chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke. Foci of acute/subacute infarction in the right putamen/corona radiata, right insular cortex, right superior frontal gyrus, and left occipital periventricular white matter. No evidence of hemorrhagic transformation or petechial microhemorrhage. No associated mass effect, midline shift, or herniation.   Generalized cerebral volume loss on a background of chronic microvascular ischemic changes.
Onset of Long Covid symptoms including but not limited to: EXTREME unpredictable fatigue,  Extreme brain fog (forgetting to turn off stove when leaving home, for example), muscle and especially joint fatigue in ALL joints, sharp headaches in the back of the head. Family Dr said that these didn't match long term covid symptoms and recommended to see a neurologist
This spontaneous report as received from a 68 years old patient refers to herself. On 27-OCT-2012 the patient was vaccinated subcutaneously with one dose of ZOSTAVAX (Lot# and dose not reported). Concomitant medications included metoprolol and lisinopril. "About a week ago" on approximately 29-OCT-2012 the patient experienced injection site pain and redness, nausea and diarrhea after receiving ZOSTAVAX. Patient stated that she had shingles outbreak at this time, in about November 2012. Patient did not seek for medical attention. No treatment was given. No lab diagnostic studies were performed. Adverse events were not improved. At the time of this report the patient had not recovered. Additional information has been requested.
called to Car after vaccine due to patient not feeling well. Quick history obtained: No pmh. Not pregnant per patient. nly allergy to milk. No history of anaphylaxis. She received vaccine at 5:42. Felt lightheaded and dizzy about 5 to 10 minutes after the vaccine. She noted chest tightness and tachycardia symptoms. We transported her via gurney to our observation area. She looked sleepy and had trouble arousing her. Blood pressure is 140/80, heart rate was in the 90s to 100s. Breath sound decreased bilaterally. No lip swelling. No rash. She noted throat felt uncomfortable.  Suspect anaphalxis reaction given rapid decline in status while talking with her. epic pen at bedside immediately and then due to increasing heart rate and complaints of chest discomfort gave her epipen times one. Paramedics were called prior to decision for Epipen.  She noted after a minute or two her chest felt better. Monitored her and blood pressure remains stable 140/80's, heart rate initially increase to 110 and then back down to 100 about 5 minutes after the first dose. Second dose of EPI readied as Paramedics not on site yet. At about 8 minutes from EPipen dose her heart rate increase to 160 and she noted additional symptoms of chest tightness again and re-gave a second Epinephrine pen. She was more somnolent but protecting airway. Oxygen was added 2 liters after second epi pen. Her sats dropped right around second epi pen to 94% but about 2-3 minutes later back to 98%. Paramedics arrived 5 minutes after 2nd epi dose and care was transferred to them. She was transported in stable condition.   Once paramedics arrived it was determined that they got a level 3 request which was not as urgent and this should have been a level 1.  We reviewed how this happened and they note that our site was listed as a level 3 site due to having staff on hand.  We were advised to ask for LEVEL 1 paramedics in futures.  This was communicated to all Medical staff as well as the Physician of the day orientation.
pt recv vax; exp arthritis & arthralgia;f/u info stated sx not due to vax;
11/18/21 presents to EC ED with "worsening shortness of breath". PMHx "CHF, COPD, hypertension, diabetes".
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 30-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
-site reaction occurred 24 hours after admin. was still present > 48 hours later - sore lower back
The patient received the vaccine 12 days past the expiration date. The vaccine was in the refrigerator for ten weeks and was 12 days past that.
1.  Local injection site reaction to vaccines received here on 2/11.   - No signs of infection. - Reviewed the difference between local injection site reaction and generalized allergic reaction. - Ice vs heat, on for 20 minutes, off 2 hours, repeat, may alternate ice and heat or stick with 1 or the other. - Tylenol/ibuprofen if needed, follow directions of package. - Recommend getting vaccines in separate locations in the future and/or separate vaccines by several weeks. - Follow up if new or worsening symptoms or failure to improve over the next 1-2 weeks.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 25-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD lot # M049122, expiration date 13-JUN-2018, for prophylaxis (strength, dose, frequency and route of administration were not provided). No adverse effects were reported.
Woke up the morning after getting the vaccine and had these symptoms  chills   achy body Temperature was around 99.0 Headache no appetite  lethargy   I usually run about 97. The symptoms got worse in the afternoon. Anytime something touched my skin, I would get goose bumps and go between feeling cold and hot. My temperature is now 99.8.
The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients).    No treatment medications were reported No concomitant medications were reported  Highest temperature reach 47.5 F. Both vaccines Bivalent and primary were involved.    This case was linked to MOD-2023-718496 (Patient Link).
Itchy; Little bit of skin Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy) and RASH (Little bit of skin Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (Little bit of skin Rash). At the time of the report, PRURITUS (Itchy) and RASH (Little bit of skin Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient advised urgent doctor put him on steroid and cream with no further information listed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Brain abscess, status post craniotomy and drainage. Hospital admission within 6 weeks of receiving the COVID vaccine.
Severe intense abdominal/stomach pain that started about 7:00pm.  The pain was (still is) an very sharp and burning pain that come and goes in waves.  It lasted with me most of the night, making it impossible to sleep.  The last time I looked at the clock before having to get up to get ready for work was 12:30am.  During my workday (Friday, April 9th) the pain would come and go throughout the 9 hours I was at work.  Again, becomming more severe and intense after I got home.  The pain is so severe that I honestly wasn't sure if I was going to wake up this morning.  As I write this (Saturday, April 10, 2021 at 9:04am) the waves of pain keep on a coming.  I have also had episodes of burping, which seems to lighten the pain a bit.  Right now the riht side of my stomach/abdomen is really sore.  I had a "wave" of severe, intense pain while writing this about 5 minutes ago.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-FEB-2015 the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient experienced pain at the injection site and left arm and shoulder. States he cannot lift his arm above his shoulders. There is no swelling at the injection site. There was a burning sensation after the shot in the arm but it went away the next day on 6/28/2016.
pt recvd vax 25FEB92 & according to mother had persistent crying > 3 hrs;
This individual has a 2 month old infant and was breast feeding at time of administration of both Pfizer covid19 vaccines. Four days after the first vaccine, individual noticed a blood tinged clot-like spit up in infant and then dark stool from infant one day later. Two days after the second vaccine, mom noticed a blood-clot-like drainage from nipple (that individual says looked just like the blood tinged spit-up that was noticed in infant).
Interstitial lung disease, Dyspnea, decreased oxygen saturation, generalized fatigue. Unchanged at over 8 weeks post vaccine. Prognosis unknown.
Facility did not specify.      She was prescribed Prednisone and Benadryl from ER and observed and never admitted.
I have a round, hard, itchy spot on my arm where the shot was administered. It isn?t too bad but definitely noticeable. I first noticed it last night. Also I am 41, not 21, but for some reason the form insisted I put 21.
Painful arm at injection site, chills, body aches, fever or 99.9 (usually has subnormal temperature because of blood pressure medicine).
pt recvd vax; 29jul95 devel red, itchy bumps all over & cold sxs; no fever; took 1 wk for the bumps to stop breaking out;
had Covid over New Years holiday; had Covid over New Years holiday; she had a lady who was pregnant/ looked like she was 7 months pregnant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient was 7 months pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid over New Years holiday"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "she had a lady who was pregnant/ looked like she was 7 months pregnant". Clinical course: The pharmacist was calling about the Covid-19 vaccine Purple Cap for Adults. She reported that she had a lady who was pregnant and just had covid over New years holiday. The patient's doctor told her to wait 90 days to get a booster, but the caller said that she was there now wanting a booster. The patient looked like she was 7 months pregnant or so. She wanted to know if it was ok that she got the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out in this 7 months pregnant female patient.
Fever-like symptoms started in the afternoon/evening, including uneasy stomach, headache, aches and chills. Sweat profusely during the night and difficulty sleeping. Felt much better in morning and all symptoms were gone by end of day.
Patient experiencing redness, inflammation, and heat on the same arm as the injection. Redness is the size of the upper arm on the outside of the arm from the deltoid to the elbow.
Pt recvd vax & 8 hrs following the vax devel macular pruritic, small, raised, red papules on forearm, inner thigh, groin & umbilicus; sx persisted 2 wks; pt's exp described as a hypersensitivity reaction w/dermatitis manifestation
When patient was in for 2nd shot, she stated she developed lower back pain the day after her 1st shot. Patient stated she had a hard time walking for about a week and a half after the shot. She is 7 weeks pregnant and due in April. She stated she went to the er and her pcp, both told her it was because she was pregnant.  She went to her ob/gyn and told her it was not related to her pregnancy and not sure why she had the back pain. Patient stated she had to do physical therapy now.
When I woke up early in the morning, I felt a little short of breath. I had a pulse detector, so I checked my pulse, and it was up to 130 BPM and up to 150 BPM when I started walking around. I was out of breath, but I tried to wait it out to see if it would go down. After 30 minutes it still wavered between 130 and 150. I went to the ER on 11/20/2021 around 3AM that same day. The doctor ran test on me and said I had tachycardia. He also said that it is a reaction to the COVID-19 vaccine. They gave me some metoprolol, and that brought pulse down to 109BPM. I wasn't prescribed anything, but I was informed that if it happens again to take an extra propranolol.
Case number PHHY2012CA011066 is an initial spontaneous report received from a consumer (patient's father) via pharmaceutical company (reference number: 2012014501) on 06 Feb 2012: This report refers to a neonate (less than 1 year) male patient. There was no relevant medical history and no family history. He was vaccinated with a dose of seasonal influenza vaccine (manufacturer and batch number: unknown) along with PREVNAR (other manufacturer, batch number: 343285) and MMR (other manufacturer, batch number: unknown) on 19 Oct 2004. On an unknown date, autism was diagnosed after these injections, and he suffered brain damage. The reporter felt there should be a warning about administering other vaccines at the same time as he report that apparently his son had too much aluminum adjuvant upon receipt of these vaccine together because the maximum aluminum adjuvant dose was 1.25 mg. The reporter further stated that his son went over that amount of aluminum and his body could not handle it. The outcome of the events was unknown. No further information was provided.
2/27/17 Monday patient got Hep A, TDaP and Influenza vaccines. Approximately 30 minutes after vaccines she said face and neck itchy and tongue feels wider. Returned to office for Dr to check her. No difficulty breathing but maybe some difficulty swallowing. BP 120/60 Pulse 80 Resp 16/1:58pm. She also states feels like glands swollen and feels like pins poking lips neck and ears. Throat dry. No rash, no hives. 1:35PM BP 130/60 P88 Resp16 O2 100. Gave water to drink. BENADRYL 25mg orally at 2:05PM. Had BENEDRYL 25mg 2 more times 2/2717 after left office. 2/28/17AM Back to normal.
Patient developed redness in her right eye 1/6/2022. Seen by pediatrician on 1/10/2022 with no sign of infection. Seen by pediatric ophthalmologist 1/13/2022 and diagnosed with bilateral uveitis, right worse than left. Responding well to topical steroids. Lab work showed no significant inflammatory or rheumatologic markers. Suspect it's a side effect of the COVID-19 vaccine.
Extreme aching in the arm for 5 weeks.  So much it's painful.   At my second dose, May 11th, I informed the tech that my arm still hurt from the first dose which she replied, "that is odd.  we'll just do the injection in your other arm".   I went another week in pain before calling my dr to inform him of the pain.  They took my information over the phone and asked me to keep them updated.  Two days ago was just too much pain to bear so i went to the pharmacy and spoke with the pharmacist.  she suggested i get an X-ray.  I called my dr and yesterday went it to have it checked out.  they did an X-ray and found nothing out of the normal.   they also ruled out a blood clot since i didn't have any of the symptoms.
Nose running, taste of bile, tiredness, started Monday 4/5/2021 around 5pm EST, persisted overnight Still present at time of report
This case was reported by a healthcare professional and described the occurrence of blister of throat in a 24-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline), hepatitis B vaccine. On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (unknown). At an unspecified time after completing the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response. On 12 March 2013 the subject received 4th dose in the form of two injections with ENGERIX B pediatric (unknown, unknown deltoid) and experienced inappropriate formulation of vaccine administered and extra dose administered. On 12 March 2013, within 12 hours of vaccination with ENGERIX B pediatric, the subject experienced throat swelling, blister/ patches in the throat. On 13 March 2013, one day after vaccination with ENGERIX B pediatric, the subject experienced neck swelling and enlarged thyroid. A healthcare professional at an employee health clinic reported, the subject, who is also an employee, received two pediatric doses of ENGERIX B to make up one dose that was counted as the 4th dose. The subject completed the three dose series previously; details regarding when and which brand of hepatitis B vaccine were unknown, but it was "completed at least more than a year ago". The subject needed an additional dose as his titers came back low. On the evening of 12 March 2013, within 12 hours, he felt throat swelling and had patches/blisters in the throat. On the morning of 13 March 2013, the subject's neck was swollen and thought his thyroid was enlarged. The subject was recommended to see his primary care physician. This case was assessed as medically serious by GSK. At the time of reporting the throat swelling, blister of throat, throat lesion, neck swelling and enlarged thyroid were unresolved.
Fever(100),  chills 12 hours after.  Severe headache 24 hours after.  72 hours later took naproxen for headache, took a nap and started feeling better
Patient complains of left sided facial numbness, right arm numbness. Progression of symptoms to left are. Patient reports numbness comes and goes. However, numbness to left side of face/upper lip remains constant. Patient refused treatment/transport despite clear clnical findings of neurologic dysfunction and sighed release paperwork and left facility with her son.
Patient received a 3rd dose of Moderna. 1st dose on 1/4/21, 2nd dose on 4/12/21, and 3rd dose on 6/17/21.
2nd dose given less than a month apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th December 2022, the patient received the 2nd dose of Shingrix. On 9th December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The patient was immunocompetent. The reporter consented to follow-up by email. Additional supportive information: The patient received second dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
Fever of 102F and chills/shivering treated with cool bath, cold compresses and ibuprofen. Headache treated with ice packs. Shortness of breath, treated with inhaler. Muscular aches, swelling at injection site. Fever decreased to 101.5F until ~5:00am where it rested at 99.5F until ~4:00pm. Raising slightly now ~5:00pm
tested positive on a rapid and PCR for COVID; sore throat; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (COMIRNATY), on 01May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 06May2022, outcome "unknown", described as "sore throat"; SARS-COV-2 TEST POSITIVE (non-serious) with onset 06May2022, outcome "unknown", described as "tested positive on a rapid and PCR for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: turned 5 on (Birth date) and got his first Comirnaty vaccine in 01May. He woke up 06May with a sore throat and fever and tested positive on a rapid and PCR for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left upper arm redness and swelling noticed on 3/22/14, looking like a spider bite.
Pt seen 12/27/13 for well visit (6 months). Pt was well at that visit. Given the following vaccines - DTaP - Hep B - Polio (PEDIARIX), PREVNAR, Hib, and Influenza. That evening proceeded to have a prolonged seizure. Taken via ambulance to Hosp. Required intubation, sedation and general anesthesia to stop seizure. MRI brain showed calcifications in area of basal ganglia. On KEPPRA.