chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was on a blood thinner; A spontaneous report was received from a consumer who is a 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was on a blood thinner.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included a blood thinner.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient called to report she was given the Moderna COVID-19 vaccine while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, was on a blood thinner, were considered resolved on 14 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number: not provided). The patient was given the mRNA-1273. while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork.  There were no reported AEs associated with his case of out of specification product use.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-AUG-2012 the patient was vaccinated with VAQTA dose 1 (lot number, expiration date, concentration and route of administration were not reported) and one month after, on 25-SEP-2012 the patient received dose number 2 (lot number, expiration date, concentration and route of administration were not reported). The patient didn't experienced any adverse event, however the vaccine was administered in an inappropriate schedule. Additional information has been requested.
stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced  Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  (hospitalization, disability, life threatening),  Treatment was given for the events of stroke, a thunder clap headache,  limbs stiffened up, eyes crossed, lost speech, and  brain aneurysm.  The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  not recovered, while Mood Swings, Anger and Pain was unknown.  Information on Lot has been requested.
Lymph node under arm swollen to 11x11 cm and painful.  Rash under arm that spread all the way  to hip. Swollen and painful spleen.  Weight loss.  Night sweats. Lasted over 3 weeks
This spontaneous report as received from a physician assistant via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) for prophylaxis of chickenpox (dose, route, site of administration and lot # not reported). On an unknown date the patient developed shingles. It was unknown if the patient sought medical attention. The outcome of shingles is unknown. Additional information is not expected.
Noted to have red raised warm area with distinct marks from where vaccine administered, pain at site warm to touch tender mother took picture of left arm on phone to show provider.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
The arm is a little bit sore; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program Support.   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  First shot on Saturday. The arm is a little bit sore. Took half a dose of Ibuprofen. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Urticaria along the face, torso, and extremities. Airway was unaffected. Referral submitted to allergist for further evaluation.
Redness, swelling at injection site, progressing to induration, pain, fever, diminished left shoulder ROM due to pain. Seen at ED 09/20, DX'd with cellulitis at injection  site, prescribed Keflex.  SX's resolved over next 7-10 days.
Vaccine administered at 9am. Tongue felt "itchy". Felt like a "hotdog" in throat. Vision changes began. Benadryl administered at 09:15am. Patient monitored for 15 more minutes. No improvement. Taken to ER.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L027726, expiration date 01-MAY-2017, exact doses were not reported, orally). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Fever of 102.7 degrees orally on A.M. of 7/6/2005.  Pt also feels weak.
Developed shakes, chills, alternating hot and cold flashes, fatigue, muscular aches starting at 11:45 pm.  Has let up some - shakes have stopped. and am generally feeling better (4:00 pm).
Information has been received from a medical assistant concerning an 18 months old male who on 15-APR-2009 was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (LOT# 662577/004Y). On an unspecified date after vaccination the patient experienced injection site redness and swelling. It also reported that unspecified medical attention was sought and the patient was recovered. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. (Complaint ID # 154668). This is one of several reports received from the same source. No further information is available.
mom reports unsual sound & saw pt having grand mal sz, jerking movements, eyes rolled back in head; pale-white skin tone; mom called ambulance pt transferred to hosp ER where skull x-rays & blood work done;
After vaccination, patient became lightheaded as she left the room. Mother lowered patient to ground with feet resting on chair in hallway. Pulse was mildy tachy and patient had severe pallor at that point per Dr. Patient was taken to urgent care via wheelchair. Blood pressure 92/61 at 1646, pulse 76 BPM.  Patient felt improvement lying on bed. Patient had been hiking that morning and admitted to not drinking enough water that day. Dr. suspected dehydration and vasovagal reaction.
I received the flu vaccine shot at my job on 10/8/2015 at 12:00pm.  I felt off from the minute the shot was given to me.  The arm the shot was given in felt tingly like it was falling asleep.  I left work at 1pm and went home. By 1:30pm I was wheezy, dizzy, and nauseous. I had a lot of tightness in my chest, I developed chest pains and it felt like I had a 5 ton weight sitting on my chest.  I felt like my chest was collapsing. I took 3 ibuprofen, two puffs of my ProAir inhaler, and 2 Dramamine and tried to lay down and rest, but I couldn't.  By 3pm these symptoms had increased in intensity and now my insides were racing and I felt like my heart was in my throat.  I felt like I had swallowed something whole and it was lodged in the very bottom of my throat.  At 3:30pm I had my aunt take me to the emergency room where I had an EKG and chest x-ray done.  I reported to the ER doctor and nurse that I had the flu shot earlier in the day and the quick onset of these symptoms.  I was not ill prior to or at the time of receiving the injection.  This is the second time I have ever received a flu shot. While at the hospital, I was hooked up to a heart monitor. My heart rate went back and forth between 85 and 100 beats perminute.  Once the doctor looked at my EKG and chest x-ray, he confirmed that I was otherwise healthy and that my symptoms were definitely caused by an allergic reaction to the flu shot.
Swelling, rash, discomfort, crying throughout night. (R) leg. Mother reports onset 10/6/14 evening, didn't report to our clinic until 10/7/14 evening. Pt seen again in office 10/8/14.
The patient received an unauthorized vaccine/ patient was not age 12 at the time the vaccine was administered.
Left arm- 5.5 - 6.5cm SL. red soft area - warm -> hot to touch.
pt recv vax; exp arthritis & arthralgia;f/u info stated sx not related to vax;pt had sustained an arm injury "on job" resulting in persistent arm pain;
8/27/04 Telephone call from patient's mom. She states patient had broken out in rash all over her body that day. 8/31/04 Spoke with patient's mom. Had been to MD (for another problem) and had MD look at rash. States unknown origin. Mom states steroids were prescribed, but unknown if steroids were for rash or other problem.
Information has been received from a registered nurse concerning a 9 year old female who on 14-FEB-1999 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 08-NOV-2007, the patient developed chickenpox lesions over her entire body. No other symptoms were reported. Unspecified medical attention was sought. The patient was treated with loratadine. The patient was noted to be recovering. There was no product quality complaint. Additional information has been requested.
Received the vaccine in the afternoon on 4/14. Morning of 4/15 started getting extreme chills, aches, and had a fever of 100.1. These symptoms continued off and on through the morning of 4/18.  All were controlled and lessened by Tylenol and Claritin. On the afternoon of 4/18 the symptoms were happening despite the Tylenol and Claritin. Had an appointment with my GP's office on 4/19. She said that they are finding that those with auto immune disorders like myself experience issues after the vaccine for an average of 7 days. I would say I had symptoms for 9 days.
Information has been received from a pharmacist referring to a 67 year old female patient with allergic reaction to "sulfa drugs". The patient had no pertinent medical history. On 03-APR-2015 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # K023622, expiration date 20-FEB-2016, subcutaneous in right arm). There was no concomitant medication. On 03-APR-2015, shortly after the vaccination, the patient developed left and right sided neck stiffness. the patient visited unspecified chiropractor for "a couple adjustments as that typically works but did not this time". The patient also tried to use heat and cold to affected area and that did not help. In addition, ibuprofen was also used but did not provide relief. The patient sought medical attention by contacting the pharmacist and no lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Information has been received from a health professional concerning a patient in kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label). Received dark pink Moderna Bivalent as 2nd dose instead of Dark blue cap .
erythema papular vesicular rash, scattered: scalp, behind ears, few on face, bottom, legs, feet, even soles. 2 or more surrounding erythema rash slight pustular appearance.
Next day arm soreness, red at injection site. Symptoms resolved by 1/6/21. On 1/8/21 new at injection site inflammation, redness,  itching,  hot to touch. Pt went to Hospital ER1/10/21 to seek medical diagnosis cellulitis in arm;  treatment medication and cream. Symptoms not resolved but improving
When she was standing up her knees kind of gave out; Hands are shaky; she could not think well and had a hard time recollecting her personal information; Body temperature reached 98.4°F today; A spontaneous report (United States) was received from a consumer concerning a 75 Years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events include when she was standing up her knees kind of gave out, hands are shaky, body temperature reached 98.4°F, she could not think well and had a hard time recollecting her personal information.  The patient's medical history includes she has mild allergies and an asthma patient. Concomitant medications used by the patient are tylenol, albuterol inhaler, vitamins, high blood pressure medication, medication for allergies.  On 24 FEB 2021, prior to the onset on events the patient received one of two planned doses of mRNA-1273 (Batch Number: 006M20A) via unspecified route for prophylaxis of COVID-19 infection.  On an unspecified date, when patient was standing up her knees kind of gave out, her hands were shaky and on 26 FEB 2021 she had 98.4°F of body temperature and patient could not think well and had a hard time recollecting her personal information.  Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided by the reporter.  The outcome of the listed events was said to be unknown.
PARTIAL ADMINISTRATION OF THE  VACCINE DOSE DUE TO A FAULTY  SYRINGE; PARTIAL ADMINISTRATION OF THE  VACCINE DOSE DUE TO A FAULTY  SYRINGE  (PRODUCT QUALITY ISSUE); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced partial administration of the vaccine dose due to a faulty syringe. On 05-MAR-2021, the subject experienced partial administration of the vaccine dose due to a faulty syringe (product quality issue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial administration of the vaccine dose due to a faulty syringe and partial administration of the vaccine dose due to a faulty syringe (product quality issue) was not reported. This report was non-serious.
12/03/21 ID note: "COVID 19 infection in vaccinated host - 3 days of sx; saturating well on RA; s/p REGN-COV x1 on 12/2. H/o alcohol abuse; multiple comorbidities that would put him at risk for severe disease w/ COVID. S/p Janssen vaccine 5/21/21. History of CVA (cerebrovascular accident), CKD"
rash; Welts; Itching; raised lesions; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1, 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: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "Itching"; URTICARIA (non-serious) with onset 2022, outcome "unknown", described as "Welts"; SKIN LESION (non-serious) with onset 2022, outcome "unknown", described as "raised lesions"; RASH (non-serious) with onset 2022, outcome "unknown".  Additional information: The reporter stated that, a 12 year old female there at the clinic for her second COVID Pfizer vaccine. She has had the first one 3 months ago at one of the local schools and she developed a rash on her entire body that resulted in welts and severe itching. The question was, should she have another vaccine or not. On paraphrasing the concern, Reporter stated, Rash with welts, raised lesions and severe itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm over bicep and deltoid area and anterior chest with reddened sunburn appearing rash. Fever 102.
Mild random phantom itching on torso, neck - it feels like I have chicken pox.
Patient woke up om 1/7/2021 and noted lump on middle of left collar bone with pain in left arm
12Pm immed p/shot red-raised, varying in size lesions covered upper lt arm @ inject site; red raised rash noted over chest & abdo; some rash noted on rt upper arm; rash behind both ears & auricular area; c/o h/a & malaise; 1215PM to ER
child received expired ACT-HIB/ liquid component of the ACT-HIB expired on 20Sep2022 with no reported AE; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced child received expired act-hib/ liquid component of the act-hib expired on 20sep2022 with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 21-Sep-2022, the patient received a  0.5ml dose of suspect HIB (PRP/T) VACCINE once ( lot UJ575AAB; expiry date; 20-SEP-2022) via intramuscular route in leg for immunization.  On 21-SEP-2022 the patient developed a non-serious event child received expired act-hib/ liquid component of the act-hib expired on 20-Sep-2022 with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
3"X3" hard lump, swollen, warm to touch, rash and significant itching to area on left upper arm that started 3 days after vaccination.  On 1-5-21 I took 50mg of Benedryl to help with swelling and itching with no response.  On 1-6-21 I took one dose of Xyzal with no response.
Ringing ears, fever 99.6, bad headache, severe muscle aches, insomnia
Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid; Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 100-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 100 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Jun2022 as dose 1, single (Batch/Lot number: unknown) and on 18Jun2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: Patient had rebound covid 19 positive binaxnow test after receiving paxlovid 300 mg. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, No known drug allergy. Patient had rebound covid 19 positive binaxnow test after receiving paxlovid 300 mg. Other medication in 2weeks was None.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.