chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intentional dose omission; Confusion and blurred vision while on way home driving/brain fog; Confusion and blurred vision while on way home driving; couldn't remember her way home and got lost.; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving), AMNESIA (couldn't remember her way home and got lost.) and INTENTIONAL DOSE OMISSION (intentional dose omission) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving) and AMNESIA (couldn't remember her way home and got lost.). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentional dose omission). At the time of the report, CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving), AMNESIA (couldn't remember her way home and got lost.) and INTENTIONAL DOSE OMISSION (intentional dose omission) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Medical history was added, events were updated to recovered, a verbatim was updated.
Tingling in the left arm from armpit to fingertips. Redness, itching, and swelling at inj. site (presented 48 hours after vaccine). Pt. taking OTC BENADRYL.
BODY ACHE; RASH AT INJECTION SITE; TENDERNESS AT INJECTION SITE; SWELLING AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, injection site rash, injection site tenderness, injection site swelling, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, headache, injection site tenderness, injection site rash and injection site swelling was not reported. This report was non-serious.
Swelling and discomfort in joints and hands, dizziness, extreme fatigue for 24 hours, pain and pressure in center of chest and upper back strait across from chest pain( lasted about 6 or 7 hours.
TRIED TO SLEEP ON TOILET DUE TO DIARREAH & VOMITING NON-STOP FOR 72+ HOURS. TREMORS, INSOMNIA, EXTREME HEADACHE, ICY TOP OF LOWER LEGS AND FEET, EXTREME FATIGUE, DIZZINESS, MULTIPLE FALLS, CHONIC DEHYDRATION, MEMORY LOSS, CAN'T DO BASIC PERSONAL HYGEINE, CAN'T STAND LONG ENOUGH TO PREPARE FOOD, LOSS OF VISON, LOSS OF SPEECH, MEMORY LOSS, DIFFICULTY IN USING REMOTE AND PHONE,SEVERE ABDOMINAL PAIN, BEDRIDDEN
had tested positive for the virus (COVID) after the first dose of the vaccine; had tested positive for the virus (COVID) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This report is for 11th of 15 residents.  A patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), at single dose for COVID-19 immunisation on 03Jan2021. The patient's medical history and concomitant medications were not reported. The patient had tested positive for the virus (COVID) after the first dose of the vaccine in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had the Pfizer shot on Monday and started to get some symptoms like headache, muscle pain. Patient already had the first shot, a congestion. Patient went for the COVID-19 test today and had not got the results yet. Patient just want to know if the first shot was that normal. Patient did have them 2 or 3 days later. Patient was suggested to contact nearest physician and was informed about Pfizer Medical information department and was provided with the number. Outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flu shot administered at her work site. Approximately 1 hour after the injection was given the patient reported generalized itching in her arm, neck and back. The nurse noted redness in these areas.The patient did not exhibit any signs/symptoms of respiratory distress. B/P 122/86, pulse 88, respiration 16. The patient denied any known allergies. The patient told the nurse that she was took 2 25mg Benadryl. The nurse instructed the patient to call her physician. The patient did so and went directly to his office. I followed up with the patient on 10/1/14. She was at work and stated the physician gave her a steroid injection and oral steroid and that she was not having any further problems.
Slight headache and sore arm day after Woke up on 4/22 with hearing loss and loud tinnitus in right ear, moderate tinnitus in left ear, tingly feeling extending from top of head down right side of face into neck. Scheduled appointment with an ENT for later in the day. Ear canals looked fine. She placed me on prednisone, symptoms have diminished (tingling sensation gone) vibrating sensation of eardrum reduced, hearing loss still persistent and still have tinnitus.
had flu like symptoms; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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 (1st Dose), for COVID-19 Immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "had flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, extreme soreness on left arm where I got the 2nd vaccine.  Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite.  Extreme fatique. was up all night
14MAR97 started w/chicken pox had 32 pox-fever inc to 101 on the 14th-15th- & 16th;fitful rest-itching;scabbed over by 17MAR97;exposed @ kindergarten;
pt recvd vax;next day, devel erythematous,hot area w/ induration at inject site,resolved w/in 2 days;
Have pain in my arm; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The patient experienced pain in arm. The patient waanted to know whether how long should this pain exist and should she get her second shot while her arm was still hurting at the time of reporting.
Pt. states that after receiving the 1st dose of 07/15/2021, started experiencing symptoms 07/21/2021 of face swelling, coughing up mucus, skin redness, heart fluttering, and eye puffiness. Urgent Care planned for 07/23/2021.
Thought the Expiration date was.  6/30/23, but it was the be used by 5/22/23. The vaccine was given on 5/26/23 . I did have njurse check with me before giving the vaccine.
I was awakened at 2:30 a.m. by severe chills.  I pulled a blanket over me, and it did not help.  The chills lasted for 20 minutes, then stopped.  There were no after-effects, and this morning I feel perfectly normal.
This spontaneous report was received from an immunization coordinator concerning a patient of unknown gender and age who on an unknown date may had been vaccinated with an improperly stored RECOMBIVAX HB vaccine. The immunization coordinator stated that the unit that had the temperature problems was in a remote area and they may not had administered any RECOMBIVAX HB, but she was unsure. Additional information has been requested.
Tinnitus starting on 22 May 2021 and continuing until today 25 Aug 2021.
Tinnitus occurred beginning 6 days after first dose and still continues.  I developed fluid in my ear as well, but fluid is now dried up, but ringing remains.
Headaches and bodyaches following shot. Numbness and tingling on the left side of body from neck to toes and joint stiffness all over body starting two hours after the shot. Sharp stabbing upper abdominal pain, starting 12 hours after the shot.  Took Tums tablets, which eased the stabbing upper abdominal pain. Though, dull pain persisted.
7/28/05 3am developed temp 104 went to ER sent back home. 7/28/05 10am had febrile seizure went to hospital by 911 and hours later discharged home.
The patient developed a measles rash, fever of 102.5, became lethargic and inconsolable for two days. Patient had been eating solid foods (non purée foods) since 8 months old. He would no longer eat solid foods after his vaccines and did not eat solids for almost a year after.  He also developed eczema patches on his left hand.
Pt had development of rash, consistent with Henoch-Schonlein Purpura on 10/19/00. No other presenting illness. No systemic symptoms.
shingles; scabs; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In October 2021, 5 months after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles was unknown and the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the shingles and scab to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient The age at vaccination was not reported. The patient had 1st shot 6 months ago from the date of reporting. The patient acquired shingles one month ago from the date of reporting, scabs were currently fading. She would not disclose any other information such as DOB or address. Permission denied for follow up.
Information has been received from a physician concerning a female who was vaccinated subcutaneously with a second dose of with varicella virus vaccine live (Oka/Merck) (lot# 655995/1303F). Two or three days later she experienced "red, wheel like localized site reaction that was swollen and warm to touch." No medical attention was sought. It was reported that this did not happen with the first dose, just the booster shot. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received from the company representative which indicated that there wasn't any additional information to provide regarding the adverse experiences. The physician does not want to provide any additional information either. This is one of several reports from the same reporter. No further information is available.
Mother called 7/12/04 to report occurrence. Reports child "felt bad" two days after she received vaccine. Went to camp for a week, came home and mother reports she slept. Reports muscle weakness at camp and upon return to home. Mother thought she was just tired from camp. Broke out in hives July 7, 2004.
11MAY91 woke up w/t103; temp cont all day 105 @ 10PM MD notified adm to Hosp IV's thru night lab work & CXR negative;
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 12-Dec-2013. The medical assistant reported that they inadvertently gave expired FLUMIST QUADRIVALENT to the patient on 12-Dec-2013. Not reported any symptoms. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Corrected report 30-Dec-2013: Key ingredient of FLUMIST QUADRIVALENT corrected from FLUMIST to Q/LAIV.
This case was reported by a pharmacist and described a 63-year-old female subject who developed severe flu symptoms after receiving an influenza vaccination (other manufacturer) . There were no concomitant medications or pertinent medical history.  The subject's concurrent medical conditions were not reported.  The subject had a sulfa allergy. On an unspecified date several years ago, the subject received influenza vaccine (unknown manufacturer: dose number and lot number not provided).  On an unspecified date, the subject developed severe flu symptoms after receiving the influenza vaccination.  No other symptoms were reported. No other information was available. This is in follow-up to report (s) previously submitted on 10/16/2006. Information has been received from a physician and a 65-year-old female who is a physician with asthma, allergies (ragweed) and penicillin an aspirin allergies, who on 22-SEP-2006 at 10:30 am was vaccinated subcutaneously in the right arm with a first dose 0.65 ml dose of ZOSTAVAX vaccine (Merck). Concomitant vaccination included: a dose of pneumococcal 23v ploysaccharide vaccine (MSD), a dose of inlfuenza virus vaccine (unspecified) (given on the same arm about 3 inches away from the site of varicella-zoster virus vaccine live (Merck) administration) and a dose of tetanus toxoid vaccine (manufacturer unknown). Other concomitant medications included: ADVAIR, SINGULAIR and ALLEGRA. On 23-SEP-2006 the patient expereinced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritus and warmth. The patient did not experience any systemic reations, no fever, no sore throat and no joint pain. It was reported that the reaction gradually subsided after 6 days and significantly reduced after 10 days. On 05-OCT-2006, the patient  was seen by the allergist, she still had a mild macular eythema, but no other skin lesions were identified. The patient was also wondering whether she should receive her additional allergy immunotherapy which she is getting about once every 4 weeks. She was also treated in the allergist office for asthma, aspirin and penicillin allergy. The physician discussed the potential etiologies for her raction to varicella-zoste virus vaccine live (Merck). The time sequence may resemble either type-3 or type-4 hypersensitivity. In addition, patch testing for varicella-zoster virus vaccine live (Merck) may also be beneficial which potentially can help us to identify whether she has any T-cell mediated hypersensitivity reaction. There is always a possibility the reaction could be directed to the preservatives. Ingredients of the vaccination have to be examined to see whether additional patch testing can be performed. The physician recommended that she get IgG and IgM antibody titers for VEV. The results of these tests were varicella-zoster Ab, IgM = < 0.90 (negative) and varicellla-zoster V Ab, IgG = 4.24 (positive). The physician noted that the patient could continue her current prescribed allergy and asthma medication and continue to receive her immunothereapy as planned. No product quality complaint was involved. No additional information has been requested.
Fever body aches Narrative: Per email from (EOH RN): "employee had an adverse drug reaction on 12/23/2020, day after vaccination. Symptoms: fever, body aches". Per Employee Adverse Reaction Report, employee also reports chills, headaches, joint pain, and fatigue. Employee reports max temp on 12/23/20 was 101-102 F, with fever breaking overnight. No symptoms other than mild soreness at injection site on 12/24/2020. Employee reported took extra strength Tylenol (500mg), 2 doses 6 hours apart.
HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No side effects with first vaccination in August 2021. The second vaccination was received at 8 am, Oct. 12, 2021. No symptoms until 6 pm that evening, began with a dull headache, some stiffness and by 8 p.m. shivers, fever, headache worsened, muscle ache that created an imbalance, tiredness but not able to actually sleep and pain, redness and swelling at the injection site.  Oct. 13, 2021, rested with ibuprofen, slept well, and felt like 110% Oct. 14th.  The vaccine kicked my immune system into high gear but worth it long term.
Soreness, swelling, redness, hardness and itching at the injection site remains significant eight days after the injection.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 55-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date July 2020) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site muscle pain and injection site swelling. The patient was treated with MOTRIN, TYLENOL and Lidocaine Cream. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site muscle pain and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The swelling resolved but the pain was continued as of the date of reporting. The patient went to the doctor. The doctor suggested taking MOTRIN, TYLENOL and lidocaine cream. No further information was provided.
fever much worse than when i actually had COVID, tiredness. loss of appetite.  The day was as bad or worse of any of the days i had Covid
left arm discrete soreness; This is a spontaneous report from a contactable Other HCP.  A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1283, via an unspecified route of administration on 15Jan2021 18:45 at SINGLE DOSE  Vaccine location: Left arm, dose number: 1 for covid-19 immunisation. Medical history is none. Concomitant medication included bisoprolol (BISOPROLOL), rosuvastatin (ROSUVASTATIN), asa (ASA). The patient experienced left arm discrete soreness on 15Jan2021 21:30 with outcome of recovered in Jan2021. The action taken was not applicable.
Information has been received from a physician concerning an 85 year old female, who on 27-FEB-2007 was vaccinated with ZOSTAVAX (Merck). On 05-FEB-2009, the patient developed "very mild" case of shingles after receiving the vaccine. On an unspecified date, the patient recovered. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Big oval patch between elbow and shoulder, really itchy; Arm is very tender; pruritus; bumps all over body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body). At the time of the report, URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment included diphenhydramine, Hydrochloride, famotidine and allergy medication azelastine.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Patient alerted staff of tingling in throat at approximately 2:10 PM.  Staff alerted nurses. I responded, ushered patient to a room to sit down. Vitals taken, assessed symptoms. Tingling in tonsil area down throat and towards ears, choking sensation, apprehension, anxiety noted. Called district clinical nursing director. Instructed me to administer EPI pen. Epi pen 0.3 mg administered to left thigh while another nurse called 911 at approximately 2:14 PM. Vital signs taken every 5 minutes. Patient began feeling better within minutes of receiving epi pen. EMS arrived at 2:30. Patient refused transport to hospital. Patient stated her husband, who was present, would drive her to the hospital. Refusal documentation signed, and incident report filled out. Patient encouraged to follow up with PCP as well.