chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 80 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May 4th. Left Arm pain became much more mild by early morning May 4th before resolving completely sometime overnight between May 4th and May 5th. Stiffness and feeling feverish starting around 11pm May 3rd lasting until around 4am May 4th. Slight nausea while standing up starting around 3am May 4th and lasting until around noon May 4th.  All symptoms managed at home.
Pt broke out in hives 5 minutes after vaccines given - head to toe hives. No respiratory distress. She was closely monitored and vitals stable. After speaking with pediatrician on-call was advised to go to ER for further observation. Hives slowly resolved. Pt was given oral BENADRYL.
2/17/2021 I had a headache for a week and heart palpitations. Turned into dizziness, and chest tightness.
Pt noticed her injection site was lumpy & swollen on 10/20/2010. She also reports of having a fever. The injection site also developed into a rash. Pt reported the adverse reaction on 10/21/10 which at that time she was feeling better.
Ten days after the first injection of the Moderna vaccine I developed a red rash on my right arm at the injection site. The red rash is round, about 3 inches in diameter, has bumps and itches. The arm  muscle is also sore and swollen.
After first doze shot, I had more than a week of feeling bad around abdomen. After second shot, I had mild to severe headache at particularly back side near neck part of my head almost three months. According to the news and research, this seemed to be caused by a choke of blood vessels. My wife who did not have headache and took the same shot at the same time at the same location started to have same symptoms.
Severe soreness of upper left arm where shot was given - time frame/ beginning Saturday early morning 1-6 to Sunday night 1-7. Beginning on Saturday (1-6) early morning around 1:00 am, experienced a severe headache, weakness of entire body and extremely tired. I could not get out of bed the entire day and could not eat any food. I took one Advil Saturday morning which helped my headache a little but it continued for the rest of the day. I slept until 5:00 Sunday morning and although still weak I felt better and continued to feel better throughout the day. This morning (1-8) I am feeling normal. During the time frame that I mentioned being sick it felt like I had a version of the flu so I thought I would  report these side effects even though they were listed on the paperwork the Pharmacy provided me.
In the kidney,the T-cell response provokes swift production of cytokines, which could trigger podocytopathies and glomerulonephritis (GN)/fourth case of tip lesion FSGS reported post-COVID vaccination; This is a literature report.  The global coronavirus 2019 (COVID-19) pandemic has caused extensive morbidity and mortality worldwide during the past year. Covid vaccines have demonstrated excellent safety profiles, with myocarditis and pericarditis as their most severe side effects. In the kidney, the T-cell response provokes swift production of cytokines, which could trigger podocytopathies and glomerulonephritis (GN). As more vaccines are being administered, the authors are encountering rarer side effects. A 31-year-old female complained of worsening leg edema two weeks after her 2nd dose of Pfizer Covid vaccine. Her exam was normal except for bilateral pitting leg edema. UA showed proteinuria >1000 with blood 27.3/hpf. Labs showed hemoglobin, 10 g/dL; creatinine, 1.2 mg/dL; total protein, 4.6 g/dL; albumin, 2.4 g/dL; total cholesterol, 290 mg/dL; spot UPCR, 4.3 g/g; serum k/(lambda) ratio, 1.13; C3 and C4 at 112 and, 26 mg/dL. She also had negative serologies for HIV, RPR, Hepatitis B and C, anti dsDNA, anti-smith, cryoglobulin, PLA2R, ANA, ANCA, and SPEP. A kidney biopsy showed on a Light microscope glomeruli tuft consolidation with focal foam cells and foci of confluence with the origin of proximal tubules. Immunofluorescence revealed glomeruli had segmental coarse granular capillary tuft reactivity with antisera specific for IgM, C3, C1q, Kappa light chain, lambda light chain most consistent with trapping in segmental sclerosis, and electron microscopy showed rare tuft lumen inflammatory cells, segmental basement membrane thinning, rare segmental matrix tinctorial variation and broad visceral epithelial foot processes effacement and segmental microvillous transformation present. Despite steroids at 1mg/kg daily with diuretics and ARBs for 16 weeks, the patient continued to have proteinuria and started on Rituximab. The most common FSGS reported occurring post-COVID vaccination is collapsing type. A literature search found very few cases (three) of tip variety post-COVID vaccine. To the best of the authors' knowledge, this is probably the fourth case of tip lesion FSGS reported post-COVID vaccination. As the authors are aware, out of all tip variety responds the best to steroids, the authors' case interestingly was found to be resistant to steroids which makes us think whether the vaccine has any role to play in its resistance.; Sender's Comments: Based on the available information in the case, an association between the reported events Focal segmental glomerulosclerosis and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sweating a lot without being or feeling hot started around 4 hours after the injection and hasn?t stopped yet, nearly 24 hours later. Extreme pain in the left arm, nausea and vomiting about 16 hours after injection. General feeling of being unwell. Fast heart rate. Gave Emetrol and Tylenol at 4:15 am after the vomiting, but nothing since.
Patient has had left sided chest pain that radiates into his left upper back and shoulder x 2 weeks. pt states that he is sob and his sob is worse when he lays down. pt states that his cp and sob improves when leaning forward. pt states that he initially got a rash, then developed the cp, sob after  getting his 2nd pfizer covid vaccine on 9/4.  No fever, n/v/d, cough,  or edema. Patient presenting with clinical pericarditis, with possible sub-acute peri-myocarditis. Prescribed losartan, ibuprofen, Pepcid,  and colchicine and instructed to follow up with primary care provider in 1 week, or to return to ER if symptoms worsen.
A report has been received from a Pharmacist concerning a 3 year old, Male patient, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. The patient experienced tested positive for flu and vomiting. The outcome of the event of tested positive for flu and vomiting was unknown. The report was considered to be non-serious.
could not have bowel movements like almost every time I will eat and turn and go the restroom/ kept having more frequent bowel movement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FREQUENT BOWEL MOVEMENTS (non-serious) with onset Aug2021, outcome "recovered" (Nov2021), described as "could not have bowel movements like almost every time I will eat and turn and go the restroom/ kept having more frequent bowel movement". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. the patient got the first vaccine around 13Aug2021. Though when she got the first one she had mild side effects but did not really think about it when she could not have bowel movements like almost every time she will eat and turn and go the restroom so it did not downed her this medicine. The patient did not have much attention to from Aug until Sep2021, after getting vaccinated she kept having more frequent bowel movement like if she would eat something or as soon as it with hit the bottom of her stomach, she have to go to use the bathroom so from there with that happened for a while until maybe Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289453 same patient/drug, different dose/event;US-PFIZER INC-202300289452 same patient/drug, different dose/event;
Injection site redness; Injection site swelling; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) had not resolved. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  On 06 Oct 2021 vaccine was moved from freezer to refrigerator.
Received vaccines on 3/16/01 and temperature rose to 103F but was relieved by Tylenol every 4 hours for 48 hours. Broke out in papules at injection site on right deltoid on 3/18/01 which became vesicular on 3/19/01.
COMPLAINS OF DIARRHEA, SEVERE HEADACHE, MUSCLE ACHES, FEVER
This spontaneous report was received from a registered nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with M-M-R II (albumin status not provided) via the intramuscular route instead of the subcutaneous route for prophylaxis (dose, lot# and expiration date were no reported). No adverse effects were reported.
Mom phoned office 6/6/06 to report swollen, red, hot deltoid at injection site. Went to prompt care and was dx'd with cellulitis. Treated with warm compresses and Keflex. Comments from ER: Pt had vaccines 4 days ago to R arm. Now red, swollen and painful.
States felt fine day of flu vaccine. Had preservative free flu vaccine in 2012 and 2013. On 10/31/14 had FLUZONE with preservative. At 0300 on 11/1/14 woke up with a "Breast and frontale headache. Slightly better with TYL and ibuprofen. States every joint and continues to ache. Fingers are swollen. (L) middle distal knuckle is red and swollen. On 11/4/14 - cont to feel achy in her joints. Waiting to hear back from her PMD.
Heart palpitations started 2 weeks after booster of Moderna - my primary care person diagnosed a variety of dysautonomia. EKG was normal, but heart rate and blood pressure elevated.
hair loss; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) and INSOMNIA (lack of sleep) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss) and INSOMNIA (lack of sleep). At the time of the report, ALOPECIA (hair loss) was resolving and INSOMNIA (lack of sleep) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that after being admitted at the psychiatric facility he could sleep and rest and after that his hair started growing again. He stated that he lost his hair because of lack of sleep and not because of vaccine. He also mentioned that the doctor at the facility kept reminding him that he had first said it was the vaccine.
I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient).  This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism.  Physician stated, "I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.
PATIENT BECAME INFECTED WITH COVID AFTER BEING FULLY VACCINATED.  SYMPTOMS STARTED 6/28/21 WITH COUGH, FATIGUE, MUSCLE ACHES, HEADACHE, AND NASAL CONGESTION.  DIAGNOSED WITH COVID ON 6/29/2021.
We all went for testing and also tested positive; We all went for testing and also tested positive; 18 month grand daughter; Off label use; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  An 18-month-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "18 month grand daughter"; OFF LABEL USE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Although our tests are positive.  Clinical information:-Forwarded as an adverse event by the epsilon escalation team on 06May2022 reporter provided verification of contact address on 05May2022. My husband and i are in our 70's and my son and daughter in-law and 18 month grand daughter live with us. She is a teacher and tested positive for Corvid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Eight days following the receipt of the vaccine in my right arm, I had pain, redness and mild swelling around the injection site.  I marked the area with a marker and used ice and ibuprofen.  However, the following morning, the redness and swelling had worsened, and I had fever up to 101.8.  I was seen by a physician on Web that morning (1/1/2021) who diagnosed me with cellulitis and prescribed a 7 day course of Reflex.  The symptoms improved within a day, and I have since completed the course with complete resolution.
Vaccine was kept in refrigerator on 22 Sep 2021 and administered on 18 Nov 2021; 606 doses were given after expiration date / vaccine was kept in refrigerator on 22 Sep 2021 and expired on 3 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 22 Sep 2021 and expired on 3 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22 Sep 2021 and administered on 18 Nov 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 22 Sep 2021 and expired on 3 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22 Sep 2021 and administered on 18 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 22 Sep 2021 and expired on 3 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22 Sep 2021 and administered on 18 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  On 22 Sep 2021, the vial was stored in the refrigerator. The vial did not undergo any temperature excursions and patient had no adverse event.
I had a pain on the Left side of the thorax, on the lower side of my back, by the bottom rib; this pain persisted and worsen from that time and has moved from the back to the front, on the level of my rib, on the left side. I will go to see a doctor tomorrow.
Ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in my ears). At the time of the report, TINNITUS (Ringing in my ears) 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.
Fever up to 104 - Tuesday 101-104 through Friday PM - seen by Dr Thurs PM - given prednisone.  Achy joints, muscles, everywhere-hard to sleep-all symptoms noted Tues AM.
This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored (Oka/Merck) VARIVAX (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
Had H1N1 on 12/14/09 with nasal vac.  Next day, had jaw ache on right side, fever 100 degrees, treated with Tylenol. Next day the same.  On 12/17/09 same jaw ache, Tylenol, no fever at 11 a.m., woke up from nap at 2:00 p.m. with 105.6 fever.  Took to emergency room, diagnosed H1N1. Given Tamaflu.  Did nasal vaccine cause this?
Severe upper Right arm pain indicative of vaccine being given above the deltoid muscle.  Increased pain from time vaccination given culminating in severe pain later in the evening with decreased mobility of RUA.  Ibuprofen 400 mg administered per spouse x1 at approximately 09:50 pm 10/04/2021.
Several days post vaccination the patient developed tremors of his hands and face and fasiculations of his tongue.  He has also had some muscle weakness per report.  These tremors have persisted to present date.
After prolonged crying and screaming prior and during vaccination, child fainted seconds after adm error of vaccine. Was out for approx 15 seconds - came to on her own, all this time child was being held in mother's lap. Child responded adequately to questions asked after incident.