chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cramping period; menstrual cycle disorder; This is a spontaneous report from a contactable nurse. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and EK9231, expiration date: 31Mar2021 and 30Apr2021), intramuscular on arm right from 22Dec2020 12:00 to 22Dec2020 12:00 and via an unspecified route of administration on arm left from 12Jan2021 12:00 to 12Jan2021 12:00 both at SINGLE DOSE for covid-19 immunisation. Medical history included IUD Placement from May2019 and ongoing.  The patient's concomitant medications were not reported. The patient said that received the first vaccine on Tuesday 22Dec2020 and on Thursday 24Dec2020 she started having her menstrual cycle disorder period which last for 8 days. The caller said that she had a legit, cramping period that she has not had for a long time (occurred on an unspecified date). She said that it was like being a teenager. She received the 2nd dose on 12Jan2021 and she started her period again on 14Jan2021, this morning. She said that her periods have been 3 weeks apart. She said that she has the IUD because she has irregular periods. Outcome of the events was unknown
Nauseous Light-headed Blurry vision  Shortness of breath Body felt cold Joints felt stiff and cold Heart was beating fast Blood pressure was high Headache Joint muscle pain Hard to breathe I reported these symptoms to the doctor that was in the facility where I received the first dose.
Patient woke up at 3am not feeling good and confused.  Became increasingly confused and uncomfortable.  Not very responsive to caregivers.  Called an ambulance at 7:30am.  ER ran tests that showed Sepsis with n o underlying infection.  Patient had to be intubated.  Admitted to ICU in hospital.  Spent 3 days there and 4 days in regular room at hospital.  Then transferred to a rehabilitation clinic where she is currently.
pt recvd vax & 45 mins p/vax exp vomiting, nausea, dizziness, h/a, weakness & elevated BP; h/a was treated w/Darvocet;
The following was reported to me on 06/27/08: On 08/28/08 the client received PEDIARIX, Hib, PCV 7 and TB skin tests. Ct's parents reported approx 1 hr to 1.5 hr after immunizations were given, pt had a seizure, respiratory distress, as noted by the lips and bluish tinge around nose. Ct was seen by EMS & ER visit, cx completely recovered. Ct has since received all childhood vaccines immunizations except pertussis w/no problems. Ct did not have fever or rash with the tx of vaccine.
itching and redness at injection site. redness was about 2inches in size. itching did not start for a week and lasted for about a week. still occasionally feels itchy but all redness is gone.
Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Administration expired vaccine, 4 days after the 30-day. Number of doses/vials: 6 doses Date the vial was initially stored in the refrigerator : 17-Mar-2022 The vial did not undergo any temperature excursions. Concomitant product use was not provided by the reporter.  No treatment information was provided.
Within a few hours of the vaccination, I mentioned to my wife I was getting discomfort in my left ear. It felt like an earache, which happens with an ear infection. My ear felt like that for a number of days afterward. As time progressed, I noticed ringing (tinnitus) in my left ear progressed to the point it was constant. I made an appointment to see a ENT doctor.
Fully vaccinated with booster on 11/5/21.  COVID breakthrough infection with inpatient hospital stay on general medical unit.
four days of fever, headache, nausea, fatigue as well as altered sense of smell and taste. resulted in dehydration and dizziness and I ended up in the ER on the fourth day. after almost a full week at this point, I still have fatigue and brain fog along with a headache and the weird smell/taste issue. I have quite a bit of swelling under my arm and a purple bruise.   History: Covid in Nov '20 resulting in blood clots in lungs.  Was quite sick after each vaccine also, but the booster kicked my butt.
This spontaneous report was received from a pharmacist via a company employee referring to a male patient of unknown age. Patient's concurrent conditions included Alzheimer's disease. On 15-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided) dose, route, and anatomical location were unknown for vaccination. No concomitant medication was reported. On unspecified date in November 2015, the patient experienced a "serious swelling" at the injection site after receipt of the injection, the patient sought for medical attention and spoke with the pharmacy, the treatment included BENADRYL. The outcome of injection site swelling was reported as not recovered/not resolved. Additional information has been requested.
Vaccines given at05/31/05 (DTaP, MMR, IPV, Hep A). Rash broke out later that day.
This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 02-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck), (dose, route, anatomical location, lot number and expiration date of the both vaccines above described were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
expired Fluzone High-Dose given to a patient; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a unknown demographic patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI999A and expiry date: 06-Apr-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.   Expired Fluzone High-Dose given to a patient.  Adverse event not reported.  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.
Pt received J+J as their first vaccination. Came in to get the moderna booster. According CDC guidelines pt is to get 0.25ml booster, instead he was given full 0.5ml booster. No adverse affects.
WITHIN SECONDS OF ADMINISTERING INFANT HAD A BREATHING HOLD UP AND APNEA EPISODE 25 SECONDS REQUIRING POSITION CHANGES, STERNAL RUB, MOVEMINT AND BLOW BY O2.  VOMITED AFTER . PALE ABOUT 15 MINUTES TO RETURN TO NORMAL BASELINE
Painful red bump on left arm on injection site . Put ice and took antihistamine and it still is painful and big.
Tachycardia, hypertension, nausea, numbness tingling weakness in arms and legs, tightness in throat and chest. Treatment was 1 liter bolus 0.9% NA fluid. 50 I.V. diphenhydramine.
Approx. 15 mins after vaccination while client was being observed client reported redness up arms bilateral, discomfort and anxiety. Client moved to private room and Benadryl was administered and EMS called.  Approx. 5 mins after Benadryl, client reported Hives to lower extremities bilaterally and numbness of the tongue. EMS arrived and transported client to nearest ER. No swelling or airway obstruction noted.
Patient was hospitalized on 31 Jan for COVID pneumonia after 3 days of increasing baseline supplemental O2 requirements and dyspnea and ultimately died on comfort care on 3 Feb 2021.
Breakthrough case after three vaccines Pfizer 1/29/21 Lot# El3249;  Pfizer 2/20/21 Lot# EN6200;  Pfizer 12/4/21 Lot# FH8027
Large bruise/hematoma developed. Pt. showed me on 10/6/15 and said it had been there about four days. Dark blue and purple mostly in the underarm area. I would estimate bruise to be at least 6-8 inches long and 4-5 inches wide.
Extreme dry mouth; Weakness; Nausea; 103.9 Fever; A spontaneous report (United States) was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 103.9 fever, nausea, extreme dry mouth and weakness.  The patient's medical history included Covid 19 prior to vaccination. He tested negative prior to receiving vaccination. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not Provided) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event- 103.9 fever, nausea, extreme dry mouth and weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- 103.9 fever, nausea,  extreme dry mouth and weakness was unknown.
A nurse reported that a 15  year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/09/00. The next day, the patient developed an injection site reaction characterized by erythema, and swelling. The patient also felt achy and light-headed. A few days later, the patient developed welts at the injection site. After the welts abated, the site became indurated. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 468-868.
Today is 04/17/2021 . A painful bubo occurs in under left armpit after a day got the first Moderna vaccine shot.
Client became pale, diaphoretic, and nonverbal approx. 4 min. after receiving vaccine. Client placed in supine with legs elevated. VS - BP 82/60 P- 80 R- 20 enc. po fluids. Client monitored x 40 min and then discharged from clinic with mother.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Urination after fainting-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Additional Details: EMS called, triaged and cleared patient.
long haul COVID symptoms; long haul COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "long haul COVID symptoms".  Clinical information: Consumer reporting for friends who are women in their 30-40s are abnormally thin and they are both experiencing long haul covid symptoms after being vaccinated. They are both so petite, they may need a child size dosage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083726 same reporter/vaccine/event, different patients.;
Received flu shot 10/30/09. On 10/31 developed a red, swollen area the size of golf ball on upper arm. By 11/1/09 swollen arm, cellulitis from her shoulder to elbow (12" x 5"). Arm red and inflamed. C/O sore throat (with yellow drainage). Pain upper arm, T 101.2=103, nausea and chills. AUGMENTIN, prednisone, TYLENOL.
Patient started with low grade fever the same evening. The next day his left upper arm became red and swollen and sore. By that evening 11/10/21, his whole upper arm circumference was swollen and red. Mom reports it was twice the size of his other arm. He went to ER 11/10/21 evening and was Rx'd Cephalexin 250/5 12ml BID
Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Pain has moved to the sternum (and almost to the spine) and sometimes hurts when she breathes; Sharp pain when she bends or moves; Aches throughout back and shoulder blades; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Area around injection site was hot, tender, a little itchy and a deep red color; Headaches; Fatigue; Malaise; This spontaneous case was reported by a consumer  of 68 years female patient and experienced   FATIGUE , MALAISE , BACK PAIN , HEADACHE and VACCINATION SITE WARMTH who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event Concomitant products included vitamin b12 and Vitamin d Lab data was not reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273  via intramuscular route and  batch number (027L20A)  then  patient experienced FATIGUE  MALAISE and HEADACHE . On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH ,VACCINATION SITE PAIN , VACCINATION SITE PRURITUS  and VACCINATION SITE ERYTHEMA .  On 30-Jan-2021, the patient experienced BACK PAIN and PAIN  . On 14-Feb-2021, the patient experienced CHEST PAIN  and sometimes hurts when she breathes) and DYSPNOEA  . and the patient pain is still persisting     The action taken with mRNA-1273 was unknown.   The outcome of the event, was considered to be unknown at the time of this report.  Based on RA comment VACCINATION SITE PAIN, PAIN, VACCINATION SITE PRURITUS and VACCINATION SITE ERYTHEMA .
Patient had a fever and related seizure about 12 hours after having his 1 year old vaccinations.
Patient reports left arm is sore beginning day after administration. Has reduced slightly over time but arm still store four months later.
Information has been received from a health care professional concerning a 7 year old pt who in 10/97 was vaccinated with one dose of varicella virus vaccine. On 2/25/00, the pt experienced chicken pox with 6-7 lesions. The pt sought unspecified medical attention. The pt's mother noted that the pt "acted fine." Additional information has been requested. Follow up states the patient recovered on 03/06/2000. No further information is expected.
After about 15 minutes, I began to feel lightheaded and experience a tingling in my arms/hands. I'd guess it was related to the nerves in the arms, because it specifically affected my pinky and ring fingers on both hands. I was also unsteady on my feet, but did not lose consciousness. The lightheadedness and tingling continued off and on for most of the day. The tingling appeared to go away the next day, but I still experienced periodic (though rare) feelings of lightheadedness. Perhaps 2-3 time the next day (Saturday) and experienced maybe 1-2 times the following day (Sunday). I did not take Adderall on the weekend. On Monday, I did take Adderall and returned to work, where I experience some tingling again and longer bouts of lightheadedness. Again, I have not lost consciousness.
Patient states she received COVID-19 vaccine on 3/5/21 and "it seemed high up" and describes site as "one finger width down from the top of the shoulder bone". Denies immediate pain with injection. Reports she went home and "kept trying to move it around" to minimize soreness at injection site. States she and her husband put together a treadmill, although she "just unwrapped the parts and did not do any heavy lifting". Reports pain worsened that night and rated it 7-8/10. Reports she used ibuprofen and ice without effectiveness. Reports she "did not sleep at all Friday night". Reports she couldn't get dressed or undressed and could not wash her hair.
SEVERE JOINT PAIN IN MY RIGHT KNEE ,MY LOWER BACK, AND MY NECK CAUSING SEVERE PAIN DOWN BOTH MY ARMS AND MY HANDS ,, CONFUSION WITH MY MIND RACING OUT OF CONTROL IN A FOG FOR OVER 2 WEEKS, INTO THE 3RD WEEKS I HAD SEVERE SCIATIC PAIN ON MY RIGHT SIDE INTO MY RIGHT LEG CAUSING SEVERE PAINFUL CRAPPING ,,MY DOCTOR GAVE ME DEXAMETHASONE, AT MY REQUEST AFTER I READ ABOUT THE SCIENTISTS RECOMMENDING  THE STEROID BE GIVEN TO PEOPLE  SUFFERING FROM SEVERE INFLAMMATION AND PAIN FROM THE VACCINES ..IT ONLY TOOK 4 -1 MG PILLS TO GIVE ME RELIEF ,, I DONT UNDERSTAND MY THE LYING CDC IS NOT BEING HONEST ABOUT THESE VACCINES ,,CVS PHARMACY. TOLD ME THERE WERE NO SIDE EFFECTS TO THE VACCINE ,,AND IM THINKING ABOUT SUING THEM FOR THAT CRIMINAL LIE ,,I WILL NEVER HAVE ANYTHING GOOD TO SAY ABOUT CVS AS LONG AS  I LIVE AND BREATH ON THIS PLANET ,,EXCEPT TO SAY THEY ARE LYING NAZIS !! EXPERIMENTING ON PEOPLE INSTEAD OF INFORMING THEM ,
Shingles on inner buttocks right side 1 week after vaccine.  Taking valacyclovir for 7 days
Headache; exhaustion; sinus pressure; fever; chills; sweats; dizzy; nausea; stomach aches; diarrhea; brain fog; sleep issues; Due to nausea & brain fog unable to work as bookkeeper; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation (57-years at the age of vaccination).Medical history included asthma from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced headache, exhaustion, sinus pressure, fever, chills, sweats, dizzy, nausea, stomach aches, diarrhea , brain fog, sleep issues, due to nausea & brain fog unable to work as bookkeeper on 14Mar2021. Therapeutic measures were taken as a result of all events. The outcome of the events Headache, exhaustion, nausea, stomach aches, brain fog, sleep issues and Due to nausea & brain fog unable to work as bookkeeper was not resolved and other events was resolved on 2021.  No follow-up attempts are possible. No further information is expected.
In May 2023I just wasn't feeling like myself and I went to the doctor.  She ran some tests. and we learned that my blood cells were enlarged.  I am now taking B Complex to see if that helps.
aches; chills; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Reporting System. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. It was unknown if the patient received other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. On an unspecified date in Feb2021, the patient experienced aches and chills. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. It was unknown whether therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
pt recv vax 2JAN96 & 26MAR97 pt devel chickenpox w/over 300 lesions;the reporting MD did not record the presence of any temp;10 days later pt recovered;
PT RECEIVED MODERNA AS 1ST DOSE ON 05/18/21 AND THEN RECEIVED PFIZER AS 2ND DOSE 6/10/21. PT DID NOT REPORT ANY ADVERSE EFFECTS.
I got all 3 shots and still had shingles/ Suspected vaccination failure; Still had shingles; I got all 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got all 3 shots and still had Shingles. He/ she found out L Lysine off the shelf keeps it down. Additional Supportive Information:  This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
shingles; This is a spontaneous report from a Pfizer-sponsored program . A non-contactable consumer (patient herself) reported that a female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. Patient wanted to know if she should take her second COVID vaccine since she broke out with shingles. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reproted). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Severe severe muscle aches. Don't remember ever aching as much. Could not sleep or find comfortable position.  Increased in severity throughout night but was about 80% better the next day. Skin was also very "sensitive" to touch. Don't recall photophobia but realize that I preferred the blinds closed. Also required asthma rescue meds twice. Developed occasional cough and with cough had head ache. Also several episodes of urinary urgency (not usual for me}.  Felt warm (temp with old battery oral thermometer only 90F. Right arm, site of two of the injections is still very tender but not red. Today the right arm is still very tender but the muscle aches have resolved.
Moderna vaccine was administered outside of facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED