chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 hours afters after receiving my Janssen vaccine, I woke up in the middle of the night with a 103 fever that was not well managed by taking Tylenol. I also suffered from extreme body aches, fatigue, nausea, upset stomach, diarrhea. This lasted a full 24 hours before my fever went away. The following day I still had an upset stomach. I also developed a red welt at the injection site which lasted for about a week, was red, swollen, bruised and itchy. 11 days later I tested positive for COVID19 and had full fledged symptoms of COVID19 as well.
got the shots and still got it/suspected vaccination failure; still got it; 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) 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 details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization 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.
Patient was sleepy, took a nap and woke up with abnormal movements and had an event where she stared off into space for 15 minutes and was very still.
Within 24-36 hours of receiving the vaccine, a rapid thumping noise developed in my right ear.  Within 48 more hours, that symptom has become less frequent but a permanent ringing noise (tinnitus) has developed.  It is primarily in my left ear but can seemingly be heard in both ears.  It has not stopped since I noticed it around 4/04. I have been checked by an ENT and they noted no conditions and my hearing/pressure/nerve tests all came back as normal.  I have never had any previous tinnitus issues whatsoever.
Headache, fever, nausea, chills, body aches, dizziness, tiredness, and ear ringing.  All symptoms subsided accept for dizziness and ear ringing as of 4/18  6pm.
Patient describes uncontrollable bowel movements, cannot hold food down, loss of appetite and body aches.
Intussusception with necrotic bowels status post colon resection and colostomy.
Body aches experienced on day of immunizations. Injection site swelled and continued swelling until entire upper arm was swollen on 10/07/2005. Patient was advised to take 50mg of benadryl and follow up with doctor.
Patient states that he was not able to stand due to muscle weakness in his lower back and started around 1405. Patient is able to move lower extremities. Recommended to follow up with his usual primary care provider.
pt recv vax & devel erythema, induration, swelling & pain @ the inj site;pt also exp pain in the axillary lymph node;
She got her vaccine, she had a lump at the injection site.  She put warm compresses on it and home treatments.  She gets a lot of blood taken due to her condition, and so she disregarded it, it went away.  She then ended up with shingles, in October of 2021.  Then she broke out with shingles again and on 4/21/21.  It attaches to her sciatic nerve, and started at the base of her spine.  The first time in December when she had it, she woke in the middle of the night had extreme pain in her buttocks and her back.  She felt a spot felt that she had been rubbing the area in her sleep.  Was going to put antibiotic salve on it, did not sleep due to the pain and burning.   When she got up again she actually took a mirror and looked and saw what she had done was around the area had scratches due to her nails.  She then noticed the shingles bumps.  That's when she immediately had called the dr, which came to her house as she does not drive.  They were shocked and told her that it does happen.  She was given a really strong shot of steroids, which was told was not to treat or help her right now.  This was to help the pain and damage she might have going forward from the shingles.  She was also put on an antiviral.  The 2nd outbreak she was not given the steroid shot, but was put on the antiviral and was using Calamine lotion and other things to help the symptoms.   She always feels like she is standing too close to a radiator and the only way she can describe it as there is heat and burning in the area of the shingles.   She continues to have the pain and burning which makes her uncomfortable to sit.
Currently pregnant 29wks due date 6/17th  When I was getting up from my seat at the observation deck both of my calfs became sore like I just had a strenuous workout or like they were about to go into spasm. Also, while I was driving home, about 15mins into my drive I all of a sudden got a dizzy spell like I was about to lose consciousness and I almost had to pull over but it went away. Then throughout the day I was just extremely tired with a little light headedness. Slept for most of the day.
Administered H1N1 immunization to patient. Within 15 min. patient developed skin irritation on arm where injection was given that steadily advanced. Noticed irritation in throat as well. Relieved after taking oral BENADRYL 50 mgm.
Reports "bruising" after vaccine administered. Pt c/o left arm swelling with numbness and tingling in fingers. No fever. Pain, numbness and tingling has worsened and pt presented to emergency room last night - She states diagnosis "peripheral neuropathy" will follow-up at Health Center.
cellulitis with pain 2d after varicella shot. occurred at sight of injection. Started on Keflex
Patient returned to office. Vomiting, chills, fatigue, and arm pain. Zofran & Benadryl given.
Pt complained of dizziness about 15 minutes after Hepatitis A vaccination then patient fainted (for a few seconds). Pt felt warm to the touch. Layed pt on back on table pt was pale.  Gave pt apple juice and removed shoes and excess clothing. Pts BP was 104/70 observed pt >15 mins, then had pt sit on edge of table gave fruit snacks. Observed for >15 mins.  Had pt stand pulse 88 observed pt for >15 mins.  Pt ambulated fine states feels ok no further dizziness color is pink.  On 02/16/2012 I phoned mom pt is doing fine and did fine last night.  No further signs or symptoms of reaction per mom.
Patient administered Pfizer COVID-19 vaccine. After administration, nursing staff realized 0.8mL instead of 1.8mL of diluent was added to the Pfizer vial when trying to draw up another dose. Patient administered a higher than recommended dose of the Pfizer COVID-19 vaccine. Physician was notified and family was contacted that evening. Mom reported on 9/10/2021 and 9/11/2021 that patient was not experiencing any symptoms. Follow up on 9/28/2021 mom reported he started having some asthma and allergy difficulty the week following vaccine, but she is unsure if this was due to the vaccine or his underlying diagnoses. He is now recovered without any symptoms.
A 10YO PT WAS VACCINATED WHEN HE DID NOT MEET THE AGE REQUIREMENTS.  PER PT'S MOTHER, PT DID NOT REPORT ANY ADVERSE REACTIONS OR SYMPTOMS.
This prompted a COVID-19 test which came back positive.; This prompted a COVID-19 test which came back positive.; Patient felt aching in her bones similar to side effect following second dose of vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received second dose of bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient felt aching in her bones similar to side effect following second dose of vaccine. This prompted a COVID-19 test which came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored ROTATEQ, (lot#, expiration date and dose were not reported) orally. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt gasped while being fed (deep cry) then turned white all over & lips turned white then face turned blusih;no tonic & clonic activity;pt passed a bowel movement during episode;
did not get his second; This case was reported by a other health professional via (Shingrix interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient needed to repeat the entire cycle or could just have the second.
A patient received MENACTRA vaccine instead of MMR vaccine no reported AE; A patient received MENACTRA on 04-OCT-2021 and received a dose of MENACTRA last year as well no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00800779) and transmitted to Sanofi on 06-Oct-2021.   This case involves a 33-year-old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the patient received a dose of MENACTRA vaccine last year as well (Extra dose administered) instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (wrong product administered).  The patient's past vaccination(s) included MENACTRA for prophylactic vaccination.  The patient's medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE for Prophylactic vaccination.  On 04-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7190AA, expiry: 16-Jan-2023, formulation: solution for injection) via intramuscular route in unknown administration site for prophylactic vaccination instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was a case of an actual medication error due to Extra dose administered and wrong vaccine administered (latency same day).  It was reported "Pharmacy manager states they administered a dose of MENACTRA to a patient on 04Oct2021, and found out afterwards that the patient received a dose last year as well. Pharmacist reports that on 04oct2021, a 33-year-old, female patient, came in seeking an MMR vaccination. She received MENACTRA instead, along with Adacel and a flu shot. Pharmacist states that she's not sure how the error occurred, but the patient does not speak english fluently, so that may have been a contributing factor."  No other adverse event was reported.   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.
No additional AE reported; VARlVAX expired on 23-JAN-2022 and was administered on 27-JAN-2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 27-JAN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 (no units provided), lot #T002843, expiration date: 23-JAN-2022 (site and route of administration were not provided) for prophylaxis (expired product administered). The varicella virus vaccine live (oka/merck) (VARIVAX) had no previous temperature excursions. No additional adverse event was reported (no adverse event).
Approximately 12 hours after my second Moderna vaccine, I experienced the typical body aches, chills, headache, and tiredness expected in someone my age (38).  I was initially happy that my immune system seemed to have a positive response to the second dose.  About 24 hours after my second dose, I developed a severe headache and nerve pain all over the right side of my head.  No over the counter medicine would relieve the pain.  The next day, I developed a rash on my forehead.  The rash quickly spread and consumed the right side of my face and my right eye.  I was seen by medical staff, and received a diagnosis of severe shingles.  I was given Valtrex and, eventually, gabapentin.  My eye continued to get worse and I lost clear vision in my right eye.  I saw an ophthalmologist and was told that the shingles had activated in the eye.  My eye pressure was dangerously high.  I was given steroid drops and drops to relieve eye pressure.     Since February 22, I have battled shingles.  My rash is gone and my eye has cleared.  But, I still suffer from intense nerve pain in my head, forehead, and eye.  All medical professionals opined that the moderna vaccine must have played a role given the timing.  If shingles can be considered a side effect, it is one that has been intense and long-lasting.
pt recv vax & exp lightening of skin in a crescent shape measuring 1/8 - 1/4 inch around the inj site;sc cont;
About 1-2 days after receiving the 1st dose my arm became sore. The sore arm won't away a few days later. About the 5-6 days later the injection site got red and was kind of warm, that lasted for a day or two. About 02/06/2021-02/07/2021 the vertigo came and then the nausea came,  the following the day after the vertigo came I started throwing up. The vomiting lasted about 2 days, because I stopped eating. I have been drink like chicken broth and liquids.  The same day I started having diarrhea. The vomiting has stopped by as of today I have a sore stomach, diarrhea, and vertigo. I get very scared when I vomit and I get very stiff so maybe that hurt my stomach muscles. I have to hold to the wall or furniture when I walk because the vertigo is so bad.  I can't take two steps without almost falling.  The last few days I have spent most of time in bed because I am afraid to get up. I can't drive either due to the vertigo.
8/15/06 pt c/o tenderness on back of both knees, soreness and pain on both shins down to ankles and pain to both shoulder blades x 1 wk after 1 week the vaccine was given on 7/31/06.
This spontaneous report as received from a consumer refers to a 70 years old female reporting on himself, with fib heart disease, tachycardia, arthritis, sulfa allergy, tetracycline allergy, codeine allergy and arthritis. The patient's medical history included thyroiditis (MARRS # 1209USA002780). Approximately on July 2012, the patient was vaccinated under the skin with ZOSTAVAX (dose and lot # not reported).  Concomitant medications included ADVIL and therapy unspecified (SOTOL). The consumer stated that approximately on 08-AUG-2012 (2-3 weeks ago), she began experiencing extreme joint pain in especially in her ankles, knees, hips, and thumbs.  She said it was worse in her ankles. She said this was the episode of arthritis far worse than any episode she's ever experienced. Laboratory diagnostics tests were not performed. Medication due adverse event was not received. Additionally, the patient stated that was not allergic to eggs. At the time of the report the patient's outcome was unknown. Additional information has been requested.
She got her vaccine, about a day later she had fever, chills, and body aches all over, especially her hips and thighs.  She got pictures where the front of her legs broke up that went from the knee to the top of her hip.  She then broke out to her butt crack.  She also had 5 cold sores on her mouth.  She also had bleeding right ear after a few days, and what was happening was lots of pressure like altitude pressure, which was happening while she was sitting in her living room.  Then on the 3rd day that happened with sharp pain and then the blood.  He went to the ENT and they put her on vitamins, dismissed that she felt it was related to the vaccine.    After a little over a year she did get all her hearing back.  She had intense ringing in her ears for close to a year and a half.  So that is now gone, but every now and then it will happen again and she can tell when it's flaring up she will get the ringing in her ears, her body aches, and will break out into shingles on her butt crack.  She did get antiviral medication from her doctor and takes it when she feels  an outbreak coming on.  It is a constant pain in her pelvic area, it never goes all the way again.  She never had any trouble before having the vaccine.    They want to do invasive testing of her like putting a camera in her bladder and look around.  She does not want to do that but feels that she has shingles all up inside of her.  She feels it is due to that as she had never had any problems prior to the vaccine, and has not had any vaccines.  This reaction has her set against having any other vaccines.  This started about 6-7 months after the COVID pandemic.    She just wants to find a way to get it fixed and not have these symptoms anymore.    When she told them how bad the pain was they felt as if she was drug seeking, which she informed them that she was not asking for pain medicine, she just wants the pain to go away.    She went to immediate care who would not see her because her BP was high, and they told her to go to the ER.  She did not feel it was an ER situation and did not go and stayed at home until she felt better, and then she started pursuing what was going on.    It comes and goes and has happened about 6-7 times, and feels like her insides in her hips is torn loose, and it comes back to the same areas.
On 1/5/2021, a week after receiving the vaccine, a 2cmx3cm hive appeared at the injection site (rt deltoid). Raised, warm to touch, itchy.  at time of reporting, approx 12 hrs later, there is minimal improvement. Took 1 benadryl at 2330 on 1/5. Mild discomfort and tingling throughout triceps on rt arm.  I did not experience any side effects other than injection site soreness for 72 hrs after receiving the vaccine.
Vaccine admin. 12/20/83, immediate adverse reaction, pt cried hysterically for next 6 months, dark black appeared under eyes, learning special ED classes. Language disorder, neurological damage.
red itchy rash; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm). On 02-May-2021, RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm) had resolved.            No treatment details were provided. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-102290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102290:First dose case
Patient was screaming in pain.  Not bearing weight on the right leg.  Refused to bend the right knee or let anyone touch her right knee.  Right knee swelling.  All symptoms starting Friday afternoon; day of injection.
Systemic: Lymph Node Swelling-Mild, Additional Details: Lymph node on the arm with injections swollen and BRUISES on that underarm.
I received my shot at 11:40 I felt fine when it hit about 5/530pm I started to feel drowsy when I woke up today I had a fever and my body feels really tired
Information has been received from a consumer concerning her 17 year old daughter with morphine allergy and history of sinusitis, tonsillitis and gall bladder removed who was vaccinated with three 0.5 ml doses of GARDASIL on 0/2/6 months respectively. There was no concomitant medication. In summer of 2010, when the patient had a pap smear, it was found that she had dysplasia. She returned for cone removal and found to have HPV 16/18. The patient has all 3 shots and they wait and see if she would clean the virus. She also didn't use condoms. There were labs diagnostics studies performed. Unspecified treatments were given to the patient for AE and she was being closely monitored. It was also reported that GARDASIL was discontinued and was not reintroduced. At the time of reporting, the patient had not recovered. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse refers to the 17 years old female patient. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 654389/0961F, route unspecified) on 17-JAN-2006, second dose (0.5 ml, lot #0243G, route unspecified) on 19-MAR-2007 and third dose (0.5 ml, lot #, route unspecified) on 17-JUL-2007. The patient had a "cone biopsy" of her cervix, and the results were pending. Additional information has been requested.