chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix in October 2019 / second dose of Shingrix was not administrated yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019, batch number-53RF3 expiration date-17th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient didn't received second dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, patient did not received the 2nd dose yet. No further events were reported. The reporter did not consent nor declined Follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The room was very warm. She was a little diaphoretic.  The vomiting happened about 3 times then subsided. Patients color came back. She sat for a few additional minutes. Drank some water and left clinic completely stable. She has had a history of fainting with heat and with injections.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pruritus
Clinical narrative: Patient started to c/o itchy face about 9 mins after covid 19 Pfizer 1st dose vaccine . Vitals taken at 1044 BP 134/86, O2 98, P 82 at 1050 Dexamethasone 4mg IM lot 7051558 Expiration 02/2022 and Diphenhydramine 50mg IM lot 080008 Expiration 08/2022 was given, vitals at 1052 BP 138/96 O2 98% P80 at 1105 patient stayed she felt better no more itching reported. Vitals at 1105 VP 124/90 O2 99, P78. Patient was examined by doctor.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the second dose of his COVID vaccine a week early. No adverse reaction during the 15minute wait time.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Initial pain (dull ache) in my left shoulder that subsided after 48 hrs. unless I raise my arm 90° from my abdomen or pick up anything over 5 lbs. Reported to Moderna after 4 weeks of pain.. Seen by my GP  on 05/03/2021 who prescribed Naproxen. This did not help at all. I could not take steroids due to acute diverticulitis. Reported to Moderna again on 05/20/2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: At 11:45 AM the day following my Vaccination, I began having chills. Then I had 102 degree fever. This last for roughly 24 hours. I has have heat and redness at the injection site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix vaccine was administered subcutaneous / given SC instead of IM; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2021, the patient received Shingrix (subcutaneous). On 17th May 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix subcutaneously instead intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021105195:same reporter (deleted case)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: client stated feeling dizzy few seconds after injection and had vasovagal response and passed out for approx 3 seconds, v/s remained stable, client required no further treatment, observed for a total of 35 mins, client states feeling better after 5 mins.  left facility in stable condition, ambulating w/o assist, accompanied by mother ( who also received injection w/o incident)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Morning sickness
Clinical narrative: I experienced on 05-11-2021, morning sickness, nausea and vomiting. I was about 4-5 weeks pregnant at he time of vaccination. I contacted my midwife via telehealth portal and gave me nausea medication.  My EDD: 12-15-2021.   ****The dose of 04-27-2021, is actually my second, first dose. my first dose was deemed invalid due to storage.  ***
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Redness on upper arm around the place that took the dose after take the vaccine for around 9 days. Didn?t take medicine. The redness disappear after two days. The lymph is swollen (and pain if I touch it) on the side that take the vaccine after 9 days after taking vaccine. Then, it recovered after gradually.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient c/o feeling dizzy, SOB, chest pain , sharp pain to the heart, numbness to the face. BP 120/80 Pulse 76 taken by nurse on site. EMS was also called to the scene. Patient refused ambulance transport and signed refusal form. Patient is okay and left facility with husband. Advised to monitor conditions closely and call 911 if it gets worse.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: unauthorized use of COVID Vaccine.  Discussed with parent, patient had fever and body aches after both vaccines. No other complaints.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Two days following vaccination, on May 1 2021, the patient experienced fatigue, headache, and swollen lymph nodes in the armpits. This lasted until May 10 2021. The patient notified the pharmacist today at the time of her second dose of the side effects experience with her first dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Glossodynia, Hypoaesthesia oral, Influenza like illness
Clinical narrative: First 3 days (72 hrs) I had severe flu symptoms, the following week to 10 days after the dose, fatigue and malaise.  At day 9 following dose (May 9) and since, there has been redness and swelling of mouth and tongue, bleeding during toothbrushing, painful tongue (like a burn from hot liquid) and excessive dryness of the lips causing splitting and peeling, diminished feeling in the inside of the mouth (no diminished feeling on tongue), and loss of taste.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Malaise, Mouth haemorrhage, Oral discomfort, Oral mucosal erythema
Clinical narrative: First 3 days (72 hrs) I had severe flu symptoms, the following week to 10 days after the dose, fatigue and malaise.  At day 9 following dose (May 9) and since, there has been redness and swelling of mouth and tongue, bleeding during toothbrushing, painful tongue (like a burn from hot liquid) and excessive dryness of the lips causing splitting and peeling, diminished feeling in the inside of the mouth (no diminished feeling on tongue), and loss of taste.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: First 3 days (72 hrs) I had severe flu symptoms, the following week to 10 days after the dose, fatigue and malaise.  At day 9 following dose (May 9) and since, there has been redness and swelling of mouth and tongue, bleeding during toothbrushing, painful tongue (like a burn from hot liquid) and excessive dryness of the lips causing splitting and peeling, diminished feeling in the inside of the mouth (no diminished feeling on tongue), and loss of taste.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: A patient was administrated with adjuvant component of Shingrix; A patient was administrated with adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient was administrated with adjuvant component of Shingrix, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, no patient's identifiers, no lot number and expiration date and no vaccination date was provided No adverse event was reported.  The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt under age. true age 16 y/o.  Originally registered D.O.B
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discharge, Underdose
Clinical narrative: ADMINISTERED COVID VACCINE (MODERNA 1ST DOSE) TO PT ON 5/14.  PT WORKS IN THE STORE AND WAS ON HER WAY TO THE BACK OF THE STORE WHEN SHE NOTICED A CLEAR LIQUID RUNNING DOWN HER ARM FROM THE VACCINE ADMIN SITE.  PT THEN TOOK OFF THE INJECT-SAFE BANDAGE AND SAID THERE WAS A CLEAR LIQUID POOLING IN THERE AS WELL.  FROM THE DESCRIPTION, IT SEEMED THAT THE MAJORITY OF THE ADMINISTERED VACCINE LEAKED BACK OUT.  PER RESEARCH FROM MODERNA/CDC, IT IS ADVISED THAT PT RECEIVE THE DOSE AGAIN, IN THE OPPOSITE ARM.  PT WAS INFORMED ACCORDINGLY.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Patient positive for COVID-19 on 04/12/21 after completing vaccination. Asymptomatic and PCR test collected the same day came back negative.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Bilevel positive airway pressure, Gastrointestinal disorder, Mental impairment, Respiratory failure
Clinical narrative: Mental Decline. Went into respiratory failure when released from rehab facility.  Also had digestive issues.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left arm swelling, redness, warmth and tenderness.  Started on Bactrim for cellulitis treatment.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea then vomiting for a full 24hrs after receiving vaccine.  It started approx 24hrs after receiving vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Loss of consciousness, Seizure
Clinical narrative: Almost immediately after patient received the second dose of vaccine he stood up and passed out to the floor. He slightly seized for a few seconds until it stopped. When patient came to he stated that his knee hurt but he didnt believe he hit his head and he felt a bit light headed. Patient laid down for a while with us until he started to feel better. His BP was 102/58, but normally  runs low. He said that he has passed out before and has been under a lot of stress, also had not eaten that morning before getting vaccinated. His significant other was with him and was planning to drive home. Patient was offered a call to EMS but refused.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Immediate post-injection reaction, Pharyngeal swelling
Clinical narrative: Anaphylaxis 2 minutes after administration; gagging and heaving; throat swelling until she couldn't breathe; 0.3 mg EPIPEN administered into left thigh; EPIPEN relieved acute throat swelling so that patient was able to breathe; blood pressure 182/127 and pounding headache; transported to hospital by EMS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Anaphylaxis 2 minutes after administration; gagging and heaving; throat swelling until she couldn't breathe; 0.3 mg EPIPEN administered into left thigh; EPIPEN relieved acute throat swelling so that patient was able to breathe; blood pressure 182/127 and pounding headache; transported to hospital by EMS.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: PATIENT WAS FEELING FAINT AFTER SHOT.  I TOLD HIM TO PUT HIS HEAD DOWN AND HE STARTED SWEATING.  HE ALSO STATED HE WAS HAVING PROBLEMS BREATHING.  I GOT A COLD COMPRESS WHICH HELPED SOME.  I MOVED HIM TO LAYING DOWN AND TOOK HIS BLOOD PRESSURE.  PRESSURE WAS GOOD.  PULSE WAS 49.  MONITORED PATIENT FOR A LITTLE.  HE STARTED FEELING BETTER AND GOT HIM BACK TO SITTING AND WAITED ANOTHER 20-30 MINUTES.  PATIENT LEFT WITH HIS FIANCE.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: Patient presented to the ED and was subsequently hospitalized with anemia within 6 weeks of receiving COVID vaccination.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Shortly after vaccination became warm, diaphoretic and pale BP 78/96
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Needle became partially unscrewed resulting in a partial dose administered. Unable to determine how much vaccine was administered compared to how much was lost on the patient's arm. Following CDC guidelines, we administered a full dose in the opposite arm immediately. The patient was notified.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: The patient, was administered Moderna for his second dose, while he received Pfizer for his first vaccination. The tech checking the patient in, double verified with the patient that he was getting his Moderna vaccination. Pt states, ?yes, I am receiving Moderna for my second vaccination.? The car window states moderna 2nd dose from registration. The RN administering vaccines, confirmed with pt, ?are you receiving your second dose of moderna?? Pt again states, ?yes, I am receiving Moderna for my second vaccination.? After being vaccinated, the scribe, noticed the vaccination card has Pfizer for first vaccination. Clinical Lead, went to our Tech Master to verify in the system what the pt received for his first dose. System shows that pt received Pfizer for the first dose. Pt was observed for 15 mins and displayed no adverse reactions. Pt is alert and oriented x4, walking and talking independently. Medical Director, was called and notified.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: I started to feel my leg starting to shake on and off but when the weekend came around , it started to shake more and more and the pain started to spread
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: First got Hives, was prescribed Steroides after subsided started again with small red lumps like bug bites, and still happening. Constant itching, went to Dermatologist twice, no cure, prescribed itch cream.  I have never had Hives or any kind of itching like this all my life until I received the vaccine.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient started feeling dizzy immediately after vaccine administration. Patient ate only a toast this morning. Patient given crackers and juice, water. Patient felt better Vital signs were stable  Discharged to home
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Four weeks after my vaccination I tested positive for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Difficulty breathing and tightness in chest  after 2nd dose Moderna. Resolved after 15 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest X-ray normal, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Acute onset tachycardia with palpitations 21 hours after the second dose of Moderna for Covid 19.  I had a pulse oximeter reading heart rate 170 and O2 saturation of 94%.  I took aspirin 81mg po once. After 15 minutes, I had left sided parasternal chest pain. I called my husband to take me to the Emergency Department. In the ED, EKG confirmed sinus tachycardia; cardiac enzymes were normal. I was given aspirin 162mg and nitroglycerin sublingual with relief within 30 minutes. Bedside echocardiogram did not reveal pericardial effusion or pericarditis. CT Angiogram of Chest did not identify pulmonary embolism. Chest xray was normal, no pneumonia or pneumonitis. D-dimer was slightly elevated. I asked asked to stay for 23 hour observation admission.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Myocardial necrosis marker normal, Palpitations, Sinus tachycardia, Tachycardia
Clinical narrative: Acute onset tachycardia with palpitations 21 hours after the second dose of Moderna for Covid 19.  I had a pulse oximeter reading heart rate 170 and O2 saturation of 94%.  I took aspirin 81mg po once. After 15 minutes, I had left sided parasternal chest pain. I called my husband to take me to the Emergency Department. In the ED, EKG confirmed sinus tachycardia; cardiac enzymes were normal. I was given aspirin 162mg and nitroglycerin sublingual with relief within 30 minutes. Bedside echocardiogram did not reveal pericardial effusion or pericarditis. CT Angiogram of Chest did not identify pulmonary embolism. Chest xray was normal, no pneumonia or pneumonitis. D-dimer was slightly elevated. I asked asked to stay for 23 hour observation admission.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, Laboratory test, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Pain in soles of both feet, knee pain, joint pain, pain in knuckles
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid factor
Clinical narrative: Pain in soles of both feet, knee pain, joint pain, pain in knuckles
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Constipation, Cough, Nausea, Pain in extremity, Pulmonary pain
Clinical narrative: Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Fall, Mental status changes, Syncope
Clinical narrative: Patient had syncopal episode at home on 3/12/21, same day as second dose of vaccine, and fell. Was on floor for 8 days until admitted to hospital upon being found by family. Admitted with altered mental status and AKI.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: On 4/10/2021 started itching, with rash on Left Lower back, size of an orange," horrible itchy and raised." Also developed rash on leg, which improved after use of cortisone. Left back has not improved with treatment of cortisone and benadryl. Made appointment with PA on Monday 5/24/2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: Pt reported that they developed a rash after receiving the first dose of Pizer COVID vaccine 4/27.  Pt came for second dose on 5/18 but was turned down at clinical review.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: "Covid arm" My left upper arm has a swollen, red, hot, tender patch and my left underarm is sensitive
Sex: U
Vaccine: HIBV, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Possible administration of Bexsero, Hiberix, Menveo and Boostrix / exposed to -11.9°F for 2 hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Hiberix, Menveo, Boostrix and Boostrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Hiberix, Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was a medical assistant.  The reporter had called to report possible administration of Menveo, Boostrix, Hiberix, and Bexsero exposed to minus 11.9 degree farenheit for 2 hours on 11th May 2021. No further events were reported. The agent tried to give time to the healthcare professional to recollect information but could not retrieve at the moment of the call.  The agent tried several times to reach the healthcare professional to retrieve information but reached voicemail every time.  The reporter did not decline nor accepted to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood pH decreased, Cardio-respiratory arrest, Death, Dyspnoea
Clinical narrative: 3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection.  She remained on mechanical ventilation, with profound metabolic acidosis.  She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98.  The patient had a cardiopulmonary arrest in the intensive care unit.  1 round of ACLS protocol was performed, with return of spontaneous circulation.  After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death.  The patient was kept on mechanical ventilation, and she passed away.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Intensive care, Mechanical ventilation, Metabolic acidosis, Musculoskeletal chest pain
Clinical narrative: 3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection.  She remained on mechanical ventilation, with profound metabolic acidosis.  She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98.  The patient had a cardiopulmonary arrest in the intensive care unit.  1 round of ACLS protocol was performed, with return of spontaneous circulation.  After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death.  The patient was kept on mechanical ventilation, and she passed away.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, Sepsis, Septic shock, Vomiting
Clinical narrative: 3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection.  She remained on mechanical ventilation, with profound metabolic acidosis.  She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98.  The patient had a cardiopulmonary arrest in the intensive care unit.  1 round of ACLS protocol was performed, with return of spontaneous circulation.  After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death.  The patient was kept on mechanical ventilation, and she passed away.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching
Clinical narrative: About 20 minutes after the patient received her dose, she became extremely nauseated and dry heaved.  The patient did take a Zofran ODT to alleviate the nausea and in about 10 minutes, was feeling much better.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Pyrexia
Clinical narrative: six hours after the vaccination chills, low grade fever, just exhausted and that lasted  12hrs, migraine of 12 days after  the vaccination , took Excedrin and talk to the doctor and the Excedrin help resolve the headache. Due to the  drug on the market and off the market and by the time was she was able to talk to the doctor she was able to resolve it self she did not. Virtual appointment she was able to determine the state of the head ache and was able to give directive for next steps if the head ache worsen. got better and did not have to go the hospital.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: at 3:43pm pt. reported dizziness. pt. placed assisted in gurney and placed in supine position. with BLE. elvauated  vitals monitored pt was given fluids and snacks as requetsed Vitals BP 119/72    P-73   RR-18,  o2 SAT 99% RA  @4pm vitals BP 101/68 P-68 - RR-17 o2 SAT 99%RA
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: There is no adverse event. This is an administration error. A 17 year old received the Moderna COVID vaccine 1st dose on 4/17/21. This was not caught until prior to 2nd dose administration on 5/13/21. Per CDC guideline, patient is to continue the Moderna series. So patient received Moderna COVID vaccine 2nd dose on 5/13/21.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Myalgia, Nausea, Pruritus
Clinical narrative: 3.5 HOURS AFTER THE VACCINATION, PT EXPERIENCED ITCHING AND HIVES.  NO SHORTNESS OF BREATH AND NO SWELLING OF THE TONGUE OR LIPS.  THAT EVENING PT. C/O GENERALIZED MUSCLE ACHES, JOINT PAIN, NAUSEA AND DIZZINESS.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 3.5 HOURS AFTER THE VACCINATION, PT EXPERIENCED ITCHING AND HIVES.  NO SHORTNESS OF BREATH AND NO SWELLING OF THE TONGUE OR LIPS.  THAT EVENING PT. C/O GENERALIZED MUSCLE ACHES, JOINT PAIN, NAUSEA AND DIZZINESS.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: On day 2, I had chills and mental confusion  On day 2 -4 days, I felt all the following symptoms:  Fatigue headache dizziness brain fog nausea (no vomiting)  day 5 - brain fog
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: On day 2, I had chills and mental confusion  On day 2 -4 days, I felt all the following symptoms:  Fatigue headache dizziness brain fog nausea (no vomiting)  day 5 - brain fog
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Retroperitoneal haematoma
Clinical narrative: Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Nontraumatic retroperitoneal hematoma.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient positive for COVID-19 on 04/16/21 after completing vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: received a dose of Bexsero on July 18,2019 / May 18th 2021, the patient received Trumenba as a second dose; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th May 2021, the patient received the 2nd dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a dose of Bexsero and she received Trumenba as a 2nd dose which led to interchange of vaccine products. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient, is a 17 y/o male that received his first dose of Moderna vaccine. Pts. mother, incorrectly registered the pt under the incorrect DOB. Pts. card has Moderna written on the car window sent from registration. The tech, checked pt in and confirmed directly with the pt his DOB. Pt states, "yes, my DOB is" After being vaccinated by, RN, the vaccination card was handed back to the mother by. Pt mother states, "the DOB on the vaccination card is incorrect, pts DOB is", I told registration to correct it from the beginning." The pts. DOB was corrected in the system by the tech, after the incident occurred. Dr. was contacted and informed of the situation. Pt did not have any adverse reactions after waiting in observation for 15 mins. Pt is alert and oriented x4. Pt is walking and talking independently. VAERS report was completed and submitted.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Myalgia, Sleep disorder
Clinical narrative: I experienced greater and greater arm pain in my left arm that seemed to immobilize my arm. The pain seemed to involve the muscle but felt deep in the joint. I could not lift my arm above my head, could not sleep on the side of injection, for several nights. I alternated acetaminophen and ibuprofen  every 4 hours for several days for relief.  (I get regular flu shots and timely immunizations and have never experienced this kind of reaction).  The height of the reaction was within the first 24 hours. The symptoms of arm immobility and pain lasted at least 2 weeks with gradual relief each day. Today, 5 weeks out, I feel almost 100%, but there is some lingering discomfort in the left arm when raised above my head to full extension.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Arthralgia, Back pain, Exposure during pregnancy
Clinical narrative: A few minutes after being vaccinated I started to feel abdominal pain in the lower part of the belly, in the lower back and hips, as the hours passed the pain intensified. My Dr. diagnosed it as colic, I am 18 weeks pregnant, the pregnancy is still normal and everything is fine. The pain lasted 36 hours and diminished little by little until it disappeared.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: A few minutes after being vaccinated I started to feel abdominal pain in the lower part of the belly, in the lower back and hips, as the hours passed the pain intensified. My Dr. diagnosed it as colic, I am 18 weeks pregnant, the pregnancy is still normal and everything is fine. The pain lasted 36 hours and diminished little by little until it disappeared.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Fatigue, Headache, Muscular weakness
Clinical narrative: 3/27/2021 vaccination Couple hours later, I got home. I got up to go down the stairs, my leg felt weak and I fell to the ground. I tried to get up but couldn't get up. My husband tried to get me up but couldn't. I crawled to the couch. My son came lifted me up, gave me a walker and I walked to my bed. I laid down and was there for quite a while, few days with loss of energy. I had a HA during these days. Called my Doctor the next day and said I could not take Tylenol, to just rest. No temp. Couple days later, HA still there but I could function. The HA lasted for about a week.  *still experiencing the fatigue, weakness  *virtual telehealth appt upcoming
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Headache, Pain, Rash
Clinical narrative: Hot & cold, body aches, wrists hurt, headache, itchy rash all over my body
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Hot & cold, body aches, wrists hurt, headache, itchy rash all over my body
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Computerised tomogram head, Dizziness
Clinical narrative: The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed.  The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision  and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired.  After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hypotension, Loss of consciousness
Clinical narrative: The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed.  The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision  and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired.  After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Pain, Peripheral coldness, Seizure
Clinical narrative: The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed.  The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision  and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired.  After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Urinary incontinence, Urinary tract infection
Clinical narrative: The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed.  The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision  and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired.  After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Injection site reaction
Clinical narrative: Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with movement now. Right arm numbness down to right leg numbness at times. Left side cheek, throat numb feeling. Tongue feels numb and down thoracic spine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pharyngeal hypoaesthesia
Clinical narrative: Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with movement now. Right arm numbness down to right leg numbness at times. Left side cheek, throat numb feeling. Tongue feels numb and down thoracic spine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site / redness still present; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 2nd dose of Shingrix. On 15th May 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix and the next day she noticed redness at the injection site and redness was still present. The reporter did not consent to follow-up with her healthcare professional. The reporter consented follow up with her.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Injection site pain
Clinical narrative: Severe headache, mild shortness of breath/cough, fever of 101.1F, muscle ache at injection site, chills
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache, mild shortness of breath/cough, fever of 101.1F, muscle ache at injection site, chills
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: 5 minutes after vaccine patient started feeling dizzy and fainted, while body was shaking for 20 seconds. Body then regained consiousness
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Janssen COVID vaccine administered to 15 year old client by LPN.  Client did not meet  current age requirement to receive Janssen COVID vaccine.  No adverse reaction noted after 15 minte oberservation. Instructed father and client to contiue to monitor for adverse reactions. Return to clinic or ER as needed.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Scleroderma
Clinical narrative: Autoimmune disease scleroderma  had been essentially dormant, now in flare and professing quickly.  Could be coincidental but happened within a couple weeks of second shot, which knocked me out for about three days.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: None, patient had a sore arm. She recieved 2nd vaccine 5/19/2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood fibrinogen, Blood test, Influenza like illness, Injection site erythema
Clinical narrative: One week after the first injection I developed some blurring of right eye but I thought I just needed new glasses. One week after the second injection I rapidly developed severe loss of vision in the right eye. I have been evaluated medically and was found to have right optic neuritis with significant loss of vision in the right eye. I had injection site redness and swelling after both injections and moderate flu-like symptoms for a day after the second injection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Optic neuritis, Vision blurred
Clinical narrative: One week after the first injection I developed some blurring of right eye but I thought I just needed new glasses. One week after the second injection I rapidly developed severe loss of vision in the right eye. I have been evaluated medically and was found to have right optic neuritis with significant loss of vision in the right eye. I had injection site redness and swelling after both injections and moderate flu-like symptoms for a day after the second injection
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Blood test, Dizziness, Weight decreased
Clinical narrative: 19 y/o male with no past medical history who presents with dizziness post vaccination. Patient states that this is his first vaccination in a two-dose series. Patient denies previous reactions to vaccinations in the past. Patient denies headache, vision changes, sore throat, difficulty breathing, shortness of breath, itch or rash. NP and Paramedics at patient side. Patient states that he has not had anything to eat since 1 am and drank only a small amount of water. Patient provided with water and a protein bar. Glucose was obtained and measured 225. Patient denies increase thirst, hunger but states that he has lost some weight recently (patient pushes carts at the supermarket sometimes in the sun). Mother states that patient went for a physical today and pending blood work. Patient vitals within normal limits, 133/89 BP, 98% RA, 77 HR, Resp 12. Patient physician office called and notified of elevated glucose here at the vaccination site. The RN states that patient will be seen tomorrow am to obtain further labs. Prior to discharge patient glucose rechecked x2 and measured 99 and 98. NP still instructed patient to keep tomorrows appointment for labs. Patient was monitored for 30 mins with resolution of dizziness. Patient discharged home in stable condition.