chrisvoncsefalvay/vaers-outcomes huggingface dataset:
monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot".  He states it feels like its hot and then it gets cold.; monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot".  He states it feels like its hot and then it gets cold.; had itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14May2021 (Lot number: EW0170) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT "ASTRAZENECA"; FLONASE ALLERGY RELIEF; OMEPRAZOL E taken for acidosis; LISINOPRIL HYDROCHLORTHIAZID taken for blood pressure measurement. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), JOINT INJURY (non-serious) all with onset 14May2021, outcome "recovering" and all described as "monitoring period he noticed a sensation in his right elbow like "someone smeared it with icy hot". He states it feels like its hot and then it gets cold."; PRURITUS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "had itching".  Additional Information: Patient had no medical history. After receiving the shot, within the 30 minutes the caller noticed that his right elbow, the arm that he had the injection, feels like it was smeared with icy hot. He stated it felt like it was hot and then it gets cold. The caller had itching as well in that spot but it only lasted for an hour and then it went away. The icy hot feeling has been there since the 14May2021 and its not as bad as when it first happened.  No follow-up attempts are possible. No further information is expected.
temperature excursion that occurred several days ago in the Freezer; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer).    Concomitant product use was not provided by the reporter.    It was reported that vaccine that underwent a temperature excursion in the freezer was just found out about the excursion today in an audit.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-676064 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676064:same reporter
Unexplained chronic lower back pain which started 5-6 days after the second injection and has not resolved; now unable to do anything; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old non-pregnant female (not pregnant at the time of vaccination) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0168, Pfizer NTEC), via an unspecified route of administration in left arm on 20May2021 (at the age of 49-years-old) as dose 2, single for covid-19 immunization. The most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0176), via an unspecified route of administration in right arm on 26Apr2021 as dose 1, single for covid-19 immunization. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date on 2021, the patient experienced unexplained chronic lower back pain which started 5-6 days after the second injection and has not resolved. No other trigger. She was an extremely active person and now unable to do anything. She wished she would have never taken this vaccine. The event was reported as serious (disabling/ incapacitating). Treatment included chiropractic care, awaiting patient to begin. The outcome for the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Body aches, chills, fever, nausea, joint pain, fatigue, feeling weak, loss of appetite. Took 2 Aleve pills 27 hours after vaccine. Symptoms started 12 hours after vaccine.  Over 48 hours later symptoms have lessened, but are still there. Appetite is back, fever is gone, chills are gone. Body aches, joint pain, fatigue, and feeling weak are still present.
Hallucinations, altered mental status; Hallucinations, altered mental status; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on Jan2021 and on 21Feb2021 both via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included aplastic anaemia and allergies pencillin. Concomitant medications included eltrombopag olamine (PROMACTA) and darbepoetin alfa. The patient experienced hallucinations, altered mental status on 01Feb2021 12:00. The patient underwent lab tests and procedures which included nasal swab: negative on 02Feb2021. Therapeutic measures were taken as a result of hallucinations, altered mental status included Antibiotics and was in observation. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
severe diarrhea; had a virus in his stomach that caused the diarrhea; fatigue; fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, on 13Mar2021, as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked can he get his second injection of the Pfizer covid-19 injection since he had a side effect after the first injection and can it cause diarrhea. The patient received the first injection of the Pfizer covid-19 vaccine about a month ago. About 3 days later, he experienced severe diarrhea. The severe diarrhea lasted 3 days and then he was recovered. He had a test done with a nasal swab for COVID-19 a week or two later and it was negative. His physician told him he had a virus in his stomach that caused the diarrhea. The patient had fever for couple a days and fatigue but it went in three days. He was scheduled to get his second injection of Pfizer covid-19 vaccine this Saturday and wanted to know was this safe to get it the secondary vaccine. The patient underwent lab test and procedure included SARS-Cov-2 with negative result on an unspecified date. Outcome of the events fatigue and fever was recovered on an unspecified date and for all other events it was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 45-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B (batch number B39CM, expiry date 3rd February 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B and the 2nd dose of ENGERIX B. On 3rd May 2018, the patient received the 3rd dose of ENGERIX B. On 8th June 2018, unknown after receiving ENGERIX B and ENGERIX B and 36 days after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. On 3rd May 2018, the patient received 3rd dose of ENGERIX-B series. On 8th June 2018, the patient underwent for serology test for hepatitis B antibody and found no immunity.
This spontaneous report as received from a consumer refers to her son, a 23 years old male patient. The patient's drug reaction and allergies were reported as unspecified "many allergies". The patient was vaccinated with unspecified number of doses of M-M-R II (lot # not reported) as a child. It was reported that the patient had negative titers for mumps at the time of reporting. The patient did not seek medical attention. No treatment was given. The outcome was unknown. Additional information is not expected.
At approximately 1058, patient reported feeling lightheaded in vaccination chair. Painted closed eyes and slumped over in vaccination chair. Patient was slumped over for approximately 2 seconds.  Nurse supported patient in vaccination chair. Patient opened her eyes immediately. Patient was alert and oriented to person, place, time and situation. Patient reported urinating in chair. Patient reported severe needle phobia, anxiety disorder and history of urination when exposed to needles. Patient given water. Patient able to drink water. Patient offered anti-gravity chair. Two nurses assisted patient into anti-gravity chair. At 1101, nurse assessed patient vital signs: blood pressure 107/84 mmHg, pulse 70 beats/minute, and SpO2 98%. At 1110, patient vital signs reassessed: blood pressure 110/80 mmHg, pulse 80 beats/minute, and SpO2 98%. Patient reported feeling dizzy. Patient given juice. Patient able to juice. At 1120, nurse reassessed patient vital signs: blood pressure 110/82 mmHg, pulse 76 beats/minute, and SpO2 98%. Patient report she felt "better". At 1132, patient reassessed. Patient reported not feeling anxious. Patient able to stand and reported feeling "a little lightheaded". Patient offered to stay for further observation. Patient refused to stay for further observation. Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on v-safe, and to follow up with primary care provider. At 1133, patient left facility with steady gait and unlabored respirations.
One day in August I went to the ER for shortness of breath. They gave me an albuterol treatment and an inhaler.
03/02/2021 vaccination. Within 5 minutes, I was lightheaded and lasted for 30 minutes. I had this with the first vaccine, as well. I did have a fever 4 hours later; was gone by the middle of the night. 03/04/202, The fatigue started to set in. The fatigue lasted for over a month, in which I saw my doctor on 04/05/2021. It lasted for approximately a couple more weeks after.
This spontaneous report has been received from a medical assistant referring to a 2 year old patient. Information regarding pertinent medical history, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (dose, anatomical location, lot#, expiration date and indication were not provided). Concomitant therapies were not provided. The medical assistant reported on an unknown date, that the patient was vaccinated with PNEUMOVAX 23 instead of PREVNAR 13, due to human error, also it was stated that no product quality complaint was involved. Additional information is not expected as the reporter did not provide the contact details.
Patient received PNEUMOVAX vaccine at 1 pm 9/8/16. Patient called at 6 pm same day stating right arm was throbbing and hurt when she moved it. Patient took ALEVE.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt lightheaded/dizzy post vaccination during her observation time. Had patient lie down on floor and offered water. She stayed in store a little later than initial 15 minutes and felt fine after to walk home. States it may have been due to anxiety from whole experience but now feels fine.
Difficulty breathing, like someone is choking me during inhale but no problems when exhaling.  I didn't have this problem while recovering from my covid-19 infection earlier this year. I tested positive for covid-19 on Jan 26, 2021 but eventually got better after three weeks and was back working.  I'm still back working but can't do much more than sit around, I have a desk job. Advil helps but the difficulty breathing comes back after a workout, running, walking up hill, lifting weights.
Palpitations evaluated in Primary Care clinic 12/1/22. Exam, EKG & lab work normal, Zio patch ordered.  Paroxysmal atrial fibrillation diagnosed 12/28/22. Refrral made to Cardiac Electrophysiology. Evaluation completed 1/25/23, started on Flecainide 50 mg bid, Metoprolol ER 25 mg qd, Eliquis 5 mg bid. Side effects of drug were not tolerable and while AF Symptoms lessened they did not disappear completely, so on 3/7/23 Flecainide was DC'd and Ablation scheduled for 4/6/23 Outpatient Pulmonary Vein Isolation via wide area circumferential radiofrequency catheter ablation was performed, with additional ablation of cavotricuspid isthmus and external direct current cardioversion of AF triggered possibly by atrial flutter.
Nauseous; Very tired; Felt like I had a bit of a fever; Feel little nervous; Very large red circle around the injection site; Injection site hot to the touch; Itchy; Arm is Painful; This case was reported by a consumer and described the occurrence of injection site erythema in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site itching, pain in arm, fever and nervous. On 28th August 2019, the patient experienced nausea and tiredness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness and nervous were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness, fever and nervous to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with the dose of Shingrix, had very large red area around the inejction site which was still hot to touch and it was itchy. The patient's arm was painful and was very tired. The first day after vaccination, the patient was nauseous. After vaccination, the patient felt like had fever, but at the time of reporting, did not feel like have fever anymore. The patient felt little nervous. There was discrepancy in the name of suspect given in the source document and that reported in system.
Patient developed a swollen rash at injection site with bruising. Within a couple of days the patients arm became very sore and has been sore for the last month with times she is unable to raise it without assistance. She has been taking Aleve and using Biofreeze on injection site.
I have spoke to patient's father, and he has stated that the child has not has any known adverse reactions
15 minutes after administration, pt developed urticaria on nose which quickly spread to face and arms over 10 minutes. Nose and midface were swelling.  She also had oxygen desaturation to mid 80's and started having seizure activity during that time.  Benadryl , oxygen, and vagal nerve stimulation were administered.  Urticaria resolved within 20 minutes but pt continued to seize and was admitted overnight.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information about patient's concomitant medication, pertinent medical history and drug reactions or allergies was provided. On 17-JUN-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) 0.5ml/once, subcutaneously, lot# K006135, expiration date: 29-APR-2015. No adverse effects were reported. Additional information has been requested.
loss of consciousness 7 hours later/blacked out; rapid heartbeat; Sweats; Arm pain; A Regulatory report was received from a Consumer concerning a female patient of 47 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Loss of consciousness, Palpitations, Hyperhidrosis, Pain in extremity.  The patient's medical history was not provided. Although the patient had loss consciousness before to other vaccines.  No relevant concomitant medications were reported.  On 26 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 010A21A) on left arm for prophylaxis of COVID-19 infection via intramuscular route.  On 26 Feb 2021, seven hours later the patient reports she received a dose of Moderna's COVID-19 vaccine (mRNA-1273) had severe reaction, rapid heart beat and black out, she felt weird and she got up and walked around and she got the sweats, she said she laid on the floor, she woke up and was kind of fine. she suffered arm pain.   The patient suffered loss of consciousness is medically significant.  Laboratory details were not provided.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events, Loss of consciousness, Palpitations, Hyperhidrosis, Pain in extremity was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccines given 7/7/11, developed fever 7/8/11 to 102.7 with multiple seizures on 7/8/11.
Patient inadvertently received two doses of varicella vaccine an subsequently experienced chest pain. Sent to ED for further evaluation.
Headache, fever, pain in the whole body including the abdominal part, extremities and back, dizziness, diarrhea and nausea.
nausea; pain at injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), INJECTION SITE PAIN (pain at injection) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (nausea), INJECTION SITE PAIN (pain at injection) and HEADACHE (headache). On 05-Feb-2021, NAUSEA (nausea), INJECTION SITE PAIN (pain at injection) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medications includes Tylenol and Antibiotic. Treatment information included Dentist Prescription:Tylenol every 6 hours Caller only took 2 Antibiotic
fever & sz;to ER, tx for febrile sz;began sz frequently; from 1 to mult sz episode;pt considered devel delayed & neurologically  impaired;tx w/phenobarb & depakote, but d/c'd d/t poor muscle tone & impaired motor skills;no further sz
11APR91 approx 1-2hrs p/immun pimples/blister like area on legs @ inject site; Seen by MD dx chickenpox; Rash got worse/covered entire body; resembled burns/blisters; MD felt rxn to HIB;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose of SHINGRIX, refer case US2019063718). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient was the caller's husband. The patient received SHINGRIX and experienced injection site pain that hurt when the area was touched. The pain went away in a few days. The patient did not consent to follow-up.
Vaccine Breakthrough. Seen in our office 03/01/2005 with fever and rash. Onset 02/28/2005. Had 10-12 lesions on trunk. Erythematous with central vesicle and few crusted. Itchy. Had varicella vaccine 01/07/2002. DX'd with varicella by Dr. on 03/01/2005.
Pt developed cellulitis at injection site right thigh. Pt was seen by physician and treated with antibiotic. Condition resolved by 03/31/2001.
I've been in general good health for my age with the exception of my kidney disease but over the past few weeks, out of nowhere, a few days before Easter, I began to feel very shaky and have lost 7lbs in the past month. I went to see my primary doctor who thought it may be panic attacks since I was also experiencing fatigue and heart pounding. He prescribed an antidepressant but I didn't like that medication. I went to a cardiologist who looked at the recent full work up that was done prior to my recent eye surgery, and added thyroid function test and he informed me that my thyroid function was up and that I would need to see an endocrinologist. I have made that appointment and am waiting to see them.
6/6 Woke up with allergy symptoms.  Symptoms progressively got worse through 6/9.  It felt like it was a sinus infection that was turning in to bronchitis.  I made an appointment with telehealth and took an at home covid test that was positive. Doctor proscribed an anti-viral molnupiravir.  Doctor follow up on 6/14 doctor proscribed Augmentin, Flonase, and medtros dose.