chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I was in motion to administer the shot, the pressurized vaccine squirted out of the syringe before the needled entered the child. It didn't appear that any of the vaccine entered the child.  During the second attempt, as I was in motion to administer the shot, the vaccine squirted out the back of the needle and sprayed onto my chest. It appeared a small amount of the vaccine entered the child, but the exact amount is unknown.
She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, very very red, it hurt, painful and itchy.  It lasted for a week to 10 days up to 2 weeks at the site of the injection.  I experienced achiness, malaise for several days afterwards, and kind of continued for about 3 weeks before it settled down.   She treated it with Tylenol, bed rest and Motrin.  She had gone to her PCP with the first vaccine which I will describe later.   She used to be very active and she now cannot walk trails, and still has the feeling of malaise 4 months post vaccine.  She feels she is still having some inflammatory ongoing process in her muscles, joints and has had three short courses of steroids over the last couple of months, and is now in physical therapy and going to be seen by an Orthopedist again to see what may be going on.    She is a retired nurse and feels that now she has a permanent condition based on having the vaccine, and does not know if she would have a booster if it was offered, and her quality of life has changed and is "no way to live".
I started itching and it progressively got worse. My skin would raise up where I scratched and stay red. It would move around when it first started to get bad. It was my left foot and then it was my right foot and then my thighs and then my arms and my back. I put on lotion thinking my skin was just dry. That didn't help. I took benadryl and that seemed to help. But it's been almost 3 weeks since the symptoms started and I'm still itching. It's not as bad as it was but I've still made myself bleed a few times scratching. It's  not like normal itching, my skin just feels really tingly and then I HAVE to scratch. It's so intense and then it just goes away like nothing happened. I'm going hunting for the next few weeks so I don't have time to get to a doctor. I'm just going to keep taking benadryl and hope it subsides.
at the injection Site My arm was very red and hot, itched a lot and pretty large. Went to my Dr they thought it might was infected and  gave me an IV of steroid and IV Pepcid, was Also given from the pharmacy methylprednisolone 4 mg  dose pack
GOT SICK; This spontaneous report received from a patient via a company representative concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220651820.
After my second vaccine within a few days my transverse myelitis was coming back. My chest felt tight and numb, fingers, and my arms. It scared me and I communicated with my doctor and He advised me to use some steroids on hand. My doctor did say it was something he was seeing in patients and he encouraged me it was temporary. Within a week things were back to normal and it did not appear to have any permanent side effects.
Menveo expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA46A, expiry date 20th March 2022) for prophylaxis.   On 6th May 2022, the patient received Menveo. On 6th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 6-MAY-2022 Reporter's Comment: The pharmacist reported that an expired dose of Menveo was administered by error. The reporter consented to follow up by email. Additional Supportive Information: The patient received Menveo, which was already expired on 20th March 2022, which led to expired vaccine used.
SWELLING AND REDNESS 85x70 area left deltoid. No systemic symptoms. IBUPROFEN AND COLD COMRESS ADVISED
Follow up information pertaining to the recovery status of the pt was received from the reporter. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 21 month old male pt who experienced bacteremia, fever and convulsion. At 7 months of age, the pt received the second dose on 09Jan03. The pt also received the second dose of Polio vaccine (poliomyelitis vaccine inactivated), the second dose of Diphtheria/tetanus toxoids/acellular pertussis vaccine and the second dose of Comvax (haemophilus b conjugate vaccine/hep b vaccine) on 09Jan03. Pt has no birth defects; was a well baby at time of second Prevnar injection. Indication for Prevnar was immunization. Product was administered on 09Jan03. Dose regimen was 1 dose. Concomitant medications were not reported. On 07Mar04 the pt experienced a seizure with fever and was taken to the ER. The pt was subsequently hospitalized with bacteremia. Blood culture results were positive for Streptococcus pneumoniae, serotype 19F. The pt recovered and was discharged on 08May04. No additional information was available at the time of this report.
he got a rash on the arm where he had the second injection and he had a rash on his legs as well; This is a spontaneous report from contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 26Feb2021 (Batch/lot number: EN62NZ), at age 84 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included diabetes and chronic obstructive pulmonary disease (COPD) both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the right arm, on 05Feb2021 13:00 (Batch/lot number: EL342Z), at age 83 years old, as dose 1, single, for COVID-19 immunisation after which the patient experienced rash on legs. The patient did not receive other vaccine in four weeks. After the first dose, he had a rash on his legs. Then after the second dose, on 26Feb2021, he got a rash on the arm where he had the second injection and he had a rash on his legs as well. The patient did not receive treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Muscle soreness at vaccine site. Started 2 days post vaccines and continues today. Soreness may be getting worse. Also, seems to have had an allergic skin reaction to the adhesive in the bandaid used to cover site.
Hospitalized 10/23/2021; COVID-19 positive 10/23/2021; fully vaccinated  Discharge Summary    Admission Date: 10/23/2021 Admitting Diagnoses: Principal Problem:   Dyspnea Active Problems:   COVID-19 infection, noted 10/24/2021   Moderate asthma with exacerbation   Details of Hospital Stay PRESENTING PROBLEM: Dyspnea   a 72 y.o. female with past medical history significant for COVID 19 infection 09/21/2021, interstitial lung disease, severe persistent asthma,  CVID on IVIG monthly, lymphoma s/p chemo and radiation (2000 to in remission), history of transverse myelitis, type 2 diabetes, dyslipidemia, OSA, hypothyroidism and depression who presents to the emergency department with dyspnea and confusion. Of note, she tested positive for COVID-19 on 9/21/21 and symptomatically improved after receiving monoclonal antibody infusion. Her last day of quarantine was 10/04/21. On arrival to the emergency department, vital signs were notable for mild tachycardia, mild diastolic hypertension and SpO2 97% on room air.  She was ambulated with O2 sats decreasing to 92% and was subsequently placed on 2 L nasal cannula for comfort.  Labs showed normal pCO2, mild hyperglycemia, troponin 15 with repeat at 17. No leukocytosis.  Film array was positive for COVID 19 has expected due to recent infection.  CT angiogram thorax was negative for PE but showed emphysema, mild bronchial wall thickening with peribronchial thickening, patchy GGO lower lobes consistent with bronchitis or viral infection along with band like opacities throughout her lobes consistent with atelectasis. Admitted to hospital medicine for dyspnea.   Pulmonology was consulted and in agreement that dyspnea was due to acute asthma exacerbation with no concern for ILD flare. She was started on IV steroids, inhalers, and nebulizer with improvement of symptoms. Pulmicort was added.  Zosyn was also started due to patient's underlying CVID.    Symptoms improved and patient was able to ambulate and work well with PT and OT. Patient was discharged home on a prednisone taper and 2 more days of antibiotics (Augmentin) for total 5 days.
Normal aching arm, and about 45 minutes of pouring sweat that evening. Along with a migraine-type headache (I feel I need to qualify that because normally with a migraine I get extreme nausea, and I had none), I experienced overwhelming depression and a feeling of ?why bother'. It was BAD! It did not progress to wanting to off-myself (or I would have been on the phone!), but absolutely nothing mattered. Lasted all evening, all night, and at 10 the next morning I still felt that way including the headache. Stayed in bed and went back to sleep. At about 1:15 I woke back up and felt ?normal? again with only a dull throb in my head.   In the back of my mind, I KNEW this wasn?t normal/right, but there was nothing I could do about it.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild, Additional Details: Patient turned pale and tired looking, sweating.  no difficulty breathing.  Paramedics arrived and took the patient away.
inadvertently administered Ipol and Quadracel to a 6-year-old patient/ double dose of IPOL/ no AE; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a six-year-old male patient who was inadvertently administered a 0.5 mL single dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot D93B4 and expiration date: 14-Jun-2021) and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot P1E170 and expiration date: 11-Sep-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 30-Jul-2020.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to extra dose administered. It was reported that the reporter had inadvertently administered a double dose of IPV.  At the time of this report, 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 Directive and Module VI of the 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.
cannot get the 2nd shot; 17 year old patient was given the 1st shot of the Moderna vaccine in April/erroneously given the first shot of the Moderna vaccine/under 18 child was erroneously given the first shot of; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was given the 1st shot of the Moderna vaccine in April/erroneously given the first shot of the Moderna vaccine/under 18 child was erroneously given the first shot of) and PRODUCT DOSE OMISSION ISSUE (cannot get the 2nd shot) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was given the 1st shot of the Moderna vaccine in April/erroneously given the first shot of the Moderna vaccine/under 18 child was erroneously given the first shot of). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (cannot get the 2nd shot). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was given the 1st shot of the Moderna vaccine in April/erroneously given the first shot of the Moderna vaccine/under 18 child was erroneously given the first shot of) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (cannot get the 2nd shot) had resolved.            Caller says her underage son received 1st dose and now cannot get his 2nd dose . She enquires what are the options at this point. She also states he does not take any medication regularly.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non-Significant Follow up appended On 18-Aug-2021: Non significant Follow-up appended On 18-Aug-2021: Significant followup ; outcome of event updated to recovered and added reporters address
2/5/21 - TIRED AFTERWARDS, THAT NIGHT COULDN'T SLEEP  HAVING TROUBLE BREATHING MORE SO THAN NORMAL.   NEEDING OXYGEN 24/7 2/6- TIRED, HAVING TROUBLE BREATHING, LOW BLOOD SUGAR, CAN'T SLEEP AT NIGHT - WHEN LAYING DOWN BREATHING IS HARDER, NEEDING OXYGEN 24/7 2/7-  EARLY A.M. - EXTREMELY DIZZY FELL AND BROKE TOILET, TIRED, CAN'T SLEEP, WEAK,  LOW BLOOD SUGAR, NEEDING OXYGEN 24/7 TROUBLE BREATHING 2/8- SAME SYMPTOMS 2/9- FELL AGAIN - LEGS AND FEET ARE SWOLLEN, NEEDING ASSISTANCE WALKING AND GETTING UP-SAME SMPTOMS AS ABOVE 2/10- SMAE SYPTOMS - TOOK A NAP, BLOOD SUGAR WAS EXTREMELY LOW - GOT BLUE IN THE FACE - METER READ LO - NO NUMBERS, THROAT STARTING TO HURT 2/11 - CAN BARELY GET OUT OF BED  SAME SYMPTOMS AS ABOVE 2/12 - SAME SYMPTOMS 2/13 - FINALLY CALLED AMBULANCE - SAME SYMPTOMS AS ABOVE 2/14- ER SAYS HE HAS FLUID IN RIGHT LUNG, POTASSIUM DEPLETED,  LEGS STILL SWOLLEN OXYGEN CONTINUES 24/7 EVERYDAY 2/18-DISCHARGED BUT STILL HAVE SAME SYMPTOMS 2/10- SAME SYMPTOMS EVERYDAY - OXYGEN DROPS TO 82- INCOHERENT - GOES BACK TO ER SAME SYMPTOMS TODAY - HAD STAGE 4 KIDNEYS WHEN NORMALLY THEY ARE STAGE 3 - FUNGAL/YEAST INFECTION IN THROAT - DOCTORS DON'T KNOW WHAT IS CAUSING ANY OF THIS ONLY VARIABLE IS THE VACCINE.  I WAS JUST THERE ON THE 6TH TO COME BACK HOME, MY DAD WAS INDEPENDENT BESIDES ALL OF HIS HEATLH ISSUES.  HE NOW NEEDS A WALKER AND HIS OXYGEN 24/7 - HE NEEDS HELP GOING TO THE BATHROOM AND WASHING HIMSELF.  HE IS STILL IN THE ER NOW
Patient received vaccine at 11:15am, Monitored for 15 mins and then returned to work. No symptoms observed. 30 mins from vaccination, experienced palpitations. Went to the ER and was treated. Placed on a heart monitor, given IV Diphenhydramine and IV fluids and monitored for over 3 hours and then discharged home. Asked to take 2 more doses after that which was completed. Have not experienced any side effcets or palpitations since.
75 yo female on plavix here for second covid without any issues with first covid  c/o lightheadess 18 min after second covid. pt admitted to poor hydration . vital sign  stable and exam unremarkable lightheadness resolved after drinking bottle water
Bell's Palsey.  10/28/09 PCP medical records service date 10/22/09. Assessment: Bells Palsy. Patient previously seen at ER. Develpoped pain in the side of her neck with swelling, drooping of mouth, and inability to close her eye. Numbness left side of face. Bump in neck is gone.
Since the 1st shot ( the 2nd was August 14,  I can no longer sleep on my left side , it is too painful..  I get a very sharp  pain from my shoulder to my wrist when strain to take a shirt over my head.  If I strain my left are to try to reach something, the pain shoots down my arm.  there has be no inprovement or change in almost 4 months
20 minutes after I was given the Influenza shot I was feeling very dizzy and felt like passing out, my heart rate elevated to 164/87 and my normal is  104/62. I was shaking all over and was taken to ER. I was given Epinephrine and hooked up to a heart monitor because my heart was skipping a beat. Went home 3 hours later still could not breathe well and was very dizzy. Went to ER again that night and was told they could not find anything and to continue to take Benadryl this continued for the next month and have been to ER 4 times total and to the clinic, Neurologist and Allergy specialist several times. I was out of work for 3 months because of trouble breathing, dizziness and weakness of arms and legs. I was given Prozac. Zoloft. Ativan, and Allegra during this time stopped taking medications and went to work on 2/16. 3/13 still not feeling like I did before having the shot. Still feeling light headed and dizzy.
Substantial flu-like, upper-respiratory symptoms with fever running as high as 100 F.
Pt was sitting in observation chair after his vaccination--a little slumped over and twitching as if he were having a seizure. He did not respond to me calling his name.  Pt gained consciousness and was a little frightened, not understanding the situation or remembering where he was at.  He felt a little better after some water.  About 4 minutes later, he said he was losing his vision and seeing flashes of light. He was told to lie on the floor with his feet up. Within a few minutes,  he said he was feeling a lot more like normal.
red raised area on L thigh approximately 5in around thigh and 6in down thigh. No blistering. Given Benadryl every 6 hrs x 24 hrs with complete resolution per mom.
PER LPN LEFT DELTOID WITH REDNESS, INDURATION OF 40MMX25MM, WARM AND PAIN TO THE TOUCH. ALSO MOTHER DECLINED FEVERS. DR. INSTRUCTED PATIENT TO PLACE ICE ON DELTOID AREA AND MOM TO MONITOR IF REDNESS AND INDURATION SPREAD TO TAKE CHILD TO ER.
Excessive hard crying. Drowsiness. Long periods of sleeping. Loss of appetite. Vomiting (projectile vomiting through mouth and nose).
Significant allergic reaction. Extremely itchy all over, with red rashes / bumps appearing all over body.
Redness the size of a half dollar at injection site.  Soreness at injection site.  No itching.
Onset of cellulitis on 10/21/2005. Redness 10 x 13 cm and some  induration left upper arm. Rocephin 1 gram and Augmentin x 10 days.
Patient was standing for injections Gardisal #3 administered in L.A. then Hep A #2 administered in R.A. About 2 minutes after receiving injections, patient stated "Can't see" and passed out.  Mom and I helped her to the floor.  Patient aroused in a few seconds was helped to table.  BP was 114/68.  Patient did have breakfast this AM.  Received small 1/2 inch superficial abrasion on left elbow. Cleansed with sterile water and gauze, neosporin and bandaid applied.   Patient moved to sitting position BP 118/62.  Patient moved to standing position. Patient able to walk out of office, no dizziness, feeling fine.
Swelling at the injection site after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site after the first dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site after the first dose). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were reported. No treatment was reported.   This case was linked to MOD-2021-032264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29-APR-2021. No new information was reported.
Swelling and pain of right upper arm, right arm pit, right back shoulder and front shoulder/base of neck,  warm to touch, mild fever, tingling in shoulder and upper back, nausea
Vasovagal syncope due to immunizations. Event happened around 10:15 am and the child fainted around 10:18 am.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-JAN-2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
1st dose on 01/25/2022, 2nd dose on 02/08/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 8th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, 11 days after starting the series, earlier than the recommended schedule, which led to shortening of vaccination schedule The reporter stated that, the patient did not experience any know side effects to her knowledge.  No medical intervention needed as of reporting date. The reporter did not consent to follow up.