chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large Covid arm 3 inches across and 4 inches deep got Covid arm again; very tired; slept for 36 hours straight; loss control of bladder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, PHENYTOIN SODIUM (DILANTIN D.A.), SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, CALCIUM, COLECALCIFEROL (CALCIUM WITH D3), SIMVASTATIN, WARFARIN and METOPROLOL for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder) outcome was unknown.            This case was linked to MOD-2021-311021 (Patient Link).
Moderna COVID-19 Vaccine EUA Felt fine for about 8 hours. Got severe case of chills overnight. Headache the following morning. Seems to have subside by about 24 hours later
Information has been received from a medical assistant concerning a 6 month old patient who on 29-SEP-2008 was inadvertently vaccinated with PNEUMOVAX 23 vaccine (lot # 655668/1004F) 0.5 mL IM, instead of  pneumococcal conj vaccine (manufacturer unspecified) because the PNEUMOVAX 23 vaccine viral did not provide an age or age group. Concomitant therapy included DTaP (+) hepatitis B virus (+) poliovirus vaccine inactivated (manufacturer unspecified), and Hib conj vaccine (manufacturer unspecified). No adverse events reported. The medical assistant indicated that one way to help prevent this from re-occurring in the future is to label the vials according to targeted age range. She reported that the patient was fine. The patient sought unspecified medical attention in the office. Additional information has been requested.
I have a very regular cycle that was disrupted for 3 months following this vaccine, finally regulating again this cycle.  NOBODY will listen to me because of age - but I am currently in fertility treatments and know that I am not yet approaching menopause because of that.  STOP ignoring the issues.
Patient was asleep by 7:30pm on 1/10/07. Around 8:15 he started crying and screaming in his bed and was restless. Mom went in to get him and picked him up. His body would tense up and go stiff and flat as a board for about 5-10 seconds and then release. About 30 seconds to a minute later he would repeat this stiffening again. During the first episode this lasted for about 15 minutes. The whole time he was going through this mom was holding him in her arms while they say on the couch. He would repeatedly call out " I want mommy" as if he didn't even recognize that mom was right there and he was in moms arms. He was not cognizant of what was going on around him at all. As soon as it was over he went right to sleep as if nothing happened. This same thing went on at 9:30 and 11pm. It may have happened a fourth time, mom can't remember but the last time was at 11:15pm. Each time that it went on the reaction time was shorter. By the final time it lasted only about 3-5minutes. Every time he would wake up from his sleep crying and thrashing around very disoriented. He continued to go through the contraction and stiffening episodes and calling out I want mommy yet not recognizing that he was in mom's arms. He would not respond to anything that you said to him or asked him. If I asked him where he hurt or to point to where he hurt, he did not respond at all.
Almost two months after receiving the Pfizer Bivalent booster, I started to show symptoms of COVID-19. Those symptoms included a fever, aching joints, cough, a runny nose and chills. I tested myself at home and the test came back negative. I tested again two days later and tested positive. I contacted my PCP and he recommended I take OTC products to help me through the virus.
LETHARGY; UPPER LEFT EYELID IS COMPLETELY SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the only side effect patient experienced was lethargy (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy was not reported. On an unspecified date in DEC-2021, the patient received additional non-company suspect vaccine BNT 162 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination.  On DEC-2021, the patient experienced his upper left eyelid is completely swollen and has been twice the size of right eye. The patient also visited ER (Emergency room) and was given Zyrtec which did not worked for him and other treatment remedy was given (unspecified). (Dose number in series 2). It was reported that, he would need a steroid or anti-inflammatory.  The action taken with BNT 162 was not applicable. The outcome of the upper left eyelid is completely swollen was not reported. This report was non-serious.
I developed severe shoulder pain that progressed that night to generalized joint pain. Then chills, low grade fever, headache and general malaise. I felt like I was hit by a truck. This lasted till approximately noon on 7/3/2018. Although the joint pain and fever have subsided I still feel very tired.
It was reported that a female pt received a Fluzone vax on 10/20/99. Reportedly on 10/21/99, the pt developed pain at the injections site that radiated to the neck and arm. The pt also had a decreased range of motion.
48 hours of chest pressure/tightness , 1/19 just after midnight woke up with chest pain and tachycardia he 140s and impending sense of doom. Arrived at ER. Cxr , cardiac markers, ekg negative.  1/19 evening still experiencing pressure and tightness, radiating jaw pain, palpitation,
pt had temp of 103-105 for 5 days p/inject; no report of sz;
Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat and tongue. Took two benadryls and four ibuprofens.
patient called an hour after shot saying he is having rash and not feeling well. when he came to pharmacy, he was almost collapsing his wife brought him in, he was having difficulty breathing , high heart rate, and rash red, high patches all over his body ..admistered  EPI-PEN and called EMS, he left the store with them symptoms improved 15-20 minutes after the epi-pen injection.
patient received 3 doses of FLUZONE QUADRIVALENT with no reported adverse event; Initial information from was received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves a 1years old male patient who received 3 doses of Influenza USP trival A-B high dose subvirion vaccine [Fluzone senior] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and Hepatitis a vaccine (Hepatitis A) for immunization.  It was reported that the patient received first dose of suspect Influenza USP trival A-B high dose subvirion vaccine (batch number: UJ696AA) (formulation, lot number, strength, route of administration, administration site: unknown) on 11-Nov-2021, second dose on 20-Dec-2021 and third dose on 18-Feb-2022 (via intramuscular route in the right thigh) for immunization with no reported adverse event (product use issue).  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product use issue).  At time of reporting, the outcome was Unknown for the event (product use issue).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient states injection site became red, swollen, and itchy on 01/18/2011.  Patient advised to use ice on the injection site and Tylenol for any discomfort per Dr. Also for patient to return to office if symptoms persist.
Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.
headache, muscle pain, fever (100.2), nausea, chills, joint pain
Stiffness & pain in arm 3-4 days after administration. Went to MD who referred to rehab. The massaged arm to spread vaccine but still no relief. Started on steroids & had MRI which indicated needle punctured tendon.
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp.   50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away.  Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
First Dose: Sore Left Arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EJ1686, Expiration Date: 31Mar2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetanus (maybe July thinks last July). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovered" (16Mar2021), described as "First Dose: Sore Left Arm".  Additional Information: Caller states she had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. There is no other product present. Reporter states at first patient was offered the Moderna and patient changed when they offered the Pfizer, because of the breast issues from the Moderna. Prior Vaccinations (within 4 weeks), patient had received both doses of the Pfizer Covid Vaccine. There was know none family medical history relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Shortly after receiving the shot (Saturday), I developed a large red welt at injection site that was warm & painful to the touch. About 24 hours later, it started itching at injection site. I'm filing this claim about 64 hours after receiving the shot, and these symptoms are diminishing, although not completely gone. Later in the evening (Saturday), I noticed that I was very tired and went to bed early. By the time I woke up the next morning (Sunday), I ached all over and had a low-level headache, in addition to the fatigue. I experienced these symptoms all day Sunday, but they had resolved by the time I woke up Monday morning.
PT IS GOING TO BE DOING IVF,  HER OB/GYN DID BLOOD WORK TO CHECK HER IMMUNITY TO SOME DISEASES AND IT WAS FOUND SHE DID NOT HAVE IMMUNITY TO VARICELLA.  THEY HAD PT CONTACT US TO GET A VARICELLA VAXINE.  IT WAS APPROVED BY THE PROVIDER THAT SHE COULD COME IN FOR A NURSE VISIT.  PT CAME IN FOR SAID VISIT AND DID NOT INFORM STAFF SHE WAS ON A MEDICATION THAT AFFECTS HER IMMUNE SYSTEM (STELARA).  THE VACCINE WAS GIVEN BY THE MA.  WHEN ENTERING THE VACCINE INTO THE PATIENTS CHART, A CONTRAINDICATION WARNING CAME UP REGARDING GIVING A LIVE VACCINE WHILE ON STELARA.  THE CURRENT EMR SYSTEM DOES NOT WARN OF THIS WHEN THE ORDER IS ENTERED, ONLY AFTER WHEN VACCINE IS BEING GIVEN.  THIS IS GOING TO BE ADDRESSED WITH IT.  ONCE DISCOVERED WE CONTACTED THE PATIENT TO LET HER KNOW THAT SHE MAY DEVELOP CHICKEN POX AND TO MONITOR SYMPTOMS.  AN INCIDENT REPORT IS BEING FILED.  THE PRACTICE MANAGER AND THE MEDICAL DIRECTOR HAVE BEEN NOTIFIED.  AS OF TODAY, PT HAS NOT DEVELOPED SYMPTOMS.  PT IS FOLLOWING UP WITH OB/GYN TODAY.  PT WAS TOLD TO NOTIFY DERMATOLOGY WHICH IS PRESCRIBING THE STELARA.
Chills, fever, headache, muscle aches, severe joint pain and swelling in knees, random acute pains in ear and abdomen, some mild nausea for about an hour after fever spiked. Fever went to 103 before I took fever reducing medication (ibuprofen).  Temperature reduced to 101 after lukewarm shower and ibuprofen. Now 24 hours after vaccine, temperature is elevated slightly from my norm (hovering around 100), head ache and joint pain is persisting.
Fridge temp went out of range by 4 degrees overnight on Sunday due to storm, was closed 1/17. Vaccine was administered to patient
Information has been received from a physician via a company representative concerning a 17 year old female patient with an unremarkable medical history and no known drug reactions/allergies who on 17-APR-2007 was vaccinated with Gardasil (Lot #654510/0962F). Concomitant therapy included Menactra and "T-DEP vaccines". On 17-APR-2007 the patient experienced pain at injection site and felt faint right after receiving this initial dose. The patient felt fine upon observation by the health care provider about 20 minutes after receiving the injection. It was noted the patient received her vaccine injection on an empty stomach. Subsequently, the patient recovered from pain at injection site and felt faint right after receiving initial dose. It was also noted the patient will receive future doses of Gardasil. No further information is available.
I woke up in the middle of the night shivering and chattering teeth uncontrollable.  I had a 102.6 fever.  After about an hour, the chattering and shivering subsided, but I felt nauseous at that point.  I had a 101 fever most of the day.  the next day I was down to 100. Then on the third day, the fever was gone.  I did not report these early symptoms to V-Safe because I was too sick to figure out the iphone app.  In addition, my left arm was incredibly sore.  I was unable to get my shirt on or off and lift my arm very much.  I've never had such a sore arm after shots.  This lasted about 3 days.
Malaise. Muscle aches. Sore throat. Runny nose. Cough - 3 days.
Pt began having swelling and discomfort in R axillae. Felt that there were palpable lymph nodes; after palpating she experienced numbness and burning pain across R breast and around R upper arm
pt recv vax 17JAN97 & 19JAN97 pt devel a recurring chickenpox-like rash in the diaper area, w/greater than 50 lesions;the rash would disappear p/3-4 days & reappear 2-3 days later;the pt rash persisted as of 13MAR97;
Information has been received from a consumer for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with no drug reactions/drug allergies reported and no pertinent medical history, who on 17-JUL-2009 was vaccinated IM with 0.5 ml first dose GARDASIL (lot number not reported). Concomitant therapy included Omeprazole. The patient stated she came pregnant after getting her first dose of GARDASIL, she was " 1 month or 5 weeks pregnant". When asked she verified that she was not pregnant at the time of vaccination. The patient did not have any regular doctor. No laboratory tests were performed. No adverse event reported. The patient sought unspecified medical attention. Follow up information has been received from a consumer who stated that she received one injection, she lost the baby and she was pregnant again (WAES 0910USA03215). At the time of this report the patient's outcome was unknown. Upon internal review, to lose a baby/abortion was determined to be an other important medical event. Additional information has been requested.
Pt became unresponsive on 2/21 and was taken to the ED. COVID test was positive, CT showed large left-sided intracranial hemorrhage with midline shift, pt was intubated and transferred to critical care. Per pt and family wishes, patient was transferred for terminal wean and end of life care. Pt was extubated at 1:00 PM on 2/21 and passed away at 3:03 PM
Had a sore arm that day, and was more sore next day to the point of not wanting to do much with it. Two days after getting the vaccine the arm was feeling better, however I started to notice muscle spasms. There was twitching, especially in my left calf (same arm as injection), and a feeling of strain and/or numbness. Today, 3 days after vaccine, the twitching and spasms continue, and have been felt in my back, all up and down left leg, and random intermittent places on body (right thigh). Feeling a bit nauseous as well, though not sure if this relates to increased anxiety due to odd adverse side effect post vaccine.
pt devel 4 rash spots (hives) on abd-noted on 24SEPAM;also had local rxn of swelling on rt arm, also red;29SEP97 no more rash spots devel & the 4 have disappeared;
Janssen Covid19 Vaccine EUA  Been telling the Doctor for months about the discomfort in my right arm since getting the vaccine..  Soreness, aching, pain travels to elbow , shoulder and neck.  I have lost half the strength in my arm.  I can't sleep do the the discomfort.  Basically I'm very uncomfortable on a daily basis.   Unable to function normally.
Immunizations given 8/18/10. 8/24/10- Diffuse rash. 8/25/10 - Seen in office with urticaria/some erythema multiforme - minor. No fever. No other illnesses present. Treatment: Diphenhydramine/Cetirizine.
IgAN relapses; Gross Hematuria; This is a literature report.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown", described as "IgAN relapses"; HAEMATURIA (non-serious), outcome "recovered", described as "Gross Hematuria".  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 currently available information the possibility of causal association between the event IgAN relapse and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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,Linked Report(s) : US-PFIZER INC-202200589675 Same article/drug/event and different patient
Headache, stomachache, chills, and sweats started Tuesday evening. Tylenol and ibuprofen administered.
I had the shot Sunday. On the following Monday and Wednesday I had clams and scallops for dinner respectively. Later that night I broke out in hives around my torso and upper body.  I took Benedryl and prednisone (from a previous reaction) and the rashes faded away. Then on Saturday night I had another allergic (hives) reaction but did not consume any shellfish or fish.
Tireness and chills began 10/16/2021 about 6:30 AM AFTER 3rd Pfizer Booster Shot on 10/15/2021.  Rested in bed.
I got shingles, 3 months after getting the shot/Suspected vaccination failure; I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
1.3 ml diluent mixed in a 6 month-4 year old vial. Should have been 2.2 ml of diluent. Parent was contacted by Dr.  to report error later on the same day.
Patient was completely healthy when given the vaccine, 4 days later she developed dystonic reactions involuntary motions of her muscle groups including fasciculations of her eyelids, periorbital muscles, fingers and toes.  Nausea and vomiting, low-grade fever. She also experiencing muscle pain in isolated areas especially between the ribs and twitching of the muscles.  No numbness of her hands or feet