chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: My stomach felt queasy, winded, feeling out of it, and I was still tired after I woke up which was unusual.  I took an at home COVID-19 test and tested positive. I called my doctor and she prescribed me Paxlovid. On the 7th day I tested again and I was still positive for COVID-19. This morning me and my wife tested negative for the first time.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: My stomach felt queasy, winded, feeling out of it, and I was still tired after I woke up which was unusual.  I took an at home COVID-19 test and tested positive. I called my doctor and she prescribed me Paxlovid. On the 7th day I tested again and I was still positive for COVID-19. This morning me and my wife tested negative for the first time.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Colitis, Computerised tomogram abnormal, Constipation, Diarrhoea
Clinical narrative: I started having symptoms after dose 1 but after dose 2, my symptoms seem to have gotten worse. I  started having diarrhea and constipation. I also continued having shortness of breath and now I have been having fatigue. I had a CAT Scan of my internal organs after the first vaccine and they found enlarged heart, enlarged liver and enlarged colon. They do not know what has caused this. I have not been prescribed any medications at this time.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Fatigue, Laboratory test
Clinical narrative: I started having symptoms after dose 1 but after dose 2, my symptoms seem to have gotten worse. I  started having diarrhea and constipation. I also continued having shortness of breath and now I have been having fatigue. I had a CAT Scan of my internal organs after the first vaccine and they found enlarged heart, enlarged liver and enlarged colon. They do not know what has caused this. I have not been prescribed any medications at this time.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient reported to the pharmacy that she had redness near her elbow after receiving the flu vaccine. The redness started the night of vaccination.There was no swelling, itching or pain to accompany the redness. The patient did not seek medical attention.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, chils,  body aches
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was administered. No adverse reactions were reported. Informed patient to follow up with provider for any adverse reactions and further re-vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardioversion, Electrocardiogram abnormal
Clinical narrative: Annual checkup  at Cardiologist revealed atrial fibrilation. (9/1/2022).  Recommended treatment (cardioversion) on 9/8/2022 restored sinus wave in heart rhythm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: I had a sore throat, cough, headache, and nasal congestion. I tested negative that night. The next day I tested positive and I called my doctor and she was busy. So, I went to the pharmacy and they thought I just had allergies and prescribed me ZYRTEC. Then, on 09/21/2022 I tested again and was positive. I still have a cough.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, cough, headache, and nasal congestion. I tested negative that night. The next day I tested positive and I called my doctor and she was busy. So, I went to the pharmacy and they thought I just had allergies and prescribed me ZYRTEC. Then, on 09/21/2022 I tested again and was positive. I still have a cough.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: "COVID arm'  About a week after the immunization, I developed a palm-sized red area under the site of the injection.  At first, it was hard and itchy.  Later, it softened.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness
Clinical narrative: Patient became lightheaded and weak after vaccine.   Has had previous episodes over the last few months, regardless of vaccainations.  Patient taken from store by ambulance to hospital.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Muscular weakness
Clinical narrative: patient complained about tired ness and muscle weakness after 7 days of vaccination which lasted for 2 weeks
Age: 36.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Candida infection, Chills, Fatigue, Injection site discolouration, Injection site erythema
Clinical narrative: We recently vaccinated a few researchers Thursday 09/22 with the Jynneos vaccine intradermally. On Friday/Saturday 09/23 and 09/24 , she presented with fever (101F), pins and needles feeling in hands and feet, fatigue, chills, adjacent rash that was painful/itchy, and redness/pain/itching at injection site. The fever, fatigue, and chills, along with the pins and needles feeling resolved a day or so later along with the rash. The researcher also developed thrush along with their child that they breastfeed, who also developed a fever of 102F. The doctor said the child had a cold. They both were prescribed nystatin. On 09/30, there was only just a slightly pink, swollen, hard bump at the site of the injection. Of note, the researcher had a mild cold at time of vaccination.    (writer) has been in communication with agency.
Age: 36.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: We recently vaccinated a few researchers Thursday 09/22 with the Jynneos vaccine intradermally. On Friday/Saturday 09/23 and 09/24 , she presented with fever (101F), pins and needles feeling in hands and feet, fatigue, chills, adjacent rash that was painful/itchy, and redness/pain/itching at injection site. The fever, fatigue, and chills, along with the pins and needles feeling resolved a day or so later along with the rash. The researcher also developed thrush along with their child that they breastfeed, who also developed a fever of 102F. The doctor said the child had a cold. They both were prescribed nystatin. On 09/30, there was only just a slightly pink, swollen, hard bump at the site of the injection. Of note, the researcher had a mild cold at time of vaccination.    (writer) has been in communication with agency.
Age: 36.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Paraesthesia, Pyrexia, Rash, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: We recently vaccinated a few researchers Thursday 09/22 with the Jynneos vaccine intradermally. On Friday/Saturday 09/23 and 09/24 , she presented with fever (101F), pins and needles feeling in hands and feet, fatigue, chills, adjacent rash that was painful/itchy, and redness/pain/itching at injection site. The fever, fatigue, and chills, along with the pins and needles feeling resolved a day or so later along with the rash. The researcher also developed thrush along with their child that they breastfeed, who also developed a fever of 102F. The doctor said the child had a cold. They both were prescribed nystatin. On 09/30, there was only just a slightly pink, swollen, hard bump at the site of the injection. Of note, the researcher had a mild cold at time of vaccination.    (writer) has been in communication with agency.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site pain
Clinical narrative: Patient was given an IM injection in the left arm, however the immunization was administered too low and toward the back of the arm. There was bruising and soreness, and concern about the efficacy of the vaccine if it was administered subcutaneously
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Body aches, fever, chills, light headed sore throat swollen lymph nodes in both axillas.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches, fever, chills, light headed sore throat swollen lymph nodes in both axillas.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 1 day after expiration date
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 1 day after expiration date.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given 1 day after expiration date
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is re$, swollen, and itchy
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I experienced amenorrhea for 9 months after receiving the vaccine with no other changes that would effect that
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Dyspnoea, Flushing
Clinical narrative: About 5 minutes after receiving  her shots, the patient told her mom present with her she was not feeling good and  having a little  a little shortness of breath.   The mom had her sit in the chairs and ask the tech to let me know.  When I got the the patient she was a little flushed in the face.   I gave her some water to drink.  She stated the feeling had started to pass. She no longer felt shortness of breath . She did state she had only had cereal at breakfast and had not eaten anything since. After about 15 minutes  the mom stated  she was feeling fine and they left.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Haemorrhage, Impaired work ability, Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states that following the injection she had bleeding and stiffness in her left arm.  Her arm became so sore she was unable to lift her arm at the shoulder and had to stay home for work for two days.  She presented to the dr on 10/3/22 and was prescribed diclofenac and baclofen.  Pt states that the doctor believed the injection was given too close to the shoulder joint.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient states that following the injection she had bleeding and stiffness in her left arm.  Her arm became so sore she was unable to lift her arm at the shoulder and had to stay home for work for two days.  She presented to the dr on 10/3/22 and was prescribed diclofenac and baclofen.  Pt states that the doctor believed the injection was given too close to the shoulder joint.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: patient tested + for covid 1/30/22 and also 2-12-22 .  I have no other information except date of death as 3/20/22
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient is supposed to receive the 1st dose but was give booster dose.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: Wheezing and coughing, starting 36 hours after the dose
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: 10/3/22 Employee contacted clinic to report pain in LDM with numbness and tingling going down arm to hand. Denies redness, swelling or bruising. Employee though it would go away but it has not. Denies shoulder pain. Referred to occupational health to be evaluated.
Age: 26.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: patient was blurred, sweeting and pale, gave him bottle of water and orange juice and 1/2 banana, turn on van and let him rest for 45min.patient felt better called his friend to pick him up.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: 9 month old patient received Pfizer COVID vaccine (maroon cap) for 6mo-4yo on 9/8/22 as a 2nd dose. However, patient received Moderna COVID vaccine (pink label) for 6mo-5yo as a 1st dose on 8/9/22. So patient should've received a Moderna COVID vaccine for a 2nd dose on 9/8/22. This is an administration error, but no adverse event to the pt occurred.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given at vaccine approved for 65 and older yet patient was only 60 years old. Patient reported no Adverse events.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Do not have much information other than date of positive test   1-25-22      and date of death   3-11-22                                      .
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Cough, Dizziness, Eye movement disorder, Fatigue
Clinical narrative: The vaccinator gave the patient her flu shot and before moving on to the COVID Moderna booster noticed she looked "flushed" and her and patient agreed to let boyfriend get his vaccines then go back for the second vaccine.  Before they switched the patient passed out while seated and the pharmacist was alerted and EMS was called. Upon entering the room, The patient was slouched over to the side and her eyes were open but slightly rolled back.  She was not answering to her name or questions but was breathing and coughing/clearing throat.  After about 1 to 2 minutes the patient came around and was confused, sweating, lightheaded, tired.  We sat with the patient and her boyfriend while waiting for EMS.  She said she has never had a reaction to vaccines before but gets lightheaded/queasy with blood draws.  I did take her blood pressure (with poor posture) and was 106/63 HR 71. She was feeling tired and wanted to lie down so we assisted her to the floor until EMS arrived shortly after.  EMS discussed it may be vasovagal reaction and is common but we agreed not to give the COVID moderna booster at that time. They/We waited with her a while longer until EMS assisted them back to their car.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Hyperhidrosis, Loss of consciousness, Throat clearing, Unresponsive to stimuli
Clinical narrative: The vaccinator gave the patient her flu shot and before moving on to the COVID Moderna booster noticed she looked "flushed" and her and patient agreed to let boyfriend get his vaccines then go back for the second vaccine.  Before they switched the patient passed out while seated and the pharmacist was alerted and EMS was called. Upon entering the room, The patient was slouched over to the side and her eyes were open but slightly rolled back.  She was not answering to her name or questions but was breathing and coughing/clearing throat.  After about 1 to 2 minutes the patient came around and was confused, sweating, lightheaded, tired.  We sat with the patient and her boyfriend while waiting for EMS.  She said she has never had a reaction to vaccines before but gets lightheaded/queasy with blood draws.  I did take her blood pressure (with poor posture) and was 106/63 HR 71. She was feeling tired and wanted to lie down so we assisted her to the floor until EMS arrived shortly after.  EMS discussed it may be vasovagal reaction and is common but we agreed not to give the COVID moderna booster at that time. They/We waited with her a while longer until EMS assisted them back to their car.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pruritus, Migraine, Pruritus
Clinical narrative: migraine headache, itchy body, itch eyes, went to hospital and was given iv fluids, also went to urgent care and got steroids
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased
Clinical narrative: Increased blood sugar from 6.9 to 8. 4
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Constipation, Death, Decreased appetite, Mental status changes
Clinical narrative: tested + for covid 1-2-22;  had constipation , loss of appetite, altered mental status, deceased on 1-9-22
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested + for covid 1-2-22;  had constipation , loss of appetite, altered mental status, deceased on 1-9-22
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting 9 hours
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: no information except date of + covid test as        2-16-22                     and date of death as        3-26-22.                     .
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Patient had a fainting spell shortly after receiving the vaccine while sitting on bench in pharmacy department
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: pt presented 10/3/22 stating that she had been having pain in her arm since her vaccination on 8/16/22 and that she was going to give it a little more time to see if it would resolve then she would seek medical treatment
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Chills, Eye swelling, Pyrexia
Clinical narrative: Patient said his eye swelled up within hours of the injections and later on that evening he had fever, chills and joint pain.  Symptoms were better the following morning and all eye swelling gone 10/3/22.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Bladder catheterisation, COVID-19, Cystoscopy, Gait inability
Clinical narrative: He was admitted 1-28-22  to  Hospital  due to GU problems and tested + for covid.  no cough , no dyspnea or sore throat.   Had fever but had indwelling foley that had been placed that day after having outpatient cystoscopy.   He reported having had one covid vaccine only.   He presented to er with urinary pain and apparently had urinary retention.  Also c/o not being able to walk for three weeks due to lower extremity edema and had anasarca and acute on chronic renal failure.  .covid- patient did  not have oxygen requirement at time of admission 1-28-22.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised oedema, Genitourinary symptom, Oedema peripheral, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: He was admitted 1-28-22  to  Hospital  due to GU problems and tested + for covid.  no cough , no dyspnea or sore throat.   Had fever but had indwelling foley that had been placed that day after having outpatient cystoscopy.   He reported having had one covid vaccine only.   He presented to er with urinary pain and apparently had urinary retention.  Also c/o not being able to walk for three weeks due to lower extremity edema and had anasarca and acute on chronic renal failure.  .covid- patient did  not have oxygen requirement at time of admission 1-28-22.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary retention, Urinary tract pain
Clinical narrative: He was admitted 1-28-22  to  Hospital  due to GU problems and tested + for covid.  no cough , no dyspnea or sore throat.   Had fever but had indwelling foley that had been placed that day after having outpatient cystoscopy.   He reported having had one covid vaccine only.   He presented to er with urinary pain and apparently had urinary retention.  Also c/o not being able to walk for three weeks due to lower extremity edema and had anasarca and acute on chronic renal failure.  .covid- patient did  not have oxygen requirement at time of admission 1-28-22.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: tested + for covid initally on  2-9-22 and on same date + at Med Center 2-9-22 and 2-17-22.  Deceased 2-22-22.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pruritus
Clinical narrative: On 9/21/22 I had my 5th covid vaccine- booster in my left arm. I had the usual arm soreness for 2 days. On day 3, my left arm was itching a lot. Prior to this day, a few days ago I had mosquito bites but they went away and now this itching has taken place after thee vaccine. Today is Oct 3 and I am still itching. I contacted my doctor a few days ago to express my concern that this had to do with the booster. He said just to use a cream he had prescribed for bites in the past. At that point it was 9 days of itching  and no relief. As of today, still itching and there are no bug bites. I think this is related to the booster. Someone else I know had this issue but she went to urgent care as she had rashes and ended up with sepsis. She too had bug bites.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: PT CAME TO PHARMACY ON 9/28/22 REPORTED THAT REDNESS ON SITE OF INJECTION, SWOLLEN AND HIVES LASTED 2-3 DAYS
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen right subclavicular lymph node, clearly visible as large raised bump about 2 inches diameter, sore to touch. Lasted about 5 days post vaccination. Returned to normal after that.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain, Pyrexia
Clinical narrative: Had to go to hospital. Couldn?t get out of bed. Couldn?t move my arms. Very weak. High temperature 102.2.  My partner called 911
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood thyroid stimulating hormone, Full blood count, Hypoaesthesia, Metabolic function test, Paraesthesia
Clinical narrative: Started with itching on abdomen and lower back an hour after injection but no rash. Shortly after - began with numbness and tingling of right arm. Throughout the rest of the evening symptoms progressed to numbness and tingling of my right neck and right side of face. Numbness would wax and wane and then would occasionally have numbness and tingling of left lower extremity. I went to the ER, due to no muscular weakness they stated it most likely was an allergic reaction and to go home but come back if symptoms worsen or persists. Symptoms began to subside. Woke up on 9/27 with numbness of right arm, neck and face. Went back to the ER, labs checked, same outcome from first visit - return if weakness begins.  I have been having numbness and tingling on bilateral hands, bilateral feet, bilateral legs, right face/neck and right arm since I received the injection. I do not have any weakness and the numbness/tingling comes and goes and is never on bilateral extremities at the same time. It bounces between different extremities throughout the day. I have an appt with a neurologist tomorrow morning to further evaluate.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Started with itching on abdomen and lower back an hour after injection but no rash. Shortly after - began with numbness and tingling of right arm. Throughout the rest of the evening symptoms progressed to numbness and tingling of my right neck and right side of face. Numbness would wax and wane and then would occasionally have numbness and tingling of left lower extremity. I went to the ER, due to no muscular weakness they stated it most likely was an allergic reaction and to go home but come back if symptoms worsen or persists. Symptoms began to subside. Woke up on 9/27 with numbness of right arm, neck and face. Went back to the ER, labs checked, same outcome from first visit - return if weakness begins.  I have been having numbness and tingling on bilateral hands, bilateral feet, bilateral legs, right face/neck and right arm since I received the injection. I do not have any weakness and the numbness/tingling comes and goes and is never on bilateral extremities at the same time. It bounces between different extremities throughout the day. I have an appt with a neurologist tomorrow morning to further evaluate.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray, Computerised tomogram head, Electrocardiogram, Full blood count, Headache
Clinical narrative: Syncope followed by Headache
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test, Red blood cell sedimentation rate, Scan with contrast, Syncope, Urine analysis
Clinical narrative: Syncope followed by Headache
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF FLUZONE HD WITHIN A YEAR DUE TO MISCOMMUNICATION FROM PATIENT TO STAFF DESPITE MULTIPLE ATTEMPT TO VERIFY THE VACCINE THE PATIENT WANTS THAT DAY. UPON CLARIFICATION AFTER ADMINISTRATION AND PATIENT ALREADY WENT HOME, PATIENT ORIGINALLY WANTED A COVID BOOSTER SHOT BUT FAILED TO COMMUNICATE IT CLEARLY WHEN ASKED BY PHARMACY STAFF. THE MEDICATION ERROR WAS DISCOVERED UPON THIRD-PARTY REJECTION FROM INSURANCE PLAN SAYING THAT THE PATIENT GOT A DOSE OF FLUZONE HD ALREADY ONE MONTH PRIOR. PATIENT WAS CONTACTED AND THE ISSUE WAS REVIEWED WITH THE PATIENT. PATIENT IS AWARE OF THE ERROR AND REPORTS NO ADVERSE EFFECTS THUS FAR. PATIENT AND PATIENT'S FAMILY MEMBER ARE AWARE OF THE MEDICATION ERROR.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold
Clinical narrative: Patient states that she starting experiencing extreme chills and was very cold in the middle of the night, the day she received the shot that lasted into the next day.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Injection site paraesthesia
Clinical narrative: Left arm numbness and tingling from infection site down to thumb and across left hand, muscle pain, chills, sore throat, headache, nausea, dizziness, and hives for 36hrs post injection.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Paraesthesia, Urticaria
Clinical narrative: Left arm numbness and tingling from infection site down to thumb and across left hand, muscle pain, chills, sore throat, headache, nausea, dizziness, and hives for 36hrs post injection.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza like illness, Sinusitis
Clinical narrative: I have sinusitus and eacj time I have taken the vaccines it seems to bring on a sinus infection, and severe sinus infections give me flu like systems, and it takes several days to recover.  I have had 2 regular vaccines - Moderna, 2 Moderna boosters, and the 3rd booster was the PFizer vaccine.  I hope there are studies or will be to see if there is any correlation from vaccine and my sinuses.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test positive, Hypersensitivity, Sleep disorder, Somnolence, Urticaria
Clinical narrative: Hives occur slowly and gradually developed from legs to body to neck, arm and face within 2-3 weeks resulting nonsleep nights. Benadryl taken but drowsy during the day. Then prednisone for over 2 weeks, still did not kill. Then, allertec 4 pills a day with hydroxyzine occasionally finally worked. Allertec was reduced after hives were in control.  About 5 months. The hives occurs again the same day after the booster (3rd) shot on 11/6/2021. And, patient is still on allertec today.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER, CHILLS
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient got monovalent covid vaccine instead of the bivalent covid vaccine for booster dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient got monovalent covid vaccine instead of the bivalent covid vaccine for booster dose
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient got monovalent covid vaccine instead of the bivalent covid vaccine for booster dose
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Paraesthesia
Clinical narrative: Patient watched for ~15 minutes after injection  called back shortly after leaving office that she  had a headache "tingling" sensation down back  and a rash on chest. Rechecked in office. Vitals stable Given small dose (12.5mg) of Benadryl- symptoms  resolved
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: There are no adverse events (symptoms, signs, time course) and treatments that I am aware of.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscle spasms, Muscle twitching
Clinical narrative: Twitching/spasm feeling in left bicep muscle; Twitching/spasm feeling in left bicep muscle; Tenderness at the injection site; This spontaneous case was retrieved on 05-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0895323-1), reported by other healthcare professional and concerned a 44-year-old, male patient.  The patient's concurrent condition included migraines. The patient was not taking any concomitant medications. The patient had no allergies.  On 07-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; dose reported as '1', route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was P100255599 (reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same day, after receiving Afluria Quadrivalent, the patient experienced immediate twitching/spasm feeling in left bicep muscle. Patient has attempted ice, heat, massage and ibuprofen to relieve the spasm. Patient also experienced continued tenderness at the injection site. There was no redness, swelling, or obvious deformity. There were no noted issues regarding strength or range of motion.  On 08-Nov-2020, the patient visited the physician's office. The physician conducted visual and palpable inspection of the injection site, and no abnormalities were noted, but the noted tenderness was still apparent. The patient completed a set of vitals: blood pressure (BP) (right arm) and the result was 125/82, pulse Ox and the result was 95%, and heart rate and the result was 72. Physician recommended the patient to continued ice, heat, massage and to visit a primary physician if the complaint continues greater 48 hours.  At the time of initial reporting, the patient had not recovered from the events of 'muscle spasm', 'muscle twitching' and 'vaccination site tenderness'.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 44-year-old male patient experienced muscle spams, muscle twitching and vaccination site pain on the same date after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A 44-year-old male patient experienced muscle spams, muscle twitching and vaccination site pain on the same date after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arteriospasm coronary, Asthenia, Back pain, Bedridden
Clinical narrative: Previous report submitted E report # 661786 VAERS ID # 1741754 Date of Report September 28, 2021 Date of Vaccination April 6, 2021 Age at Vaccination: 20yrs COVID-19 Janssen and Janssen - 042A21A Severe tachycardia and supraventricular tachycardia with intense chest pain that radiates to her left arm, neck, jaw, and back.  She has been diagnosed with Postural Orthostatic Tachycardia Syndrome based on a positive tilt table test conducted at Hospital in August 2021.  Just by standing her heart rate increases from 90bpm to 170bpm which is debilitating.  To keep her chest pain below 150bpm she takes Propranolol daily (40mg).  She is also being treated for Prinzmetal angina based on symptoms and several abnormal EKGs showing an ST depression indicating angina.  This angina causes severe chest pain and palpitations daily.  This is a chronic condition with intense suffering.  She has to take calcium blockers (Ranexa and nitroglycerin sublingual tablets), which does not reduce the pain on most occasions.  This pain causes extreme emotional anxiety, fear and depression.  Patient has been to the ER 40 plus times between April 2021 and October 2022.  She has seen several cardiologists.  Patient is currently taking propranolol daily to keep her heart rate under 150bpm.  She takes Lorazepam for severe anxiety, Ranexa and nitroglycerin sublingual tablets for coronary artery vasospasms that cause severe, daily chest pain.  She has to routinely see a psychologist, psychiatrist, primary care doctor, and cardiologist.  This vaccine caused her to become disabled, reducing her to spend the majority of her time in bed and requires constant care.  All of these health problems began 12 hours after the Janssen vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Depression, Disability, Electrocardiogram ST segment depression, Emotional distress
Clinical narrative: Previous report submitted E report # 661786 VAERS ID # 1741754 Date of Report September 28, 2021 Date of Vaccination April 6, 2021 Age at Vaccination: 20yrs COVID-19 Janssen and Janssen - 042A21A Severe tachycardia and supraventricular tachycardia with intense chest pain that radiates to her left arm, neck, jaw, and back.  She has been diagnosed with Postural Orthostatic Tachycardia Syndrome based on a positive tilt table test conducted at Hospital in August 2021.  Just by standing her heart rate increases from 90bpm to 170bpm which is debilitating.  To keep her chest pain below 150bpm she takes Propranolol daily (40mg).  She is also being treated for Prinzmetal angina based on symptoms and several abnormal EKGs showing an ST depression indicating angina.  This angina causes severe chest pain and palpitations daily.  This is a chronic condition with intense suffering.  She has to take calcium blockers (Ranexa and nitroglycerin sublingual tablets), which does not reduce the pain on most occasions.  This pain causes extreme emotional anxiety, fear and depression.  Patient has been to the ER 40 plus times between April 2021 and October 2022.  She has seen several cardiologists.  Patient is currently taking propranolol daily to keep her heart rate under 150bpm.  She takes Lorazepam for severe anxiety, Ranexa and nitroglycerin sublingual tablets for coronary artery vasospasms that cause severe, daily chest pain.  She has to routinely see a psychologist, psychiatrist, primary care doctor, and cardiologist.  This vaccine caused her to become disabled, reducing her to spend the majority of her time in bed and requires constant care.  All of these health problems began 12 hours after the Janssen vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Heart rate increased, Neck pain, Pain in jaw, Palpitations
Clinical narrative: Previous report submitted E report # 661786 VAERS ID # 1741754 Date of Report September 28, 2021 Date of Vaccination April 6, 2021 Age at Vaccination: 20yrs COVID-19 Janssen and Janssen - 042A21A Severe tachycardia and supraventricular tachycardia with intense chest pain that radiates to her left arm, neck, jaw, and back.  She has been diagnosed with Postural Orthostatic Tachycardia Syndrome based on a positive tilt table test conducted at Hospital in August 2021.  Just by standing her heart rate increases from 90bpm to 170bpm which is debilitating.  To keep her chest pain below 150bpm she takes Propranolol daily (40mg).  She is also being treated for Prinzmetal angina based on symptoms and several abnormal EKGs showing an ST depression indicating angina.  This angina causes severe chest pain and palpitations daily.  This is a chronic condition with intense suffering.  She has to take calcium blockers (Ranexa and nitroglycerin sublingual tablets), which does not reduce the pain on most occasions.  This pain causes extreme emotional anxiety, fear and depression.  Patient has been to the ER 40 plus times between April 2021 and October 2022.  She has seen several cardiologists.  Patient is currently taking propranolol daily to keep her heart rate under 150bpm.  She takes Lorazepam for severe anxiety, Ranexa and nitroglycerin sublingual tablets for coronary artery vasospasms that cause severe, daily chest pain.  She has to routinely see a psychologist, psychiatrist, primary care doctor, and cardiologist.  This vaccine caused her to become disabled, reducing her to spend the majority of her time in bed and requires constant care.  All of these health problems began 12 hours after the Janssen vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Prinzmetal angina, Supraventricular tachycardia, Tachycardia, Tilt table test positive
Clinical narrative: Previous report submitted E report # 661786 VAERS ID # 1741754 Date of Report September 28, 2021 Date of Vaccination April 6, 2021 Age at Vaccination: 20yrs COVID-19 Janssen and Janssen - 042A21A Severe tachycardia and supraventricular tachycardia with intense chest pain that radiates to her left arm, neck, jaw, and back.  She has been diagnosed with Postural Orthostatic Tachycardia Syndrome based on a positive tilt table test conducted at Hospital in August 2021.  Just by standing her heart rate increases from 90bpm to 170bpm which is debilitating.  To keep her chest pain below 150bpm she takes Propranolol daily (40mg).  She is also being treated for Prinzmetal angina based on symptoms and several abnormal EKGs showing an ST depression indicating angina.  This angina causes severe chest pain and palpitations daily.  This is a chronic condition with intense suffering.  She has to take calcium blockers (Ranexa and nitroglycerin sublingual tablets), which does not reduce the pain on most occasions.  This pain causes extreme emotional anxiety, fear and depression.  Patient has been to the ER 40 plus times between April 2021 and October 2022.  She has seen several cardiologists.  Patient is currently taking propranolol daily to keep her heart rate under 150bpm.  She takes Lorazepam for severe anxiety, Ranexa and nitroglycerin sublingual tablets for coronary artery vasospasms that cause severe, daily chest pain.  She has to routinely see a psychologist, psychiatrist, primary care doctor, and cardiologist.  This vaccine caused her to become disabled, reducing her to spend the majority of her time in bed and requires constant care.  All of these health problems began 12 hours after the Janssen vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Asthenia, Biopsy artery abnormal
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain scan abnormal, Capillary fragility, Cyanosis, Dyspnoea, Fatigue
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Giant cell arteritis, Headache, Hypoaesthesia, Impaired work ability
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Loss of personal independence in daily activities, Memory impairment, Muscle spasms, Myalgia
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oesophageal obstruction, Pain in extremity, Painful respiration, Peripheral swelling
Clinical narrative: The patient stated that he got GCA from the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Atrial fibrillation, Prehypertension (Marginal blood pressure) and Hay fever. Concomitant products included PREDNISONE, DILTIAZEM HYDROCHLORIDE (CARTIA XT), RIVAROXABAN (XARELTO), LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, MULTIVITAMINS [VITAMINS NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, CALCIUM CITRATE, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and TILACTASE (LACTAID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine). At the time of the report, GIANT CELL ARTERITIS (The patient stated that he got GCA from the Moderna vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  The patient stated getting GCA from the Moderna vaccine and patient should never have gotten the vaccine starting in 27-Jan-2021.   This case was linked to MOD-2022-653944 (Patient Link).