chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking uncontrollably/shaking violently like seizure attack; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking uncontrollably/shaking violently like seizure attack) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DIGOXIN, DILTIAZEM, FOLIC ACID, METHOTREXATE, POTASSIUM CHLORIDE (KLOR CON), PROPYLTHIOURACIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and APIXABAN (ELIQUIS) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced TREMOR (Shaking uncontrollably/shaking violently like seizure attack). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 12-Jan-2021 for Symptomatic treatment, at a dose of 1 dosage form. In January 2021, TREMOR (Shaking uncontrollably/shaking violently like seizure attack) had resolved.            The patient's symptoms began at 10:00 PM. The patient called 911, and by the time the paramedics arrived, the shakiness started to settle down. The paramedics recommended that the patient take Benadryl to treat her symptoms and left within 30 minutes.   This case was linked to MOD-2021-193735 (Patient Link).; Sender'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.
Hives, swollen lips, started after the first shot very sporadically and they were mild; since 4-5 weeks ago the reactions are severe. Hives all over the body. Swollen lips every morning. Swollen face.
injection site swollen, hard to touch, and painful; fever, waves of chills, body aches, short of breath, chest tightness, SaO2 90-91% room air, slept from 1530 on 12/21/21 to 0630 on 12/22/2021. This morning continue with body aches, and injection site painful to touch, hard, and swollen about 2 inches in diameter. Continue with feeling exhausted and wanting to sleep.
Narrative: 03/25, Moderna , dose #1 04/22, Moderna , dose #2 03/12 COVID swab, result: not detected 10/10 pt cc: fever, cough, chill, loss of smell, dyspnea, diarrhea, fatigue, headach, myalgias, rhinorrhea, sore throat exposure: unknown 10/13 COVID swab, result: detected 10/13 SARS-COV-2 Variant Sequencing result: pending
Patient has had continual pain, discomfort, inflammation and redness at injection site since the vaccination date.
Pain level 8/10 arm throbbing pain woke me up. Felt like my upper arm was throbbing like a heart and was going to burst open. My fingers were swollen and I couldn?t get my ring off. I was unable to extend my arm fully. This lasted 40 hours . Then it subsided to a 2/10 ache in my arm that felt like I had been punched hard and felt like I had a salad plate size bruise on my arm. This lasted 2 more days.
Patient got COVID-19 three weeks ago; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient got COVID-19 three weeks ago) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient got COVID-19 on 2020 and was hospitalized) in 2020. Concurrent medical conditions included Thyroid disorder (Thyroid issues).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, the patient experienced COVID-19 (Patient got COVID-19 three weeks ago). At the time of the report, COVID-19 (Patient got COVID-19 three weeks ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. The caller stated that she was calling on behalf of her son. who presumably received 1st, 2nd and 1st booster shot of Moderna COVID-19 Vaccine (caller did not know dates). also caller did not know for sure, but caller thought her son did not experienced any Adverse Events after any of the vaccines, but the patient got COVID-19 3 weeks ago. It was unknown if symptoms from COVID-19 were still ongoing by the time of reporting. No treatment information was provided.  Company comment: This spontaneous case concerns a 63 years old male patient with no relevant medical history, who experienced the unexpected non serious AESI event of Covid -19, which occurred unspecified days after a third dose (reported as booster)of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that patient got Covid-19 3 weeks ago. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63 years old male patient with no relevant medical history, who experienced the unexpected non serious AESI event of Covid -19, which occurred unspecified days after a third dose (reported as booster)of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that patient got Covid-19 3 weeks ago. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
S. In monitoring area, patient complained of a feeling of swelling and tingling in the lips. She denied shortness of breath, pruritus, or light headedness.   History of multiple drug allergies reviewed   O. BP  166/77  P84  R14  SPO2 95%  Repeat. 159/76 81 14 96%  No rash. No visible facial swelling  No respiratory distress or stridor   Diphenhydramine 50 mg PO given Symptoms resolved over 15 minutes   A. Possible hyperventilation v. allergic response. Rapid resolution rules out anaphylaxis or serious allergy.   P. After 10 more minutes of observation, symptoms resolved.  Discharged in personal vehicle.
Redness and swelling of the back of the tongue - discomfort for two days, and gone in about a week. No difficulty breathing.
nausea; chills; arm pain; body aches/severe under arm pain; fever; injection site itchiness; discomfort; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Age at vaccination 40-years-old), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took keflexin and experienced allergies. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not have covid prior vaccination and not tested for covid post vaccination. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunization on 24Mar2021 at 12:15PM, in left arm and had nausea, injection site pain and itchiness and underarm pain. On an unspecified day in 2021, the patient experienced nausea, chills, arm pain/severe under arm pain, body ache, fever, injection site itchiness and discomfort. No treatment was received for the events. The clinical outcome of the events was recovered in 2021.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained
PATIENT EXPERIENCED A MUSCLE TWITCH AT TIME OF IM INJECTION OF VACCINE.  THE DAY AFTER IMMUNIZATION PATIENT HAD RED BAND ON LEFT ARM UNDER INJECTION SITE WHICH WAS HOT TO THE TOUCH AND ARM WAS SWOLLEN, ARM TURNED PURPLE.   A WEEK LATER PATIENT HAD ULTRASOUND, RESULTS SHOWED  MULTIPLE BLOOD CLOTS IN ARM UNDER THE INJECTION SITE RESTRICTING BLOOD FLOW. PATIENT WAS PLACED ON BLOODTHINNERS. PATIENT STATED SHE HAD WORKED OUT AT GYM THE MORNING OF THE IMMUNIZATION.  HER HEMATOLOGIST STATES POSSIBLE INJECTION TRAUMA CAUSED MUSCLE SPASM AND MAY HAVE CAUSED MULTIPLE BLOOD CLOTS IN ARM.
I have Heart Palpatations that occure atleast 5 times a week. They can last for an hour to 4-5 hours.
10 mins after receiving vaccine pt became diaphoretic, pale, light headed, had abd pain, placed supine on cot, had change in vs (hr 40, bp 76/60), but pulse ox 99% on RA.  Ambulance called, pt treated with epi x1. Felt better in 5 mins Ambulance arrived 5 mins after that and assessed pt.  Ambulance released pt and he was taken to urgent care by a family member for further evaluation
Fever; Chills and Shivering; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Nov-2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea). On 26-Mar-2021, PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (High) High. On 24-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 product use was not provided by the reporter.   ?No treatment information was provided.
pt recv vax; varicella rash, scattered,vesicles w/ itching; no systemic sz, signs otherwise;
Major chills, fever, headache, muscle pain, major tiredness,  nausea, ear ringing
2-3 hours after vaccination, pt had extreme headache, pain and redness at the sight.  Later developed respiratory difficulty, controlled by use of pro-air inhaler.  Next morning pt's headache remained and had large local reaction at the site of the injection.  Pt called the office and came in for an evalution.
He described having a lump in his throat as well as hives and itching 1 hr after his first vaccine.  Then, had taken Benadryl and sx were self limited.    For the 2nd vaccine, he premedicated with Benadryl with a plan to observe 30 min.  Approx 23 min after injection, developed L arm burning and redness.  He developed a lump in his throat.  BP 137/90, HR 71, SpO2 97%.  He was directed to the ER where he received Benadryl, Solumedrol, Pepcid and was discharged home.
This study case was received from the investigator on 13 April 2012. A 29-year-old male subject who had no significant medical history was found to have chest pain, unspecified 29 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 11 May 2011. On 24 May 2011 the subject had an abnormal electrocardiogram. On 25 May 2011 the subject had a normal troponin I level and a normal echocardiogram. The diagnosis of chest pain, unspecified was made on 09 June 2011. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Patient was accidentally given PCV13 instead of HPV #1. No untoward reactions.
Persistent fever, weakness, muscle pain, fatigue, headache, nausea, leg pain, paleness.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/3/2023 HX OF SLEEVE GASTRECTOMY
11/2/21 presents to EC ED with "with slurred speech and right-sided facial droop" and "blurred vision and left-sided neck pain". PMHx "arthritis, carpal tunnel syndrome, osteopenia, cyst of the right kidney".
mild fatigue; run down feeling; Also pain in my arm - I couldn't lay on that side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 10:00 (Lot number: EW0187) at the age of 50 years as dose 2, single and administered in arm left, administration date 24Apr2021 10:15 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "mild fatigue"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "run down feeling"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Also pain in my arm - I couldn't lay on that side".  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No, Reported Event: Extreme fatigue, high fever, pain in all my muscles and joints (extreme) I could barely walk up the stairs. Chills, sweating, sore throat, congestion, migraines, cough . I couldn't even get out of bed. The pain I had in my muscles was so severe it was difficult to stay in one position or find relief. I took OTC Tylenol , Sudafed. I never felt like this in my entire life . Pain in right calf was unbearable. As was pain in my quads, shoulders , traps and neck. Words cannot express or describe what I went thru. I felt like death! 1st/2nd doses - mild fatigue , run down feeling . Also pain in my arm - I couldn't lay on that side. adverse event start date: 03Jan2022, adverse event start time: 11:00 AM, ae resulted in: [None of the above], if patient recovered: Recovered with lasting effects, if treatment ae: No, Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 05Jan2022.  No follow-up attempts are possible. No further information is expected.
Systemic: patient complained of mouth swelling and shortness of breath-Medium; symptoms lasted 1 day
4 months after 3rd shot got 24 hour headaches. Other symptoms then started- fatigue, hair loss, numbness in hands and feet, joint pain, fainting, rapid heart rate, POTS, now at 9 months after shot started stomach issues. It hurts after eating anything.
This report described the occurrence of an injection site reaction in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/22/03, the subject reportedly received his fifth injection of Infanrix. The mother stated that her son developed an injection site reaction characterized by redness and swelling within 24 hours of immunization. He also developed fever. Reportedly the physician suggested that the mother apply cold packs to the injection site and give her son ibuprofen. As of 4/25/03, the events reportedly persisted. On 7/15/03, the mother reported, Our pediatrician saw [the subject] for his local reaction (redness, swelling from elbow to shoulder). She did not evaluate him for his systemic reaction - low grade fever, and behavioral issues - irritability, aggressiveness, short term memory problems, alternating periods of hyperactivity versus extreme tiredness and depression (two days), cold and cough, spaciness (staring), feeling of bowel movement need when urinating, several urinary accidents, etc. The mother did not report the outcomes of these events, except that the depression resolved after two days. She declined to grant authorization to contact the pediatrician.
Pt hospitalized 12/24 for unrelated reason now positive for COVID on 1/17/2022 checked due to fever no other symptoms being treated with Remdesivir.
Pt recv vax on 11/3/95; on 11/7/95 pt exp chicken pox
Patient received less than half of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 6th April 2022, the patient received the 2nd dose of Shingrix. On 6th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.       Additional Information: GSK Receipt Date: 6th April 2022 Reporter's Comments: The pharmacist reported that patient came for second dose of Shingrix series.  During administration, some of the product leaked out of a gap between needle and syringe.  The pharmacist estimated patient received less than half of the vaccine.  At the time of reporting, patient had not been redosed. The reporter consented to follow up. Additional Supportive Information: The patient received less than half dose of shingrix which led to accidental underdose.
Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot.  Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ).  Administered epi-pen immediately, and called 9-1-1.  Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls.  A nurse at the facility was the one to administer her epi-pens.  They were the patient's prescribed epi-pens
Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; This is a spontaneous report from a contactable consumer or non hcp reported for herself. A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on Apr2021 10:00 hr (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Lobster from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks, no covid prior vaccination and covid was not tested post vaccination. The patient experienced headache, diarrhea and myalgia all over body still two weeks after 1st dose on Apr2021. AE resulted in none of the above (unspecified details). Patient received no treatment. Clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks.; Stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks.; This is a spontaneous report form a contactable consumer. This patient (reported for himself):  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0185), via unspecified route of administration, in left arm on 13May2021 12:45 (at the age of 65-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included allergies and high blood pressure. The concomitant medication of the patient included nifedipine (NIFEDIPINE), terazosin (TERAZOSIN), labetalol (LABETALOL), potassium (POTASSIUM) and valsartan (VALSARTAN). Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 15May2021 04:00 the patient experienced stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks. Outcome for all the reported events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
t104.4 & vomiting "6-8" hr p/shot; resolved 24 hr tx APAP & Advil
Father reports that while changing her diaper, baby threw out her arms and "her eyes fixated for three seconds". Baby continued to have these episodes and was referred to a pediatric neurologist.
Patient developed 2 red bumps around injection site (look like insect bite) 3 days after injection. Very itchy. She is using an antihistamine cream on it.
Extreme fatigue and exacerbation of my multiple sclerosis and rheumatoid arthritis symptoms
18May2019/ received the first dose of Shingrix/ did not return/ to receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th May 2019).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not return to receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Mandatory flu vaccine for employees. I received injection around 1:45pm on 9/29/2020. Approximately 45 minutes later, I felt a little light headed. Continued job. Went to bed at 8pm and felt really exhausted. Woke up on 9/30/2020 at 1:30am with uncontrollable shaking. I was very disoriented. My husband (who is a nurse) took my temp and it was 104.8. My blood pressure was 156/82. He gave me a tylenol and took my temp 20 minutes later and it was 102,6. He then took me to ER. I was put in a  negative pressure room. They did a rapid Covid test, CBC and CRP. Covid was negative and lab work was within normal limits. The injection sight was swollen and warm to the touch. Every bone and muscle in my body was hurting. My throat was sore and scratchy but no shortness of breath. I had a temp of 100.7 in the ER and still very disoriented. Dr informed me that I was having a sever auto immune reaction to the flu vaccination. He stated rest, fluids and to return if symptoms persisted on 9/30/2020. My husband brought me home and I slept for almost 24 hours. I am still experiencing body aches and dizzy to stand or ambulate on 10/01/2020. I am fever free at this time. I have been told by my employer that I cannot return to work until I am fever free for 24 hours. Again, the body and bone aches persist.