chrisvoncsefalvay/vaers-outcomes huggingface dataset:
eye will not stop twitching; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of ad-ministration on 13Aug2021 (age at vaccination 33years old) as for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. The patient experienced eye will not stop twitching on 15Aug2021 16:00, tired on 14Aug2021. Clinical course was reported as she is calling to see where to report side effects. Two Fridays ago, about 2 and a half weeks ago. She was tired. Two days after the vaccine her eye will not stop twitching. It is 80% of the day. Only her left eye. The clinical outcome of the event tired was recovered on 15Aug2021 and another event was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 12-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Started with both lower extremities hurting - then progressing to Right shoulder and right arm - with decrease in mobility - like limbs were going to sleep - did not seek treatment, then those symptoms resolved.  On Saturday 12/12/09 woke up with sever pain in legs advancing up to arm. Did seek medical attention - was sent for lab work - not seen until 12/16/09. Because of timing of H1N1 vaccination -symptoms were thought to be related. A rheumatologist consulted - appointment 12/22/09. Still stiff and sore. A neurologist was consulted to r/o Guillain Barre - which was ruled out - nerve conduction studies were done - Lyrica started. Saw Dr. on 12/29/09 - and symptoms of acute pain to right arm and shoulder and occasionally involving left arm - symptoms are such that pain shoots from shoulder to elbow - no numbness or tingling noted.
Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
3 AM - woke with itching, rash noted on elbow spread to legs, trunk, arms, head progressed to hives
pt recv vax & devel a fever which persisted for 2 days, loss of appetite, & was sleepy;pt also devel an inj site rxn characterized by redness & swelling @ the site of vax;one day post vax pt devel cough & congestion;
Patient stated she had a red streak crossways on arm approximately one inch in length and was warm to the touch.
Woke up with headache.  Became nauseous, then dizzy.  As the day progressed nausea went away but dizziness turned to vision problems.  Headache remains as well.
Patient got Boostrix after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th April 2022, the patient received the 2nd dose of 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: 28-Apr-2022 Reporter's comments: The patient received Boostrix, later got a call from that facility that the storage was out of temperature range. The reporter did not know if it was frozen, or if it was lower temperature. The reporter asked for advise they did not know the excursion parameters. HCP did not have the lot and expiry at time of interaction but stated that they were in attempts to contacting the other facility to gather that information. The consent to follow up given via postal. Additional Supportive Information: The patient received Boostrix that was stored out of temperature range, which led to incorrect storage of drug.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021 at 3:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 3:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.61 for dose administered on 27-OCT -2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29 and 32 Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-OCT-2021 and beyond use date for the vial was reported as 04-NOV-2021. Product moved to clinic on 27-OCT-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Flu-like symptoms; pain; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) at the age of 75 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown If other vaccine in four weeks. The patient experienced Flu-like symptoms and pain on an unspecified date. Patient went to the emergency department where he was evaluated and then released. Adverse events resulted in Emergency room/department or urgent care. It was unknown if treatment received. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Pt. here for second pfizer dose, complaint of dizziness nausea and lightheadedness. Describes as "carsick feeling". Pt reports history of reynauds. Pt. cleared by EMS.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL (MARRS# 1312USA002103), PNEUMOVAX 23, RECOMBIVAX (MARRS# 1312USA005448), and VAQTA (MARRS# 1312USA005449) were improperly stored. On unknown date unspecified patients vaccined with improperly stored RECOMBIVAX. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recorded to Incorrect storage of drug.
Felt short of breath 4 hours post vaccine. Apical rate increased 120 to 130 / min.  Later several coldness of bilateral hands /feet with severe pain of those extremities. Fever, up to 101.4  Felt severely jittery likes some one gave me a stimulant , unable to sleep Later severe body pain to extent i couldnt walk.  Extreme weakness.  Tachycardia continued 4 days Hives and rash.  Days 3 to 5 upset stomach and diarrhea  2 weeks post vaccine dx stage 3 kidney disease .  Brand new dx
Extreme cold and freezing; Shaking; had chills to where she felt she was having a seizure; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (Extreme cold and freezing), TREMOR (Shaking) and CHILLS (had chills to where she felt she was having a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concomitant products included HYDROCHLOROTHIAZIDE, THYROID (ARMOUR THYROID), ZINC, VITAMIN C [ASCORBIC ACID], UBIDECARENONE (COQ 10), FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (had chills to where she felt she was having a seizure). On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (Extreme cold and freezing) and TREMOR (Shaking). At the time of the report, TEMPERATURE INTOLERANCE (Extreme cold and freezing), TREMOR (Shaking) and CHILLS (had chills to where she felt she was having a seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included colon prep medications, No Treatment information provided
Within 5 weeks post vaccination the pt became pale, monitored with breath rate, was around 20-normal respiration and fully concious. Steadily improved and seemed  normal in 15 weeks.
Started about 3-5 minutes in with clammy hands and a very dry ?cotton mouth? sensation in my throat. Metallic taste in my mouth was noted. I felt tachycardic, then as if my heart was pounding out of my chest. Asked to have vitals checked, BP 179/99, pulse 130-140s, oxygen sat 97-100%. Started feeling chest burning from left to right chest and also palpitations. Was given Zyrtec by on site RPh, then eventually transferred to the  ED at approx 9am. I was given IV Pepcid  20mg and PO Benadryl 50mg, potassium repletion for incidentally low level of 3.1. Had  BMP /CBC/ Complement total and triptase levels drawn. Kept for observation until pulse and Bp were within normal range. Discharged around 11:45am
Weeekness in both legs leading to inability to walk (in wheelchair for 6 weeks). Additionally, when standing up from sitting became light-headed at times collapsing.  Just now being able to start with stretching, exercising at a very low level. Lost significant strength.
Pt reported a full body rash/hives which began at 03:00 on 10/19/00. He stated that the rash began in his lower extremities and by 09:00 had spread completely up his body to his finger tips. He denied itching or tightness in throat or chest. He was advised to go to the ER. He went and received Benadryl.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received KINRIX (batch number 95ZT, expiry date 22nd October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration .On unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule pf drug administration were unknown. Additional information: The nurse reported that a 5 month old received a dose of KINRIX instead of the intended dose of INFANRIX.
Patient received 2 doses of Moderna vaccine; first dose on 4/14/21, second dose on 5/12/21. Patient reported a high risk work exposure with prolonged contact of longer than 15 minutes within 6 feet of a COVID positive patient on 6/7/21 with a breach in PPE. They reported COVID symptom onset starting 6/10/21 of cough and scratchy throat. They tested COVID positive via PCR test on 6/15/21. Symptoms remain through 6/17/21.
Information has been received from a certified medical assistant concerning a 12 month old white male with no past medical history and no recent exposure to chicken pox or shingles who on 30-Sep-2003 was vaccinated with a first dose of varicella virus vaccine live (lot #645048/0197N) (0.5 ml), subcutaenously in the right thigh. There was no concomitant medication or illness at the time of vaccination. On 08-Oct-2003 at 12:00 PM the patient developed shingles with a vesicular rash "on his right side only, from his spine to his nipple, that has continued to the present." The number of lesions were reported to be too numerous to count. It was also reported that the patient "had shingles on left side of body from mid back around the nipple/low grade fever." The patient had a body temperature of 101 F. There was no product quality complaint involved. The patient sought unspecified medical attention. On 15-Oct 2003 the patient was improving and a dried lesion previously collected on 10-Oct-2003 was going to be sent for analysis. The specimen was sent to the laboratory on 13-Oct-2003. Subsequently the specimen was reported to be positive. The VZV DNA was amplified and the results of the PCR analysis revealed that the specimen contained the wild-type varicella zoster virus. On 14-Nov-2003 follow-up information from the reporter stated that the patient had "recovered completely and to date, has no further problems." Additional information has been requested.
Pt developed fever 100.7 at home (despite antipyretics) and about 8 x 7cm erythematous to ecchymotic warm, tender, indurated area around injection site.
By the evening legs started itching. Breakout started on lower legs. Rash changed from coin shaped to diffused. Went to dermatologist who diagnosed a type of eczema. Used topical cortisone cream but did not help so stopped using it. Instead used topical treatment with water based application of BENADRYL; it helped with itching but rash was still there. Applied SOVEREIGN SILVER for the skin rash and itching. Continued to be red and inflamed. On January 23-25, 2015 had flu and noticed that rash improved even without BENADRYL treatment by eliminating milk products while sick. Had a flare up of the legs when took ORGAIN so determined that allergy was specifically to milk protein. Food allergy started after Tdap vaccine.
I DID NOT HAVE AN ADVERSEN REACTION.  I am reporting a coincidence that happened both times on vaccines within 5 days or more.  I took first vaccine on March 1st and on March 5th I went for a blood test.  The results showed my glucose level was 67.  I am not diabetic nor have I ever had such low glucose level.  On March 29th I took my  second vaccine. Yesterday, April 6 I went to get another blood test and my glucose was 75.  Again,  I never prior to vaccination have I had such low sugar level.  However, I do have primary Myleofibrosis.   Because I have low hemoglobin and experience occassion lightheadness, I did not previously reported.  But having 2 blood test done and both glucose level being so low was concerning and reason why I am reporting it.
This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first, second and third 0.5ml dose of GARDASIL (Lot # and route not reported) respectively in May 2011, July 2011 and on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was not known if the patient sought for medical attention. No adverse effects were reported. Additional information has been requested.
RECEIVED LESS THAN 0.5ML AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total administered on unspecified day for prophylactic vaccination (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) less than 0.5ml dose (approximately around 0.3m), 1 total administered on 01-DEC-2021 on left arm for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 01-DEC-2021, the patient experienced administered less than 0.5ml as a booster dose (Vaccine under dose and off label use). The health care reporter (HCP) reported that they had a pod on 01-DEC-2021 and a HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered less than 0.5ml as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211209775, 20211210610, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209921, 20211210585, 20211210141 and 20211209912.
NO ADVERSE EVENT OCCURED. RESIDENT ONLY HAD 1ST DOSE OF PFIZER COVID 19 VACCINE.  SHE DID NOT HAVE THE 2ND DOSE.  NOT A COMPLETE SERIES.
fever 101  with chills, body aches for more than 24 hours, severe swelling of all armpit and head/neck lymph nodes persisting for over 72 hours - starting to lessen on day 4, tonsils swelled enough to push out all tonsil stones - still red and inflamed as is throat 4+ days later, lungs and chest pain on left side, injection site red, raised, inflamed and about 2 inch diameter for over 4 days, fatigue preventing regular daily activities, headache and nausea for the first 72 hours,tongue and mouth sores appeared on the third day and are persisting onto day 4; spoke with NP who has cared for me for almost a decade and was advised to take my Advair 500mg taken 2 times daily to alleviate lung issues, along with albuterol as needed, Tylenol 500mg and Ibuprofen 200mg taken every 4 hours for first 72 hours
Patient came into pharmacy around 6:30 pm on 08/06/21 to discuss symptoms occurring after receiving a vaccine on 08/05/21. Patient complained of sharp pain radiating into neck and shoulder joint very soon after vaccine administered on 08/05/21. Overnight, the soreness and pain intensified in left shoulder and down left arm without any improvement throughout the day.  I asked patient to show me her arm and there is definitely what appears to be a typical presentation of cellulitis forming around the injection site. I then explained what was possibly going on and instructed patient to seek medical attention at an urgent care or E.D. to be assessed for possible cellulitis as well as possible irritation in shoulder joint occurring from too high vaccine administration (dose being administered into tendon or joint).
Lymphedema in right arm and also right chest; more swelling and not just right arm but also right chest, and there was pain.; more swelling and not just right arm but also right chest; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer (treated for several year ago, generally good health), mild lymphedema due to resection of several lymph nodes, and seasonal allergies. Concomitant medications included levothyroxine sodium (EUTHYROID), cholestyramine (MANUFACTURER UNKNOWN) from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced lymphedema in right arm, lymph node pain and swollen lymph nodes on 13Mar2021. It was further reported that this episode involved more swelling and not just right arm but also right chest, and there was pain. Amelioration after a few days, but some of the problems was persisting. The patient would visit specialist eventually and would likely refuse second shot unless much smaller dose could be administered. 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 lymphedema in right arm, lymph node pain and swollen lymph nodes were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.