chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's arm turned red and he developed a fever.  He visited the emergency room where he was given prednisone.
acute left ACA/MCA ischemia cerebrovascular accident; acute left ACA/MCA ischemia cerebrovascular accident; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.  On or around 03-OCT-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered right upper extremity weakness and dysphagia. Pt was hospitalized and diagnosed with acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident with resultant right sided facial asymmetry, distal right upper extremity weakness and aphasia. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Upon internal review, acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident  was determined to be medically significant. Acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident was considered as disability by the reporter.
4 days after I received 1st shot of the Moderna Covid 19 Vaccine in April.  I had sticking, stinging and burning pains  in my skin and my fingers and toes joints hurt. My skin felt like it was on fire. No rash,however my hands and sole of my feet became  became excessively dry with several painful cracks. Water burned and felt like gasoline on my skin.
anaphylactic reaction to the vaccine almost immediately and was hospitalized; antihistamines were not working; cellulitis around the injection site; Her left arm felt like it had "snakes crawling underneath it" and was swollen; Her left arm felt like it had "snakes crawling underneath it" and was swollen; fever; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient did not have any concomitant medication or pertinent medical history.  On 07-NOV-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) in the left arm for chicken pox prophylaxis.   On 07-NOV-2005, almost immediately after vaccination, the patient experienced an anaphylactic reaction to the vaccine and was hospitalized. She reported that her throat closed up, her tongue became swollen, she felt like she couldn't breathe, was unable to swallow, and her mouth became very dry and had a "metallic" taste. It was reported that the back of her throat "looked like Hiroshima", being bright red and her tongue "tripled in size". She had a fever and was sweating for a few days. Her chest turned red and "felt like it was on fire". Her left arm felt like it had "snakes crawling underneath it" and was swollen (vaccination site swelling, vaccination site discomfort). Her armpits and groin "were on fire". She developed cellulitis around the injection site (vaccination site cellulitis). She felt pain behind her eyes and her eyes became red. It was also reported that her lymph nodes were swollen and that she "looked like a Fighting Championship fighter". She reported that antihistamines (unspecified) were not working (drug ineffective). She sought medical attention and there were no lab diagnostics/studies performed. The patient did not receive the 2nd dose of the vaccine due to her reactions. The outcome of drug ineffective to antihistamines was unknown. The outcome of remaining events was recovered on an unknown date (reported as a few weeks afterwards). The reporter considered anaphylactic reaction, vaccination site swelling, vaccination site discomfort, vaccination site cellulitis to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality was not provided for other events.   Upon internal review, anaphylactic reaction to the vaccine was determined to be medically significant.
Days after receiving the second Moderna vaccine I had an episode where while I was driving I got extremely lightheaded, nauseous, heart racing, whole body shaking this lasted for about 10 minutes after that I have not felt right. I am always light headed and nauseous, it's very hard to drive to get back and fourth to work. It is effecting my daily living
High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
pt recv vax 13JAN98 & 21JAN98 devel hives;
The 3rd full dose was administered in the mid arm, very sure that the injection missed the deltoid muscle; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The 3rd full dose was administered in the mid arm, very sure that the injection missed the deltoid muscle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L213) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The 3rd full dose was administered in the mid arm, very sure that the injection missed the deltoid muscle). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The 3rd full dose was administered in the mid arm, very sure that the injection missed the deltoid muscle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
It was reported in a published article that a 75 year old female with a history of angioimmunoblastic lymphadenopathy (AILD), which was currently suppressed, who was vaccinated with a 0.5ml dose of pneumococcal vaccine 14 polyvalent. Prior to the vaccination, the patient presented with fevers, night sweats, cough, anorexia, and weakness, with diffuse lymphadenopathy and hepatosplenomegaly. The patient had a Coombs positive hemolytic anemia and polyclonal gammapothy. Lymph node biopsy confirmed AILD. After a course of chlorambucil, vincristine, and prednisone, the symptoms and physical findings resolved. With the patient's maintenance therapy of prednisone, the patient's disease was completely suppressed for 4 months. Three weeks after vaccination, the patient experienced a sudden onset of high fevers, adenopathy, and recurrent organomegaly progressing to renal failure and pancytopenia despite aggressive support and combination chemotherapy. Immonulogical studies before death demonstrated an IgG kappa monoclonal gammapathy of 654 mg/dl with free kappa chains in the urine. Permission for necropsy was refused. No further information is available.
expired Adacel was administered to a senior citizen, no symptoms reported; expired Adacel was administered to senior citizen, no symptoms reported; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA177590 and 2019SA178356 (same reporter).  This case involves female patient (senior citizen) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
That night I started feeling bad, I woke up with a fever of 103 and I took some tylenol. The next day I had fever, chills, nausea and it just continued. Yesterday morning I had my husband take me to ER and I had lost 15 pounds since Wednesday. I couldn't keep down fluids. They tested me for Corona and the flu but both were negative. They also gave me fluids. Everything and smells and tastes terrible. They gave me Zofran but it didn't help. I haven't been able to take my medicine.
11/1/15 One hour after vaccination, pt. complained of a severe headache. 11/2/15 pt complained of having a fever 100.7 F; pt took TYLENOL after speaking with the pharmacist, 11/3/15 pt felt a little better. No headache or fever. 11/4/15 pt noticed that the injection site on the left arm was swollen and warm. Red area was 2 1/2 inch in diameter when she showed it the pharmacist. Pharmacist told her to see the doctor. She went to urgent care-which referred pt to hospital emergency room. Er said that pt has cellulitis and gave the patient cephalexin 500 TID x 7 days. 11/9/15 pharmacist called pt to check up w/pt. Pt is feeling better and arm is darker at the site of injection not red. Pt has an appt w/MD on Thurs. 11/1/15 per pt.
My left underarm area is swollen and feels soft. The same consistency as a water balloon.  There is some redness in my armpit as well. And the vaccination site is reddish and feels tougher than the rest of my arm or my right arm.
temp to 106 R;erythema, warmth 10x10cm @ site of inj;
Pt vaccinated with MMR/HIB developed fever, possible convulsion, bacterial meningitis.
At 1 am (10 hours after the vaccine was administered) my temperature spiked to 102 and I was shaking uncontrollably. The fever continued for several hours, breaking around 3 or 4 in the morning. I woke up at 6 am with a severe migraine and was very nauseated. I also had diarrhea throughout the morning. My arm was also extremely sore and sensitive. I took Excedrin for the migraine, and woke up at 10 am feeling somewhat better. I remained shaky and fatigued throughout the rest of the day. The next day I still felt fatigued with a slight headache.
On the day after the vaccine, he reported right arm redness and subjective fever. The following day, started fevers (up to 102.5 F) and severe fatigue, became functionally bedbound (though denied focal weakness) due to fatigue; fever responded mildly to antipyretics (TYLENOL, ibuprofen). Called our office; given that he had 3 sick contacts with influenza, suspected possible URI, recommended supportive care and to call us if symptoms evolved. The following day, presented to an urgent care facility for further evaluation; tested negative for the flu, was prescribed course of OMNICEF. The redness in his right arm had spread, he was denying any upper respiratory symptoms/cough at this point. Continued with supportive care and agreed with course of antibiotics for 5 days to see if he'd improve. By the following Monday, his fevers had improved and he had not developed any sore throat, rhinorrhea, cough, shortness of breath; however, his right arm had continued to become more red, and he was still reporting malaise. On exam, showed erythema over the vaccination site. His fevers had resolved by day 5 off of antipyretics. Suspected that he had a systemic inflammatory response after vaccination.
Box 17 - Shingrix   1st dose - 10/16/19 2nd dose - 02/14/20
Got a high fever 103.6 and felt very ill.  Could not hardly get out of bed. Weak, light headed, general feeling of being out of presence of mind.    Sick for a few days and then felt OK.   Called doctor and just said if could breathe then I should  take aspirin, rest, drink fluids. Also got sick from the first vaccine shot I got but the second shot was much worse and I felt like I really was sick.
rash all over the body; chills; soreness around the injection site; light headed; fatigue; feeling weak; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), RASH (rash all over the body), FATIGUE (fatigue), ASTHENIA (feeling weak) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (itchiness), FATIGUE (fatigue), ASTHENIA (feeling weak), VACCINATION SITE PAIN (soreness around the injection site) and DIZZINESS (light headed). On 13-Mar-2021, the patient experienced CHILLS (chills). On 15-Mar-2021, the patient experienced RASH (rash all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness), RASH (rash all over the body), FATIGUE (fatigue), ASTHENIA (feeling weak), CHILLS (chills), VACCINATION SITE PAIN (soreness around the injection site) and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Benadryl was taken as treatment for itchiness.  Concomitant medications were used for high blood pressure.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 21-JAN-2013 was vaccinated subcutaneously with lot # (672476/ 1605AA exp date: 13-JAN-2013), 0.65 ml live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had any adverse effects. This is one of several reports from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 04May2021 as dose 2, single (Lot number: EW0172), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2583), in left arm and on 22Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizures" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Over active bladder" (unspecified if ongoing); "Known allergies: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas, Penacillin, Octopus, Squid, Casein, Whey, Chickpea; "Known allergies: Penacillin" (unspecified if ongoing); "Known allergies: Octopus" (unspecified if ongoing); "Known allergies: Squid" (unspecified if ongoing); "Known allergies: Casein" (unspecified if ongoing); "Known allergies: Whey" (unspecified if ongoing); "Known allergies: Chickpea" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; MARIJUANA; PEPCIDAC; TROKENDI XR; OXYBUTIN; NALTREXONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient had taken Other medication in 2 weeks.Patient taken Paxlovid treatment for Covid-19 started on 05Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/25 7PM started to feel chills and body aches and woke up in the middle of the night with a fever.  3/26 Continued fever (103.1), body ache, foggy head, head ache, slight  loss of taste 3/27 Fever broke, still body ached, foggy head, head ache, slight  loss of taste 3/28 foggy head, slight  loss of taste 3/29 foggy head, slight  loss of taste
Got hepatitis b vaccine june 21 2008 a which time at work my Right knee started to get an ache later in shift turned to pain. When I want home that night after work my knee was very swollen. I worked 2.30 pm till 11pm shift. Next day I worked Right knee bothered me I did not know why. I stand, sit, bend, and walk alot at my job. Just seemed to get more agravated and got worse on my feet and bending. Had 5 day off thought it would go away. Worked the next weekend when working got worse swelling still their did not know why maybe from bending at the knees to pass medication. That Sunday was very painfull and had joint pain. Had more days off thought maybe a sprain elevated it and more to help get better. Did get better what but still swollen and when standing for longer period hurts. Saw in computer join pain could be an adverse reaction to the vaccine I took. Want to facility July 9, 2008 to make sure has nothing to do with vaccine. He did not think so but can not explain why I got this the same day I got the shot. I have allergies to grass and dust and more pollen stuff. But as far as I know I do not have any allergy to medications. I feel since I still have it. It might have something to do with the vaccine and wanted you to know about this and to put it on record.
No additional adverse events reported; dose of PROQUAD had expired on 4/7/2021 was inadvertently administered on 4/29/2021; This spontaneous report was received from a pharmacist and nurse via a vaccine representative and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-APR-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # S031884, expiration date: 07-APR-2021 (exact dose, route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.
Progressive side effects with each subsequent dose. Emotional instability.  Depression. Anxiety lasting over two weeks
Excessive crying and redness at the site of injection with pain during moving the legs actively needing 1 ml of 160/5ml Tylenol and induration at the site of vaccines- Pediarix and PCV on the left thigh with 3 cm diameter induration on 12/6 when they came back to see me. Will follow up in 2 days to see if it is resolving. Vaccine administered 12/5. Seen again by PCP 12/7 - patient moving legs actively but induration of 3 cm still palpated.
Patient showed image of face swollen; bumps on skin over thighs and midsection of stomach.
Date of symptom onset: 05/10/21  New cough, New sore throat, New headache
Right thigh red, swollen, warm to the touch. 3x1.5 cm without fluctuation.
Client spiked a fever of 101.3 Mother gave Ibuprofen to reduce temp. Advised to see PCP. 2nd Phone conversation @ 1:45pm Temp now reduced, mother states her son had previous Sx's last year but not associated with Flu vaccine. been slightly ill since returning to school this year. Advised to still seek PCP for evaluation.
RASH ON ARM AND FEVER.  DEVELOPED CHICKEN POX RASH 4 WEEKS AFTER THE IMMUNIZATION.
Put me in the ER / Hospitalization; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Put me in the ER / Hospitalization) (serious criteria hospitalization).  The outcome of the hospitalization was not recovered/not resolved.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingles shot put him/her in the emergency room.  The patient was sent to the emergency room and it was unknown if the patient was hospitalized after that. Follow-up would not possible as no contact details were available.
Pain and swelling 4 hours after injection, 7 cm red, tender, warm area extended towards elbow. Treatment: ZYRTEC morning, BENADRYL at night, warm compression and 4 time a day, Sunday itching with chills