chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning an approximately 11 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 19-NOV-1999 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and a second dose on 20-OCT-2010 (Lot # 668533/0969Z) SQ. Patient also received on 20-OCT-2010, a dose of GARDASIL and influenza virus vaccine (unspecified). Patient's mother called the physician and stated that on an unspecified date the patient had developed chicken pox marks on her body. There were no Lab diagnosis/studies performed. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
No additional AE reported; administration of expired vaccine; This spontaneous report was received from registered nurse and refers to 78-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.   On 11-FEB-2022, the patient was vaccinated with expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), dose: 1 (unit not provided), lot# T009744, expiration date: 28-JAN-2022 (route of administration was not provided) for prophylaxis (expired product administered). The reporter confirmed Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not involved in any prior temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event was reported.
Headache Narrative: headache, fatigue both improved. swollen gland (arm pit) still not resolved
Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful.
Sudden onset of bilateral tinnitus on the late afternoon of March 26, 2021. I did not have a history of tinnitus and was not exposed to any events that could induce it (no illness, trauma, exposure to loud noise)
Itching from the injection site all down arm. Redness. Swollen circle around site.
Light headedness; Fatigue; A spontaneous report was received from a consumer concerning a 64-years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced light headedness and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported.  On 01 JAN 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 03 JAN 2021, the patient experienced light headedness and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of light headedness and fatigue, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On June 16, I had heart palpitations for the very first time in my life (103-150 hbm for ~10mins) and went to the ER.  They ran blood work, heart ultrasound, lung xray, and ECG and didn't find any issues so assumed it was hyperthyroid related.  Afterwards, I could only do light activity and tired very easily.  I experienced another episode on June 19 (103-140 hbm for ~10 mins) and again went to the ER and this time they ran a MRI to rule out lung blood clot, put me on a beta blocker med, ordered a heart monitor, and referred me to my endocrinologist.  I did talk to my endocrinologist and he said the level of my hyperthyroidism was too low to cause the heart palpations.   On June 24th, I experienced a suspected panic attack but the symptoms were different than the first two episodes (i.e., felt like a was breathing with half a lung and my heart rate was ~113 hbm).   Right now I'm on a heart monitor and waiting for the results.  I don't have any confirmation that the heart palpitations are COVID vaccine related but they do seem very random and before June 16th, I was doing 30 mins of medium yoga and 30 mins of cycling per day and could do 5 mile hikes on the weekends without any issues.
About two weeks after I received the vaccine (almost a week ago as of present) I began experiencing rapid muscle twitches near the injection site. I can send a video if necessary.  Only muscle experiencing these symptoms is one on my left shoulder, where the injection occurred. Twitches a couple times a second for a couple minutes at a time. Frequency of these events per day has increased over the past week.  Presents without pain, numbness, tingling, etc. No past history of chronic muscle twitches. I am capable of fine motor movements such as writing and maintaining full motion of my arm while it occurs.  Consulted with a doctor (my employer) informally and they recommended I submit this form. Willing to answer any questions that might show up.
Bivalent vaccine incorrectly administered for the second dose of the primary series.  Patient reported no adverse events
He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, start date: Jan2021, tolerated the first Covid 19 vaccine very easy), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon".  Additional information: Reporter reported that his wife tolerated the first Covid 19 vaccine very easy. He reported after the second Covid 19 vaccine he and his wife were both down for the afternoon, then they both picked up. number of covid-19 vaccine was not provided. Consumer stated that his wife was doing fine.  Follow-up attempts are completed. No further information is expected.
Upon injection I experienced severe pain at the injection site which lasted for a couple of hours. The next morning upon awakening my arm was very sore at the injection site and the soreness radiated up to the right shoulder. The area was painful to touch. The immediate site soreness subsided after a couple of days but the pain in the deep tissue and shoulder area has remained and progressively worsened over time. I have limited ROM in the right shoulder now and daily pain. I am unable to reach behind my back, straight up or forward above the shoulder level without pain. I cannot sleep on my right side without pain in my shoulder and upper arm. I have reduced strength in my right arm as well. The pain, reduced ROM and reduced strength have gradually worsened over the last 3 months and continue to worsen. I did not experience any right arm pain, decreased ROM or arm strength prior to recieving the COVID vaccine on April 10, 2021.
pt. left office- returned within 3 minutes s.o.b., coughing, facial swelling, hives, bp: 90/50 hr:140's O2 stat:98 pt. was given benadryl 15mg IM and EMS was called.  Pt. was taken to hospital where he stayed for 4-5 hrs for observation. The follow up received on 11/3/03 states upper chest edema, no admission, reaction to flu. Medical records state sleepy. msv
having a heart attack and went to the hospital; gained 80 pounds; some chest pain; had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required"; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "having a heart attack and went to the hospital"; CHEST PAIN (non-serious) with onset 2022, outcome "unknown", described as "some chest pain"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained 80 pounds". The events "having a heart attack and went to the hospital" required physician office visit.  The patient underwent the following laboratory tests and procedures: Chest X-ray: (2022) Negative, notes: all results came back negative they couldn't find anything; Electrocardiogram: (2022) Negative, notes: all results came back negative they couldn't find anything; Exercise electrocardiogram: (2022) Unknown result, notes: test was inconclusive; another test: (2022) Negative, notes: all results came back negative they couldn't find anything; (2022) Unknown result; Weight: (unspecified date) 80 lbs, notes: gained 80 lbs.  Clinical course: It was reported that patient received the first and then the second a month later of the Pfizer Covid 19 Vaccine while in the nursing home. He received the booster a year later. Caller reported that he has gained 80 pounds. He has been getting pains in his chest and like a heart attack and 3 weeks ago he went to the hospital and they gave him a chest X-ray and EKG and another test and they couldn't find anything. A week later he went back and had a stress echo test and he did not finish and he is not in great shape and he did test on the treadmill and he was supposed to walk for 5 minutes and his legs starting hurting and he did 3 minutes and the test was inconclusive. Asking if taking the injection could have damaged his chest? Caller said he would provide contact information if it didn't take too long.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
generalized urticaria - treatment to start H1/H2 antihistamines with topical hydrocortison 1% PRN
It's worst when I'm lying down/The room is spinning when lying down.; difficulty walking/walking into walls/I was walking sideways; dizziness; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.), GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) and DIZZINESS (dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     It was unknown that patient ever had COVID + test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1st dose Lot number: EW0161 Dose: full dose) on 17-Apr-2021, Pfizer (Dose Number: 2nd dose Lot number: ER8736 Dose: full dose) on 08-May-2021 and Pfizer (Dose Number: 1st booster Lot number: FJ1611 Dose: booster dose) on 08-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Hypertension and Diabetes.    On 09-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) and DIZZINESS (dizziness). On 14-Jun-2022, the patient experienced VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.). At the time of the report, VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.) and DIZZINESS (dizziness) had not resolved and GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) was resolving.            Concomitant medications was not provided by the reporter. It was unknown that recent change in status such as improvement or worsening.  Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Treatment information was not provided.
This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 16:30 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for Covid-19 immunization. Relevant medical history included: "Liver problems" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: Gabapentin; Atorvastatin; Fenofibrate. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain at the injection site". Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain; fever; chill; severe headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test (positive-negative): positive (Positive) tested + month ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.
01/02/2022- History of Present Illness: The patient presents with patient arrives from home with friend who states she has been sick nearly a week and today couldn't get out of bed. Called EMS because of patients profound weakness.  States fever, cough and cold SXS. Negative Covid test few days ago. Hasn't been able to eat/drink or take her home medications. When EMS arrived, patient was just profoundly dehydrated and too weak to stand. Received 500ccNS EN route and already feeling much better. Currently, patient states she just feels like she "got hit by a truck" but starting to feel thirsty and hungry. The onset was 5 days ago. Associated symptoms: shortness of breath, dry cough, nasal congestion, and headache.
Approximately 5 hours post vax, this pt developed a red swollen ring around the injection site which was warm to touch.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27 ) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 12:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 12:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27 ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 12:11:27 ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported . It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. Concomitant product use was not provided by the reporter. It was unknown if the patient received any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. It was unknown if the patient received other vaccines given on the same day and it was also unknown if the patient received other vaccines within one month prior to any dose of Moderna vaccine. It was unknown if the patient experienced any adverse events or not. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine was administered on 11-Mar-2022 at 12:11:27. It went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Cellulitis at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th October 2021, 3 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a vaccine representative calling on behalf of the customer. The reporter reported that the patient received dose of Bexsero vaccine Friday (15th October 2021) in left arm and today (day of reporting) came back to HCP office and was diagnosed with cellulitis at injection site. The vaccine was given by an experienced MA, spoke per content. The reporter consented to follow up. This is one of the 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215480:Same reporter. Pt 2 of 2
Patient presented with severe chest pain x 2 1/2 hours, found to have EKG changes consistent with strain, dramatically elevated troponin to 13.2, ultimately peaked at 15.  No pericardial fluid, diagnosed with myocarditis, treated in healthcare facility.
After 12 hours temperature went up to 101.4F, tired for the next 18 hours, and after 36 hours noticed redness around the injection site.
Hives all over the body . Itchy and burning sensation. Didn?t resolved with binedryl and Zyrtec
Patient "dizzy" after receiving both HPV and MCV Vaccines @ physical. Sx within 30 minuts. HA, blurry vision, did not understand some words). Slept x 1 hr and improved. Recurred sx 2 days later - see ER Note. Patient is a 11 year old female. Seen earlier today for HSE, and received HPV and meningococcal vaccines. Within 30 minutes, developed a headache, visual disturbance (blurry and couldn't read clearly, and didn't understand some words. Complained of dizzyness. No vomiting. No LOC. Did nap for 1 hour. felt better after the nap, and only symptoms now is a mild headach. Denies any illness symptoms at this time. Sat Aug 3, 2019 4:25 PM: Patient is a 11 year old female with PMHx of ADHD who presents today with headache. 3 days ago had meningococcal and HPV vaccines at PCP. Approximately 25 minutes later complained of a headache, and felt that although she could see the letters on a text message she was not able to verbalize her words out loud. Had no facial droop at that time or weakness. PCP had patient return to office and was observed with no further symptoms. They plan to report this to vaccine injury reporting. The following day had a brief headache as well, this time without any changes in reading, and felt better after laying down. Yesterday overall felt well, although did mention some mild abdominal pain and nausea yesterday. No vomiting. No fevers. No dysuria. Today she was at the mall, developed a headache that was significant enough to cause her to have to lie down at the mall. Mom notes that during the headaches being only sometimes looks a little pale. Patient also reports that earlier prior to the headache, she felt that she had a gap in her vision, where there was a banner that said "family 2018" and she could only read the word family. This has resolved. Currently reports 3 out of 10 headache mostly centered over her right occiput and right frontal area. Feels worse when she turns her head. No headaches waking her from sleep, no balance changes, no behavioral changes, no recent trauma, no polyuria or polydipsia, no weight loss, no fevers, no cough, no congestion, no syncope. No increase in pain with valsalva or coughing. Also reports that she had a brief episode of chest discomfort 2 days ago, no palpitations, no syncope, self resolved. Has no other history of chest pain, no chest pain with activity, no skipping beats. Mother does also note that patient has had some new stressors including starting middle school and upcoming dental extraction. She does note that patient sometimes has anxiety related to stressors, but typically is present more with racing thoughts and has never presented with other somatic symptoms. Has not yet started menses, grandmother started approximately to be this age, patient's mother did not have menarche until 2 years older than patient. Spoke with PCP today regarding ongoing symptoms, and they recommended MOC bring patient in for eval at ED. Also reports sometimes feeling lightheaded with headaches, although not always. Headaches do happen when standing up but also happened once when lying on couch. Has never had any alterations in level of consciousness with these.
6x8 cm area of swelling and erythema surrounding vaccine site in (L) deltoid.
Severe muscle pain in middle of night for two weeks. Went to clinic and got gabapentin. No effect. Went to ER and got muscle relaxer. Taking Tylenol for pain.