chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient in to Covid Vaccine Clinic for first Covid vaccine dose, Pfizer. Received dose around 1308, was flagged to wait for 30 minutes in observation area due to history of anaphylaxis. RN was in observation area and noted patient having difficulty at approximately 1329. Upon assessing patient and asking if she was okay, RN noted stridor and patient having difficulty breathing. Patient was moved to observation room for further assessment and treatment. Patient received 2 doses IM epinephrine and then 50mg IM benadryl. EMS called and arrived shortly after. Patient taken to nearby ED. Patient's husband and grandson both notified and at bedside prior to patient leaving with EMS. Per husband, patient coded in November due to an anaphylactic reaction, possibly to Ancef. Patient departed in care EMS Unit at 1341. Vitals and medication administrations as follows: 1329 - Pt c/o SOB, noted stridor, 96%RA and HR 110, feeling "closing of throat" 1330 - 127/87, 127, 97%RA, RR36 IM epinephrine 0.3mg auto injector administered to right thigh 1333 - 99%RA, c/o throat tightness 1334 - 124/87, 114, 99%RA, second dose of IM epinephrine 0.3mg auto injector administered to left thigh 1338 - 113, 99%RA, 50mg IM benadryl administered to left arm 1339 - EMS arrival and care taken over of patient; report given
Redness and swelling noted to LA. Advised to apply cool compresses and give Tylenol.
Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and pain in the arm. About  01:00, I woke up and I was in a lot of pain. I had hives all over me. Hives were spreading all over my body: hair; arm with the injection; we called 9-1-1 I went to the hospital. They gave me some meds through IV. By that time, I had taken Bendryl and I was there about 4 hours with IV. I felt better but hives didn't subside. That Sunday afternoon they started getting worse again and I went back to the hospital  (16th)and they gave me rounds of something through IV.  On 17th, I went back to hospital - they gave me another shot for the hives. I worked on the 18th - but was they said I should go home because I didn't look well. My lip started swelling that night. On the 19th, I went to my doctor and the Dr, used an epi-pen on me and gave me a shot of something for the  welts still on my body. They still didn't go away.  Symptoms have calmed down - but I still have spots on me. I am on Prilosec and anti-itch - Atarax and some others.
Patient developed a rash on the legs and arms 24 hours after the second dose of the oral typhoid vaccine.  She took Benadryl which helped.  She then took the third dose and then developed generalized malaise, arthralgias (especially in the hands and knees) without joint effusion or redness, and myalgias.  After the third dose the vaccine was discontinued.  She felt poorly for 3 days and then symptoms began to improve.  She felt better by June 10.
she still has heat in her arm; there is a big red circle around the site; sore arm\progressively worsened; red arm which progressively worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm\progressively worsened), ERYTHEMA (red arm which progressively worsened), FEELING HOT (she still has heat in her arm) and VACCINATION SITE ERYTHEMA (there is a big red circle around the site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm\progressively worsened) and ERYTHEMA (red arm which progressively worsened). On 19-Mar-2021, the patient experienced FEELING HOT (she still has heat in her arm) and VACCINATION SITE ERYTHEMA (there is a big red circle around the site). At the time of the report, PAIN IN EXTREMITY (sore arm\progressively worsened), ERYTHEMA (red arm which progressively worsened), FEELING HOT (she still has heat in her arm) and VACCINATION SITE ERYTHEMA (there is a big red circle around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
08/03/2021 pt had at-home COVID-19 test, results positive; presented to ED on 8/12/2021 with SOB, cough, nausea, malaise, weakness; condition worsened; pt was a DNR; admitted to hospice on 08/18/2021 where he passed away
At 1402 client reported to RN feeling "lightheaded, nausea, dizzy and ringing in the ears." RN placed client in anti-gravity chair. Ancillary informed PHN. Upon arrival at 1405, client sitting in semi-fowler's position, pale, diaphoresis noted. Client alert and oriented x4. Vitals at 1405 by RN: blood pressure 125/83, pulse 83, oxygen sat 98%. Client stated previous symptoms had resolved. RN asked client to remain for 30 min observation. Vitals at 1411: blood pressure 144/83, pulse 92, oxygen sat 97%. RN gave client Capri-Sun juice and client began drinking sips. Client denied shortness of breath or itchiness. Vitals at 1419: blood pressure 132/82, pulse 82, oxyen sat 96%. Client skin normal for ethnicity, no diaphoresis noted. Per client all symptoms resolved. Last vitals at 1432: blood pressure 129/80, pulse 84, oxygen sat 98%. Per client would leave alone, verbally stated he "felt fine do drive." RN gave education about adverse reactions, ER precautions, and V-Safe. Client left facility with steady gait at 1433.
PATIENT REPORTED PAIN, HALLUCINATIONS, COULD NOT EAT, OR SLEEP WELL NIGHT OF INJECTION, NAUSEA.
This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No concurrent conditions were reported. The patient's parent's medical history unknown.  The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported.  In MAR-2021, the subject experienced breastfeeding exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding exposure was not reported. This report was non-serious. This parent/child case is linked to 20210332395.
Dose of TDAP (Adacel) given instead of DTAP (Daptacel).
administrated with / batch recall on  July 20 2021/ recall date 10FEB2021; administrated with / batch recall on  July 20 2021/ recall date 10FEB2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 20th July 2021, the patient received Shingrix. On 20th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169134:Same reporter
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Nurse reported that the patient received a first dose of CERVARIX (lot number and expiration date not reported) on 26-MAY-2013, and might be in the office to receive a dose of GARDASIL (dose, route, lot number and expiration date not reported) on 21-NOV-2013 as next dose in HPV series because office did not have CERVARIX in stock. No adverse event was reported. Additional information has been requested.
INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
having so much fluid in his heart/had fluid around his heart; pericarditis; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at an unspecified dose for an unspecified indication.  Medical history and concomitant medications were not reported.  The patient had the first shot of the Pfizer BioNTech COVID-19 vaccine "on 06Jan2021 or 07Jan2021 or 04Jan2021" and by 17Jan2021, he was rushed to the emergency room because he couldn't breathe. He was having so much fluid in his heart and had to re-do the operation in Feb2021, and "they took biopsies of the fluid and they came back saying it might be pericarditis." She further described that he had fluid around his heart, they thought it was pericarditis and have been treating him all winter. He had a pericardial window and was on medication. The reporter stated that it started Jan2021 after the first shot,  but "it might be too close to the first shot to actually be caused by it". The patient had a pericardial window now which would take the fluid out should it come back again, but would have to go on antibiotics. They did an antibody test last week (as of 20Aug2021) and the patient's came back as negative; so he has an appointment for a third vaccine The outcome of the event(s) was not recovered. The reporter further provided that they are scheduled for a third dose of Moderna and Pfizer because the patient's doctor said that if the Pfizer (vaccine) didn't give him antibodies, they should try Moderna.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I got a flu shot about 25 years ago got the flu haven't had one since and never had flu since; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves a patient of unknown demographics who got a flu shot about 25 years ago got the flu haven't had one since and never had flu since (Influenza), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that he/she got a flu shot about 25 years ago got the flu haven't had one since and never had flu since (Influenza).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was resolved.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.  No further relevant information was reported.
Information has been received from a physician concerning a 3 month old patient who "1 week ago", on 19-JUN-2009 was vaccinated with a dose of ROTATEQ. It was reported that, on approximately 26-JUN-2009, the patient experienced vomiting and diarrhea. The patient also had a positive rotavirus stool antigen test. It is unknown if the patient sought medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
High fever, chills it was awful; within 24 hours after taking the shot patient got the flu!; High fever, chills it was awful; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who within 24 hours after taking the shot got the flu (influenza) high fever, chills (pyrexia), (chills), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, within 24 hours after taking the shot patient got the flu (influenza) high fever, chills (pyrexia), (chills) it was awful (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
severe headache and dizziness; severe headache and dizziness; This spontaneous report was received from a nurse referring to an adolescent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 mL/dose as prophylaxis (lot#, expiration date, route of administration and anatomical location not provided).  On an unknown date, the patient experienced severe headache and dizziness, of which it was recommended to discontinue the series. It was unknown whether the patient received treatment for severe headache and dizziness. Additional adverse event details were unknown. At the reporting time, the outcome of severe headache and dizziness was not reported. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was withdrawn.  The causal relationship between severe headache and dizziness and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
8/23 I started with Nausea & vomiting, I vomited around 4 times in 8 hours. This was followed by a pain in my lower left quadrant and, over the next few days belly pain and a feeling of extreme tiredness, I saw my primary care doctor on 8/31 and was prescribed Augmentin but was told that if my symptoms did not start to improve within a couple of days I was to make an appointment for a CT scan. I had a CT scan, I was called by my PCP the following morning advising me to go the emergency room for a follow up as the scan had shown an entero-enteral intussusception. The follow up scan showed the intussusception was no longer there and i returned home with a follow up appointment with my Gastroenterologist. For the following 4 weeks I have felt very tired and had a brain fog which is finally starting to improve
Onset of symptoms/signs: Approx 12-14 hours.  Signs & Symptoms: Shortness of breath, joint and muscle pain, loss of appetite, mild nausea, loss of stamina, lethargy, diaphoresis.  All lasting approximately 24 hours from onset.
5 days into receiving the Moderna booster (I had Pfizer the first 2 doses), I noticed nausea and complete loss of appetite. I did not eat for 3 days and then could only eat one meal a day taking anti nausea pills prescribed to a family member. At this point, I can only eat if I smoke Marijuana. Both symptoms have shown no improvement. I'm waiting to be seen by my primary care physician on 2/22/22.
Pt. complained of itchiness surrounding area of injection. Inspected area, and it looked red. Not sure if that was from pt. scratching. Gave pt. a Ziploc filled with ice to apply to area and asked her to wait in store.
arm was sore; Arm was heavy; gets cold and can't get warm; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (gets cold and can't get warm), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced NASOPHARYNGITIS (gets cold and can't get warm) and INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy). At the time of the report, NASOPHARYNGITIS (gets cold and can't get warm), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy) outcome was unknown. Unknown          Concomitant product use was not provided by the reporter. Treatment information  was not provided. The action taken with mRNA in response to these events was not applicable.
Red, raised rash. I looked it up and apparently it?s being called ?covid arm?. It is not itchy or hurting at this point. Last night is when I first saw it and it was just light pink, this morning it is red and slightly raised up.
Within 24 hours of receiving my second dose of the Pfizer COVID19 vaccine I started to have chest pains during any exertion like walking up a inclination or small hill (things I could do before without issue.) The pain was located just left of center and felt like beats on my heart. This pain was consistent during exertion for the first month after the shot. There was also an increased level of fatigue present after normal activities that I had not experienced before the shot. This fatigue has increased since the shot to the point where it has become debilitating. Normal activities, walking, stairs, lifting small items, or any kind of physical activity completely drain me to the point where I have to rest.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: Ew0162), on 06May2021 as dose 2, single (Lot number: Ew0165) and on 13Dec2021 as dose 3 (booster), single (Lot number: Fj1611) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Regalin with an intolerance to seafood" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started Paxlovid (lot Fy9918) on 04Jun2022 as COVID 19 treatment.
Experienced vertigo after receiving the Pfizer booster. Woke up to severe dizziness/room spinning at approximately 3am on 11/25/21. Severe sensation lasted throughout the day, becoming more manageable and allowing for movement/walking around 6pm on 11/25/21. Symptoms became more mild, tapering each day, but persisted through 10/4/21. Took OTC Dramamine to assist with symptoms during that week. In the coming months, continued to experience mild feeling of lightheadedness on the right side when lying down for sleep.  [Had never had an episode of vertigo previously; no issues following the Moderna 2-dose series.]
Patient's skin became red and itchy. Skin began to peel. Small bumps noted to neck.
Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking,  weakness all over, headaches, and I feel so out of it.
This case was reported by a nurse and described a 34 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 112 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Information has been received from a consumer concerning her friend's mid 20 year old daughter who was vaccinated with the first and second dose of Gardasil. She indicated that her daughter developed "cancer cell" after the second dose. The patient had pap smear before the first dose and had normal results. However, after the second dose about a month ago the patient had abnormal pap smear results, "cancer cells," which had to be removed. It was indicated that cancer cells were removed and the patient was fine. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. On 30-Oct-2007 the followup information indicated that the patient never received the third dose of vaccination. This is one of two cases from the same source. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 16NOV91 & it was determined that pt did not respond to the vax series;
Erythema and swelling og the (L) upper arm, 13 x 11 cm.