chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, had no reaction afterwards.  She felt fine after the J&J as well.  After the booster she has been more tired and achy.  On 5/14/22 she woke up with shingles on her right buttocks and her right thigh.  She still has sores and dots on her legs.  She used some new leg cream, and woke up on Mother's day with pain on her right side.  She went to an UC and found that she had a hernia.  She felt that perhaps the radiation she was undergoing had some reaction to the lotion.  Called her mother and she said it looked like Shingles.  On 5/19/22 she went to Hospital and was diagnosed with singles.  She was told to take Ibuprofen and Gabapentin and took it for a couple of weeks.  The biggest spot she has in on her spine, on top of her right cheek, and still has really red areas and are still scabby.  The ones on her legs are little dots that are fading, hot feeling, pins and needles.    She had  a shingles vaccine in about 2016 and then the 2nd one in 2020.    Ever since having the shingles she is always cold, shivering to the bone and cannot get warm.
8/8/16 Pneumococcal vaccine given 8-8-16. 8-10-16 pt. seen for nausea, patches of erythema, tender to touch left arm, swelling and warmth to touch on left arm.
within 3 hours of shot I had fever body aches and weakness. also lost sense of smell and taste after 4 days. Also had a sore throat and nasal congestion.
About 22:00 (12 hours after administration), onset 103 degree fever, then seizure x about 5 minutes-paramedics to ER.  NoPH febrile seizure-FH, 101 degrees on arrival in ER and physician stated otitis media, but no abnormal ear findings 24 hours later when seen by PCP.
Prior to the vaccine I have since July 2003 had a consistent dosage to maintain my INR between 2-3. Since the 6 weeks after the vaccine I have struggled to get to an INR of 2.0 . Just recently I increased the dosage I use and got my INR to 2.2. I am going to increase even more until I am consistently getting an INR of at least 2.5. What this means is that blood has thickened after the vaccine injections. I can provide the detailed INR's and dosages. I have reported it both to my Doctor and to hospital. No one contacted me about it.
DVT to left arm, pt came to appt reporting left arm redness and swelling. Sent to hospital for venous doppler ultrasound that confirmed DVT to site. Pt started on blood thinners at this time.
ACHES/PAIN; FEELING TERRIBLE; DIARRHEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced aches/pain. On 19-MAR-2021, the subject experienced feeling terrible. On 19-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches/pain, feeling terrible, and diarrhea. This report was non-serious.  Additional information was received from patient on 24-Mar-2021, following information was incorporated into case: Other AE characteristics added (Physicians/HCP office).
No adverse event; Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received from initial reporter: The reporter confirmed that the patient not experienced any adverse event due to medication error
7-10-07 - Temp 99-100, Tylenol. 7-17-07 - Temp 103, abd. pain - 4 hours. 7-31-07 - no temp.
Maculopapular rash; Somewhat burning; rash over 75 percent of body, allergic rashes; Somewhat itching; allergic reaction, urgent care ER; rash over 75 percent of body, allergic rashes; This serious case was reported by a consumer and described the occurrence of maculopapular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included cholesterol. Concomitant products included atorvastatin calcium.  On 01-APR-2023, the patient received the 1st dose of Shingrix. On 07-APR-2023, 6 days after receiving Shingrix, the patient experienced maculopapular rash (Verbatim: Maculopapular rash) (serious criteria clinically significant/intervention required). In APR-2023, the patient experienced burning sensation (Verbatim: Somewhat burning) (serious criteria clinically significant/intervention required), allergic rash (Verbatim: rash over 75 percent of body, allergic rashes), pruritus (Verbatim: Somewhat itching), allergic reaction (Verbatim: allergic reaction, urgent care ER) and rash (Verbatim: rash over 75 percent of body, allergic rashes). The patient was treated with prednisolone and methylprednisolone. The outcome of the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash were not resolved.  It was unknown if the reporter considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  It was unknown if the company considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The reporter stated that while recognizing there were many causes for allergic rashes, the first Shingrix vaccination seems to require some investigation as a cause. Been to urgent care a dermatologist, no real diagnosis beyond an allergic reaction. Methylprednisone injection was given, rash over 75 percent of the patient's body. Somewhat itching. Somewhat burning. The symptoms were still there after almost 3 weeks. The reporter consented to follow up.
patients taking fluzone high-dose quadrivalent under age 65 years old with no reported adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient and reporter reported that patients taking Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] under age 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a total dose of suspect Influenza quadrival A-B high dose HV vaccine 0.7 ml (with unknown strength, from, batch number, expiration date) via intramuscular route in Left Deltoid for immunization under age 65 years old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information on the batch number was requested.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (patients taking fluzone high-dose quadrivalent under age 65 years old with no reported adverse event).  Outcome: Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Pt recvd 1st dose of Recomb on the following day pt exp fine, papular, nonpruritic, nonurticarial rash which included the inject site; pts rash resolved a/it was seen by MD;
APPROXIMATELY 1.5 HOURS AFTER RECEIVING HER FLU VACCINATION, SHE BEGAN TO FEEL HER TONGUE WAS SWOLLEN AND THROAT WAS SORE.
Advil or Tylenol or any pain types of medications might affect its effectiveness; I was going down the sore arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; meloxicam (MELOXICAM), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK UNK, as needed (took one dose on Tuesday and one dose on Wednesday morning) for back pain. Medical history included thyroid, ongoing osteoarthritis (Caller mentioned that she has osteoarthritis in which she usually takes a cortisone shot in her spine to alleviate symptoms), back issues. Concomitant medication(s) included atorvastatin and thyroid medications (unspecified). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as dose 1, single for covid-19 immunisation. Caller mentioned that she got the 2nd dose of the vaccine yesterday (unspecified date). She had been looking at news websites and tv and they say that one should not take Tylenol or Ibuprofen or any pain types of medications before getting the vaccine because it might affect its effectiveness. Caller mentioned that she has osteoarthritis in which she usually takes a cortisone shot in her spine to alleviate symptoms. She was told by her doctor to hold off on the Cortisone for 2 weeks after receiving the 2nd shot in order to not affect her immune system. She was prescribed Meloxicam in order to address her back pain. She mentioned that she took one dose on Tuesday and one dose on Wednesday morning because of back pain before receiving the shot yesterday. She was asking if that will affect the vaccine and if that should affect her response, how will she determine that the vaccine was effective for her. She further stated that she has back issues and she does not take these drugs every single day, only when it really gets bad. Yesterday and this morning, she took one dose each day of Meloxicam. She stated she did not take it just to anticipate that she was going down the sore arm. She took it basically because she had a back issue. And the reason she took it (Meloxicam) because it was not hard on her stomach as taking Advil. Seriousness of the events was reported as non-serious. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
suspected vaccination failure; shingles; pain; I have been miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles nonstop for almost 2 years since the patient got the shot. The patient was miserable and in pain since received the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
On 3/30/2021, I received the second dose of Moderna. On 4/5/2021, I underwent an echocardiogram. No abnormalities were detected. On 10/4/2021, while I was washing floors, I began to feel winded, dizzy, and like I was about to pass out. I broke out into a cold sweat and had chest pains. I called my cardiologist's office, and I was advised to go to the ER. I went to the ER. An EKG was done, and then I underwent a heart catheterization, as they thought at the time I was having a heart attack. When they saw that there were no blockages, they determined I had a case of Takotsubo cardiomyopathy. I was kept in the ICU for a day and a half, and then I was transferred to the cardiac care unit. Bloodwork, EKGs, and echocardiograms were done daily. I was hospitalized for 5 days and then released on 10/9/2021. I was told that it could take a couple of months for me to fully recover and that I should take things easy. I was prescribed metoprolol, which I took for 2 weeks; however, it gave me such a terrible headache that my cardiologist advised me to stop taking it. He then told me I could take low-dose "aspirin." My lisinopril dosage was also cut in half.
Patient's mother reported patient had fevers and headache pain since immunizations on 12/15/2008. Patient had high fever and also seemed to be having hallucinations the night of 12/15/2008 in which he was running up and down stairs and swatting at things.  On Tuesday morning (12/16/2008), patient was taken by an ambulance to ER because his behavior was out of control per Mom. He had a rapid strep test done there, which was negative. Mom also reported one more brief episode on Tuesday night (12/16/2008) lasting only 3 minutes where patient seemed very afraid.
Discomforting muscle aches starting around 9:00 PM. Feeling of flu like symptoms. Retired at 10:00 PM. Awoke at 2:30 AM with heavy sweating. Possible fever but did not check. Awoke again at 5:30 AM feeling better. Arose the next morning at approximately 8:00 AM feeing fine. No other effects afterwards.
About three days after the shot, I noticed my left ear felt clogged.  5 days after the shot, I was jumping on a trampoline and the clogged feeling in my ear became much more pronounced feeling and I had a pain in my upper left chest and shoulder area while jumping on the trampoline.  Over the next week, the clogged feeling in my ear never got better so I went to an urgent care facility 10 days after my shot and was told that my left ear was very red, inflamed and full of fluid.  I was given steroids and antibiotics.  Six days later (16 days after the shot) I went to my primary care doctor to follow up because the ear still felt clogged.  I was told it was no longer red, but the tube was still inflamed and full of fluid.  I was told to stop the antibiotics and just use Flonase to get that tube to drain.  It is now 24 days after the shot and eight days since starting to use Flonase and my ear still fills clogged.  I have never previously had an ear infection or tube problems in my entire life, so the inflamed tube occurring three days after the shot feels related to me.  I also felt the same upper chest/shoulder pain when using my push mower again 11 days after the shot.
Fever, moderate chills, Severe  nausea, giddiness, vomitings X 2, diarrhea X 2, Moderate fatigue and malaise.  Had to leave work before noon to rest.  Self-treated with appropriate supportive measures
Covid Morderna Spikevax 2023-24 (12YUP) SYRG Lot 3030068 was administered in my RIGHT arm (Pharmacy emailed my shot record to me and it indicated the vaccine was given in my left deltoid but that is not correct) by RPh.  I was feeling perfectly well before the shot and felt fine after the shot.  Two and a half hours after getting the shot, however, I suddenly noticed a pain in my left hip as I was walking in my kitchen.  I had not injured or bumped my hip.  The pain came on rather suddenly and increased to the extent that it made me limp (I never have had that place on my hip hurt before).  The pain was pinpointed on the side of the top front point of my left ilium (pelvic bone).  It caused me so much discomfort that I had to lie down with a heating pad, and sleep with the heating pad the next 2 nights.   It is now one week post vaccine and the place on my hip is still tender an occasionally causes me to want to  limp slightly as I walk (I am an extremely active person for 70 -- I usually walk 20+ miles per week).  The only other side effect I experienced was tiredness
pt received shot on 10/7/2020.  when she came in to the pharmacy today 10/28/2020, she mentioned that her arm was very sore the following  day and that she still had a little soreness occurring currently.  she was able to raise and lower her arm, unrestricted, with no pain, but said that sometimes it still wakes her up at night.    She stated that it is feeling better at this time.
Dose given 130 PM 12/19. 3 A 12/20 woke to sore, achy, burning at injection site. 12/20 Later noticed lump at inj. site, achy, burning, red, getting overall burning hot body feeling and took TYLENOL with relief. 12/21 9 AM Reported to me. Arm very sore, red and swollen.
Information has been received from a physician concerning a 17 year old female with PENICILLIN allergy and no other pertinent medical history who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot# 660389/1968U).  There was no concomitant medication.  Subsequently the patient experienced myalgas and fever that lasted for three days after  receiving the first dose.  STD panel routine PAP were performed.  On an unspecified date, the patient recovered from myalgas and fever.  The patient sought medical attention seen by the practice.  Additional information has been requested.
pt recv vax 4AUG95 & 13MAY96 pt devel chicken pox, which were everywhere;
rash on shoulder and neck worsened; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN9581; expiration date: 31May2021), via an unspecified route of administration, administered in right arm on 01Feb2021 16:30 (at the age of 86 years) as dose 2, single for COVID-19 immunization. The patients medical history included ongoing gout diagnosed two or three years ago and ongoing palpitation of the heart. The patient started Eliquis at 2.5mg tablet twice a day and then he found out he was bleeding to death, clarifies he was bleeding internally in his small intestine, so he cut his Eliquis in half, stated the doctor did not like that he cut his dose in half, but he stopped bleeding internally after about a week. He was left-handed, so he got the injection in his right arm. Concomitant medications included apixaban (ELIQUIS, formulation: tablet, strength: 2.5mg) for palpitation of the heart that he had very often taken half tablet by mouth twice daily; diltiazem hydrochloride (DILTIAZEM XR, formulation: capsule, strength: 240mg) for an unspecified indication taken once a day by mouth. Both recommended by patients cardiologist. The patient also took febuxostat (ULORIC, formulation: tablet, strength: 80mg) for gout taken half tablet once a day by mouth. The patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiration date: Apr2021), via an unspecified route of administration, administered in right arm on 07Jan2021 around 10:30am (at the age of 86 years) as dose 1, single for COVID-19 immunization and experienced rash on shoulder and neck. The events at the time of last observation were not recovered and ongoing. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) were none except the first dose of COVID vaccine. On an unspecified date the patient mentioned the rash on shoulder and neck worsened. He also stopped using his laundry soap since he was not sure if it was his laundry soap the rash symptoms. AE did not result in visit to physician office or emergency room. On an unspecified date the patient took pantoprazole 40mg (oval yellow tablet, delayed release, lot number: QASB2000 (thinks the last digit was a 0, not sure), expiration date: Feb2023) as a therapeutic measure. He read the one of the side effects of long-term use was a rash so he confirms he stopped taking it but the rash was still there. He was putting Eucerin for the rash and it seems to soothe it over somewhat. Outcome of event was not recovered patient stated it was hard to tell, he thinks it was getting a little worse.  No follow-up attempts are needed. No further information is expected.
Shaking chills and headache 3 hours after injection. It is supposed to be an IM injection and was given SC, I am a nurse so know the difference
Swelling, warmth, redness at injection site which began on 4/25/06 about 24 hrs after vaccination, worsened over next 2 days, he also felt ill, generally achy on 4/25/06. Band of induration of skin measured 10cm wide by 30cm in length.
A report has been received from a Physician concerning 11 subjects of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patients received expired FLUMIST during January or February 2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Hives, not as severe as event reported in news with another man at end of 03/2021. Slowly went from itching on extremities to torso and back hours later.
nausea, vomit for 12 hours, feverish .  Took Zofran
Mom reported that patient developed a rash on the thigh at the site where she was given Vaxelis.