chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, admitted for small bowel obstruction
Breakthrough COVID infection in fully vaccinated patient. Positive date 10/12/2021.
Maladministration; This non-serious case was reported by a nurse via sales rep and described the occurrence of product lot number issue in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced product lot number issue (Verbatim: Maladministration). The outcome of the product lot number issue was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter asked the timeframe for Menveo to go to fully liquid as he/she was working through an error in one of their clinics. The private doses would be available to order in July, others would be 4 to 6 weeks behind and hopefully that would help the back-to-school season. The reporter asked if they knew about the extra lot numbers on the current supply of Menveo.  A picture was shared of a vial, a staff had been voicing confusion on which lot number they were to be using for documentation. Not only did they have the lot number from the diluent, 2 different numbers on the vial with the powder as well.  They discussed that they should always use the one that matches the one on the box, but unfortunately some of their clinics did not order by the box from the pharmacy.  Not sure why there would be 2 different lot numbers on one vial, and asked if moving forward with the new formulation of being fully liquid if that was going to perhaps be corrected. The fully liquid Menveo would have just one lot number so it should be much less confusing. Both the mix version & the fully liquid version would be available on the order screen so they may have to make sure the hospital understood which one they want & orders it properly.  The reporter consented to follow up. The vial had multiple batch numbers, which led to product lot number issue.
patient reported 1-2 asthma attacks/day x 2 weeks from the time of vaccination.
Patient received Moderna COVID vaccine on 3/17/21 and 4/16/21. On 1/5/22, patient tested positive for COVID and admitted to our CCU with acute on chronic hypoxemic respiratory failure, acute diastolic heart failure exacerbation, and cellulitis. As of today (1/6/22), patient is still in CCU.
Given 3rd ROTATEQ on 3/14/11, seen in E.R. 4/1/11 for diarrhea & bilious emesis. Recheck 4/2 in our office with continued vomiting/diarrhea and admitted. Dx intussusception 4/3, not able to reduce so transferred to PCU for surgery 4/4. 4/10 surgery for obstruction, perforated bowel.
She said she felt very sick and was in bed, she had also had the FLUZONE HD vaccination the same day. She felt better then next day but the injection of the PNEUMOVAX 23 injection was very red and hot and had a white discoloration in the middle. It did have heat in it but no streaking. A severe site reaction most likely, told her to use a cold compress, take ibuprofen and maybe diphenhydramine at bedtime. Called her on 12-15-17 pt said that the site looked much better.
This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go). At the time of the report, CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had side effect of constipation. He asks if there is any recommendation Patient received the first dose on 16MAR2021 and does not have his vaccination card as it is in a locker at work. He has not gone to work due to the feeling of always needing to go.   It was reported that Patient took a natural vitality anti-stress mix which is vegan verified and restores Magnesium called Calm. Since vaccination, Patient had a sense of constipation, burning feeling in the lower rectum, fire burning feeling, which has gone on 3 days or so. He goes a little each time. Patient has taken 8 oz of prune juice so far. Patient is prediabetic and after eating papaya just now, his blood sugar is a bit higher.
took the first one and got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (more than once), rash (for the first time had a very mild) and nerve pain (lasted for 6 months).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient could only wear pants with a stretch waistline.  The second and third time it was very mild and short lived.  There were better antiviral medicines available.  The patient endured second and third case after vaccination, but patient was later informed that particular vaccine at that time was only 35 percentage effective, so patient needed to get the newer 2 shot preventative.  The patient took the first one and got so sick, so patient was never boostered.  The patient had kept the fingers crossed now.
7 days p/vax-fever, rash & cranky; sx lasted 3 days;
Weakness and severe pain in arm where injection was given. Ongoing weakness and pain in arm, 6 months later.
Moderna COVID-19 Vaccine EUA On day 8 after receiving the vaccine my left arm became red, swollen, hot and itchy.  I contact my physician to find out if it could be a reaction to the covid vaccine I received.  I was told it was most likely cellulitis and given antibiotics.  After a few days the swelling and warmth went away.  It was still itchy for a few more days.  I am going to have the second vaccine next week so I decided to check on line and find out if I should have the shot on my other arm.  When I looked on line I found several articles about covid arm
Severe dizziness; Disorientation; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to seafood allergy. The patient reported no other medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  On 02Apr2021, the patient underwent rapid and Polymerase Chain Reaction (PCR) test (nasal swab) and the result was negative. On 03Apr2021 at 14:05, 5 minutes after the vaccination, the patient experienced severe dizziness and disorientation. It had not been 3 hours and he was still dizzy and disoriented. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe dizziness and disorientation was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
NO ADVERSE EVENT, VACCINE GIVEN OFF LABEL, ONLY AUTHORIZED FOR 18YO AND OLDER
Patient presented to ED with black stool and anemia, hemoccult positive, Hgb 6.2. Patient received 1 unit packed blood and IV protonix. Pt admitted. AKI improving on floor. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Fever of 100.8 F by 2am (15 hours after injection). Fever gone by 8am. Glands sore in underarm and neck on right side where shot given.  Migraine during fever. Headache fo 24 hours after shot starting at 2am.
Had the vaccine, and had a little bit of soreness and a slight headache.  The 2nd day she had some bruising at the site of the injection and no headache.  Then was fine, and on 3/21/21 her arm was itching, she had a huge hot red rash, which was 2" wide and 2" long, and she took a Benadryl.  Her arm is better today, the rash is still there, but it is not hot to the touch today.
Information has been received from a certified medical assistant concerning a 12-year-old white male with no pertinent medical history or allergies who on 18-SEP-2007 was vaccinated subcutaneous with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U). The patient received his first dose years ago at another practice. There were no illnesses at the time of vaccination. Concomitant vaccines included hepatitis A vaccine (inactive) (HAVRIX) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 27-SEP-2007 (previously reported as 26-SEP-2007) the patient experienced nausea and vomiting. On 27-SEP-2007 the patient developed a rash on his chest and itching. It was also reported the patient had a "temperature" and vomiting the day after the shot was given. The patient's mother phoned the office and the child was seen the next day (28-SEP-2007). On 28-SEP-2007 the patient had a varicella like rash on his chest with 10-12 lesions. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information is not expected.
SLEEPLESS NIGHTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included salicylic acid. On an unspecified date, the patient experienced sleepless nights. The action taken with covid-19 vaccine was not applicable. The outcome of sleepless nights was not reported. This report was non-serious. This case, involving the same patient is linked to 20210738895.
Delayed local reaction with induration and pain 1 week after administration of vaccine. Treated as cellulitis with bactrim.
Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration.
Received flu vaccination. Patient reported she felt head rush. Her face was flushed. Nurse did not observe respiratory distress or difficulty swallowing. Patient was seated, vitals taken, monitored patient until she decided to leave clinic with her husband.
6 hours after injections chills and sweats started, 8-10 hrs after injection muscle pains started stronger in the gluts and hamstrings, but pain all over body, they all continue about 30 hrs after injection. 2/7/22 - 3 days after injection, started having shortness of breath intermittently.
Almost immediately after receiving the shot, my heart started racing . we called for help and the emt's on site took my bp. It was 184/125 and my heart rate was through the roof. I think it was around 135. I was pale and felt funny!   After around 15 minutes I felt better. My heart rate and bp started coming down but the emt's advised me to go by ambulance to the ER and be checked out. I was fine once I got to the ER. they did a 12 lead EKG and I waited three hours to see a doctor who discharged me and advised against getting the second dose of the vaccine.
Patient is a 56yo male who presents for evaluation of symptoms of paresthesia that he experienced after receiving the first Pfizer COVID-19 vaccine. He received the first dose on April 10th at 0900 at a church near his home. 15 minutes after receiving the vaccine he reports experiencing sensation of pins and needs of his tongue, lip and face. He left the vaccine site and the symptoms became more noticeable. 90 minutes after the injection he took Benadryl which resolved his symptoms of pins and needle sensation, but it returned 4 hours later. He continued to take Benadryl every 4-6 hours from the 10th to the 14th until finally he decided to stop by the Emergency Department. There he was given a 5 day course of prednisone (40mg daily) and switched from Benadryl to Zyrtec BID. He reports good symptoms control on the Zyrtec but states that it still doesn?t feel completely resolved. He didn?t feel like the steroids helped at all. If he misses a dose of Zyrtec he feels the symptoms start to worsen again which prompts him to take another dose of Zyrtec. He denies any numbness, tingling, weakness anywhere else on his body. He denies difficulty speaking or swallowing. He has not experienced any syncope, shortness of breath, hives, flushing, vomiting, or diarrhea in conjunction with the injection. The only other time he has experienced symptoms like this was when he was given an IM injection of PCN > 10 years ago. He was then given a one-time dose of Benadryl and the symptoms resolved within an hour and never returned.
Hepatitis A immunization was given in error as Hep A is not given until the age of 15 months.   Incident was explained to mom.  She verbalized understanding.  Patient was asked to wait for any signs of adverse reaction.  None were noted.  Mom was asked to call if she has concerns regarding the incident.  Patient left our office in good condition.
Pt. reported redness and itching around injection site on Left arm (started the day after injection). Pt. took BENADRYL and redness began to disap.
Change in menstruation following does one and two of vaccine, has not improved since onset, very heavy menstruation, increased duration of menstruation and painful menstruation since the two days following does one of the vaccine, worsened following does two.
Patient came into COVID vaccine clinic at 2 weeks for her 2nd COVID vaccination. She was told that she was too early and demanded she get her vaccination. Nurse gave it to her without going over education.
shoulder pain in which he can't move it for more than a few degrees; sore arm; He has tingling and numbness in his hand and finger tips; bruise really high on his shoulder; He has tingling and numbness in his hand and finger tips; arm which have been progressively getting worse; extreme shoulder pain; tingling fingertips, hand and arms; This is a spontaneous report from a contactable Consumer. This 26-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FM9809) via intramuscular route of administration on 08Feb2021 at 16:30 on left arm (at 26-year-old), as dose 1, single for COVID-19 immunization. It was mentioned that patient had no other products and underwent no investigation assessment. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks), events following prior vaccinations, medical History (including any illness at time of vaccination), family medical history relevant to events and relevant tests were reported as none. On 08Feb2021, an hour after vaccination he said that he had typical sore arm the night of the vaccination, within a couple of hours the pain started progressing and by the next morning on 09feb2021 he was not able move his shoulder and if he tried it was excruciating pain. On an unknown date in Feb2021 the patient had extreme shoulder pain, tingling fingertips, hand and arms, patient's arm which have been progressively getting worse, he had tingling and numbness in his hand and fingertips and bruise really high on his shoulder. He said that he no major redness or swelling, but he had a bruise really high on his shoulder. He said that he was concerned because he did not expect it to hurt like this and they say that the second dose was worse than the first. Caller asked if there was something that we were seeing with other people and was there any guidance on what to do next. Caller does not have a primary care physician to provide. He asked if this is a common experience and what should he do to address this. The patient did not require emergency Room and physician office visit. The patient had not recovered.
In Nov 2020, she and her bother had 3rd DTap booster. Immediately after the injection, she looked lethargic, and then a couple hours later she had 103 fever, nausea, vomiting, diarrhea, stomach cramps. Denies rash, swelling, or breathing difficulties. They went to the ED and got antiemetics and ibuprofen with some relief. They started feeling better in 24 hours but their symptoms lasted for a couple days. Dad denies any sick contacts or them feeling ill prior to the vaccines.
On the 14th I woke up with an upset stomach and fever of 99.5. Aches and pains all over with a sever headache. On the 18th I again woke up with all over aches and pains, shortness of breath, and heart palpations. Symptoms started to subside after 4  hours and taking an asprin.
flu; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media.  This case involves a patient (with unknown demographics) who experienced flu (influenza) every time he/she received INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) every time following the administration of INFLUENZA VACCINE.  Laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome was unknown for influenza.
Skin lesions (blistering sores) and rash on outer skin all over body, particularly arms, chest, back, legs, hands, feet, scalp consistent with and confirmed by testing to be bullous pemphigoid
Muscle cramps, heart fail, irritable bowels, joint pain and muscle.  2/13/07 Received medical records from VAMC from 4/1999 through 5/06 which reveal patient experienced: PTSD & depression & received psychotherapy, + H. pylori infection, lumbago, DDD, dermatophytosis, dyslipidemia, NIDDM, GERD, hiatal hernia, gastritis, fatty liver, Hep C, colonic diverticulosis, CAD s/p angioplasty w/stent placement 1997 & repeated in 2005 for RCA lesion, HTN, angina class 3, LV dysfunction, vertigo, labyrinthytis, allergic rhinitis, polymyalgias, carpal tunnel syndrome bilat, smoker
0n 01/29.2021, about 24- 26 hours post vaccine- it was my right thumb, it swelled up in the whole joint area on my right hand was so swollen I could not use it. In my upper back, just above my shoulder blade, that also hurt. Any place I have arthritis it just attacked those 2 spots on my body. I had nothing else, no fever. Just pain in those 2 areas, redness and swelling. I went to my chiropractor, I showed him my thumb, he said he could not touch it because it was too inflamed. He just gave me an adjustment in my back and that was it. I recovered in about a week, from the swelling and redness to go away.  It went away without any treatment.
Initially, my injection site was sore and then became itchy. After I woke up the next day I was extremely itchy all over my body. It began at my neck and proceeded to travel all down my body. It felt as if I had a horrible case of poison ivy. My PCP gave me two rounds of prednisone and also had me take allegra and Pepcid AC. , Thr full-body itchy became very painful and I am left with hundreds of little sores and scratches all over me. I am now almost 20 days from the first shot and on a daily basis I have 2-3 painful itchy hot spots. My doctor recommended that I do not get the second shot.I am so angry I put this unapproved poison in  my body.
Pt recvd vax later mom noted pt became stiff & arch back & fall to floor; when pt got up, became limp & then started to cry; pt recvd APAP; pt felt sl warm, but not hot; temp not taken; mom called MD who felt rxn related to pertussis;
Information has been received from a physician concerning her 61-year-old husband (who is also a physician) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) on 02-Nov-2007. The husband did not develop a rash. On 06-NOV-2007, the reporting physician's 27 year-old daughter began to experience itching. She then developed a macular papular rash that came up in crops. The rash began on her limbs and spread to her trunk. The patient is being treated with Benadryl and will be seen by a dermatologist. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.