chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was injected as an intramuscular injection. Public health notified us with our error. Vaccine does not need to be reinjected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram normal, Cardiac monitoring abnormal, Cardiac stress test abnormal, Dysstasia, Echocardiogram
Clinical narrative: In September 2021, I started having vertigo, sensitivity to light, leg weakness and a decreased ability to stand. These continued for a week or two and I went to my primary care physician who referred me to a cardiologist. I saw this cardiologist on September 28, 2021 and he ordered alot of different tests with only my cardiac stress test showing abnormal. He started me on Crestor and baby aspirin following the stress test. He also started me on a cardiac event monitor which showed abnormal tachycardia rhythm from both chambers. He has referred me to an electro physiologist for further workup. I am currently awaiting that appointment. I am still experiencing all of these symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemia, Left ventricular hypertrophy, Muscular weakness, Photophobia, Tachycardia
Clinical narrative: In September 2021, I started having vertigo, sensitivity to light, leg weakness and a decreased ability to stand. These continued for a week or two and I went to my primary care physician who referred me to a cardiologist. I saw this cardiologist on September 28, 2021 and he ordered alot of different tests with only my cardiac stress test showing abnormal. He started me on Crestor and baby aspirin following the stress test. He also started me on a cardiac event monitor which showed abnormal tachycardia rhythm from both chambers. He has referred me to an electro physiologist for further workup. I am currently awaiting that appointment. I am still experiencing all of these symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tilt table test normal, Vertigo
Clinical narrative: In September 2021, I started having vertigo, sensitivity to light, leg weakness and a decreased ability to stand. These continued for a week or two and I went to my primary care physician who referred me to a cardiologist. I saw this cardiologist on September 28, 2021 and he ordered alot of different tests with only my cardiac stress test showing abnormal. He started me on Crestor and baby aspirin following the stress test. He also started me on a cardiac event monitor which showed abnormal tachycardia rhythm from both chambers. He has referred me to an electro physiologist for further workup. I am currently awaiting that appointment. I am still experiencing all of these symptoms.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Mass, Urticaria
Clinical narrative: brother who reports patient had third COVID-19 vaccination and a few hours later developed erythema and itching at injection site.  The next day he developed what brother describes as hives with multiple red raised lesions on his arm and axilla.  He denies significant pruritus, fever, nausea or vomiting, respiratory distress or coughing.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Hypertension, Laboratory test, Vision blurred
Clinical narrative: Patient had dizziness, blurred vision, sweats, high blood pressure starting two hours after Shingrix vaccine (10:08 AM administered). He is doing some better after going to the hospital.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was injected as an intramuscular injection. Health department notified us with our error. Vaccine does not need to be reinjected.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Computerised tomogram head, Febrile convulsion
Clinical narrative: febrile seizure 8 hours after administration
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Patient did not have adverse event. Reporting a VAERS due to administering vaccine when FDA/CDC released on August 31, 2022 that we were supposed to stop administering monovalent Pfizer boosters. Vaccine was administered in the morning prior to the news release in the afternoon. The pharmacy was unaware of the news release during time of administration.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: Herpes Zoster.  I cannot identify any ?drop in defenses? or special stress, usually associated with Herpes Z. That is why I think it could have been  precipitated by the booster or by COVID (in February ), a very mild case.  Although it was intense, the pain was tolerable. I took one week of aciclovir (every 5 hours)  pills and cream. And pregabalina for pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, heat, and pain at injection site. Headaches unresolved with Tylenol. Fatigue, and general malaise.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: Swelling, redness, heat, and pain at injection site. Headaches unresolved with Tylenol. Fatigue, and general malaise.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient did not have adverse event. Reporting a VAERS due to administering vaccine when FDA/CDC released on August 31, 2022 that we were supposed to stop administering monovalent Moderna boosters. Vaccine was administered in the morning prior to the news release in the afternoon. The pharmacy was unaware of the news release during time of administration.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Bedridden, Cardiac disorder, Colonoscopy
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Endoscopy, Feeding disorder, Feeling abnormal
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Hypertension, Hypophagia, Immunisation reaction
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging, Muscle spasms, Nausea
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Palpitations, Ultrasound scan, Weight decreased
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: - Started having severe head/brain pain, stomach and leg spasms (uncontrolled), extreme body pain and nerve pain, back pain, heart problems (racing heart, heart pain, high blood pressure), extreme nausea; felt as though I was dying.  I could not eat and nothing would take the pain, spasms, nerve pain away. I was bed-bound for almost 3 weeks.  Just as I thought the symptoms would subside, they would return.  I saw my primary care doctor at least 40 times, along with over 50 labs and CTs.  The nerve pain, stomach problems and brain/head pain never had went away.  I was refereed to numerous specialists (gastro, urology, cardiologist, neurologist, neuro surgeon, cardiologist, internal medicine, ortho, ortho surgeon).  Since the COVID 19 vaccine, I have lost 36 pounds, as I just never feel good and just can't eat well.  I'm still seeing a neurologist, who recently diagnosed me with white spots on my brain, which he believes came from the vaccine.  I never had any head or brain issues in my life, until I received the COVID19 vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: A week or so after receiving the vaccine my hair started to fall out in a small patch that progressively grew in size, multiplied throughout my head and has resulted in most of my hair fallling out. I am still currently receiving corticosteroid shot treatment on the affected areas  and it has yet to resolve after over 7 months of treatment.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Pain, swelling and redness at injection site. Nausea, chills, fever, fatigue, tiredness, cough, hard to breathe, muscle pain & aches, joint pain and chest pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain, swelling and redness at injection site. Nausea, chills, fever, fatigue, tiredness, cough, hard to breathe, muscle pain & aches, joint pain and chest pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Pain, swelling and redness at injection site. Nausea, chills, fever, fatigue, tiredness, cough, hard to breathe, muscle pain & aches, joint pain and chest pain.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: I was given the incorrect vaccine; I needed the first dose of a Hepatitis B vaccine. The error was not caught until I went in for my second dose today at 5:30pm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Palpitations, Ventricular tachycardia
Clinical narrative: Subsequent to the vaccine, patient developed palpitations and intermittent angina. Bedside monitor documented at least one 13-beat run of slow ventricular tachycardia in February, 2022. Symptoms lasted approximately 4 months. Symptoms resolved since approximately April 2022.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and smell
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Fall, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 5/21/21 (lot # EW0183), 6/11/21 (lot # EW0183), and 1/27/22 (lot # FJ5682). Patient admitted to our inpatient hospital (med/surg unit) on 8/26/22 s/p a fall with acute hypoxemic respiratory failure due to COVID-19 pneumonia. As of today (8/31/22), patient is still admitted in the med/surg unit.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PATIENT STARTED NOTICING PAIN IN LEFT  DELTOID MUSCLE THAT DID NOT SUBSIDE AFTER 3 DAYS. HAS TROUBLE LIFTING ARM OVERHEAD. IS CURRENTLY TAKING TYLENOL AS RECOMMENDED BY HER PRACTITIONER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: On 8-30-22 while organizing the fridge, I discovered that our box of Pneumovax-23 had expired in June of 2022. I checked our computer to see if any patients had been given that vaccine since then, and unfortunately, this patient had. The first step I took was to call Merck product support and ask for any safety and efficacy data I could relay to the patient. They said as long as the product was still in the fridge during that month period there weren't safety concerns, but that the CDC did recommend revaccination in the event of an accidental expired product administration. I have called the patient and explained what happened and let the patient know that we called the manufacturer and confirmed from the manufacturer that there weren't any safety concerns, but I did say that the CDC did recommend revaccination. She was very understanding and although surprised at first didn't seem upset at all.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Pyrexia, Syncope
Clinical narrative: I had Shingle vaccine yesterday afternoon(8/30/3022), had low fever last night, the temperature was 99.5 this morning. My blood pressure was 73/112  heart rate: 100 at noon, lower than my usual 80+/120+. Around 6:30pm after dinner, my blood pressure dropped to 43/77,  I felt dizzy,  I went to bathroom and dropped to floor and fainted for a couple of minutes.  I was awake after a few minutes, and my blood went back to 75/106.    I am healthy and never had low blood pressure or faint before. I monitor my blood pressure because I  sometimes had blood pressure higher than 80/130 and wanted to document it to show to my doctor on my next appointment.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Lymphadenopathy, Oropharyngeal pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt stated his arm begin to swell the day after the vaccination on 17 AUG 2022 and turned red with a 50 cent size mark on his R ARM/SHOLDER. He stated it was sore to the touch but no itching was reported.  Pt. also stated he was experiencing a sore throat as well as swollen lymph nodes in his neck lesions in is mouth and a fever (which as subsided since he reported it) , lastly the patient stated he has a rash all over his body but mainly on his trunk and legs. Pt stated he has no rashes on his face at this time.     While the patient and I were on the phone, Dr. called the pt. to inform him of his appointment day and time, which will be on Friday 02 SEPT 2022 at 9:20am at Clinic. The patient left me on the line while speaking with Dr. and after a few minutres the call was ended by the patient.  The patient was called back and did not answer the phone, so I left a vm informing the patient that I would call again tomorrow to follow-up with him.  No further informaton is needed from the patient at this time.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Sexually transmitted disease test
Clinical narrative: Pt stated his arm begin to swell the day after the vaccination on 17 AUG 2022 and turned red with a 50 cent size mark on his R ARM/SHOLDER. He stated it was sore to the touch but no itching was reported.  Pt. also stated he was experiencing a sore throat as well as swollen lymph nodes in his neck lesions in is mouth and a fever (which as subsided since he reported it) , lastly the patient stated he has a rash all over his body but mainly on his trunk and legs. Pt stated he has no rashes on his face at this time.     While the patient and I were on the phone, Dr. called the pt. to inform him of his appointment day and time, which will be on Friday 02 SEPT 2022 at 9:20am at Clinic. The patient left me on the line while speaking with Dr. and after a few minutres the call was ended by the patient.  The patient was called back and did not answer the phone, so I left a vm informing the patient that I would call again tomorrow to follow-up with him.  No further informaton is needed from the patient at this time.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Atrophy, Brachial plexopathy, Carpal tunnel decompression, Electromyogram abnormal, Injected limb mobility decreased
Clinical narrative: Brachial Plexopathy in left arm. Deltoid and bicep muscles cease to function causing advancing atrophy destroying my life. Had nerve transfers performed. I can't lift my left arm. My right arm has severe weakness and severe atrophy. Though not the total devastation experienced in my right arm but a nightmare  nonetheless.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Muscular weakness, Nerve injury, Surgery
Clinical narrative: Brachial Plexopathy in left arm. Deltoid and bicep muscles cease to function causing advancing atrophy destroying my life. Had nerve transfers performed. I can't lift my left arm. My right arm has severe weakness and severe atrophy. Though not the total devastation experienced in my right arm but a nightmare  nonetheless.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Nausea, No adverse event
Clinical narrative: Patient recieved Covid vaccine, waited 15 minutes No reaction. Patient left and husband was joking. He took off his band aid w/ Blood and she became nausea.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Pain, Pyrexia, Syringe issue
Clinical narrative: Patient received Meningococcal Polysaccharide A,C,Y,W-135 TT Conjugate vaccine, vaccine leaked out from the syringe during administration. Per PCP she recommends that we give the patient a second dose. Manufacturer was called after incident and they stated that 76.9% of patient that did not receive a second did not have a reaction to the vaccine and the 30 % that reported a reaction was  fever,pain and redness at the site of the injection. Patient will be scheduled to receive a second dose of the vaccine. All needles with the same lot number were pulled from the clinic-Multiple 25g needles were assessed and tested and were unable to pull up liquid or administer liquid.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring abnormal, Cardiac stress test normal, Dyspnoea, Palpitations
Clinical narrative: March 4, 2021 received 1st Moderna Vaccine; April 1, 2021 received 2nd Moderna vaccine. Approximately April 28, 2021 began having air hunger. Began feeling heart palpitations. Symptoms continued to worsened. June went to PCP multiple tests ordered: pulmonary function, stress test 7 day patch monitor. Monitor showed irregular heart rhythm with runs of SVT. Saw cardiologist due to irregular heart rhythm. He indicated other tests were with in normal limits. And that arrhythmias were not life threatening. He would continue to monitor me. Over the next few months arrhythmias worsened. Medication started and arrhythmias again. 14 day monitor completed - multiple runs of SVT daily as well as some PVCs. Medication changed. Symptoms persist on the medication, but not as sever as before. Will need medication the rest of my life. Prior to the Moderna vaccine I had absolutely no heart issue, no palpitations, no shortness of breathe, etc.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test normal, Supraventricular tachycardia, Ventricular extrasystoles
Clinical narrative: March 4, 2021 received 1st Moderna Vaccine; April 1, 2021 received 2nd Moderna vaccine. Approximately April 28, 2021 began having air hunger. Began feeling heart palpitations. Symptoms continued to worsened. June went to PCP multiple tests ordered: pulmonary function, stress test 7 day patch monitor. Monitor showed irregular heart rhythm with runs of SVT. Saw cardiologist due to irregular heart rhythm. He indicated other tests were with in normal limits. And that arrhythmias were not life threatening. He would continue to monitor me. Over the next few months arrhythmias worsened. Medication started and arrhythmias again. 14 day monitor completed - multiple runs of SVT daily as well as some PVCs. Medication changed. Symptoms persist on the medication, but not as sever as before. Will need medication the rest of my life. Prior to the Moderna vaccine I had absolutely no heart issue, no palpitations, no shortness of breathe, etc.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: After receiving Covid 19 shot, Pfizer, LOT# ER8734 in left arm and Pfizer, LOT# EW0161 in right arm, I am continuing to have severe upper arm and shoulder pain. The shots were given on 4/3/21 (Left arm) and 4/24/21 (right arm). The shots were given at store. The pain started about two months after the injections and continues until this day (08/29/22).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: After my Third Covid-19 booster injection I got mild pain in my left shoulder and arm (injection arm). Consult doctor, advised me it normal and go away in couple of day or month. Later after my fourth booster the pain got worse and now it seem frozen shoulder. Got advise from doctor and gave me shot in shoulder and taking pain medication and physiotherapy. Symptom did not subside, cannot move my arm above shoulder, cannot sleep well. Next appointment with doctor is coming and advise to get MRI.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: After my Third Covid-19 booster injection I got mild pain in my left shoulder and arm (injection arm). Consult doctor, advised me it normal and go away in couple of day or month. Later after my fourth booster the pain got worse and now it seem frozen shoulder. Got advise from doctor and gave me shot in shoulder and taking pain medication and physiotherapy. Symptom did not subside, cannot move my arm above shoulder, cannot sleep well. Next appointment with doctor is coming and advise to get MRI.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Anaphylactic reaction, Reaction to excipient, SARS-CoV-2 test
Clinical narrative: Adult Covid Vaccine: Severe immediate reaction/might be allergic to the polyethylene glycol/Doesn't want to have anaphylactic reaction; Adult Covid Vaccine: Severe immediate reaction/might be allergic to the polyethylene glycol/Doesn't want to have anaphylactic reaction; This is a spontaneous report received from contactable consumer. The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EN9318) at the age of 62 years, in left arm for covid-19 immunisation; polyethylene glycol compound (POLYETHYLENE GLYCOL COMPOUND) is the excipient of BNT162b2. The patient's relevant medical history included: "had reactions to other pharmaceuticals" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EL3246, vaccine location: left upper arm), administration date: 08Jan2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". When got the second dose of the Pfizer Adult Covid Vaccine, patient had a severe immediate reaction. The severe reaction started within a couple of seconds and then progressed over an hour. Doctor then gave patient a bunch of shots immediately and kept in office for a while and said patient could never take booster dose of Adult Covid Vaccine (Pfizer product). Thinks patient could have been allergic to peg, which is polyethylene glycol. In past, has had reactions to other pharmaceuticals. Other pharmaceutical names not provided. Polyethylene glycol is an ingredient in the Adult Covid Vaccine, is a carrier. Thinks patient might be allergic to the polyethylene glycol. Was never able to determine, went to allergist in town and did not know how to test. Patient had Covid (positive) on an unspecified date. Patient has not taken Paxlovid because Paxlovid is coated in peg, polyethylene glycol: Now, patient has been prescribed Paxlovid. Went to take the first dose of Paxlovid last night, 25Aug2022 and read paperwork that states Paxlovid is coated in peg, polyethylene glycol. Both of the Paxlovid pills have polyethylene glycol in the coating of the pills. Now patient is terrified to take Paxlovid. Doesn't want to have anaphylactic reaction. Did not administer any Paxlovid because read before took and was scared and afraid. Patient is going to call doctor to see if any other protocols to do because patient is high risk for hospitalization and death. Patient confirmed she has not administered any of the Paxlovid. Outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Adult Covid Vaccine: Severe immediate reaction/might be allergic to the polyethylene glycol/Doesn't want to have anaphylactic reaction; Adult Covid Vaccine: Severe immediate reaction/might be allergic to the polyethylene glycol/Doesn't want to have anaphylactic reaction; This is a spontaneous report received from contactable consumer. The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EN9318) at the age of 62 years, in left arm for covid-19 immunisation; polyethylene glycol compound (POLYETHYLENE GLYCOL COMPOUND) is the excipient of BNT162b2. The patient's relevant medical history included: "had reactions to other pharmaceuticals" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EL3246, vaccine location: left upper arm), administration date: 08Jan2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". When got the second dose of the Pfizer Adult Covid Vaccine, patient had a severe immediate reaction. The severe reaction started within a couple of seconds and then progressed over an hour. Doctor then gave patient a bunch of shots immediately and kept in office for a while and said patient could never take booster dose of Adult Covid Vaccine (Pfizer product). Thinks patient could have been allergic to peg, which is polyethylene glycol. In past, has had reactions to other pharmaceuticals. Other pharmaceutical names not provided. Polyethylene glycol is an ingredient in the Adult Covid Vaccine, is a carrier. Thinks patient might be allergic to the polyethylene glycol. Was never able to determine, went to allergist in town and did not know how to test. Patient had Covid (positive) on an unspecified date. Patient has not taken Paxlovid because Paxlovid is coated in peg, polyethylene glycol: Now, patient has been prescribed Paxlovid. Went to take the first dose of Paxlovid last night, 25Aug2022 and read paperwork that states Paxlovid is coated in peg, polyethylene glycol. Both of the Paxlovid pills have polyethylene glycol in the coating of the pills. Now patient is terrified to take Paxlovid. Doesn't want to have anaphylactic reaction. Did not administer any Paxlovid because read before took and was scared and afraid. Patient is going to call doctor to see if any other protocols to do because patient is high risk for hospitalization and death. Patient confirmed she has not administered any of the Paxlovid. Outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Anaphylactic reaction, Reaction to excipient, SARS-CoV-2 test
Clinical narrative: has COVID; has COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm and on 29Jan2021 as dose 2, single (Lot number: EN9318) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to peg" (unspecified if ongoing), notes: allergic to peg. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown, notes: Not Provided. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had not taken Paxlovid because Paxlovid was coated in peg, polyethylene glycol. Paxlovid: Dose: Was provided the 300mg-100mg dose pack. Each dose pack has two Nirmatrelvir 150mg and 1 Ritonavir 100mg in the blister packs for morning and night dose. Caller clarified caller has not administered any of the Paxlovid. Received first and second dose of Adult Covid Vaccine and had COVID. Thinks was allergic to Polyethylene glycol, ingredient in the Adult COVID Vaccine. In past, has had reactions to other pharmaceuticals. Other pharmaceutical names not provided. Polyethylene glycol is an ingredient in the Adult COVID Vaccine, is a carrier.  No follow-up attempts were possible. No further information was expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: has COVID; has COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm and on 29Jan2021 as dose 2, single (Lot number: EN9318) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to peg" (unspecified if ongoing), notes: allergic to peg. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown, notes: Not Provided. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had not taken Paxlovid because Paxlovid was coated in peg, polyethylene glycol. Paxlovid: Dose: Was provided the 300mg-100mg dose pack. Each dose pack has two Nirmatrelvir 150mg and 1 Ritonavir 100mg in the blister packs for morning and night dose. Caller clarified caller has not administered any of the Paxlovid. Received first and second dose of Adult Covid Vaccine and had COVID. Thinks was allergic to Polyethylene glycol, ingredient in the Adult COVID Vaccine. In past, has had reactions to other pharmaceuticals. Other pharmaceutical names not provided. Polyethylene glycol is an ingredient in the Adult COVID Vaccine, is a carrier.  No follow-up attempts were possible. No further information was expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US227660_OS (Novartis Pharmaceuticals Corporation). A 62-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; secukinumab (COSENTYX), on 16Aug2021 (Batch/Lot number: unknown) and in May2022 (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Feb2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose), administration date: Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Terrible right leg pain"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare up". The action taken for secukinumab was temporarily withdrawn. Additional information: Patient reported receiving COVID-19 vaccine Feb2021, March2021 and a booster 18Aug2021. At same point she had started back on Cosentyx, because she reports taking Cosentyx on Monday, and the covid booster on Wednesday 18Aug2021. At this point she had terrible right leg pain, Aug2021 after receiving the booster. HCP advised to stop taking Cosentyx. She restarted Cosentyx May2022 due to Psoriasis flare up when off Cosentyx. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19, COVID 19 Treatment: Paxlovid; COVID 19, COVID 19 Treatment: Paxlovid; Rebound Covid - tested negative 20Aug and 21Aug. Positive and symptomatic Monday 22Aug; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 19:00 as dose 3 (booster), single (Lot number: PF2589) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; MONTELUKAST; OMEPRAZOLE. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen", notes: Known allergies: Naproxen. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 22Aug2022 at 07:00, outcome "recovering", described as "Rebound Covid - tested negative 20Aug and 21Aug. Positive and symptomatic Monday 22Aug"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19, COVID 19 Treatment: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (20Aug2022) negative, notes: tested negative 20Aug and 21Aug; (21Aug2022) negative, notes: tested negative 20Aug and 21Aug; (22Aug2022) Positive, notes: Positive and symptomatic Monday 22Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: It was reported that vaccine was received by patient. Patient received other medication in 2 weeks. Patient received treatment for COVID 19 with Paxlovid from 14Aug2022 to 18Aug2022. It was reported that rebound Covid - tested negative 20Aug2022 and 21Aug2022. Positive and symptomatic Monday 22Aug2022 at 07:00 AM with outcome recovering and no treatment.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: COVID positive. Symptoms include:  muscle aches, cough, shortness of breath, fatigue, and abdominal pain.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Cough, Culture, Dyspnoea
Clinical narrative: COVID positive. Symptoms include:  muscle aches, cough, shortness of breath, fatigue, and abdominal pain.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test positive
Clinical narrative: COVID positive. Symptoms include:  muscle aches, cough, shortness of breath, fatigue, and abdominal pain.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Heart rate, Heart rate increased, Limb discomfort
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Dose 2 in left arm; lot number=EW0183; administration time=09:45 AM), administration date: 03Jun2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1 in left arm; lot number=FJ5682; administration time=11:30 AM), administration date: 13May2021, when the patient was 9-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain. Additional information: There were no other vaccine in four weeks. Treatment included ibuprofen for chest pain.; Sender's Comments: Linked Report(s) : 202200802375 same patient/drug, different dose/event;
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Dose 2 in left arm; lot number=EW0183; administration time=09:45 AM), administration date: 03Jun2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1 in left arm; lot number=FJ5682; administration time=11:30 AM), administration date: 13May2021, when the patient was 9-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain. Additional information: There were no other vaccine in four weeks. Treatment included ibuprofen for chest pain.; Sender's Comments: Linked Report(s) : 202200802375 same patient/drug, different dose/event;
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Limb discomfort
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Dose 2 in left arm; lot number=EW0183; administration time=09:45 AM), administration date: 03Jun2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1 in left arm; lot number=FJ5682; administration time=11:30 AM), administration date: 13May2021, when the patient was 9-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain. Additional information: There were no other vaccine in four weeks. Treatment included ibuprofen for chest pain.; Sender's Comments: Linked Report(s) : 202200802375 same patient/drug, different dose/event;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis pulmonary" (ongoing); "Cholesterol" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing); DULERA taken for sarcoidosis (ongoing); LOSARTAN HCT oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose-1, Time: 16:30, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch Lot number: EL3247), administration date: 21Jan2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19"; BNT162b2 (Dose-2, Time: 16:00, Site and Route of injection, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 11Feb2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19"; BNT162b2 (Dose-3, Time: 09:00, Site and Route of injection, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 17Aug2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19". The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid-19 complications). Booster dose due to a weakened immune system: Use of medication that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biological therapies like rituximab and etanercept). No prior vaccinations (within 4 weeks). Post recovery from symptoms and after negative antigen test, patient experienced rapid heart rate greater 115 BPM on multiple occasions for duration of 15-25mins.; Sender's Comments: Linked Report(s) : PFIZER INC-202201054994 Same patient/drug, different dose/event;