chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 86-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: when I caught Covid last year, I picked up the positive virus. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient stated that he received two shots of the vaccine and two booster shots. The patient had COVID last year with the added immunity from the boosters. The patient stated that he was travelling internationally and it was the reason why he had COVID. when he caught Covid last year, he picked up the positive virus in his system within 5 days and he took Paxlovid prescribed and it wiped it out completely in 3 days and that was incredible.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable other healthcare professional. An adult female patient (over 50 years as reported) of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of MMR II (lot# K012472 with expiration date 11-JUN-2016; lot# K009956 with expiration date 14-JUL-2016; lot# L043704 with expiration date 04-NOV-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored STERILE DILUENT (lot# K023007 with expiration date 24-SEP-2017; lot# L017417 with expiration date 02-FEB-2018; lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
She received her vaccine, just felt very very tired, and achy.  She is a walker and found it hard to lift her legs up to walk.  She had a headache and shortness of breath.  It's now feeling like she is having the same reaction that she had after the 2nd vaccine.  She had the same reaction with the first one as well.  She has notified her doctor her symptoms, and they did not give her any recommendations.
Relative took the vaccine and experienced a sore arm for a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter was patient's relative. This reporter had questions about possible side effects and if it was appropriate to get the Shingrix vaccine after already taken the Zostavax. The reporter stated that the patient took the vaccine and experienced a sore arm for a week. The reporter ended the call precipitously due to an incoming call and agent was unable to provide any information. The reporter did not wish to provide demographic information and did not consent to follow-up.
One day after receiving shot had pain and itching in (R) axilla - MD diagnosed as shingles.
PATIENT REP STATES  HE IS HAVING INCREASED HEART RATE AND HEART PALPITATIONS
Ruptured Appendix. I was hospitalized and given IV antibiotics then sent home with 2 weeks of oral antibiotics, when the abscess clears up I will need surgery.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a male patient of an unknown age 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-423296 (Patient Link).
I had extreme pain in my left arm.; I also had numbness in both arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 11:30 (Lot number: ER8727) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "Thyroid disorder" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "cholestrols" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; RESTASIS; TRIAMTERENE; ATORVASTATIN; SYNTHROID. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 17:00, outcome "recovered", described as "I had extreme pain in my left arm."; HYPOAESTHESIA (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "I also had numbness in both arms.". Therapeutic measures were not taken as a result of pain in extremity, hypoaesthesia. Additional information: The patient also received BNT162B2 in arm left, administration date 21Apr2021 11:30 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. The patient's concomitant medication also included latanaprost. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
After receiving immunization, pt. broke out in blotchy red rash B/L arms. Rash was raised and rough like sandpaper. Denies itchiness, difficulty breathing or swallowing. Face red and blotchy. Given BENADRYL in office.
Soreness in arm and bad headache 4-5 hours after injection.  Woke in the morning feeling like I'd been hit by a truck - body (muscle and joint) aches, bad headache, extreme soreness in arm (difficult to move and tender to the touch), fatigue, fever, and blurry vision.  Symptoms still present at time of form submission.
One week after vaccine, patient had pain, redness and swelling starting at injection site and continuing down length of arm.  Reactions did not clear up until after physician started her on Keflex 500mg on 04/01/21 and Methylprednisolone Pak on 04/06/21.
c/o double vision - seen by ophthalmology & cleared. Was treated for strep throat 6 days before shots.
4 hours after the flu shot, her voice was hoarse, 5th hr; her eyelids began to swell & become puffy (wears contacts). At 6 hrs lips became puffy & inside of mouth began to swell. Went to ER at hour #6. Rec'd IV BENADRYL & prednisone IM. 2 hr ER observation vs normal on discharge get symptoms gone. Now taking 40 mg prednisone QD x 5 days. To see allergist.
SORE THROAT RININGING IN EARS HEADACHE  HYPERTENSION  PATIENT SELF TRANSPORTED TO EMERGENCY ROOM REFUSED EMS TRANSPORT
Within 24hrs of receiving Hepatitis B and Varicella vaccinations, my son displayed extreme fatigue and lethargy, loss of balance, pale complexion, had a glazed look in his eyes and was disoriented. The symptoms would occur intermittently and would subside immediately after he ate food. However, within an hour or so after eating, the symptoms would reappear. The pediatrician examined patient by the second day of these unusual symptoms but was not able to pinpoint what was wrong with my son. Three days later I felt the symptoms appeared to be more severe and occurring more frequently so I rushed him to Hospital and he was immediately admitted and put on I.V. after discovering his glucose level at 30ct. Patient was transported to hospital the following day for 1 week and remained on IV along with days and days of blood tests before the doctors could find a way to stabilize his fatally low glucose levels.  He was diagnosed with Hyperinsulinism. When put on a moderate dose of Diazoxide his glucose stabilized. He was released from the hospital and remained on this medication for 2 yrs. As of 6/07 patient's glucose levels have been at a safe level without medication. His diet has some restrictions, but overall he appears to have out grown the Hyperinsulinism condition. Please note: Prior to this adverse reaction patient was completely healthy.  05/08/2008 MR received for DOS 5/15-21/2005 with D/C Dx: Protein Sensitive Hyperinsulinism.  Pt presented to local hospital with ataxia, irritability and lethargy. Found to be hypoglycemic (BS 27) and transfered to current facility for eval. PE WNL.  Pt had bouts of hypoglycemia throughout hospitalization, which resolved with D10. Pt tx with Diazoxide.
Shot scheduled time was 8:35 AM.  I had symptoms of swelling in my throat and lymph nodes, only on the left side, after the Pfizer vaccination was given. It occurred 5 minutes after injection. At 7 minutes after my vaccination,  I approached EMS to report my symptoms to EMS. EMS did an exam and said my lymnode on my left side was a little swollen. Pharmacist took my name and number for contact information. Benadryl (25 mg) was given to me from the Giant Eagle Pharmacist  after seeing EMS at 8:55 AM. Waited an additional 30 minutes with EMS to monitor symptoms. Symptoms decreased in severity after Benadryl  (25 mg) was given.  ?Pfizer-BioNTech COVID-19 Vaccine EUA"
pt recv vax;2 wk later,devel inc AST & LDH  levels;there had been no changes in liver function tests following 1st dose;
This initial spontaneous case received on 23-Oct-2017 from other health professional (nurse), concerning an elderly, male patient of age over 65-year-old (as reported). On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiration date: not reported). At the time of the vaccine administration, the needle was not tightened enough on the syringe and about half of the vaccine leaked out upon administration (explicitly considered as wrong injection technique, product leakage and incomplete dose administered) and patient had not experienced any adverse effects (side effects) after the vaccination. The reporter assessed this case as non-serious. Follow up received on 27-Nov-2017: New event (No adverse effect) was coded. It was reported that, the patient had not experienced any adverse effects (side effects) after the vaccination. The narrative was amended accordingly. Non-significant case correction received on 27-Nov-2017 with CRD on 08-Dec-2017: Age group (elderly) was added in the screen and narrative.
1JUL91 acute cellulitis of rt leg, high fever, slight cough;
Chest pain presented 3 days after vaccination and worsened for 2 days before slowly diminishing.
No adverse events noted. See explanation on Continuation Page On August 28, 2023, a RN preparing to administer a Menveo meningococcal vaccine to a patient. She noted that there were 2 component/powder - Vial 1 and one vial 2 component left in Menveo box. In inventory, it shows that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode #1389665, 4 doses had been previously administered. Those 4 doses had been administered by 2 other RNs. Each RN was questioned about mixing vials, but neither can remember if they had mixed vial 1 and vial 2. Dr was notified of incident and his recommendation was to contact parents of each patient and left know that each patient is covered on Meningococcal C, Y, and W-135 but not covered on Group A, which is not needed unless traveling outside of the country.
My daughter initially had a cough. She was recovering from the Norovirus, but she had a cough that lingered. She developed a fever on the evening of 4/1/2023, and her fever worsened and spiked for a few days. At its lowest point, the fever was 100.8; at its highest, it was 102. I occasionally gave her TYLENOL to treat the fever, and it helped for a little while. It helped overnight and into the morning, but then she would get a fever again in the mid- to late afternoon or evening. On 4/4/2023, I took her the pediatric NP. The NP checked her lungs and determined that she needed a chest X-ray, which my daughter underwent at the radiology lab that day. It was determined that my daughter had bacterial bronchial pneumonia. The NP prescribed a ten-day course of amoxicillin. She also said that if my daughter needed TYLENOL for relief, it was okay to also give that to her. We were also advised to make sure she was getting plenty of fluids and that we should give her water or PEDIALYTE. We came home and followed the NP's orders. The fever went away as of the morning of 4/7/2023. My daughter then progressively got better. My daughter has regained about 85% of her appetite. She coughs less frequently now, but it's still persistent. We were told that this would probably happen.
Approx. 15 hrs later (Saturday), diffuse red spots all over back &  torso and near hands. Injection site negative for any rxn. Pt took two BENADRYLS (7 hrs apart) which helped. But, rash returned "angrier" ~30 hrs later. Next AM, campus health (Monday) Rx for Prednisone taper. On Thurs, rash clearing up in "less affected" areas, added ZYRTEC to prednisone & BENADRYL at night. Thurs night/Friday, good improvement in less affected area and from angry red to light pink in worse areas. Monday, rash mostly resolved with some sensitive areas due to scratching.
Dizziness- a few hs after getting the vaccine plus nausea. Lump/Red/heated at injection site Headache
Breakthrough case admission after 2 vaccines  Moderna 3/5/21 Lot# 010A21A;  Moderna 4/2/21 Lot# 017B21A
Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 6/10/22, patient recieved vaccine on 6/16/22. Patient has not reported any adverse events or symptoms to our facility.
She developed tinnitus in both ears about 2 hours after administration of the 1st dose. This seemed to resolve 2 days later. However after the second shot she similarly developed tinnitus 2 hours after her 2nd shot. This time however the tinnitus has not resolved almost 2 weeks after shot
pts exp swelling & erythema surrounding vax sites to a great extent than was prev exp; Pt had rxn to both Td & Yellow Fever site
Pt. here on 1-17-11 for well 4yr old physical exam. He rec'd 2 vaccines in upper (L) arm, Polio & DTAP. A few hours later his upper (L) arm deltoid region became red, progressively swollen & indurated. Occasional tenderness. No fever. Pt. seen at MD's office 40 hours later. Well otherwise. Symptomatic tx reviewed. Recheck prn s/s infection.
fever, chills, high temp, nausea, fatigue, joint pain-drank extra fluids, second day took naproxen, day three fever gone only ache in shins
Abnormal swelling 6 days after the vaccine. Very hot to the touch, sweats and a slight fever. The redness where I received  the injection grew in size.  I am being treated for an infection at the injection site with antibiotics.
Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 21-MAY-2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021) (dose and vaccination scheme frequency were not reported).   The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion.
Information has been received from a nurse concerning a 61 year old patient (sex not reported) who on 06-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified) given at the same time.  On 06-NOV-2006, the patient experienced chills, achy and felt flu-like for 2 days.  It was also reported that the patient experienced swelling, redness, rash on the lower arm, and pain.  The patient sought medical attention.  On 07-NOV-2006, the patient recovered from the chills, achy, and flu-like feeling.  The outcome of the swelling, redness, rash and pain was not reported.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  This is a consolidation of WAES 0611USA04692 and 0701USA00012.  No additional information is available.
ABOUT 10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT WAS SITTING WITH HER MOTHER AND BECAME LIGHT HEADED AND BEGAN SWEATING.  SHE NEVER LOST CONSCIOUSNESS AND WAS ABLE TO FOLLOW DIRECTIONS DURING THAT TIME.  EMS WAS ALREADY ON SITE ATTENDING TO A PREVIOUS PATIENT WHO HAD FAINTED.  THEY RENDERED AID TO PATIENT BY CHECKING HER VITAL SIGNS.  SHE WAS HYPOTENSIVE ON A MONITOR.  THEY DID NOT CHECK BLOOD SUGAR.  UPON GETTING HER HISTORY, IT WAS DISCOVERED SHE HAD DRIVEN 3 HOURS  FROM HER HOME TO FIND A LOCATION WITH THE VACCINE AND HAD ONLY EATEN LITTLE DURING THE DAY.  AND PRIOR TO HER VACCINE, ANOTHER PATIENT FAINTED.
It was like having a flu, body aches, muscle aches and tired and slept a lot. I had headaches and took ibuprofen and Advil. It passed away after 36 hours.
Cases of shingles following COVID-19 vaccinations; 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 HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations) 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 HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations). At the time of the report, HERPES ZOSTER (Cases of shingles following COVID-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment medications were reported
Low grade temperature, above 99/below 100 which lasted for more than a week, became more hyper/restless, it became harder to get her to sleep at night, she began asking for things to be repeated, which she hadn't done before, she had a hard time adjusting to her new school (this was a little unusual for her, she is very social, and had easy times adjusting to schools/classes (3) before, it seems like she's had a hard time containing herself, began throwing tantrums at home, hitting.  Her focus has been off.  I know she's five, but she seems to have taken a giant step back.  Whereas she'd had sensory issues before, she seemed to have been growing out of them but after her last vaccination, it really became a problem.
Seriousness criteria other medically significant (OMIC). Initial report received on 11/20/06 from a health care professional. A female of unk age (demographics not reported, who has food allergies, had received a dose of Adacel, on 11/14/06. The lot number, route and site of administration were not reported. Twenty four hours post immunization, the pt experienced a decreased pulse (50), decreased blood pressure (value not reported), was pale, and diaphoretic. The normal pulse and blood pressure values for the pt were not reported. The pt was evaluated in the ER and diagnosed with anaphylaxis presumed due to foods eaten. A myocardial infarction was being ruled out. The reporter is sending more information in a few days. Treatment received and diagnostics performed were not reported. At the time of this report, the pt had recovered. The reporter for this case is the same as for case 200603200.
The nurse in observation found the patient laying down on the floor accompanied by the mother. Patient vomited, was diaphoretic, awake, oriented, able to follow commands. Vitals signs were completed, water , crackers were offered patient tolerated well. Observation time was extended, Patient reported feeling better minutes after nursing interventions. Patient left on stable condition, accompanied by his mother.
Pt received in (L) arm FLUZONE HD and PNEUMOVAX 23 and in (R) arm ZOSTAVAX. Pt reported on 10/21 that her arm on 10/18 (day after immunization in (L) arm was swollen from shoulder to wrist w/water hanging down that she could hold. She also reported that she thought she had shingles on both lower extremities but they did not hurt were only red.