chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up Sunday (3/7/2021) morning at approximately 6:00am and my injection arm was itching very bad. My arm swelled up around my injection sight over the day to about the size of a baseball. It was a red and itchy rash.  The swelling went down over the next few days. Oh n Monday 3/8/2021. I woke up at 7:00am and my hands had a bumpy, itchy rash. My feet slightly itched too it not as bad as my hands. I would wake up almost nightly to myself itching my hands raw. They are finally not as itchy today (3/16/2021).
Lump, redness, and heat in injection site on the day after the second shot.   The second day after the shot developed swelling in the neck on left side between neck and shoulder area.  Third day lymph node swelling and pain when swallowing.  Arm still red, swollen and hot on third day after the shot.   I have iced down both area which has not helped.  I contacted occupational health as I work at a hospital and received the vaccine there.  I was told to contact my PCP,  which I did and am waiting to hear back.
After 48 hours of the vaccine, patient was very ill, she could not walk, both legs are numb, and experienced urinary incontinence. She is partially paralyzed from the vaccine. Right now, she is seeing physical therapy to help her recovery from normal daily activities.
Vaccine given on 6/5/09. On 6/7/09 area on left leg - raised, warm, measuring at 6 x 8 cm.
Information has been received from manf for hep B recombinant (Engerix B) and was assigned manf control number A0567601A. A female infant was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Following the administration of the vaccine. The pt experienced high pitched crying. The vaccination series with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) was discontinued. At 19 yrs of age on an unspecified date in June 2005, the pt was vaccinated with a first dose of hep B vaccine, recombinant (Engerix B). Concomitant medication included valacyclovir (HC1) (Valtrex) and ibuprofen. Approx two hours later, the pt experienced nausea and a headache. The reporter stated that the pt complained the headache was the worse headache that she had ever experienced. Approx three days later, on an unspecified date in June 2005, the pt developed a rash on her chest, back, and arms and muscle pain. The headache and nausea resolved after three or four days, the rash resolved three weeks after onset; the resolution date of the muscle pain was an unk date in Jul 2005. The reporter considered the events of nausea, headache, and rash to be possibly related to vaccination with hep B vaccine, recombinant (Engerix B). This was originally reported by a registered pharmacist. Additional information has been requested.
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later  developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
Vaccinated at 3 pm on 3/14/21. At 12:30 am (3/15, 9 hours post) woke with chills. At 2:30 am, woke again overheated and with a bad headache. Could not sleep well. Some muscle aches in my upper legs. Checked temp at 6 am. No fever. Hot/chills resolved. Tired all day 3/15. Headache and muscle aches resolved by noon 3/15. Fatigue resolved when awoke on 3/16/21. Bruising and soreness at injection site. Still present.
I started to notice that when I woke up my right index finger felt stiff. It seemed to be getting worse within a period of 7 weeks. As time went on it would hurt and be stiff when I woke up. When I would try to use it felt tender in the middle joint and then spread to the top joint and the joint where it connects to my hand. In general, I notice stiffness in my knees and just stiff when I wake up than I did before. This started a month after the booster. I had a baby in April 2021 and all stuff feels different. I went to a hand specialist orthopedic surgeon Dr. and she did some imaging and said it looks like early arthritis. and hypermobility in my hand. I've taken Ibuprofen for a short period of time and now glucosamine, tart cherry and chondroitin. It doesn't seem to be getting worse.
Resident received vaccine on 7/26 with no s/s of adverse reaction noted. On 7/27 in morning, resident was drowsy, with altered mental status and slurred speech.  Redness and pain noted to L arm. Resident was sent to hospital for evaluation and returned with new antibiotic order for dx of UTI.  On 7/28 resident is more alert and oriented, states she feels better but remains tired. L arm near injection site in red, swollen and warm. Left arm noted with hard area 2 inches beneath injection site. Red area extends from injection site down arm approx 4 inches. Resident states it feels itchy, but is otherwise able to move arm to her previous extents.
Covid-19; COVID-19; Stress; Colitis ulcerative aggravated/ulcerative colitis flare ups; This is a solicited report based on information received by Pfizer (Manufacturer Control Number 21K-163-3988258-00). A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular at age of 63 years on 08Apr2021 (Batch/Lot number was not reported) as single dose, dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to Severe ulcerative Colitis.  Medical history was not reported. No Known Allergies. Concomitant medications were none. On unknown dates, the patient experienced Humira Completely Stopped Working, Covid-19 and Stressed. In 2021, the patient experienced ulcerative colitis flare ups/ colitis ulcerative aggravated. The events reported as non-serious and treated with prednisone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per reporter for colitis ulcerative aggravated with bnt162b2 was possible. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date (as reported). The outcome of event colitis ulcerative aggravated was recovering, other events was unknown.  The reporter's assessment of the causal relationship of the events (except  Colitis ulcerative aggravated) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the events colitis ulcerative aggravated, stressed and the suspect drug BNT162B2  cannot be ruled out. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
"flu-like symptoms" Narrative: Per supervisor report: "received Covid Vaccine on Friday 7/23/2021 c/o having flu-like symptoms" (I was unable to obtain more detail but presumably fever, headache, myalgia)
Patient fainted out and felt woozy within the minute after the shot administration . Patient was evaluated by EMT . 1hr lapse in time. Patient came to and was stable and no hospitalization required.
On the day of the shot (11/03) the patients arm was very sore and her entire body started to become sore. The next morning her soreness intensified including severe back pain up and down the entire back. Patient stated it hurt so much she could not leave her bed. She also stated that she could "taste" the medication in her mouth even when brushing her teeth. On 11/07 she contacted the pharmacy to report these reactions and said today she felt better, was up out of bed, and the taste in her mouth was gone. She said 11/07 was the first day she felt better. I instructed her to discuss with primary care doctor on if she should get the second pneumo shot next year and that if symptoms return to contact us.
Administered the expired product with no received expired dose of FLUZONE QUADRIVALENT with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from other health professional via Medical Information (Reference number- 00842588) and transmitted to Sanofi on 04-Nov-2021.  This case is linked to cases 2021SA371630(CLUSTER), 2021SA369789(CLUSTER), 2021SA370183(CLUSTER), 2021SA370209(CLUSTER), 2021SA371632(CLUSTER) and 2021SA369806(CLUSTER).  This case involves a patient (unknown demographic) receiving expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once), (suspension for injection, lot UJ507AC, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "A Nurse reporting a medication error described as 20-staff members and 7-Residents received expired doses of FLUZONE QUADRIVALENT MDV from 2020-2021 year after receiving these 6-vials of the FLUZONE QUADRIVALENT MDV in the current years flu vaccine shipment. The Nurse reported that the 20-staff members received the dose since the end of Oct-2021; that the information on the staff members are not known, at the time of this report; that the staff has had no reports of adverse issues since dosing; that the 6-Residents received their dose on 03-Nov-2021; that the information for the residents is known to the reporter; that the residents have had no reports of adverse issues since dosing."  At time of reporting, no adverse event 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed breast pain; and a fast heartrate and a fever. I felt generally unwell and had a reduced appetite. After 4 hours, I was quite unwell. I went to Urgent Care and they gave me a course of antibiotics which I took for 10 days. They worked quite quickly so I was only unwell for two days. Pregnancy history - my first pregnancy; Baby has been born on 19th of June - 7 lb and 14 ounces.   Right after this 2nd dose of the vaccine I had: a low grade fever - that lasted 12 hours, tiredness and nausea for 12 hours, too.
This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247; Expiration Date: May2021), via an unspecified route of administration on 01Mar2021 at the age of 39-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Feb2021 at the age of 39-year-old as dose 1, single for covid-19 immunisation and had he got fever and chills. On 01Mar2021, patient experienced rash at night on genitals has not gone away and chills not so bad as first dose. He has not consulted his physician yet. Patient don't know what it to or visit the doctor or wait until it is go away on it own. Patient tried some cream, topical cream for the rash. The outcome of the event rash was not recovered, and event chill was unknown. No follow-up attempts are possible. No further information is expected.
Significant redness at site, whole arm pain leading to decreased ROM in entire arm, fever at 102 per pt. report.
Patient is a 16 yr-old male who was administered a Janssen & Janssen Covid vaccine. Janssen & Janssen is EAU approved for 18y.o. and older.
Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Pt received 2nd hep A & TIV Flu vaccines on 10-04-2011. Developed fever same day then wheezing on 3rd day. Fever persisted for 3 days. Also received: 1st varicella & 1st MMR.
Pfizer-BioNTech COVID-19 Vaccine EUA  Injection site pain that started 7 hours after injection and has continued to now. Pain is lessening as time goes on. Tylenol has helped.  Headache, Nausea and ear ache all started this morning (7am). Headache is continuous; nausea and ear ache are intermittent
Condition aggravated; Difficulty sleeping; Drug effect decreased; Localised exfoliation; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and SKIN EXFOLIATION (Localised exfoliation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis aggravated. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Localized exfoliation). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). In 2021, SKIN EXFOLIATION (Localized exfoliation) had resolved. At the time of the report, CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use information was not provided by reporter. On unknown dates, the patient experienced humira helped first but now arms flared up again felt like humira was not working anymore, peeling hands and can not sleep at night with Humira. On 15Mar2021, the patient experienced peeling hands and in 2021, the peeling hands resolved. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the event(s) of humira helped first but now arms flared up again felt like humira was not working anymore unknown onset, peeling hands and can not sleep at night was not provided. The reporter causality of the Humira for the event of drug effect decreased was a reasonable possibility. Treatment medication use information was not provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact.
2 days after receiving the vaccine I had some joint pain and body aches. At first it was mild and moderate. Then over the next 2 weeks the body aches became more severe. It was primarily in the shoulders and not at the injection site, but in the joint themselves. It was more so in the left and right shoulder. Then it began to move to my wrists, but predominantly in the right wrist. Then it went into my left knee which became swollen with fluid accumulation. This had continued. The pain was more severe at night, and it was very difficult to sleep. I sleep on my side and the pressure on my shoulder was painful so I tried sleeping on my back. For the 1st week or 2 I tried sitting up in a chair to take the pressure off my shoulders, but it was uncomfortable so I was losing sleep. This continued for several weeks. I eventually went to see a doctor and I was complaining about having myalgia. The doctor advised that it would go away. It did go away eventually but it took 3 months. I took Advil and Aleve as necessary to get the joint pain under control. I was taking ibuprofen sometimes too. The joint pain was severe at times. It would move from my shoulders to my wrists then to my knees and back to my shoulders again. I never had any fever, nausea, or loss of taste or smell. I just had the joint pain. Then it resolved around August 2021 or September 2021.
Pt had pain in the left calf 10 days after his first vaccine. Pt then went to state on April 2. Pt came back home, the pain was gone. He had his second vaccine on 4/23 of pzifer. After 15 days of getting the second vaccine he felt very short of breath when riding his bicycle. He went to his primary care doctor and he was advised to go into the ER. He was diagnosed with a PE and left leg DVT
fainted; collapsed; This is a spontaneous report from a contactable other health care professional. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955), via intramuscular route of administration in deltoid on 04Apr2021 at 02:00 PM at single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN), congestive heart failure (CHF), diabetes mellitus (DM) and had chronic/long-standing health conditions (pacemaker). Concomitant medication was not reported. Patient previously received first single dose of bnt162b2 (Lot number: EP6955, Pfizer Covid Vaccine) via intramuscular on 14Mar2021 on deltoid for Covid-19 immunization. Patient fainted while shopping after receiving second dose of vaccine. Patient was fine for initial 15 mins but shortly after collapsed. Patient had BP Of 120/70 an unknown glucose level. Patient was conscious coherent the entire time. On 04Apr2021, patient underwent lab test included blood pressure (BP) with result 102/70. Adverse events were resulted in emergency room or emergency department visit. The outcome of events was unknown.  Follow-up attempts are needed; Information related to batch/lot number could be requested.
Patient had a vasovagal reaction. Was sitting in a chair in our waiting area and fell off his chair and "passed out" for no more than a few seconds. After that he reported he felt weak and dizzy and nauseous
This is a  38 Years  old  Male  presenting with 1 days of moderate shortness of breath without cough, which began gradually.  Patient states onset occurred after COVID-19 vaccination yesterday. Symptoms are worse with exertion. Pt c/o chest pain and SOB. pt sts he woke up with pain and is feeling disoriented.
Admit 4/16. Vaccine 3/3, 3/24. Admit for sepsis, PNA, however MD states difficult to attribute it to COVID. Treated w/abx and steroids. DC'd home.
A day after my Shingrix vaccination I had nerve twinges, on and off  on the left side of my head, for a few days.  (I was vaccinated on my left arm.)  I have had terrible pain in my upper arm for 6 weeks and 4 days.  In addition to icing, I have taken ibuprofen and Aleve, but it does not make a difference.  I hurts when I raise my arm half-way up in front of me.  It hurts when I put my arm behind my back.  It is painful to get dressed, take a shower, dry myself, do my hair, drive, put dishes in the cupboard, make a left-hand turn in my car with my left arm.  I could go on and on.  It is terrible and I am trying to be optimistic that it will go away.
I received my first shot / in 2018 but never got the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot of Shingrix in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by patient for herself/himself. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked  he/she needs to start all over and get two shots at proper interval or just get a second shot. The patient was 80 years old and also received two shots of the Moderna vaccine in March and April of this year.
Pt received a dose in (L) arm - area was increased in redness and swollen. Erythema went from neck to elbow. TX for cellulitis.
She got her vaccine, she was driving home at 11:30 at night and all of a sudden her car started going into the wrong land and almost hit a bridge and determined that she could not drive.  She had just brought her sister-in-law home, was tired, and was hungry and tried to eat.  She realized that she was feeling very tired and tried to get up and realized she had a hard time moving, and used furniture.  She called her daughter who took her to the hospital to the Medical Center, who did a CAT scan immediately and was a brain stem stroke.  She was there for 2 1/2 weeks, and then transferred to Rehab hospital for about 3 weeks, and has been doing out-patient.  She fell on 10/3/22 and broke her hip and leg.  She is now on Amlodipine, Atorvastatin, Lisinopril, Xarelto.    She can use a walker, but does not have her balance back and cannot use a cane.  She also has a knee problem and needs a replacement, but can't due it yet.  She had a hip replacement after she fell and broke her hip and her fibula.  She still cannot walk mainly because of the stroke.    She was very healthy prior to the vaccine, took care of other people and had no issues and was still working, and since the vaccine she has not been able to go anywhere and has to do everything on line, and not able to work now.     Was in Hospital initial for about 2 1/2 weeks, and then Hospital for Rehab for 3 weeks, and then returned for another 2 1/2 weeks, and then now out patient therapy.    This destroyed her ability to take care of herself, and doing everything she can to get back to where she was and hopes that she will be able to.  She cannot drive anymore and is scared to after having the stroke.
Started itching in Nov.  Dermatographia occurs with scratching  itchy areas. Itching has continued since shot. Saw allergy doctor and she hade change allergy medicine to Zyrtec. I'm taking 30 mg daily with intermittent improvement.