chrisvoncsefalvay/vaers-outcomes huggingface dataset:
we all had this head toll/a rash; hives on the face that is itchy; arm was sore; hives on the face that is itchy; blotches on the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "we all had this head toll/a rash"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "hives on the face that is itchy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious), outcome "unknown", described as "blotches on the face".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received 2nd dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 16Feb2021 12:00 at single dose for covid-19 immunisation. Medical history included nocturnal seizures, hypothyroid, sinus infections, seasonal allergies, allergies to sulfa drugs. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine, glucosamine, naproxen sodium (ALEVE), cetirizine hydrochloride (ZYRTEC). The patient previously received 1st dose of bnt162b2 on 26Jan2021 at 11:00 in left arm for covid-19 immunisation. At about 11 pm after the vaccination (16Feb2021 23:00), started feeling run down. Woke up the next morning (17Feb2021) with headache, on and off chills, lethargic, with nasal congestion. No treatment received in response to the events. The outcome of events was recovering. This case was reported as non-serious. The patient was not pregnant. The patient did not receive 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 has not been tested for COVID-19.   Information on the lot/batch number has been requested.
At the time of vaccine she didn?t experience any problems but a sore arm.  A couple weeks later, she developed a barking cough, vomiting, sore throat.  This would reoccur every couple of months and then it grew worse after getting Covid in January 2022
Light brown spotting started 3 days after receiving my third dose  (booster) of the Moderna vaccine.  Spotting then turned into full menstrual period, ending 12/22, then continuous light brown spotting to 12/1.  My last regular menstrual period began 11/6 and ended 11/9 - 11/10.   The period caused from the booster included cramping, clotting, bright red blood, dark blood, everything indicating a normal menstrual cycle.    No disclosure was made at the time of any of the vaccinations that moderna could potentially effect menstrual cycles.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 26-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Fever, Full body muscle and organ pain for 12 hours, pain on a  8 on a scale of 1-10.
dose of Pentacel was administered on 11/16 but expired on 11/03/20 /No AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Medical Information (Reference number- 00363926) and transmitted to Sanofi on 18-Nov-2020 via call-center.  This case involves a patient of an unknown demographic who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 16-Nov-2020 which was expired on 03-Nov-20 via unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number of PENTACEL for this case.
black and blue the whole width of the arm; bruising the  size of 2 x 3 inches.; swelling felt hard; arm was swollen; arm was warm; redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness), CONTUSION (black and blue the whole width of the arm) and INDURATION (swelling felt hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RISEDRONATE SODIUM, CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B), LOVASTATIN and METHIMAZOLE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness) and INDURATION (swelling felt hard). On 02-Mar-2021, the patient experienced CONTUSION (black and blue the whole width of the arm) and CONTUSION (bruising the  size of 2 x 3 inches.). At the time of the report, PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness), CONTUSION (black and blue the whole width of the arm), INDURATION (swelling felt hard) and CONTUSION (bruising the  size of 2 x 3 inches.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
shingles after completing series/Suspected Vaccination failure; shingles, lower spine; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix. In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: The patient self-reported the case and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient was continuing to experience outbreaks of mild cases of Shingles. The patient reported outbreak was always around their lower spine and the most recent outbreak occurred at the beginning of March of the year of reporting.  The patient reported taking antivirals to treat outbreak, with good success. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
On Friday, September 24, 2021 patient came to vaccination POD for the second COVID-19 Pfizer dose. Upon arrival, the lead nurse was called to assess client as she stated she had an allergic reaction after her first Pfizer dose (batch/lot# EW0168) she received on August 29, 2021. After her first Pfizer dose, client stated she broke out in a itchy rash on her arms and legs the next day after vaccination that lasted for a day and would "come and go" for the next three weeks. Client denied going to MD and stated she took Zyrtec on days rash appeared that helped with the itchiness and redness. The lead nurse escalated to the vaccine operations leadership, who consulted with the county MD. Per county MD, administration approved. Advised client to get her second dose of Pfizer COVID-19 vaccine with 30-minute observation. Client vaccinated with COVID-19 Pfizer vaccine (batch/lot# FF8839), left arm, at 12:54 pm. Client was educated by lead nurse on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client also encouraged to sign-up on V-safe. Client experienced no adverse reaction while waiting in observation area and left vaccination site with a steady gait at 1:35 pm.
About 13 hours after shot, tiredness, mild nausea. At 15 hours, flu-like symptoms like body aches, chills and 100.8 fever. After taking NSAID and resting, Fever down to 99 at 18 hours. Slept on and off until 23 hrs post shot.
Intranasal H1N1 administered without difficulty about 9:00 am - left after observation of 15 minute period no problem reported or observed. Returned to administration area with school teacher saying child came to class put head down, closed eyes when questioned to her see was tired. States child was slow to answer or question - brought her back for further observation - vitals P80, R20 B/P 126/78 - skin warm, dry kept holding head up - complaining of headache, nausea and dizzy no respiratory distress reported or observed. Had not eaten breakfast before vaccine administration. After 15 minutes - moved from room to other - walked without difficulty - still complained of headache and nausea - was able to answer questions appropriately and coherently reporting symptoms, health and family. Left school with mother approximately 1 -1 1/2 hrs past vaccine administration.
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves female patient (unknown age) who experienced body aches, cheeks were red and flushed, rash on her face, headache, fever and chills, while she received vaccines MENACTRA and TRUMENBA. The patient's past vaccination(s) included MENACTRA in DEC-2006 without a reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 16-Aug-2017, the patient received a second 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5567CA via intramuscular route in the left arm. On 16-Aug-2017, the patient received a 0.5 ml dose of suspect TRUMENBA lot S26985 via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious body aches, cheeks were red and flushed, rash on her face, headache, fever and chills few hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. (Other relevant tests included no lab data.) Final diagnosis was chills, fever, headache, rash, flushing and pain. It was not reported if the patient received a corrective treatment. The patient recovered from chills, fever, headache, rash, flushing and pain the next day. List of documents held by sender: none.
Seizures -- led to an EEG -- diagnosed with idiopathic infantile spasm. 11/19 and 11/20/2009 HR for 11/10-11/12/2009.  Dc Dx infantile spasms Patient with c/o's body jerking, seizure-like activity. LP norm. Tx: ACTH 12/8/2009 DC summary, H&P, Pediatric Neuro consult records for 11/10-11/12/2009, ICD-9 code 780.39 convulsions
Started getting sick about 1 week after vaccine, on 12/18 mid-morning around 9am.  Sore throat: 12/18 9am to 12/19 ~2pm - it felt like strep Running Nose: 12/18 ~3pm to 12/19 ~7pm Brain fog: 12/18 11pm to 12/18 4am Body Aches started around 12/19 3am and progressively got worse through 12/19 afternoon, moving hurt towards the late morning. At around 12/19 5a/6a I felt like I was fighting a fever but temperature only registered in the mid 97 degrees area Chills 12/19 8a to 2pm - some of the worse chills I've ever had while sick, my skin hurt from how chilled I felt 12/19 12pm registered a fever of 100.7, moving was difficult from the pains from the body aches. Fever went down to around 99 by around 11pm that night 12/20 7am, felt light headed and dizzy most of the morning into the afternoon. Temperature did not go into fever that day. Cough started sometime around then, it was a dry cough that didn't produce any mucus and gave me a sore throat. 12/20 11pm, woke up and lost my voice for an hour, likely from the coughing I call out from work on Sunday night(12/19) and Monday(12/20) night (3rd shift). I returned to work on the night of 12/21, I felt weak that night As of 12/27 I still have a dry cough and some mucus production
Patient reported no adverse reaction immediately. 4 days later, he reports head and ear congestion,headaches and intermittent spaciness with visual disturbance just like" feeling drunk". On 06/22/10 he reports a hearing loss in his right ear which was later diagnosed with an ENT doctor as acute sensorineural hearing loss. Doctor is currently treating him with prednisone.
HIGH BLOOD PRESSURE; SLIGHTLY DISORIENTED FROM THE SHOT; FELT ANTSY TO GO FOR WALK; This spontaneous report received from a patient concerned a 51 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure monitoring, overweight, non-smoker, and no alcohol use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 in morning, the patient reported his blood pressure was 170/100 which he felt high for him. It was stated that, usually patient's blood pressure was 125-138 systolic blood pressure. On 10-APR-2021, when he first woke up in the morning patient measured his blood pressure as 109/75 and was therefore concerned about the increase. Patient visited physician office for high blood pressure. Patient felt slightly disoriented since he received vaccination and felt antsy to go for a walk. It was stated that patient did not have any fever and felt okay. Laboratory data included: Blood pressure (NR: not provided) 170/100, 109/75. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 125-138 systolic blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, slightly disoriented from the shot, and felt antsy to go for walk. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421042-covid-19 vaccine ad26.cov2. s-High blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt did not convert p/a series of 3 Engerix-B vax on 02NOV90, 02DEC90 & 02MAY91, repectively; Each inject recvd was 1 adult dose; Pt was advised of need for further inject & testing;
Fast heart rate, sought treatment at the ER, dc paperwordkstated orthostatic hypotension
Vaccine administered in the morning 03/02/2013, reaction started in the later afternoon. Patient reports 36 hrs of symptoms: local pain in deltoid, chills, fever, body aches, weakness/fatigue. Patient treated herself with ADVIL as needed, which states was effective.
(DOB 06/10/1970) received the first dose of Pfizer with lot number EP7534 exp 03/20/2021 at 1530. At 1538 client walked to EMT station with her husband notifying EMT staff that client felt lightheaded and was moved to zero-gravity chair for closer monitoring. Client disclosed at 15:42 that she has been fasting since last night in anticipation for her colonoscopy the following day. Medical history was reviewed: heart problems, thyroid issues, cancer, and immunocompromised (Hashimoto). RN visually noted patient started having physical tremors, apple juice and water were offered to client by staff. No signs of respiratory compromise or itching/hives were noted. Vital signs at 1545: BP of 150/100, pulse of 76bpm, and 14 respirations per minute. Client reported feeling anxious and visibly wearing clothes with extremities exposed, RN staff discussed with husband getting jacket for client. Husband refused at this time, not wanting to leave as was actively providing emotional support to client. 1550 vital signs: BP of 140/90, pulse of 70bpm, and 14 irregular respirations per minute. Client refused oral nutrition interventions at this time in anticipation of colonoscopy. 1557 vital signs: BP of 140/90, pulse of 80bpm, and 16 respirations per minute. Patient accepted apple juice at this time. RN discussed with client if felt chilly, client stated just couldn't stop shaking, husband agreed to retrieve a jacket from the car. RN engaged with patient to provide distraction discussing what client had done prior in the day. Client remained alert and oriented x3 noting the gardening client had done prior to arriving for vaccination. 1606 vitals: BP of 150/100 and at this time client was offered EMS. Client agreed to having EMS called, EMS call was placed at 1606. 1610 EMS arrived with two paramedics and 1 EMT, client was moved into side hall for privacy and EMS assumed care of client. 1620 client left site to board the ambulance with her husband to take more tests on heart at a higher level of care, symptoms were not completely resolved. Client remained alert and oriented x3 on exit of site.
This spontaneous report as received from a nurse via company representative refers to a 12 month old female patient with none medical history and none drug allergies. On 22-MAY-2014 the patient was vaccinated with VARIVAX (lot#J007679, exp 13-JUN-2015 subcutaneous). There was none concomitant drug. On 29-MAY-2014 the patient experienced red pustules at the injection site. The patient's parents called the physician for attention. He was given BACTRIM. None lab was performed. He was recovering. This is one of the reports from the same source. Additional information has been requested.
Swelling, redness, tenderness upon injection administration. Round, reddened area around injection site warmer than surrounding area, and upon palpating there is a large, hard, round knot approximately 50mm in diameter, and very tender. Area is painful, and sore, and continues to be warm and red around knot as of 10/29/21. Tylenol and Ibuprofen taken as directed and ice applied to area as needed.
Pt recvd 3 doses of Engerix-B 5SEP90, 5OCT90, 5MAR91 & f/u testing p/last dose revealed neg HBSAB; pt recvd 4th dose of vax;
Starting in the evening the day following my vaccinations, my left toe, then foot began to swell and ache.  The pain continued to increase over the next 12 hours.  I believe I have gout.  I will be seeking medical treatment on Monday, March 22.
Got the 2nd vaccine and still on my menstrual cycle 15 days and counting; This is a spontaneous report from a Pfizer of a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for  injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for  injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient received the second vaccine and still on her menstrual cycle 15 days and counting. The patient reported that, more trials of COVID-19 should be done on women specifically. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
feeling ill last night; fever; body aches; stuffy nose; coughing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (last Thursday) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date (last night), the patient experienced feeling ill in which his symptoms proceeded to become worse. The patient experienced a fever, body aches, stuffy nose, and coughing. The patient was treated with paracetamol (TYLENOL). The outcomes of feeling ill, fever, body aches, stuffy nose, and coughing were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5 Days after vaccine patient had fever 7 days after vaccine patient had Varivax.
Vacc on Wed afternoon, woke up Thurs morning with generalized myalgia, headache, dizziness, chills, moderate tenderness (no erythema) at injection site.  24 hours later, I am much improved, but still slight headache and feel weak.
Patient lost consciousness displaying signs of syncope and brief convulsions  within 2 minutes following the vaccine administration. Patient fell out of chair causing minor injury to abdominal area. Patient was moved safely back to reclining chair with feet elevated until she regained consciousness.
Pt in around 2.25 to get MMR and DTaP. Given around 2.25pm. Approximately 2.35 mom called to say child had headache: gave 3 Tylenol chewable.  Had ice-cream was  when mom noticed both eyelids swelling. Seen in office 3.15. Both eye lids urticarial lesions. No other signs or symptoms. Given 1 tsp (12.5mg) Benadryl . Hives in 20-30 minutes.