chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; This spontaneous report received from a patient concerned a maleof an unspecified age.  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: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total, administered at right arm on 23-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-OCT-2021, the patient experienced general off feeling, headache and weakness were reported. On 25-OCT-2021, the patient started to feel partial paralysis in the right hand and leg and he went to work for a few hours and was sent home by employer. On 26-OCT-2021, the patient visited emergency room due to persistence of symptoms and he underwent through laboratory tests included blood tests, assessments for strength and motor skills and CAT (computerized axial tomography) scan performed results were not reported and he was admitted to the hospital along with this an MRI (magnetic resonance imaging) was performed. The next day, 27-OCT-2021, he got confirmation of a stroke had occurred. On 30-OCT-2021, the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered stroke.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211106356-COVID-19 VACCINE AD26.COV2.S-stroke. This event(s) is considered unassessable. The event(s) 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(s).
Per mothers hx 30 min /p leaving HD, pt adv pt had just a seizure-focal (s/s eyes to side & blank stare)
Swollen rash; Rash that has not gone away for three days/swollen rash; covid arm; red splotch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm), RASH MACULAR (red splotch) and RASH (Swollen rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm) and RASH MACULAR (red splotch). On an unknown date, the patient experienced RASH (Swollen rash). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form, qd. On 19-Feb-2021, RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm) and RASH MACULAR (red splotch) had resolved. At the time of the report, RASH (Swollen rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported Treatment medication used was topical ointment.    Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: No specific follow-up information recorded. On 18-May-2021: ADR, form with page 1 and 2 was received.
Upper lip swelling when awoke 9/21/10. 9/21 Swelling has subsided in P.M.
discomfort in my left are where the shot was given and I  couldn't lift my left arm, it lasted 48 hours; I am experiencing mild soreness in my left arm 18 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Lot number: ER8727) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stress test" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 28Mar2021, outcome "recovered" (2021), described as "discomfort in my left are where the shot was given and I  couldn't lift my left arm, it lasted 48 hours"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "not recovered", described as "I am experiencing mild soreness in my left arm 18 days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received the COVID vaccine, and did some background research so she is  aware that arm soreness is a side effect. She did have soreness for 2-3 days. There after, it did become mild, but she has had mild soreness every day since. It is not severe by any means, but this is her 18th day with continual arm soreness. It is mild soreness on the arm that was vaccinated. Is this normal. She has had no other side effects, but this has been wild. It is continuous arm soreness every day. The shot was 18 days ago. She didn't have a prescribing doctor. Her concern is yes there is soreness, but she is supposed to get her second dose on Monday. She is concerned about that. Since the first two days of arm soreness, the soreness is just mild and persistent.  Honestly since the vaccine her left arm has been through the windmill. One time they had trouble getting an IV in her left arm. They were twisting her arm. She also had a a stress test, a Lexiscan, and they were pulling her arm.  This was all shortly after the vaccine. She has been trying to get a hold of someone for over an hour and 40 minutes.  No follow-up attempts are possible. No further information is expected.
arm red & swollen shoulder to elbow on 3NOV96;swelling on 4NOV AM had progressed to 1/3 way below elbow;
Information has been received from a health professional concerning a 2 month old female, with no medical history, who on 11-OCT-2006 was vaccinated with a first 2 ml oral dose of ROTATEQ. It was reported that the patient vomited immediately after the first dose, and about 1/2 the dose made it in. Vaccines, given post vomiting, included "two month old series." It was noted that the patient recovered immediately after. It was reported that a second and third dose would be given on future dates. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report from a contactable other health care professional (patient himself). A 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on left arm on 20Jan2021 06:30 (at the age of vaccination of 37-year-old) as dose 2, single for COVID-19 immunization. Historical vaccine included, bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0140) via an unspecified route of administration on left arm on 30Dec2020 06:30 as dose 1, single for COVID-19 immunization. On an unspecified date, after dose 1 patient experienced his arm completely cramped up. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Patient's relevant medical history included, arthritis in hips and allergy to sulfur drugs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021, patient experienced entire body became full blown itchy an hour after. Day after patient's arthritis flared up and had lower back pain since. MRI (magnetic resonance imaging) showed bulging disc and was given steroid shot. Patient still had pain. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as steroid shot. The patient underwent lab tests and procedures which included magnetic resonance imaging: showed bulging disc on an unspecified date in Jan2021. Outcome of the all events was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a mother concerning her daughter who, she reported, received three doses (dates not provided) of GARDASIL. Vaccine that had been improperly stores (not further specified). No details of the temperatures that the product was exposed to were provided. No adverse effect was reported. Additional information has been requested.
Case number PHEH2015US000764 is an initial spontaneous report from a nurse received on 07 Jan 2015. This report refers to an adult male patient (in his 50's). He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the arm on an unknown date. On an unknown date, after vaccination he experienced unilateral hand contracture in the arm where vaccine was given as well as had bilateral upper extremity swelling. The outcome of the events was unknown. The seriousness and causality of the events was not reported. Seriousness assessment of the events (unilateral hand contracture and bilateral upper extremity swelling) was upgraded based on the available information in the source document.
Client had a Moderna booster IM immunization and a skin TB test intradermal injection scheduled. Picked up the Moderna booster and gave to client intradermally in left forearm. After giving realized that Moderna 0.25 ml booster dose was given in place of 0.1 ml TB skin test in error. Redness at the site of the left forearm injection and mild burning discomfort noted. Client waited the 15 minutes according to the protocol of the Moderna booster immunization and left after feeling well. Spoke with client the next day and she said she did feel the side effects of the covid vaccine, that she had felt in her previous doses (tired, chills), but they went away soon after. Client came back into office 1/14/2022 and site was noted to be pink, raised 4cm x 3 cm area. Noted the site was uncomfortable upon movement but "not bad". No warmth noted.
dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the right arm, on 01Feb2021 at a single dose for COVID-19 immunization. The first dose was received on 11Jan2021 (lot number: EL0142) Medical history included GERD. Concomitant medication included pantoprazole and other unspecified product. Patient got the first shot of the COVID vaccine three weeks ago, and she didn't know anything had happened to her. She got the second dose of the vaccine yesterday at noon, and she was fine, although she didn't sleep very well on 01Feb2021. But the morning of 02Feb2020, she went in the kitchen and dropped some blueberries because the plastic boxes don't close easily, and she bent over to pick the blueberries up and she got dizzy. She did not know why she should get suddenly dizzy, and her stomach seemed a little upset, but she has no fever on 02Feb2021. Patient was just wondering if the dizziness is a side effect of the vaccine. Patient had no other vaccines on the same day as the COVID vaccine and stated when she had the incident where she bent over and was dizzy, it felt just really terrible, but she was feeling fine now, but the incident did shake her up a bit. Outcome of the events was unknown.
Information has been received from a consumer concerning his wife who participated in an unspecified study for ZOSTAVAX on an unspecified date.  At first the patient received a placebo and later she was administered the actual ZOSTAVAX.  A year after that she developed a mild case of shingles.  The shingles went away after about 3 days.  It was not reported if the patient sought medical attention.  No further information is available
Information has been received from a registered nurse (school nurse), via an agency, concerning a 17 year old female student, who at 9:00am on 02-MAY-2007 was vaccinated with a dose of Gardasil. Thirty minutes after the vaccine was administered, the patient experienced nausea, dizziness, headache, stomach ache and blurred vision. The patient reported to the school nurse, who made the call to the agency to question if the symptoms had been previously reported after vaccination with Gardasil. At the time of this report, four and one half hours after receiving the vaccination, the patient had not recovered and was referred to her primary physician. Additional information has been requested.
A non-serious spontaneous report fever, rhinorrhea, fatigue has been received from a father/consumer concerning a 11-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history includes, flu like symptoms for approximately ten days. Her symptoms included fever (99 to 103 F otic), sore throat, runny nose, body aches, headache, chills, and fatigue. The patient's concomitant medication included vaccine injection for seasonal influenza. On an unknown date, the patient received H1N1, Intranasal, for an unknown indication. Following day of vaccination, at school, the patient felt ill (approximately 12 to 20 hours following the vaccinations). The patient was seen by the school nurse who sent her home with a fever of 101 F, fever gradually rose throughout the evening to 104.8 F (otic). Approximately two hours after receiving a dose of ibuprofen her temperature decreased to 101 F. The patient was fever free by the morning. Other symptoms, rhinorrhea and fatigue, subsided the following day. The outcome for the reported events was recovered.
Approximately 7 day after inoculation (2/10/21) the individual developed redness, and warmth, at the initial injection site. She is without any other vaccine related issues.
Profound weakness, unusual sleeping and awakening tired.  Orthostatic dizziness.  Chest tightness.  No Cough, history of asthma.  No sneezing No OTC medications.
Left arm cellulitis. Swollen, red, painful from injection site to inner elbow-warm soaks to area.
p/vax pt arm very swollen; very hot & hard; lt also itches; MD recommended ice pack; Vaccinated arm is very swollen, very hot and hard. It also itches. Started 24 hrs after vaccine DT. Doctor recommended ice pack, continued conditions for two days. Doctor not able to see patient. Office was closed at 1:30 PM
Patient presented to the hospital with rising creatinine. She was seen in another ED the morning of 01/06/2014 dt 3d of nausea, anorexia, fatigue, intermittent HA, weight loss of 5 lbs since last week and was found to have a rising Cr of 2.6, where last clinic lab visit showed Cr 1.3 and BUN 39 on 12/17/13.
BlurredVision, Dizziness, Headache, pt reported bruising on right UE and left wrist and rt ant chest  Narrative: In vaccination clinic observation area 10-15 minutes after vaccine #2 pt reported bruising on right UE and left wrist and rt ant chest, dizziness, headache and blurry vision right eye. Pt noted improvement in symptoms 30 minutes post-vaccination and no treatment was needed. pt contacted on 3/10 for f/u after side effects from vaccine; Pt reported dizziness, fatigue, numbness/tingling in left hand  and right arm painful to touch at injection site. Pt stated no change in symptoms since yesterday. Pt also reported he has a small amount of redness at the right deltoid injection site. Denied any swelling or discharge. Pt encouraged to take some Tylenol as needed and may apple some ice to right arm injection site if needed. Pt denied any chest pain or dyspnea.
Chest pain, injection site pain,  joint pain, nausea vomiting, hot sensation. Generalized fatigue
pt had mil rash on both arms two days p/vax;no feverl rash lasted for 2 days;
In ER  1 am had a fever 103. Diagnosed with cellulitis. Gave antibiotics in IV and was given LEVAQUIN and Doxycycline is recovering. Also had swollen arm.
Had slight reaction to initial injection (FE3590 on 10/21/2021) lasted 2 days.  Second injection developed Covid-19 symptoms within an hour, isolated per treatment requirements at the time.  Ongoing symptoms (in 2023) are: extreme fatigue, weakness, headache/migraine, loss of smell/taste, difficulty focusing/brain fog, and weight gain.
Severe aches / pain knees, hips, thighs bilaterally beginning the night of vaccination and ongoing x 48 hours Hypotension and chest pressure beginning 3-4 days after vaccination
flu; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
We were completely unaware of an underlying severe health condition: Inoperable, Stage 4 Adenocarcinoma that had metastasized to his liver, lymph nodes, bones, blood.  The Moderna Shot triggered the cancer to become aggressive resulting in rapid atrial fibrillation and subsequent pleural effusion progressively getting worse until on August 14, 2021 patient was admitted to Hospital. A drain port was installed and a right lung catheter and later after his first round of chemo a left lung catheter was installed.  After two rounds of chemotherapy (the second round included immunotherapy) and a mismanagement of meds, patient died of cardiac arrest during a routine NG tube insertion procedure one Saturday, October 16, 2021.
the patient did not experience any adverse reactions; the patient was administered with an expired dose; This spontaneous report was received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 18-APR-2019, the patient was vaccinated with expired (expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose unknown), therapy type: rHA, lot # N009799, expiry: 24-MAR-2019, single injection, subcutaneous in the left thigh for prophylaxis. The patient did not experience any adverse reactions.
not yet received a second dose; Pain at the injection site; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix in the right arm and had pain and swelling at the injection site that lasted approximately 2 weeks. The patient had not yet received a second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. The patient declined to answer additional questions.
Information has been received from a nurse concerning a 20 year old female who was vaccinated with the first and the second doses of GARDASIL (Lot # of first dose: 666597/0768Z; Lot # of second dose: 667194/1271Z) on 23-NOV-2010 and on 21-MAR-2011 respectively. On approximately 26-APR-2011 the patient was then testing positive for HPV. The patient sought medical attention by phone call. No treatment was given for the event. At the time of the report, the status of the patient was not reported. Additional information has been requested.
At the time of injection, he experienced a burning sensation immediately from the injection site to the fingers.  The burning lasted a few minutes.  He then was standing waiting for his wife to receive her vaccine.  He became dizzy and diaphorectic.  He passed out for a moment.  I kept him in the chair and monitored his breathing and tried to keep him alert and responding  to my questions.
Information has been received from a mother concerning her 5-year-old daughter who had no pertinent medical history or allergies who on 31-JAN-2003 was vaccinated SC with a 0.5 mL dose of MMR II (Lot #643499/0538M). There was no concomitant therapy. The mother reported that on approximately 07-FEB-2003, her daughter experienced vomiting and fever. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient's vomiting and fever persisted. No further information is available.
liquid leaked out of the space between the needle and syringe; Product complaint; some of vaccine liquid leaked; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe issue and pharmaceutical product complaint were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Oct-2022 Reporter's comment:  The pharmacist reported that the patient was administered with Twinrix and some of vaccine liquid leaked out of the space between the needle and syringe.  The pharmacist believed that this may be related to a problem with the tip of the pre filled syringe (PQC). The reporter consented to follow up. Additional supportive information: The patient was administered with Twinrix and some of vaccine liquid leaked out of the space between the needle and syringe, which led to incomplete dose administered.
Per nurse "did not realize the year was 2013 Nov for vaccine" she stated got confused with dates. Pt is fine. Follow up call, provider spoke with pt and parent.
Sweating, low blood pressure, totally messed labs up from previously normal, pain in abdomen woke me, diarrhea, blood in stool, vertigo, can't sleep, nauseated, light headed.