chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around the 2nd  night/3rd morning, my arm began to swell. It was hot to the touch and feels like a knot. The knot and size keeps increasing for nearly a full week-still has a fever, hot to the touch, and very hard. The injection site is not sore. I'm now at day 17 and I still have a golf ball size knot that I'm very concerned about. It does not have a fever and the red swelling has gone away.
Vaccine Expiration Date 11/07/2022. Hepatitis A vaccine given on 11/10/2022. RN spoke with Merck representative who said that there is evidence that within 3 days of expiration date, vaccine still has efficacy and patient is not required another dose of Hepatitis A.
rash on her injection arm; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority SUPPORT via contactable consumer or other non HCP (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on her injection arm on 17Feb2021 (three days later after vaccination). It was reported that symptoms went away in 2-3 days. The outcome of event reported as recovered (went away in 2-3 days) on an unknown date of Feb2021.  Follow-up attempts completed. No further information expected, information about batch/ lot number cannot be obtained.
This spontaneous report was received from a medical assistant, referring to an unspecified 12 month old patient. The patient had no known drug allergies. His medical history, concurrent conditions and concomitant therapy were not provided. On 21-SEP-2017 the patient was inadvertently vaccinated with the first dose of PROQUAD subcutaneously, in the left thigh, lot # M033216, (dose and expiration date were not provided) for prophylaxis. At the same visit, the patient was also vaccinated with the first dose of VARIVAX subcutaneously, in the right thigh, lot # M038857, (dose and expiration date were not provided) both for prophylaxis, which were reconstituted with sterile diluent (MERCK). Nurse saw M-M-R II component on PROQUAD box thinking it was M-M-R II. The patient had no illness at the time of vaccination. No adverse effects were reported.
1/1/21Body ache, headache, no fever,1/03 sore throat and was tested positive on  01/05/21 and then was sick with COVID
THE PATIENT PASSED OUT ONCE SHE WAS HOME.  SHE PASSED OUT IN THE BATHROOM AND THEN AGAIN WHEN CRAWLING TO HER BED.  AFTER THAT SHE DID NOT PASS OUT.  SHE WAS VACCINATED AT ABOUT 10AM AND THEN WENT HOME AND PASSED OUT AROUND 12NOON AND PASSED OUT AGAIN SHORTLY AFTER NOON.  SHE HAS NOT PASSED OUT SINCE THEN.  SHE DID NOT CONSULT HER PCP.  SHE DID NOT CALL AN AMBULANCE.  SHE SAID SHE PASSED OUT YEARS BEFORE AFTER TAKING ADVIL.  THE PATIENT DID NOT KNOW IF SHE HAD EATEN BEFORE GETTING HER SHOT THAT DAY.  SHE WAS NOT ABLE TO TELL ME WHAT TIME SHE NORMALLY EATS BREAKFAST.  I ADVISED HER TO CONSULT WITH HER PCP REGADING WHETHER OR NOT SHE SHOULD GET THE
Pain, marked swelling area of vaccine and throughout upper arm - suggestive of Arthus phenomenon.
Dizziness when patient walks; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when patient walks), CHILLS (Chills) and MYALGIA (Body aches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness when patient walks), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Dizziness when patient walks), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not reported  treatment information was not provided
Patient developed hives, swelling, and welts, including near the site of vaccination of one vaccine.  Patient was seen in the emergency department and monitored for several hours.
Evening of given vaccination 6 hrs later, developed redness, swelling at site. Continued to develop through next 48 hrs and called Dr who suggested to go to the ER where cephalexin given for cellulitis.
Swelling and erythema at vaccine site x 1 day.  Advised anibulizers.
It took all the strength from her leg; major flare up; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (It took all the strength from her leg) and CONDITION AGGRAVATED (major flare up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced CONDITION AGGRAVATED (major flare up). On 28-Aug-2021, the patient experienced MUSCULAR WEAKNESS (It took all the strength from her leg). At the time of the report, MUSCULAR WEAKNESS (It took all the strength from her leg) and CONDITION AGGRAVATED (major flare up) had resolved. Not Provided          The patient experienced a bad reaction from the Moderna Covid vaccine clarified as a major flare up describe as that morning she could not get out of bed, and it took all the strength from her legs, and she had to crawl out of bed. No concomitant medications information was reported. No treatment medications were provided.
Hives, itching, restricted airway all occurring approx. 12 hours after vaccine. Hives and itching continued all over body for 5 days. Used Benadryl, Prednisone, and Ranitidine.
notice swelling & itching the next evening 18FEB98;called hlth dept 19FEB;no nurse available was referred to MD;pt called MD office clerk insisted pt apply ice;swelling cont  to inc w/itching;rash appeared & spread;fever inc;pt to ER T105.0
This case was reported by a pharmacist and described the occurrence of a rash in a 21 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date, the pt received the 2nd dose of Engerix-B.  At an unknown time, post-immunization, the pt experienced a rash. The outcome of the event is unknown.
Bell's Palsy; Felt lightheaded and dizziness; Fatigue; A spontaneous report was received from a consumer concerning an 83 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy, Dizziness, and Fatigue.  The patient's medical history and concomitant medications were not reported.  On 03-FEB-2021, prior to the onset of events, the patient received his first dose of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 04-MAR-2021, the patient was taken to ER and was diagnosed with a mild case of Bell's palsy. He also felt dizziness, lightheaded, and fatigue. Attending doctor at the Veterans Administration said he could take the vaccine but his primary care physician advised him to wait a week. Treatment included prednisone and valacyclovir.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of events, Bell's Palsy, Dizziness, and Fatigue, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I felt like I had Covid. Arm soreness increased throughout the day to the left shoulder blade like someone hit it really hard and I could not lift anything with even a little weight to it. I gradually got sleepy throughout the day and by 6:00 pm the day of the shot I was in bed for 36 hours only to get up to use the bathroom and possibly eat a little. Loss of appetite and I lost 3 lbs. (I am 5'4" and weigh 128). Brain fog was a real thing. Day 3 I had more energy back, but still didn't feel 100%.  Day 4 (today), I finally feel more normal, but I still have a bad taste in my mouth and the smell of poop in my nose. I had Covid in September and I would say I felt 75% as bad as when I had it.
Patient adverse reaction to Shingrix redness, swelling 24h after injection. 5 days post vaccine, some improvement w/bandage hydrocortisone . Pt concerned w/administration too low immunization 12ph, PharmD, confirms 3 finger technique
First shot was 01/25/21 and I had very mild chill snd dull  headache for about 24 hours and sore arm for 3 days. A little tired for 4 days afterwards but nothing bad.   Second vaccine was 02/222/21 and I had a fever of 101.5  for 24 hours and chills for 8 hours than a headache - migraine for 24 hours then dull headache for 2 more days but bearable. Tired for maybe another day.    The symptoms were worth it bc I prefer to have these now and avoid covid-19 in future with much more complicated possible factors.
SWOLLEN LYMPH NODES; SORE THROAT; BODY ACHE; CHILLS; MASSIVE HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced swollen lymph nodes. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced body ache. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced massive headache. On JUN-2021, the subject experienced fever. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 18-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, massive headache, swollen lymph nodes, sore throat and body ache was not reported. This report was non-serious.
Uncontrollable shaking (chattering of jaw), musculoskeletal pain, burning sensation of skin, fever <102 degrees, uncontrollable vomiting.
Pt developed fatigue, headache, acute renal failure, and anemia shortly after the injection.   Cr was 2.0 on 3/9/21 and peaked at 2.5 on 4/28/21 and was last 1.2 on 7/26/21.  Saw nephrology who found no other cause of the acute renal failure.  Hgb was 10.6 on 3/9/21 with a low of 9.0 on 5/6/21 and was up to 10.6 on 7/26/21.
Patient called to report strong metallic taste and smell. Seemed concerned that it came on so fast.
pt recvd vax & was found to be Hep B core antibody positive & a non-responder;
Fever, nausea, body aches, mouth sore, neck pain, ear pain. Doctor visit:10/21/21. Results: Upper Respiratory Infenction. Prescribed: amox-clav 875mg.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not take other medication in 2 weeks and did not know allergies. He did not have other medical history. He took as antiviral for Covid-19 as Paxlovid treatment start since 13May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Pt had a fever to 102 the night of the vaccine administration.  Dad called to tell me that pt weemed to be acting emotionally labile since that time.  I saw the pt today (3/26/04) and pt was acting quite out of control behaviorally.  She has always been astubborn child, but father states that this has greatly increased since the day after the vaccine was administered.
This spontaneous report as received from a registered nurse concerning multiple unspecified patients that might have received doses of GARDASIL (doses, routes and lot # not reported) at longer intervals than those recommended. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Patient stated she had flu-like symptoms and sore arm the day after the vaccine. Today, she complained of redness on and around injection site (not tender or warm to touch, no pain). She also stated that she had swelling around her sinus area (on both sides of her face but more pronounced on her right side of face). She mentioned that the swelling was worse this morning. It is still visible but decreasing. Her husband who is an MD told her it is not an allergic reaction and that she should still receive the second dose. Patient's mother and husband also came in for the same injection on the same day. Both only experienced a sore arm.
Pt developed rash in the vicinity of the injection site within a few hours of vaccination  initially was "extremely painful) for a day then pain receded but complains of "extreme" itching up to and including time of reporting. As of time of reporting (09/27 1115AM) rash unchaned in color or size        (coverage area approximately size of 3x5 inch area).
12 days after first vaccination:  Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of "lopsidedness"; unsteady on feet, requiring assistance to walk.  Primary care physician recommended ER visit where possible stroke was diagnosed.  Hospital MRI confirmed: " Left acute arterial ischemic stroke, MCA (Middle cerebral artery)" .  Spent 2 days in hospital with high blood pressure, dizziness.  Residual right finger numbness upon release.
The pharmacy received Moderna vaccine (lot number 069H21A, expiration 4/6/22) from the local Department of Health on 12/6/21 at 3:23 PM. The pharmacy miscalculated the beyond use date as 1/6/22, when it should have been 1/5/22 (30 days from the date received). It appears the pharmacy did not account for December having 31 days, which lead to the miscalculation. Patients administered vaccine after 3:23 PM on 1/5/22 received product that was past its beyond use date.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. The patient was not sure if she was vaccinated with a dose of MMR II. Date, dose, route, frequency, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. On an unspecified date the patient had titers drawn as part of employment testing, and titers for MMR II were negative (Viral test negative). The outcome of the event was unknown. The causality between the therapy with MMR II and the event was unknown. Additional information is not expected since there is no contact information.
shivering; fatigue; myalgia; headache; This case was reported by a physician and described the occurrence of shivering in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced shivering, fatigue, myalgia and headache. On an unknown date, the outcome of the shivering, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the shivering, fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's neighbor. The patient received the 1st dose of Shingrix and experienced shivering, fatigue, myalgia and headache. All symptoms had resolved. The reporter would like to know if she had a reaction to the first injection, does that mean that she would also have a worse reaction on the second injection. The reporter consent to follow up.
Pfizer BIO-NTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer BIO-NTech vaccine on 9/1/21 and 9/22/21. Recent admission 7/16/22 for acute hypoxemic resp fail 2/2 covid-19 c/b acute encephalopathy, severe COPD and CKD3. Tmax 101.7, RR mid 20s, satting mid to high 90s on 4L. CBC and CMP wnl, Cr 1.44. Lactate and Procal wnl. Trop/BNP wnl. CXR negative  D/c'd 7/20 and readmitted 7/20. EMS reported pt noted with SPO2 87% on room air, placed on 4L with resultant SPO2 100%. VS on arrival significant for RR 24, SPO2 91% on RA; BUN 32, Cr 1.44, K+ 5.3, PCO2 28, Ph 7.46, WBC 9.3, UA (-) for UTI; CXR with increased interstitial markings likely scarring at lung bases but no acute process. Transitioned to hospice. Expired 8/1/22. Tx'd w/decadron and cefepime over entire stay.
Flu like symptoms (nausea, vomited) 9/3/13; left arm tenderness. Shortness of breath 9/5/13.
received only the liquid DTAP-IPV component of PENTACEL vaccine with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who  received only the liquid dtap-ipv component of pentacel vaccine with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine  (formulation, strength, route, anatomical location, batch number and expiry date Unknown) for proplylactic vaccination (Immunisation).   the patient "received only the liquid dtap-ipv component of pentacel vaccine with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event "received only the liquid dtap-ipv component of pentacel vaccine with no reported adverse event."   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 the 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
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878 and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # M046133, expiration date: 26-SEP-2019) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.