chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; Vaccine brand=Other, vaccine brand other= Moderna; vaccine brand= Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "known allergies Dairy" (unspecified if ongoing), notes: known allergies Dairy. Concomitant medication(s) included: CHLORTHALIDONE, start date: 04Apr2021, stop date: 01Nov2022; METFORMIN, start date: 08Mar2021, stop date: 01Nov2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown", described as "Vaccine brand=Other, vaccine brand other= Moderna; vaccine brand= Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I test positive on a rapid (at home) test for 21 days total. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 18Jul2022 to 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.The causal association between the at-risk event interchange of vaccine products and the use of suspect product BNT162B2 cannot be fully excluded.
1st vaccine - within 24 hours started period. Heaviest period of my life. Bled through a super tampon in less than an hour for 10 hours. Bled through pants while sleeping. Heavy bleeding lasted about 20 hours   Terrible back pain.  No other symptoms but sore arm.   Same exact thing happened with second shot. Except I also had flu like symptoms too - fever, body aches, tired.
Pain and swelling at injection site, overall not feeling well within a few hours after the vaccine.  These symptoms lasted for approximately 36 hours.  Continued pain in left arm as well as weakness after the initial 36 hours had passed.  It has been over one month since the vaccine and I still have pain and weakness in my left arm when raising my arm above shoulder height.  For example when I hang up a towel or try to take off my shirt I have extreme difficulty.
Approx 10 hours after administration, baby became increase lethargic, difficulty with feeding and poor sucking. Sx's continued until about 1225PM on 3/11/10. Better feeding and more alert
Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 10 doses of improperly stored VARIVAX (Merck) (dosages and routes of administration not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for VARIVAX (Merck) was found to be supported with in-house stability data. This is one of two reports from the same reporter. Additional information has been requested.
Client was given Pfizer Covid vaccine that had expired the day before it was administered. No adverse events reported. No treatment required. Per onsite Dr., since vaccine was administered less than 24 hours after expiration, it is not necessary to repeat dose. Parent/guardian notified.
Started with headache at around 4:00 pm. Then, at around 6:45 pm when starting dinner felt throat like closing and started to cough and respiratory difficulties. Took a dose of ZYRTEC 10 mg (OTC) PO.
pt recv vax 25OCT95 & 27OCT95 devel a scattered erythematous rash on torso & upper arm which consisted of some vesicular lesions & some dry & scaly lesions;pt was seen @ clinic on 1NOV95 & 1 reviewing MD felt the rash resembled hives
Onset of headache 2-3 days following immunization.  On 7/4/10 developed double vision, mother reports eyes turning inward.  Sought care of ophthalmologist.  Eye surgery on 8/30/10, to "tighten the muscles of outside portion of eye" (per mother) by Dr. Vision corrected for a few week then double vision returned.  A second opinion identified the need for surgery again.  Mother states Dr. told her the eye problem was due to menginigitis vaccine and child had a mild case of meningitis.  Mother reports MRI done that was negative.  She reports no lab tests were done.
Cellulitis site of injection (SQ). Fever, sepsis syndrome. WBC 20 K sed rate 65.
120111 Premature infant needed 1st shots. Wt: 5 lbs 4 oz. Per OK from MD DHI, HIB, PCV (P13) & RVV given. Per mother infant had a seizure on 120211 was seen in ER transported per ambulance and admitted. ER doctor & Pediatrician told mother reaction due to Pertussis. Spinal tap done also.
My whole body started convulsing and my fever shoot up to 105.  The burning in my feet spreading to the whole body. the fever lasted for 3 days the shaking lasted for one day.
I was fine until I woke up at 12 am feeling sick ....I felt very achy, joint pains both knees, jaw and back. Headache and skin tender These lasted for at least 36 hours. The next day very tired and a a slight headache which lasted only a few hours.  I did start taking Tylenol at 12:15 at night on 2/4/21 every four hours.
DTaP-IPV portion of Pentacel was inadvertently administered to a 2-month-old patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who was first dose vaccinated with DTAP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ014AA, expiry date: 10-Oct-2020 via intramuscular route in the right thigh) On 15-Jul-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  It was unknown if any adverse event occurred.  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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
He has a fever of 102.2 and having chills and body aches complaint about lack  of energy .
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
patient developed Bell's palsy, left sided facial nerve palsy 2 days after getting first Pfizer vaccine. he is being treated with oral prednisone/Valtrex for bell's palsy now. no fevers or bodyaches. mild left deltoid soreness after injection.
I got the injection Friday Morning I had a little soreness and tiredness and when I drove home at 7pm I was having bad arm pain , Saturday morning the arm pain was really bad I couldn't lift my arm, I called my Dr I assumed it was the same and my palanziq. Dr said the pfizer and palanziq both made my immune system hyperactive and was prescribed acetaminophen and 6 days steroid pack that starts with "M", after I took the steroid my mobility was better by Monday the arm pain was gone. one ear temp was 99.4 and the other ear was 98.6 I never spiked a fever
pt started crying about noon & the crying got worse & worse until 5PM;top of eyes were red & eyes were black & blue underneath;didn't sleep until MN;had a fever but temp not taken;pt would hold breath;eyes stayed sore couple of days
A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Pretty severe leg pain for several weeks: doctor (in June) sent me to physical therapy. I got a little better. Early September, much worse leg pain and really bad back pain; Diagnosed: Sciatica and Degenerative Disc Disorder; 8 mm disc bulge that they found on an MRI. I have been two different muscle relaxants. Stopped those. I am still taking Gabapentin and high doses of Ibuprofen for the pain. In the last couple of days I am finally feeling some relief in symptoms. I had gone to Urgent care visits (Urgent Care facility)  twice due to pain.
Shivering for 4 hours. Headache for 16 hours. Tiredness for 14 hours.
48 hours after vaccine administration the injection site became swollen, red, and itchy. The redness is about 3-4 inches in diameter. Left deltoid.
she "has high-risk HPV; This spontaneous report as received from a physician assistant via company representative refers to a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, reported as years ago, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) ,0 .5 milliliter, intramuscular for prophylaxis (dose number, and expiration date were not reported), unidentified Merck hpv vaccine administered (name and lot number not provided)". The administration dates of vaccinations were unknown.  It was reported that recently, on an unspecified date, the patient received results (test unspecified) stating that she  "has high-risk HPV" (papilloma viral infection). The outcome of papilloma viral infection was reported as not recovered.   The causal relationship between the aforementioned event hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
He got his vaccine, and within 30 minutes felt something in his leg, a dull ache in his right leg, probably have arthritis and normally he is fine, but occasionally he will fill an ache in his hip or knee.  Since the vaccine he has a light ache, but it seems that in the arch of his foot he is having severe pain and on Saturday he could not walk on the foot and the heel hurt extremely bad.   This symptom is still there, and sometimes it is a little worse than other times but does notice it when he walks.
Headache Eyes itching, intense burning back of head/neck, upper back burning, back itching-went down to side, sweating, left 4th toe hurts Narrative:  Employee states she got Benadryl 25mg po x 2 doses for the intense itching. Right eye still itching, face is red today and left 4th toe hurts
A non-serious spontaneous report of "administration of FLUMIST to a 60-year-old" was received from a registered nurse concerning a 65-year-old patient (gender not reported). On 28-Sep-2009, the patient received FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Information has been received from a 71 year old male "allergic to shellfish)", with thyroid problems and a history of shingles (the patient "had shingles about 5 years ago"), who on 10-OCT-2008 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included PROTONIX and thyroid medication.  The caller reported that he received ZOSTAVAX (Merck) and about a week ago, on approximately 27-OCT-2008, he started experiencing itching on his chest.  The physician told the patient it was caused by dry skin, however about 3 or 4 days ago, on approximately 30-OCT-2008, he started experiencing itching, tightness of the skin (sometimes painful) and a rash (small red dots) on his chest and thigh going down to his groin area.  At the time of the report, the patient had not recovered.  The patient sought medical attention.   No further information is available.
Pain, swelling, redness, heat tingling, decreased touch sensation Rt. upper arm & deltoid area. Headache.
Pt received vaccination approximately @ 1340 on 03/03/2021. She then reported to the post vaccination holding area for observation. At 1345 pt alerted staff to the sensation of tingling and numbness in throat and lips this was followed by difficulty swallowing. Pt was given 0.3mg EPI and 0.5mg diphenhydramine IM and symptoms started to resolve. Pt was transported via EMS to local Emergency Room for continued observation.
Vaccines given on 8/29/11. Same night developed fever & rash on legs on 8/31/11 has rash on upper limbs no fever - seen at clinic. Seen in clinic on 9/1/11 welts on upper legs, abd, arms; advised BENADRYL. 9/2/11 seen at clinic for f/u on welts -> symptoms resolved.
Resident received vaccine at 10am and was observed for 15 minutes post vaccine with no reaction noted. Pre and post vitals were at baseline. Upon rounds at 12pm, nurse noted resident with increased respirations and an elevated temperature (Resp 40, Temp 103.5). Nurse notified nursing supervisor and MD called.  Patient was transferred via 911 to Hospital at 12:25pm.
Left shoulder rotator cuff tendinitis symptoms.  Still hurts when I move my left arm above my neck length.  Has affected my ability to do things that I enjoyed doing.  In addition I now have poor gut health.  Also started at the same time.  Feels like inflammation in my gut and is getting worse.  No idea if it was vaccine related but I have never had either of these chronic synptoms and both started happening weeks after my second dose of the vaccine and both feel like inflammatory issues.  I have gone to the DR multiple times now for both and think I am being mid diagnosed as far as root cause consider I am having multiple unusual problems that all appear to be inflammatory related and frankly they can?t tell me what is wrong with me.    My stomach issues are really impacting my well being and there have been many weeks I?ve felt like going to urgent care or ER as a result of this chronic, unknown pain.  I have an ultra sound scheduled now as next step on 1 week.
Fatigue, headache, body aches, low grade fever (99.5), nausea
At 2:30 Pm, this infant had an IM PCV-7; at 6 :00 Pm he was vomiting, listlessness, fever, and irritable. On 05/02/01 at 2:45 AM, he had vomiting 6 - 7 times. The patient was directed to the ER. The patient was hydrated with pedialyte p.o. and given suppository to stop the vomiting and was released.
No additional adverse effects reported; one patient was administered improperly stored proquad; This spontaneous report was received from a registered nurse referring to a 12 month old infant patient of unknown gender. Information regarding the patient's pertinent medical history or drug allergies was not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 31-MAR-2020, the patient was vaccinated with an improperly stored dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency and anatomical location were not reported (valid lot number: S022917; expiration date: 19-JAN-2021). The administered dose of the vaccine experienced a temperature excursion -14.1 degrees Celsius for 26 minutes, as recorded by a data logger. There was no adverse effect reported.  This is one of several reports received from the same reporter.
5 hours after vaccination patient developed  hives all over her body, eyes started watering, lips started to swell. cheeks were very pale.  I am an RN and gave her diphenhydramine 50 mg and symptoms were 80% better within 3 hours.  She did not consume any foods or come into contact with any allergens that would have caused this reaction other than the vaccine.
Patient had a syncopal episode on 11/13/21. Subsequently she continued to have intermittent episodes of nausea, dizziness & headache. On 1/27/22 she was admitted to Hospital for weakness of her lower limbs diagnosed as Guillain-Barre Syndrome. Treated with IV Ig x 5days. Currently as of 2/7/22, patient continues to have weakness of her lower limbs which has also spread to her upper limbs. She is ambulatory, but with an unsteady gait.
REDNESS, SWELLING, BRUISING, AND KNOT LASTED OVER 24 HOURS PATIENT SAID ADVERSE REACTION WAS SUBSIDING, BUT STILL VERY VISIBLE OVER 24 HOURS LATER.
Normal labor and delivery on 8/31/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Deep axillary pain appeared 6 days following vaccination. Area is tender, but lymph nodes do not appear to be swollen.
I experienced at 3:30AM 5/4/21 I woke up feeling off, and once I went to the bathroom I could not walk the rest of the way back to bed. I was hot (felt feverish), was incoherent and laid in the floor. I was very fatigued, had body aches, excessive sweating. I still had great difficulty walking the next morning or standing up straight. I couldn't work or do any of my normal activities. I had a teledoc visit since I was in no shape to go seek care in person. It took over 48 hours for the symptoms to begin lessening. I was able to return to normal activities within a few days. At my 09/15/2021 annual physical my blood work test for blood sugar was high and in the pre-diabetes range.
patients exposed to vaccine with temperature excursion of 47.5°F/ 22 minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: The health Care Provider called and reported that 2 patients were vaccinated with vaccines that were exposed to a temperature excursion of 47.5 degree Fahrenheit for 22 minutes.  The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix which was went to temperature excursion of 47.5 degree Fahrenheit for 22 minutes, which led to incorrect storage of drug. This case was linked with US2022113808 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022113808:Same reporter
Information has been received from a health professional concerning a female child who was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. It was reported that the pt developed breakthrough chickenpox and had less than 50 lesions. The child also had a mild fever. Subsequently the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.