chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant via company representative referring to an 80 year old male patient. Information about medical history and concurrent condition was unspecified. On an  unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose and route were unknown). Concomitant medication was unspecified. On an unknown date, one week after the administration of ZOSTAVAX, the patient developed paralysis in the lower extremities and went to the emergency room, then he was diagnosed with Guillain-Barre Syndrome. The outcome of Guillain-Barre Syndrome and the causality were unknown. Upon internal review, the event Guillain-Barre Syndrome was considered to be medically significant. Additional information has been requested.
I woke up with severe face swelling it continued to my lips and then my tongue . I went to hopital . I was there for around 14 hours until they could monitor swelling and ensure my throat was. not obstructed . I was referred to an allergist that did blood tests and determined i  have no allergies. He prescibed an EPI PEN and steroid to use if it occurred again . Symptoms did not go away for about 5 days . Since then I have had 8-10 episodes of severe swelling and welts all over my body.TodayI woke with the left side of  my face very swollen and welts on my thigh. I am taking the benadryl and steroid he prescribed. The
Intense itching throughgout body, hives, throat swelled. Lasted for about 4 hours.
Developed chronic spontaneous urticaria on Tuesday, Feb. 8, 2022, and still having symptoms to this day. Urticaria develops in random areas and will last hours unless I take several medications, including prednisone, hydroxyzine, Zantac, and Benadryl.
Information has been received from a nurse concerning an adult in 50s, who in October 2008 ("past week") received a first dose of 0.5 ml PNEUMOVAX (lot # 660718/0551X, route and injection site unknown). It was reported that the patient had pain and burning while the injection was given. The events resolved in a minute or two. The patient sought unspecified medical attention; no treatment was required. Additional information has been requested. This is one of 3 reports from the same source.
Fever, NauseaVomiting, General symproms: chills, fever, headaches, joint pains, nausea. Narrative:
pt recvd vax in the AM 1PM 12JAN93 had fever 104R; had been given APAP; shrill crying for 1PM-13JAN93 2 or 3 AM 14JAN93 irritable, restless but sleep between 2 or 3AM & 5AM; did not take much milk/fluid & was dehydrated;
heat on the arm, which is warm to the touch; redness on arm; second dose administered subcutaneously; A spontaneous report was received from a health care professional (HCP) concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the second dose administered subcutaneously, redness on arm, and heat on the arm.  The patient's medical history was not provided. Concomitant medications reported included Senna, Zoloft, Risperdal, Aspirin, Aricept, finasteride, Lasix and multivitamins.  on 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K208) . On 26 Jan 2021, approximately 28 days after the first dose, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012M20A) subcutaneously for prophylaxis of COVID-19 infection.  The HCP stated that the patient's second dose was inadvertently administered subcutaneously. The patient experienced redness and heat on the arm, which was warm to the touch. Treatments of these events included Benadryl and Tylenol.  The event, second dose administered subcutaneously was resolved.  The events, redness on arm, and head on the arm were not resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 91 year-old, male patient, who experienced the events of redness on arm, and heat on the arm. The events occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
I have been in menopause for at least 2 years.  No menstrual cycle at all for 2 years.  30 days exactly to the date from getting the vaccine I get a period.  It was not just spotting here and there, it was a full period that lasted for one week.  This is highly coincidental if you ask me.
Pt. C/o numbness/heaviness in her left ring and pinky fingers.  This spread throughout the rest of her fingers and up her arm and across her chest.  All vitals were normal.. she has declined a hospital visit.
Erythematous raised rash on upper chest, upper back, arms extending from elbows up. Flushing of cheeks.
Bright red rash, intense itching, skin peeled like from bad sunburn - multiple areas. Hives - abdomen, upper back, forearms and hands. Intense extended itching! Facial, eyelid and neck swelling.  Fri May 7th (last area that week) - Face and neck also developed bright red rash and itching. As rash decreased skin felt dry and papery. Did peel /exfoliate. Last area to have response.
Pt felt faint & flushed post vaccine. Given water VS stable (BP 95/60; HR 100; RR 18; T 97.8; o2 sat 100%).  NP assessed pt, symptoms resolved. Pt sent home in stable condition with father.
Client reports pain (L) shoulder which started after getting flu vaccine 11/17/11. States it hurt immediately after getting shot. Today he reports pain (L) shoulder on ROM & weakness (L) arm. I have advised him to see a provider at health center & he refuses.
Information has been received from a certified medical assistant concerning a 10 year old Caucasian female patient who on 30NOV1998 was vaccinated with a first dose of varicella virus vaccine live (Lot no. 626768/0669H). On 25-APR-2003, the patient developed chickenpox. On 28APR2003, the patient presented to the doctor's office with a few "typical" lesions on her face and chest. The lesions were dry. The patient did not have a fever. It was noted that the patient had been around a girl who had chickenpox. Subsequently, the patient recovered. Additional information is not expected.
patient got worst respiratory infection; patient was deathly sick for 12 long weeks; Initial information was received on 23-Nov-2020 regarding an unsolicited valid serious case from a social media via consumer (patient).  This case involves patient of unknown demographics who got worst respiratory infection (respiratory tract infection) and was deathly sick for 12 long weeks (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  The patient had no health issue prior.  Past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious worst respiratory infection (respiratory tract infection) unknown latency (within a week) and was deathly sick for 12 long weeks (illness) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  It was reported that, patient was put on three strong different antibiotics that did not work and finally had to be put on complete bed rest to recover. It was the sickest patient had ever been had not been sick again once recovered. Patient did not take another flu shot.  Details of laboratory data not reported.   At the time of reporting, the event outcome was unknown for events.  Information on the batch number was requested.; Sender's Comments: This poorly document case received from social media concerns a patient with unknown demography who experienced illness and respiratory tract infection, after vaccination with INFLUENZA VACCINE (Flu shot), produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Feeling of elevated temperature, rash, light headness, nausea, feeling of lump in the throat.
Severe shoulder pain felt the day after receiving influenza vaccine and ongoing 4+ weeks later. I get the vaccine each year but this time it was given higher up my arm than previous years (near the shoulder).
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days   Upper arm still sore after 12 days. Pain on movement and unable  to sleep on that side, as the arm pain awakens me.   Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
12 hours after vaccine became very nauseous and achy. In bed and very ill for 18 hours. Had Covid in March of 2020. Should never have gotten the vaccine as I still had antibodies.
pain in the muscle where the injection was given (sore arm).; since yesterday evening the left side of my throat has become tender and feels a bit swollen in places; causing some pain when swallowing or when touched; This is a spontaneous report from a contactable Nurse (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on an unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in the muscle where the injection was given (sore arm), since yesterday evening the left side of my throat has become tender and feels a bit swollen in places, causing some pain when swallowing or when touched. Not sure if these are lymph nodes. The vaccination was given in my left arm 6 days before this new symptom occurred. The outcome of event was unknown.
Urticaria, generalized. Benadryl 6.25 BID X 5 days ; weak 2y in
Seizure; Patient received Janssen as dose 1, Moderna as dose 2, and Pfizer bivalent as dose 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: GH9703) at the age of 23 years, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Autism" (unspecified if ongoing). There were no concomitant medications; patient did not receive other vaccine in four weeks and did not receive other medication in two weeks. Patient had no known allergies. Patient was not diagnosed with Covid prior to vaccination. Vaccination history included: Moderna (second dose (not bivalent), via an unspecified route of administration, administered in the left arm, on 20Nov2021 at 14:00 (batch/lot number: 065F21A) as DOSE 2, SINGLE), when the patient was 22 years old, for COVID-19 Immunization; Janssen (first dose (not bivalent), via an unspecified route of administration, administered in the left arm, on 08Apr2021 at 14:00 (batch/lot number: 043A21A) as DOSE 1, SINGLE), when the patient was 21 years old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022 at 14:00, outcome "unknown" described as "Patient received Janssen as dose 1, Moderna as dose 2, and Pfizer bivalent as dose 3"; SEIZURE (medically significant) with onset 25Oct2022 at 16:45, outcome "recovered with sequelae." The event "seizure" required emergency room visit or urgent care and patient recovered with lasting effects. Therapeutic measures were not taken as a result of seizure., Patient was not covid tested post vaccination.
Patient presented one hour after receiving 2010 influenza vaccine with sudden onset of fever (102F), tachycardia, vomiting.  Patient treated with epinephrine and Benadryl, and corticosteroids.  Resolution of S/S within 20 minutes.
This spontaneous report was received from a physician and refers to an unspecified group of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with VARIVAX for prophylaxis (dose, route of administration and anatomical location were not reported). The physician recalled reading that, among the vaccinated patients an increase of diseases they were vaccinated against was noted (varicella) (onset dates were not provided). The outcome of the event was unknown. The relatedness between the event and VARIVAX was not reported. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1709USA007573: US-009507513-1709USA007574.
(rash)red; a little swollen; looks like a Covid arm; super super tired/tired; Rash was growing again/Rash was growing again/her whole upper arm has a rash; Woke up and had a Rash; Arm was really really sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Patient states that the only other time she had a reaction to a medication was to an antibiotic.). Concomitant products included METOPROLOL for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was really really sore). On 08-Aug-2021, the patient experienced RASH (Woke up and had a Rash). On 09-Aug-2021, the patient experienced RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash). On an unknown date, the patient experienced RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and FATIGUE (super super tired/tired). At the time of the report, PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm), RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash), RASH (Woke up and had a Rash) and FATIGUE (super super tired/tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Antihistamines for the adverse events.
severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
SADDLE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
This spontaneous report as received from a pharmacist refers to a 68 years old male patient with depression, high cholesterol and no drug allergy. On 03-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot #671780/0170AE, exp date 06-MAR-2013). No other co-suspects were reported. Concomitant medications included sertraline hydrochloride and Atorvastatin. On 04-JUL-2012, the patient developed a "red hard lump at the site of injection, that itched and burned. It was 2 inches by 3 inches in size. It looked like a rash." The patient had sought medical attention via came into the pharmacy. There was no treatment information for the event and no laboratory performed. At the time of report, the patient had not yet recovered. Additional information is not expected.
Day after shot had red 50 cent size spot at injection site, not painful.  Lasted 4-5 days then gone.  2 weeks ago, noted a ring of blisters and dried lesions around front of neck triple antibiotic cream got rid of it.  After 2-3 days.  3 days later same thing under left breast.  2 days later same on chest, still there. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.
Information has been received from an office manager concerning a 60 year old female with hyperlipidaemia, hypothyroidism and drug hypersensitivity to IODINE, CODEINE, COMPAZINE, DEMEROL and anesthetics;  a history of gastrooesophageal reflux disease (GERD), kidney stones and atrial fibrillation in 2003 who on 26-AUG-2008 was vaccinated intramuscularly into the right arm with a dose of PNEUMOVAX (Lot # 660717/0224X).  Concomitant therapy included influenza virus (unspecified) into the left arm, SYNTHROID, SIMVASTATIN (MSD), estrogens, conjugated PREMARIN and ASPIRIN.  On approximately 26-AUG-2008 the patient experienced the injection site to be hard as a rock and the size of a golf ball.  The right arm throbbed and the injection site area was red and the size of a 50 cent piece.  It was unknown if the patient received the vaccine in the past.  The past sought unspecified medical attention.  The patient was given BENADRYL.  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
pt recv vax 8JUL96 & 20MAY97 pt devel 5 lesions;
This case was reported by a consumer (also the subject) and described the occurrence of extensive swelling of vaccinated limb in a 84-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included flu like symptoms following previous flu shots. The subject reported that she had received flu shots for several years, but had never experienced such a reaction. Concurrent medical conditions included hypertension. On 3 October 2011 at 13:30 the subject received a dose of FLULAVAL (unknown route, right arm). The lot number was reported as AFFLLA669AA from the reporter; however, based on a safety lot number review, the lot number was updated to AFLLA669AA. On 3 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced extensive swelling of vaccinated limb, arm burning upon injection, itching near injection site and erythema near injection site. The subject reported that the extensive swelling, burning and redness occurred at the inner aspect of her right arm (arm of vaccination), but not at the site of the injection. The size of her arm had doubled. She also experienced flu-like symptoms. At the time of reporting the outcome of the events was unspecified.
This spontaneous report as received from a physician via a company representative on 27-OCT-2014 refers to a female patient of unknown age On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 injection (strength, dose and lot # unknown). On an unknown date the patient experienced a Upper Respiratory Infection (URI) after receiving the PNEUMOVAX23. The patient had an office visit on an unspecified date for seeking medical attention. The outcome of URI was unknown. Additional information has been requested.
component of Menveo reconstituted with the MMR varicela vaccine diluent; component of Menveo reconstituted with the MMR varicela vaccine diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva604a, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included MMRV VACCINE for prophylaxis.   On 17th February 2022, the patient received Menveo and MMRV VACCINE. On 17th February 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administrated a dose of the lyophilized component of Menveo reconstituted with the MMR varicella vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Note: The start date of Menveo conservatively captured as 17th February 2022 as there is a discrepancy.