chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: No symptoms when having the vaccine until 2 weeks later, when I developed a heavy sort of chest pain on the left side of my chest directly on the area around my heart. The chest pain got worse when I breathed in too deeply and was relieved slightly by leaning forwards. After a couple weeks of my symptoms I told my family about it since it wasn't getting better. We decided to wait it out because of our income. Reaching about mid October, my symptoms were at their peak so I looked into going to a free clinic. I eventually got my first appointment the next month or so, where the doctor told me my blood pressure was abnormally high at around 145 over 90, so I was put on blood pressure medication. The doctor said that should help with my chest pain, but it didn't, so I went back in a month for a follow-up. At the follow-up, the doctor said my blood pressure was lower but that it could be lower so my blood pressure medication was doubled. This didn't help my chest pain either so I went back in a few months to talk with the doctor again, who said that I would need to go to a cardiologist, so I went there after a couple months. The cardiologist asked me all my symptoms and such, and eventually decided I had residual pericarditis due to the Covid vaccine, and she advised me to file this form with the CDC so here I am now, about 3 months after she told me to.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deafness bilateral, Dizziness, Hypoaesthesia, Tinnitus
Clinical narrative: Developed bilateral ear muted hearing on evening of October 17, progressed to numbness extending from behind left ear up towards left eye and into cheek area, lesser extent on right. Right resolved. Left numbness resolved within short time but hearing remained muted. Woke up next morning and muted hearing was gone, but I was dizzy for a several minutes, as that resolved, I developed tinnitus in my left ear and it has persisted. I have been seen by my PCP shortly after this started, no issues have been identified. I am seeing an EENT in April. I have not had any further dizziness. Right ear has been fine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient said after the Pfizer COVID booster shot (3rd dose) on 11/23/2021 she broke out with severe itchy rash. She was very tired, felt cold. She has a lot of pain in the arm and shoulder at the injection site.  This pain was never recovered. Currently, she still cannot raise her arm or put it behind her back. She has been admitted to the hospital, ER, and seen providers continuously since May 2022
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Patient said after the Pfizer COVID booster shot (3rd dose) on 11/23/2021 she broke out with severe itchy rash. She was very tired, felt cold. She has a lot of pain in the arm and shoulder at the injection site.  This pain was never recovered. Currently, she still cannot raise her arm or put it behind her back. She has been admitted to the hospital, ER, and seen providers continuously since May 2022
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular disorder, Catheterisation cardiac, Cerebrovascular accident, Chest pain, Coronary arterial stent insertion
Clinical narrative: Prior to receiving the vaccine I was in excellent physical condition - able to run, lift, and exert myself to high capabilities. Shortly after receiving the vaccine I started experiencing chest pains, intense palpitations, and a sharp decline in cardiovascular performance. I could not find a doctor to take my concerns seriously. Fast forward to 11/22 and I was hospitalized with chest pains. I have since then suffered a heart attack and a stroke and am on several heart failure medications.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myocardial infarction, Palpitations
Clinical narrative: Prior to receiving the vaccine I was in excellent physical condition - able to run, lift, and exert myself to high capabilities. Shortly after receiving the vaccine I started experiencing chest pains, intense palpitations, and a sharp decline in cardiovascular performance. I could not find a doctor to take my concerns seriously. Fast forward to 11/22 and I was hospitalized with chest pains. I have since then suffered a heart attack and a stroke and am on several heart failure medications.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Performance status decreased, Ultrasound scan
Clinical narrative: Prior to receiving the vaccine I was in excellent physical condition - able to run, lift, and exert myself to high capabilities. Shortly after receiving the vaccine I started experiencing chest pains, intense palpitations, and a sharp decline in cardiovascular performance. I could not find a doctor to take my concerns seriously. Fast forward to 11/22 and I was hospitalized with chest pains. I have since then suffered a heart attack and a stroke and am on several heart failure medications.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Body aches roughly 20 hours after the injection, Extremely red and inflamed injection site. Pain and inflammation at the injection site lasted until 2/14/23.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Non-ADVERSE EVENT, THE VACCINE WAS ADMINISTERED BEYOND DATE., MODERNA IS EVALUATING EFFECTIVENESS PERCENTAGE OF THE VACCINE ADMINISTERED.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Swelling, redness, and tingling in extremities and in face.  Itching due to swelling.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Asthenia, Blood pressure diastolic increased, Blood test, Chest X-ray
Clinical narrative: arm became swollen and red, hot and itching for 10 days, then I started to forget or could not put words together (I knew what I wanted to say but could not find the correct words), extremely tired all the time, sleeping for hours, taking 2 or 3 naps a day, head began to "feel funny" like my brain was swelling but no headache, diastolic pressure was consistently high (86, 90, 100) systolic was around 110 to 105.  Passed out and hospitalized on Feburary 1, 2023.  Went to ER  February 14, 2023 feeling weak and dizzy with high blood pressure which was 181 over something at admittance and at release 155/76.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Dizziness, Electrocardiogram, Erythema, Fatigue
Clinical narrative: arm became swollen and red, hot and itching for 10 days, then I started to forget or could not put words together (I knew what I wanted to say but could not find the correct words), extremely tired all the time, sleeping for hours, taking 2 or 3 naps a day, head began to "feel funny" like my brain was swelling but no headache, diastolic pressure was consistently high (86, 90, 100) systolic was around 110 to 105.  Passed out and hospitalized on Feburary 1, 2023.  Went to ER  February 14, 2023 feeling weak and dizzy with high blood pressure which was 181 over something at admittance and at release 155/76.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Head discomfort, Hypersomnia, Hypertension, Loss of consciousness, Memory impairment
Clinical narrative: arm became swollen and red, hot and itching for 10 days, then I started to forget or could not put words together (I knew what I wanted to say but could not find the correct words), extremely tired all the time, sleeping for hours, taking 2 or 3 naps a day, head began to "feel funny" like my brain was swelling but no headache, diastolic pressure was consistently high (86, 90, 100) systolic was around 110 to 105.  Passed out and hospitalized on Feburary 1, 2023.  Went to ER  February 14, 2023 feeling weak and dizzy with high blood pressure which was 181 over something at admittance and at release 155/76.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Pruritus, Skin warm, Urine analysis
Clinical narrative: arm became swollen and red, hot and itching for 10 days, then I started to forget or could not put words together (I knew what I wanted to say but could not find the correct words), extremely tired all the time, sleeping for hours, taking 2 or 3 naps a day, head began to "feel funny" like my brain was swelling but no headache, diastolic pressure was consistently high (86, 90, 100) systolic was around 110 to 105.  Passed out and hospitalized on Feburary 1, 2023.  Went to ER  February 14, 2023 feeling weak and dizzy with high blood pressure which was 181 over something at admittance and at release 155/76.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Postural orthostatic tachycardia syndrome, Urticaria
Clinical narrative: A few hours after the first shot of the pfizer Covid-19 shot I broke out in hives while working out. I had never had hives and was currently training for a boxing match. Since having this shot, I have been unable to exercise without getting hives. I also developed POTS.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: Swollen neck glands and mid back hives, itching
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Nervousness, Vision blurred
Clinical narrative: Pt. started to feel dizzy and HA started while waiting in clinic x15 min.  Pt. able to walk to room to lay down with legs elevated.  Pt. reported feeling better/HA resolved but had him wait in clinic for the remaining 5 min.  Felt fine upon leaving with mom but returned before getting to the car as pt. was feeling shaky, dizzy, nauseous and vision blurriness returned.  Returned to clinic at 5:23 pm and had pt. lay down again with legs elevated.  Took BP/HR at 5:29 pm while supine and WNL.  Had pt. transition to sitting and at 5:51 pm BP/HR again WNL.  Stood without difficulty and discharged at 5:52 pm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine. Expired 2-6-23, patient received 2-10-23. Patient has not reported any symptoms.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Expired product administered
Clinical narrative: Pentacel was given after vaccine had expired. Vaccine expired 1-28-23 & was given 2-9-23. Mother notified. Patient reported to be doing well at this time.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient c/o of lightheadness O: pt AAO x 3; BP 134/100 P: 80 O2 99 good color; (-) distress A/P provided pt water, recheck BP in 10 min patient stable; BP 130/100  discharged pt to home with husband
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Nervousness, Rash
Clinical narrative: S: I feel shakey and c/o headache O: AAO x 3, BP 250/140, P=100 regular O2 99 mild diaphoresis; (-) SOB (-) wheezing skin: mild B/L arm flat macular rash  chest - upper chest & neck - red, small raised papules. A/P R/O allergic reaction - called ambulance @ 2:50pm gave benadryl 50 mg PO; EMT & RN present
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Wheezing
Clinical narrative: S: I feel shakey and c/o headache O: AAO x 3, BP 250/140, P=100 regular O2 99 mild diaphoresis; (-) SOB (-) wheezing skin: mild B/L arm flat macular rash  chest - upper chest & neck - red, small raised papules. A/P R/O allergic reaction - called ambulance @ 2:50pm gave benadryl 50 mg PO; EMT & RN present
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Heart rate irregular, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: 9:45AM Patient pale; diaphoretic, unresponsive x 10 sec O: BP 80 palpable, P 70 irregular O2 99% 9:50AM pt admits to no food intake; feels nausea A/P hypotensive - gave H2O, check BP, called ambulance RN and EMT with patient; elevated legs 9:55A BP 110/60 - transported to hospital; wife present
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: 9:45AM Patient pale; diaphoretic, unresponsive x 10 sec O: BP 80 palpable, P 70 irregular O2 99% 9:50AM pt admits to no food intake; feels nausea A/P hypotensive - gave H2O, check BP, called ambulance RN and EMT with patient; elevated legs 9:55A BP 110/60 - transported to hospital; wife present
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel was given after vaccine had expired. Vaccine expired 1-28-23 & was given 2-9-23. Mother notified. Patient reported to be doing well at this time.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin plaque, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Large erythematous plaque several inches below the vaccination site on the same arm which was itchy, painful. Also diffuse itching, red streaks over arm. Taking Benadryl and Zyrtec around the clock relieved symptoms partially. Upon my advice she stopped Miralax. Within a day redness and itching improved, completely resolved symptoms in 3 days.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Large erythematous plaque several inches below the vaccination site on the same arm which was itchy, painful. Also diffuse itching, red streaks over arm. Taking Benadryl and Zyrtec around the clock relieved symptoms partially. Upon my advice she stopped Miralax. Within a day redness and itching improved, completely resolved symptoms in 3 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: S: I feel faint, I wanna lie down; feel hot O: patient c/o lightheadness post vaccine BP: 148/100 P: 76 O2: 99; mild diaphoresis A/P monitor x 30 min, gave water, check BP 11:05AM B/P 120/84; pt ambulating with no problems no complaints d/ced @ 11:10AM.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 11/03/2022.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 7/26/2022.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 08/04/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 08/04/2022.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 08/04/2022.
Age: 101.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 12/15/2022.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was on 07/13/2022. Dose administered on 07/26/2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose was administered on 08/04/2022.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 107.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 08/04/2022.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 08/04/2022.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 08/19/2022.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 08/04/2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/22.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration dare. Expiration date was 07/13/2022. Dose administered on 08/04/2022.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was07/13/2022. Dose administered on 08/04/2022.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 09/30/2022.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was07/13/2022. Dose administered on 07/26/2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 08/04/2022.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest pain, Echocardiogram abnormal, Electrocardiogram, Myocarditis
Clinical narrative: Myocarditis - morning of April 5, 2021 - major chest pain
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis - morning of April 5, 2021 - major chest pain
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Complication associated with device, Hyperventilation, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Presented to ED 08/22/2022 for feeding tube problem and hyperventilating.  Tested positive for COVID on presentation. Unclear onset. Patient poor historian.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, tenderness on the injection site; Pain in the injected arm; Swelling in the injected arm; Received a dose that was 1 mL; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 30th November 2023) for prophylaxis.   On 4th February 2023, the patient received Menveo 1 ml. On 4th February 2023, less than a day after receiving Menveo, the patient experienced pain in arm, swelling arm and overdose. On 7th February 2023, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, pain in arm and swelling arm were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and swelling arm to be related to Menveo.     Linked case(s) involving the same patient:  US2023019065   Additional Information: GSK Receipt Date: 07-Feb-2023: Reporter's Comment:  The patient's father called on behalf of his son.  The reporter stated that the patient received a dose of Menveo that was 1 mL.  The adverse event was filed.  The reporter stated the experienced pain and swelling in the arm that was injected.  On 07th February 2023, the pharmacist called to inform that a patient received 1 mL of Menveo instead of the normal 0.5 mL of such vaccine. The patient experienced pain and tenderness on the injection site.  The reporter consented to follow up. The consumer did not provided healthcare professionals details at the time of the call. The healthcare professionals told it was ok with Safety follow up via phone number. After 3 days, the patient experienced injection site pain. Additional Supportive Information: The patient received 1 mL of Menveo instead of the normal 0.5 mL dose, which led to overdose. The case US2023019065 was identified as duplicate of case US2023019062. All future correspondence would be added in case US2023019062, which stands as case of record this patient and the case US2023019065 would be deleted.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pain, tenderness on the injection site; Pain in the injected arm; Swelling in the injected arm; Received a dose that was 1 mL; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 30th November 2023) for prophylaxis.   On 4th February 2023, the patient received Menveo 1 ml. On 4th February 2023, less than a day after receiving Menveo, the patient experienced pain in arm, swelling arm and overdose. On 7th February 2023, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, pain in arm and swelling arm were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and swelling arm to be related to Menveo.     Linked case(s) involving the same patient:  US2023019065   Additional Information: GSK Receipt Date: 07-Feb-2023: Reporter's Comment:  The patient's father called on behalf of his son.  The reporter stated that the patient received a dose of Menveo that was 1 mL.  The adverse event was filed.  The reporter stated the experienced pain and swelling in the arm that was injected.  On 07th February 2023, the pharmacist called to inform that a patient received 1 mL of Menveo instead of the normal 0.5 mL of such vaccine. The patient experienced pain and tenderness on the injection site.  The reporter consented to follow up. The consumer did not provided healthcare professionals details at the time of the call. The healthcare professionals told it was ok with Safety follow up via phone number. After 3 days, the patient experienced injection site pain. Additional Supportive Information: The patient received 1 mL of Menveo instead of the normal 0.5 mL dose, which led to overdose. The case US2023019065 was identified as duplicate of case US2023019062. All future correspondence would be added in case US2023019062, which stands as case of record this patient and the case US2023019065 would be deleted.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, tenderness on the injection site; Pain in the injected arm; Swelling in the injected arm; Received a dose that was 1 mL; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 30th November 2023) for prophylaxis.   On 4th February 2023, the patient received Menveo 1 ml. On 4th February 2023, less than a day after receiving Menveo, the patient experienced pain in arm, swelling arm and overdose. On 7th February 2023, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, pain in arm and swelling arm were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and swelling arm to be related to Menveo.     Linked case(s) involving the same patient:  US2023019065   Additional Information: GSK Receipt Date: 07-Feb-2023: Reporter's Comment:  The patient's father called on behalf of his son.  The reporter stated that the patient received a dose of Menveo that was 1 mL.  The adverse event was filed.  The reporter stated the experienced pain and swelling in the arm that was injected.  On 07th February 2023, the pharmacist called to inform that a patient received 1 mL of Menveo instead of the normal 0.5 mL of such vaccine. The patient experienced pain and tenderness on the injection site.  The reporter consented to follow up. The consumer did not provided healthcare professionals details at the time of the call. The healthcare professionals told it was ok with Safety follow up via phone number. After 3 days, the patient experienced injection site pain. Additional Supportive Information: The patient received 1 mL of Menveo instead of the normal 0.5 mL dose, which led to overdose. The case US2023019065 was identified as duplicate of case US2023019062. All future correspondence would be added in case US2023019062, which stands as case of record this patient and the case US2023019065 would be deleted.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 13-FEB-2023 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 35 years old. No concomitant medications were reported. On 13-FEB-2023, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: PNC15
Symptoms: Impaired work ability, Injury associated with device, Limb injury, Product quality issue, Syringe issue
Clinical narrative: unsafe syringes shipped to us; right hand palmer 1mm puncture wound base of the 4th finger, Left hand palmer 1mm puncture wound base of the 5fth finger; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; 3 broken syringes found when employee was removing from tray after initially opening sealed carton/shattered barrel, broken plunger side of syringe; This spontaneous report has been received from an administrator form provider's office and refers to a patient (medical assistant) of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 20-JAN-2023, the medical assistant was cut on both hands by glass when taking a prefilled syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNUEVANCE) (lot # W021510 confirmed to be valid with expiration date 08-OCT-2023) from the original, unopened package carton (injury associated with device). The reporter stated that 3 broken syringes were found when employee was removing from tray after initially opening sealed carton (shattered barrel, broken plunger side of syringe) (syringe issue). The syringe tip cap was attached properly prior to use, the syringe tray was intact and undamaged on receipt, the cellophane covering the syringe tray was intact and completely sealed, and the syringe carton was not damaged prior to use. The medical assistant was sent out for treatment and at time of last call, was at urgent care but had not been seen yet. Broken syringes were not administered to any patient. The outcome of the events was not reported.  The causality assessment between the events and the suspect vaccine was not provided.  Follow up information was received from the clinic administrator on 10-FEB-2023. The patient was female. It was reported that the patient had the injury due to the unsafe syringes shipped to them (Product quality issue). The patient experienced right hand palmer 1mm puncture wound base of the 4th finger, left hand palmer 1mm puncture wound base of the 5fth finger, and left middle finger proximal palmar 2mm laceration (Limb injury). She had been referred to physical therapy for multiple appointments, would need a follow-up with her provider. She was working at the moment, but was not able to perform her essential job functions. She had 1 week where she was not able to work and continued to need time off for her appointments. The outcome of the event was not reported. No causality assessment was provided.   This case was previously considered non-valid, but became valid upon receiving follow up information.
Sex: F
Vaccine: PNC15
Symptoms: Wound
Clinical narrative: unsafe syringes shipped to us; right hand palmer 1mm puncture wound base of the 4th finger, Left hand palmer 1mm puncture wound base of the 5fth finger; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; medical assistant was cut on both hands today by glass when taking a prefilled syringe of Vaxneuvance; 3 broken syringes found when employee was removing from tray after initially opening sealed carton/shattered barrel, broken plunger side of syringe; This spontaneous report has been received from an administrator form provider's office and refers to a patient (medical assistant) of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 20-JAN-2023, the medical assistant was cut on both hands by glass when taking a prefilled syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNUEVANCE) (lot # W021510 confirmed to be valid with expiration date 08-OCT-2023) from the original, unopened package carton (injury associated with device). The reporter stated that 3 broken syringes were found when employee was removing from tray after initially opening sealed carton (shattered barrel, broken plunger side of syringe) (syringe issue). The syringe tip cap was attached properly prior to use, the syringe tray was intact and undamaged on receipt, the cellophane covering the syringe tray was intact and completely sealed, and the syringe carton was not damaged prior to use. The medical assistant was sent out for treatment and at time of last call, was at urgent care but had not been seen yet. Broken syringes were not administered to any patient. The outcome of the events was not reported.  The causality assessment between the events and the suspect vaccine was not provided.  Follow up information was received from the clinic administrator on 10-FEB-2023. The patient was female. It was reported that the patient had the injury due to the unsafe syringes shipped to them (Product quality issue). The patient experienced right hand palmer 1mm puncture wound base of the 4th finger, left hand palmer 1mm puncture wound base of the 5fth finger, and left middle finger proximal palmar 2mm laceration (Limb injury). She had been referred to physical therapy for multiple appointments, would need a follow-up with her provider. She was working at the moment, but was not able to perform her essential job functions. She had 1 week where she was not able to work and continued to need time off for her appointments. The outcome of the event was not reported. No causality assessment was provided.   This case was previously considered non-valid, but became valid upon receiving follow up information.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reports improperly stored PROQUAD was administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant medications included sterile diluent.   On 13-NOV-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #W012730 with expiration date 16-OCT-2023 had a excursion of temperature -14 degree Celsius up to-10 degree Celsius (-13.7 degree Celsius) at a time frame of 5 hours 15 minutes 0 seconds, with no previous temperature excursion. On 01-DEC-2022, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis (dosage, route of administration and anatomical location were not provided) (product storage error). No additional adverse event (AE) reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2301USA008948: US-009507513-2301USA008846: US-009507513-2301USA009147:
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No additional AEs were reported; Nurse practitioner reported that a pregnant patient received GARDASIL 9; pregnant patient received GARDASIL 9 (u032636 10/26/2023) on 2/1/2023. The first dose was given on 12/29/2021; This spontaneous prospective pregnancy report has been received from a nurse prescriber referring to a 21-year-old female patient. The patient's medical history included preeclampsia. Concurrent conditions included asthma and penicillin allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT) and acetylsalicylic acid (ASPIRIN).  On 29-DEC-2021, the patient was vaccinated with the first dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis.   The patient became pregnant with last menstrual period (LMP) date of 18-JUL-2022 and estimated date of delivery (EDD) of 24-APR-2023.  On 01-FEB-2023, the patient was vaccinated with the second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  lot #U032636, expiry date 26-OCT-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of vaccine administered, maternal exposure during pregnancy).   The pregnancy outcome was outcome pending. Fetal outcome was unknown. No additional adverse event (AE) was reported (no adverse event).
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a Certified medical assistant regarding a 15-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022, an improperly stored vaccine of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes.   On 29-DEC-2022, the patient was vaccinated with the improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in the right thigh, for prophylaxis (strength was not provided) (Product storage error). Digital data logger was involved. No adverse event was reported. The vaccine was available for return/evaluation and it was used according to the instruction leaflet.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report was received from an other health care professional and refers to a 7-month-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (dose, strength was not provided) after a temperature excursion of 47.9 degrees Fahrenheit for 47 min which occurred on 01-DEC-2022 (product storage error).  The vaccine was available for evaluation. The vaccine was used according to the instruction leaflet. Trained health care professional was the operator of the vaccine. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. No additional adverse events details were reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old female patient. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 30-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W017343, expiration date: 13-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  On 01-DEC-2022, the administered dose of the vaccine experienced a temperature excursion (product storage error). The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175:
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event; LPN called to report that an adult dose of VAQTA was administered to a pediatric patient. Nurse refused to give any patient or HCP information but it did happen within her office and she mentioned she already made the providers in the office aware. R; This spontaneous report was received from a licensed Practical Nurse and refers to a 13-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JAN-2023, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Adult product administered to child).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; PROQUAD being administered to a patient over age 12; This spontaneous report was received from a medical assistant and refers to a patient over age 12 of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (product administered to patient of inappropriate age), 0.5 milliliter, lot #W016356, expiration date: 16-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event (AE) was reported.
Sex: F
Vaccine: PPV
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Vaccination site soreness; Vaccination site erythema; This spontaneous report has been received from a physician via Pfizer, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  On an unspecified date, the patient experienced erythema and soreness, but there was no general anaphylaxis nor anything similar (vaccination site erythema, vaccination site pain). The reporter stated he did not know if the reaction could have been related to the antigens of the vaccine, or if it was completely separate, and was regarding if there was any information regarding of it as he wanted to administer PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR20) to the patient. The outcome of the events was not reported.  The causal relationship between vaccination site erythema and vaccination site pain and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: A nurse practitioner called to report an expired dose of GARDASIL 9 was administered to a patient.  No addiitonal AE's and PQC's were reported.; A nurse practitioner called to report an expired dose of GARDASIL 9 was administered to a patient.  No addiitonal AE's and PQC's were reported.; This spontaneous report has been received from a nurse practitioner and an office manager, regarding an identified patient of unknown age and gender.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 08-FEB-2023, the patient was vaccinated with one expired dose (product quantity: 1) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, administered as directed to prevent human papilloma virus (lot #R025729 confirmed to be valid, expiration date reported and stablished as 18-JUN-2021; exact dose, vaccination scheme, strength, and route of administration were not provided). No additional adverse events (AE).