chrisvoncsefalvay/vaers-outcomes huggingface dataset:
09:20 Patient walked up to observation station with monitor at side stating she felt lightheaded. Patient received Pfizer vaccine at 09:09 and felt symptoms around 09:12. Patient walked to gurney and placed in trendeleburg position. During RN assessment  patient reports symptoms began with moderate chest tightness radiating to left shoulder, nausea followed by lightheaded. States she's had chest tightness with anxiety in the past. Patient alert oriented x4 talking in full sentences with no respiratory distress, wheezing, stridor, lungs clear to auscultation. She denies intraoral swelling, itching and no visible rash. Vitals: BP 96/61, Pulse 86, RR 20 99% on room air, Temp 96.6. 09:22 Patient states mild chest tightness with no lightheadedness. Sat up on gurney. Vitals: BP106/53, Pulse 71, 100% on room air. 09:30 Patient reports chest tightness/lightheadedness/nausea resolved. 09:37 Dr. consulted and advised can order EKG if patient is worried. Patient agrees to EKG today when she leaves vaccine clinic. Advised to call 911 or go to Ed if necessary for reoccurring chest tightness/lightheadedness or worse symptoms or follow up with primary MD. 09:40 Patient states she feels fine and states ready to go. Her friend sitting at side and will take her to get EKG. 09:56 Vaccine adverse reaction form given and walked out with RN at side. Patient passed the walk test.
A few hours after I received the vaccination, I was working at my computer.  I experienced vision issues where my eyes became unable to focus on words I was trying to read, no matter how I tried, even by squinting. And along  with it, in my field of vision were translucent,  zig-zaggy or wavy lines. I've never experienced this before. I Googled the symptoms, and I believe  it may have been an ocular migraine. Later I had a headache. I recovered within a short time, within a couple of hours.
Rigors; fever to 104; Swelling at the Tdap vaccine site on R arm with redness, pain and warmth.
At 5:30 pm.  I was unable to stand up and walk.  It attached my knee joints and leg muscles.  I took a Vicodin and 2 extra strength Tylenol  and after 1 1/2 hours I was able to walk but still with some pain and problems.   I then started to take 800 mg of Ibuprofen and 2 extra strength Tylenol  3 times a day and was able to function but with some discomfort.  Day 4 I woke up in the middle of the night and was unable to feel my arms and not able to move my hands and fingers. They were numb and Tingley.    I had to press them together and once I manually moved them they were able to move a little and then I tried to squeeze and rub them against my legs and then I was able to start to move them.   That continued until day 10 when i got a steroid pack from the Dr and took that Saturday morning around 5 am an by that afternoon or the 5th pill then majority of the symptoms where gone.  Starting day 2 everything was back to normal.   I finished my does on Wed 4/29 and everything was fine.  Then on May 2nd  in the evening the symptoms started to appear again but not as sever.  The arm and finger numbness when I'm sleeping   comes back and with taking the ibuprofen and Tylenol has helped during the day along with moving them has helped but my hands feel really bruised.  I just put a call in to my Dr again to see if there is anything else we can do.
Patient states that immediately after receiving the shot her arm was sore. It became really painful 2 days after the vaccine. At some point, a "baseball sized" bruise appeared on her arm that persisted up to 7 weeks after the vaccination. Even once the bruise disappeared her arm was still sore.
From initial information received on 1/10/05 from the patient's son regarding an adverse event, it was reported that this 74 year old female patient received FLUZONE, lot number U1552AA, administered IM on 12/10/04. Four to five days later, the patient developed fatigue, weakness, and a poor appetite and was hospitalized. She also developed influenza and a staph infection, but the onset dates were not provided. The patient's recovery status is unknown.
3-4 in induration on right thigh 1-2 days after 4 year old vaccinations.
Two dots of blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Two dots of blood) in a patient of an unknown age and gender 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 VACCINATION SITE PAIN (Two dots of blood). At the time of the report, VACCINATION SITE PAIN (Two dots of blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Bivalent vaccine incorrectly adminstered for the second dose of the primary series.  Patient reported no symptoms.
Local reaction red,hard,warm to the touch,tender area on her left arm that was about 4 inches long x 3 inches wide.Seen in clinic on 04/08/21 by MD naproxen and benadryl prescribed.
Fever, chills, severe arm pain, blocked milk ducts/mastitis (breastfeeding ~ 3 month old)
Less than 24 hours after injection pt developed severe neck pain that increased in severity over the next 72 hours. Pt also developed extreme Headache on Oct 23 2005. Pt self administered (without physician notification) pain killers (per pt) and ibuprofen with out relief.
(1) Unwitnessed seizure. Found down on bedroom floor by parents. (2) Second seizure since 1st on 10.30.2010. Pt now began on LAMICTAL.
Feels like he is going to pass out.; All his extremities are ice cold; Blood pressure is dangerously low; diarrhea; Throwing up; Fever; Pneumonia; His heart was in A-Fib; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and ATRIAL FIBRILLATION (His heart was in A-Fib) in a 63-year-old male 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 and Cancer.    On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ATRIAL FIBRILLATION (His heart was in A-Fib) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), PRESYNCOPE (Feels like he is going to pass out.), PERIPHERAL COLDNESS (All his extremities are ice cold), HYPOTENSION (Blood pressure is dangerously low), DIARRHOEA (diarrhea), VOMITING (Throwing up) and PYREXIA (Fever). At the time of the report, PNEUMONIA (Pneumonia) had resolved and ATRIAL FIBRILLATION (His heart was in A-Fib), PRESYNCOPE (Feels like he is going to pass out.), PERIPHERAL COLDNESS (All his extremities are ice cold), HYPOTENSION (Blood pressure is dangerously low), DIARRHOEA (diarrhea), VOMITING (Throwing up) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.         No relevant concomitant medications were reported  No treatment information was provided.  Company Comment: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and cancer, who experienced the unexpected events of pneumonia and atrial fibrillation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The events were considered related to the product per the reporter's assessment. The medical history of hypertension and cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and cancer, who experienced the unexpected events of pneumonia and atrial fibrillation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The events were considered related to the product per the reporter's assessment. The medical history of hypertension and cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Shortly after vaccination (~15-20 minutes) patient became very faint and nauseous. Was pale in the face and vomited. Patient was seen by several firefighters that happened to be in the store at the time. She mentioned to them having fuzzy hearing, heavy arms, and sweating. They  checked vitals and gave oxygen supply. Patient was then taken via ambulance to hospital but was feeling much better.
12/2/21 ID's note: ". Multifocal pneumonia due to COVID-19 virus with hypoxia, Onset 11/28, positive on 12/1/21;  Fever of 100.3 on admission, was saturating at 91% on RA, now on 2 LPM NC; Cxray 12/1: No significant focal pulmonary parenchymal infiltrative changes are noted. Started on remdesivir/decadron 12/2"
Breakthrough hemolysis; Hemolytic flares; This is a literature report.  The author recently showed that the addition of Spike protein didn't increase hemolysis of paroxysmal nocturnal hemoglobinuria (PNH) erythrocytes ex vivo, suggesting that hemolysis isn't due to the direct effect of Spike protein on red blood cells but rather to the activation of the classic pathway after antibody generation. Clinically, 8 PNH patients experiencing hemolytic flares after SARS-CoV-2 vaccine have been reported, including 6 breakthrough hemolysis (BTH) and 2 exacerbations in treatment naïve subjects (Table 2). The author reported six patients with PNH, who received either Moderna or Pfizer-BioNTech vaccine. Four, all on intravenous ravulizumab and one in combination therapy with D inhibitor danicopan, showed signs BTH from the vaccine up to 5 days later, 2 with severe anemia, and 1 requiring transfusion support. Interestingly, only 1 patient who was on therapy naïve experienced a likely thrombotic episode. Although the author observed BTH episodes in patients received COVID-19 vaccine more than 4 weeks after last ravulizumab dose, hemolytic flares may occur as soon as the day after the last complement inhibitor administration, so that it is difficult to suggest a specific timing, although it would be advisable to give vaccinations closer to anti-complement therapy.  Table 2: Hemolytic flares in patients with paroxysmal nocturnal hemoglobinuria after SARS-CoV-2 vaccine. Patient #2: PNH type - aplastic anemia (AA) PNH; Therapy - Ravulizumab; Vaccine - Pfizer; Time to BTH - same day of first dose; Therapy for BTH - Ravulizumab; Outcome - resolved.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101854207 same article, different patients/events
Vaccine site discomfort, chills, low grade fever, bad headache and body aches. Lasted about 12 hours after onset of symptoms.
He got a sudden fever and at 4:30 PM he had febrile seizure.  He was taken to Hospital by ambulance.
Tinnitus lasting 8+ months. Began after first dose and worsened after second dose.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a licensed practical nurse concerning an eight-year-old female. The product expired on 19-Jan-2010. On 20-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Was hospitalized; Pharmacist wants to know should the second dose be given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Was hospitalized) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Was hospitalized) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist wants to know should the second dose be given). At the time of the report, HOSPITALISATION (Was hospitalized) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist wants to know should the second dose be given) outcome was unknown. Not Provided      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.   Concomitant product used was not provided by the reporter. A pharmacist received a call from a doctor that a patient received first dose of vaccine and was hospitalized. No additional patient information. Treatment information was not reported by the reporter.  Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        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 treatment medications were provided.  No concomitant medications were provided.
5/4/2023 I woke up with a headache and one the next morning. I treated the headache with TYLENOL and a saline nasal spray. It felt like a sinus infection. Everything was fine for a few days until 5/9/23. I developed a cough, congestion, some loss of equilibrium, lightheadedness and dizziness. On 5/11/23, I had reduced hearing in the left ear. I went to the doctor on 5/12/23. I had COVID, Flu, and Strep tests and all were negative. My left inner ear was very red and the doctor could see the mucous causing my coughing. I was given a dexamethasone shot. I was prescribed amoxicillin and benzonatate.
Immediately after her second Covid vaccine injection, she began to have a cluster headache and felt flushed.  O2 was administered for 15 minutes to treat headache.  All vitals were normal  Cardiopulmonary assessment was normal.  All abnormal feelings resolved prior to her leaving the vaccine clinic approximately 45 minutes after injection.  Later that day, she started to have "lockjaw" symptoms and went to her PCP.  She received an IM injection of dexamethasone and has been fine since.
Within minutes of receiving the vaccine, I got a headache.  For 12 hours after receiving the vaccine, I felt exhausted, nauseated, mucle aches (severe cramps in my left leg).
Rheumatoid Arthritis; Drug dose administration interval too long; This case was reported by a lawyer and described the occurrence of rheumatoid arthritis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27May2021. As per the pharmacy record, the patient received Shingrix intramuscular in right deltoid 0.5 ml on 11 Sep 2018 and intramuscular in left deltoid 1 ml dose on 8 Apr 2019. Subsequently, patient drug dose administration interval too long. She had two doses administered with interval of 209 days. The patient experienced rheumatoid arthritis. On an unknown date, the outcome of the rheumatoid arthritis was unknown.
Pt recv vax on 9/30/98; on same day pt exp muscle pain, stomach pain, fever, dark urine, diarrhea
first dose of Shingrix in December of 2021 and has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix in December of 2021 and has not received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 17 August 2023: The pharmacist reported a patient received their first dose of Shingrix in December of 2021 and had not received a second dose yet.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination.
Patient presented to the ED on 1/16/22 with chest pain - EKG showed a STEMI, patient emergently taken to the cath lab with 2 stents placed.  Patient tested positive for COVID 1/16/22 XR Chest 1V [Auth (Verified)] (01/16 1517): FINAL IMPRESSION: Diffuse prominence of the interstitial markings.  Pt vaccinated with Moderna 2/6/21 & 3/6/21.  Pt discharged 1/22/22
Patient presented to COVID vaccine site for COVID vaccine #2. Upon arrival patient reported having a history of vasovagal effect post injection. Patient scheduled for 30 minutes observation post injection.   During monitoring patient complained tingling going down right arm, nausea, dizziness, and chest "heaviness". Patient denied loss of sensation, headache, fatigue, shortness of breath, radiating pain, and palpitations.  Vital signs: 138/82, 22, 70, 97% on room air. 11:13 am- 126/88, 66, 21, 98% on room air. 11:17- 118/76, 20. Staffed called 911 who evaluated patient and transported to the hospital.
Had seizure 2 days after 2nd dose. Has never had a seizure before and is and has been completely heathy
Employee received his first dose of the Pfizer Vaccine  and approximately 5-10 minutes after receiving his dose he began to feel very light-headed and faint. Vitals were taken. BP "higher than his usual" but within acceptable paramaters. Vaccine clinic staff continued to monitor, but he continued to report not feeling well. He was transported non-emergently to the ED for further evaluation.  In ED: highest BP charted was 178/90. Patient monitored in ED for 1 hour then discharged. No chest pain, headache, n/v/d, or rash. No antihypertensives administered.
pt recv vax 29MAY96 & OCT97 pt devel mild case of 20-40 chickenpox described as a fluid filled rash which crusted over & a sl fever;pt was ill for 5 days & subsequently recovered in OCT97;
Right side face/lip swelling, coughing, difficulty breathing, and right arm pain.  Denies going to hospital - reports just taking Benadryl 50mg then going to sleep.  Waking up next morning with facial swelling.  Reports taking Chlorotabs x 2 and Zyrtec x 1.  States facial swelling resolved.  Patient came to see me today: gave daily Zyrtec and Zantac BID to block both histamines.  f/u one week for evaluation - was educated to go to ER if s/s progressed or did not improve.
Patient returned to clinic one day after receiving fourth DTaP. Left upper arm became red and swollen the evening following vaccination. Family denies fever and applied ice to site.  Benadryl and Ibuprofen ordered by physician.
Information has been received from a nurse practitioner concerning a female licensed practical nurse (L.P.N.) who was splashed in the eye with Gardasil during administration. The patient receiving the vaccine had pulled her arm away during administration. Subsequently the L.P.N. was experiencing eye twitching. Additional information has been requested.
Patient stated having itching and rash and tingling in the right arm (flublok arm), patient is taking benadryl and calling pcp.