chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother states at 0500 on 11/18/06 child "did not respond to shaking or voice, eyes were open but was just staring, just laid there and did not do anything." Child "felt hot", mother did not take temp. By noon on 11/18/06 child was responding and was fussy, "but was more himself" and wanted to be held remainder of day. By am of 11/19/06, child "was back to normal" and eating. Mother did not seek medical care.
A nurse reported that a 75 year old male received Pnu-Imune 23 and Fluvirin vaccines on 10/24/00. The reporter stated that the vaccines were administered after being mixed in the same syringe. Approx. 6 hours later, the pt developed a fever, nausea and swelling at the injection site. He recovered by 10/27/00.
I have COVID; I have COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (005570). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 29Jul2021 as dose 2, single (Lot number: EN5318), in left arm, on 07Sep2021 as dose 3 (booster), single (Lot number: FE3592, Expiration Date: 04Oct2021), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893, Expiration Date: 17Jun2022) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: anastrozole 1mg for breast cancer 2 years ago. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I have COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (2022) 101 and 102; SARS-CoV-2 test: (unspecified date) Negative, notes: she tested negative and she had to test negative; (unspecified date) Positive, notes: did a home test an d the test was positive; (2022) Positive, notes: had a PCR and that was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient reported that she have COVID and took Paxlovid fir 5 days. The patient have been vaccinated and double boosted and have had a relapse of symptoms after 10 days with fever, congestion and body aches.
2X GRAND MAL SEIZURE; TENDER; SORE; LUMP AT INJECTION SITE; INJECTION SITE FELT HOT; This spontaneous report received from a patient concerned a white, not hispanic or latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure which was under control with medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,expiry: UNKNOWN) dose was not reported,1 total administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced tender, sore, lump at injection site, injection site felt hot to touch. On 11-APR-2021, the patient had two grand mal seizure and and had to visit an emergency room/hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump at injection site, and injection site felt hot on 11-APR-2021, was recovering from tender, and sore, and the outcome of 2x grand mal seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210424069- covid-19 vaccine ad26.cov2.s -2x grand mal seizure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Pt reports swelling R thigh at injection site, erythema, warmth, no pain.
Patient's family member states that 3 days after receiving vaccine,  patient reports not "being able to form words". Also complained of a swollen lymph node under arm pit of arm where vaccine was given. She also states patient had a fine red rash all over his body. All symptoms have resolved as of today.
This spontaneous report as received from a healthcare worker and a licensed practical nurse refers to a 13 year old female patient. On 15-JUN-2012 the patient was vaccinated with first dose of GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified). On 20-MAY-2013 the patient was vaccinated with second dose of expired GARDASIL (injection, lot # 668554/0306AA, exp date 10-MAY-2013, 0.5 ml, intramuscular in the left arm). No adverse effects reported. Patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Patient states she still experiencing pain/limited mobility of her L arm from 10/10/13 vaccination (reported 11/13/13 at 9:30 PM) by patient. No fever, swelling, redness.
Change in menstrual cycle. Spotting on day 17 of cycle, 11 days before expected period. Spotting duration began on May 14th to current date 5/21.
Only able to get pregnant through IVF/FET. I received the vaccine at 11 weeks pregnant. And the next day I was bleeding and miscarried.
2 month old baby administered Fluzone Quadrivalent / no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received 0.25 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647ja (Expiry date 30 June 2020) via intramuscular route in the left thigh on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) ; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and HEPATITIS B VACCINE (HEPATITIS B VACCIN).  It was an actual medication error case due to inappropriate age at vaccine administration.   At a time of reporting no adverse event was reported.  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 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.
This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them RECOMBIVAX HB injection (dose, route, lot number, expiration date and thimerosal content not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient Recieved Vaccine at 11:00 am on 10-13-03 at 1:30pm Patient noticed a sore arm and Muscle stiffness and reports can't lift arm without pain.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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) all with onset Dec2021, outcome "unknown" and all described as "Covid". The patient has Covid. The reporter was unsure about vaccination status, but more than likely the patient has been vaccinated. The reporter was unsure what vaccine and dosage the patient received.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Patient received 1st dose of Moderna Covid 19 vaccine. Lot 032B21A at 12:58PM. Approx 1:05pm she started having chills/tingling all over body.  No shortness of breath/tongue swelling/lip swelling. No epinephrine was given due to no SOB. Patient experienced nausea, chills, hot flash, elevated heart rate. This continued for 50 minutes. RPH called her PCP. We both agreed best to send patient to hospital for further monitoring considering elevated heart rate. Called 911, who came immediately to take patient to hospital. Patient was alert and oriented when she left store pharmacy approx 2:15pm.
Vaccine used was compromised over the weekend when freezer temperature was not recorded. At time of incident this nurse was unaware that vaccine was not to be used. Patient as suffered no ill effects at this time.
Chills, shivering, fatigue, loss of appetite, muscle soreness (especially at injection site)
Soreness, heat in arm, swelling,unable to raise arm. Swelling has continued to 10/04/2009 along with redness  and soreness.  Not as sore as Friday-able t raise arm Sunday.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP obesity; "obesity" (unspecified if ongoing), notes: Other medical history: HBP obesity; "Cymbalta and cephalexin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Treatment of COVID-19 from 24Feb2023 to 01Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099886 Same patient, different product, different event;
Fever, large area of erythema, 8x3", unable to use rt arm to get out of chair.
I got the vaccination on Monday. On Wednesday I developed fever, chills, body aches. On Friday I was admitted to the Hospital for cellulitis in my right leg. In addition, I have an implanted loop recorder that detected a 4-second flatline sometime on the 20th and as a result of that, I will have a pacemaker installed.
It was kind of hard to open and close; Numbness at the bottom of my toes and on the right side where I had the shot and under my foot; Pain in my arm;my foot and my hand had a lot of pain in it/I only took some Tylenol as I started getting pain in my arm and it got worse and worse but it (Tylenol) really didn't do anything for it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 13Mar2021 (age at vaccination 65 years), (Batch/Lot Number: EN6199) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High blood pressure. Concomitant medication included losartan and amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) for covid-19 immunisation on unspecified date. Patient stated, "I had the second Covid-19 Pfizer vaccine yesterday and I wanted to know if it is one of the side effects that you had numbness in your foot. I had numbness at the bottom of my toes and on the right side where I had the shot and under my foot, was that normal" Patient stated, "No, I started to get numbness today (14Mar2021). Yesterday (13Mar2021), I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it and then I took some pain reliever. I had the shot around 2:00 yesterday(13Mar2021) and I didn't start getting a pain in my arm until 6 o'clock in the evening. It was little better today (14Mar2021); it was just this numbness was on that same side and my foot and my hand had a lot of pain in it earlier and it was kind of gone away and it was kind of hard to open and close it when I woke up this morning." Therapeutic measures were taken as a result of pain in my arm; my foot and my hand had a lot of pain in it/ I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it as Tylenol. The clinical outcome of the event Pain in my arm; my foot and my hand had a lot of pain in it/I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it was not recovered and remaining all other events was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Extreme runny nose...tightness in chest....wheezing....some itching...soreness around shot area.
Fever (lasted about 12 hours); headache (lasted about 24 hours); chills (lasted 1-2 hours); vomiting (twice in six hours); muscle aches (lasted a few days); onset of monthly period (started day 16 of my cycle)
Since getting the vaccine I have been having an insane amount of hormonal issues that I previously never had. I am dealing with extreme exhaustion, brain fog, breast tenderness, extreme mensural cycles (multiple in one month) as well as weight gain.
Seeing double (thought it was prism error in new glasses but didn't see double  the next day). The evening after the vaccination, got bad headache, nausea, chills. Arm soreness.
About 36 hours after the vaccine during the middle of the night the patient woke up with swelling of the R side of his face and pain. He went to the dentist the next morning who diagnosed him with parotiditis. He also saw a NP at his PCP office that afternoon. He was started on Augmentin and took ibuprofen with improvement of symptoms. Symptoms were mostly resolved by 1/31.  It is unclear if this was related to the vaccine, but given the timeline decided to report it.
03/23/21 at approximately 2:00 pm.  After recieving vaccine client had a vasalvagal/syncopy espisode.  Drop in blood pressure recorded. Return to normal limits within a minute. Client stated they were a self-proclaimed fainter
entire body horribly achy, awful sweating (soaked thru pair of pajamas), so uncomfortable I couldn't sleep, site of injection very sore. the next day (11/4) felt like I had the flu, nauseau, horrible aches, every joint hurts to move, sweat and chills, fever ranged from 99.9 down to 97.4. I'm writing this the night of 11/4 and I still feel awful.
pt recv vax 20APR98 & pt states on 22APR98 notice a knot @ inj site w/red bumps that radiated down to bend in elbow;28APR98 pt states knot going down but feels redness inc-advised to see pvt MD if worse;
This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
low grade headache /headache in the right temple; A spontaneous report was received from a healthcare professional concerning a 72 years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade headache, headache in the right temple /headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) low grade headache, headache in the right temple.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade headache, headache in the right temple was unknown.
pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 65-year-old female patient. Medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot # and expiration date were not provided) by a pharmacist.  On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): suffered shortness of breath, fever, chest pain and on 13-DEC-2016, the patient was diagnosed with pneumonia. The patient claimed damages as a result of: injury to themselves. The outcome of the event was not provided. The lawyer felt the event was related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of pneumonia was considered to be medically significant.
(L) arm neuropathy radiating to neck. Presented w/ 2 rx for tramadol 50 mg po q 6 hour and diazepam 5 mg po BID.
Woke up in the middle of the night with fever and chills.  Took Advil the next morning and later that afternoon.  I also experienced a sore throat all day.  Two days later, arm is still sore and there is redness around the injection site.  Fever and sore throat are gone.
Case number PHEH2013US026142 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 17-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medication was reported. She was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Rash; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 44-year-old female patient who experienced rash, while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided. At the time of the event, the patient had ongoing egg allergy.  On 12-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6092BA and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination..  On an unknown date, the patient developed a non-serious rash few days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event (reported as lasted for few weeks).  There will be no information available on the batch number for this case.
Arrived @ AP 6D OHS for reading of TB.  TB reading is 0mm, negative.  Also reporting a reaction that she feels is related to Hep A injection which was given 3/23/05. Employee states she woke up in the morning of 3/24/05 with a swollen, itchy face.  Went running & when she returned her face was itching, red & burning. States she took Bnadryl.  Went to work & around 4:15pm on 3/24/05 felt like inside her throat was itchy & burning. Blotchy red cheeks.
Pt's parent wrote the date of birth for their child on the consent form incorrectly but the real birthday for the child is one year difference. The patient was four years old receiving a 5-11 year old monovalent Pfizer. The parent has been notified that the child should have not received this vaccine at four years of age.
Strong metallic taste in my mouth that started about 24 hours after the vaccination.  Also, chills, hot flashes, and severe joint pain, which lasted about 36 hours and have much improved. However, the metallic taste is still present and very strong.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored VAQTA (lot # K004856, expiration date 07-DEC-2016, route not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who was vaccinated with a "larger than recommended dose" of pneumococcal vaccine 23 polyvalent.  The reporter indicated that the patient "later developed Complex Regionalized Pain Syndrome".  No patient specific information was available.  Unspecified medical attention was sought.  The was no product quality complaint.  Additional information has been requested.
Very sore arm, shortness of breath, weakness, all these have cleared up as of today but there is a swelling in my upper lip on the left
Saw dr on 7/20/23 - Received bivalent COVID vaccine several weeks ago complicated by profound weakness - to the point that he went back to using a walker and almost went to ED. Reminiscent of when he was very weak and ill with COVID. Reticent to take this again. Fully recovered now.
pt recv vax;exp dull ache in both arms;testing showed that pt failed to seroconvert;exp unspecified allergies;
Moderna Covid-19 Vaccine EUA chills from 1:00am to 6:50 am (took Ibuprofen then) chills again from 1:00 pm  to 2:30pm (took Ibuprofen again) sore, hard,  itchy red lump at vaccination site day 1-day 5 Diarrhea on day 4 for 2 hours
So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fever that was constant from Friday through Sunday. My left leg was twitching and also my left bicep. I had left sided twitching that was off and on. I had fatigue and some aching in my knees.
pt recvd Hep B vax on 6NOV91; next day devel a fever & exp nausea & shakiness; pt recovered;