chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Nervousness, Night sweats, Pyrexia, Renal function test normal
Clinical narrative: I had a headache, fever, elevated pulse, chills, slight nausea, and diarrhea on 3/6/2023. On 3/7/2023, I also had nasal congestion and night sweats. I continued to have intense night sweats for about a week. I was treated with PAXLOVID, and I took TYLENOL for my headache. On 3/7/2023, I tested positive on a PCR test. I was on a cruise at the time, and the ship's doctor prescribed me the PAXLOVID, which I began taking on 3/9/2023. I was advised to stop taking atorvastatin while I took PAXLOVID. The doctor did a blood test to check my kidney function before prescribing the PAXLOVID, and the results were normal. The headache subsided after maybe four or five days. The nausea was very mild, but it continued for three or four days. The diarrhea changed to frequent, solid, soft bowel movements; this lasted for about a week. The nasal congestion probably lasted for five days. Slowly, things subsided, and I was isolated at home for ten days. From day three to day seven, I was irritable and had difficulty concentrating and remembering. For example, I would get irritated whenever more than one person was talking at the same time. I raised five children, so I'm used to noise and confusion, but I was definitely more irritable than usual when I was sick, and my nerves were on edge. I couldn't stand myself! Thankfully, though, the symptoms subsided, and everything returned to normal.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a headache, fever, elevated pulse, chills, slight nausea, and diarrhea on 3/6/2023. On 3/7/2023, I also had nasal congestion and night sweats. I continued to have intense night sweats for about a week. I was treated with PAXLOVID, and I took TYLENOL for my headache. On 3/7/2023, I tested positive on a PCR test. I was on a cruise at the time, and the ship's doctor prescribed me the PAXLOVID, which I began taking on 3/9/2023. I was advised to stop taking atorvastatin while I took PAXLOVID. The doctor did a blood test to check my kidney function before prescribing the PAXLOVID, and the results were normal. The headache subsided after maybe four or five days. The nausea was very mild, but it continued for three or four days. The diarrhea changed to frequent, solid, soft bowel movements; this lasted for about a week. The nasal congestion probably lasted for five days. Slowly, things subsided, and I was isolated at home for ten days. From day three to day seven, I was irritable and had difficulty concentrating and remembering. For example, I would get irritated whenever more than one person was talking at the same time. I raised five children, so I'm used to noise and confusion, but I was definitely more irritable than usual when I was sick, and my nerves were on edge. I couldn't stand myself! Thankfully, though, the symptoms subsided, and everything returned to normal.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood creatine phosphokinase increased, Blood lactic acid increased, COVID-19, Chest X-ray
Clinical narrative: Patient is a 74 y.o. female patient of local MD with history of DM2, GERD, gout, HLD, HTN, kidney stones. Presented with fevers, body aches and was found to be positive for COVID-19. Initially required 2L O2 via NC, weaned to RA on discharge. PT/OT evaluated Patient and noted that she is appropriate for HH PT. Medically stable for DC.   COVID-19 Acute hypoxic respiratory failure, resolved  COVID positive, Flu negative, Strep negative CXR non-acute S/p dexamethasone, remdesevir Weaned to RA prior to discharge PT and CM following, discharged with home health care Reviewed masking recommendations around family until 3/17 Recommend Covid-19 vaccination 3 months after recovery   Elevated CK and lactate on presentation Likely secondary to COVID-19   Elevated troponin 46>42 EKG non-ischemic Likely demand ischemia secondary to COVID-19   HTN Hypertensive on admission, now improved following medication adherence  Continue home coreg, losartan, amlodpine, ASA on discharge   DM2 1/2023 A1c 7.2 Discontinued home glipizide 2/2 good control Continue Metformin on discharge   Gout Not in acute flare Continue allopurinol   HLD 11/2022 total cholesterol 179, LDL 93 Continue statin
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram abnormal, Hypertension, Influenza virus test negative, Myocardial ischaemia
Clinical narrative: Patient is a 74 y.o. female patient of local MD with history of DM2, GERD, gout, HLD, HTN, kidney stones. Presented with fevers, body aches and was found to be positive for COVID-19. Initially required 2L O2 via NC, weaned to RA on discharge. PT/OT evaluated Patient and noted that she is appropriate for HH PT. Medically stable for DC.   COVID-19 Acute hypoxic respiratory failure, resolved  COVID positive, Flu negative, Strep negative CXR non-acute S/p dexamethasone, remdesevir Weaned to RA prior to discharge PT and CM following, discharged with home health care Reviewed masking recommendations around family until 3/17 Recommend Covid-19 vaccination 3 months after recovery   Elevated CK and lactate on presentation Likely secondary to COVID-19   Elevated troponin 46>42 EKG non-ischemic Likely demand ischemia secondary to COVID-19   HTN Hypertensive on admission, now improved following medication adherence  Continue home coreg, losartan, amlodpine, ASA on discharge   DM2 1/2023 A1c 7.2 Discontinued home glipizide 2/2 good control Continue Metformin on discharge   Gout Not in acute flare Continue allopurinol   HLD 11/2022 total cholesterol 179, LDL 93 Continue statin
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive, Streptococcus test negative, Troponin increased
Clinical narrative: Patient is a 74 y.o. female patient of local MD with history of DM2, GERD, gout, HLD, HTN, kidney stones. Presented with fevers, body aches and was found to be positive for COVID-19. Initially required 2L O2 via NC, weaned to RA on discharge. PT/OT evaluated Patient and noted that she is appropriate for HH PT. Medically stable for DC.   COVID-19 Acute hypoxic respiratory failure, resolved  COVID positive, Flu negative, Strep negative CXR non-acute S/p dexamethasone, remdesevir Weaned to RA prior to discharge PT and CM following, discharged with home health care Reviewed masking recommendations around family until 3/17 Recommend Covid-19 vaccination 3 months after recovery   Elevated CK and lactate on presentation Likely secondary to COVID-19   Elevated troponin 46>42 EKG non-ischemic Likely demand ischemia secondary to COVID-19   HTN Hypertensive on admission, now improved following medication adherence  Continue home coreg, losartan, amlodpine, ASA on discharge   DM2 1/2023 A1c 7.2 Discontinued home glipizide 2/2 good control Continue Metformin on discharge   Gout Not in acute flare Continue allopurinol   HLD 11/2022 total cholesterol 179, LDL 93 Continue statin
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling from injection site all the way down the arm past the elbow.   This started the day of the injection.  Her condition improved when I viewed her arm on 4/10.  The site involved was about 4 inches in diameter around the injection site.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Ear discomfort, Erythema, Fatigue
Clinical narrative: I had an extreme headache, fatigue, slight cough, sneezing, felt feverish. I tested positive for COVID-19 and was prescribed Paxlovid. When I was taking Paxlovid my face was very flush and my ears were red, they also burned a little.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Flushing, Headache, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had an extreme headache, fatigue, slight cough, sneezing, felt feverish. I tested positive for COVID-19 and was prescribed Paxlovid. When I was taking Paxlovid my face was very flush and my ears were red, they also burned a little.
Age: 43.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Diverticulitis, Gastrointestinal pain
Clinical narrative: I had my vaccination on 01/05/2023. In 03/2023 I started to experience symptoms of diverticulitis. I am in pain in my gut area and being treated as if I do have diverticulitis. If the symptoms persist their going to a CAT Scan to determine if it is something else in 04/2023 or 05/2023.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Catheterisation cardiac abnormal, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Chest pain with shortness of breath, headache, nausea, high blood pressure. Called 911; did EKG and ambulance showed was having heart attack. Had cardiac catheterization at hospital, showing heart attack in small vessel, likely caused by clot.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram abnormal, Headache, Hypertension, Laboratory test, Myocardial infarction
Clinical narrative: Chest pain with shortness of breath, headache, nausea, high blood pressure. Called 911; did EKG and ambulance showed was having heart attack. Had cardiac catheterization at hospital, showing heart attack in small vessel, likely caused by clot.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Thrombosis, X-ray
Clinical narrative: Chest pain with shortness of breath, headache, nausea, high blood pressure. Called 911; did EKG and ambulance showed was having heart attack. Had cardiac catheterization at hospital, showing heart attack in small vessel, likely caused by clot.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dry throat, Dysphagia, Headache
Clinical narrative: I came down with COVID, 5 MONTHS AFTER receiving the vaccine!!!
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngitis streptococcal, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I came down with COVID, 5 MONTHS AFTER receiving the vaccine!!!
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: WE GAVE PATIENT WHAT THE PHARMACY HAD IN STOCK. THE PATIENT RECEIVED ONLY 1 DOSE OF PFIZER BIVALENT FOR THE PRIMARY SERIES.
Age: 17.0
Sex: M
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider advised me he had seen a patient for Well Child Check, and saw the patient was behind on immunizations. Provider ordered PCV13, but was not aware of the vaccines catch up scheduled according to CDC guidelines. Per CDC guidelines, PCV 13 catch up schedule is for ages of 4 months through 4 years old. Patient was 17 years old when the vaccine was administered.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: The classic symptoms of shingles, with 4-5 blisters. Still painful after almost 3 weeks.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Exposure to communicable disease
Clinical narrative: Bronchitus.  I don?t think this is related to Covid shot.  I was exposed to someone with bronchitis.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Pain
Clinical narrative: I had a cough, fatigue, headache, body aches, and runny nose. I tested positive for COVID-19. I talked to a doctor, and I was prescribed Paxlovid. I was coughing for a couple of weeks.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a cough, fatigue, headache, body aches, and runny nose. I tested positive for COVID-19. I talked to a doctor, and I was prescribed Paxlovid. I was coughing for a couple of weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pt received third dose of shingrix vaccine (series is two). Pt completed series on 05/27/2019 and 08/15/2019 at same facility. Rph did not see record of administration prior to providing immunization. Discovered when patient presented today 4/11/23 for "second dose" and different RPh realized series had been completed in 2019. Pt reported marked nausea after 1/31/2019 dose for 1-2 days but reported no other adverse effects.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: I started having a tickle in my throat on Saturday April 1, 2023. Then it became a cough. On Sunday I had a cough and fever. Monday I a cough fever, sore throat, headache, and body ache. I sought on Tuesday and that's when I tested positive for COVID-19. All of my symptoms continued through Thursday April 6, 2023. On Friday the sore throat and fever was gone, but cough, congested head, and runny nose was still present. I'm still coughing, and the headache comes and goes. I frequently blow my nose.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: I started having a tickle in my throat on Saturday April 1, 2023. Then it became a cough. On Sunday I had a cough and fever. Monday I a cough fever, sore throat, headache, and body ache. I sought on Tuesday and that's when I tested positive for COVID-19. All of my symptoms continued through Thursday April 6, 2023. On Friday the sore throat and fever was gone, but cough, congested head, and runny nose was still present. I'm still coughing, and the headache comes and goes. I frequently blow my nose.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Throat irritation
Clinical narrative: I started having a tickle in my throat on Saturday April 1, 2023. Then it became a cough. On Sunday I had a cough and fever. Monday I a cough fever, sore throat, headache, and body ache. I sought on Tuesday and that's when I tested positive for COVID-19. All of my symptoms continued through Thursday April 6, 2023. On Friday the sore throat and fever was gone, but cough, congested head, and runny nose was still present. I'm still coughing, and the headache comes and goes. I frequently blow my nose.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Respiratory symptom, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: I tested positive for Covid-19 on March 07, 2023 with home test provided by govt. I had a Telemedicine Appointment with staff at the Family Medicatl Center while in city and took Paxlovid.. Symptoms were primarily upper respiratory and I was treated for a sinus infection by Staff  with Prednisone on April 04, 2023.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: PAIN, ITCHING,  REDNESS, AND WARMTH AT THE SITE OF ADMINISTRATION THAT SPREAD ALL OVER HER LEFT ARM.  ITCHING WAS SEVERE PER THE PATIENT THAT WAS RELIEVED BY OTC BENADRYL.
Age: 10.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HPV9
Symptoms: Product administration error, Wrong product administered
Clinical narrative: After I gave her vaccines, I realized that I had given her a Pentacel instead of an Adacel. This was my error as I am the one who drew up the vaccines. I have apologized to the mother. Because the DTap contains a higher diphtheria dosage, then the Tdap this will count for her 11-year-old Adacel and will not need to be repeated.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PT DID NOT REPORT ANY ADVERSE EVENTS
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: Patient has started developing swollen lymph nodes an hour after administering the vaccine. Patient had to seek health care assistance from an urgent care on the next day and discharged with instructions for observation and to take otc tylenol.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram thorax, Cough, Dyspnoea
Clinical narrative: Ongoing investigations for initial flu like symptoms leading to 3 months of shortness of breath, cough, haemoptysis, fluid retention, general malaise, fatigue etc
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Fatigue, Fluid retention, Haemoptysis, Influenza like illness
Clinical narrative: Ongoing investigations for initial flu like symptoms leading to 3 months of shortness of breath, cough, haemoptysis, fluid retention, general malaise, fatigue etc
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Investigation, Malaise
Clinical narrative: Ongoing investigations for initial flu like symptoms leading to 3 months of shortness of breath, cough, haemoptysis, fluid retention, general malaise, fatigue etc
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt came in for third dose of Toddler series. Updated guidelines states that pt should have received Bivalent dose. Mom states no adverse reaction from vaccine. Notified parents to return in >8 weeks for bivalent vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dental restoration failure, Immediate post-injection reaction, Nausea, Neck pain
Clinical narrative: After vaccine given pt. immediately c/o severe neck pain and nausea. The physician's assistant examined her & felt she was stable. Pt was asked to rest in exam room for 45 mins. Then felt better. Left in good condition. Later had OV 3/29/23 & c/o fillings fell out of bottom teeth.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Pain, Platelet count decreased, Pruritus, Thrombocytopenia
Clinical narrative: On 4/3 consult noted Achy sore 2 days with some itching severe thrombocytopenia - plt coungt 175k on 4/3 18k 4/3 4pm  24k 4/4  4/7 41k  4/10 50k  Bone marrow transplant 10-29-22
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Occupational exposure to SARS-CoV-2, Pruritus, Pyrexia, Rash
Clinical narrative: Exposed to Covid by co-worker wk of 5/17/21. On 5/23/2021 I woke up broken out from head to toe in a rash/hives/itching. Went to clinic for Covid test. Negative, they prescribed Prednisone. By 5/25/2021 it was worse. I went to my family physician. He immediately sent me for an antibody test. I am one out of 20 that the vaccine did not work. No antibodies. Detergent, medicine was ruled out. On 6/10/11 I was sent to hospital by my dcotor for fever, shortness of breath an rash/hives. They prescribed Dexamethasone 6MG, 2X a day. Referred me to an allergist. Allergist took me off cholesterol med an prescribed a non-steroid for itch.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Exposed to Covid by co-worker wk of 5/17/21. On 5/23/2021 I woke up broken out from head to toe in a rash/hives/itching. Went to clinic for Covid test. Negative, they prescribed Prednisone. By 5/25/2021 it was worse. I went to my family physician. He immediately sent me for an antibody test. I am one out of 20 that the vaccine did not work. No antibodies. Detergent, medicine was ruled out. On 6/10/11 I was sent to hospital by my dcotor for fever, shortness of breath an rash/hives. They prescribed Dexamethasone 6MG, 2X a day. Referred me to an allergist. Allergist took me off cholesterol med an prescribed a non-steroid for itch.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood glucose increased, Dizziness, Hypotension, Laboratory test normal, Loss of consciousness
Clinical narrative: Patient received moderna bivalent booster around 02:30 PM on 02-01-23. Patient felt fine and had no signs of allergic reaction while in 10-15 minute observation period at the pharmacy. Patient then left and went over to the next shopping center to have lunch. While in the restaurant Just before receiving meal (around 03:15 PM), patient felt dizzy and lightheaded. He then proceeded to pass out. An ambulance was called and the patient was taken away to a hospital. He stayed at the hospital for a day and a half. All kinds of tests and scans were performed (according to wife), and everything came back negative. The only abnormalities noted were high blood sugar and low blood pressure.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Scan normal
Clinical narrative: Patient received moderna bivalent booster around 02:30 PM on 02-01-23. Patient felt fine and had no signs of allergic reaction while in 10-15 minute observation period at the pharmacy. Patient then left and went over to the next shopping center to have lunch. While in the restaurant Just before receiving meal (around 03:15 PM), patient felt dizzy and lightheaded. He then proceeded to pass out. An ambulance was called and the patient was taken away to a hospital. He stayed at the hospital for a day and a half. All kinds of tests and scans were performed (according to wife), and everything came back negative. The only abnormalities noted were high blood sugar and low blood pressure.
Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cardiac function test, Loss of consciousness
Clinical narrative: Patient received moderna bivalent booster around 02:30 PM on 02-01-23. Patient felt fine and had no signs of allergic reaction while in 10-15 minute observation period at the pharmacy. Patient then left and went over to the next shopping center to have lunch. While in the restaurant Just before receiving meal (around 03:15 PM), patient felt dizzy and lightheaded. He then proceeded to pass out. An ambulance was called and the patient was taken away to a hospital. He stayed at the hospital for a day and a half. All kinds of tests and scans were performed (according to wife), and everything came back negative. The only abnormalities noted were high blood sugar and low blood pressure.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Injection site pruritus, Invasive ductal breast carcinoma, Mammogram abnormal
Clinical narrative: No symptoms at time of vaccine other than an itchy arm at the site of injection. Then no symptoms until my annual mammogram on June 10, 2021 of hospital with a call back and biopsy finding Invasive Ductal Carcinoma on the left breast. The vaccine was given in my left arm.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: pt got pfizer vaccine around at 7pm. Then fell down from chair less than 5 min. Pt drank a cup of water then fell down again. An eyewitness said his head was not hit on the floor. EMS came and check BP, O2. Ask questions and wait 30-40 minutes EMS left w/o pt. Pt. left w/ security gurad
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Covid tested positive. Mild cough, runny nose. Received Paxlovid.. Negative within 5 days and continue to feel well with negative tests
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypoventilation, Mental status changes, SARS-CoV-2 test positive, Total lung capacity decreased
Clinical narrative: pt tested positive for COVID 19 on 06/20/2021 when reporting to the ED for altered mental status. No oxygen or further treatment required. No follow up needed on COVID related event
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dyspnoea, Erythema, Hypoaesthesia oral
Clinical narrative: Itching, skin rashes, red and black balls, numb tongue, fever, sore throat, stomach pain, swelling in the body,no energy and difficulty breathing
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Rash, Skin discolouration
Clinical narrative: Itching, skin rashes, red and black balls, numb tongue, fever, sore throat, stomach pain, swelling in the body,no energy and difficulty breathing
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Itching, skin rashes, red and black balls, numb tongue, fever, sore throat, stomach pain, swelling in the body,no energy and difficulty breathing
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Joint pain in hands, wrist, shoulders and hips. Along with swelling of the joints.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chest pain, Injection site nodule, Injection site warmth, Musculoskeletal pain, Painful respiration
Clinical narrative: Left upper arm feels a knot and warmth to touch. Pain is on back shoulder blade and left upper chest. Hurts to breath.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer vaccine for individuals 12+ years old given to child under this age. No side effects noted.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Patient was given too low a dose of the Covid vaccine
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Haemoglobin decreased, SARS-CoV-2 test negative, Vaccine breakthrough infection
Clinical narrative: Pt was admitted to COVID unit at Hospital on 4/16/21 and given bamlanivimab tx. Pt was in hospital for 4 days. Pt also had a COVID negative PCR test 8 days later at pharmacy. Did not have another test 24 hours later to prove or disprove if they were a false positive. Case will be reported to VAERS due to breakthrough with hospitalization. Pt medical history of: rheumatoid arthritis, heart disease, Pulmonary atrial HTN, a-fib, sleep apnea, and presented with low hemoglobin at time of infection 6.9 and was on iron (45mg) BID
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Arthralgia, Deep vein thrombosis, Magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Bilateral shoulder pain 10-14-22 R > L (R) hand pain and swelling - 12-30-22 HH/Physical Therapy Neck shoulder & hand xrays - 12-30-22 given prednisone & cyclobenzaprine. 1-6-23 MRI C-spine, prednisone, cyclobenzaprine 1-26-23 Ortho consult 1-26-23 DVT proximal to distal brachial vein - Eliquis
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Peripheral swelling, Ultrasound Doppler abnormal, X-ray abnormal, X-ray limb abnormal, X-ray limb normal
Clinical narrative: Bilateral shoulder pain 10-14-22 R > L (R) hand pain and swelling - 12-30-22 HH/Physical Therapy Neck shoulder & hand xrays - 12-30-22 given prednisone & cyclobenzaprine. 1-6-23 MRI C-spine, prednisone, cyclobenzaprine 1-26-23 Ortho consult 1-26-23 DVT proximal to distal brachial vein - Eliquis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Antibody test, Blood thyroid stimulating hormone, C-reactive protein, Catecholamines urine
Clinical narrative: The first reaction was the same day on the second dose given on January 22, 2021 (Manufacturer: Moderna). Reactions were heart palpitations, high blood pressure, Shortness of breath, and tagitue.  The next day left neck nodule swelled and developed photophobia.  The consequence of the reaction was with medical provider with follow-up.   The second reaction event was the covid booster Administered on July 7, 2022 (Manufacturer: Pfizer,  Inc). On August 3, 2022. I had symptoms of Covid and experienced increased photophobia and fatigue.  September 2022-present and continue with follow-up with specialists ophthalmologist for Strabismus.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Full blood count, Haemoglobin, Hypertension
Clinical narrative: The first reaction was the same day on the second dose given on January 22, 2021 (Manufacturer: Moderna). Reactions were heart palpitations, high blood pressure, Shortness of breath, and tagitue.  The next day left neck nodule swelled and developed photophobia.  The consequence of the reaction was with medical provider with follow-up.   The second reaction event was the covid booster Administered on July 7, 2022 (Manufacturer: Pfizer,  Inc). On August 3, 2022. I had symptoms of Covid and experienced increased photophobia and fatigue.  September 2022-present and continue with follow-up with specialists ophthalmologist for Strabismus.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging head, Malaise, Palpitations, Photophobia
Clinical narrative: The first reaction was the same day on the second dose given on January 22, 2021 (Manufacturer: Moderna). Reactions were heart palpitations, high blood pressure, Shortness of breath, and tagitue.  The next day left neck nodule swelled and developed photophobia.  The consequence of the reaction was with medical provider with follow-up.   The second reaction event was the covid booster Administered on July 7, 2022 (Manufacturer: Pfizer,  Inc). On August 3, 2022. I had symptoms of Covid and experienced increased photophobia and fatigue.  September 2022-present and continue with follow-up with specialists ophthalmologist for Strabismus.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, Strabismus
Clinical narrative: The first reaction was the same day on the second dose given on January 22, 2021 (Manufacturer: Moderna). Reactions were heart palpitations, high blood pressure, Shortness of breath, and tagitue.  The next day left neck nodule swelled and developed photophobia.  The consequence of the reaction was with medical provider with follow-up.   The second reaction event was the covid booster Administered on July 7, 2022 (Manufacturer: Pfizer,  Inc). On August 3, 2022. I had symptoms of Covid and experienced increased photophobia and fatigue.  September 2022-present and continue with follow-up with specialists ophthalmologist for Strabismus.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vial was punctured/opened on 2/23/23 and not discarded after 12 hours. Patient was given vaccine on 2/28/23 several days after vial was to be discarded\. Pfizer safety team deemed vaccine no longer good. CDC stated patient may be revaccinated with repeated dose with no minimum interval.
Age: 1.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP, FLU4, HIBV, MMR, PNC, VARCEL
Symptoms: Fatigue
Clinical narrative: Fatigue the day of vaccination. Resolved the following day
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Laboratory test normal, Neck pain, Pain
Clinical narrative: Sudden onset of multiple painful joints without swelling or redness. Pain level 7-8 out of 10. Joints included bilateral mid foot and ankles, base of both thumbs and R shoulder and neck. I have had pain with osteoarthritis with a rheumatoid factor for many years but this pain was very intense and occurred in multiple joints.   Saw my functional medicine Nurse Practitioner after 2 months of putting up with pain and not getting any relief - she treated me with low dose Naltroxone and Boswellia and symptoms started to resolve after 1 week and then resolved back to usual aches and pains after 3 weeks of treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sudden onset of multiple painful joints without swelling or redness. Pain level 7-8 out of 10. Joints included bilateral mid foot and ankles, base of both thumbs and R shoulder and neck. I have had pain with osteoarthritis with a rheumatoid factor for many years but this pain was very intense and occurred in multiple joints.   Saw my functional medicine Nurse Practitioner after 2 months of putting up with pain and not getting any relief - she treated me with low dose Naltroxone and Boswellia and symptoms started to resolve after 1 week and then resolved back to usual aches and pains after 3 weeks of treatment.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was vaccinated with pediatric Pfizer vaccine. The patient was 4 years 7 months at the time of vaccination. Per manufacture guidelines pediatric Pfizer vaccine indicated for ages 5-11 years of age.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/11/21 Lot# 002B21A;  Moderna 4/8/21 Lot# 017B21A
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was vaccinated with pediatric Pfizer vaccine. The patient was 4 years 8 months at the time of vaccination. Per manufacture guidelines pediatric Pfizer vaccine indicated for ages 5-11 years of age.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023; No adverse event; Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023).    No concomitant medications was reported.  The dose of suspect Spikevax Bivalent was reported as additional booster. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 26-FEB-2023. The vial did not undergone any temperature excursions.    No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719026 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719026:Patient 1
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; This spontaneous report has been received from a healthcare professional, via medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2207USA007680), concerning 14-day-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.      On 29-JAN-2007, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).         On 12-FEB-2007, she received the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration) and on 17-JUL-2007, the third dose of inappropriate schedule of product administration was administered (inappropriate schedule of product administration).  On 26-OCT-2007, the patient received a 4th dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (extra dose administered).; Sender's Comments:  US-009507513-2207USA007680:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; GARDASIL 9 was stored out of range and administered.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.  On 24-MAR-2023, the patient was vaccinated with an improperly store dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # W009829, expiration date 19-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route were not reported) (product storage error). Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored out of range (specific information not reported). No adverse effects and nor product quality complaint were reported.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer and refers to a 69-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No additional adverse event was reported.  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002667: US-009507513-2304USA002675: US-009507513-2304USA002694: US-009507513-2304USA002759:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Mar2023 to 03Apr2023 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148547 same reporter/patient, different drug/event;
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (08Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient had no known allergies. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient took Paxlovid starting on day 1 of COVID-19 from treatment from 31Mar2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Vaccine brand=Pfizer/BioNTech/had 2 additional booster shots of Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Mar2021 at 12:00 as dose 2, single (Lot number: EN6299), in left arm and on 30Sep2021 at 12:30 as dose 3 (booster), single (Lot number: FD0809) at the age of 63 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Vaccine brand=Pfizer/BioNTech/had 2 additional booster shots of Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. No Known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received two expired vaccines with no reported adverse event; Initial information was received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 months old male patient who experienced patient received two expired vaccines with no reported adverse event while receiving vaccines diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 04-Apr-2023, the patient received a 4th dose of 0.5ml suspect hib (prp/t) vaccine lot U7260AA expiry date: 30-MAR-2023 via intramuscular route in the left thigh for Immunization. On 04-Apr-2023, the patient received a 4 dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine lot number not reported via intramuscular route in the left thigh for Immunization.  On 04-Apr-2023 the patient developed a non-serious event of patient received two expired vaccines with no reported adverse event (expired product administered) following the administration of hib (prp/t) vaccine and following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) and DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received two expired vaccines with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received two expired vaccines with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I am and was post menopausal and a few days after my vaccination I had a full period which lasted 5 days.  I have not had another period since.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, Erythema, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Patient c/o left upper arm pain in the evening of 11 April 2023 after received his 3rd dose of Anthrax vaccine. Patient reported to Urgent Care the next day c/o deltoid area pain that radiating to whole left arm. Pt has a small 3mm raised erythemic bump and pain of 7/10. Loss of sensation/numbness to entire left arm around 0900, he is able to move the arm but unable to fully assess strength. Patient has sharp/dull sensation fully intact to his right arm with some sensation of pressure to anterior right finger but unable to identify which finger. Patient had hx of vasovagal reaction to the 2nd Anthrax vaccination.  Consulted with neurologist regarding the symptoms, unlikely to be a nerve related injury but recommended 20mg of prednisone x5 days.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Sensory loss, Swelling
Clinical narrative: Patient c/o left upper arm pain in the evening of 11 April 2023 after received his 3rd dose of Anthrax vaccine. Patient reported to Urgent Care the next day c/o deltoid area pain that radiating to whole left arm. Pt has a small 3mm raised erythemic bump and pain of 7/10. Loss of sensation/numbness to entire left arm around 0900, he is able to move the arm but unable to fully assess strength. Patient has sharp/dull sensation fully intact to his right arm with some sensation of pressure to anterior right finger but unable to identify which finger. Patient had hx of vasovagal reaction to the 2nd Anthrax vaccination.  Consulted with neurologist regarding the symptoms, unlikely to be a nerve related injury but recommended 20mg of prednisone x5 days.