chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: Technician gave the Flucelvax Vaccine to a patient who requested, and was supposed to get Fluad HD 65+. After giving the shot, the technician gave the VAR to the Pharmacis. to sign off on and she noticed that the lot number sticker was for Flucelvax. She asked the technician if she had given the patient Flucelvax and she said yes. She said that the patient was supposed to get Fluad HD. The technician paged the patient to return to the pharmacy, and informed her that she had given her the regular flu shot instead of HD.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: resident expired, resident was on Hospice at the time
Age: 12.0
Sex: F
Vaccine: COVID19, FLU4, HPV9
Symptoms: Incorrect product formulation administered
Clinical narrative: At the end of day when my nurse was documenting our wasted doses of COVID vaccine she noticed the lot numbers were different and we both quickly realized I must have grabbed a monovalent vial by mistake. I drew up all 6 doses from that multi-dose vial. The patient was given a monovalent 12+ COVID vaccine in error whereas should have been given a Bivalent 12+ COVID vaccine booster.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Memory impairment, SARS-CoV-2 test positive
Clinical narrative: I got COVID in July, 2022. I now feel very foggy and out of it, am having memory problems.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: patient called saying after getting vaccine she developed a hardened, itchy, ball at the site of injection. no fever and the area was not hot to the touch.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: At the end of day when my nurse was documenting our wasted doses of COVID vaccine she noticed the lot numbers were different and we both quickly realized I must have grabbed a monovalent vial by mistake. I drew up all 6 doses from that multi-dose vial. The patient was given a monovalent 12+ COVID vaccine in error whereas should have been given a Bivalent 12+ COVID vaccine booster.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong patient received product
Clinical narrative: nurse brought to room and we were instrcuted to administer a bivalent moderna booster.  call the pts name and patient responded.  he rolled up sleeve and took the shot.  after it was given, he asked if his roommate was going to get one. Roommate was the pt who signed up for the vaccine and 1st patient did not.  he didnt have an AEs and his wife and the facility was notified of the error.  Both pt and wife were fine with it.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: I have developed debilitating, persistent pain in my left upper arm at the injection site. The pain interrupts my sleep and limits my ability to perform ADLs, such as getting dressed or lifting objects >5 lbs independently. It is provoked by direct pressure and particular motions, such as shoulder flexion and abduction. It has been nearly 3 weeks and the pain has not yet improved with time or conservative measures
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Right arm pain that radiates down to her Right wrist continuously since injection
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: THE PATIENT WAS TO RECIEVE THE SECOND DOSE OF THE MONOVALENT COVID 19 TO COMPLETE THE INITIAL SERIES.  THE BIVALENT WAS ADMINISTERED INSTEAD.  THE PATIENT DID WAIT IN THE OFFICE FOR THE RECOMMENDED TIME OF 15 MINUTES AFTER ADMINISTRATION WITH NO PHYSICAL ADVERSE REACTION NOTED.
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: At the end of day when my nurse was documenting our wasted doses of COVID vaccine she noticed the lot numbers were different and we both quickly realized I must have grabbed a monovalent vial by mistake. I drew up all 6 doses from that multi-dose vial. The patient was given a monovalent 12+ COVID vaccine in error whereas should have been given a Bivalent 12+ COVID vaccine booster.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Angiogram pulmonary normal, Cardiac failure congestive, Catheterisation cardiac normal, Chest X-ray abnormal, Chest pain
Clinical narrative: admitted to local hospital on 10/21/22  until 11/10/2022 for chest pain, which was non-radiating, dyspnea, and dry cough. EKG showed diffuse ST elevations. TTE showed EF of 30-35% and evidence of myocarditis. Left heart cath showed normal coronary arteries. CTA ruled out a PE. Chest X ray showed pulmonary edema. infectious work-up negative including Influenza, COVID-19.  discharge diagnosis was Pericarditis, Myocarditis, and acute congestive heart failure.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Cough, Dyspnoea, Echocardiogram, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: admitted to local hospital on 10/21/22  until 11/10/2022 for chest pain, which was non-radiating, dyspnea, and dry cough. EKG showed diffuse ST elevations. TTE showed EF of 30-35% and evidence of myocarditis. Left heart cath showed normal coronary arteries. CTA ruled out a PE. Chest X ray showed pulmonary edema. infectious work-up negative including Influenza, COVID-19.  discharge diagnosis was Pericarditis, Myocarditis, and acute congestive heart failure.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Influenza virus test negative, Myocarditis, Pericarditis, Pulmonary oedema, SARS-CoV-2 test negative
Clinical narrative: admitted to local hospital on 10/21/22  until 11/10/2022 for chest pain, which was non-radiating, dyspnea, and dry cough. EKG showed diffuse ST elevations. TTE showed EF of 30-35% and evidence of myocarditis. Left heart cath showed normal coronary arteries. CTA ruled out a PE. Chest X ray showed pulmonary edema. infectious work-up negative including Influenza, COVID-19.  discharge diagnosis was Pericarditis, Myocarditis, and acute congestive heart failure.
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Biopsy breast abnormal, Breast cyst, Invasive lobular breast carcinoma, Mammogram abnormal, Mastectomy
Clinical narrative: Starting in June, I noticed a swath of density on my right breast from the 11 o'clock area to the 1 o'clock area, upper right breast area. I went to see my PCP who stated that it was most likely a cyst. She ordered an ultrasound and when I went to get that done, they also did a mammogram for screening. Between the two tests, it was noted that I had an abnormality and had a needle core biopsy done which showed cancer. The type of cancer was lobular and invasive. After the pathology came back on the needle core biopsy, I had surgery scheduled for a double mastectomy and had that done. I have to start chemo next week. Unsure if this is even in relation to the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pathology test, Ultrasound breast abnormal
Clinical narrative: Starting in June, I noticed a swath of density on my right breast from the 11 o'clock area to the 1 o'clock area, upper right breast area. I went to see my PCP who stated that it was most likely a cyst. She ordered an ultrasound and when I went to get that done, they also did a mammogram for screening. Between the two tests, it was noted that I had an abnormality and had a needle core biopsy done which showed cancer. The type of cancer was lobular and invasive. After the pathology came back on the needle core biopsy, I had surgery scheduled for a double mastectomy and had that done. I have to start chemo next week. Unsure if this is even in relation to the vaccine.
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: full body urticaria
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Oedema peripheral, Ultrasound Doppler abnormal
Clinical narrative: DVT presenting with acute onset worsening severe lower extremity edema.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Headache, Pyrexia
Clinical narrative: Tested positive for COVID on 11/7/22 - felt tired and took several naps on 11/6/22, husband was positive on the evening of 11/6/22.  More naps on 11/7/22.  Mild cough throughout, mild headache about day 4 + 5, low grade (never higher than 100.4) day 2-5
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Somnolence
Clinical narrative: Tested positive for COVID on 11/7/22 - felt tired and took several naps on 11/6/22, husband was positive on the evening of 11/6/22.  More naps on 11/7/22.  Mild cough throughout, mild headache about day 4 + 5, low grade (never higher than 100.4) day 2-5
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy
Clinical narrative: lethargy, headaches, chills
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: Patient developed left shoulder pain immediately post vaccine administration in the left deltoid (intramuscular). Patient is currently being evaluated by orthopedic physicians.
Age: 97.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received Moderna Bivalent Vaccine on 9/15/22 and 11/11/22.   No adverse effects noted from incorrect administration.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Pfizer Bivalent vaccine on 9/14/22 and 11/11/22.  No symptoms noted at this time.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain, Swelling, Tenderness
Clinical narrative: SORENESS, TENDERNESS LASTING SINCE ADMINISTRATION OF SECOND DOSE. SIDE EFFECT WAS REPORTED A FEW DAYS AGO, ALTHOUGH PATIENT STATES THE SYMPTOM HAS BEEN PRESENT AND GETTING WORSE SINCE ABOUT 30 DAYS AFTER THE SECOND DOSE, WHICH WAS OVER 1 YEAR AGO. SIDE EFFECT DESCRIBED AS PAIN AND TENDERNESS AT TOUCH AND APPEARS TO BE A VISUAL BUMP. PAIN INCREASES WITH EXERCISE AND TOUCHING OR MASSAGING OF THE AREA. PATIENT DESCRIBED THAT THE BUMP HAS NOT GONE AWAY AFTER OVER A YEAR AS IS BOTHERSOME. THIS SIDE EFFECT WAS REPORTED TO MODERNA ON 11/16/2022 AND PATIENT WAS ADVISED TO SEE MD AS SOON AS POSSIBLE.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Inflammation, Rash, Rash erythematous, Rash macular
Clinical narrative: Red, inflamed spots and blotches on arms.  Worsening inflammation of spider bites on neck/ upper chest area. Sensation of being in a "fog" mentally.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sore, red, itchy rash on skin around injection side. Large circle around injection site.  On day after vaccination (11/15/22) experienced chills, muscle pan, extreme fatigue.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Myalgia
Clinical narrative: Sore, red, itchy rash on skin around injection side. Large circle around injection site.  On day after vaccination (11/15/22) experienced chills, muscle pan, extreme fatigue.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received COVID Pfizer Bivalent booster instead of scheduled Pfizer Monovalent dose #2 at 11/15/22 visit.  No harm to patient/adverse reaction.  In process of notifying family as to plan for series/booster once finalized by Dept of Health.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3rd Shingrix shot on 11-16-2022, had first two shots on 4/25/2022 then 7/2/2022, when asked what shot in the series she was here for, she stated second dose. It was later discovered already received two doses .
Age: 98.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness
Clinical narrative: PT PASSED OUT AND FELL ROUGHLY 10 MINUTES AFTER ADMINISTRATION
Age: 2.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix and proquad outside recommended age schedule of four years of age. Currently patient is two years of age.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: On 11/03/2022  I had a mild cough. On 11/04/2022 I had the same symptoms along with  mild fever but I was feeling  extremely tired. I tested negative. On 11/05/2022 I tested positive for COVID-19.  I went to the urgent care the doctor said if the symptoms gets worse to call him so he can prescribe  Paxlovid. I didn't need medication. My symptoms were mild  so I got better in few days.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 11/03/2022  I had a mild cough. On 11/04/2022 I had the same symptoms along with  mild fever but I was feeling  extremely tired. I tested negative. On 11/05/2022 I tested positive for COVID-19.  I went to the urgent care the doctor said if the symptoms gets worse to call him so he can prescribe  Paxlovid. I didn't need medication. My symptoms were mild  so I got better in few days.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysphonia, Fatigue, Oropharyngeal pain
Clinical narrative: I was coughing a lot, fever 101, sore throat, tired, congestion, mucus, and drainage. I took Tylenol to get rid of fever. I tested positive for COVID-19 at home. I called my doctor and she prescribed me Paxlovid and I got better. I still have  a cough and my voice isn't how it used to be. My voice is a little horse and I can't scream.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: I was coughing a lot, fever 101, sore throat, tired, congestion, mucus, and drainage. I took Tylenol to get rid of fever. I tested positive for COVID-19 at home. I called my doctor and she prescribed me Paxlovid and I got better. I still have  a cough and my voice isn't how it used to be. My voice is a little horse and I can't scream.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: This patient was given Tdap, but patient needed Hep-B.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Computerised tomogram, Electrocardiogram, Hypertension, Laboratory test
Clinical narrative: High fever, 103 degrees from 6-18 hours after the vaccine.  Left axillary swelling starting 6 hours and lasting  x5-6 days (require massage therapy which was effective) New- onset Chest pressure event 4 days after vaccine.  New-onset hypertension 4 days after vaccine (requiring clinic visit, ER visit, PCP visit and medication treatment that is not yet effective). EKG in the clinic (physician was concerned about pericarditis, sent me to the ER) New onset tachycardia with minimal exertion starting 4 days after vaccine (previously an avid hiker and 2-3/week cardio classes with no issues)
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral, Pyrexia, Tachycardia
Clinical narrative: High fever, 103 degrees from 6-18 hours after the vaccine.  Left axillary swelling starting 6 hours and lasting  x5-6 days (require massage therapy which was effective) New- onset Chest pressure event 4 days after vaccine.  New-onset hypertension 4 days after vaccine (requiring clinic visit, ER visit, PCP visit and medication treatment that is not yet effective). EKG in the clinic (physician was concerned about pericarditis, sent me to the ER) New onset tachycardia with minimal exertion starting 4 days after vaccine (previously an avid hiker and 2-3/week cardio classes with no issues)
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent covid vaccine, not the bivalent that is documented. Chart should be updated accordingly.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, FLUA4
Symptoms: COVID-19, Condition aggravated, Death, Dehydration, Dementia
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021, 02/26/2021, and 10/18/2021. The lot numbers and injection sites were not reported to the state immunization system for the first 2 doses. The individual also received a FLUAD Quad dose on 10/18/2021. The lot number was not reported for this dose.   The individual tested positive for COVID-19 on 08/08/2022, when they presented to emergency department via EMS for evaluation regarding shortness of breath, hypoxia, and frequent falls.  They were found to be dehydrated and have a urinary tract infection. However, the individual had an advanced directive in place that refused IV fluids or nutrition, so they were given antibiotics and discharged back to the assisted living facility at which they were a resident. They were re-admitted to hospital on 08/23/2022 after they stopped eating and drinking. They were admitted to hospital at request of wife and primary care provider, in order to obtain comfort/hospice/end of life care. They were diagnosed with respiratory failure and remained hospitalized until their death on 08/25/2022.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, FLUA4
Symptoms: Dyspnoea, Fall, Head injury, Hypophagia, Hypoxia
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021, 02/26/2021, and 10/18/2021. The lot numbers and injection sites were not reported to the state immunization system for the first 2 doses. The individual also received a FLUAD Quad dose on 10/18/2021. The lot number was not reported for this dose.   The individual tested positive for COVID-19 on 08/08/2022, when they presented to emergency department via EMS for evaluation regarding shortness of breath, hypoxia, and frequent falls.  They were found to be dehydrated and have a urinary tract infection. However, the individual had an advanced directive in place that refused IV fluids or nutrition, so they were given antibiotics and discharged back to the assisted living facility at which they were a resident. They were re-admitted to hospital on 08/23/2022 after they stopped eating and drinking. They were admitted to hospital at request of wife and primary care provider, in order to obtain comfort/hospice/end of life care. They were diagnosed with respiratory failure and remained hospitalized until their death on 08/25/2022.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, FLUA4
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Urinary tract infection, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021, 02/26/2021, and 10/18/2021. The lot numbers and injection sites were not reported to the state immunization system for the first 2 doses. The individual also received a FLUAD Quad dose on 10/18/2021. The lot number was not reported for this dose.   The individual tested positive for COVID-19 on 08/08/2022, when they presented to emergency department via EMS for evaluation regarding shortness of breath, hypoxia, and frequent falls.  They were found to be dehydrated and have a urinary tract infection. However, the individual had an advanced directive in place that refused IV fluids or nutrition, so they were given antibiotics and discharged back to the assisted living facility at which they were a resident. They were re-admitted to hospital on 08/23/2022 after they stopped eating and drinking. They were admitted to hospital at request of wife and primary care provider, in order to obtain comfort/hospice/end of life care. They were diagnosed with respiratory failure and remained hospitalized until their death on 08/25/2022.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Bedridden, Chills, Decreased appetite, Delirium
Clinical narrative: From 1am to 5:30am - High fever 102+ degrees, delirium, fast breathing, chills, shortness of breath, weakness, slight nausea Since then weakness, fatigue, loss of appetite, fog brain.   It felt as if I had an adrenal crisis as opposed to a fluish feeling.  There were no activities or events that day that would cause an adrenal crisis like this, especially in the middle of the night. .   Due to the delirium, I didn?t realize I was sick.  At 5:30, was conscious and chills had stopped.  I took 500mg of  Tylenol and fever broke.  Today I am weak and mostly bedridden.    fatigue, loss of appetite
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Influenza like illness, Nausea
Clinical narrative: From 1am to 5:30am - High fever 102+ degrees, delirium, fast breathing, chills, shortness of breath, weakness, slight nausea Since then weakness, fatigue, loss of appetite, fog brain.   It felt as if I had an adrenal crisis as opposed to a fluish feeling.  There were no activities or events that day that would cause an adrenal crisis like this, especially in the middle of the night. .   Due to the delirium, I didn?t realize I was sick.  At 5:30, was conscious and chills had stopped.  I took 500mg of  Tylenol and fever broke.  Today I am weak and mostly bedridden.    fatigue, loss of appetite
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: From 1am to 5:30am - High fever 102+ degrees, delirium, fast breathing, chills, shortness of breath, weakness, slight nausea Since then weakness, fatigue, loss of appetite, fog brain.   It felt as if I had an adrenal crisis as opposed to a fluish feeling.  There were no activities or events that day that would cause an adrenal crisis like this, especially in the middle of the night. .   Due to the delirium, I didn?t realize I was sick.  At 5:30, was conscious and chills had stopped.  I took 500mg of  Tylenol and fever broke.  Today I am weak and mostly bedridden.    fatigue, loss of appetite
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: subjective fever, chills, and unilateral left axillary lymphadenopathy with measured fever 100.3F
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Needle issue, No adverse event
Clinical narrative: No adverse event.  a 5/8 needle was used instead of 1-11/2' needle based on gender, age and weight.
Age: 82.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Cough, Death, Dyspnoea, Wheezing
Clinical narrative: cough, wheezing, worsening SOB, hospitalized next day at a local HCF/ passed away
Age: 16.0
Sex: M
Vaccine: COVID19, FLU4, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient already had 2 Primary series of Pfizer vaccine  (11/23/21 & 2/25/22), and was given a primary dose of Moderna.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine Expired
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Needle issue, No adverse event
Clinical narrative: No adverse outcome.  5/8 needle used instead of 1-11/2' needle based on gender, age and weight.
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLU4, HPV9
Symptoms: Underdose
Clinical narrative: Patient received 5-11 year old Pfizer bivalent booster immunization instead of age appropriate Pfizer booster (12+)
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bone marrow disorder, Full blood count, Immunoglobulin therapy, Inflammation, Laboratory test
Clinical narrative: I noticed I was starting to feel achey and my left armpit was a bit swollen. After a few days, the right armpit began to swell as well.  Swelling kept going up, but 8/21 my left armpit was swollen to the size of a grapefruit and I couldnt sleep on my left side, couldn't put my arm all the way down, felt very sick.  Right armpit was tangerine sized.   I went to urgent care on 8/22, they ran a CBC. They thought the glands being swollen could be from the virus or IVIG. THey also noted i had glands swollen on my scalp that i hadnt noticed before.  After that I called my PCP who suggested i follow up with breast care. I had to get a mammogram and 2 ultrasounds to monitor the swelling. I also had a hospitalization from 9/7-9/13, but it was due to an inflammatory reaction to a virus that shutdown my marrow blood production and injured my liver.  It was determined not to be caused by the vaccine or my IVIG, but rather since my body was still recovering from the inflammation due to the vaccine that it exacerbated the virus so much that I was in the hospital. If more information on that is required, please contact me, as the labwork was a huge amount.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Liver injury, Lymphadenopathy, Malaise, Mammogram, Mobility decreased
Clinical narrative: I noticed I was starting to feel achey and my left armpit was a bit swollen. After a few days, the right armpit began to swell as well.  Swelling kept going up, but 8/21 my left armpit was swollen to the size of a grapefruit and I couldnt sleep on my left side, couldn't put my arm all the way down, felt very sick.  Right armpit was tangerine sized.   I went to urgent care on 8/22, they ran a CBC. They thought the glands being swollen could be from the virus or IVIG. THey also noted i had glands swollen on my scalp that i hadnt noticed before.  After that I called my PCP who suggested i follow up with breast care. I had to get a mammogram and 2 ultrasounds to monitor the swelling. I also had a hospitalization from 9/7-9/13, but it was due to an inflammatory reaction to a virus that shutdown my marrow blood production and injured my liver.  It was determined not to be caused by the vaccine or my IVIG, but rather since my body was still recovering from the inflammation due to the vaccine that it exacerbated the virus so much that I was in the hospital. If more information on that is required, please contact me, as the labwork was a huge amount.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oedema peripheral, Pain, Sleep disorder, Ultrasound scan
Clinical narrative: I noticed I was starting to feel achey and my left armpit was a bit swollen. After a few days, the right armpit began to swell as well.  Swelling kept going up, but 8/21 my left armpit was swollen to the size of a grapefruit and I couldnt sleep on my left side, couldn't put my arm all the way down, felt very sick.  Right armpit was tangerine sized.   I went to urgent care on 8/22, they ran a CBC. They thought the glands being swollen could be from the virus or IVIG. THey also noted i had glands swollen on my scalp that i hadnt noticed before.  After that I called my PCP who suggested i follow up with breast care. I had to get a mammogram and 2 ultrasounds to monitor the swelling. I also had a hospitalization from 9/7-9/13, but it was due to an inflammatory reaction to a virus that shutdown my marrow blood production and injured my liver.  It was determined not to be caused by the vaccine or my IVIG, but rather since my body was still recovering from the inflammation due to the vaccine that it exacerbated the virus so much that I was in the hospital. If more information on that is required, please contact me, as the labwork was a huge amount.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Conjunctival haemorrhage, Fatigue, Gingival bleeding
Clinical narrative: At some period after dose 3 I became ill and appeared to recover but had subconjunctival hemorrhage, bleeding gums, arthrology, (shoulders, elbows, and hips). I also experienced forgetfulness and extreme fatigue. I believe there are more symptoms, but these are most memorable. Most have resolved over time, but I remain easily tired and with extreme shoulder, elbow, and hip pain. I am an employee at a diagnostic center and have access inflammatory marker testing which revealed sCD40L levels more than 35000. Whole body diffusion MRI did not indicate lymphadenopathy but showed shotty lymph nodes. There was no evidence of pancreatic or diffusion, abnormalities in other organs or osseous structures. My ability to engage in physical activity is limited. However, I completed 2 5K runs and each took triple the time it would normally have taken me. I was advised to adopt an anti-inflammatory diet eliminating red meat, processed sugars, alcohol, and high sodium foods. I still experience pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test, Loss of personal independence in daily activities, Lymphadenopathy, Magnetic resonance imaging abnormal, Malaise
Clinical narrative: At some period after dose 3 I became ill and appeared to recover but had subconjunctival hemorrhage, bleeding gums, arthrology, (shoulders, elbows, and hips). I also experienced forgetfulness and extreme fatigue. I believe there are more symptoms, but these are most memorable. Most have resolved over time, but I remain easily tired and with extreme shoulder, elbow, and hip pain. I am an employee at a diagnostic center and have access inflammatory marker testing which revealed sCD40L levels more than 35000. Whole body diffusion MRI did not indicate lymphadenopathy but showed shotty lymph nodes. There was no evidence of pancreatic or diffusion, abnormalities in other organs or osseous structures. My ability to engage in physical activity is limited. However, I completed 2 5K runs and each took triple the time it would normally have taken me. I was advised to adopt an anti-inflammatory diet eliminating red meat, processed sugars, alcohol, and high sodium foods. I still experience pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: At some period after dose 3 I became ill and appeared to recover but had subconjunctival hemorrhage, bleeding gums, arthrology, (shoulders, elbows, and hips). I also experienced forgetfulness and extreme fatigue. I believe there are more symptoms, but these are most memorable. Most have resolved over time, but I remain easily tired and with extreme shoulder, elbow, and hip pain. I am an employee at a diagnostic center and have access inflammatory marker testing which revealed sCD40L levels more than 35000. Whole body diffusion MRI did not indicate lymphadenopathy but showed shotty lymph nodes. There was no evidence of pancreatic or diffusion, abnormalities in other organs or osseous structures. My ability to engage in physical activity is limited. However, I completed 2 5K runs and each took triple the time it would normally have taken me. I was advised to adopt an anti-inflammatory diet eliminating red meat, processed sugars, alcohol, and high sodium foods. I still experience pain.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Muscle swelling, Myosclerosis, Pruritus
Clinical narrative: Right deltoid became red, swollen, hardened, and itchy.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vial punctured at 1:35PM with vial expiring at 1:35AM.  Dose given after vial BUD of 0135AM.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED PFIZER BI-VALENT ADULT DOSE. PATIENT IS 9 YEARS OLD
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 0.2ml undiluted pediatric bivalent pfizer booster given.  No immediate symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was punctured at 1:35PM, and vial expired at 1:35AM.  Dose was given after that time but within 24 hours of puncture date.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 0.2ml undiluted pediatric bivalent pfizer given
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Cyanosis, Hypopnoea, Pallor, Unresponsive to stimuli
Clinical narrative: Approximately 4 hours after receiving the vaccines pt. projectile vomited. Then she started to look really pale and started breathing really shallowly. Her lips turned blue so mother gave her a couple of rescue breaths. She would cry for a little bit then go unresponsive. Mother would then give her a few more rescue breaths and this happened a few times. Mother then called our office and since we couldn't get her in right away instructed her to go to the emergency room. Mother opted to take her to urgent care. Urgent care monitored her for a little while but couldn't tell family if this was a reaction to the vaccine or may just to vomiting. They sent her home to be observed carefully. Since then she has not had any further problems/adverse effects.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Vomiting projectile
Clinical narrative: Approximately 4 hours after receiving the vaccines pt. projectile vomited. Then she started to look really pale and started breathing really shallowly. Her lips turned blue so mother gave her a couple of rescue breaths. She would cry for a little bit then go unresponsive. Mother would then give her a few more rescue breaths and this happened a few times. Mother then called our office and since we couldn't get her in right away instructed her to go to the emergency room. Mother opted to take her to urgent care. Urgent care monitored her for a little while but couldn't tell family if this was a reaction to the vaccine or may just to vomiting. They sent her home to be observed carefully. Since then she has not had any further problems/adverse effects.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: 0.2ml undiluted pediatric bivalent pfizer
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Brachial plexopathy, Electromyogram abnormal, Hypoaesthesia, Magnetic resonance imaging, Nerve injury
Clinical narrative: I received my Moderna for COVID-19 on 02/02/2021. On 02/06/2021, in the morning I had numbness and tingling on my left hand and palm. My arm was very sore and  it was extremely painful. I also had fever of 99.2. My arm numbness and tingling is still going on that hasn't resolved and I've been seeing a doctor for it. I had an MRI on 03/10/2021 and I had an EMG on 03/22/2021, It confirmed that I had a nerve damage. On 06/08/2021 I went to a Neurologist who told me I had Brachial Plexopathy which was caused by the vaccine. My doctor followed up for few months. On 11/11/2021 she did another EMG it showed her the same nerve damage that was there. I am still dealing with it now and it hasn't resolved yet.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: I received my Moderna for COVID-19 on 02/02/2021. On 02/06/2021, in the morning I had numbness and tingling on my left hand and palm. My arm was very sore and  it was extremely painful. I also had fever of 99.2. My arm numbness and tingling is still going on that hasn't resolved and I've been seeing a doctor for it. I had an MRI on 03/10/2021 and I had an EMG on 03/22/2021, It confirmed that I had a nerve damage. On 06/08/2021 I went to a Neurologist who told me I had Brachial Plexopathy which was caused by the vaccine. My doctor followed up for few months. On 11/11/2021 she did another EMG it showed her the same nerve damage that was there. I am still dealing with it now and it hasn't resolved yet.
Age: 3.0
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU4, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given too high of a dose of covid vaccine.  He received 0.2mL of the 30 microgram dose (intended for ages 5-12) rather than the expected 0.2mL of the 3 microgram dose (for his age range).  Report was filed immediately after the event, so unknown if any adverse events happened.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Tremor, Vision blurred
Clinical narrative: Shakiness, pressure in chest, unfocused vision about 10 minutes after receiving vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy skin abnormal, Dehydration, Dermatitis, Dermatomyositis
Clinical narrative: Soreness, fatigue. rash, hospitalization for 5 weeks, Rare Auto Immune Disease - Dermatomyositis created from vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Hypervolaemia, Hypokalaemia, Immunisation reaction
Clinical narrative: Soreness, fatigue. rash, hospitalization for 5 weeks, Rare Auto Immune Disease - Dermatomyositis created from vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test abnormal, Pain, Rash, Rhabdomyolysis, Swallow study abnormal
Clinical narrative: Soreness, fatigue. rash, hospitalization for 5 weeks, Rare Auto Immune Disease - Dermatomyositis created from vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Soreness, fatigue. rash, hospitalization for 5 weeks, Rare Auto Immune Disease - Dermatomyositis created from vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Contusion, Peripheral swelling
Clinical narrative: possible cellulitis... bruising and swelling extended down the arm
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient came by today stating that she had a localized rash to the Shingles shot the next day after  her shot.  She said she it was a little itchy and felt like a stink at the area near the opposite side of her left elbow.  She said a few weeks later it appeared to migrate down to her wrist and that is when she decided to make an appointment to go see her dermatologist on 12/16/2022.  Patient will keep us posted after her appointment.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient name and DOB identified and verified what we were doing today (Flu vaccine and Shingles vaccine). Patient agreed with plan. Here with family if needed help understanding my questions. Flu shot administered and then family said he only needed the Shingles vaccine and that he had already had the flu vaccine. Patient told family it was in September but it was given in October 2022. Had patient wait in clinic for 20 minutes. No adverse effects noted. Patient advised to go to ER if he experiences anything overnight. Patient in agreement with plan.
Age: 66.0
Sex: M
Vaccine: FLUA4, PNC20
Symptoms: Lip swelling
Clinical narrative: Patient called on 11/16/2022 around 12:15 pm saying that he has swollen lower lip which he noticed 11/16/2022 morning and he thinks it is due to getting the pneumonia vaccine (Prevnar 20) on 11/11/2022. Recommended the patient to see the doctor.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: gave bivalent booster instead of dose 1 primary series
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site mass, Pigmentation disorder
Clinical narrative: Patient presented to the pharmacy concerned... had decent erythema and demarcations  all along his deltoid and lower arm. Also had a lump from injection site still present one 1 week later. Explained to let us know if does not improve.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cold sweat, Heart rate irregular, Pallor, Unresponsive to stimuli
Clinical narrative: After patient received vaccine dose, they sat in a chair in the 15 minute observation area.  Patients spouse reported that they were not responding to verbal responses. Patient did not offer any verbal complaints.  Skin was cool and clammy/pale.  Pulse was irregular, pulse ox 95%.    Called 9-1-1.  Paramedics arrived and transported patient to local hospital. Patient was conscious and aware.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient did not have adverse reaction.  Patient received Pfizer Monovalent vaccine as 4th dose and not Pfizer Bivalent.  At this time have not been able to reach patient to notify her.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Hyperhidrosis, Salivary hypersecretion, Swollen tongue
Clinical narrative: Patient said one week after vaccination he started to experience weakness, sweating, tongue swollen, increased saliva.
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Cough, Headache, Influenza like illness, Influenza virus test negative, Pyrexia
Clinical narrative: Flu-like symptoms, including mild fever, congestion, headache, sneezing, and cough began a few days after son  tested positive for flu and strep throat.
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Respiratory tract congestion, Sneezing, Streptococcus test negative
Clinical narrative: Flu-like symptoms, including mild fever, congestion, headache, sneezing, and cough began a few days after son  tested positive for flu and strep throat.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Diarrhoea, Electric shock sensation, Fatigue
Clinical narrative: vision disturbances/vision problems; couldn't focus; feeling flu-ish under the weather; not feeling well; headaches; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b84h) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Thyroid disorder (was irradiated when he was in his 20s) and Type 2 diabetes mellitus (border line type 2 diabetic). Concomitant products included GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches). At the time of the report, VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was stated that with the first two vaccines, patient had some vision problems, vision disturbances, could not focus, not feeling well, feeling flu-ish under the weather and headaches for a few days, but they went away. No treatment information was reported.   This case was linked to MOD-2022-672439, MOD-2021-161677 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gastrooesophageal reflux disease, Head discomfort, Hypophagia, Immunisation reaction
Clinical narrative: vision disturbances/vision problems; couldn't focus; feeling flu-ish under the weather; not feeling well; headaches; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b84h) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Thyroid disorder (was irradiated when he was in his 20s) and Type 2 diabetes mellitus (border line type 2 diabetic). Concomitant products included GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches). At the time of the report, VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was stated that with the first two vaccines, patient had some vision problems, vision disturbances, could not focus, not feeling well, feeling flu-ish under the weather and headaches for a few days, but they went away. No treatment information was reported.   This case was linked to MOD-2022-672439, MOD-2021-161677 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lactose intolerance, Migraine, Muscle twitching, Muscular weakness, Myalgia
Clinical narrative: vision disturbances/vision problems; couldn't focus; feeling flu-ish under the weather; not feeling well; headaches; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b84h) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Thyroid disorder (was irradiated when he was in his 20s) and Type 2 diabetes mellitus (border line type 2 diabetic). Concomitant products included GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches). At the time of the report, VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was stated that with the first two vaccines, patient had some vision problems, vision disturbances, could not focus, not feeling well, feeling flu-ish under the weather and headaches for a few days, but they went away. No treatment information was reported.   This case was linked to MOD-2022-672439, MOD-2021-161677 (Patient Link).