chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 93-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588), via an unspecified route of administration on 28Aug2021 15:00 as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that caller would like to ask you what medication to take when my mom got a first dose of vaccine yesterday and today, she is having a headache. further stated her temperature is normal but she experiences headache. It was asked that Should mother take any medication. The patient underwent lab tests and procedures which included body temperature: normal. The outcome for the event was reported as unknown at the time of this report.
This case was reported by a nurse and described the occurrence of strange taste in mouth in a 61 year old female subject who was vaccinated with Twinrix for prophylaxis. The nurse reported that, "several other patients" also experienced a strange taste in the mouth following vaccination with Twinrix, however a specified number of subjects was not reported. The subject had no pre-existing medical conditions. There were no concurrent medications. On 29 December 2005, the subject received the 1st dose of Twinrix. On 07 February 2006 at 9:30 am, the subject received 2nd dose of Twinrix (lot AHABB043AA). This is longer than the recommended interval of one month between the 1st and 2nd doses of Twinrix. "Right after getting the Twinrix dose," on 07 February 2006, the subject experienced "a funny taste in her mouth." The event resolved on 07 Feb 2006.  The nurse considered the funny taste in mouth to possible be related to vaccination with Twinrix.
Vaccine was put high up on arm & RPH hit bone twice. Patient has difficult time moving arm even after 7 days.
Change in smell; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 19Mar2021 at 10:30 (at the age of 56-years-old), as single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, fibromyalgia, carpal tunnel, cervical disc replacement lower back. The patient was allergic to morphine and hydrocodone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within 2 weeks of vaccination. On 20Mar2021, the patient experienced change in smell. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event change in smell was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt given vaccine (Varivax) approx 5 min later c/o throat swelling, lip stinging, red blotchy rash noted on R arm where vaccine given.  Administered Benadryl, epi.  Sent pt to local ER via ambulance.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored VAQTA lot # K019560, expiry date 02-JUN-2017 for prophylaxis on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt. developed a typical (for her) migraine headache about 5-10 minutes after vaccination. She also described significant flushing and feeling hot, quickly removing her head covering and scarf. She took her regular dose of aspirin which she carries with her and we applied cold compresses to her neck which relieved the flushing and hot flash. We turned the lights low above the cot, she rested and symptoms all resolved over about 20 minutes and she left feeling relieved her headache did not progress.
Fever, headache, chest wall soreness, muscle and joint pains, and site of injection redness and pain
Got up to to go work 10/24/07 and felt extremely nauseated and felt like I was going to faint. Laid down for 20 min, lightheadedness left, nausea, chills, fever up to 101 for the next 48 hours with lightheadedness on moving but never felt as if I was going to faint again. Also experienced achiness - general for 3 days after injections.
patient got her 1st Menactra on 30Apr2019 and then came in today (03-May-2019) and got another one; Initial information received on 03-May-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 32 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Myasthenia gravis.  On 30-Apr-2019, the patient received a 0.5 mL 1st dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA, expiry date: 29-Mar-2020, via intramuscular route in left arm.  On 03-May-2019, the patient received another 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA, expiry date: 29-Mar-2020, via intramuscular route in right arm.  It was a case of actual medication error due to extra dose administered. It was reported that it was not realized till after the fact that she had gotten the same vaccine 4 days ago. Her neurologist wanted her to get the Meningococcal vaccines. She had a pre existing diagnosis of Myasthenia gravis and therefore the doctor wanted her to have this vaccine. She is supposed to get a series of Meningococcal vaccine and the 1st on would have been the one she got on 30Apr2019.  It was not reported if the patient experienced any adverse event following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
No additional information; a dose of PNEUMOV AX 23 was given today after its labeled expiration date; This spontaneous report was received from a nurse referring a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 11-OCT-2021, a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given after its labeled expiration date (lot # T010293 with expiration date 30-AUG-2021; dose and route were not reported) for prophylaxis. This vaccine had been stored in the recommended range and had never undergone a temperature excursion. No additional information was reported (no adverse event).
This spontaneous report was received from a nurse and refers to a 3 year old patient (unknown gender). The patient's current conditions, medical history and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot # L039094 and expiry date 08-JAN-2017) instead of an intended dose of VARIVAX (wrong vaccine administered and inappropriate schedule of vaccine administered). This occurred since a dose of ZOSTAVAX was inadvertently place in a storage area where only VARIVAX was typically kept, so the nurse who administered the dose thought she was grabbing a dose of VARIVAX. No adverse effect was reported.  Product quality compliant (PQC) was not involved. Additional information has been requested.
Pt reports her (L) apella is swollen, red and tender. The area around the injection slightly red. She was seen by health services and started on PREDNISONE 12/05/2008 for 6 days with decreasing doses to treat swollen lymph glands related to recent vaccine. 12/08/2008 swelling resolving.
LOW PLATELET COUNT; FLU LIKE SYMPTOMS; This spontaneous report was received from a health care professional and concerned a 50-year old female. The patient's height, weight, past medical history and concurrent conditions were not reported.  The patient received COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose/anatomical site unspecified, and start therapy date were not reported (reported as a few weeks ago, the Friday right before it was paused) for the prevention of SARS-COV-2-virus infection. The batch number was not reported and has been requested. No concomitant medications were reported.  Post vaccination, the patient presented with "normal" flu-like symptoms.    On an unspecified date (reported as last Wednesday),  the subject experienced low platelet count. The reporter indicated that the patient's last platelet count (NR: not provided) was 136 K and dropped again to 107 K the following Monday. At reporting, the patient consulted with a hematologist. A platelet antibody test was pending. The action taken with COVID-19 Vaccine Ad26.COV2.S was not applicable. The outcome of the low platelet count and flu like symptoms was not reported. This report was non-serious..; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
No adverse event; GIven the bivalent instead of a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  The patient's past medical history included Transplant (patient had a transplant that wiped patient's entire immune system). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose of Moderna) on 18-Aug-2021 and Moderna COVID-19 Vaccine (Second dose of Moderna) on 15-Sep-2021; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Booster) on 12-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series).    No concomitant medications were reported.  The pharmacist stated that she had a patient that got the primary series when Moderna first came out. But then patient had a transplant that wiped patient's entire immune system. patient's doctor wanted patient to repeat the series. They initiated it back in 2Sep2022 and gave patient another first dose of Moderna. When patient came in on 11Oct2022, patient was given the bivalent instead of a second dose. The pharmacist stated that the patient did not report any adverse reactions.  No treatment medications were reported.   This case was linked to MOD-2023-715985 (Patient Link).
approx 19mos p/ vax pt devel varicella & temp began increasing. on 7oct98 pt presented to MD ofc & dx w/varicella
10 minutes after injection I felt a flushing feeling through my entire body. I felt my heart pounding and the rate increase. My heart rate went up to 130-140bpm for 10 minutes. It slowly returned to normal over the next several hours. I felt jittery the entire evening.
I noticed ringing in ears about 2 months later and I discovered that I had high blood pressure at a subsequent doctor visit in August. Doctor prescribed losartan for high blood pressure.
1st dose 2 years ago, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consented to follow up. No vaccine data was provided. This case was linked with US2021227428, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227428:Same reporter.
After 30 minutes , Pt C/O throat dryness, cough, SOB nausea and anxiety
During a review of the records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
On 9/22/00 the pt experienced a localized reddened area that was warm to the touch. There was a knot at the side of the site within 2 hours of the injection. Was advised to place ice packs to the area. On 10/2/00 the pt experienced a temp of 100.2 and on 9/25/00 lethargy. No other symptoms were reported.
Awakened with very severe chills that seemed to come in waves and lasted for about 10 minutes. Felt too weak to even get out of bed. Temp was slightly elevated to 99.6F when checked later that morning. Had ?unusual? aches and pains throughout his body all yesterday and then one brief episode of chills this morning, 1/17.
Sore arm, ltd. ROM and nodule at injection point initially; next day swollen red warm patch appeared not at injection point but about 2" below. Dimensions: at 24 hrs., golf ball size; 48 hrs, tennis ball size; 96 hrs 3" wide x 6"long, spreading downward and back towards elbow. Warm & tender to touch. Each day, the new expansion area is swollen but the prior days' swelling has receded. But entire area is red, warm and sore to touch. No fever, headache, other myalgias, or GI symptoms. My primary care doc not sure whether it's a reaction or cellulitis. Now 96 hrs and the reaction keeps progressing.
My arm became red and painful. Swollen 5 inch area.; My arm became red and painful. Swollen 5 inch area.; My arm became red and painful. Swollen 5 inch area.; This is a spontaneous report from a contactable consumer (patient).A 63-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 18:45 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included osteoporosis. Concomitant medications were not reported. The patient did not take no other vaccine in four weeks and other medications in two weeks. The patient had no known allergies. The patient did not had covid prior vaccination and not tested for Covid post vaccination. On 04Mar2021 at 07:00 the patient experienced Redness, Pain in arm and Swollen arm. The patient reporter her arm became red and painful. Swollen 5-inch area. Lasted 5 days. The patient did not receive any treatment for events. On 09Mar2021 the patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Paresthesia starting in left arm especially along the outside of arm to the outside of hand and little finger. Progressed to affect both arms within several hours. Numbness, cold, burning sensations, tingling. Also feeling of weakness and slight loss of motor control. Symptoms continued to occur intermittently for around 6 days affecting the arms and legs along the outer part of the limbs. At one point I had almost no feeling in my lower legs. I still have numbness/loss of feeling in the outside portion of my left thigh which became worse after the second does of the vaccine, but has persisted since my first does of the same vaccine. I also experienced severe stiffness and strong pain in my spine. The pain affected different parts of my spine but the worst of it was concentrated in my lower back, which lasted several days.
Patient was originally diagnosed with Myasthenia Gravis in November 2022 (not even a month after injection).  Then patient has worsening respiratory distress resulting in hospitalization 12/9/2022.
Patient is COVID + 11/17/2021.  Patient is fully vaccinated. Admitted dx: Hyponatremia, AKI, COVID urinary retention. Presented for generalized weakness.Patient reports a "few days ago" she began feeling under the weather.  She admitted to having a headache, myalgias, diarrhea, decreased appetite, cough, loss of taste/smell.  Additionally she endorses increased generalized weakness. At day of hospitalization, she felt too weak and her legs gave out and she fell on carpet. Denied that she hit her head/loss consciousness.  Patient reports she then crawled to her phone and then called emergency to be taken to the hospital.  Decadron and SQ heparin were ordered and patient declined these. Spoke to patient at length about these medications and she made the informed decision to refuse them. On bladder scan she was found to have >1L urine and patient declined straight catheterization despite being informed that urinary retention could be contributing to her kidney failure. She was eventually able to urinate by herself, however, and her kidney function improved.Remdesivir was ordered however patient was able to go back to her baseline oxygen requirements prior to it being administered. Given that she was at her baseline O2 requirements and that her kidney function had improved, she was deemed stable for discharge.
Patient given a Pfizer vaccine instead of a flu vaccine. He had no reaction to the vaccine.
Received the Pfizer vaccine for dose one on 1/22/2021. He came for dose #2 Pfizer today; however, he was given Moderna vaccine instead.  Was immediately told and observed for any adverse reaction. He did not display and adverse reactions during his monitoring period.
Syncope, cyanosis, apnea, pallor (5 min) after vaccine. Lethargy. Given oxygen and transported to hospital.
Patient came in for the COVID vaccine booster. When in the clinic the patient received a dose at 0.3ml of the vaccine that was undiluted. The correct dose was provided, the wrong concentration was given.
1-2 days later started having leg pain, 3 days later left sided numbness, stroke like symptoms
Extremely tired, disoriented to place, time, and family, loss of appetite, cold, left shoulder and neck pain, intermittent diarrhea that lasted for approximately 8 days before seeing improvement. Symptoms are now intermittently, states this has been the best days.  continuation of medications Metoprolol, Digoxin, Diltiazem, Losartan Potassium, Chlorthalidone, Hydroxyzine, Benadryl and Tylenol as needed
Severe headache; earache; stomach pain; vomiting; uncontrollable chills;  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Nov2021 16:15 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. Concomitant medication(s) included FLU, administration date Oct2021 administered in Left Arm; MELATONIN; TYLENOL. Past drug history included Amoxicillin, with reaction of Known Allergy. The following information was reported as HEADACHE (non-serious) with onset 08Nov2021 23:30, outcome recovering; EAR PAIN (non-serious) with onset 08Nov2021 23:30, outcome recovering; ABDOMINAL PAIN UPPER (non-serious) with onset 08Nov2021 23:30, outcome recovering; VOMITING (non-serious) with onset 08Nov2021 23:30, outcome recovering; CHILLS (non-serious) with onset 08Nov2021 23:30, outcome recovering. The events severe headache, earache, stomach pain, vomiting, and uncontrollable chills were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, ear pain, abdominal pain upper, vomiting, and chills.   The most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This study case was received from the investigator (MILVAX) on 19 August 2011. A 29-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 31 March 2011. Hep A - Hep B vaccine (other manufacturer, lot number not reported) had been administered concomitantly. On 11 April 2011, laboratory and diagnostic findings consisted of abnormal troponin I (08.50) and an abnormal ECG and abnormal Echocardiogram. On 15 April 2011, the subject was diagnosed with Prinzmetal angina. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Ringing in ears, both. Tinnitus. Came on like a light switch a few days after Booster Vaccine
I developed Bell?s Palsy on the right side of my face. This has never happened before and I have not had chicken pox, shingles, or any recent viral infection that could have caused this.
59 yo patient given Influenza High Dose vaccine indictated for 65 and older
Hospitalization: 10/18/22 - 10/24/22. Presentation to the ED: R ANKLE FRACTURE. COVID + date: 10/24/22. Treatment: NONE, PATIENT WAS ASYOMPTOMATIC - TESTING POSITIVE ON A TRANSFER SCREEN FOR LTCF PLACEMENT.  Discharge to: LONG TERM ACUTE CARE HOSPITAL.
Phone call from patients mother 1-2-07 reports child had hives on face and chest/abdomen 1 hour after Hep B #2. Tolerated Hep B #1 without problem. Was seen at urgent care and given Benadryl with good results and no further hives. Had mild upper respiratory symptoms then.