chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was screened prior to vaccination to include pregnancy screening, Member was notified of Positive pregnancy test 26 Jun 2019. member LMP 4 May 2019, Member and healthcare team advised of vaccination.
Constant dull pain throughout entire arm. Unable to lift the arm, limited back and forth movement.
Extreme horrible headache/Mirgraines every day for the last 3 weeks.  Every single day.  I wake up with them, I go to sleep with them.  I have photophobia, nausea, dizziness, sensitivity to noises and what feels like extreme pressure in my brain.
Vaccine was administered into the left deltoid. Patient had usual response initially to vaccine administration aside from what was described as 'unusual sensation', describing a sensation of having a bubble moving in his muscular tissue. The patient had typical soreness for the first 2 days after administration, however had worsening arm and shoulder pain over the subsequent days. He followed up for assessment with his primary care provider, who ordered MRI. Patient had no baseline shoulder injury or pain. MRI revealed supraspinatus tendinosis as well as subacromial bursitis. Patient in the course of continued workup currently, planning on having corticosteroid administration to address symptoms.
Chills started 12 hours after injection and lasted for 48 hours Intermittent fever for 72 hours. Highest fever 99.8 F Fatigue for 48 hours with body aches Swelling and pain at injection site  Injection site rash the size of a quarter started 24 hours after injection and lasted at least 48 hours (as of the time of this report)
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
The vial was not diluted and 0.3ml im injected to pt. Pt had no adverse symptoms.
chest pain and shortness of breath for 2 days after 1st dose of Moderna Vaccine
Mother called and stated child was nauseated, had a headache, feeling achy. However, the daughter also reveled she had some blurred vision an at one point it "went black" - Encouraged mother to take her to a ER for consult.
Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known allergies.  Concomitant products included AMLODIPINE, LOSARTAN, PHENYTOIN SODIUM, GABAPENTIN, INSULIN GLARGINE (BASAGLAR), NAPROXEN, ASA and ATORVASTATIN for an unknown indication.    On 06-Apr-2022 at 9:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had COVID-19 positive or negative preceding month of vaccination. Total number of doses/vials was 36.  Vial did not undergo any temperature excursions. Patient not experienced any side effects yet.  Treatment medications were not reported.
A third Shingrix dose was given to the patient, identified after checking system to document administration. Patient was contacted about the event, and told that he will not need an additional dose, and that his series is complete.
Approx 6 inch diameter area of swelling, tenderness, and warm to touch. Area of redness and swelling 15 cm x 1 cm provider notified see medical record.
Headache Narrative: Dose Number 1 (given 12/23/20) - Pain at injection site for 2 days Dose Number 2 (given 1/20/21) - Pain at injection site for 2 days, generalized myalgias and headache for 2 days. also developed tinnitus and hearing loss in my  right ear that started yesterday evening.
Currently, my husband is in the ICU with Covid pneumonia and on full psh oxygen of 80 liters fighting for his life. The J & J vaccine gave him little or no protection against the virus
Patient also received an injection of just the adjuvant/diluent for Shingrix in the left arm. Once error was caught, patient received the vaccine in full with adjuvant mixed with antigen in the right arm. Followed up with patient after about 24 hours, and patient stated she had a low grade fever of about 100 degrees Fahrenheit. She had no injection site reactions at any of the 4 injections. This was the only symptom reported.
Headache; Injection site soreness; Tiredness; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 15:15, the patient experienced headache, tiredness and injection site soreness. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, tiredness and injection site soreness. The clinical outcomes of the events headache, tiredness and injection site soreness were recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
I had tight and swollen joints. I had inability to close or clinch anything with my hands. I got trigger fingers to where it was difficult to grasp things. It was difficult to bend my knees, and my feet felt tight. I had gone to the doctor, and he tested for rheumatoid arthritis which came back negative. I don't have a diagnosis yet. I was prescribed Ibuprofen 800mg and a medication for my cholesterol. The doctor also upped my dose of Levothyroxine.
First of all, important to state my first three shots were Pfizer. I chose Moderna for my second booster, and appear to have had a different reaction to it.  Effects came on very suddenly that night driving home from shopping across town, I see now that I was impaired driving, came on very suddenly. I do no alcohol or drugs so it has to have been the vaccine.  Shortly after getting home and unpacking car, 930pm I got very fevery and shaking a lot. Wrapped up in winter coat and double blanket even with heat on in my home, was so knocked out I couldnt even get up to take my temperature, that was worse than with previous vaccines. About 10-11pm, I also got chest pains. Pain was about a 3-4 out of 10, uncomfortable but definitely noticeable. Lasted for hours on and off, different spots in left chest. Hard to sleep between chest pains and shaking. Slept a couple of hours, woke up and chest pains were mostly gone. Little twinge or two in the morning, just pressure, maybe a 1 or 2, nothing after that. Had a fever that morning about three points above my normal.  Monday afternoon I went to the emergency room for chest pains and slept most of the day, did not feel well enough to drive myself, different than previous vaccines. Temp then was slightly above my normal. I was admitted to the ER and was held there for 6 hours while they completed tests, released when they saw results were negative for cardiac event.  Tuesday I was still out of it, but I could drive myself to local spot to get food. Fever normal.  Wednesday symptoms were gone and I felt back to myself. Body still a little achey and tired.
Patienr reports low fever, chills, sore throat and diarrhea onset approximately 5:00 PM on 6/3/2021 lasting approximately 2 days.  States watery diarrhea 3 or more times daily since 6/3/2021.  Patient states hallucinations began on approximately 6/5/2021.  States multiple episodes occurring most days.  Reports memory loss as well.
Recipient reported sudden worsening of urinary retention following the 1st dose of Covid19 vaccine.   The symptoms did resolve within 24 hours and did not reoccur with the second dose administration.
This spontaneous case reported by a consumer, describes the occurrence of diarrhea, pyrexia (high temp) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced diarrhea, pyrexia (high temp) and fatigue. At the time of the report, diarrhea, pyrexia (high temp) and fatigue outcome: unknown. No concomitant medication or treatment information reported.
At 10 minutes after receiving Pfizer booster, patient began complaining of chest tightness, nausea, and an "indigestion" feeling. Patient's vitals were routinely monitored in 5 minute increments. EMS was notified. Patient remained alert and oriented and vitals stable until EMS arrived. Care was transferred to EMS once they arrived at 02:00PM. They transported patient to local hospital. Patient was assessed and released from hospital and advised to follow up with cardiologist.
Client c/of heartburn and dryness to back of throat.  Client seen and assessed by EMT and Vitals are: B/P 156/90, HR 89, O2 99.  Client continued being monitored for30 min. and cleared by EMS after she stated that she no longer felt sensation.
Client developed, 2 days post/vax (7/16/05), L lateral jaw pain, edema, difficulty opening mouth and minimal difficulty swallowing; denies SOB, afebrile. No erythema, no edema; deies pain in the injection sites. Evaluated at clinic on 7/18/05 and dx'd with TMJ.
Severe vertigo, severe nausea lasting for 6 days. Could not keep food down, Room was spinning.
This spontaneous report was received from an unspecified healthcare provider and refers to a 30 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 12-SEP-2018, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The reported stated that the patient has experienced no adverse effects.
Information has been received concerning a 10 year old male with no medical history or allergies who on 25-JUL-2007 were vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a hepatitis virus vaccine (unspecified) that was administered on 25-JUL-2007. On 14-AUG-2007 routine blood tests revealed the patient experienced an abnormal lymphocyte count. It was reported the patient called their physician and was advised that a repeat blood test would be performed to confirm the abnormal lymphocyte count. A product quality complaint was not involved. No further information is available.
Patient started intching, mostly on trunk, last night; woke up itching all over and has rash (fine maculopapular rash) all over; given hydroxyzine for itching;
patient felt off, not quite right. looked pale. BP which was low during her infliximab infusion continued to be in the 90/50s. Not tachcardic.. she had no neew findings on physical exam
Pt devel hive like rash appeared immediately p/inject of MMR lt arm; No resp distress; Rash faded w/in 4-5hrs; Flat rash-no elevation about size of .50 piece;
last night legs began burning like she had rubbed icy hot on them, extending down feet/the feeling was all over her body; This is a spontaneous report from a contactable nurse.  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 17Dec2020 09:30 at single dose for immunization (reported as COVID-19 vaccine). Medical history included vertigo and small whole in heart.  Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), ergocalciferol (VIT D), magnesium taurate, selenium and zinc. The patient previously took Kepra, Oxtellar and Sulfa which she had allergies. The patient experienced that last night (17Dec2020) her legs began burning like she had rubbed icy hot on them, extending down to her feet. Then woke at 2am and the feeling was all over her body. Awoke again at 6am and feeling was still there. She went to work, feeling wass not confined to ankles and feet...icy hot although warm to touch. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 13Nov2020  and sars-cov-2 test: unknown results   on Dec2020. Outcome of event was not recovered.
Period Stopped altogether. Thought I just might be in menopause, but it started up again today. I am scheduled to get the booster tomorrow, so we'll see if it stops again.
Client reported to RN after second dose of RabAvert administered on 9/16. She felt her neck and throat spasm and tightness occurring and while eating a sandwich, choked and spit it out.  Doctor notified.
riggors, fever,, severe body aches, flank pain, headache, eyes hurt
severe side effects; scared to get another dose; heart beat was very high; high blood pressure.; lower back pain; pressure in the left part of back; arm was very swollen for 7 days; had lot of pain; whole body pain; felt like I was going to get heart attack; fever was 101degF; fatigue; nausea; blood pressure was very high 176/142; heart rate was very high 110 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (severe side effects), FEAR OF INJECTION (scared to get another dose), HEART RATE INCREASED (heart beat was very high), HYPERTENSION (high blood pressure.) and BACK PAIN (lower back pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HYPERTENSION (blood pressure was very high 176/142) and HEART RATE INCREASED (heart rate was very high 110 beats per minute). On an unknown date, the patient experienced VACCINATION SITE REACTION (severe side effects), FEAR OF INJECTION (scared to get another dose), HEART RATE INCREASED (heart beat was very high), HYPERTENSION (high blood pressure.), BACK PAIN (lower back pain), MUSCULOSKELETAL DISCOMFORT (pressure in the left part of back), PERIPHERAL SWELLING (arm was very swollen for 7 days), PAIN (had lot of pain), PAIN (whole body pain), MALAISE (felt like I was going to get heart attack), PYREXIA (fever was 101degF), FATIGUE (fatigue) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (severe side effects), FEAR OF INJECTION (scared to get another dose), HEART RATE INCREASED (heart beat was very high), HYPERTENSION (high blood pressure.), BACK PAIN (lower back pain), MUSCULOSKELETAL DISCOMFORT (pressure in the left part of back), PERIPHERAL SWELLING (arm was very swollen for 7 days), PAIN (had lot of pain), PAIN (whole body pain), MALAISE (felt like I was going to get heart attack), PYREXIA (fever was 101degF), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown and HYPERTENSION (blood pressure was very high 176/142) and HEART RATE INCREASED (heart rate was very high 110 beats per minute) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 176/142 (Inconclusive) 176/142. On an unknown date, Body temperature: 101 101 F. On an unknown date, Heart rate: 110 (High) heart rate was very high 110 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Swelling/ redness within 24 hrs. Streaks X 3 10X10 mm. Antibiotic for cellulitis @ shot site & warm compress TID. Follow-up appointment 1 week.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (dose and route not reported, lot# L019994, expiration date: 02-DEC-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
having trouble breathing; temperature; nausea; lots of pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having trouble breathing), PAIN (lots of pain), TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and NAUSEA (nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (lots of pain). On 04-Feb-2021, the patient experienced DYSPNOEA (having trouble breathing), TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and NAUSEA (nausea). At the time of the report, DYSPNOEA (having trouble breathing), PAIN (lots of pain), TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and NAUSEA (nausea) outcome was unknown.        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 concomitant medication information was provided. No treatment medication information was provided.
Pt got vaccinated with ZOSTAVAX. 2 weeks later pt was at dermatologist and Dr said pt. had chicken pox.
patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284AA, expiry date 25-05-2020 via intramuscular route in the right deltoid on 02-Oct-2019 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines received.   It was a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and Overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
swelling of the lymph nodes in same arm of the injection starting March 9.  Became painful on March 10.  Swelling started to recede March12.
Patient received 3 doses of the Pfizer vaccine before the 3rd dose was approved by the FDA. The patient did not report any adverse reactions to the vaccine and stated that she did not report having taken a first dose of Pfizer on January 14, 2021. She returned on July 22, 2021 to get another vaccine and the series was started again. She then had a third dose on August 12, 2021.
Pt recvd vax & 28OCT93 a pregnancy test was pos; pt elected to terminate pregnancy during the wk of 23OCT93;
Hospitalization for COVID-19 on dates 1/1/23- 1/6/23.  Treated with hydrocortisone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Ruptured Brain aneurysm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in the right arm, on 07Apr2021 10:00, as 2nd dose, single, for COVID-19 immunisation, at a hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination and has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 69 years, administered in the right arm, on 05Mar2021 10:00, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Apr2021 at 11:00, the patient experienced ruptured brain aneurysm. This resulted to physician's office and emergency room visits, hospitalization for 14 days (dates not reported), and disability or permanent damage. The event was reported as a life-threatening illness (immediate risk of death from the event). Treatment included surgery. The outcome of the event was not resolved.  Information about lot/batch number has been requested.
Pt came to pharmacy on 10/19 (today) with a pink inflamed baseball size mark on arm. Pt said did not start right away. Pt said had red lines going towards heart--but none now. Pt did was not feverish, did not experience swelling elsewhere, not run down or dizzy. Pt said it was getting better.