chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle pain, joint pain, and dizziness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose, given 0.25ml instead of 0.5ml recommended dose.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nausea, Paranasal sinus discomfort, Respiratory tract congestion
Clinical narrative: I experienced a breakthrough case of COVID-19, nausea, nasal pressure, congestion, coughing, mucus.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Secretion discharge, Vaccine breakthrough infection
Clinical narrative: I experienced a breakthrough case of COVID-19, nausea, nasal pressure, congestion, coughing, mucus.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare consulted with the Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose given, 0.25 ml was administered instead of recommended dose of 0.5ml.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Dizziness, Loss of consciousness, Myalgia
Clinical narrative: Intense dizziness, brief loss of consciousness the next morning. The intense dizziness lasted about 25 minutes, including a brief period of unconsciousness. It resolved after that without intervention. Other concurrent events were fever, chills (beginning midnight after the shot), weakness, muscle aches.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Intense dizziness, brief loss of consciousness the next morning. The intense dizziness lasted about 25 minutes, including a brief period of unconsciousness. It resolved after that without intervention. Other concurrent events were fever, chills (beginning midnight after the shot), weakness, muscle aches.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient is experiencing issues with numbness in fingers that started about 2 weeks after the vaccine was administered. It is affecting the same arm the vaccine was administered in.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient called 9/19/22 he received moderna bival booster on 9/15/22 he had a rash start on left arm spread to right arm by Friday it was all over red bumpy rash. He contacted primary care their secretary told him to call us. I counseled him to seek medical attention for the rash either at urgent care of primary md. He said he has tried benadryl it does help but it causes too much drowsiness to take constantly.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product availability issue
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: I started experiencing about 2 mins. after receiving the vaccine I started having difficulty breathing. I did not tell Pharmacy, I told my husbands since he is a doctor. I wheezing, very tight it got a little better but I am still not breathing the way I normally do, feels heavy.  Better but not gone.  I call the allergist and talked to him but did not go in. I started using an inhaler and inhaling steroids and trying to loosen things up with Allegra D along with deep breathing exercises to try to open up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Computerised tomogram normal, Echocardiogram
Clinical narrative: In December 2021 I noticed I had pain developing in my chest on my right side just slightly above my breast. It feels like it is inside my body beneath ribcage. I would only develop during exercise and when I would go up hill. It was not painful just uncomfortable. Within a month it became a pain. Within two months I could no longer go up the hill without stopping to relax totally. I began seeing a cardiologist because I was concerned. By July 2022 I had two events where the pain was so excruciating that it felt like my chest was going to explode. I've seen the pulmonologist. I am on a high-powered inhaler. The pain continued and has stayed on the 8-9 of the pain scale. I am no longer able to walk up severe hills. I am only able to go up slight inclines. And even then, I still need to take a break.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Exercise tolerance decreased, Magnetic resonance imaging spinal normal
Clinical narrative: In December 2021 I noticed I had pain developing in my chest on my right side just slightly above my breast. It feels like it is inside my body beneath ribcage. I would only develop during exercise and when I would go up hill. It was not painful just uncomfortable. Within a month it became a pain. Within two months I could no longer go up the hill without stopping to relax totally. I began seeing a cardiologist because I was concerned. By July 2022 I had two events where the pain was so excruciating that it felt like my chest was going to explode. I've seen the pulmonologist. I am on a high-powered inhaler. The pain continued and has stayed on the 8-9 of the pain scale. I am no longer able to walk up severe hills. I am only able to go up slight inclines. And even then, I still need to take a break.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product availability issue
Clinical narrative: Monovalent given as booster after cdc recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Oropharyngeal pain, Pain
Clinical narrative: Body aches, Head aches, sore throat, weakness
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Feeling hot, Nausea, Thirst, Vertigo, Vomiting
Clinical narrative: Pt states that 30 minutes post vaccination he became ''hot and thirsty'', stopped to get ice cream and then got severe vertigo, nausea and vomiting so went to the ER for evaluation
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Wrong product administered
Clinical narrative: Given monovalent vaccine inadvertently. Should have received bivalent. No side effects noted by patient
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Incorrect dose was given.  We gave 0.25 mL instead of 0.5 mL.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Drainage, Headache, Injection site erythema, Injection site induration
Clinical narrative: 09/15/2022 Awakened with moderate to severe headache, joint popping (crepitus) in all joints large and small including wrists and fingers bilaterally. Difficulty moving around, sleepiness. I also had a fever of 38.4 c. By mid-day had a hard lump about 5 to 7 cm diameter and redness larger than that over the injection area. That increased each day and finally today, 9/19/2022 the size of the hard lump is smaller. On Saturday 09/17/2022 my spleen was very enlarged and caused me a lot of pain when I would bend forward and my ribs put pressure there. I've had this happen other times and know it is my spleen. The size got smaller on Sunday. I can't feel it today. (I'm a healthcare provider and know how to assess this). The redness over upper left arm increased ever day, and now is a dark red color with several satellite papules, most of which popped open and drained (clear?) fluid. Four of them extended to my back. I have photos of my arm.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site mass, Injection site papule, Injection site reaction, Joint noise, Mobility decreased
Clinical narrative: 09/15/2022 Awakened with moderate to severe headache, joint popping (crepitus) in all joints large and small including wrists and fingers bilaterally. Difficulty moving around, sleepiness. I also had a fever of 38.4 c. By mid-day had a hard lump about 5 to 7 cm diameter and redness larger than that over the injection area. That increased each day and finally today, 9/19/2022 the size of the hard lump is smaller. On Saturday 09/17/2022 my spleen was very enlarged and caused me a lot of pain when I would bend forward and my ribs put pressure there. I've had this happen other times and know it is my spleen. The size got smaller on Sunday. I can't feel it today. (I'm a healthcare provider and know how to assess this). The redness over upper left arm increased ever day, and now is a dark red color with several satellite papules, most of which popped open and drained (clear?) fluid. Four of them extended to my back. I have photos of my arm.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Somnolence, Splenomegaly
Clinical narrative: 09/15/2022 Awakened with moderate to severe headache, joint popping (crepitus) in all joints large and small including wrists and fingers bilaterally. Difficulty moving around, sleepiness. I also had a fever of 38.4 c. By mid-day had a hard lump about 5 to 7 cm diameter and redness larger than that over the injection area. That increased each day and finally today, 9/19/2022 the size of the hard lump is smaller. On Saturday 09/17/2022 my spleen was very enlarged and caused me a lot of pain when I would bend forward and my ribs put pressure there. I've had this happen other times and know it is my spleen. The size got smaller on Sunday. I can't feel it today. (I'm a healthcare provider and know how to assess this). The redness over upper left arm increased ever day, and now is a dark red color with several satellite papules, most of which popped open and drained (clear?) fluid. Four of them extended to my back. I have photos of my arm.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Feeling abnormal, Malaise, Vomiting
Clinical narrative: WOKE UP THE NEXT MORNING SICK- VOMITING-CHILLING-PATIENT STATED SHE THOUGHT SHE WAS GOING TO DIE.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given the monovalent in error should have been bivalent
Age: 57.0
Sex: F
Vaccine: COVID19, PNC
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pain, Pallor, Pruritus, Skin warm
Clinical narrative: Patient states her arm is itchy, red and hot to touch. The area is as big as the bottom of a coke can and the center is blanchable. She states she has taken Ibuprofen and Tylenol to treat the pain.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: .5 ml was given ID instead of .1 ml
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Wrong dose give, 0.25ml administered instead of recommended dose of 0.5ml.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare consulted with the Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: Patient was given a monovalent booster instead of a Bi-valent booster
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: inadvertently administered monovalent instead of bivalent vaccine. No side effects/adverse effects noted by patient
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, General physical health deterioration, Hypophagia, Respiratory tract congestion
Clinical narrative: pt in Health and Rehab; on hospice; pt had a positive COVID test on 7/8/22; pt gradually declined with increase in congestion; poor oral intake; pt passed away in the facility
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt in Health and Rehab; on hospice; pt had a positive COVID test on 7/8/22; pt gradually declined with increase in congestion; poor oral intake; pt passed away in the facility
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haematoma
Clinical narrative: HEMATOMA  AT INJECTION SITE AND RADIATING UP TO  RIGH HAND
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: inadvertently administered monovalent instead of bivalent. no detrimental effects to the patient
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus, Throat irritation
Clinical narrative: vaccine administered at facility. Approximately two hours later, patient reported feeling flushed, itching ears and throat. Patient stopped at clinic, where she was treated with an antihistamine. No acute distressed noted at the time. vital signs stable. Patient reported improving symptoms upon arrival.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent booster instead of the bivalent booster
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Bloom consulted with the Dept and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Skin warm
Clinical narrative: PATIENT STATED SHE HAD EXPERIENCED NUMBNESS IN THE ARM. SHE HAD TRIED HEATING PAD, EPSOM SALT, PAIN KILLER BUT THE NUMBNESS HAS NOT GONE AWAY. SHE STATED THE NUMBNESS HAS NOT GOTTEN ANY BETTER SINCE 9/14/22 (AS OF 9/19/22). IT IS WARM TO THE TOUCH.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: inadvertently gave monovalent vaccine instead of bivalent no adverse reactions with the patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED
Age: 44.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Dermatitis bullous, Fatigue, Lymphadenopathy, Rash, Urticaria
Clinical narrative: Swollen lymph nodes, extreme fatigue, rash that got worse over several days, hives. Rash & hives look and felt like dermatitis herpetiformis which I have had in the past with my Celiac disease. Took Tylenol, Benadryl, and occasionally Loratidine
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chest pain, Cough, Death
Clinical narrative: deceased 8-18-22:   positive for covid 8-13-22   , to ER 8-15-22   DNR status,  chest pain, shortness of breath for one day, cough and admitted.  felt to have chf exacerbation;  family member reported he had rec'd monoclonal antibody treatment.  He had been to ER and released 8-13-22 because of no further complaints
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: deceased 8-18-22:   positive for covid 8-13-22   , to ER 8-15-22   DNR status,  chest pain, shortness of breath for one day, cough and admitted.  felt to have chf exacerbation;  family member reported he had rec'd monoclonal antibody treatment.  He had been to ER and released 8-13-22 because of no further complaints
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The medication that was supposed to be administered was the Pfizer bivalent vaccine but the monovalent vaccine was accidentally administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Positron emission tomogram, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had vaccination on 09/17/21. I had started Chemo 08/03/2021 for bladder cancer that had spread to my lungs. On 04/20/2022 I had a mild sore throat. I had a PET scan on 04/21/2022. On 04/23/2022 I had a fever 101.3. I took a at home test on 04/23/2022 and it was COVID-19 Positive. I went to the emergency room on 04/23/2022 and gave me monoclonal antibodies and Tylenol. I am unsure if I had my flu shot at the same exact time as my 4th vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer bivalent was supposed to be administered but monovalent was given
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis diagnosed 19 September 2022
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a bivalent dose of pfizer vaccine as a primary dose in error, no signs/symptoms noted over the following 2 hours patient was in the clinic
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer bivalent was supposed to be administered but the Pfizer monovalent was administered
Age: 26.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: I administered Jynneos vaccine into patient's left deltoid. Patient tolerated vaccine no visible symptoms.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Abdominal discomfort, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Day after injection: swelling, redness and tenderness and the site of the injection. No noticeable wheal was present in the 24 hours following vaccination. Injection site side effects cleared within 24 hours. For 7 days following vaccination: migraine, varying fever up to 101.8°F, chills, severe fatigue, sore throat, cough and congestion (excessive mucosal drain resulting in gastro distress, namely diarrhea), swollen lymph nodes of the neck (severely so on the right side), nuchal rigidity. Managed with bed rest, acetaminophen and naproxen, and home remedies for other symptoms. All began to fully/finally resolve the morning of 9/14/2022.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Migraine
Clinical narrative: Day after injection: swelling, redness and tenderness and the site of the injection. No noticeable wheal was present in the 24 hours following vaccination. Injection site side effects cleared within 24 hours. For 7 days following vaccination: migraine, varying fever up to 101.8°F, chills, severe fatigue, sore throat, cough and congestion (excessive mucosal drain resulting in gastro distress, namely diarrhea), swollen lymph nodes of the neck (severely so on the right side), nuchal rigidity. Managed with bed rest, acetaminophen and naproxen, and home remedies for other symptoms. All began to fully/finally resolve the morning of 9/14/2022.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Urticaria
Clinical narrative: Day after injection: swelling, redness and tenderness and the site of the injection. No noticeable wheal was present in the 24 hours following vaccination. Injection site side effects cleared within 24 hours. For 7 days following vaccination: migraine, varying fever up to 101.8°F, chills, severe fatigue, sore throat, cough and congestion (excessive mucosal drain resulting in gastro distress, namely diarrhea), swollen lymph nodes of the neck (severely so on the right side), nuchal rigidity. Managed with bed rest, acetaminophen and naproxen, and home remedies for other symptoms. All began to fully/finally resolve the morning of 9/14/2022.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Dementia, General physical health deterioration, Hip fracture
Clinical narrative: pt had a positive COVID and FLU A test on 7/3/22; pt in Hospice for right hip fx and dementia; pt's condition worsened and she passed away in the hospice facility
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test positive, SARS-CoV-2 test positive
Clinical narrative: pt had a positive COVID and FLU A test on 7/3/22; pt in Hospice for right hip fx and dementia; pt's condition worsened and she passed away in the hospice facility
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red  area around injection site. Oval about 4x3 inches Sore and warm to touch
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine had been stored at temperatures 35-45 degrees Fahrenheit for greater than 10 weeks prior to being discarded. Discard date was 9/2
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose normal, Electrocardiogram normal, Eye movement disorder, Loss of consciousness
Clinical narrative: Pt was nervous about getting the vaccine. Pt has a seizure type event (eyes rolled back, pt was shaking and then fainted). Pt had no recollection of adverse event when he regained consciousness. Emergency services was called.  Pt's BP, glucose and EKG was ok per EMS. EMS suspected that pt had an anxiety attack but additional information not available at this time.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: Pt was nervous about getting the vaccine. Pt has a seizure type event (eyes rolled back, pt was shaking and then fainted). Pt had no recollection of adverse event when he regained consciousness. Emergency services was called.  Pt's BP, glucose and EKG was ok per EMS. EMS suspected that pt had an anxiety attack but additional information not available at this time.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 9/16/22. I had very mild symptoms, stuffy nose, and a slight cough. I was prescribed PAXLOVID and it seems to be working well. My symptoms only lasted for about 2 days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Impaired work ability
Clinical narrative: Initially I had a headache, congestion and a fever of around 100.0. A week ago I developed a cough and I was staying home from work but it got to the point where I was not able to complete an online call so I called the doctor. I tested on September 02, 2022 and it was a faint positive. I have been testing myself every 3 days since and just tested negative on 09/17/2022. I talked to the doctor on September 13th or 14th and they recommended that I take benzonatate, SUDAFED, an albuterol sulfate inhalation aerosol and a cough medicine with codeine to take at night. It is helping because I can talk more but I still have the cough. I have congestion, cough and tiredness. No additional tested was requested by the doctor.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Initially I had a headache, congestion and a fever of around 100.0. A week ago I developed a cough and I was staying home from work but it got to the point where I was not able to complete an online call so I called the doctor. I tested on September 02, 2022 and it was a faint positive. I have been testing myself every 3 days since and just tested negative on 09/17/2022. I talked to the doctor on September 13th or 14th and they recommended that I take benzonatate, SUDAFED, an albuterol sulfate inhalation aerosol and a cough medicine with codeine to take at night. It is helping because I can talk more but I still have the cough. I have congestion, cough and tiredness. No additional tested was requested by the doctor.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Cardiac flutter, Electrocardiogram normal, Heart rate decreased
Clinical narrative: So I started having heart fluttering and beating super slow and pulse rate would drop and it would go away and I started having multiple episodes and by now it has almost gone away. They did an EKG and it was normal. The Dr. heard an abnormal rhythm but by the time they checked it was gone. They did recommend a Cardiologist to see.
Age: 61.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Product not approved for patient age. No adverse events known at this time.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pruritus, Rash, Skin irritation, Urticaria
Clinical narrative: He has a heavy, dry cough a couple of weeks after receiving his vaccine. Days after that, he started having hives on his arm and really bad itching like something was irritated him. I contacted his doctor about it and they informed me to put hydrocortisone cream on it to see if it would reduce the itch and hive outbreak. They told me if the coughing and hives persist to wear he can't breathe to take him to the emergency room. He still does his normal daily activities, but the cough won't subside since receiving his vaccine. When he's having a breakout, the pediatrician told me to give him an allergy medication (I alternate between BENADRYL and ZYRTEC to help the breakout as well).
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: RED, HOT AND ITCHY RASH THAT STARTED ON THE LEFT ARM MOVING TO THE RIGHT ARM, STOMACH, BACK AND THIGHS. THE RASH IS WORSE ON THE LEFT ARM. PATIENT HAS BEEN TAKING BENADRYL AND APPLYING CALAMINE LOTION AND CORTISONE CREAM. I RECOMMENDED SHE GO TO THE DOCTORS OFFICE HOPING THEY RECOMMEND STEROIDS TO STOP THE SPREAD.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Fully vaccinated and boosted twice.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness
Clinical narrative: She got lightheaded and dizzy and had passed out in the chair as mom and I were holding her up and then had a few uncontrollable full body jerks while being passed out  and she was passed out for about 45 seconds total and when Dr had walked in she had come to already, I gave her apple juice and crackers and she waited about ten minutes to leave until she felt she was ready
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site warmth, Pyrexia
Clinical narrative: Chills for 45 min ( felt like a seizure) . injection site was warm. low grade temp for 2 days
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 8/31/22 ---Emergency Authorization for Pfizer monovalent had been rescinded and as of 9/1/22 only the bivalent was approved for BOOSTER doses.  Patient came first thing in the morning before communication had been received by pharmacist from company and the pharmacy did not email until 9:08am on 9/1/22 and the pharmacist had not received that communication either.  Patient received vaccination at 9:28am.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Patient received her flu vaccination at a clinic.  Patient later contacted store concerned that the vaccine had been administered too low on her arm.  No adverse effects to patient health were reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 2 Staff member's used monovalent Pfizer vaccine thinking it was Bivalent Vaccine and administered doses to a total of 4 patients between 09/16/2022 and 09/19/2022
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site reaction, Rash
Clinical narrative: rxn at site in addition to rash from the knee down
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Fully vaccinated boosted twice
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: About five months after receiving my fourth dose of the COVID vaccine, Pfizer, I came down with the COVID-19 virus twice. I went on a cruise and after the cruise I started with a cough, feeling exhausted, got headaches and had a sore throat. I did receive the anti-viral and it worked perfectly.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: About five months after receiving my fourth dose of the COVID vaccine, Pfizer, I came down with the COVID-19 virus twice. I went on a cruise and after the cruise I started with a cough, feeling exhausted, got headaches and had a sore throat. I did receive the anti-viral and it worked perfectly.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash pruritic, Swelling face
Clinical narrative: Patient had immediate itchy rash, facial swelling and limb swelling, given benedryl to treat symptoms, and symptoms subsided. Itchiness persisted until 9/19/22.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 12 days following vaccines
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: I cleaned patient's left deltoid with alcohol wipe and administered 0.5 mL of monkey pox vaccine intramuscular. Patient tolerated vaccine with not reaction.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This patient was scheduled for the Covid-19 Pfizer Bivalent vaccine but was actually given the Covid-19,mRNA, LNP-S,  PF, 30 mcg/0.3ml dose, tris-sucrose  Pfizer vaccine.  This patient was notified by phone and rescheduled in two months to receive the Covid-19 Pfizer Bivalent vaccine.  She agreed to come back for the appointment in two months.  She reported no adverse symptoms at this time.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT WAS GIVEN INCORRECT VACCINE FOR HER BOOSTER DOSE.  SHOULD HAVE RECIEVED MODERNA BIVALENT FOR BOOSTER, HOWEVER THERE WAS NO MODERNA BIVALENT BOOSTER DOSES IN STOCK AT THE CLINIC. AEMT PROCEEDED TO VACCINATE PATIENT.   PATIENT HAS NOT HAD ANY ADVERSE EVENT. SHE IS NOT EXPIERENCING ANY SIDE EFFECTS TO THE VACCINATION.
Age: 13.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given one dose of Proquad and one dose of IPV at time of visit. After entering vaccines into database and printing record to give to parent, this RN realized report read "invalid" for Varicella. Mother of the patient was notified immediately while still present at clinical site by this RN, and mistake was explained. After waiting 15 minute period, this RN explaining that the patient  would need to have the dose repeated on or after 10/17/22. Patient was overserved prior to leaving clinic and reported, as well as appeared to be in no apparent distress prior to departure. This RN immediately notified Nursing Director who notified vaccine coordinator.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Headache, Injection site pain, Mobility decreased, Throat clearing
Clinical narrative: Approx 18hrs after receiving a 2nd booster of the latest Pfizer Bilavent vaccine patient awoke at 4am  on 9/15with an acute headache that was exasperated with any cough or throat clearing.  Expected right arm pain at injection site was also prevalent.   At approx 8am Patient attempted to get out of bed but was unable to freely move about without acute headache pain and retired back to bed after a few minutes.  Patient remained bed ridden for most of the day 9/15 with on/off sleep thru 4pm.  Acute headache pain started to subside late evening and was gone by the next morning 9/16. Injection site pain subsided on 9/19.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Tdap vaccine was administered on 8/23/2022 but had expiration date of 8/19/22
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test normal, Cardiac monitoring abnormal, Palpitations, Sleep disorder
Clinical narrative: Starting 10/08/2021, I was sleeping and my heart started pounding which woke me up. I did some deep breathing and went back to sleep. Then, it happened again and I repeated the breathing exercises and went back to sleep. After I was woken up the 3rd time, I went to the ER. They did blood tests and monitored me. They did not find anything and discharged me. About 1 week later, my doctor put me on a heart monitor and it caught one episode of atrial fibrillation. The doctor put me on baby aspirin. I have not had any episodes since.
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Asthenia, Chills, Headache, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Severe flu-like symptoms with headache, chills, body aches, sinus congestion, weakness, and malaise. Patient has been treating symptoms on his own but has reached out to this office and to his provider.
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Influenza like illness, Malaise, Pain, SARS-CoV-2 test negative, Sinus congestion
Clinical narrative: Severe flu-like symptoms with headache, chills, body aches, sinus congestion, weakness, and malaise. Patient has been treating symptoms on his own but has reached out to this office and to his provider.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, SARS-CoV-2 test positive
Clinical narrative: It started with a scratchy throat and feeling very tired. I developed sneezing, respiratory coughing and headaches. I did not have fever. I took a home COVID-19 test on July 06, 2022. It was positive. I contacted the doctor on July 06, 2022 and they called in PAXLOVID and I started it that night. I was not able to finish it due to a headache and elevated blood pressure issues. I had 2 doses remaining when I had to stop. My symptoms improved except for the headache. I was prescribed a different medication. Gradually my blood pressure got back to normal over several weeks. I was prescribed additional blood pressure to deal with my symptoms. I was able to skip the 2nd dose of blood pressure medicine after August 22, 2022. I am 90% back to where I was but I am still recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Throat irritation
Clinical narrative: It started with a scratchy throat and feeling very tired. I developed sneezing, respiratory coughing and headaches. I did not have fever. I took a home COVID-19 test on July 06, 2022. It was positive. I contacted the doctor on July 06, 2022 and they called in PAXLOVID and I started it that night. I was not able to finish it due to a headache and elevated blood pressure issues. I had 2 doses remaining when I had to stop. My symptoms improved except for the headache. I was prescribed a different medication. Gradually my blood pressure got back to normal over several weeks. I was prescribed additional blood pressure to deal with my symptoms. I was able to skip the 2nd dose of blood pressure medicine after August 22, 2022. I am 90% back to where I was but I am still recovering.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects. Vaccine re-dose was administered at 32 days rather than at 60 days like it is supposed to be
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: none
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Yesterday after the vsafe check in, I went to the doctors, two instances came to my mind. One was, in august 2022, there was a growth and had a biopsy squamous cell carcinoma (cancer). I noticed the growth in July 2022. It was in the morning; it wasn't dark, but it grew like a narrow dome shape. One other thing that caught my attention was my pacemaker. I got it checked in 2021 before the vaccination, and I was 2 percent dependent. Now, I am 98 per cent dependent on the pacemaker and I will be getting forth pacemaker scheduled in spring 2021. I do a remote transmition.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO KNOWN SYMPTOMS OCCURED
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the high dose flu shot instead of Fluarix flu shot in the left Deltoid. Also given the Moderna Bivalent Booster in the left Deltoid. NO adverse side affects noted .
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Extra dose administered
Clinical narrative: Patient was administered Dose #4 pfizer bivalent booster @ 4pm. Patient went to monitoring area then @ 4:30pm sad she has redness on both arms and in chest area. Patient denied any SO(shortness of breath) and redness on both arms began to lighten. Patient had no hives, no itchiness and was advised to apply cool compresses and monitor.  Patient to contact PCP /Doctor with changes or concerns
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient called store to report having side effect from shingles vaccine administered on 9/16/22. Patient reports getting at the site of injection a red knot, itching, soreness, tenderness. It was not hot to the touch. Symptoms started after injection on same day and has continued to today. Patient has been applying warm compresses to her arm, but still complains of itching. Patient counseled to try applying Benadryl cream to the area.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: About 8 PM I noticed a scaly patch on the middle finger left hand and some other small areas. It was itchy. About 2 hours later my back left shoulder was itchy and I felt another scaly area. 20 minutes later it occurred on my right side in the same general area. I had my partner take a picture because I'm a nurse and I noticed the same thing on my upper back and left lower quadrant of my back and I recognized it as a systemic reaction and went to the ER for treatment. I was given prednisone and BENADRYL and waited an hour and the rash had substantially subsided. I was sent home with a prednisone script for 5 days and triamcinolone cream.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, UNK
Symptoms: Febrile convulsion, Pyelonephritis, Pyrexia, Seizure, Urinary tract infection
Clinical narrative: Febrile convulsion; Pyelonephritis; Information has been received from regulatory authority (agency # AU-TGA-0000719447) on 12-SEP-2022.  This spontaneous report was received from a physician and refers to a 1-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, dose number, lot #, expiry date and route of administration were not provided); meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX), administered for prophylaxis (strength, dose, dose number, formulation, lot #, expiry date and route of administration were not provided); and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) administered for prophylaxis (strength, dose, dose number, formulation, lot #, expiry date and route of administration were not provided).  On 26-APR-2021, the patient experienced two seizure episodes at home and on 27-APR-2022, presented with third episode (duration: 35 minutes) to emergency department (ED) (febrile with seizure) and admitted to the hospital. All seizures were self resolving. There was no past history of seizure, but it was noted that the patient had fevers daily since vaccines was given. At the hospital, the patient received antibiotics administered intravenously fot bilateral pyelonephritis. After discussion with neurologist, clobazam was continued. On 29-APR-2021, the impression was that there was a complex febrile seizure and urinary tract infection/ bilateral pyelonephritis. At the time of reporting, the outcome of the events was unknown.  The reporter considered the events of febrile convulsion and pyelonephritis to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pain
Clinical narrative: Patient said his symptoms were the same as what he had with the COVID vaccine (body aches, soreness, redness at injection)