chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is not an adverse event report to patient but rather an vaccine administration error report. This patient came into obtain his second dose of Pfizer COvid-19 vaccine and it was administered without incident. However it was later discovered that the diluent used to reconstitute this vaccine was Sterile Water for injection (NDC: 00409-4887-17) instead of the recommended 0.9% normal saline.  No expected adverse event expected from this vaccine admin error, Clinical team, Pfizer and CDC were contacted.  We were advised that a diluent of Sterile Water for injection was not studied and therefore it could not be determined if vaccine from 8-25-21 would be efficascious.  Was finally able to contact patient on 9/10/21 who spoke another language and with assistance of interpreter. was advised of the error. Patient stated he was doing fine  had no problem with vaccine. Patient was advised it was recommended that he be revaccinated. Patient indicated his wife was at hospital and would consider coming in next week or two.
Pfizer-BioNTech Covid-19 Vaccine.  I received the 1st dose at approximately 11am on April 2nd.  I went to sleep and woke at approximately 4am on April 3rd  with a sharp pain/ache in my side.  I went to the bathroom and began to experience chills and started sweating.  I was sitting on the toilet and passed out.  My wife heard me hot the ground and I came to.  I had had another experience passing out while on the toilet a month earlier, for which I went to the ER and was discharged.  Test run on the early occasion were all negative.  I did not seek any medical attention immediately following this event but will be following up with my primary physician.
Immediately after receiving first dose of Lymerix, the pt experienced injection site pain which resolved. Immediately after receiving second dose of Lymerix, pt experienced pain at injection which resolved. Immediately after receiving third dose of Lymerix pt experienced injection site pain which resolved. The most recent information reports the outcome of the event as resolved.
Pt stated that they went to ER for swollen right knee on 11/03/2021. The ER doctor was not sure but stated that the vaccine may have caused the swelling of the knee.
pt recv vax & pt exp rash;in 1997 pt was exposed to a needle stick from child;
TIRED; SORE ARM; FELT LIKE A BIG PIECE OF LEAD GOING IN WHEN VACCINE WAS INJECTED FOR ABOUT 15 MINUTES; This spontaneous report received from a patient concerned an 80 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included previous diphtheria infection during childhood, and 2 episodes of potential mini-stroke, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1803070,  expiry: UNKNOWN) 1 total dose, administered on 22-MAR-2021 at 13:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 22-MAR-2021, the subject experienced felt like a big piece of lead going in when vaccine was injected for about 15 minutes. On 23-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and tired on 24-MAR-2021, and felt like a big piece of lead going in when vaccine was injected for about 15 minutes on 22-MAR-2021. This report was non-serious.
Patient called on 6/21/2022 at 0900 reported rash and swelling to site. Stated that a rash started the day of injection 6/19/2023 and stated that today the swelling became worse. Patient was instructed to call VAERS and report the adverse reaction.
Pt developed swelling, redness, and warmth at injections site. Pt denies pain or difficulty breathing, no other symptoms.
I have not had my monthly menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 05Mar2021 at 15:30 (at the age of 46-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 26Mar2021 (at the age of 46-years-old). The patient's medical history included penicillin. The patient had no concomitant medications. The patient previously received amoxicillin and contrast iodine and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 05Mar2021 at 15:30, the patient experienced irregular menstrual cycle. It was reported that it could be just mother nature, but just wanted to note that she not had her monthly menstrual cycle since the first vaccine, that she had never missed. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The patient did not receive treatment for the adverse events. The clinical outcome of the event irregular menstrual cycle was unknown at the time of report.    No follow-up attempts are needed. No further information is expected.
First dose was given on 24Dec2019 and second dose 20Apr2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received first dose on 24th December 2019,  batch number 227FL, expiry date: 26th November 2021).   On 20th April 2021, the patient received the 2nd dose of Shingrix. On 20th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: Patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Reporter consented to follow up.
Mother reported redness and swelling to left arm, states she left band aid on arm all night and could see imprint on child's arm the next morning. LPN took information  from parent. Per LPN, she talked with stated to instruct mom to give child anti-inflammatory meds and alternate heat and cold 15 minutes each also draw a circle around site to see if redness goes down, Mom verbalized understanding and also instructed  to take to MD if not better.
Injection site tenderness; big pale pink rectangular area / Slight reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site tenderness and injection site discoloration. On an unknown date, the outcome of the injection site tenderness and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site discoloration to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a slight reaction which was tender at the injection site with a big pale pink rectangular area around it which faded within 3-4 days.   The reporter consented to follow up. This case has been linked with US2019AMR138299, reported by the same reporter for the same patient.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 20-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting). At the time of the report, irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting) outcome: unknown. Diagnostic results: On an unknown date, heart rate: 100 (high) increased. Concomitant product use and treatment information, if any, not provided. Action taken with mRNA-1273 in response to the event: not applicable.
pt rcvd vax; 16jun94 approx 12:30pm pt started crying; different sound for approx 2hrs; pt devel cold symptoms; crusty nose; vomiting t 99.8; RL red area;
Witnessed LOC with slumping in chair, eyes rolled back in head - unable to respond to name briefly. Pale and skin temp cool. Sent to urgent care with father and twin brother.
pain, swelling, redness, on inject site; pt c/o inc temp, chills & h/a 2 days p/vax;
Dizzy, lightheaded, shaky, felt faint, was given water and a snack. Symptoms resolved in 20 min.
Right shoulder vaccination site has been continuously sore since injection 3 weeks ago. Pain and muscle tension migrated across RIGHT neck to LEFT neck, then RIGHT neck, then RIGHT forearm, then RIGHT bicep over ten days. Right arm is mildly weak now. Any muscle movement of right shoulder causes right shoulder moderate pain now.
This is second dose: Day1-intense muscular soreness within hours of receiving injection (first dose soreness not as intense). Day 2- I noticed a little after 24 hours of receiving injection a red triangular in shape area upper arm below injection site. Warm to touch, slightly raised. Day 3-muscular soreness lessened but red area still present and warm  NO fever at any time.  So far, I do not think any of this has warranted a trip to see a doctor
Patient reports to ED ~4 hours after COVID-19 vaccine with itching/burning on chest/arms/trunk/back that began 1 hour after COVID-19 vaccine. Provider noted warm, dry skin with rash and erythema as well as generalized urticaria mostly at the trunk Vitals: 135/70, 99, 18 Provider noted allergic reaction is dominant only without any other system involvement. Patient was given methylprednisolone 125mg injection (steroid shot) , Benadryl 25mg , and Pepcid 20mg in the ED. Patient was observed with symptom improvement and stable for home. Provider noted likely minor allergic reaction from COVID-19 vaccine and discharged patient with prednisone 10mg - 2 tabs BID x4 days and hydroxyzine 25mg - 1 tab TID prn.
The area swelled and a knot formed.  My whole arm hurt, but the knot was hard, red, very tender, and feverish.  The next day I noticed 2 blisters had formed on top of the knot.
Given tdap at 08:30am, complained of itching at 10:00am, Her MD was notified and ordered benadryl 25mg, she took 2 right away. At 11:40am she complained only of chest tightness, Md notified and patient seen, given eip pen sub-q. At 3:07pm oxygen sats 95% she sates"just tired, but I feel ok".
3/8 headache left arm, pm stomach cramps body aches left side of body, shortness of breathe,ears red lasting various stages and intensity  until 3/12 joint aches continued. 3/17 pm entire left side of body started tingling with severe cramps in left foot, neck and hand, upper back pains. 3/18 diarrhea and neck ,back pains.3/21 reported to PFIZER / REFERENCE # b4d779aa-eeb2-4e16-bbe7-91e26202292f .  3/23 dr visit concerning side effects of tingling in entire left side of body. 3/24 pm headache left hand and arm tingling at night . 3/30 , shortness of breathe, pm lying down head ache  and slight tingling. headache treated with advil.  4/2 headache and slight shortness of breathe. 4/5 tingling and hand cramp before bed lying down
Patient received one dose of moderna vaccine from a vial that was out of temperature control; Patient received one dose of moderna vaccine from a vial that was out of temperature control; A spontaneous report received from a consumer of unknown age and gender. Patient  received dose of Moderna COVID-19 vaccine and said the vial was out of temperature control.    The patient's medical history was not included. Patient's concomitant medication was not included.    On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 unknown arm (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated they received one dose of Moderna COVID-19 vaccine from a vial that was out of temperature control.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of "Product storage error" and "Out of specification product use" for mRNA-1273, lot # unknown with no associated adverse events.
NO ADVERSE EVENT-THIS CLIENT HAS PREVIOUSLY BEEN VACCINATED IN MEXICO WITH THE ASTRA ZENECA AS THE FIRST DOSE BUT RETURNS TO THE USA FOR SECOND DOSE IN WHICH THIS VACCINE IS UNAVAILABLE TO ADMINISTER THE SECOND DOSE; THEREFORE, THIS CLIENT CHOSE TO COMPLETE A VACCINATION  SERIES (2 DOSES) OF PFIZER TO COMPLETE FULL VACCINATION FOR THE COVID-19 VIRUS.
Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022; A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that number of doses/vials were 1 dose and vial was not undergone any temperature excursions.  The treatment information was unknown.
CASE IS HAVINF RUNNING NOSE AND HEADACHE. ONSET DATE 8/7/2021
My thyroid went hyper, which is new for me because I didn't realize what it was until I ended up in the hospital, twice. My blood pressure, heart rate went up and I started getting panic attacks from my thyroid being hyper. It was high and then they kept dropping my medication dose then I ended up being hypo and sleeping for 2 months. And I'm still not where I should be.
Initial report received from nurse on 05-Dec-2013. A female patient (age unknown) (medical history and concomitant medications were not reported) received FLUZONE HD (lot number, expiration date, route and site unknown) on an unknown date. Patient had a 4 in open wound at injection site. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Occular migranes and roving scotomas causing partial blindness for 7 out of 30 days. Strongest symptoms during days directly after vaccine injection. No history of similar symptoms prior. Emergency medical care received at a Medical Center (out of state). Checked for retinal detachment with ultrasound (no retinal detachment found). Further medical care received at another Medical Center (with neurologist) who ordered an MRI (taken at a local imaging center) that was inconclusive. Then a visit with an Eye care Dr. locally was ordered to have an fMRI with contrast taken to investigate possible causes of the migranes and scotomas. This fMRI was not taken because symptoms had subsided and medical costs were becoming unwieldy.
Joint pain in elbows and wrists started evening after receipt of anthrax vaccine #1 and lasted until vaccine #2. After anthrax vaccine #2, joint pain continued through July 03. After anthrax vaccine #2 in June, started having bilateral knee pain which continues today.
Patient called and reported feeling tired & achy & lightheaded for past 2 days, also a little itchy.
could not breathe; The coughing and trouble breathing was due to mucus in my chest; coughing; the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021). The patient was treated with AZITHROMYCIN for Adverse event, at a dose of UNK dosage form; BROMPHENIRAMINE for Cough, at a dose of UNK dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-403097 (Patient Link).
ABSENCE EPILEPSY 4/16/2023 HTN (HYPERTENSION)  TYPE 2 MI 4/16/2023 HTN (HYPERTENSION)  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/16/2023 HTN (HYPERTENSION)  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/19/2023 HTN (HYPERTENSION)
Severe pain at injection site from day 1. Day 2, I experienced vaginal bleeding, very light.  Day 3, pain in armpit below injection site and swelling.  (FYI: after 1st dose, menstrual cycle was abnormal)
Patient had orbital cellulitis and cavernous venous sinus thrombosis accompanied by IJ thromboses. She has significant cognitive delay and was not able to give much details; she lives in a group home so I was told that she had 2nd Moderna vaccine on 6/1, but I was unable to confirm. Her platelets were normal and she improved despite treatment with heparin.
This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with MMR II via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. The nurse reported that a patient who may have had the MMR II vaccination on an unspecified date had negative titer's on an unspecified date. Nurse did not want to share any further information. The outcome of negative titer's is unknown. Additional information has been requested.
Headaches, severe muscle and joint pain, fatigue for 24 hours.  Elevated blood pressure (134/82 vs usual 126/76) and nose bleeds Then about 80 hours after the injection, severe Vertigo symptoms resulting in being bedridden for about 10 hours.
Hypo-osmolality and hyponatremia Thrombocytopenia, unspecified
Tingling feeling in tongue started a couple hours after injection. That went away by next day, but then metallic taste in mouth. Strong for 4-5 days, then came and went for a couple of weeks.
Seconds after receiving HIB, patient had a generalized tonic-clonic seizure within 1 min. Postictal after 7 mins log-rued and given O2. After seizure, sent to urgent care for testing.
The arm is red and swollen from the injection site of the PNEUMOVAX 23 all the way to the elbow.  The greatest swelling is close to the elbow. It is warm to the touch. Patient has used ice last night and taken a single dose of BENADRYL last night. She is going to repeat the BENADRYL this morning and a dose of MOTRIN.
Dizziness, Rash on body, Ring around injection site. All on 11/24/2022. 3 days after vaccine. Treated with Steroids at hospital. Currently outpatient on short term steroid therapy.
Information has been received from a physician concerning an 82 year old female who on 26-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658207/0883U). Concomitant therapy included CRESTOR and vitamins (unspecified). On 27-APR-2008, the patient experienced back pain and went to an emergency room (ER). On 28-APR-2008, the patient was seen in a doctor's office and diagnosed with shingles. The patient was place on treatment therapy PERCOCET and VALTREX. As of 29-APR-2008, the patient's shingles persisted. Follow-up information from the patient indicated that she had a dry rash which cleared up with the use of VALTREX. It was noted that the patient's current symptoms included redness and pain. It was also noted that the patient takes oxycodone (unspecified manufacturer) and ibuprofen (unspecified manufacturer). The patient reported that the pain caused nausea and weakness; therefore, she cannot eat and has lost weight. It was noted that the pain intensifies at certain times. The patient stated she does not want to become addicted to medication so she tries to avoid taking pain medication whenever possible. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the nurse indicated that as of 04-JUN-2008 the patient was still having Post-Herpetic Neuralgia (PHN) and had not called since. The patient was having issues with pain and was switched from PERCOCET to DARVOCET. The nurse explained that the patient did not have blisters or vesicles as her shingles presentation and the patient stated that she "knew the vaccine was not 100% effective". Additional information has been requested.