chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse refers to an unknown number of patients (gender unspecified). No concomitant medications were reported. The nurse reported that on an unknown date some doses of ZOSTAVAX (lot # not reported) had been transported using dry ice and the temperature might have gone down below -58 F and these doses might have been administered to an unknown number of patients. No adverse effects were reported. Additional information is not expected.
The pt developed itchy rash on legs about four days after HBV #3. Referred to student health services physician.
No additional AE's were reported; A vaccine coordinator reported that improperly stored doses of PEDVAX HIB and ROTATEQ were administered to two patients.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, vaccines included haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U034522, expiration date: 22-JUN-2024) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #W011278, expiration date: 01-NOV-2023) underwent a temperature excursion at 34.3 Fahrenheit (F) for 1 hour 18 minutes. There was no previous temperature excursion.  On 04-OCT-2022, the patient was vaccinated with improperly stored doses of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (quantity: 1, lot #U034522, expiration date: 22-JUN-2024; strength, dose and route of administration were not provided) used as directed to prevent haemophilis influenza B infection; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter oral liquid, quantity: 1, lot #W011278, expiration date: 01-NOV-2023, administered orally as directed to prevent rotavirus infection (Product storage error). No additional AE's and no PQC's were reported (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA001275:
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a male patient who received TWINRIX. On an unknown date, the patient received TWINRIX. On an unknown date,  unknown  after receiving TWINRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and hepatitis A. On an unknown date, the outcome of the vaccination failure and hepatitis A were unknown. It was unknown if the reporter considered the vaccination failure and hepatitis A to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2008, the patient received a series of TWINRIX  and developed hepatitis A. This case had been considered as a suspected vaccination failure case since the completion of vaccination schedule, lab test confirmation and time to event onset  for hepatitis A were unknown at the time of reporting. The reporter had no patient and vaccine information.
Client COVID PCR positive on 12/04/2021. Vaccinated with Moderna on 02/03/2021 and 03/03/2021. COVID PCR Presumptive on 4/26/2021 and listed as suspect reinfection. Client hospitalized on 4/26/2021 with signs of bowel obstruction, but also noted to be diagnosed with DVT. Notes indicate client was bedbound. Submitter does not have access to further vaccination or medical records for additional information.
10/21 PM through 10/23 AM, patient had 6-7 seizure episodes which lasted anywhere from 5 seconds to 20 seconds long. Patient would sleep approximately 20 minutes after the longer episodes. Had low grade fever of 100.5 and was nauseated. Instructed by Dr. to give and extra dose of Lorazepam.
Patient received incorrect Covid-19 2nd dose. Patient received the Orange monovalent 5-11yr pfizer dose and should have received a Gray monovalent pfizer 12+yr dose.
pt recvd vax 1SEP92 & unconsolable crying >3 hrs in 1st 12 hrs p/vax;
Initial misuse report received from a healthcare professional on 18 September 2013. A patient had received FLUZONE subcutaneously in arm. It's an inappropriate route of vaccination. No adverse event was reported. List of documents held by sender: none
Patient came to get a COVID vaccination on 7/25/2021. Patient fainted after receiving his COVID-19 1st dose Pfizer vaccine. He recovered within a few minutes. Per patient, he has history of fainting from vaccination and bloodwork because of fear or anxiety from needles. He was sitting in a chair. Patient's father held him when he fainted. Patient's father and patient refused to call 911. I recommended him to go to hospital so that further treatment/evaluation can be determined. I called patient on 7/26/2021 at 4:45 pm to follow-up. He said he went to hospital/ER for post-vaccination evaluation and everything was ok.
Swelling of the injection site within 3 minutes of injections. No systemic allergic reaction present. Pharmacist reccomended Benadryl.
"My skin around shot area turned red, swollen with itching, followed with wheezing and mucous in my lungs, nausea, sneezing and coughing  both. Back, left side tender and inflammation.
Patient came to get Vaccinated with Covid Vaccine and flu vaccine. Patient verbally requested to receive the flu vaccine as well while in vaccinating chair. Vaccinating nurse overlooked chart verification and proceeded to give FLUZONE quadrivalent vaccine to the patient. Patient received fluvaccine previously this year 9/20/22. Patient had no adverse reaction and left in stable condition AxOx4 speaking in full complete sentences with unlabored breathing and in a pleasant mood.
Red and itching circle area approximately 1 and 1/2 in in diameter at injection site. Dose not  feel warm to touch, She states hydrocortisone cream helps the itching. I suggested to continue and an ice pack occasionally and check back in 3 days still having issues.
After two weeks of receiving injection, redness, swelling and mild itching remain at injection site. Area of redness and swelling is approximately 2x3 inches.
Severe pain through her arm. When she saw the doctor she was told it was a rotator cuff injury from the shot.
Sore arm, next day very sore and rash.  Also total body ache.
vestibulitis; significant dizziness; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for a 43-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 04Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient was given the Pfizer COVID vaccine on 04Jun2021 four days later on 08Jun2021 he developed significant dizziness and increasing the stipulate us he had been followed by ear nose and throat physician he took eight weeks for this problem to resolve he never had problems with this or any other problems in the past he have seen him for an infectious diseases consultations. AEs resulted in physician office visit. The outcome of both the vents was recovered on an unspecified date in 2021  No follow-up attempts are needed; information about lot/batch number can not be obtained.
This case was reported by a physician, via a sales representative, and described the occurrence of blood in stools in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (details unknown). One day after vaccination with ROTARIX, the subject experienced blood in stools. The infant went to the physician's office for a well visit and was administered the ROTARIX vaccine. The physician was notified the following day that the infant had blood in stool. No additional details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow up information was received from the physician on 13 March 2012. On 23 January 2012, the 3-month-old female subject received 1st dose of ROTARIX (oral route). On 27 January 2012, 4 days after vaccination with ROTARIX (the physician noted it was 3 days but the dates indicated 4 days), the subject experienced blood in stools and was diagnosed as having a reaction to ROTARIX. On 31 January 2012, the event was resolved. The physician considered the event was probably related to ROTARIX. The physician noted that the event was not serious, but then indicated that the event jeopardized the patient or required intervention. The physician explained that the subject's stool was monitored daily for 2 to 3 days by keeping in contact with the mother. The physician noted that the event could have been associated with the subject's medical history, but noted it was "hard to say, patient was not exposed to anybody with diarrhea". According to the physician, the ROTARIX series was discontinued.
PHARMACIST IN CHARGE INCORRECTLY PREPARED VACCINE.  SHE FAILED TO DILUTE COVID-19 VACCINE BIVALENT UPDATED BOOSTER 4 -11 YEARS OF AGE.  PATIENT RECEIVED  0.2ML IM OF CONCENTRTATED VACCINE.   15 MINUTES AFTER ADMINISTRATION PARENT WAS CALLED AND REPORTED NO ADVERSE REACTIONS.  PARENT WAS ADVISED TO CALL WITH ANY FINDINGS AND CONTACT DOCTOR AS SOON AS POSSIBLE.    AT THIS PREWSENT TIME WE HAVE NOT HEARD FROM PARENT OR DOCTOR.
About 2 hours after the vaccine I started filling dizzy. It was evening, so I just went right to bed. When I woke up in the middle of the night the room was spinning. I fell back asleep, but when I woke up in the morning the room was still spinning and stayed spinning all day. I was very, very dizzy and nauseous all day (3/18). I vomited twice and struggled to keep even water down. I slept on and off all day due to fatigue and anything I tried to do made me dizzy, so sleeping was about all I could do anyway. The next day (3/19) I woke up improved, not 100%, but better. Still dizzy at times, but not as intensely and I was able to eat and drink without vomiting or nausea. For the next couple of days (3/19-3/21) the dizziness came and went, but was overall much better than 3/18. On 3/22 I woke up feeling terrible again, very, very dizzy and unwell. I was slightly nauseous from the dizziness, but was able to keep water and food down. I did a virtual appointment with a doctor, who said I had vertigo. I've had vertigo only once in my life (in January 2021), and it wasn't anything as bad as this. By 3/23 I was so miserable, I couldn't walk without assistance since I was afraid I would fall. I went in to see a doctor in person,  confirmed the vertigo diagnosis and recommended physical therapy. I did physical therapy and they said I had benign paroxysmal positional vertigo both in my left canal and in my horizontal canal. I started to slowly improve, but was unable to work due to my inability to look at a computer screen that week (3/22-3/28). I was well enough to work for 5 hours a day the week of 3/29, but unable to drive as sudden head movements continued to cause dizziness. As of 4/4 I started driving again and am feeling mostly better, but I still have dizzy spells. Dizzy spells are short and manageable. I've been very fatigued (likely from the vertigo, but who knows) since receiving the vaccine. As of today (4/8), I'm still not feeling 100%. I'm still very fatigued and still experience dizziness if I move my head too much.
Day 1-Day 5 Injection site soreness Day 1-Day 5 Deep Joint Pain Day 3-Hematuria Day 5-Headache
Mild swelling in my left leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Mild swelling in my left leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Mild swelling in my left leg). At the time of the report, PERIPHERAL SWELLING (Mild swelling in my left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Extreme itching over arms, face, head, legs, back, broken skin, headaches.
p/vax pt exp back pain to lt side as well as abdominal pain; back pain became more diffuse; CT scan revealed pelvic mass;under investigation;MD states mass no clear relation to vax; also local react; sore & swollen arm; low-grade fever;
Heavy menstruation within 3 days of first shot. Menstruation has continued everyday with no break in bleeding since the first shot was provided. Patient had blood work drawn to include CBD, lipid panel, thyroid, and hormones.  All blood work came back normal. Patient was referred to a gynecologist and under went tramsvaginal ultrasound to check uterus and ovaries for abnormalities.  No abnormalities we found. Due to bleeding which has continued daily with no stop, it has been recommended Patient undergoes uterine ablation,  to cauterize the uterus. This procedure will lighten bleeding and cause sterilization.
pt recv vax & mom report child is having problems w/child mentally & physically;dx of attention deficit hyperactivity disorder made a number of times;mom attributes problems to stealth virus infect & believes orimune to be the source of inf
As soon as the shot was given, the patient fainted. I then lifted her feet onto a chair. Then, she became disoriented, stiff. Patient's mother was holding her, holding cold water to her forehead/face. After becoming alert, she sat up and vomited. After taking a nap at home, pt. fully recovered.
Patient broke out in a red, raised, itchy rash on the same day he received the flu vaccine (10/24/14). He tried topical cortisone cream and topical triple antibiotic ointment without relief. Methylprednisolone 125 mg once, prednisone taper (20 --> 10 --> 5 mg) mg every day.
I have been diagnosed with having pseudogout in right knee. I had never had any problems with this condition before, so do not know if from vaccine but thought I would report
Patient reported tight chest and swollen throat and eyes. She took BENADRYL and symptoms resolved.
I had no reaction following the vaccination.  The next day I had very mild soreness at the injection site. The next morning (about 36 hours after the vaccination) I woke up with fatigue and a sore throat.  I had breakfast and about 10 minutes later I vomited everything (projectile vomiting, no nausea or abdominal pain). An hour later I had episode of severe watery diarrhea (just one episode).  Felt very weak so I decided to sit down, stumbled to a chair, and then proceeded to have a syncopal episode with about 4 minutes of seizure like activity (witnessed, I don't remember that part).  Decided to go to the ER, where I had labs, EKG, CXR, head CT scan, MRI and EEG.  I was admitted for 24 hour observation, all the tests were normal.
-Mild to Moderate headache, mild dizziness on and off, and increased body aches  for 4 days following vaccination.  -Generally felt 'under the weather'  not quite myself for a full week following vaccination.   Gradually starting to feel back to baseline second week post vaccine
Pt called the office stating she has three red spots on arm at site of vaccine that are painful. Denied fever, trouble breathing, N/V. Pt advised to apply ice to area, use TYLENOL for discomfort and report if not improving.
21 year old female patient gave an expired ADACEL vaccine with no reported AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a Pharmacist via non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819294).  This case involves a 21 year old female patient who was vaccinated with the expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5666BA and expiry date: 17-Sep-2021, Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, no 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.
Upon waking this morning I got very dizzy and needed to lie back down. This happened 3 or 4 times. I have a slight headache, feel achy (especially in my back), injection site hurts and it is difficult for me to raise my arms above my head.
6/11/2010 pt to office for left thigh, red swollen, warm at injection site. Pt also had a viral illness at this time, her pangina with high fever. Local Reaction, Tx-Ice and Motrin.
IMMEDIATELY AFTER INJECTION SHE INDICATED SHE HAD TROUBLE BREATING AND FELT NUMB ALL OVER HER BODY.PHARMCY TECHNICIAN CALLED 911 FOR PARAMEDICS IN THE MEANTIME  I GAVE HER AN EPIPEN INJECTION WHICH SHE IMMEDIATELY INDICATED SHE  FELT BETTER AND HAD IMPROVED BREATHING. THE PARAMEDICS CAME IN A FEW MINUTES AND CHECKED HER AND TOOK HER TO THE HOSPITAL. LATER IN THE DAY SHE STOPPED IN WITH A PRESCRIPTION FROM ER AND INDICATED SHE WAS FEELING BETTER.
Information has been received from a health professional concerning a 6 to 12 week old female with gastrooesophageal reflux disease who was vaccinated with a first 2 ml oral dose of ROTATEQ.  Concomitant therapy included "other recommended vaccines at two months of age".  Subsequently the patient experienced fussiness and crying for about 24 hours after receiving ROTATEQ.  Subsequently, the patient recovered.  Medical attention was not sought.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Client had syncope post vaccination. Lost consciousness for approximately 5 seconds. No visible head or body injury noted. Client was assisted to flat surface. Vital signs x3 performed every five minutes. Client was observed at vaccination area for 30 minutes post incidence. Client returned to normal. Denied lightheadedness or dizziness. Left site in stable condition.
Case became symptomatic about 04/09/2023 , tested positive on 04/11/2023. Spouse became symptomatic before this case. Case was hospitalized on 05/01/2023 with COVID pneumonia.
Hep B was given on 12/5/19. On 12/6/19 patient started with red dots on Left thigh, on 12/7/19-hives spread to both legs and arms. Went to Urgent Care and told probably a vaccine reaction. Benadryl given. Rash is gone.
Extreme pain at injection site. Unable to use arm. Flu symptoms from November to March 2000. Joint and muscle pain with difficulty in stooping, bending, walking, etc. Pt did not produce results. Treated with pain medicines (Ultram 50 and Vioxx). Continues to see 2 different doctors.
Fever x 5 days tmax 104, cough, rash/blisters appeared in left cheek on 2/7/15. Treatment: Acyclovir 1/2 tsp po TID x10 days. Dry patches, oozing and red, yellow blistering lesions over (L) side of face around (L) earlobe.
Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At 7 days after administration of the vaccine, lymphadenopathy in left armpit persists and remains painful. At 7 days post vaccination a 2 inch patch of swollen skin appeared at the injection site. This is accompanied by redness, itchiness, and pain.
Received Vaccine that expired on 4-17-2022, information from Moderna internal analysis:  Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Starting 07/03/2022, I had a weird cough. I tested positive on 07/04/2022 with an at-home COVID-19 test. On 07/05/2022 I contacted my doctor who prescribed me Legavrio. I had a cough, sinus drainage and light fatigue. The symptoms would seem to resolve by 07/08/2022 and I finished the last dose of the medicine by 07/09/2022. I did not have any symptoms after that.
Large palpable hard mass under skin at injection site. Does not go away. Slightly painful.
pt recv vax 19APR96 & 14MAR98 pt devel chickenpox, 15-20 lesions;
Pain/Discomfort in Shoulder over first 24 hours. Over the next 24 hours shoulder exhibited approximately four quarter sized red/inflammed areas on skin. These areas were exhibiting warmth and inflammation.  Patient arrived at pharmacy on 12/12/15 and allowed pharmacy to see shoulder.  Pt. said area felt better and seemed to be getting better.  Pharmacist on duty recommended oral Benadryl as well as ibuprofen over next 24-48 hours to help alleviate reaction.
14 mo child rec'd HIBTITER/OPV/DTP on 11DEC90. Developed H. Influenza meningitis on 23JAN91. Hospitalized. Child doing well at time of this report.
3rd day, post vax, I felt a lot of aching in area where vaccine was given. It felt like muscle spasms. I called MD and was told to come in and I did. I also had swelled and had a lump in the area. I went back on the 10th day, 17th day, 20th day, and am still going to physical therapy now. I asked hospital to fill out form, also, but don't know if they did. They have all test and medical records as of February 2000. I am suffering from numbness and tingling in arm and fingers, aching in upper arm and twitching in arm.
Information has been received from a registered nurse concerning a 30 year old female patient who on 24-FEB-2012, was vaccinated IM with 0.5 ml first dose of GARDASIL (lot # not reported). On 25-APR-2012, the patient was vaccinated IM with the second dose of GARDASIL (lot # not reported). On 03-JUL-2012, the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot # not reported). The nurse stated that the patient got her third dose of GARDASIL too early. No adverse effects were reported. No further information is available.
pain, redness and itching at injection site lasting 5 days, stopped at pharmacy to let us know
Vaccine administrator began the immunization of the patient while being observed by RPh.  When the administration of the immunization began the injection site instantly started swelling before the injection needle was placed into the subcutaneous site completely.  The area was very tough, and the needle would not go in farther.  No Zostavax vaccine was injected at the sight due to the instant swelling.  The injection was repeat at a site near the first injection and the same event occurred. The location area swelling was the approximately the size of a pencil eraser. With the patients permission the immunization was completed by RPh at a subcutanous site a few inches away from the others.  The skin was tough when injected but was successful.  The patient reported recently falling with possible unseen bruisings. No known scar tissue in the right arm where the injection was given.  The patient reported feeling fine after the immunization was given and waited an additional 15 minutes to ensure he still felt ok.  A card was given to the patient with contact information in case any worsening at the injection site occured.  No treatment was given.