chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 29JAN96 & devel a fever of 103 & an inj site rxn, characterized by swelling & erythema w/inability to move;tx w/APAP w/o results;
hot flash; 26Dec2020 1st dose / 12Jan2021 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 12Jan2021 15:00 (Lot number: EK5730) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Rupture" (not ongoing); "Appendectomy", start date: 1991, stop date: 1991, notes: Open appendectomy after rupture; "Seasonal allergies: Seasonal allergy" (ongoing); "Obesity", start date: 2019 (ongoing); "Frequent hypoglycemia" (ongoing), notes: Onset date: Childhood; "Suspected endometriosis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing); "known allergies: adhesive" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; FISH OIL; VITAMIN D [COLECALCIFEROL]. Past drug history included: Zantac, reaction(s): "drug allergy"; Prilosec, reaction(s): "drug allergy"; Pepcid, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose 1; Batch/lot no.: CV19PF; Route of Administration: IM; Anatomical location: Left arm), administration date: 26Dec2020, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "Sore injection site", "hot flashes with no fever", "styes on both eyes". The following information was reported: HOT FLUSH (non-serious) with onset 13Jan2021 07:00, outcome "recovered" (13Jan2021 08:00), described as "hot flash"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Jan2021 15:00, outcome "unknown", described as "26Dec2020 1st dose / 12Jan2021 2nd dose".
injection site pain-minor; tiredness-moderate/fatigue; headache-mild to moderate; muscle pain-minor/muscle aches; chills; fever-low grade; injection site redness light pink; nausea-comes and goes; feeling unwell-mild to moderate; muscle weakness; weak; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 12:15 on the right arm at a single dose for COVID-19 immunization. Medical history included allergies to anxiety medication. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced mild to moderate side effects: injection site pain (minor), tiredness (moderate), headache (mild to moderate), muscle pain (minor muscle aches), chills (sometimes), fever (low grade), injection site redness (light pink), nausea- (comes and goes), feeling unwell (mild to moderate), muscle weakness and feeling fatigue which were moderate Friday, Saturday, and Sunday and Monday. If patient was active, for example Christmas shopping for about an hour, she was very fatigue, weak and the nausea was strongly moderate and it would come and go. Outcome of the events was recovering. No treatment was received for the events. The events were considered non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination.
Next morning, stomach cramps started and lasted a couple of hours.   On 10/12 had diarrhea; it lasted about 9 hours on and off.   Patient took some Tylenol and it helped.   Called store to get item for diarrhea (Kelp acidopholis Saccharomyces Boulardii probiotic) and started taking them 10/13. Medicine helped and also took some water with electrolytes.   Patient has not called administering facility yet.    Has received Flu vaccine before with no problems.
Large area of erythema (6x6cm), with small area of induration, pruritis, pain, pain with range of motion with shoulder and elbow. Improved over 48 hours with Tylenol, Naproxen, and Benadryl.
t102 on 20JAN93 pt given APAP; cried 2-5AM 21JAN93, t101; hoarse cry, rt eyelid mildly swollen, pharynx moderately hyperemic; dx acute pharyngitis & laryngitis;
Having muscle aches, runny nose, sore throat, extreme fatigue, cough, vomiting, SOB, chest pain in August
Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L033545, expiration date: 30-MAY-2017 and lot# M004885, expiration date: 23-OCT-2017 (dose was not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes, on unknown date. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately one week after his wife was vaccinated with one dose of rubella virus vaccine live (second generation), the pt developed myalgia and paresthsia. At the time of this report, his experiences had persisted for seven weeks. A Lyme disease test was negative and an MRI was performed for multiple sclerosis (results pending). No further information is available.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-JUN-2015 the patient was vaccinated with improperly stored VARIVAX injection (lot # K018961: expiry: 15-OCT-2016 9dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Arm pain and flu like symptoms for 24 hours following the shot.   The worst side effect by far is hives/dermatographia that began about 2-3 weeks after getting the shot. This has persisted for several weeks and consists of random flair ups of hives all over my body all day / night. Any slight pressure on my skin results in a bright red flair up as well. I've had two doctor appointments and been prescribed Prednisone and antihistamines to manage the symptoms but the flair ups continue.
SWELLING NOTED 2-3 DAYS AFTER VACCINATIONS WERE GIVEN.  HAD A RED BUMP ON RIGHT THIGH WHICH FADED OVER THE NEXT THREE DAYS BUT THEN REAPPEARED 12/12/07.  DIAGNOSED AS A LOCAL REACTION.  WARM COMPRESSES ADVISED.  TOLD TO CALL IF INCREASED SWELLING OR REDNESS NOTED.
Pt received first dose of Pfizer COVID-19 at Vaccine Clinic 2/3/2021.  Patient had previously tested positive for COVID at a community testing center on 10/2/2020, but is outside of the 90 day window where retesting is not recommendation.  Pt began having headache and dizziness 2/21/2021, BP checked at home and was very elevated.  Presented to ED and was diagnosed with hypertensive urgency, then admitted.  Pt tested for COVID via PCR, positive.
On 4-18-07 Patient received 4 shots from our office around 1600. 24 hours later red tender warm area back part of left arm where Varicella was give SQ used ice, Ibuprofen, Benadryl - By 4-22-07 area increase 3" around red, raised, tender- warm to tender, warm to touch - continued comfort treatment - by 4-23-07 4 pm red edematous reactions gone but tender to touch.
4 large rashes with bumps, red one on shoulder where shot was administered and three on front of arm.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 24-JUN-2014 the patient was vaccinated with M-M-R II (lot # J011332, expiration date 13-SEP-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
redness on resident's chest, observed some redness on resident's upper chest, resident denies itchiness. Resident had received Moderna booster shot on 7/7/22 and also noted redness on injection site, Rt deltoid and tender to touch. CRNP gave order for Loratidine 10 mg daily for 3 days. CRNP will be here to assess resident tomorrow. Message left to resident's daughter to call bac
Systemic Lupus Erythematosus,  cardiac arrest for 6 minutes requiring CPR, global heart dysfunction, respiratory failure, received ECMO therapy  Patient originally presented with new symptoms of diarrhea, rash, proximal weakness, and functional decline.  Her outpatient workup included positive ANA and anti-SSA.  She was then referred to Rheumatology for new diagnosis of Lupus.  6/11/2021 she was referred to the hospital for management of acute lupus flair.  On admission she was found to have acute kidney injury and thrombocytopenia. AIR team was consulted given concern for active lupus, she was started prednisone as well as Plaquenil.   On 6/17/2021, she brought emergently to MICU for lethargy, WOB, hypoxia, and new onset A-Fib. She was intubated and continued to clinically deteriorate with persistent lactic acidosis.  An ECHO showed severely depressed EF and right heart dysfunction.  On 6/17/2021 she experienced PEA arrest with 6 minutes of CPR.  She was placed on VA ECMO with Impella.   Patient was extubated on 6/19/2021 and was reintubated on 6/20/201 for hemoptysis.  A CT on that day showed RP bleed on the left with extension into the left thigh and ground glass opacities throughout suggestive of ARDS.  She tolerated a slow ECMO wean and was explanted successfully on 06/23. She was extubated on 06/25.    Over the next several days she was able to be successfully weaned from HFNC and was transitioned to NC. On 6/28 she passed her swallow evaluation and was okayed for a PO diet. Plan is to transition patient to the floor in the next few days
Patient reported severe chills (described by patient as "shaking the bed"), fever, headache, nausea, fatigue starting about 6 hours after administration of Shingrix and Fluzone High dose.  The  fatigue, fever and headache continued into the following day. The patient treated symptoms with over-the-counter ibuprofen.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # L008054 with expiry date 30-NOV-2016, lot # M002252 with expiry date of 28-FEB-2017, lot # L020862 with expiry date of 05-MAR-2017 and lot # L029618 with an expiry date of 20-MAY-2017). The ROTATEQ vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
A female patient reported worsening morphea following a 2001 vaccination against tetanus (type unspecified); vaccination and event specifics are unknown. MassBiologics did not receive patient information, except for gender and patient's initials. The source of the event indicated that provider did not have a complete record regarding event, and MassBiologics was not given permission to contact provider directly. MassBiologics' Td vaccine could not be ruled out.
child rec'd dose on 1/25/22. On 1/27 child temp went up to 101F and unable to weight bare. Child taken to ER xray done-negative results. Saw PCP on 1/31 as follow up, temp 99.  Child's temp did not exceed 101 and  other than sore leg, no other symptom, no redness at all
CLIENT DENIED RECEIVING A DOSE OF THE COVID VACCINE WITH A PUBLIC HEALTH AGENCY AND NURSE, HOWEVER WHEN PUBLIC HEALTH EMPLOYEE ENTERED CLIENTS  VACCINE RECORD ON THE CARE PROGRAM, IT SHOWED THAT CLIENT RECEIVED THE MODERNA VACCINE (ONE TIME DOSE ONLY) AT STORE ON 05/29/21. CLIENT WAS CALLED ON 8/24/21 BY THE PUBLIC HEALTH AND CLIENT DENIED ANY ADVERSE REACTIONS OR PROBLEMS AT THE TIME PHIZER WAS ADMINISTERED TO TODAY. THEREFORE, THERE HAVE BEEN NO ADVERSE REACTIONS AT THIS TIME.
This case was reported by a pharmacist and described the occurrence of hepatitis b surface antigen positive in a 63-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There were no concurrent medications. On 25 June 2008 the subject received 1st dose of TWINRIX at 1.0 ml intramuscularly in the right arm. This was the 1st dose in the accelerated schedule for administering TWINRIX. Following this 1st injection, the subject donated blood. Recently, the subject received a letter stating that she could no longer give blood because her blood tested positive for hepatitis B surface antigens which to them indicated that she has hepatitis B. As of 17 July, 2008 the subject has received three of the  four doses of TWINRIX at the accelerated schedule. Follow-up information was received on 11 August 2008 via a pharmacist, who reported that the TWINRIX vaccination series was neither delayed nor discontinued. The pharmacist stated that the subject was removed from the blood donor list. At the time of reporting, the events were unresolved. The reporting pharmacist did not consider the events to be serious, indicating that the events have been due to a lack of knowledge on behalf of the blood center.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-SEP-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications.  Later in 2014, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with ROTATEQ lot # L039298 (expiration date 27-JUN-2017) which was improperly stored at 31.4 F for 1000 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received the COVID-19 vaccine on 5/12/21.  He stayed 15 minutes in the vaccination area and went back to work.  He did NOT have any issues until that evening. He had respiratory issues for 3 weeks after the vaccination.  He did NOT go to the ER or a doctors office for evaluation.  He "toughed" it out at home and eventually felt better.  He felt like he "couldn't breathe."   I had a long conversation with him on 6/30/21 when he came in for his 2nd shot.  I had concerns about giving him a 2nd vaccination and told him that he would need to speak to his medical doctor / an allergist to see if he can get a 2nd shot.  i did NOT give him the 2nd shot.   He did not have a  typical reaction (in my opinion) and did NOT sound like a cold or illness.  I advised him to log his side effects in the V-Safe website and he did this today.
Administered past the 30 day refrigeration time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
p/recv vax pt exp redness at inj site; 6/3 pt recovered from redness
They both later tested positive for COVID at around the same time; They both later tested positive for COVID at around the same time; This is a spontaneous report from same non-contactable consumer for 2 patient about same events. This is 2 of 2. This consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Lot unknown) as a single dose for COVID-19 immunization. It was unknown If Covid prior vaccination. Medical history and concomitant medications were not reported. This report is about two patients, both of whom received the vaccine. They both later tested positive for COVID at around the same time. Their illness was not severe and was mostly coughing, sneezing, etc. Event was reported as serious. There is Covid tested post vaccination with the result of Positive. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116677 Same reporter/drug/event for different patients.
Swelling, redness, pain, hot to the touch on (R) thigh erysipelas. Amoxicillin TID x 10 days. ROCEPHIN injection 1 gram today in clinic.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient who received 0.5 ml dose of TYPHIM VI (lot N1K911M, expiry date: 27-Oct-2019) via unknown route. This is a PTC case as it this involves TYPHIM pre-filled syringes with the tip which having difficulty when attaching a needle to the barrel / attempted to connect the needle to the barrel, it fell apart. This case was reported for two patients, out of which one was immunized. PTC number: 100002476 status: in process. It was reported that, a Product Technical Complaint involving (2) different TYPHIM pre-filled syringes with the tip caps. The first was reported to the pharmacist on 9/21/2018. A nurse reported having difficulty when attaching a needle to the barrel, it fell apart and fell to the floor. No product was leaking. Denied any cracked tips. No reported problem with the plunger. International travel was planned. The patient did not receive the vaccine due this incident. Pharmacist refused to share any patient information for this report citing HIPAA concerns. The second incident occurred today. A nurse reported that when she attempted to connect the needle to the barrel, it fell apart. No vaccine was leaking. Denied that the tip was cracked. No reported problem with the plunger. Nurse did reconnect a new needle and patient did receive this immunization. Patient was preparing for international travel. No information about relevant tests reported. Outcome: not applicable. Follow up information received on 05-Oct-2018 from a pharmacist. No new information received. Follow-up report received from a pharmacist on 08-Oct-2018. The PTC ID updated. Follow up information received on 11-Oct-2018 from a pharmacist. No new information received. List of documents held by sender: none.
Child developed swelling from his elbow up to his shoulder. Right arm circumference was 9' and left arm was 7 1/2'. Area felt warm and tight, and it was painful to the touch. Primary care physician notified, child will be seen today.
Body aches, chills, muscle soreness, fatigue, GI upset for 48hours,  no measurable fever but feeling feverish, lack of appetite, severe back soreness which has escalated in the last 5 days to severe back pain,  severe insomnia, fatigue is severe.
about 5 minutes after receiving vaccine pt developed hives, scratchy throat,  felt like throat was closing, coughing
Varicella vaccine breakthrough; Developed fever and rash on neck and trunk on 1/29/06. Temp max 101.2 oral. Had scattered papules (about 30) and 3 crusted lesions and 2 oral lesions. Diagnosed with varicella in our office on 1/30/06 by Dr.
The day after receiving her first dose of SHINGRIX, the patient developed a red, spreading rash that was warm to the touch. It continued to spread for 5 days, and was not alleviated by several doses of diphenhydramine. The patient then sought medical treatment with her PCP, who prescribed both Cephalexin in case of cellulitis, and Methylprednisolone in case of allergic reaction to vaccine. One day after starting both medications, rash began resolving.
She has been having aches and pain; This is a spontaneous report from a Program. A specialty pharmacy (other HCP) reported for patient that, A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Patient stated that  is not as effective since receiving covid vaccines, she has been having aches and pain on unspecified date. She has been to hospital emergency room, urgent care and md office (dates not provided), nothing has been determined as to source/cause of pains and aches, patient was told it's not rheumatoid arthritis, had seen md 3 weeks ago, will see md again a couple of weeks. The outcome of the event was unknown.  Information about batch/Lot number has been requested
"Awoke in middle of the night with dull aching pain in left arm. Up by shoulder where it connects - rotator cuff." Reports intermittent pain "(achiness) and weakness when using left arm to carry/lift from the point of the injection site down the arm, usually to elbow sometimes down to fingers." Recommended to see primary care physician or urgent care.
Started that night after supper with nausea and vomiting violently per mom, also had chills during the night and both visits continued into this morning