chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Cardiomegaly, Decreased appetite, Pain in jaw, Sudden death
Clinical narrative: Jaw pain Not hungry Sudden death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Head discomfort, Headache
Clinical narrative: I started to have a scratchy throat. The next morning I had a severe headache. On the 4th day I developed a low grade fever, fatigue, cough and nasal congestion. About 4 days later I went in to see the doctor, and they did a COVID-19 test that came back positive. I got medication to help with my cough, and steroids. I was unable to keep taking the steroids because my throat started to close up. So I just took Nyquil day and night time. I still have fatigue, and congestion in my throat, and head.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal discomfort, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I started to have a scratchy throat. The next morning I had a severe headache. On the 4th day I developed a low grade fever, fatigue, cough and nasal congestion. About 4 days later I went in to see the doctor, and they did a COVID-19 test that came back positive. I got medication to help with my cough, and steroids. I was unable to keep taking the steroids because my throat started to close up. So I just took Nyquil day and night time. I still have fatigue, and congestion in my throat, and head.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Anxiety, Aphasia, COVID-19
Clinical narrative: I got COVID-19. I had chills for about 3 days then I had brain fog and memory loss and difficulty finding words. I went to the doctor and they said had paresthesia and neuropathy in arms and legs and it was intense pain. I also had nausea and upset stomach. I had bruising splotchy skin. I had salt cravings, edema, and I and a mood shift. I was anxious, irritable, and depressed.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Depression, Feeling abnormal, Irritability
Clinical narrative: I got COVID-19. I had chills for about 3 days then I had brain fog and memory loss and difficulty finding words. I went to the doctor and they said had paresthesia and neuropathy in arms and legs and it was intense pain. I also had nausea and upset stomach. I had bruising splotchy skin. I had salt cravings, edema, and I and a mood shift. I was anxious, irritable, and depressed.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Nausea, Neuropathy peripheral, Oedema, Pain
Clinical narrative: I got COVID-19. I had chills for about 3 days then I had brain fog and memory loss and difficulty finding words. I went to the doctor and they said had paresthesia and neuropathy in arms and legs and it was intense pain. I also had nausea and upset stomach. I had bruising splotchy skin. I had salt cravings, edema, and I and a mood shift. I was anxious, irritable, and depressed.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash macular, Salt craving
Clinical narrative: I got COVID-19. I had chills for about 3 days then I had brain fog and memory loss and difficulty finding words. I went to the doctor and they said had paresthesia and neuropathy in arms and legs and it was intense pain. I also had nausea and upset stomach. I had bruising splotchy skin. I had salt cravings, edema, and I and a mood shift. I was anxious, irritable, and depressed.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Pt started with low grade fevers on 7/2 and those continued through midday 7/5. After her fevers stopped she broke out in a while body rash, which looks like a roseolla.  Her twin sister did not have any of these symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, UNK, UNK
Symptoms: Explorative laparotomy, Ileocolectomy, Intussusception, Pathology test
Clinical narrative: This patient developed intussusception irreducible by air enema requiring  ex-lap with ileocecetomy 5 days after Rotavirus vaccine administration. Pathology was negative for a lead point.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Extra dose administered, Hypokalaemia
Clinical narrative: Patient received Moderna COVID vaccine on 1/22/21 (lot # 028L20A), 2/25/21 (lot # 002A21A), 11/3/21 (lot # 026D21A), and 4/3/22 (lot # 002M21A). Patient tested positive for COVID (external result) on 7/1/22. On 7/4/22, patient admitted to our inpatient facility (med/surgical unit) with acute hypoxemic respiratory failure due to COVID-19 pneumonia and hypokalemia. Patient discharged home on 7/6/22.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 1/22/21 (lot # 028L20A), 2/25/21 (lot # 002A21A), 11/3/21 (lot # 026D21A), and 4/3/22 (lot # 002M21A). Patient tested positive for COVID (external result) on 7/1/22. On 7/4/22, patient admitted to our inpatient facility (med/surgical unit) with acute hypoxemic respiratory failure due to COVID-19 pneumonia and hypokalemia. Patient discharged home on 7/6/22.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site discomfort, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: I'm not sure which type of pneumonia vaccine it was. Fatigue lasting 2-3 days and pain and swelling at injection site lasting 6+ days. Still have a hard lump at the injection site that is uncomfortable and itchy.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: I'm not sure which type of pneumonia vaccine it was. Fatigue lasting 2-3 days and pain and swelling at injection site lasting 6+ days. Still have a hard lump at the injection site that is uncomfortable and itchy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: 4th dose in series injected left IM deltoid around 10am. Patient later reported back at 1:45pm same day, experiencing soreness at the injection site, along with tingling and numbness that radiated from the injection site down to the hand. Patient was concerned whether that this was a normal side effect. I informed patient that these side effects have been reported in the past and referred patient to advice nurse to see if further evaluation same day is needed. Patient called advice nurse and informed me that this is a rare side effect, and that the nurse instructed patient to continue self-monitoring and to report back if side effects worsen. Unclear if patient has recovered from side effects and the time of this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drainage, Headache, Lethargy
Clinical narrative: May 16 started with scratchy throat. Progessed to congestion aches, fever, drainage, coughing, sneezing, lethargy.  Later, after Paxlovid, headaches.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Sneezing
Clinical narrative: May 16 started with scratchy throat. Progessed to congestion aches, fever, drainage, coughing, sneezing, lethargy.  Later, after Paxlovid, headaches.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: May 16 started with scratchy throat. Progessed to congestion aches, fever, drainage, coughing, sneezing, lethargy.  Later, after Paxlovid, headaches.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Exposure during pregnancy, Eye movement disorder
Clinical narrative: Patient previously had 3 Moderna (18+) COVID vaccines. This was their first Pfizer (12+). Patient received the Pfizer Adult (Age 12+) vaccine at 3:20pm. Patient started to not feel well 10 mins after the vaccine was given. Patient stated that they felt nauseous. Patient's eyes rolled back, head was leaning back in chair, and was unresponsive for 30 seconds to 1 minute. During that time patient made noises with throat and sounded like she was gasping for air. Patient regained consciousness, laid patient down, blood pressure was 77/51 on left arm, pulse was 55 and O2 was 97%. Patient stated that they do not know what happened. Patient stated that they are feeling weak, faint, cold, shivering, and "spacey". Patient was also pale.  Patient stated that they have a history of fainting after blood draw, history of low blood pressure, history of brain lesion, and is currently pregnant. Patient stated she has never made the throat noises when she has fainted. Blood pressure at 3:35pm was 105/68, pulse 55. Nurses advised patient to call husband. Patient was advised to go to ED to get assessed. Patient was still feeling weak, cold, and shivering. Patient said they are feeling better but still feels weak. Patient blood pressure was at 110/66, pulse was 75 at 3:45pm. Patient's husband escorted patient out in wheelchair.  clinical manager informed of the situation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Head titubation, Interchange of vaccine products, Loss of consciousness
Clinical narrative: Patient previously had 3 Moderna (18+) COVID vaccines. This was their first Pfizer (12+). Patient received the Pfizer Adult (Age 12+) vaccine at 3:20pm. Patient started to not feel well 10 mins after the vaccine was given. Patient stated that they felt nauseous. Patient's eyes rolled back, head was leaning back in chair, and was unresponsive for 30 seconds to 1 minute. During that time patient made noises with throat and sounded like she was gasping for air. Patient regained consciousness, laid patient down, blood pressure was 77/51 on left arm, pulse was 55 and O2 was 97%. Patient stated that they do not know what happened. Patient stated that they are feeling weak, faint, cold, shivering, and "spacey". Patient was also pale.  Patient stated that they have a history of fainting after blood draw, history of low blood pressure, history of brain lesion, and is currently pregnant. Patient stated she has never made the throat noises when she has fainted. Blood pressure at 3:35pm was 105/68, pulse 55. Nurses advised patient to call husband. Patient was advised to go to ED to get assessed. Patient was still feeling weak, cold, and shivering. Patient said they are feeling better but still feels weak. Patient blood pressure was at 110/66, pulse was 75 at 3:45pm. Patient's husband escorted patient out in wheelchair.  clinical manager informed of the situation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Patient previously had 3 Moderna (18+) COVID vaccines. This was their first Pfizer (12+). Patient received the Pfizer Adult (Age 12+) vaccine at 3:20pm. Patient started to not feel well 10 mins after the vaccine was given. Patient stated that they felt nauseous. Patient's eyes rolled back, head was leaning back in chair, and was unresponsive for 30 seconds to 1 minute. During that time patient made noises with throat and sounded like she was gasping for air. Patient regained consciousness, laid patient down, blood pressure was 77/51 on left arm, pulse was 55 and O2 was 97%. Patient stated that they do not know what happened. Patient stated that they are feeling weak, faint, cold, shivering, and "spacey". Patient was also pale.  Patient stated that they have a history of fainting after blood draw, history of low blood pressure, history of brain lesion, and is currently pregnant. Patient stated she has never made the throat noises when she has fainted. Blood pressure at 3:35pm was 105/68, pulse 55. Nurses advised patient to call husband. Patient was advised to go to ED to get assessed. Patient was still feeling weak, cold, and shivering. Patient said they are feeling better but still feels weak. Patient blood pressure was at 110/66, pulse was 75 at 3:45pm. Patient's husband escorted patient out in wheelchair.  clinical manager informed of the situation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: Patient previously had 3 Moderna (18+) COVID vaccines. This was their first Pfizer (12+). Patient received the Pfizer Adult (Age 12+) vaccine at 3:20pm. Patient started to not feel well 10 mins after the vaccine was given. Patient stated that they felt nauseous. Patient's eyes rolled back, head was leaning back in chair, and was unresponsive for 30 seconds to 1 minute. During that time patient made noises with throat and sounded like she was gasping for air. Patient regained consciousness, laid patient down, blood pressure was 77/51 on left arm, pulse was 55 and O2 was 97%. Patient stated that they do not know what happened. Patient stated that they are feeling weak, faint, cold, shivering, and "spacey". Patient was also pale.  Patient stated that they have a history of fainting after blood draw, history of low blood pressure, history of brain lesion, and is currently pregnant. Patient stated she has never made the throat noises when she has fainted. Blood pressure at 3:35pm was 105/68, pulse 55. Nurses advised patient to call husband. Patient was advised to go to ED to get assessed. Patient was still feeling weak, cold, and shivering. Patient said they are feeling better but still feels weak. Patient blood pressure was at 110/66, pulse was 75 at 3:45pm. Patient's husband escorted patient out in wheelchair.  clinical manager informed of the situation.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Focal dyscognitive seizures, Incorrect dose administered, Pain
Clinical narrative: Child given 10 mcg dose (instead of 3 mcg dose).  Was monitored x 30 minutes.   Day #1 mild symptoms - body ache - responded well to acetaminophen.  had 1-2 minute complex partial seizure on day #3.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Irritability, Urticaria, Vomiting
Clinical narrative: Day 0 of vaccine  Day 1 - fussiness/single episode of vomiting Day 2-4 - loose stool, lasted 2-3 days Day 3 -5- urticaria of extremities, brief, self resolving
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Facial pain, Fatigue, Pain, Rash
Clinical narrative: Just like with first three shots I felt sharp stinging sensations in my upper abdomen and face. This time it was followed by large red patches including a large red patch on my face, as well as hives on my face and on a few of the red spots. They were itchy. The spots and itching lasted a few days. It was at its worst the first night and following day. The areas also felt warm to the touch. I also felt extra tired in the weeks following the injection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Urticaria
Clinical narrative: Just like with first three shots I felt sharp stinging sensations in my upper abdomen and face. This time it was followed by large red patches including a large red patch on my face, as well as hives on my face and on a few of the red spots. They were itchy. The spots and itching lasted a few days. It was at its worst the first night and following day. The areas also felt warm to the touch. I also felt extra tired in the weeks following the injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Granuloma annulare, Rash
Clinical narrative: Rash on right inner arm, started the size of finger print, grew to larger than a baseball. Biopsied and determined to be granuloma annulare. 16 months later, the rash is still there and there are 6 similar spots (left bicep, front of right thigh, back of left thigh, inner right thigh, lower stomach, and right elbow).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diplopia, Laboratory test, Magnetic resonance imaging head normal, Visual impairment
Clinical narrative: Patient experienced acute onset diplopia the morning after her Pfizer booster vaccine. She had chills the night preceding her vision changes. Patient was evaluated at ED. A brain MRI was normal.
Age: 52.0
Sex: F
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vaccine received 7/5/22 @ 1:15 PM, symptoms of fever   (101.6 at highest) and vomiting began @ 7:45 AM on 7/6/22.  Symptoms resolved around 10:30 AM and were not present throughout the day but both fever and vomiting returned around 9:30 PM.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Echocardiogram, Extra dose administered, Full blood count, Metabolic function test
Clinical narrative: THIS FORM IS SUBMITTED AS PER FAMILY REQUEST: DO not have the details of the vaccine Patient presented with abdominal pain 1 day after receiving her 2nd booster dose admitted for acute pancreatitis with necrosis with respiratory failure and renal failure
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis acute, Pancreatitis necrotising, Renal failure, Respiratory failure, X-ray
Clinical narrative: THIS FORM IS SUBMITTED AS PER FAMILY REQUEST: DO not have the details of the vaccine Patient presented with abdominal pain 1 day after receiving her 2nd booster dose admitted for acute pancreatitis with necrosis with respiratory failure and renal failure
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Tech who administered vaccine was new and had supervisor with her. She set up the shot and then the supervisor had her move the site up my arm a few inches. The shot was incredibly painful. Far more pain than I?ve experienced from other vaccines. I was in a lot of pain afterward- couldn?t sleep without pain medication. It went away over the next couple of days. Over the course of the following week, when I lift my arm, especially if it?s left in a lifted position (like putting elbow on the back of couch) I have pain in my muscle at the injection site. It is not resolving. I?ve never experienced pain in my shoulder before injection.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Very tired and headache
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac ventricular disorder, Catheterisation cardiac abnormal, Echocardiogram
Clinical narrative: On March 3, 2022 I suffered a stress-induced heart attack, while exercising. Ambulance to hospital. EKGs, O2 checks, Heart catheter; bloodwork; ultrasound. Meds.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram T wave inversion, Electrocardiogram abnormal, Myocardial infarction, Stress, Troponin increased
Clinical narrative: On March 3, 2022 I suffered a stress-induced heart attack, while exercising. Ambulance to hospital. EKGs, O2 checks, Heart catheter; bloodwork; ultrasound. Meds.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain,erythema,weakness, difficulty raising arm Since that first vaccination I have had 3 boosters last beeing 4/2/2022 I continue to have pain at night when lying in bed in my Rt arm. I also have waekness and difficulty lifting it at tiimes when lying. MRI scheduled
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID while vaccinated.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID while vaccinated.
Sex: U
Vaccine: MMR, VARCEL, MMR, UNK, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported; Caller reports MMR II and VARIVAX administered after reconstitution with expired sterile diluent.; Caller reports MMR II and VARIVAX administered after reconstitution with expired sterile diluent.; This spontaneous report was received from registered nurse, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter  subcutaneous, lot #T032319, expiration date: 22-SEP-2022, for prophylaxis (strength was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  0.5 milliliter subcutaneous, lot #U022175, expiration date: 14-JUL-2023, for prophylaxis (strength was not provided); after reconstitution with sterile diluent 0.5 milliliter, product quantity: 2, lot #S030249, expiration date: 02-JUN-2022, administered subcutaneously (strength was not reported) (Expired product administered) (Product preparation issue). No additional adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL, MMR, UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reports MMR II and VARIVAX administered after reconstitution with expired sterile diluent.; Caller reports MMR II and VARIVAX administered after reconstitution with expired sterile diluent.; This spontaneous report was received from registered nurse, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter  subcutaneous, lot #T032319, expiration date: 22-SEP-2022, for prophylaxis (strength was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  0.5 milliliter subcutaneous, lot #U022175, expiration date: 14-JUL-2023, for prophylaxis (strength was not provided); after reconstitution with sterile diluent 0.5 milliliter, product quantity: 2, lot #S030249, expiration date: 02-JUN-2022, administered subcutaneously (strength was not reported) (Expired product administered) (Product preparation issue). No additional adverse events were reported.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I started having a scratchy sore throat, headache, congestion, fatigue, I used a home COVID-19 test that came back positive. I called and had a telephone visit with my doctor, she prescribed Paxlovid, I also used pseudoephedrine and Tylenol. I started feeling better in a week but I did have rebound COVID-19 that lasted for a couple of days. Other symptoms seem to have come back but haven't ingered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I started having a scratchy sore throat, headache, congestion, fatigue, I used a home COVID-19 test that came back positive. I called and had a telephone visit with my doctor, she prescribed Paxlovid, I also used pseudoephedrine and Tylenol. I started feeling better in a week but I did have rebound COVID-19 that lasted for a couple of days. Other symptoms seem to have come back but haven't ingered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I started having a scratchy sore throat, headache, congestion, fatigue, I used a home COVID-19 test that came back positive. I called and had a telephone visit with my doctor, she prescribed Paxlovid, I also used pseudoephedrine and Tylenol. I started feeling better in a week but I did have rebound COVID-19 that lasted for a couple of days. Other symptoms seem to have come back but haven't ingered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Broke out in hives all over her body
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over her body
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Emotional disorder, Endocrine disorder, Invasive ductal breast carcinoma, Investigation
Clinical narrative: Diagnosed with triple positive invasive ductile carcinoma. I have been without a menstrual cycle for over 10 years and within weeks of taking my second dose of Pfizer covid vaccine, I started. Went to Dr to have ovaries cervix and uterus checked. Have been very emotional/hormonal since. Crying at the drop of a hat. I believe the vaccine accelerated my IDC. I have a family history of IDC but none diagnosed under the age of 76 and none with triple positive. I still continue to have A small cycle. I was clear of any issue below and then at my annual physical, I went for my annual mammogram and the lump was found. I have had the lump removed with all margins cleared. I will be undergoing chemotherapy and herceptin treatment followed by radiation and then continued medication up to 10 years trying to hold off the her2 + part. I am willing to participate in data collection for this to determine if my theory is correct and try to protect others.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, SARS-CoV-2 test
Clinical narrative: Diagnosed with triple positive invasive ductile carcinoma. I have been without a menstrual cycle for over 10 years and within weeks of taking my second dose of Pfizer covid vaccine, I started. Went to Dr to have ovaries cervix and uterus checked. Have been very emotional/hormonal since. Crying at the drop of a hat. I believe the vaccine accelerated my IDC. I have a family history of IDC but none diagnosed under the age of 76 and none with triple positive. I still continue to have A small cycle. I was clear of any issue below and then at my annual physical, I went for my annual mammogram and the lump was found. I have had the lump removed with all margins cleared. I will be undergoing chemotherapy and herceptin treatment followed by radiation and then continued medication up to 10 years trying to hold off the her2 + part. I am willing to participate in data collection for this to determine if my theory is correct and try to protect others.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Crying, Emotional disorder, Invasive ductal breast carcinoma, Postmenopausal haemorrhage
Clinical narrative: Diagnosed with triple positive invasive ductile carcinoma. I have been without a menstrual cycle for over 10 years and within weeks of taking my second dose of Pfizer covid vaccine, I started. Went to Dr to have ovaries cervix and uterus checked. Have been very emotional/hormonal since. Crying at the drop of a hat. I believe the vaccine accelerated my IDC. I have a family history of IDC but none diagnosed under the age of 76 and none with triple positive. I still continue to have A small cycle. I was clear of any issue below and then at my annual physical, I went for my annual mammogram and the lump was found. I have had the lump removed with all margins cleared. I will be undergoing chemotherapy and herceptin treatment followed by radiation and then continued medication up to 10 years trying to hold off the her2 + part. I am willing to participate in data collection for this to determine if my theory is correct and try to protect others.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Blood test, Echocardiogram, Headache
Clinical narrative: He received the pnemococcal vaccine Feb 24 at 4 pm. He had a headache and severe back and stomach pain February 24 at 6 pm. He was pain free and illness free before 4 pm nothing was wrong with him before he got the vaccine.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Illness, Laboratory test normal, Ultrasound abdomen, Ultrasound chest, X-ray
Clinical narrative: He received the pnemococcal vaccine Feb 24 at 4 pm. He had a headache and severe back and stomach pain February 24 at 6 pm. He was pain free and illness free before 4 pm nothing was wrong with him before he got the vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Episcleritis
Clinical narrative: Have had joint pain since shot and specifically this event was Episcleritis. Seems my body is attacking collagen since this third dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rectal cancer
Clinical narrative: Patient has recurrence SSC of rectum
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Crying, Gait inability, Hypotonia, Skin discolouration
Clinical narrative: vomiting, fainting, turning purple, unable to walk temporarily, drop in blood pressure, loosing body function, crying
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: vomiting, fainting, turning purple, unable to walk temporarily, drop in blood pressure, loosing body function, crying
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Palpitations
Clinical narrative: Heavy heart, chest pain, heart palpitations, light head
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Goitre, Laboratory test, Thyroid pain, Thyroiditis subacute, Ultrasound thyroid abnormal
Clinical narrative: Felt a painful lump on my thyroid, went to my endocrinologist who ordered ultrasound and labs, diagnosed with subacute thyroditis post covid booster.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Patient received his first covid Moderna shot 28Jun22 without problems. Patient states he had a reaction 5 days later that consisted of redness larger than the patients palm with irritation.  Patient went to 6Jul22 and was told reaction was normal and not given any medication but to follow up if symptoms worsen.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vials expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vials expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and administered on 19-May-2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011F21A, 045A21A and 031M20A) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac pacemaker insertion. Concurrent medical conditions included Blood pressure high.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 9:06 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 9:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and administered on 19-May-2022). At the time of the report, PRODUCT STORAGE ERROR (The vials expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and administered on 19-May-2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and administered on 19-May-2022).    No concomitant medications was reported.  The vaccines expired on 13-May-2022 and administered on 19-May-2022. The vials were placed in refrigerator on 17-May-2022.  The patient had no known allergies. It was unknown if the patient was diagnosed or tested positive for COVID-19. Also unknown if the patient had acute illnesses at the time of vaccination and up to one month before and unknown if prescriptions, over-the-counter medications, dietary supplements or herbal remedies were taken at time of vaccination and/or at the time of the adverse event. It was also unknown if the patient had experienced a similar event in the past.  No treatment medications was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator and then administered; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 003F21A) for COVID-19 prophylaxis.     It was unknown  if patient had ever been diagnosed with or tested positive with COVID-19 or not. It was unknown if the patient had any allergies to any medication, food or other products and if the patient had any acute illnesses at the time of vaccination and up to one month before it.  Concurrent medical conditions included Blood pressure high (no recent change in condition status), Asthma (no recent change in condition status) and Diabetic (no recent change in condition status).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 11:22 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 11:22 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered). At the time of the report, PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator and then administered).    No concomitant medication information was provided.  The vaccine expired on 13-May-2022. The vial was initially stored in refrigerator on 17-May-2022.  No treatment information was provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:Master case (same reporter)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011F21A, 044A21A and 011A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 2:46 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 2:46 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.).    Concomitant product use was not provided by the reporter.  Vial expired on 13-May-2022 and were placed in refrigerator on 17-May-2022.  Event didn't cause the patient to seek medical care and no other potential causes.  It was unknown that the patient experienced similar event in the past.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:MCN No.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 013F21A, 011M20A and 032H20A) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Blood pressure high.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 10:10 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 10:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022).    No concomitant medications were reported.  The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realized that on the 08-Jun-2022.  The vial was placed in refrigerator on 17-May-2022.   Vials did not undergo any temperature excursion.  The event did not cause patient to seek medical care. The reporter did not report any other potential causes.   No treatment information was reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:Master case
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 013F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Lot number; 1805018 and 0.5 mL in left deltoid) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Diabetic (No recent change in condition status).   On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-May-2022 at 9:13 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 9:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022).    No concomitant medication was provided by the reporter.  The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realize this on the 08-Jun-2022.  On 17-May-2022, vials were initially stored in refrigerator.   Vials did not undergo any temperature excursion.  The patient did not seek medical care for events.  There were no other potential causes for the event.  No treatment medication was provided by the reporter.