chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a lump in his left arm pit; Extra dose administered; This case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menactra (had Menactra 2 years ago).   On 9th September 2019, the patient received the 1st dose of Menveo (intramuscular). On 9th September 2019, less than a day after receiving Menveo, the patient experienced axillary lump and extra dose administered. On an unknown date, the outcome of the axillary lump was recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the axillary lump to be related to Menveo.  Additional details were provided as follows: The reporter was the mother of the patient. The patient had Menactra 2 years ago from the date of reporting and did not had any issue. The patient received dose of Menveo in the left arm. The reporter stated that, the patient received dose of Menveo past monday of the date of reporting, and developed a lump in his left arm pit, in the night of the day of vaccination. The patient received Menactra 2 years ago and again received Menveo, which led to extra dose administered. The reporter reported that, the lump was decreased some in size. The reporter stated that, the patient needed another dose of Menveo. The patient's mother did call in the event to the physician but hasn't been seen by the doctor. The reporter did not consent to follow up, but open to authiorization form sent later.
Headache, chills, general body aches, and fever of 100.9 F. The patient stated there was swelling of the left arm around the injection site that seems to be spreading down to the left hand. The patient stated that the skin of her left arm/hand feels warm to the touch. The patient reported the adverse events to the pharmacy the morning of 10-1-20. At the time when I spoke with the patient (at about 2:15 pm on 10-1-20) she did not mention any treatment yet. I told her that based on what she was describing that she should seek medical attention. She indicated that she would be seeking medical attention, so treatment and outcomes are pending.
I fainted the morning after receiving my second dose of the Moderna vaccine.  I had a slight fever, chills, and nasuea, and was walking to the bathroom when I lost consciousness for a few seconds.   Three days after receiving the 2nd dose of the vaccine, I broke out in itchy hives on my hands and feet.  This issues has not resolved, yet.  My fever, chills, nausea, and dizziness has resolved, though.
Pityriasis Rosea times 1 day. Tx Caladryl PRN
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to an 81-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. In 2016, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
generalized  hives 1 hour post vaccination.  No other known etiology for hives.   Has received previous influenza vaccines but no similar reaction.
Sore arm five minutes after injection Swollen aches GI No Appetite Not feeling well
According to daughter pt was in his usual state of health  (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021.  He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray.  He expired with in hours of arrival to the ER despite full attempts at resuscitation.
Warm, red, swollen area to left leg (upper). Pt appears to be ok, runs on legs with no problems. Suggested to follow up with MD.
approx 4hrs p/vax pt exp erythema, swelling, pain & tenderness @ the inj site in lt deltoid muscle;pt also exp weakness & lightheadedness evening of vax;MD visit following AM;ice packs applied to inj site
unresponsiveness; lethargy; This is a spontaneous report from a contactable physician via a Pfizer-sponsored program. A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), first dose (at age of 2 months old) and second dose (at age of 4 month old) both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation. The patient medical history and concomitant medications were not reported. The physician had a patient that was 10 years old (at this time) and was being cared for by another pediatrician before the reporter. After his 2 month and 4 month vaccines which included PREVNAR 13 he was hospitalized after each dose of the vaccine for lethargy and unresponsiveness. The patient had a medical exemption for vaccines that were administered at this time. When it comes to all those ingredients in those vaccines, was there anything in common with the ones he received back in 2011 and the ones he has not yet received. The reporter pulled all the package inserts from all the vaccines in his/her office and reporter had gone through them. The patient was looking at the other ingredient section which was the descriptions section. The reporter figure patient's never going to get PREVNAR 13 again. His hospitalization with lethargy and unresponsiveness sounds like a typical reaction to the pertussis component of the DTP vaccine and usually when the child comes in you don't give them a pertussis containing vaccine. You give them the diphtheria tetanus without pertussis. The reporter didn't think his doctor did that so he didn't know which component he reacted to. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product, events most likely due to patient underlying contributory factors
Case number PHEH2014US022656 is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a 02 year old male patient. His medical history and concomitant medication were not reported. On 06 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 1411301) via intramuscular route. No adverse event was reported following this administration error.
101 fever from 11:00 pm until 7:00 am, returning at 8:30 am and continuing inconsistently throughout the day. Spiked at 8:00 pm to 100 and continued until 6:00 am on 2/7/21. Body aches and sore muscles, headache lasting two days, large swollen area near injection site.
Had shot in Dec had a dull burning sensation at first where sot was. As time went by it moved from my bicep to my shoulder then the pain radiated up to my neck and back between my shoulder blades. As time went by it got worse. I wasn't able to lift anything. My left arm felt like a sack of flour and had prickly feeling then my should joint started hurting severely. Now I can't lift my arm up even half way without excruciating pain. I didn't think much at first about the burning sensation after the shot. And when the pain started in my shoulder and back I sought out a masseuse, that sent me through the roof, so I went to see my chiropractor. Because of what I told him about the pain location he was concerned I may be having a stroke or heart attack and took my blood pressure which was high 186/84 - I felt it was because of the pain I was enduring. I was able to go about 5 more days before the pain escalated again I went back to my chiro got an adjustment had him take my blood pressure which went up even higher 179/109. The pain was pretty intense. He suggested I go to the ER to get checked out so after I left his office i was in the ER. They were more concerned with my blood pressure more than my pain. I checked out fine - they gave me flexirol for my pain which didn't do a thing. I have also seen a acupuncturist - which help alliviate the weightedness and the prickly feeling in my arm. Not so much the pain. I decided to see what was going on and scheduled an MRI at Hospital. The MRI showed little to nothing. I then scheduled with an Orthopedic Surgeon and he verified I had frozen shoulder and that I would need therapy. I have done nothing to injure my shoulder and cause it to be this way. The conclusion was that the shot I received from the flu vaccine was the culprit it all stems back to that day - I had no pains or any issues prior to this. I have taken every effort to find a answer to this very debilitating problem and it all reverts back to the shot. That is why I'm reporting this. I have documentation all along the way that starts back in January in regards to this issue.
Pfizer IMZ was short-dated and we were unaware of this and administered an expired vaccine.
Bronchitis flare up; This is a spontaneous report from a contactable other hcp.   A 73-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Deltoid Right on 17Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease States she was diagnosed in her 50's. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in left arm (Batch/Lot Number was EP6955) as single dose for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Caller said she received the second dose last 17Apr2021. She did not take her steroids for her bronchitis yet. She wants to know if it's going to impact the efficacy of the vaccine if she takes her medication. She got the first dose last 27Mar2021. On 24Apr2021 the patient experienced bronchitis flare up with outcome of not recovered.  Follow-up (09Jul2021): Follow-up attempts completed. No further information expected.
Pressure  in head (pain) severe headaches dizziness (blurred vision) stomach problems heart pains, tremors (hands shake) pain in joints & muscles (spasms) in muscles (more tolerable) I got sick within 5 minutes & sent to the emergency room. When the vaccine was first given to me it took 5 minutes & I felt dizzy & like I was going to go to the bathroom & I had a bad taste in my mouth. I was then taken to hospital & given a BENADRYL & told I would be ok, but I wasn't that was only the beginning of a nightmare. Confusion, dizziness pain in my body sleeplessness couldn't eat. I couldn't take care of my then 5 year old daughter. Also tremors (hands shake) nervousness spasms in different areas of my body. Lost my job. I worked at a dept store for 5 years. I looked for help by going back to doctor and the nurse practitioner who then sent me to every other kind of doctor there was for every symptom I was having. And still today no one has helped me.
I gave pt his Covid vaccine. Pt does not like needles, but he was fine after I gave pt his shot. His complexion was normal after the shot. The mother wanted pt to sit in the chair in the imz booth and I told them it was fine to have pt sit there as we didn't have anyone in line for shot.  Pt and mother move to one of the chairs that is reserved for post vaccinated pts.  A few minutes later tech called out for me as pt is going down from the chair.  I had tech dialed 911, came to the pt and trying to get him to be responsive.  Pt came to it after like 3-4 seconds.  Pt sat up and we offered him some water.  Per pt and mother, he had not had anything to eat yet.  So mother went and got pt some crackers. We got pt more water. They sat for a few more minutes and when he felt well enough they left.
Fever, sore throat, muscle aches, chills, dizziness, and fatigue 12/31 0300-12/31 2200
Pt became gray and unresponsive 10 min after starting nap.911 called, pt was staring straight ahead, tonic, stiff.  Ativan was administered with good response.  HR 150, B/P 80, palpitations, postictal sleepiness, 8-10 seizures.Hospitalized. Follow-up: 2/15/00 consent form returned by parent - Mailed with letter to hospital.
pt called clinic on 27AUG98 & reported that had nausea, stomach/abd, cramps, h/a, feeling bad 1 1/2 days p/vax 1st dose;
Itchy rash developed 1 day after receiving vaccine. Rash on legs, arms, trunk & neck. Instructed to use antihistamine & OTC Hydrocortisone cream prn.
Information has been received from a registered nurse concerning a female with reactive airways disease and penicillin allergy who on 21-MAR-2007 was vaccinated IM with a 0.5mL first dose of Gardasil vaccine (yeast) (lot#654540/0800F). Concomitant therapy included "multiple psychiatric medications." On 26-MAR-2007 the patient experienced numbness in fingertips that gradually spread up both arms and to her legs, pruritus and "funny feeling" in extremities. The patient sought medical attention at the emergency room and no laboratory tests were performed. The patient's numbness in fingertips, both arms and legs and pruritus and "funny feeling" in extremities persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. The patient sought medical attention at the emergency room and no laboratory tests were performed. It was confirmed the patient does not have a rash or any other symptoms. It was reported that the patient had adjustment of her psychiatric medications just prior to getting GARDASIL. The patient was seen by psychiatry and her symptoms resolved when dosage were readjusted. The patient's symptoms were felt to be secondary to medications. No product quality complaint was involved. Additional information is not expected.
Information has been received from a medical assistant concerning a patient (age and gender unknown). On 09-NOV-2012, the patient was vaccinated with ZOSTAVAX (H016230; 30-NOV-2013) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 09-NOV-2012, the medical assistant noted that the patient was administered ZOSTAVAX that were exposed to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days). No adverse effect reported. At the time of the report, the outcome of the event of ZOSTAVAX were expose to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days) was unknown. Additional information has been requested.
Little rash immediately after shot. Brought him to hospital at 4pm. Tongue was hanging out, was weak, couldn't walk, was falling all over the place. Eyes were rolling and staring.
This spontaneous report was received from a medical assistant and refers to a 11 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe weakness, body ache, fever, and redness at injection site. Adverse event per doctor.
Patient received 2 primary doses of pfizer vaccine 9/28/2021 and 9/7/2021. She expereinced severe swelling and pain at injection site for 1 week following these vaccines. On 2/22/2022 patient received the pfizer booster vaccine. Two days after the vaccine, patient had to leave work (patient is a nurse) due to severe swelling of her arm, up to her shoulder and neck and today welts started developing on her neck. She is seeking medical advice with a doctor 2/24/2022 due to the new worsening reaction. She is not taking other medications besides tylenol and ibuprofen. She has no significant past medical history and has multiple drug allergies.
Fever 101F, chills, nausea, fatigue, shortness of breath lasting about 24 hours after onset
Affected my Menstruation CYCLE and I lost it for 3 months and was irregular for 6 months. And I have had really bad head aches.
took vaccine, died 3 months later; got shingles after vaccine/Suspected vaccination failure; got shingles after vaccine; got tumor after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female 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 unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and neoplasm. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, shingles and neoplasm were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient took shingles vaccine. The patient got shingles and tumor after taking the vaccine. The patient died three months later. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Time to onset for event unknown cause of death was conservatively captured as 3 months as it was not clear if it was after vaccination or other events.; Reported Cause(s) of Death: Unknown cause of death
Headache; Tiredness; Muscle pain; Chills; Joint pain; Swelling; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL8982) as single dose for an unspecified indication. Medical history included multiple sclerosis (Verbatim: MS), hypertension (Medical condition: Consumer stated, "High pressure") and covid-19 from an unknown date and unknown if ongoing (I had COVID in the last days of October around 21sth, 30 or 31st October). Concomitant medications included losartan taken for an unspecified indication. The patient experienced headache, tiredness, muscle pain, chills, joint pain, swelling, nausea, feeling unwell on an unspecified date. Patient had vaccination, Pfizer's dose, 20Jan2021 and should have my second dose of the vaccine on 09Feb2021 but had COVID in the last days of October around 21sth, 30 or 31st October and was diagnosed with MS (Later clarified as Medical history). Patient had very bad reaction the second day, I have the vaccination on Wednesday, didn't have any reaction in the moment or one hour or two hour but Thursday since the morning felt really bad with all the side effects that are listed in the paper that they gave me, I had everything, I had headache, tiredness, muscle pain, chills, joint pain, swelling and nausea, felling unwell." The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was unknown.  Information about Lot/batch no has been requested.  Follow-up (05Feb2021): Follow-up attempts are completed. No further information is expected.
He is in so much pain with his tooth; My husband is in a lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "He is in so much pain with his tooth"; PAIN (non-serious), outcome "unknown", described as "My husband is in a lot of pain".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from health care worker/medical assistant refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 15-MAY-2014 the patient was vaccinated with VAQTA (dose, route, lot# not reported) was improperly stored. No information provided regarding concomitant medication. No adverse effect reported and PQC was not involved. This is one of two reports received from same reporter link (1405USA008846). Additional information has been requested.
Patient was administered the Pfizer bivalent booster as his first dose of COVID vaccine series. Followed guidelines and did not repeat dose and continued primary series vaccinating 2nd dose with appropriate monovalent dose. Pt denies any adverse reactions after receiving COVID vaccine.
Very painful leg muscle cramps, profuse sweating, unintelligible speech, huge bowel movements to the point of empty.
Admitted to the hospital 9/29/2021 because of shortness of breath and altered mental status.  Was COVID+ 0n 9/24/2021.  Required intubation and mechanical ventilation 10/9/2021. No improvement with maximum therapy.  Expired 10/10/21.
pt recvd vax & immed p/vax exp lower arm itching & reddening,small bumps on arm,sl swollen finger;these sx cleared w/in 15mins;when discharged,arm was still sl red;