chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exactly two weeks after the booster shot, I started to experience itching all over my body that would not stop - 24/7. It started on the palms of my hands and then the soles of my feet. It would move all over my body and could not be relieved. I only place I did not itch was the front of my face. Welts and white spots would develop as if I touched something I was allergic too. Once an area stopped itching, it would move to another spot on my body.  After speaking with my PCP, she advised me to take a daily dose of Zyrtec.  I started taking it and within 24hrs the itching stopped. To test out the theory, a week later i stopped taking the Zyrtec and within 24hrs of it being out of my system, the itching started again. It has been almost 3 months and any time I stop taking Zyrtec, the itching immediately starts again. Upon doing research,  my symptoms are similar to other patients who had the vaccine/booster and had "chronic spontaneous urticaria".  Patients had the same timeline/symptoms/outcome as myself and the only relief they found was after taking Zyrtec. I have not sought additional help from my PCP.
No Adverse event; administered 0.25ml of the Moderna bivalent booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose).    No concomitant medications were reported.  Pharmacy technician reported to administered 0.25ml of the Moderna bivalent booster dose to a patient on 05-Oct-2022. Lot number was 057F22A and expiration date (30 days use by) 24-Nov-2022.  No treatment information was reported.
about 1hr p/vax pt exp transient episode of pallor, tremulousness, hyporesponsiveness lasting about 4-5hr; temp spike to 103 in hosp; rt oM devel p/admission;
Anaphylaxis (wheezing, throat swelling, rash) nearly 24 hours after vaccination
first shot felt like I was drugged. Slurring speech and dizzy. Second shot incredible body pain, couldn't get warm, left arm that received shot was swollen, itchy, and red for three days.
8/15/21: Patient presented secondary to shortness of breath. history of COPD maintained on inhalers and no oxygen who states he has been short of breath "for a while".  He did report being dizzy with increased shortness of breath since waking up today.  Patient has had nausea and difficulty with taste and smell more recently, reporting that food just does not taste right.  Patient tested positive for COVID-19 in the ER.  Note: patient previously vaccinated with Moderna Covid-19 vaccine on 6/11/21 & 7/9/21.   Diagnosed with Covid viral pneumonia and acute hypoxic respiratory insufficiency.  8/28/21: discharged Covid vaccine on 7/9/21.  Diagnosed with Covid viral pneumonia and acute hypoxic respiratory insufficiency. Remain in hospital as of 8/26/21.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age and ethnicity. 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, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced suspected covid-19 infection, and had experienced low symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210648299-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS
No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related.    No concomitant medications were reported. No treatment medications were reported.
mom states 20OCT began having hives, multiple bruising, petechiae, 27OCT idiopathic thrombocytopenia dx-h/a, n,v followed by coma-brain hemorrhage which was surgically drained, splenectomy followed, surgery for replacement of bone;
just didn't feel good; Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well; Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose number unknown (booster), single (Lot number: GJ6738, Expiration Date: 30Jun2023) at the age of 54 years, in right deltoid for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Nov2022, outcome "unknown" and all described as "Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well"; MALAISE (non-serious) with onset 05Nov2022, outcome "not recovered", described as "just didn't feel good".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296261 Same reporter/patient/drug, different event/dose;
Persistent pain in my upper right arm. Pain when I touch my left shoulder with my right hand. Pain when I do tasks like cleaning dishes with a sponge using my right arm. Pain running along my right shoulder blade.
No other AE's reported; temperature excursion involving VARIVAX.  VARIVAX was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) 0,5ml, lot # T017681, expiring on 21-MAY-2022, for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -7.4 degrees Celsius for 3 hours and 54 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Patient complains of headache after injection. Redness at injection site. Continued with headache and then aches, tiredness. Called our office 10-14-11. 10-17-11 talked with patient - symptoms improving.
NO ADVERSE EVENT; Caller reports expired dose of MMR II was administered; This spontaneous report was received from an unspecified reporter regarding to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and  historical drugs, were not reported.  On 18-APR-2022, the patient was vaccinated with a expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II)  0.5ml, subcutaneously (SQ)  (lot number T013003 has been verified to be valid, expiration date: 15-APR-2022), in addition with sterile diluent (manufacturer unknown) (lot number U006619 has been verified to be valid, expiration date: 06-SEP-2023) (anatomical location was not provided) as prophylaxis.   At the time of reporting, no additional information was provided, furthermore no adverse events were reported.
VACCINE ADMINISTRATINO ERRORS. BIVALENT BOOSTER WAS ADMINISTERED ON 10/22/22 HOWEVER ANTOHER BIVALENT BOOSTER WAS ADMINISTERED ON 12/12/22. NO ADVERSE EVENT REPORTED
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on an unknown date. The reporter reported that we inadvertently gave an expired dose of FLUMIST which started on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST was unknown. The report was considered to be non-serious by reporter.
Developed abdominal pain and vomiting on 9/4/2021; ultimately found to have acute appendicitis by CT scan, underwent laprascopic appendectomy
Pt reports she developed shivering, myalgia, swelling around knees, and leg weakness approximately 4 days after receiving vaccine. This has spontaneously resolved with time. It has been severe enough to cause her to miss work.
Very tired; Arm was killing her; Did not sleep well; hot at injection site; 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 received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EP6955, Expiration Date: 30Jun2021) in 2021 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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Very tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was killing her"; POOR QUALITY SLEEP (non-serious) with onset 2021, outcome "unknown", described as "Did not sleep well"; VACCINATION SITE WARMTH (non-serious) with onset 2021, outcome "unknown", described as "hot at injection site". Additional information: Following the first dose of COVID vaccine, patient was very tired, did not sleep well, tossed and turned, woke up tired. Her arm was killing her and hot at injection site. Tired all next day. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Pt was noticed to have swelling of the eyelids, was found to have bilateral wheezing & tachycardia.  There was no rxn to the 1st MMR received.
Information has been received from a healthcare professional concerning her daughter who in 1996 was vaccinated with VARIVAX (Merck). The patient was 6 or 7 year old when she received the vaccination. The patient got a bad case of chickenpox after she got the vaccine. The patient was treated with home remedies like baths and things like that. She did recovered. It was not considered life threatening. The reporter did not remember the doctor's name. No further information is available.
December 2nd- sore throat and acid stomach  December 23- still insanely sore throat acid in stomach, fever blister & canker sores covering the inside mouth and throat, tiny little blisters started on face, tongue is white and cottony,  have underlying metallic taste many days, fever blisters on lips.  I need to take  Valacyclovir 1 to 2 times a day to keep them from inflaming they will get out of control in 2 days after no meds tightness in chest like asthma when working out it is bad started with the 23rd but thought it was from the stomach. I hike a mountain for my workout. 1,400 ft in 1.1 mile. Dec 22n time 34 minutes, January 7th  46 minutes, January 23rd 57 minutes.  I felt my my next would explode with the pulse yet it wasn't that high only 140bpm which this Mtn can get me over 155 and I'm fine usually.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
Doesn't feel good in stomach; wasn't feeling well; running nose; cough; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), COUGH (cough), ABDOMINAL DISCOMFORT (Doesn't feel good in stomach) and VACCINATION COMPLICATION (wasn't feeling well ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN DIHYDRATE (AZITHROMYCIN +PHARMA) from 14-Jan-2021 to an unknown date and LORATADINE (LORTADINE) from 14-Jan-2021 to an unknown date for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RHINORRHOEA (running nose), COUGH (cough) and VACCINATION COMPLICATION (wasn't feeling well ). On 15-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Doesn't feel good in stomach). At the time of the report, RHINORRHOEA (running nose), COUGH (cough), ABDOMINAL DISCOMFORT (Doesn't feel good in stomach) and VACCINATION COMPLICATION (wasn't feeling well ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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 company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.
pt recv vax 27OCT98 & exp 2mo of pain in neck & shoulders; now able to sleep better & thinks sx are gradually getting better but cont to have some stiffness almost everyday;
Intense upper back pain and spasm on side of body where I received shot. It?s been about two full days and my back pain has only intensified. I also ran a low fever the night after vaccination.     Currently pregnant 14 weeks, previously 2 miscarriages.
Immediately following injection a large red swollen hot mass formed followed by a bruise.  The next morning she woke up with a fever up to 103.2 and breathing difficulty.  She did not want to speak says she has mouth sores. Very lethargic.  Does not wish to eat or drink now for 2 days. Phone Dr. office and told to observe and that it is common with a live virus.
Patient presented for Urgent Care hives/allergic reaction from Flu vaccine on 11-2-16.
Pt sitting in observation area.  c/o L arm whole arm aches and pinky finger feels numb on outside.  does have feeling, can move fingers equally, blood flow to finger with blanch test slightly slower.  no redness/swelling noted on arm.  no bleeding under bandaid.  not improving.  no s/sx distress.  (dizzy, SOB, ) directed to ED (where pt works) for assessment at 0810.   Pt will complete workers comp form.
Swelling in palate. Took an Allegra. Eyes, throat started swelling, bowel movements and vomiting. Dizzy and weak. Throat swollen. By 11 PM, swelling and symptoms totally resolved.
Muscle (internally) bleeding after pneumonia vaccine administered. Diagnosed by Dr. Lasted 4 days.
8MAY91 fever of 103, large local rxn 5x7cm; 9MAY91 temp 101.5, p80, BP136/76, ax node normal, no sign of cellulitis;
This spontaneous report was received from a registered nurse and refers to a 18 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 30-JUL-2018, the patient received PROQUAD, subcutaneously, lot number R002936, expiration date on 29-JUL-2019 for prophylaxis (strength, dose number and anatomical location were not reported). There was no adverse effect reported.
delayed cutaneous hypersensitivity; Woozy feeling; Bit short of breath; Unsteady; Hives; Site of inoculation on left upper arm was very itchy; Red hive at injection site; Rash devolved at injection site; It was raised (at injection site)/2x3 inch raised; Soreness at the injection site; Not feeling great; it was red (at injection site); Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady) and URTICARIA (Hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy), VACCINATION SITE URTICARIA (Red hive at injection site), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jan-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy) and VACCINATION SITE URTICARIA (Red hive at injection site) had resolved. At the time of the report, DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 62-70 (Inconclusive) 62-70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-235772, MOD-2021-025863.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: received on 24-Jun-2021 contains significant information about  AE details and outcome On 24-Jun-2021: Follow-up 2 received on 24-Jun-2021 contains non-significant information.
Generalized rash including palms and soles. Raised reddened areas times 4 on thighs.
The pt's face was red, he was very agitated, vomiting with hives on face and legs. He was given Epinephrine 1:1000, Benadryl 25mg q 6 hours X 48 hours and Advil 1 tsp po now and q 6 hours. Improvement was seen right away.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a 17-year-old male patient who received BEXSERO (batch number 16E601, expiry date unknown) for prophylaxis. Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, numbness, weakness and pain. On an unknown date, the outcome of the fever, numbness, weakness and pain were unknown. It was unknown if the reporter considered the fever, numbness, weakness and pain to be related to BEXSERO. Additional information was received as follows: This case was reported by the physician assistant. The patient received BEXSERO on the left arm which was one month apart from the 1st dose vaccination. On 11th September 2018, the patient called clinic after hours of vaccination. The patient spiked a fever and the provider had instructed him to go to emergency room (ER). The reporter agreed for follow up contact.