chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morning/couldn't eat dinner because people couldn't wake her up; This is a spontaneous report from a contactable consumer (patient's husband).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history was not reported.  Concomitant medications were not specified (reported the patient was taking bunch of medications, but the reporter did not know exactly what they were). Historical vaccine included first dose bnt162b2 on 24Dec2020 and second dose bnt162b2 on 11Jan2021, both for COVID-19 vaccination. She didn't have any side effect from the first shot or the second shot. The patient received 3 shots of COVID vaccine, received 1st dose of vaccine on 24Dec2020, 2nd dose on 11Jan2021. Then inadvertently given another dose yesterday, on 12Jan2021.  Immediately after the 3rd dose of vaccine, the patient almost "like fell asleep". She was hardly open her eyes this morning. The patient was in a nursing home. The nursing home staff was finding it difficult to feed her now. The patient couldn't eat dinner because people couldn't wake her up. The patient just had the COVID test, no other lab test. The outcome of the events was unknown. Information of lot/batch number has been requested.
Fever of 101.8 after Tylenol, increase of GERD symptoms, severe headache, swollen arm with redness.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of varicella zoster virus vaccine live. Three days after vaccination, the patient had manifestations of herpes labialis and herpes genitalis. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Fever, lethargy, joint pain,  headache, nausea, vomiting, diarrhea for 3 days. The worst was the joint and skin pain.
On 4/27/06, client received ORA Typhoid 4 tabs. On the 7th day after taking the 4th pill, client complained of rash in the torso area. Bumps were red, raised, painful and itchy. Client saw doctor and said they didn't look like shingles. Will f/u with doctor.
CLOTS; This spontaneous report received from a consumer via a company representative via social media 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, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced clots. The reporter stated that "My friend got clots from vax as well. Not good" The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220920781 -covid-19 vaccine ad26.cov2.s-Clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Immediate shoulder pain after injection. Unlike prior influenza vaccination soreness. Pain was worse the following morning and has not gotten better.
SLIGHT PAIN IN ARM; This spontaneous report received from a patient 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced slight pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight pain in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428453.
Employee came by on 01/07/08 to report that he had begun feeling poorly yesterday. Complains of aches, fever, and just not feeling well.  Difficulty sleeping.
This spontaneous report as received from a pharmacist refers to a 60 years old male patient. The patient was vaccinated with ZOSTAVAX (subcutaneous)(lot number 0257AE, exp. date 15-MAR-2013) on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: aspirin. On an unknown date the patient developed a blood clot in an unspecified anatomical location after receiving ZOSTAVAX. The patient sought unspecified medical attention. Treatment included heat. No lab diagnostics studies were performed. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness for the adverse event is unknown for ZOSTAVAX. The pharmacist mentioned the patient reported having "problems with AFLURIA (case number 1211USA007429) as well as with other unspecified vaccine in the past", but did not have any information to clarify what those problems were. This is one of several reports received from the same source. Additional information has been requested.
Employee is a 22 year old male with PMHx of depression on Wellbutrin, presenting today for an MMR booster. He recieved the vaccine and shortly after, stated that he felt pre-syncopal. He had a witnessed LOC event lasting ~30 seconds while in vaccination chair. Did not fall or hit head. Upon regaining consciousness, stated that he was confused, but was alert and oriented x3. Denied any nausea. Stated feeling "off". Denies any drugs/alcohol yesterday or today. States that he is likely dehydrated, did not drink water today. Had a meal about 2 hours prior to arrival. Has has syncopal events in the past, usually with prolonged standing.   OBJECTIVE: Vitals checked immediately after syncope: BP 90/50, HR 101, Oxygen level 97% on room air Vitals checked 10 minutes later: BP 131/82, HR 80, oxygen level 98% on room air Diaphoretic and pale appearing, improved with time  ASSESSMENT: Syncopal event post-MMR booster vaccination, likely vasovagal  PLAN: - Patient was  provided with cold towel for head/neck, juice, peanut butter and granola bar. Stated that he began to feel better right away.  - After ~20 minutes of recovery, patient stated he felt back to normal and was ready to leave without assistance.
Face is red; Face is little swollen like she had a bad sunburn; Fever; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Face is red), SWELLING FACE (Face is little swollen like she had a bad sunburn) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever). On 15-Jan-2021, the patient experienced ERYTHEMA (Face is red) and SWELLING FACE (Face is little swollen like she had a bad sunburn). On 14-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, ERYTHEMA (Face is red) and SWELLING FACE (Face is little swollen like she had a bad sunburn) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided.  No treatment medications are provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The pt received the influenza vaccine on 11/3/98 and 11/4/00 without incidence. The pt was dx'd with breast cancer in 1980, which is currently in remission. For the treatment of this cancer, the pt has for years been taking raloxifene Hydrochloride and megestrol acetate orally on a po basis. The pt has also, for an unspecified period, been taking hydrochlorthiazide orally on a PO QD basis, for the treatment of hypertension. On 11/20/01, the pt experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the pt was seen by a physician, was dx'd with Bell's Palsy and Prednisone was prescribed with some improvement. On 11/27/01, the pt was seen by her regular physician for follow-up. The dx of Bell's Palsy was again confirmed as the pt presented with lip drooping, however, swallowing had improved. Prednisone for an additional 2 weeks, was prescribed. The reporter has assessed the relationship of Fluvirin to the event as possible. This was considered to be an "Other Important Medical Event".
Heart was racing; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number- EN6198) via an unspecified route of administration on 02Mar2021 as dose 1 single for COVID-19 immunization. Medical history included autoimmune disease. Concomitant medication included Prednisone for autoimmune disease. Patient stated, she had no high blood pressure and she do not have heart disease and she was not a diabetic. So, she do not have any of those, other than a rare autoimmune disease that she had, she had the Prednisone to take for. Patient stated that she had a shot this morning but she had a severe reaction which lasted for 25 minutes but she went to the holding area that they put us in, a waiting area that they put us in to wait for 15 minutes but she had to wait a half an hour because she have had severe reaction to a drug (Unspecified Medication) before. So, she waited a half and hour but between that her heart was racing and she was slightly dizzy on 02Mar2021. So, her concern was none of that was documented, but she wanted to know do she go back for a second shot after what happened. The patient underwent lab tests and procedures which included heart rate: racing on 02Mar2021. The outcome of the events was recovered on an unspecified in 2021.  No follow-up attempts are possible; Information on lot/batch number could not be requested
Approx. 10 fluid-filled papules located on face, head and chest; flu-like symptoms and fever.
Patinet received his Janssen Covid Vaccine today. He was fine in the immunization room and  he went to the waiting area. Patient lost conciousness and fell on his partner. We went to him when we heard from another customer. He said he was feeling really lightheaded and thirsty.  He had Syncope (Paleness, excessive sweating, and Loss of Consciousness for few seconds). He mentioned he did not drink much water today before the appt and also worked outside in the sun. We had him wait  for 30  mins and he was perfectly fine. Coach came to do an incident report and then he left. His partner was with him all the time.
Initial report received from non-healthcare professional on 03 October 2013. A female patient, whose initials, date of birth and age was not reported, had received a dose of FLUZONE intradermal vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. The patient also had received PNEUMOVAX (batch number, route and anatomical site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that after vaccination the patient had enlarged lymph nodes in the arm pit of the injection site. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of the adverse event was not reported. Documents held by sender: none.
Neurological damage; Left pupil is permanently dilated; have blurry vision; Extreme sensitivity to light; Trouble sleeping/insomnia; Have not received the 2nd dose, because got neurological damage.; This spontaneous case was reported by a nurse and describes the occurrence of NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) for Headache, HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]) for Sleep problem, BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light), INSOMNIA (Trouble sleeping/insomnia) and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.). At the time of the report, NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
approx 24 hrs p/vax pt c/o joint pain (lt wrist, hips, ankles, shoulders); 16FEB94 low grade t99; pt inc Feldene also took Ibuprofen & APAP; used ice to affected joints; did not contact MD-will see him MAY;
The day I got the vaccine, I started getting severe diarrhea and it lasted for 4 days. I then got severe upper abdominal pain for 2 days where I could not stand up straight. My lower abdomen is now swollen and painful and my entire stomach aches every time I eat. I also had 101°F fever for 2 days following vaccination. I have lost 5 pounds since I got the vaccine.
Visible swelling and aching left deltoid injection site; no redness except at bandaide site, which he states is not unusual; site not particularly warm to touch. Swelling measures 90mm laterally and 65mm proximally. Denies shortness or breath or difficulty swallowing. Self treatment with ice and analgesic suggested.
Patient order for 1st dose COVID vaccine (monovalent) , but was administered Pfizer bivalent vaccine.
Received Vacination around 2:30 PM Tuesday Nov 22,2005. About 8:30 PM I started having chills, fever and loss of energy, and bad headaches, followed by aches and pain. Symptoms continued until approxamately 8AM on Nov. 23 2005, except for the loss of energy which I still have, but not as severe.
Erythematous area on Right thigh surrounding innoculation site measuring approx 15x15cm, indurated and ecchymotic area approx 5x5cm surrounding innoculation site. Local R inguinal lymphadenopathy 1x1cm. Blanching erythema with minimal tenderness to palpation.
3 days after vaccine with axillary swelling, skin erythema distal to injection site
The first 4hrs after administration of vaccine, extreme tiredness was evident, with nasal stuffiness. 24hrs after administration, shortness of breath was noted, which lasted at least 36 hours.
My COVID-19 infection symptoms started on 12/31/2022 in the evening at 06:00pm. I had a dry cough, post nasal drip and fatigue. I did 2 COVID-19 home  tests on 12/30/2022 and 12/31/2022 which were negative. On 01/01/2023 I took another COVID-19 home test this time I tested positive.  On Wednesday/ Thursday I called my doctor and ask for cough medication. He prescribe me with a cough medication.   I received the  cough medication  after 1 week since because they ran out of it.   When I got the medication I only used it 1 time. I used   over the counter  medication such as  Dextromethorphan and a nasal spray. I still have  cough and the worst nasal dip which I can't get rid off.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 08-MAR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy (Dosage, route of administration, Lot number and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about 23-SEP-2015, the patient was treated at an urgent care facility (by an unspecified healthcare professional) for the onset of a painful and pruritic rash, which was diagnosed as shingles. The female patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcomes of the events were unknown. Causality assessment was related. Additional information has been requested.
Fever 99, sore throat, lymph node tenderness 2-3 hours after MMR
Had four bruises under the opposite arm (right arm) two days after vaccine given.  No injury or explanation for the bruising  Also moderate tinnitus started in both ears for no apparent reason about two months after vaccination and continues until present ?-awaiting an ENT referral visit in early November since it has not resolved
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out for about a minute or 2 after receiving a flu and a covid booster vaccines. paramedics were called in and checked vitals. all vitals were normal. patient left home with parent afterwards
~ 4 hours after administration developed facial numbness, no weakness or other neurologic symptoms. Evaluated on 3Feb21 and symptoms had resolved, unremarkable neuro exam.
A non-serious spontaneous report of administration of expired vaccine was received from a pharmacist concerning a 36-month-old patient. Neither past medical history nor concomitant medications were reported for this patient. On 07-Dec-2010, patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report as received from an office worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dosage, route and injection site were not known) on 07-JUL-2011. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient was given the second dose of GARDASIL (lot number, dosage, route and injection site were not known) late and the second dose was given on 22-MAY-2012. It was unspecified if the patient had sought medical attention. Additional information has been requested.
patient reports two weeks after vaccine developed numbess abdominal numbess which has progressed to numbess from breasts dowwn to bilateral knees, around left and right flank, left leg primarily affected with numbess and pain. has seen several doctors including PCP dr   at  hospital.
PROBLEM A. PSVT Dx 1989 with rare episodes; 2018 episodes increased, PSVT Dx confirmed, put on metoprolol 12.5mg daily, PSVT controlled; 20Sep2021-6hour episode PSVT, Dx of Wide-complex Tachycardia & Paroxysmal A-Fib with Rapid Ventricular Response; metoprolol increased to 25mg daily; apixaban, atorvastatin added; as of 03/28/2022 I am awaiting further testing and evaluation regarding my condition. PROBLEM B. Since 1 April 2021 I have experienced 3 separate episodes of muscle/tendon inflammation, pain & weakness in my right foot/lower right leg, left hip, and bilateral shoulders; I have had to undergo 3 separate courses of Physical Therapy for all 3 body parts in order to regain my mobility and reduce my pain.
Widespread hives which lasted almost 10 days. Began approx. 3 hours, post vax. Treated with Benadryl and cool compresses.
Ached all over but that was in the list temperature of 100.4 after taking 2 TYLENOL 500 mg each. Did not take temp before that.
Information has been received from a physician's office concerning a 21 month old Vietnemese female patient who on 03/10/99 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. Concomitant vaccinations the same day included a 3rd dose of Haemophilus B conjugate vaccine, and a 3rd dose of Diphtheria Toxoid (+) Pertussis vaccine (+) Tetanus Toxoid. On 06/12/00, the patient's laboratory results were positive for Hepatitis B surface antigen. Additional information has been requested.
Reported Shortness of breath-Treated for bilateral pulmonary embolism-treated with a regimen of eliquis
Redness, swelling & induration at injection site, 14cm long x 9.5cm wide. Questionable secondary cellulitis. No fever or other systemic s/s. Injection site central to lesion. Right arm.
a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "a little soreness".  Additional information: The patient stated, she did not have a problem her call was about the timeline for her 2nd vaccine. They gave her 28 days instead of 21 and she was concerned. Aside from a little soreness no problems after either shot. Thank you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (09Mar2021): The initial was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 09Mar2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported in response to the Non-HCP letter sent which included that: Event little soreness and other additional information was added.  Follow-up attempts completed. No further information expected.
p/vax pt exp flu-like symptoms & tingling in different areas of the body; tx: w/aspirin & resolved in 2-3 days;