chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure was also elevated; severe pain in the upper, right, injection arm and the middle of the back of his neck; severe pain in the upper, right, injection arm and the middle of the back of his neck; Initial information received on 16-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 72 years old male patient who experienced severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain) and blood pressure was also elevated (blood pressure increased), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 21-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot 2SAA1937 and expiry date: 16-Jun-2022) via unknown route in the right arm.  On an unknown date, the patient developed a serious severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain), and blood pressure was also elevated (blood pressure increased) 2 week  following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event during 5 days. The patient was admitted 07-Nov-2019 and discharged on 12-Nov-2019 (hospitalization during 5 days).  Reporter informed that the pain occurred for 4 weeks. The patient was given many tests but the could not determine a diagnosis. Nothing helped the pain, they tried everything.  (Other relevant tests included CT scans, MRIs and blood work.)  Final diagnosis was pain, vaccination site reaction and blood pressure increased.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome was reported as unknown for the all events.; Sender's Comments: This case concerns an 72 years old male patient who presented with pain, vaccination site reaction and blood pressure increased after vaccination FLUBLOK QIV. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
redness, swelling 2-3 cm thick in dermal and epidermal layer of skin entire circumference and length from shoulder to elbow on rt arm. Highn fevers not responding to 4000 mg ibuprofen or 1 gram acetaminophen. Dehydration, sore stiff muscles entire body bloated and puffy, diarrhea, shocky 24-36 hrs. after injection. Diagnosed w/acute cellulitis 48 hrs post injection at Emergency Dept. 875 mg of Augmentin was administered in emergency dept. Diarrhea/loose stools and edema have not resolved as of today 6/19/07.  07/16/2007 MR received for ER visit 4/22/2007 for c/o fever and R arm pain.  Also c/o dull H/A x 2 days. PE significant for R arm erythema and tenderness. DX: Cellulitis.  Vaccine reaction.  Viral Syndrome. Ambulatory Care note 5/16/2007 reports no nausea, vomiting, diarrhea etc
Palpable bullous purpuric lesions which spread to cover bilateral lower extremities, face, head, arms, lower back and groin found to be leukocytoclastic vasculitis with further specification pending.
muscle aches, body aches.  joint pain that persists for several months.   chronic headaches elevated blood sugars
Temp 100 F Orally. R leg swollen groin to knee.  Red & hot. To ER 8/4/05. Gave Benadryl, steroids, antibiotic.  Per Mom 8/16 @ 1045,"Took to hospital 8/5 because leg worse. Kept for 3-4 hours. Admin additional steroids& antihistamine. Lasted 3-4 days, then resolved. No further problems. Never had problems before."
Narrative: COVID infection following COVID vaccine series 01/11, Pfizer, dose #1 02/02, Pfizer, dose #2 08/06 COVID swab, result: not detected 09/07 COVID swab, result: detected 09/07 pt cc: exposure: unknown 09/07 CRP: 0.553 09/09 DDIMER 1.31 09/09 ESR 21 09/07 SARS-COV-2 Variant Sequencing results: pending 10/11 COVID swab, result: NOT detected 10/13 Pt/INR 10.8/0.96
PAIN IN LEFT BREAST. SWOLLEN MILK DUCT ON THE AREOLA. PAIN LASTED FOR A FEW DAYS. STILL SLIGHT PAIN BUT NOT AS BAD AS BEFORE.
Redness on the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient herself) via Pfizer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Apr2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced she noticed that there is a redness on the injection site after she received the dose and is still red as of now. The outcome for the event was no recovered.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered pharmacist refers to an unspecified patient. On an unknown date the patient was to received VARIVAX (Merck) however vaccinated with ZOSTAVAX (dose, route and lot # not reported) in error. Additional information has been requested.
pt had a recent UTI with AMS; 8/10/22 pt to hospital with c/o right lower quadrant abdominal pain; nausea and vomiting; CT scan showed rectosigmoid colon wall thickness with right pyelonephritis; colonoscopy showed 1 polyp; stercoral ulcer; internal hemorrhoids; pt developed fever; 8/20/22 pt was positive for COVID; pneumonia; O2 supplementation; remdesivir. dexamethasone; pt did not improve; dc'd to home with hospice (name of company not in medical records); pt passed away at home
This spontaneous report was received from healthcare professional refers to a 1 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # M024680, expiry date: 18-MAY-2018), dose 1, subcutaneous and (Oka-Merck) PROQUAD (Lot # M029599, expiry date: 10-DEC-2017 (Overdose). No adverse effects were reported. Additional information has been requested.
I?ve been fine up until day 7 (1/22/21) when I noticed my arm felt itchy at the injection site. When I checked, there is a red, raised bump. It still feels itchy, very warm and tender to touch.
arms hurting. covid arm still hurts over 24 hours later. woke in the middle of the night throwing up. Next morning just achy and sore arm.
anxiety before receiving vaccine, received vaccine, felt sick to her stomach, lightheaded, passed out and vomited while unconscious and very diaphoretic
This case was reported by a physician to a sales representative and described the occurrence of generalized rash in a patient who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date, the patient received the 1st dose of Engerix-B. At an unspecified time following the first administration of Engerix-B, on an unspecified date, the patient experienced a "generalized rash." The outcome of the event was not reported.
Screwed up stomach; Chills; Fever; This is a spontaneous report received from a contactable consumer (patient friend) via medical information team. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153, expiry date: unknown) via unspecified route of administration in right arm between 09:00-10:00 on 20Apr2021 (age at vaccination 40-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included bipolar (Diagnosed with over 13 years before, maybe 14 years) and depression (Diagnosed with over 13 years before, maybe 14 years). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot: EP6955, expiry date: unknown) via unspecified route of administration in right arm between 09:00-10:00 on 22Mar2021 (age at vaccination 40-years-old) as DOSE 1, SINGLE for COVID-19 immunisation, felt soreness in the arm and sleepiness and anxiety attacks after the first dose Pfizer Covid Vaccine. After the second dose, the patient experienced chills and fever which had lasted for 7 days. After receiving the second dose, reporter stated that something screwed up patient stomach on 27Apr2021. The patient used bathroom and felt better after that. The patient was felt better in the morning. The patient has some mental illness that the vaccination has affected after the first dose. The reporter stated that he and his girlfriend had tons of ills because of the shot. The outcome of the event abdominal discomfort was recovering, outcome of fever and chills were recovered in 2021. No follow-up attempts are needed. No further information was expected.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (Injection site induration/firmness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 04-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness) 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 medication were reported No treatment medication were reported.
pt has had multiple , nausea, vertigo, dehydrated , heart palpitations, ear problems, knee pain, neck pain, heart problems
Tachycardia that began night of vaccination.  Tachycardia peaked following day at 130 beats per minute (bpm).  Patient visited doctor and went to emergency room.   Heart rate is currently elevated but less than 100 bpm
Sore to touch for days after at injection site (normal, no skin discoloration) But on 3.31.21 in the morning noticed arm is swollen and red in a circle around injection site (~2 inch diameter circle, maybe a little smaller). Researched and it seems to align with "covid arm" side effect, topical steroid and Zyrtec taken to help reduce it and will monitor will go to doctor for review if it doesn't go away in a week per online recommendation.
Fluttering, pass-out feeling, non-diapharetic, several times a day. Two weeks later subsided to happening ocassionally as prior to vaccination. A-fib, worsened 2 weeks after vaccination (can be induced by stress). Zotolol and Coumadin taken now and prior to vaccination.
Acute occlusive SVT - 8.4 cm; This is a spontaneous report received from a contactable consumer.  A 67-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318 expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 02Feb2021 14:30 as (At the age of 67-years), as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing and Known allergies: Sulfa. Concomitant medication included atenolol 50 mg and simvastatin 25mg all was taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced acute occlusive SVT - 8.4 cm (supraventricular tachycardia) on 15Mar2021 11:00. Patient underwent Ultrasound and blood thinner treatment for the event. Post the vaccination the patient underwent lab tests and procedures which included covid-19: negative on 13Mar2021. The events were assessed as Non serious by reporter. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information was expected.
SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) (seriousness criterion medically significant). In 2021, PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) had resolved.            After second vaccine of Covid, the patient had a bit of side effects. They were watching liquid around the heart but it mellowed out. No concomitant drugs taken.  The reporter's causality for the event(s) of side effects, liquid around the heart was watched with respect to Skyrizi(risankizumab) was no reasonable possibility.  No treatment medication was reported.  No known allergy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company comment: This is a spontaneous case concerning a 83-year-old female patient with Moderate to severe plaque psoriasis, who experienced the serious (medically significant) unexpected event Pericardial effusion, on an unknown date (on the same year) after receiving the second dose of mRNA-1273. It was reported that "They were watching liquid around the heart but it mellowed out". Clinical course, diagnostic tests and treatment details were not provided. At the time of the report, the event had resolved. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 83-year-old female patient with Moderate to severe plaque psoriasis, who experienced the serious (medically significant) unexpected event Pericardial effusion, on an unknown date (on the same year) after receiving the second dose of mRNA-1273. It was reported that "They were watching liquid around the heart but it mellowed out". Clinical course, diagnostic tests and treatment details were not provided. At the time of the report, the event had resolved. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received the DTaP-IPV on R thigh and VAR on L thigh approximately noon on 5/24/23.  Parents state overnight (Wednesday  evening 5/24/23 to Thursday morning 5/25/23), he was more uncomfortable, fussy and itchy.  They checked his temperature frequently, never higher than 99 oF.  He was eating less than normal on Thursday 5/25/23.  On Friday 5/26/23 when he woke up in the morning, the parents noted his R thigh was erythematous, swollen and with a blotchy rash.  He was itching this leg more frequently.  He was seen in the clinic. on 5/26/23 at 11 am.  At the visit on 5/24/23 he had stranger anxiety and was frequently crying; at the follow up visit on 5/26/23 he was crying again - not clear if due to pain or anxiety.  His R cheek was slightly flushed.  His R thigh was noticeably swollen compared to the L thigh (circumferentially) with an amorphous erythematous blanching rash and warm to touch compared to other skin sites.  There were no urticaria, bruises, petechiae.  No evidence of purulence or drainage.  The R and L legs had full range of motion at hips, knees, ankles, without effusions.  The patient was able to walk normally.  The patient was prescribed oral diphenhydramine, topical triamcinolone 0.1% ointment for the reaction site.  I also advised cool compresses to the area.
Had shot on Thursday 2/25/21.  Friday didn't feel well-laid around all day. Saturday was so dizzy I had to hold on to walls and furniture to walk around house. Sunday was still dizzy and nauseous so I ate a sandwich and 3 or 4 tums.  All came up and I continued to vomit throughout the day. Could not even keep water down. Monday I had someone bring Ginger Ale. Nausea gone, but still very dizzy. Never had a temperature but continue to be dizzy.   I am a very active 80.  Clean my own house and Mow my yard.  I play bridge 2 or 3 times a week and walk my 2 Yorkie Dogs several times a week and never have been dizzy before.
On 4/22 at 10AM, started feeling drained and low energy. 4/22 by 15:00, temperature was up 1 degree. 4/22 by 18:00. temperature was up 3.5 degrees. Took 1 Tylenol. 4/22 by 19:00, temp was only up by 2 degrees. 4/23 at 07:00, after sleep, temperature was up 1 degree. Took 1 Tylenol. Temperature was normal.  4/23 at 08:00, felt normal again.
Lightheaded, headaches, extreme fatigue, insomnia, exercise intolerance, inability to tolerate heat, excessive sweating, tachycardia, blurry vision, heavy legs and intermittent anxiety starting about 1-2 weeks after 2nd dose of vaccine; and increasing in severity over summer. Diagnosed with POTS via tilt table test from a cardiologist. No history of above symptoms before vaccine. No concomitant infections.
Cellulitis required KEFLEX, IV Vancomycin, BACTRIM DS.
This case was reported by a physician via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th January 2022, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: The reporter stated that the patient received a pediatric dose of Engerix B, 2nd dose in series, which led to underdose and adult use of a child product. No reactions were reported. The reporter consented to follow up via email.
pt states that he developed a headache, sore arm, had fatigue along with body aches and pains.  He was dizzy and eyes were very droopy.  He woke up next day and his arm is very sore, he is very tired and has a flushed face.  Pt feels like his symptoms are improving now.
patches appearing all over my body, these patches are red; patches are red like hive patches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age (Age: 38; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got vaccinated with the Pfizer-BioNtech covid-19 vaccine on 22Dec2020. And since that day she started experiencing a side effect described as "patches appearing all over my body, these patches are red like hive patches. These patches pop up and stay for a couple of hours". The patient wanted to know if the appearance of red patches described as "hive patches" all over the body has been reported by someone as a side effect due to the use of the vaccine or if this is independent from the vaccine. The patches are still appearing. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt was given Rotateq at 1 pm-later that evening pt started having vomiting and diarrhea-went to ER
Migraine, extreme fatigue, injection site redness dime size after 12 hours, redness increased to 3? circle
25OCT93 TC from pt shot made sick, wanted to let know; approx 6 hrs p/inject c/o fever, chills, nausea then sl diarrhea; h/a
Muscle soreness; Tingling in right arm; Low grade fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 18Apr2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (PCN allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm left on 26Mar2021 at 12:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 the patient experienced muscle soreness, tingling in right arm, low grade fever, chills and nausea. Therapeutic measures were taken as a result of muscle soreness, tingling in right arm, low grade fever, chills, and nausea and included treatment with Tylenol and Advil from unknown date. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle soreness, tingling in right arm, low grade fever, chills, and nausea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a patient who who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL vaccine. The nurse practitioner stated the patient was tested positive for HPV on a Papanicolaou test (PAP smear) after completing the GARDASIL vaccine series, on an unspecified date. The patient was seen at the office. Additional information has been requested.