chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech /Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 12:30 as dose 1, single (Lot number: PAA165969), in left arm and on 01May2021 at 12:30 as dose 2, single (Lot number: EW0167) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 013F21A), in left arm and on 23May2022 at 10:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 30Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 013H22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Pfizer / BioNTech /Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Jul2023 to 30Jul2023.
When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave after sitting for 20 minutes and go back to work because it got a little better. on tuesday.   A few hours later, my chest started to ache and my throat started to hurt. thinking I had asthma due to the heat, i ignored it and used my inhaler.   By the next day, I was coughing and it hurt worse. I was still dizzy but worse, felt neasious and had a headache. I used my inhaler twice with no help. My arm started to hurt to move, and my injection spot became a red lump.   By Thursday, I could barely take a normal breath. It hurt to walk, talk, yawn, sneeze or anything that lifted my need to breathe above bare minimum. It hurt greatly and I couldn't take a full breath. I felt like my lungs were swollen and my throat hurt to swallow. I was very dizzy and had horrible nausea.
3-4 hrs p/shot pt exp temp, dizziness, disorientation & h/a; temp was reduced by APAP (temp not taken) but disorientation continued; sleep that night was sporadic w/intermittent tremors;
This spontaneous report as received from a 69 year old female patient regarding herself. The patient's medical history was not reported. The patient had drug reactions/allergies to a number of antibiotics (unspecified). The concomitant therapies included unspecified over the counter medications, metoprolol and levothyroxine sodium. On an unspecified date in 2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot/batch # and expiration date  were not reported) subcutaneously. On an unspecified date in June 2016, the patient had a knee replacement surgery. "Recently, around the beginning of October 2016" the patient experienced a case of shingles. The patient had to reschedule knee replacement surgery in her other knee that was scheduled  for 12-OCT-2016 "because of the shingles".  On an unspecified date, a biopsy was performed which confirmed shingles. The patient sought medical attention by going to the physician. The patient received treatment by the use of VALTREX, gabapentin and clobetasol propionate. As of the date of this report, she has  almost recovered, but still has shingles in her left thumb. The outcome of knee replacement surgery and shingles was recovering. The causality assessment was not provided by the reporter. Upon internal review, the event, knee replacement surgery was considered to be medically significant. Additional information has been requested.
Severe Migraine, with nausea and gagging through Monday 3/22 around 8am. Then it subsided to a headache
PATIENT COMPLAINED OF REDNESS AND SWELLING TO LEFT ARM THAT IS MOVING UP ARM TO SHOULDER, BROKE OUT IN RASH WITH SLIGHT SHORTNESS OF BREATH.
PREVNAR 13 injection caused raised red feverish rash the size of a hand on shoulder.
Thenwhy do I get sick every time I have a flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 27-Nov-2020.  This case involves a patient of unknown demographics who got sick every time when have a flu shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick every time when have a flu shot (illness), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
I had a sore arm and fatigue for about a day after receiving the vaccine. I was exposed to heavy perfume at the end of September which aggravated my asthma.  I took a dose of Prednisone to manage my symptoms until I contacted my doctor.  After seeing my doctor, I took another dose of Prednisone and Protonic. I have an appointment with a Pulmonologist in about a week.
Information has been received from a registered nurse concerning a health 29 year old male with no pre existing allergies, birth defects, or medical conditions who on 8/4/2004 was vaccinated subcutaneously in the left deltoid with a 0.5ml first dose of varicella virus vaccine live (lot 646676/0711N). There was no illness at the time  of vaccination. There was no concomitant medication. A few days later, the patient developed a full blown case of chickenpox characterized by head to toe lesion and a fever of 101F. Medical attention was sought and he was treated with anti viral medication. It was reported that the patient recovered on an unknown date. On Product quality complaint was involved. Follow up information received from a registered nurse indicated that on 7/22/2004, the patient had a varicella titer drawn which showed no protection against chickenpox. It was noted that on 8/22/2004 at 5:00 PM after mowing the grass the patient began breaking out with vesicles resembling chicken pox. He came to employee health on 8/24/2004 with a temperature of 100.4 degrees. Vesicles on the scalp and right chest were noted. The patient was sent for lab work with showed negative varicella tests on 8/24/2004 and protection against chickenpox on 8/30/2004. The physician diagnosed him with varicella. The outcome was reported as recovered on 8/30/2004. Additional information has been requested.
It was reported that a 63 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001  at 11:30am. Reportedly on 01/27/2001 at 12pm, the pt developed redness and itching. The pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, additional  pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447 through U2001-00450, U2001-00452 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Wide spread itching - redness - blurry vision know egg allergy - so given cell growth vaccine after inject found out has canine allergy - dander contact allergy Prednisone for 3 day.
sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; sore at injection site, armpit and scapula; Fatigue; overall muscle soreness; This is a spontaneous report from a non-contactable other health care professional (patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0170, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 19Apr2021 17:00 as dose 2, single (age at vaccination: 36-Years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (MOTRIN [IBUPROFEN]). The patient was allergic to Haldol. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Er8733, expiry date: unknown) via an unspecified route of administration, administered in Left Arm on 29Mar2021 05:45 PM as dose 1, single (age at vaccination:36-Years-old) for COVID-19 immunisation and experienced fatigue, muscle soreness, low grade fever, and chills. The patient was not diagnosed with covid-19 before, and was tested post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Received Motrin medications in two weeks prior to the vaccination. On an unspecified date the patient experienced sore at injection site, armpit and scapula, fatigue, and overall muscle soreness. On an unspecific date the patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative. The patient had not received treatment for all the events. The outcome of the event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning his 75 year old female friend with no known allergies or pertinent medical history who "about 3 weeks ago" on approximately 16-MAR-2008 was vaccinated with Zostavax (Oka/Merck). There was no concomitant medication. On approximately 29-MAR-2008, about two weeks after vaccination the patient developed an upper respiratory illness. Medical treatment was sought in the emergency room on 29-Mar-2008, and the patient was prescribed unspecified medication. The patient seemed to be recovering until 03-APR-2008. The patient experienced extreme weakness and pain on the side of her hand. On 05-APR-2008 the patient was admitted to the hospital and was undergoing a diagnostic work up which included a magnetic resonance imaging scan and computed tomography. No other symptoms or treatment reported. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  4/18/08 Reviewed PCP medical records which consisted of vax record, hospital admit & transfer records of 4/7-4/10/2008. FINAL DX: general weakness following remote episode of transverse myelitis Records reveal patient experienced URI w/fever, stuffy nose & sore throat approx 1 week prior to admit.  Seen in urgent care & tx w/antibiotcs.  Developed dry cough but overall improved until developed sharp pain in left temple 3 days PTA followed by general malaise, shakiness, general weakness & inability to walk 1 day PTA.  Neuro consult done.  Exam revealed patient had difficulty standing.  W/U was WNL but remained weak clinically.  Transferred to rehab.  5/6/08 Reviewed additional hospital medical records of 4/10-4/23/2008. FINAL DX: Recurrent transverse myelitis; steroid induced hyperglycemia; hypothyroidism; osteoporosis; neurogenic bladder/bowel. Records for inpatient rehab stay reveal patient tx w/high dose IV steroids x 12 doses then tapering oral steroids, last dose 4/18.  Developed steroid induced hyperglycenia tx w/sliding scale insulin.  Received PT/OT & remained stable throughout.  Continueed intermittent self catheterization as at home.  Improved to ambulate w/rolling walker w/supervision.  D/C to home on oral antibiotics for UTI w/continued outpatient PT & f/u w/PCP & neuro.
Pfizer-BioNTech COVID-19 Vaccine EUA: During vaccine administration, the vaccine leaked out of the syringe. Vaccine recipient was vaccinated again.
got Shingles vaccination and still got the Shingles/Suspected Vaccination Failure; got the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got Shingles vaccination and still got the Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient's wife via interactive digital media. The reporter stated that please be careful as her husband got his Shingles vaccination and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
BREAKTHROUGTH COVID: PT FULLY VACCINATED WITH J&J VACCINE: This is a 62 year old female Admitted for Fever, COVID19, Hepatomegaly with Splenomegaly, UTI, Left Flank Pain, Kidney Stones, Pyelonephritis, Thrombocytopenia, Positive Troponin, Sleep Apena, Diabetes Mellitus, Diabetic Neuropathy, and Leukopenia.  I Consulted Dr for COVID19 and Dr for Recurrent UTI and Kidney Stones.  Patient does complain of left flank pain prior to coming in.  Does complain of some coughing spells.  Patient was found to be COVID positive in the emergency room.  Apparently son was found to be positive2 days ago.  Denies any shortness of breath.  No nausea vomiting.  No abdominal pain.
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N019923 expiry date: 28-APR-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
feels like she is a little drunk; hasn't been able to go to work; she is in the acute stage of feeling sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient with unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered, on 27Jan2021, yesterday, as single for COVID-19 immunization and she got the vaccine at the university. The patient's medical history and concomitant medications were not reported. On 27Jan2021, last night, the day of vaccination, the patient was fine. On 28Jan2021, the patient felt like she was a little drunk, not been able to go work and she was in the acute stage of feeling sick and unable to complete a report at this time. No laboratory data was provided. Outcome of the events were unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Felt malaise and sick starting 15 min post vaccination.  Later afternoon went to ER & was admitted for tachycardia.  11/26/2008 MR received for DOS 11/12-13/2008 with D/C DX: Paroxysmal Atrial Fibrillation, now in sinus.  Mild hypertension. Ptpresented to ER with tachycardia, palpitations, and SOB which began after receiving flu shot. Found to be in A-fib upon arrival with ventricular rate 130-190s. Tx with diltiazem with improvement to the 110s. No cardiac hx. Self converted to SR during stress echo. D/C on ASA.
CHILLS LASTED 3 HOURS FEVER MUSCLE ACHE HEADACHE PATIENT TOOK ALEVE
Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 31-Mar-2021 and the estimated date of delivery was 05-Jan-2022. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18-may-2021 and contains no new information
Intense painful low back, radiating down into sciatica pattern on right leg. Unrelenting pain. Treatment: Naproxen, chiropractic, heat, ice, massage, Epsom salts bath in which I slipped and fell, injuring my right knee. I then went to Urgent Care for my knee.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient received 2nd dose and experienced headache. The patient knew the side effects but could not find out if the patient could take Ibuprofen for headache.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, Diarrhea  and Headache developed within 4 hours of getting shot.  Menstrual spotting, and cramping, started less than 24 hours after getting shot. Enlarged and painful breasts started with in 48 hours of shot. Spotting and cramping lasted 4 days from onset. Breast symptoms lasted 5 days from onset.  Still experiencing lingering headaches and nausea a week later.  I have not menstruated in almost ten years. Had a D&C, Hysteroscopy and Uterine Ablation to end my heave periods.
Intermittent dull pain in chest lasting for a few minutes each time.  This occurred for the two days after vaccination.
It seemed to be an allergic reaction about an hour after the vaccine - throat partially swelling up, difficulty breathing, severe headache, and fatigue for a few days.   The first reaction lasted half an hour. After taking two Benadryl tablets and Abuterol every four hours, the throat swelling calmed down. I still had difficulty breather for the following two days, but my Abuterol kept it at bay.
Pain in (L) deltoid started the day received the vaccine; only 20% better after 5 weeks of pain with shoulder ROM mildly tender to palp.
ErythemaMultiform injection site swollen, red, warm to touch, "hard" Narrative: One week after vaccination, injection site became "swollen, warm to touch, red and "hard." 7 cm x 7 cm area of upper left arm noted by NP to be as described. Employee also states tips of left middle and ring fingers have "tingling/numbness, NP reports they are "cool to touch, but sensitivity and neuro function WNL."
My entire body from my head to my toes was so painful that I couldn't even walk. My knees, my ankles, my feet and my neck and shoulders and fingers- a squeezing sensation and pain in my entire body and it was that way for the entire day and the next day it was gone. I never had this pain any other time.  I went to my physical therapist that next day after the vaccine because I thought I had done something to my body - he stretched out my back, knees and so with his help maybe it resolved faster than it would have.
EMPLOYEE STATED THAT THE NEXT DAY, 21DEC2017, THE SITE WAS TENDER, SORE AND HAD REDNESS. THEN 2-3 DAYS AFTER THE INJECTION SHE DEVELOPED A RASH ON HER UPPER BODY THAT TOOK ABOUT A WEEK TO RESOLVE.
patient received two doses of YF-VAX (Both from the same lot number) with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old male patient who received two doses of yellow fever vaccine - [YF-VAX] (both from the same lot number) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch VI (Typhim VI) for Immunisation.  On 24-May-2023, the patient received two doses of 0.5 mL dose of suspect yellow fever vaccine - (Strength: Normal) (batch number: UJ818AA; expiry date: 18-April-2024) via subcutaneous route in the left thigh and right thigh for immunization (both from the same lot number) with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of yf-vax (both from the same lot number) with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
WOKE UP FOR WORK, FELT BAD-FEVERISH, CHILLED, HEADACHE. AS DAY PROGRESSED FELT WORSE-FEVER, SORE THROAT, WEAKNESS, HEADACHE.  OVER NEXT FEW DAYS, FELT LIKE HAD BAD COLD-SICK FOR 8 DAYS, FINALLY WENT AWAY
Extreme hive that progressed into angioedema. After 2 weeks on 2 terms of 4mg  medrol dosepak, it wasn't getting any better with super swollen red face and tongue, ended up going to Urgent Care near by and got a shot of steroid along with 15 days of 30m,20mg,10mg of predisone. Still not all healed up with hives, going on 5th week.