chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up 3 am next morning and felt like she couldn't move limbs hardly at all and "felt like a boulder sitting on my chest".  She also felt nauseous, dizzy and a headache.   By 5 am the "heaviness" of her limbs and her chest and throat felt so heavy patient was scared and was transported to ED by her husband.  ED physician didn't think it was an anaphylactic reaction, but just thought it was an extreme adverse reaction. EKG, labs including Cardiac enzymes, and chest xray were all normal.  Given IV benadryl, IV zofran, Aspirin,  tylenol and norflex.  during ED visit.  Discharged from ED 10:30 am.   Took Benadryl and Solumedrol dose pack once home.  by Saturday patient felt 95% better, but as of this report, still says arms still feel heavy and she is fatigued.  Went back to work today.
3 to 5 minutes after administering vaccine mom say son is not looking good -lightheaded -profuse sweating -He felt like he wanted to faint -EMS was called Patient stated he played 2 games (sport) the previous day and did not rehydrate
Information has been received from a physician concerning a 4 yr old male who at 12 months of age, in approx 2002, was vaccinated with a dose of varicella virus vaccine live. He was seen in the office on 09May05 and had approx 50 chicken pox. It was noted that the child experienced no complications, did not need hospitalization, and is recovering. No additional information was provided. Additional information has been requested.
metalic taste; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 26Jun2021 15:00 (Lot number: EW0198) at the age of 46 years 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: DYSGEUSIA (non-serious) with onset 26Jun2021 15:00, outcome "recovered" (2021), described as "metalic taste"; NAUSEA (non-serious) with onset 26Jun2021 15:00, outcome "recovered" (2021), described as "Nausea". Therapeutic measures were not taken as a result of dysgeusia, nausea.  Additional Information: Patient did not provide information regarding the reported adverse event(s) with the use of the product. Patient is willing to be contracted again by Pfizer on the reported adverse event. Dose 2 administration date reported as 17Jul2021 on 15:00 at right deltoid with route intramuscular with lot number as FA6780. On 17Jul2021 15:00, patient experienced metallic taste as non serious with outcome recovered. No Treatment was received.  No follow-up attempts are possible. No further information is expected.
Information has been received from an emergency medical technician concerning a 15 year old female with asthma who was vaccinated with the complete series of GARDASIL on an unspecified dates in the past. In September 2008, the patient experienced shortness of breath. The shortness of breath occurred when she was stressed or sitting still and not when exercising. She was seen in the office and Echocardiogram was performed but no result was provided. She has been prescribed antibiotics and 2 "puffers" (unknown names and manufacturers for both). At the time of reporting, the patient's shortness of breath persisted. Additional information has been requested.
Patient was first given ROTA by mouth Tolerated fine. Then Patient then was given Pediarix in also in  Upper right Thigh area and tolerated well.  After giving patient PVC-13 in right thigh. I notice the patient holding breath and not breathing and eyes rolled in back of head for about 2 seconds, I called for Nurse Manager RN and Provider FNP and Dr. in the room to help
Patient reported immediately feeling numbness/"pins and needles" down her left arm after injection. Monitored for about 25 minutes and no other signs or symptoms of a serious reaction or injection site reaction occurred. When patient left the pharmacy she stated the "tingly feeling" was only in her fingertips.
After the vaccination extreme Fatigue, Nausea, and Depression. I contacted my doctor, but I was exposed to someone and did not have COVID-19. Due date for the baby is January 16.
28 DAYS AFTER VACCINE, PATIENT ENDED UP WITH BRONCHILITIS/ASTHMA
Awoke 9-23-16 with fever, chills, (L) deltoid hot to touch, redness, swollen. Given TDaP 9-21-16. TX with KEFLEX one tab QID x 7 days.
Initial report received on 19 November 2008 from a health care professional. A male patient had received a dose of FLUZONE SV 2008-2009 on 05 November 2008. The lot number, route and site of administration was not provided. Approximately 12 days post-vaccination, the patient began to experienced symptoms that were later confirmed by his family physician to be Bell's Palsy. It was not reported whether any diagnostic test's or laboratory data were completed. It was also not reported whether any treatment was received for the event. The recovery status of the patient was not provided. The reporter is not convinced the event is related to the vaccine. Documents held by sender: None. The reporter for this case is the same as for case 2008-03427.
22AUG91 immun given & exp sl elevation of temp; 23AUG91 fever ended about noon; pt was well til 25AUG91 vomited once-no temp elevation til 26AUG91 t105.1; Hospitalized on 27AUG91; 30AUG91 surgery for ruptured appendix; 10SEP91 recovered;
Pt recvd 1st dose of Energix-B vax 23FEB90,2nd dose 20MAR90 & 3rd dose 21AUG90.P/ 3rd dose titer indicated non-responder;recvd booster vax from different lot & titer showed seroconversion.
12/2/11 Rec'd phone call from patient's older bro. He reports his younger bro rec'd 2 shots on 11/30/11 & states his bro. c/o upper arm feeling hard at injection site with mild swelling on 12/1/11. Advised to apply warm compresses to injection site & gave pain med of choice as comfort measure. Instructed to seek medical evaluation at local ER, if no improvement to left arm.
Received vaccination at 10:36 am Saturday, 2/13/21. At approx. 9:15 pm began with headache, then ,rapid heartbeat...agitated thoughts;  fears there were ''things in my room or on me'' ...chest tight to breathe.  Chills.;did not sleep well.   Sunday   Next day, 2/14/....beginning 6am......awoke with body aches , joint pain, headache continued., weakness in limbs,  extremely tired.  Afternoon of 2/14/21...began runny nose, violent repeating sneezing spells ...chills ..By 5 pm on Sunday  2/14 symptoms were subsiding...slept better.  Today 2/15  much resolved except for runny nose and some sneezing .  No Fever was ever present.
right armpit also hurts and it is inflamed; right armpit also hurts and it is inflamed; after vaccination his right arm injection site started to hurt really bad; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (right armpit also hurts and it is inflamed), VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad) and AXILLARY PAIN (right armpit also hurts and it is inflamed) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad). On an unknown date, the patient experienced SWELLING (right armpit also hurts and it is inflamed) and AXILLARY PAIN (right armpit also hurts and it is inflamed). At the time of the report, SWELLING (right armpit also hurts and it is inflamed) and AXILLARY PAIN (right armpit also hurts and it is inflamed) outcome was unknown and VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has not taken any treatment medications.
Severe swelling and pain in left arm; Severe swelling and pain in left arm; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; Severe swelling and pain in left arm & armpit (assume it is a very swollen lymph node).; 3rd booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included cold. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and lansoprazole (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 07Mar2021 and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 as a single dose for COVID-19 immunisation. On 08Oct2021 at 20:00, the patient experienced severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node). On 04Oct2021, the patient underwent PCR test via nasal swab and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe swelling and pain in left arm & armpit (assume it was a very swollen lymph node) was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt woke up with tingling sensation in feet and numbness up to knees, progressed up to right below shoulders throughout the day. Ended up being hospitalized with transverse myelitis. Was given steroids, metoprolol, pantoprazole, heparin,  and other treatments (that is all patient could recall, wasn't sure of the rest) in the hospital. Discharged, but still having lasting numbness/tingling in hands and feet.
wide-spread rash, hives, and itching.  Swelling and feeling of warmth around injection site.  Taking diphenhydramine otc to help resolve symptoms
Pt received Prevnar during morning appt. Called c/o pt with SOB, fussy. Pt had shallow breathing, no cyanosis, ? secondary to pain, given blow by O2, started crying more alert, breathing comfortably, O2 taken off; pt comfortable, d/c to home, to ER if repeat respiratory distress.
Patient reported:  Fever-chills, Nausea, Headache, Dizziness. Started that afternoon and peaked around midnight with uncontrollable shivering. Pt treated side effects at home with home care.
9-6-13 client c/o "heart did not feel right and jaws did not feel right" at 1140A. After receiving the vaccines named below.
Initial misuse report received from a nurse on 07 November 2013. The patient had received ACTHIB, MENACTRA, DAPTACEL, FLUZONE and ADACEL. On 31 October 2013, temp went down to 33 F. On 01 November 2013, temp went down to 33F. On 04 November 2013, temp went up to 50.7 F. On 06 November 2013, the alarm went off at 29F. As of 31 October 2013, all MENACTRA were unstable. As of 06 November 2013, all products except ACTHIB are unstable for use. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
24 hours after vaccination given in Left deltoid, patient developed painful, left axillary swelling.  Patient given Ibuprofen, compresses and Keflex.
05/09/2022 I got really hot and cold the same night as the vaccine. I was very tired and a consistent symptom I had prior with my other vaccines. I also had headaches very bad that were on and off up till 05/18/2022. I had swelling on the inside of my ear as well and overall body aches and muscle aches as well. I did have a runny nose as well and a lot of sneezing as well as a sore throat. I did have to miss work for about 5 and I did go to the doctor 05/13/2022 with a virtual appointment. I did receive two COVID-19 PCR test symptoms and a Flu test as well since I had symptoms of both, which both came back negative. I was having sneezing coughing, I could not focus at all either. I am still feeling very unhealthy and fatigued. My nose is still congested, my throat is still sore and I am coughing as well. I am also still having issues with focus and concentration.
8PM that evening devel rash clusters of bumps on legs, buttocks, arms;SOB for about 30min, joint pain, flu like sx;self administered Deredol;
pain in the left side of her face; pain traveled to her ear; hard for her to hear; suspected COVID-19 symptoms; A spontaneous report was received from a consumer concerning a 48-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis  The patient's medical history was not reported. No relevant concomitant medication were reported  On 15 jan 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 037K20A) via unknown for prophylaxis of COVID-19 infection.  On 15 feb 2021, approximately 3 days prior to receiving  mRNA-1273  the patient experienced symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis.Treatment for the events included different antibiotics and a steroid  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events, symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis  were unknown.
Redness, swelling, soreness, pain over about a 48 hour period.  Treated for possible cellulitis.
Patient presented on 10/18/2021 with lightheadedness + shortness of breath for 3 weeks- was orthostatic Found t have + clot left greater saphenous + was started on anticoagulants
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender with unknown concurrent conditions or medical history. The nurse stated that the unspecified numbers of patients, on unknown dates were vaccinated with VARIVAX (Merck) (dose, route, frequency, lot number not provided) that were improperly stored. No adverse events were reported due to the incorrect product storage. At the time of this report, the outcome of the patients was unkonwn. Additional information has been requested.
Patient had and uneventful COVID 19 infection in Dec 2019. Recovered quickly and completely. Had Moderna Vaccine April 29, 2021 with only a temporary low grade fever as the side effect. Underwent his second Monderna vaccine June 6, 2021 and 2 days later developed a high grade fever and severe chest pain. Admitted to the hospital and had a positive troponin I to 18. Also COVID SARS 19 PCR positive on admission. Cardiac Cath showed normal coronaries with non thrombosis. Cardiologist confirmed acute myocarditis due to troponins, chest pain, and segmental wall motion abnormalities by Cath and echocardiogram. ID has been consulted and confirmed diagnosis as well.
Patient reported sleepiness and dizziness, camps and soft stool, has been nauseous
high fever & presumed febrile seizure 5-10 mins; only treatment given was APAP;
pt recv vax & devel fever to 102 several hr later then 2 febrile sz shortly thereafter pt hosp x 4 days w/full sepsis w/u;remained febrile x 4 days;all cult were negative;
A physician reported that an elderly patient received a dose of Flu Shield (2001-2002 formula ) vaccine and subsequently developed shingles. The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Severe migraine headaches, dizziness, painful canker sores on roof of mouth, numbness on right side of body from toes to head, brain fog, light sensitivity, intermittent ringing in ears, nausea, vomiting, fatigue, chills/fever, severe body aches. Went to hospital ER on 4/16/21 - had CT scan, ECG. Returned to ER on 4/17/21 - symptoms had escalated. MRI was performed, she was kept over night for observation.  4/20/21 - back to ER - Abdominal pain radiating to every nerve in body, burning in neck, nausea, throat itchy and closing. Released after more testing. 4/21/21 - Appointment with neurologist who ordered Stat Lumbar Puncture, MRV, MRA, stayed overnight again. Was given and/or prescribed varying drugs to combat pain, swelling, etc.
The patient received the vaccine on 1/27/21. He had a therapeutic INR on 1/25/21 and also on 2/15/21. On 2/3/21 he developed expressive aphasia with naming difficulties and generalized weakness. CT brain on 2/15/21 showed a left hemisphere subcortical infarction. He has been on warfarin for atrial fibrillation for 9 years without any strokes prior to this.
Pt this dose as third dose.  This shot is out of guideline, pt should have only had two shots. So far, he reports no problem.
Expired Drug Used; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received DTPa (Infanrix) (expiry date 10-JUN-2023) for prophylaxis.   On 11-JUL-2023, the patient received Infanrix. On 11-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used 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 Information: GSK receipt date: 13-JUL-2023 The reporter reported that expired dose of Infanrix was administered to a patient which led to expired vaacine used. The reporter consented to follow up.
Swelling and pink/purple discoloration to lower legs below knee and feet bilateral. Lasted approximately 3-4 hours with progressive resolution. Mother did give another dose of Tylenol around 6pm as infant was fussy.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Course: It was reported that 80 year old male and female patient received the Pfizer Bivalent COVID vaccine back in Oct2023 (Late clarified as Oct2022) and in the past months they got a positive PCR test so they were positive for COVID. The reporter had called to question about when they should get the Bivalent Booster now if they had their original Bivalent Booster back in October, when now should they (Incomplete sentence) now they are advising over age 65 to get a second Bivalent Booster. The patient was vaccinated in a clinic somewhere else and the reporter did not have any other details about the vaccine the patient received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175805 same reporter/drug/AE, different patients;
This spontaneous report was received from a certified medical assistant via a company representative refers to a 83 year old male patient with no drug reactions/allergies. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001690, expiration date 08-MAY-2014) subcutaneously. On 22-AUG-2013, 3 days after onset of therapy the patient developed a pruritic ras on (his) lower back. The patient was on dialysis for chronic kidney disease and had renal failure. The outcome of th event was unknown. The patient was prescribed ATARAX (unspecified dose and frequency) as treatment for the event. Laboratory diagnostic studies were unspecified by the reporter. The patient sought medical attention by visiting the physician on an unspecified date. Causality was not reported. Additional information has been requested.
Ringing in my right ear; severe hearing loss. Tinnitus. I previously suffered from Ménière's disease. I have not had any effects of clogged ears in over a year. Never had an issue with ringing in the ears. 11/22/2021: Visited ENT to discuss. Initially cleaned-out ears for any wax buildup. Performed a hearing test. Seemed to believe it was the return of the previously diagnosed Ménière's issue.  I did not give it any thought until I began reading of others having the same tinnitus issues after receiving the vaccine.
Menstrual cycle extremely disrupted, shortened. Period was the strangest of my life.  Extremely little to no bleeding four days into the ?period? I thought I was pregnant. My Cycle is very regular and I have never observed a cycle like this on my adult life.
States that she did not begin itching or breaking out with hives until the next day. She wasn't sure it was due to flu shot or cleaning chemicals.
Information has been received from a consumer concerning her daughter an 18 year old female with allergy to (unspecified medication) who on 23-FEB-2009 was vaccinated with a "third dose" of GARDASIL. Lot number was not available. Concomitant therapy included MENACTRA. The patient's mother reported her daughter experienced rash, fever, headache and stiffness in her neck on 06-MAR-2009 after receiving her third dose of the vaccine. Additional information is not expected.
Information has been received from a nurse concerning a 13 month old male with no pertinent medical history, drug reactions or allergies who on 04-APR-2008 was vaccinated subcutaneously with 0.5 ml of ATTENUVAX (Enders- Edmonston) (Lot# 659617/0187X) and subsequently developed "all over body rash" and a fever of 101 F. There was no concomitant medication. Medical attention was sought via an office visit. No lab diagnostic studies were performed. At the time of reporting the patient was recovering. There was no product quality complaint. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologic Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.