chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 05/16/03 from an LPN, regarding an adverse event occurring in the US, it was reported that an 18 year old female pt received a dose of TD ADS ADULT, Lot # U0831AA (site/route not reported) on 05/12/03.  The expiration date for this product is 10/28/04.  Three days later, the pt went back to the clinic's office with a severe headache, neck aches, and pain down her spine, everything hurt. The pt was treated with Flexeril for the pain and Motrin. Reportedly, the pt is improving.
Fever 100.3, severe joint and muscle pain, severe headache, severe fatigue, mild nausea, mild abdominal pain
Patient experienced weakness, fatigue, dizziness, and tingling of her arms and rest of body the morning after she received the vaccine.
neck is swelling between the collar bone and going up her neck; Headache; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired). At the time of the report, SWELLING (neck is swelling between the collar bone and going up her neck), HEADACHE (Headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
Same day swelling, pain, redness and induration in upper arm distal to injection site, lasting over 72 hours at time of reporting
Pt called stated he had tingling in hands & behind knees, dry mouth, anxiety, light headed, SOB. Sx started 2-3 hours after vaccine was given. Pt states he has never had a rxn to a shot. Says he has asthma & has had SOB off and on far about a month. Use of inhaler improved SOB. Pt will go see MD if sx continue or get worse. Pt unsure if sx related to shot or if it is anxiety or asthma attack.
Jynneos (Monkeypox vaccine), administration date: 7/26/22. Given in left arm, sub cut route. Tolerated well in clinic. Patient reports felt like a larger lump formed at injection site over next few days, then noted decreasing in size (now about less than dime-size), did not experience  pain.  She reported improvement noted in this #1st dose in series. She reports injection site has been slightly swollen for past month, no swelling in triceps area, nor lymph nodes.
Dizziness, numbness and tingling bilateral legs and arms, developed after 5 minutes of vaccination. Vaccine at approx 1:00 PM, 1:05 dizziness, 1:07 numbness and tingling legs, spreading to arms. Denied SOB, chest pain.
a mild anaphylactic reaction; tongue numbness/lips and tongue started to get numb; throat swelling; she was getting a migraine; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; This is a spontaneous report from a contactable other health professional (patient).   This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730, Expiry Date Mar2021), via an unspecified route of administration at single dose in the left arm on 28Dec2020 for Covid-19 immunisation. Medical history included allergies to beestings. There were no concomitant medications. On an unspecified date, the patient experienced a mild anaphylactic reaction, tongue numbness, she was getting a migraine, throat swelling, she was flushed and her head got sick, and she got congested. No treatment required. The outcome of the events was recovered. The events were described as follows: Patient stated that she took the first dose of the Pfizer vaccine on 28Dec2020. She had an immediate reaction where she was thinking that she was getting a migraine; those symptoms included that the room got loud, she was flushed and her head got sick, and she got congested. She works at a hospital, and she got the vaccine at that hospital where she works. She waited the standard 15 minutes after the injection and then she walked back to her office. After 25 minutes had passed after getting the vaccine, her lips and tongue started to get numb and she could feel like her throat was starting to swell. Se did not take Benadryl, although in hindsight, she should have. She does have allergies to beestings, but the people administering the product did not know that. The primary care physician said that he did not think that she should take the second dose.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mild anaphylactic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
3/4/21-  experienced skipped heartbeats which later found out are pre-ventricular contractions (PVC) that preceded chest pain with shortness of breath  that would last between 2-3 minutes.  Went to my PCP and  ER and  no one could tell me what was happening.  Occurred from 3/2/2021  -7/16/21.  I?m a pharmacist who counsels  and administers all covid vaccines and when VIS was updated to include myocarditis/ pericarditis and symptoms,,  as I was counseling a patient it dawned on me that those were my symptoms.  My doctors could not find anything but I began treatment for pericarditis on my own,.  On 7/14/21 I started taking ibuprofen 600mg  three times a day for 14 days .   I have not had  any episodes since 7/16/21.
Syncopal episode x 5-10 seconds approximately 3-4 minutes after receiving 3 vaccines.  Client had not eaten all day.  Was given 2 oreo cookies to eat approximately 15-20 minutes prior to vaccination.  BP and pulse monitored.  Ambulated to lobby with nurse assist.  Instructed to wait in lobby x 15 minutes and may be discharged if feeling okay.  P/C to Mom the next day, patient was "fine."  Instructed to make sure he reclines for future immunizations and to eat before coming in.
Dry Cough; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix (intramuscular) .5 ml. On 16th July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced dry cough. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the dry cough was unknown.   It was unknown if the reporter considered the fever and dry cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The pharmacist on the line reporting that the patient developed a fever the evening of the dose and it was persisting.  The patient said their fever was around 100 degrees Fahrenheit. The patient provided no information on the dry cough, just mentioned to contact that they had one.  The reporter did not know whether this was the 1st or 2nd dose did not capture during the call. The reporter consented to follow up.
Briefly, Patient is a 79 y.o. male vaccinated current smoker with a 60 pack year history of tobacco use who is admitted with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia. His past medical history is notable for COPD, CAD, CKD Stage 3, prostate cancer, brain aneurysm s/p coiling, hypertension, depression and anxiety. He initially developed symptoms consisting of headache, shortness of breath and malaise on 10/5/21. Home COVID test was positive on 10/6. He presented to the ED on 10/9/21 with dyspnea and had oxygen saturations in mid 90s on room air. COVID-19 test was positive and he was started on prednisone 40mg daily and azithromycin. Home bronchodilators were continued. On 10/10/21, he re-presented to the ED with anxiety and was prescribed lorazepam. Oxygen saturations at that time were >95% on room air.    Today, he re-presented to the ED with respiratory distress with respiratory rates in the 60s and oxygen saturations 80% on room air and was initially placed on BIPAP. Labs notable for D dimer 5400, ABG 7.19/50/86, WBC 20, K 5.8, Cr 2.3. He continued to have increased work of breathing. Goals of care discussions were had with patient and wife and they requested preference to be full code and he was intubated by anesthesia. He received 1L NS, dexamethasone 20mg, ceftriaxone 2g, fentanyl, versed and rocuronium. BP 126/90 following intubation and oxygen saturations were 100% on FiO2 100%. He was transported to hospital via air.    On arrival to the Hospital, he is intubated, normotensive with oxygen saturations 100% on FiO2 1.0 and we have been able to wean FiO2 to 0.35.   Additional information for Item 12:  Hospital Pneumonia Due To COVID-19 Chronic Obstructive Pulmonary Disease Exacerbation (HCC) Cachexia (HCC) Pneumonia Community Acquired Tremor Hyperreflexia Depression Anxiety
Myalgia, chills, headache, low-grade fever (99.9F), nausea (no vomiting), dysesthesia.
lethargy; myalgia; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), MYALGIA (myalgia) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LETHARGY (lethargy), MYALGIA (myalgia) and FATIGUE (tiredness). On 07-Feb-2021, LETHARGY (lethargy), MYALGIA (myalgia) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-043740 (Patient Link).
Sore arm; Vomiting; A spontaneous report  was received from a consumer concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 0316204) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) sore arm. vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, vomiting was unknown.
sore underarm; lymph node was swollen in the axillary area. my armpit; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient received the first dose of vaccine on an unknown date. The patient medical history was not reported.  The patient's concomitant medications were not reported.  On 13Feb2021 the patient woke up the morning with a sore underarm, she noticed that her lymph node was swollen in the axillary area. Her armpit and its the same side that she received the injection. She wondered if she should take any thing like ibuprofen or put a warm compress. The outcome was unknown.    Follow-up (13May2021): Follow-up attempts completed. No further information expected.
swelling around one eye; hives on arms, neck and chest; This case was reported by a pharmacist via call center representative and described the occurrence of periocular swelling in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   On 30th June 2022, the patient received Shingrix. On 30th June 2022, less than a day after receiving Shingrix, the patient experienced periocular swelling and hives. On an unknown date, the outcome of the periocular swelling and hives were unknown.   It was unknown if the reporter considered the periocular swelling and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022. Reporter's Comments: The patient had hives on her arms, neck and chest. The patient also had swelling around one of her eyes. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Pt received Pfizer x2.  Pt tested COVID + on 10/14/21 and admitted to hospital for COVID on 10/14/2021. Pt receiving remdesivir and dexamethasone.
Symptoms (Occurred 11/19 at 4:45pm): Palpitations Shortness of breath Chest tightness Near syncope Dizziness & anxiety   Emergency room visit, admitted for continued monitoring, discharged due to asymptomatic 11/20 at 8:30  Diagnosed with bifascicular bundle branch block - NSR, RBBB, LAFB ECG's, x_ray, and TTE performed Troponin: < 0.03 Potassium: 3.7meq/L Covid test: Negative   Background:  no previous indications or occurrences of issue, sister with WPW, mother with MI in 60s  Notes from ER: "Patient is a 31 year old year-old male presenting with palpitations, dyspnea, chest pain, resolved. Upon arrival the patient is afebrile, hemodynamically stable, comfortable appearing, normal work of breathing on room air, normal heart tones, no lower extremity edema or asymmetry.   Differential diagnosis includes arrhythmia, ACS, heart failure, electrolyte derangement, thyroid abnormality, pulmonary embolus, pneumonia, pneumothorax, acute intoxication, withdrawal, and others.   Based on the differential, IV access obtained, labs are sent, repeat EKG obtained, chest x-ray performed.   Overall the patient's clinical exam is reassuring.  No clinical signs of decompensated heart failure without a history to suggest this.  Low suspicion for ACS without acute ischemic changes on EKG although no prior EKG for comparison.   EKG is notable for right bundle branch block with left anterior fascicular block with no prior for comparison.  No clear delta wave, no epsilon wave, no other evidence of malignant arrhythmia at this time.   Considered pulmonary embolus however the patient is without symptoms of shortness of breath at this time, no hypoxemia, no tachycardia, low risk by Wells, negative PERC.   Labs revealed grossly normal electrolytes, renal function, TSH, with negative troponin.   Cardiology and electrophysiology were consulted due to concern for his episodes of palpitations, lightheadedness, which in light of his EKG showing bifascicular block, was concerning for an episode of complete heart block.   The patient remained asymptomatic in the emergency department.  He was admitted to the cardiology service for telemetry and further evaluation management."
Irregular heartbeat; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route administration in the right arm on 26Mar2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive other vaccines within four weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021, the patient experienced irregular heartbeat. The treatment received for the reported event was unknown. The clinical outcome of the event irregular heartbeat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 29Mar2021 03:00 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included pitavastatin calcium taken for an unspecified indication, start and stop date were not reported.  The patient experienced heart attack due to blood clot in rca. occurred on 27Apr2021 at 11 pm. The patient was hospitalized for the reported events and was Life threatening (immediate risk of death from the event). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events which includes Emergency Heart Cath and Stent. The outcome of the events was recovered with sequel.   No follow-up attempts are needed. No further information is expected.
For quality, patient reports burning, aching, throbbing, tightness, pain, and dull. For severity, he reports moderate. For associated symptoms, he reports no vomiting, no sensitivity to light, tearing/watery eyes, no confusion, no slurred speech, no double vision, no dizziness, and no sore throat. Hx of chicken pox. The headaches are very unusual. Woke up with it. No associated dizziness. Neck slightly off still and tight. No prior activty out of usual. No rash. On Zyrtec for sinus issues and allergies. Right half of head sore/tender - felt funny feeling and scalp tender to touch.. No vision changes. No additional stressors. No head injury prior. No hand weakness, fumbling or tingling. I cu coffee in am. Admits not drinking enough H2O. Hx of left leg DVT approx 10 yrs ago. 1-2 81 mg ASA daily.  LAst 3-4 mos noted issues w/ peanuts. Cough and then vomits. No SOB or tongue swelling. 66 y/o that presents for headache and stiff neck after receiving his 2nd pfizer covid vaccination on 4/23/21
This medically confirmed spontaneous report (initial receipt 06-NOV-2014) concerns a 62 year-old female patient with no known allergies. On an unknown date in October 2014, the patient received flu vaccine (manufacturer and batch number not provided) and subcutaneous ZOSTAVAX (batch number not provided) 0.65 ml both vaccines were given in the left arm. On an unknown date in 2014, the patient experienced swelling, itching and redness at the injection site. There was no rash. The swelling at the injection site somewhat had decreased. The patient's husband contacted their health care provider who advised them to keep monitoring these events. Outcome was reported as not recovered.
SWELLING, REDNESS, FEVER, AND KNOT AT INJECTION SITE. PT. HAS BEEN EXAMINED BY MD IN OFFICE ON 4-6-2010 AND NO SYMPTOMS AT THAT TIME
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. Au3917B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 18-Nov-2023, PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.
Large Painful, Swollen area around injection site that is very very itchy and has been for 5 days so far. It's constantly itching and burning.
Covid-19 Pfizer bivalent given instead of Covid-19 PFR-BTN Pfrizer as patients second dose.
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis. On 3rd December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The reporter called to report that she administered the second dose of Shingrix to a patient before the recommended 2-6 month window of time (second dose was given early), which led to drug dose administration interval too short. Patients personal healthcare professionals information was not known by the reporter. The consent to follow up was denied.