face and L thigh; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2468403-1. The original narrative from the sender is the following:  Red patches developed on face and L thigh.  The reporter did not provide an assessment of causal relationship between the event "Red patches developed on face and L thigh" and Vaxelis.  No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Husband tested positive on 2/23. I had a headache and scratchy throat. I was ok 2/24-2/25. On 2/26 symptoms returned and I had a faint positive on at home COVID-19 test. Had telehealth visit with PCP and was prescribed PAXLOVID. Symptoms resolved and I tested negative. On 3/15 began feeling not well again and tested when I got home from work and it was positive. Symptoms resolved again around 3/18.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: Husband tested positive on 2/23. I had a headache and scratchy throat. I was ok 2/24-2/25. On 2/26 symptoms returned and I had a faint positive on at home COVID-19 test. Had telehealth visit with PCP and was prescribed PAXLOVID. Symptoms resolved and I tested negative. On 3/15 began feeling not well again and tested when I got home from work and it was positive. Symptoms resolved again around 3/18.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Throat irritation
Clinical narrative: Husband tested positive on 2/23. I had a headache and scratchy throat. I was ok 2/24-2/25. On 2/26 symptoms returned and I had a faint positive on at home COVID-19 test. Had telehealth visit with PCP and was prescribed PAXLOVID. Symptoms resolved and I tested negative. On 3/15 began feeling not well again and tested when I got home from work and it was positive. Symptoms resolved again around 3/18.
Age: 42.0
Sex: F
Vaccine: HEPA, HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered
Age: 42.0
Sex: F
Vaccine: HEPA, HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a certified medical assistant,  and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U006486, administered subcutaneously in the left tight, for prophylaxis (strength was not provided).  The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) expired on 26-FEB-2023.  No adverse events were reported.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: if the second dose of PROQUAD, that was administered when the patient was 17 years old; No additional AE reported.; This spontaneous report has been received from a nurse prescriber, referring a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (strength, dose, frequency, administration route, lot number, and expiry date were not provided) (product administered to patient of inappropriate age) indicated as prophylaxis.  No additional adverse events were reported.  This is one of several reports received from the same reporter; Sender Comments: US-009507513-2304USA000015:Original Case : 2303USA006657
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; HCP reported VARIVAX was administered after the expiry date.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 20-MAR-2023, the patient was administered with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), dose of 0.5 mL, lot number: U008180, expiration date: 12-MAR-2023 (dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the varicella virus vaccine live (Oka/Merck) (VARIVAX) did not have a history of temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).