chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I had sore throat, running nose, and cough. It was cold symptoms. These lasted for about 4 days. On Jan 14th, I tested positive for COVID-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had sore throat, running nose, and cough. It was cold symptoms. These lasted for about 4 days. On Jan 14th, I tested positive for COVID-19.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 73.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Aortic thrombosis, Arthralgia, Chest pain, Chills, Computerised tomogram abnormal
Clinical narrative: pt states he started getting numbness and tremors within his muscles in his hands, arms and face.  He developed shortness of breath and cardiac palpitations.  He had chest pains that would come and go. He would get abnormal headaches sometimes.  He had no fever but had chills and joint pains that would experience everyday.  He also had optical migraine headaches a couple of time per week.  He had shaking of his muscles in his arms and legs that would come and go.  He had intermittent bleeding within the layers of his skin that would appear in one place, disappear and then reappear in different places.  Some of his non varicose veins turned to varicose veins.   He had intermittent neck pain.  He went to the Hospital ER.  they did blood work and scans.  It was  recommended he go to another Hospital to have another scan.  The doctor has ordered him  more testing to be completed that he has not had done at this time.   His symptoms are unresolved and his is still seeking treatment.  He provided this information to his PCP.
Age: 73.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Laboratory test, Neck pain
Clinical narrative: pt states he started getting numbness and tremors within his muscles in his hands, arms and face.  He developed shortness of breath and cardiac palpitations.  He had chest pains that would come and go. He would get abnormal headaches sometimes.  He had no fever but had chills and joint pains that would experience everyday.  He also had optical migraine headaches a couple of time per week.  He had shaking of his muscles in his arms and legs that would come and go.  He had intermittent bleeding within the layers of his skin that would appear in one place, disappear and then reappear in different places.  Some of his non varicose veins turned to varicose veins.   He had intermittent neck pain.  He went to the Hospital ER.  they did blood work and scans.  It was  recommended he go to another Hospital to have another scan.  The doctor has ordered him  more testing to be completed that he has not had done at this time.   His symptoms are unresolved and his is still seeking treatment.  He provided this information to his PCP.
Age: 73.0
Sex: M
Vaccine: COVID19, FLUN4
Symptoms: Ophthalmic migraine, Palpitations, Skin haemorrhage, Tremor, Varicose vein
Clinical narrative: pt states he started getting numbness and tremors within his muscles in his hands, arms and face.  He developed shortness of breath and cardiac palpitations.  He had chest pains that would come and go. He would get abnormal headaches sometimes.  He had no fever but had chills and joint pains that would experience everyday.  He also had optical migraine headaches a couple of time per week.  He had shaking of his muscles in his arms and legs that would come and go.  He had intermittent bleeding within the layers of his skin that would appear in one place, disappear and then reappear in different places.  Some of his non varicose veins turned to varicose veins.   He had intermittent neck pain.  He went to the Hospital ER.  they did blood work and scans.  It was  recommended he go to another Hospital to have another scan.  The doctor has ordered him  more testing to be completed that he has not had done at this time.   His symptoms are unresolved and his is still seeking treatment.  He provided this information to his PCP.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone decreased, Discomfort, Influenza A virus test negative, Influenza B virus test
Clinical narrative: About 10 days after my booster shot, I started experiencing full body urticaria, which caused swelling, itchiness, and general discomfort. I went to a local Clinic to see a FNP on 15-Nov-2021 where she elected to test me for SARS-cov-2, Strep Group A, Influenza A/B, and mono. She additionally prescribed me 20 mg of Prendisone, BID for three days. I took all of the prendisone as prescribed. All of my lab results came back as negative.  Since I have a history of food allergies, I was recommended to go see an allergist. I saw a MD at an allergist office . He looked at my skin and he definitively stated that the reaction was "non-allergic." He then recommended that I take claritin and bendrayl until the histamine response (what he referred to my skin as) reduced.  On 7-Dec-2021, I became so uncomfortable that I went to the acute care clinic locally. My skin was still swollen, red to the touch, and itchy. I saw a PA-C, and he saw the quick histamine response that I was experiencing. Since I have celiac disease, therefore predisposed to autoimmune illnesses, he decided to do laboratory tests for auto-immune antibodies (ANA) as well as CBC testing. It all came back negative.  Since November 2021, I take 180 mg of Fexofenadine HCl QD. If I do not take the allergy medication, I will break out in hives and redness. Physicians assumed that it would not take "too long' for my histamine response to subside, but I am still experiencing this.  It should be noted that I made sure I was exposed to no new allergens, foods, chemicals, etc. The only new change in my life in early November was my SARS-COV-2 booster. I will say that I am very grateful for the science that has enabled us to receive these vaccines, but I also think that it is important that I share my experience.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test negative, Streptococcus test negative, Swelling, Urticaria
Clinical narrative: About 10 days after my booster shot, I started experiencing full body urticaria, which caused swelling, itchiness, and general discomfort. I went to a local Clinic to see a FNP on 15-Nov-2021 where she elected to test me for SARS-cov-2, Strep Group A, Influenza A/B, and mono. She additionally prescribed me 20 mg of Prendisone, BID for three days. I took all of the prendisone as prescribed. All of my lab results came back as negative.  Since I have a history of food allergies, I was recommended to go see an allergist. I saw a MD at an allergist office . He looked at my skin and he definitively stated that the reaction was "non-allergic." He then recommended that I take claritin and bendrayl until the histamine response (what he referred to my skin as) reduced.  On 7-Dec-2021, I became so uncomfortable that I went to the acute care clinic locally. My skin was still swollen, red to the touch, and itchy. I saw a PA-C, and he saw the quick histamine response that I was experiencing. Since I have celiac disease, therefore predisposed to autoimmune illnesses, he decided to do laboratory tests for auto-immune antibodies (ANA) as well as CBC testing. It all came back negative.  Since November 2021, I take 180 mg of Fexofenadine HCl QD. If I do not take the allergy medication, I will break out in hives and redness. Physicians assumed that it would not take "too long' for my histamine response to subside, but I am still experiencing this.  It should be noted that I made sure I was exposed to no new allergens, foods, chemicals, etc. The only new change in my life in early November was my SARS-COV-2 booster. I will say that I am very grateful for the science that has enabled us to receive these vaccines, but I also think that it is important that I share my experience.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: About 10 days after my booster shot, I started experiencing full body urticaria, which caused swelling, itchiness, and general discomfort. I went to a local Clinic to see a FNP on 15-Nov-2021 where she elected to test me for SARS-cov-2, Strep Group A, Influenza A/B, and mono. She additionally prescribed me 20 mg of Prendisone, BID for three days. I took all of the prendisone as prescribed. All of my lab results came back as negative.  Since I have a history of food allergies, I was recommended to go see an allergist. I saw a MD at an allergist office . He looked at my skin and he definitively stated that the reaction was "non-allergic." He then recommended that I take claritin and bendrayl until the histamine response (what he referred to my skin as) reduced.  On 7-Dec-2021, I became so uncomfortable that I went to the acute care clinic locally. My skin was still swollen, red to the touch, and itchy. I saw a PA-C, and he saw the quick histamine response that I was experiencing. Since I have celiac disease, therefore predisposed to autoimmune illnesses, he decided to do laboratory tests for auto-immune antibodies (ANA) as well as CBC testing. It all came back negative.  Since November 2021, I take 180 mg of Fexofenadine HCl QD. If I do not take the allergy medication, I will break out in hives and redness. Physicians assumed that it would not take "too long' for my histamine response to subside, but I am still experiencing this.  It should be noted that I made sure I was exposed to no new allergens, foods, chemicals, etc. The only new change in my life in early November was my SARS-COV-2 booster. I will say that I am very grateful for the science that has enabled us to receive these vaccines, but I also think that it is important that I share my experience.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: As per mother, patient experienced chest and heart pain, shortness of breathe, and heart palpitations 3 hours after vaccination. Symptoms occurred immediately in conjunction to soccer practice.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Palpitations
Clinical narrative: As per mother, patient experienced chest and heart pain, shortness of breathe, and heart palpitations 3 hours after vaccination. Symptoms occurred immediately in conjunction to soccer practice.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Sudden vertigo episode. Long lasting for 1 week. Followed by dizziness still ongoing 8 months later. Symptoms have improved but have not disappeared.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cervical radiculopathy, Pain in extremity
Clinical narrative: Per patient, she has been experiencing pain starting from her shoulder to her pinky and ring finger .  The pain is deep and started around the same time that she got her Pfizer Covid Vaccine.  She doesn't know whether or not the vaccine is causing the pain, but since the pain present around the same time, she is relating it to the vaccine as the possible cause.  The pain initially come and go but in recent weeks has been constant.  Nothing help with the pain, moving her arm around or taking ibuprofen 800mg.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: My fiance, received his Moderna booster during same visit and is experiencing the same reaction (he will fill out a report as well) Booster given 2/5. Itch on hand began 2/14 or 2/15. In the matter of two days, back of neck began to itch-after itching skin would welt and turn bright red. Went to urgent care on 2/27 and was prescribed prednisone I took for three days in addition to daily Allegra. Symptoms are still present.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, General symptom, Laboratory test, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: patient was a resident of Health and Rehabilitation Center. Was symptomatic on 12/15/2021. Death abstracted stated date of death 1/19/2022 at 01:00. client was fully vaccinated. no booster noted.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Insomnia, Migraine
Clinical narrative: I reported this through the system.  A agency representative called me and recommended I report this. For both dose 2 and dose 3 I had a severe migraine headache  (I am an established, stable migraineur, on therapy I get 0-1 headaches per YEAR). that lasted 4 days each time with a 2-week loss of sleep from the additional symptoms I experienced at night after the shots (shaking chills, nausea, dry heaves).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: I reported this through the system.  A agency representative called me and recommended I report this. For both dose 2 and dose 3 I had a severe migraine headache  (I am an established, stable migraineur, on therapy I get 0-1 headaches per YEAR). that lasted 4 days each time with a 2-week loss of sleep from the additional symptoms I experienced at night after the shots (shaking chills, nausea, dry heaves).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal
Clinical narrative: Unstable blood sugar I met with Dr it resolved its self on its own
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: The next of the shot I was having a hard time breathing (Asthma) It lasted 30 days. I went to doctors and they gave me inhalers.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: I developed shingles starting at the injection site and then lower on my arm as well as my wrist and shoulder. I treated it with Advil and calamine lotion. It took 2 weeks for the pain to resolve and the final marks are now fading.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Culture urine negative, Diarrhoea, Differential white blood cell count abnormal, Full blood count abnormal
Clinical narrative: Acute pancreatitis with Vomiting/diarrhea.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Metabolic function test abnormal, Pancreatitis acute, Ultrasound abdomen normal, Urine analysis normal
Clinical narrative: Acute pancreatitis with Vomiting/diarrhea.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Acute pancreatitis with Vomiting/diarrhea.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Patient admitted to hospital for Covid pneumonia.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthma, COVID-19, Dyspnoea, Fatigue
Clinical narrative: 09/04/2021 Booster / Vaccination 01/19/2022 Diagnosed with COVID. I got really sick; 'long-hauler'. I went to Dr. and told it was sinus infection. Test came back originally as negative. Medication was not helping, I couldn't breath. Test then came back positive. I developed asthma. Couldn't get antibody infusions. I am left with a lot of fatigue, RA in my hands, hair loss; inflammatory symptoms.  01/08/2021 1st vaccination Moderna 025L20A 03/27/2021 2nd vaccination Moderna 027A21A I had all 3 vaccinations and had a breath thru case of COVID, resulting in 3 major inflammatory symptoms. Considered a 'long-hauler'.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rheumatoid arthritis, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: 09/04/2021 Booster / Vaccination 01/19/2022 Diagnosed with COVID. I got really sick; 'long-hauler'. I went to Dr. and told it was sinus infection. Test came back originally as negative. Medication was not helping, I couldn't breath. Test then came back positive. I developed asthma. Couldn't get antibody infusions. I am left with a lot of fatigue, RA in my hands, hair loss; inflammatory symptoms.  01/08/2021 1st vaccination Moderna 025L20A 03/27/2021 2nd vaccination Moderna 027A21A I had all 3 vaccinations and had a breath thru case of COVID, resulting in 3 major inflammatory symptoms. Considered a 'long-hauler'.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Burning sensation, Computerised tomogram, Laboratory test
Clinical narrative: Chronic hives and welts -urticaria accompanied with swollen upper lip, abdomen cramps, pain of dull and sharp pain with feeling like intestines are on fire, and vomiting. Symptoms continue to spread and worsen with treatment of Zyrtec and Pepcid. CT scan ordered along with multiple blood tests for possible allergies, urine tests and tests ran for Mast Cell Activation.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pain, Urine analysis, Urticaria, Urticaria chronic
Clinical narrative: Chronic hives and welts -urticaria accompanied with swollen upper lip, abdomen cramps, pain of dull and sharp pain with feeling like intestines are on fire, and vomiting. Symptoms continue to spread and worsen with treatment of Zyrtec and Pepcid. CT scan ordered along with multiple blood tests for possible allergies, urine tests and tests ran for Mast Cell Activation.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Chronic hives and welts -urticaria accompanied with swollen upper lip, abdomen cramps, pain of dull and sharp pain with feeling like intestines are on fire, and vomiting. Symptoms continue to spread and worsen with treatment of Zyrtec and Pepcid. CT scan ordered along with multiple blood tests for possible allergies, urine tests and tests ran for Mast Cell Activation.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Lip swelling, Musculoskeletal discomfort, Swelling face
Clinical narrative: The patient reports the day of the vaccine he had swelling of left side of lips and cheek. Additionally he started having superficial abdominal discomfort on the LUQ that radiated to the back. Abdominal pain is described as a superficial, pinching. Not stabbing or visceral.  The lips and cheek swelling has resolved since day of exam (3 days after the vaccine) - he took cetirizine on Sunday and Monday  The abdominal discomfort is improving- using ice & naproxen as needed to alleviate it.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None at this time
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C).  Vaccine was administered to this patient while not knowing it was stored improperly.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal
Clinical narrative: I went for my annual wellness check on November 23, 2021 and my Doctor said my BP was elevated.  I had not had a BP issue before this. He did a second check and confirmed it.   He asked me to come in the following week, November 29 for another check. It was still elevated.  He asked me to start checking daily and send him the results.  BP remained elevated so we made an appointment for January 28, 2022, 8:00 am.  I continued to document my BP up to that time.  He placed me on Lisinopril 10Mg tablets 1 per day and that has brought my BP under control over the next month and I have been cutting back on the medication.  I seem to be in good health now.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse events. Patient was not in the age group authorized to receive the Moderna booster.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Pruritus, Urticaria
Clinical narrative: Booster received on 2/5 from the pharmacy. 2/19 I started to experiencing itchy skin that would welt and turn red. Itching has not eased at this time. Itching will come and go in waves. However, whenever I do itch skin becomes extremely inflamed, red to the touch and covered in welts.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Chest X-ray, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: COVID vaccination in mid December.  Started developed heart failure symptoms in mid January.  Echo in early Feb 2022 showed a significant drop in ejection fraction to 30% from previous echos showing normal EF.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe urticaria.  Treated with IM epinephrine.  No respiratory compromise.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse events. The patient wasn't in the approved age group for Moderna booster.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Hypoxia, Influenza virus test negative
Clinical narrative: Pt presented to the ED on 1/1/2022 with weakness, hypoxia, afebrile, sats in the mid 80s, productive cough - white sputum. CXR showed L lower lobe pneumonia, pericardial effusion. Tested negative for influenza and positive for Covid. Started on cefepime and dexamethasone, O2 at 2L and was admitted.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pneumonia, Productive cough, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Pt presented to the ED on 1/1/2022 with weakness, hypoxia, afebrile, sats in the mid 80s, productive cough - white sputum. CXR showed L lower lobe pneumonia, pericardial effusion. Tested negative for influenza and positive for Covid. Started on cefepime and dexamethasone, O2 at 2L and was admitted.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured
Clinical narrative: Pt presented to the ED on 1/1/2022 with weakness, hypoxia, afebrile, sats in the mid 80s, productive cough - white sputum. CXR showed L lower lobe pneumonia, pericardial effusion. Tested negative for influenza and positive for Covid. Started on cefepime and dexamethasone, O2 at 2L and was admitted.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Ultrasound scan, X-ray
Clinical narrative: Chest pain for over 1 month post vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Increased appetite, Intermenstrual bleeding, Polymenorrhoea, Weight increased
Clinical narrative: Increased urge to eat.  15 pounds weight gain in a few weeks.  Menstrual period started earlier than usual for two months following and now only spotting. Extreme stomach bloating that hasn't decreased.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: booster dose of moderna covid vaccine was given after it was at room temp for 26 hours
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No known adverse event. Patient received wrong Pfizer based on age group.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac failure congestive, Cardiomyopathy, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: COVID vaccination booster in late December.  Now with cardiomyopathy and worsening of congestive heart failure over the last 2 months since the booster.  EF has dropped to 30% from normal last year.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt reports injection site reaction of pain and bruising that began immediately after injection and within a few days noticed erythema, edema, pruritis, and heat of upper left arm that lasted about 2 weeks. She took benadryl q 8 hours during those 2 weeks until symptoms resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Pt reports injection site reaction of pain and bruising that began immediately after injection and within a few days noticed erythema, edema, pruritis, and heat of upper left arm that lasted about 2 weeks. She took benadryl q 8 hours during those 2 weeks until symptoms resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Blood test normal, Burning sensation, Magnetic resonance imaging, Oedema peripheral
Clinical narrative: I got the first vaccine and I noticed burning under my arm. Then, I noticed the burning sensation with dose 2 and it didn't seem to be going away. Then I noticed a bump was forming under my armpit and it grew as big as the palm of my hand. I went and got medical attention about one month later because it was getting bigger and the burning sensation was not going away. I had a ultrasound first and then a MRI in which the doctor confirmed that I would need to have surgery in order I have the mass tumor removed or it would increase in size. So I had surgery 12/10/2021 where I had the tumor was completely removed but I noticed that the area of my armpit has some sight swelling. I will be seeing my doctor soon to make sure the tumor is not coming back.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: I got the first vaccine and I noticed burning under my arm. Then, I noticed the burning sensation with dose 2 and it didn't seem to be going away. Then I noticed a bump was forming under my armpit and it grew as big as the palm of my hand. I went and got medical attention about one month later because it was getting bigger and the burning sensation was not going away. I had a ultrasound first and then a MRI in which the doctor confirmed that I would need to have surgery in order I have the mass tumor removed or it would increase in size. So I had surgery 12/10/2021 where I had the tumor was completely removed but I noticed that the area of my armpit has some sight swelling. I will be seeing my doctor soon to make sure the tumor is not coming back.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: 12/12/2021 Vaccination / Booster 12/15/2021 I noticed that my skin became hyper itchy over all extremities. I would scratch, within 10 seconds, it was like I was writing on myself. I can write a word and it will be on there 20 minutes later. Every night, its worse at night and stressed, I would break out in hives all over face and neck; itchy. I took pictures and I still have. The hives really started a month after the vaccination. I was perfectly healthy but within a couple days of having the booster, I have been having this issue to presently.  Dr. diagnosed with Hyperdermagraphia  / 'skin writing disease' *doctor gave me referral to allergist
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse event. Patient received wrong Pfizer based on age group.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine dose 3, booster was given 7 days early. At that time it was due to be given 6 months after the 2nd dose, it was given 7 days early.  The patient has been in for regular prescription refills and has noted no concerns.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Multiple patients received Moderna vaccination at a vaccine clinic on 1/11/22. It was later discovered on 1/11/22 that the vials used to draw up doses were assigned a 30-day expiration out of freezer stored in fridge BUD 1/8/22. Remaining un-used doses were discarded. Per CDC/FDA, Moderna vaccine must be stored frozen. Expiration date printed on the vial label applies to frozen vials. Once vaccine is removed from the freezer, unpunctured vials may be stored in the refrigerator for 30 days. This requires manual labelling of a beyond use date (BUD) when vaccine is removed from the freezer. Unpunctured vials may be stored at room temperature for up to 24 hours. Punctured vials should be discarded after 12 hours. Pre-drawn syringes may be stored at room temperature or in the refrigerator for 6 hours from the first time the source vial is punctured. Typically, the commodity manager reaches out to the clinic to obtain volume of vaccine needed for the clinic (which does not have a freezer) and sends over vaccine from the central campus on a courier. The 30-day expiration date is written somewhere on the box by whomever on central campus is sending the vaccine. Per outpatient RPh, sometimes the expiration date is on the box, sometimes it is on plastic wrapping outside of the box and can be consequently lost. Unclear if this occurred during the event. Manufacturer was contacted for further information and direction. Manufacturer completed analysis of vials associated with storage excursion and confirmed no additional action was required and that the lot number given maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test normal, Intervertebral disc degeneration, Spinal X-ray abnormal, Spinal deformity
Clinical narrative: 03/03/2022  I have had back pain starting about a month back . Sought care from  my doctor because it seemed worse after my booster shot. She took my blood work because it was my usual yearly appointment anyway. Also did an x-ray and found a continued degeneration of my disc and curvature.  Nurse called with these results yesterday and suggested to get an MRI.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse event. Patient received wrong Pfizer based on age group.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Pt is a 32 yo female presented to clinic for her Pfizer COVID-19 booster vaccination appointment on 12/27/21. Received dose 1 on 4/16/21 with shortness of breath that resolved with albuterol and received dose 2 on 5/19/21 without difficulty. Several minutes after booster injection, patient experienced sudden onset headache, nausea, vomiting. Epi-pen 0.3 mg IM administered. Vital signs obtained (baseline BP 110s/70s, decreased to 107/63, then 89/43). Patient alert and oriented, denied chest pain, dyspnea, visual disturbances, or further acute distress during 1 hour observation period. Patient returned to baseline and instructed to request Epi-pen prescription from PCP. Allergy updated in patient profile.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt due for Meningococcal B Cat B vaccination and Meningococcal Conjugate administered instead.  Error was not discovered until after pt left facility.  Attempted to contact pt's mother without success.  Left message to call back to our facility.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No known adverse event. Patient received wrong Pfizer based on age group.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Illness, Loss of personal independence in daily activities
Clinical narrative: On 1/24/2022, I began having a fever. The fever ended up lasting for 4 days. At its highest point, it was 102 degrees, though it progressively declined over the following 3 days. I first took a PCR test on 1/24/2022, and the result was negative. I took another PCR test on 1/27/2022, and the result was positive. I got another positive result when I took a PCR test on 1/31/2022 and finally got a negative result when I took a PCR test on 2/3/2022. By 1/28/2022, the fever was gone, but I still had a cough. On 1/28/2022, my husband and I had a virtual conference with his doctor, who works in the same practice as my doctor, and we were just told to tell him if the cough worsened. It didn't worsen, but it did linger until March 2022. Until 2/23/2022, I was also very fatigued. I also experienced slowed mental function from the outset of the illness until 2/11/2022. Altogether, I wasn't able to do much for about a month. I was fully vaccinated (but without the booster), so this was a breakthrough case.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: On 1/24/2022, I began having a fever. The fever ended up lasting for 4 days. At its highest point, it was 102 degrees, though it progressively declined over the following 3 days. I first took a PCR test on 1/24/2022, and the result was negative. I took another PCR test on 1/27/2022, and the result was positive. I got another positive result when I took a PCR test on 1/31/2022 and finally got a negative result when I took a PCR test on 2/3/2022. By 1/28/2022, the fever was gone, but I still had a cough. On 1/28/2022, my husband and I had a virtual conference with his doctor, who works in the same practice as my doctor, and we were just told to tell him if the cough worsened. It didn't worsen, but it did linger until March 2022. Until 2/23/2022, I was also very fatigued. I also experienced slowed mental function from the outset of the illness until 2/11/2022. Altogether, I wasn't able to do much for about a month. I was fully vaccinated (but without the booster), so this was a breakthrough case.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood test, Diabetes mellitus, Dyspnoea, Dysstasia
Clinical narrative: After receiving the vaccine I had issues breathing immediately and it last 30 to 62 minutes. It continued on for two weeks and and I wasn't feeling well and I was having a hard time getting up. The doctor checked my liver function and my blood sugars and diagnosed I have diabetes.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Liver function test, Malaise
Clinical narrative: After receiving the vaccine I had issues breathing immediately and it last 30 to 62 minutes. It continued on for two weeks and and I wasn't feeling well and I was having a hard time getting up. The doctor checked my liver function and my blood sugars and diagnosed I have diabetes.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The adverse event was that the patient was given a Covid 30 mcg dose for 12+ yrs but was only 10 yrs of age at time of administration. Patient should have received the recommended  the recommended Covid 10 mcg dose for 5-11 yr olds.  Follow up with the family was done on 1/3/2022 by speaking to mom on phone. No adverse events regarding symptoms were noted.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Lipids, Metabolic function test, Rash pruritic, Urine analysis
Clinical narrative: Itchy hives/rash with whelps break out in all areas (hands, feet, legs, arms, torso, back, neck).  Treated with antihistamine, 5 days of prednisone, pepcid (and other blockers), anti itch creams/gel.  Outcome- no flares if medication stays in system.   Tried to discontinue the meds for approx 48 hours and itchy hives/rash will return
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy hives/rash with whelps break out in all areas (hands, feet, legs, arms, torso, back, neck).  Treated with antihistamine, 5 days of prednisone, pepcid (and other blockers), anti itch creams/gel.  Outcome- no flares if medication stays in system.   Tried to discontinue the meds for approx 48 hours and itchy hives/rash will return
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Skin disorder
Clinical narrative: I have continuing scalp issues. In the beginning, I was just using a shampoo. After I got the shots it did not work. I tried shampoos with zinc in them. I was told it was making it worse. My doctor said it could be an autoimmune disease.  Never had any COVID symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. I also uncovered a likely vaccine administration error while looking into this adverse event.   The individual was vaccinated with the Pfizer product on 09/13/2021, 10/22/2021, and 11/05/2021. The first 2 doses were administered at the facility indicated in Item 17 of this form, but the third dose seems to be a deviation from protocol and was administered at a Pharmacy in a city that the individual does not live in.   The individual presented to Emergency Dept for cough and shortness of breath on 01/03/2022 and was discharged 01/04/2022. The individual tested positive for COVID-19 on 01/03/2022. The individual reported a symptom onset of approx 12/29/2021. They were transported to Emergency Dept again on 01/08/2022; it appears they were dead on arrival. Death date was 01/08/2022.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. I also uncovered a likely vaccine administration error while looking into this adverse event.   The individual was vaccinated with the Pfizer product on 09/13/2021, 10/22/2021, and 11/05/2021. The first 2 doses were administered at the facility indicated in Item 17 of this form, but the third dose seems to be a deviation from protocol and was administered at a Pharmacy in a city that the individual does not live in.   The individual presented to Emergency Dept for cough and shortness of breath on 01/03/2022 and was discharged 01/04/2022. The individual tested positive for COVID-19 on 01/03/2022. The individual reported a symptom onset of approx 12/29/2021. They were transported to Emergency Dept again on 01/08/2022; it appears they were dead on arrival. Death date was 01/08/2022.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: We came to complete vaccines at the nursing home and was told Patient needed a 2nd dose. We did not have a pt's vaccine card available.  No immediate access to Database was available.  Shortly after giving vaccine, I came back with information that the pt was previously given Pfizer.  Pt was monitored and did not have any adverse effects at the time of this report.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Blood urea increased, Dyspnoea, Eosinophil count, Heart rate increased
Clinical narrative: I gradually felt shortness of breath about a week after 1st Pfizer shot. I went to the hospital three weeks after the shot because it became worse and worse. Clinic exam shows blood oxygen level dropped to 80s percent. Blood oxygen level takes 5 months to become nearly normal.  My doctor said we cannot prove the 1st shot caused that issue, even if it does, my low blood oxygen level will make me vulnerable if I don?t take the 2nd shot and get infected. So I took the 2nd shot. Then my heartbeat rate doubled within 24 hours. I am not recovered yet after 5 months. A doctor called an ambulance to send me to ER during a clinic visit in early Feb 2022 (about 5 months after 2nd shot), because my heartbeat was too fast. Then I was held in hospital overnight. I could not do any exercise or intensive work after the 2nd shot for months.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, PO2 decreased
Clinical narrative: I gradually felt shortness of breath about a week after 1st Pfizer shot. I went to the hospital three weeks after the shot because it became worse and worse. Clinic exam shows blood oxygen level dropped to 80s percent. Blood oxygen level takes 5 months to become nearly normal.  My doctor said we cannot prove the 1st shot caused that issue, even if it does, my low blood oxygen level will make me vulnerable if I don?t take the 2nd shot and get infected. So I took the 2nd shot. Then my heartbeat rate doubled within 24 hours. I am not recovered yet after 5 months. A doctor called an ambulance to send me to ER during a clinic visit in early Feb 2022 (about 5 months after 2nd shot), because my heartbeat was too fast. Then I was held in hospital overnight. I could not do any exercise or intensive work after the 2nd shot for months.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lipoma, Lymphadenopathy, Ultrasound scan
Clinical narrative: Lipoma on left shoulder with generalized enlarges lymph nodes on left side.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Injection site reaction, Neck pain, Paraesthesia
Clinical narrative: Skin pealing at injection site Tingling felling in fingers and lip/chin area Sporadic pain in right knee Pain in neck and back area  All symptoms appeared in both original shot j+j (9/20/2021) and j+j Booster shot 3/1/2022
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccine positive rechallenge
Clinical narrative: Skin pealing at injection site Tingling felling in fingers and lip/chin area Sporadic pain in right knee Pain in neck and back area  All symptoms appeared in both original shot j+j (9/20/2021) and j+j Booster shot 3/1/2022
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Cardiac ablation, Cardioversion, Condition aggravated
Clinical narrative: Nine weeks after I got my third dose of the vaccine, I had an Atrial Fibrillation attack that lasted for 5 days. It happened on 01/22/2022 and lasted for 5 days. My Oncologist noticed that my Rhythm was not right and I was short of breath. I was having shortness of breath and it took me a while to recover. I saw my Cardiologist and my Heart Rhythm had returned to normal. I had a history of Atrial Fibrillation, and I had an Ablation in July of 2019. About 18 months later I had a Cardioversion to stabilize my heart rate in January of 2021. I am scheduled for another Ablation on 05/11/2022.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Nine weeks after I got my third dose of the vaccine, I had an Atrial Fibrillation attack that lasted for 5 days. It happened on 01/22/2022 and lasted for 5 days. My Oncologist noticed that my Rhythm was not right and I was short of breath. I was having shortness of breath and it took me a while to recover. I saw my Cardiologist and my Heart Rhythm had returned to normal. I had a history of Atrial Fibrillation, and I had an Ablation in July of 2019. About 18 months later I had a Cardioversion to stabilize my heart rate in January of 2021. I am scheduled for another Ablation on 05/11/2022.
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reactions at the time.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric 5-11 dose instead of 12+ dose. NO symptoms or adverse event during course of vaccine administration or observation period.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Blood test, Chest discomfort, Chest pain, Electrocardiogram
Clinical narrative: Chest pain/pressure beginning evening of 11/3/2021. Called PCP to be seen and they recommended I go to the ER because of chest discomfort. Went to the ER morning of 11/4/2021. Abnormal D Dimer, normal CTA. Discharged with a diagnosis of adverse vaccine reaction.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Immunisation reaction
Clinical narrative: Chest pain/pressure beginning evening of 11/3/2021. Called PCP to be seen and they recommended I go to the ER because of chest discomfort. Went to the ER morning of 11/4/2021. Abnormal D Dimer, normal CTA. Discharged with a diagnosis of adverse vaccine reaction.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Blood test, Gait disturbance, Inflammation
Clinical narrative: 12 days following my second Covid19 vaccine I developed severe pain in both of my wrists and shoulders.  Soon after, pain manifested  in both hips.  So I had pain in six joints in my body that I'd never before experienced.  The pain grew more severe over the next two weeks, to the point I felt like I wanted to naw the hands off my wrists.  I had trouble walking and getting in and out of bed and chairs.  Only with some creative help (using a back scratcher to pull my clothes on) did I manage to get myself dressed each day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Loss of personal independence in daily activities, Mobility decreased, Polymyalgia rheumatica
Clinical narrative: 12 days following my second Covid19 vaccine I developed severe pain in both of my wrists and shoulders.  Soon after, pain manifested  in both hips.  So I had pain in six joints in my body that I'd never before experienced.  The pain grew more severe over the next two weeks, to the point I felt like I wanted to naw the hands off my wrists.  I had trouble walking and getting in and out of bed and chairs.  Only with some creative help (using a back scratcher to pull my clothes on) did I manage to get myself dressed each day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Inflammatory marker increased, Laboratory test, Limb injury, Petechiae
Clinical narrative: A rash broke out on my stomach, legs, feet.  It mostly was not topical - it was from under the skin - red petechia.  I also then got three large perpura that appeared on my left foot.  Additionally I had bruising that appeared on both 2nd toes of each foot and the bruising turned into bad wounds that took about six weeks to close back up.  the odd thing about both of those is that nothing happened to cause the bruising or the wounds - it appeared and the wounds seemed to pop up from the inside of the skin.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Rash, Rash erythematous
Clinical narrative: A rash broke out on my stomach, legs, feet.  It mostly was not topical - it was from under the skin - red petechia.  I also then got three large perpura that appeared on my left foot.  Additionally I had bruising that appeared on both 2nd toes of each foot and the bruising turned into bad wounds that took about six weeks to close back up.  the odd thing about both of those is that nothing happened to cause the bruising or the wounds - it appeared and the wounds seemed to pop up from the inside of the skin.