chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My periods (I've had 4) since the shot have been extremely and abnormally heavy; My periods (I've had 4) since the shot have been extremely and abnormally heavy; Days of painful cramps which turn into a dull heavy feeling in my uterus; Covid test result - Positive Date 09Aug2021; Covid test result - Positive Date 09Aug2021; This is a spontaneous report from a contactable consumer (patient herself). A 47-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0181, Expiration Date: Unknown), via intramuscular route of administration in Right Arm on 26Jul2021 11:00 AM (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Cyst for which I take nuvaring to keep under control from an unknown date and unknown if ongoing. Patient had Penicillin allergy. The concomitant medications included Flonase Nuvaring from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient received other medications within 2 weeks of vaccination was reported as Flonase Nuvaring. On 09Aug2021, the patient experienced drug ineffective, suspected COVID-19, on 18Aug2021 07:30, the patient experienced, heavy menstrual bleeding, menstrual irregular, and dysmenorrhea. Her periods since the shot have been extremely and abnormally heavy. She never had periods like this before. Days of painful cramps which turn into a dull heavy feeling in her uterus. The cramps start about 2 days before she starts bleeding which was not normal for her. On 09Aug2021 the patient underwent lab tests and procedures which included COVID-19 test results Positive, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for adverse event reported that she will have a pelvic ultrasound on December 10. The outcome of all the events was reported as Not Recovered.
Low grade fever, muscle aches, weakness, sore throat.  Symptoms intensified to total exhaustion and extreme muscle aches in evening.  Followed by symtoms of rhinitis and URI.
Mom reports that child has "a soft ball sized red lump on the back of the right arm" when MMR vaccine was given. No fever. Mom reports child has been "tired and says she doesn't feel well."
Patient is a 26 year old male in the observation area presents with itching and rash on his right lower back post vaccination. Hysical exam with singular hives with 1cm x 1 cm but otherwise physical exam unremarkable. Vital signs stable. Possible allergic reaction from pfizer vaccine. Improved pruritus and hives post cetirizine. Will refer to Allergist for clearance before next COVID 19 vaccine.  Sent home stable.
Exact date and time of COVID vaccination unknown. Patient presented to Medical Center on 04/02/21 with left sided weakness and slurred speech. He reports receiving the COVID19 Janssen vaccine 15 days prior. Details of vaccination beyond patient report are unknown. Diagnosed with acute left cerebellar stroke, status post TPA on 04/02/2021. Extensive workup in hospital negative and unremarkable, including TEE, and hypercoagulable state so far negative. Follow up with hematologist as outpatient underway to evaluate for any possible coagulation disorders.
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose unspecified, subcutaneous, indication reported as "age-based, it was recommended"). Concomitant medications were unspecified. On an unknown date the patient experienced a "burning sensation" at the injection site. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Headache, fatigue and nausea for 2 days, which I expected.  On the 3rd day, both arms (from wrist to shoulder), both thighs and chest became bright red and very, very warm.  This lasted for 2 full days.  After 2 weeks, the dead skin flaked off of these areas.  Similar to when you get a sunburn which later heals.
PT started having chest pains however it was couple of months after his 2nd dose of pfizer.
My daughter received the GARDASIL vaccination and within 4 hours was screaming with her head hurting. From this day until present she has had 30 episodes of fainting, severe migraines, fatigue, body aches, missed 25 days of school, contracted pneumonia, the flu, viruses, and had sinus surgery. The syncope has worsened so that she stays home, absent from dance and swimming, battles with asthma, and has an immune disorder. This all began after that shot and has been downhill ever since. My daughter has developed anxiety, and depression due to the change in lifestyle.
patient called on 1/11/2021 and reported a reaction after getting Moderna vaccine.  Vaccine administered on 1/4 and later that evening she noticed a generalized rash and some tightness/tingling in throat.  She took benadryl.  Symptoms progessed over 24-48 hours and throat tightening worsened so she took epi pen & benadryl.  This relieved symptoms.
headache; muscle pain; joint pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 30th December 2019, 1 days after receiving Shingrix, the patient experienced headache, muscle pain, joint pain and shivering. On an unknown date, the outcome of the headache, muscle pain, joint pain and shivering were unknown.   It was unknown if the reporter considered the headache, muscle pain, joint pain and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had severe headache, muscle pain, joint pain, and shivering after administration of Shingrix dose.
PATIENT REPORTED NUMBNESS AND TINGLING TO RIGHT FOOT.  PATIENT OBSERVED.  PATIENT REFUSED AMBULANCE SERVICE.
SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: The patient was on medication for rheumatoid arthritis (RA). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious. This case is a duplicate of 20221238194 and 20221240998. This case, involving the same patient is linked to 20221238349.
tested for Covid 19 IgG and IgM antibodies, and the result was negative; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested for COVID 19 IGG and IGM antibodies, and the result was negative. The physician reported that the patient, after 2 doses of the covid vaccine the patient decided a month after to get a blood test, it was at a commercial lab, and tested for Covid 19 IgG and IgM antibodies, and the result was negative. The physician stated that it could be possible that the specific antibody was not part of the testing panel or if this is a concern that immunity was not generated with the vaccine. The patient was concern that immunity was not generated with the vaccine.  The patient had tests and procedures which included blood test: Negative a month after to get a blood test/ and tested for Covid 19 IgG and IgM antibodies, the result was negative. The clinical outcome of  tested for COVID 19 IGG and IGM antibodies, and the result was negative was unknown.
It was noticed that the member was coughing across the room. Member was assessed and was having difficulty breathing. Patient had used her inhaler a few times on her own. Patient was given o2 via a NR at 156pm. On call provider was notified and patient was helped to administer her own Epi-pen and EMS was activated.
On 10/9/20 the patients wife presented to the pharmacy to pick up a prescription for methylprednisolone 4mg pak that was sent in by the patient's primary care doctor.   The patient asked for the "person who gives shots," so I went over to consult.  She stated that her husband was in significant pain and had localized swelling in his right arm where he received pneumovax and flublok.  She stated that when they spoke to the doctor's office they stated that pharmacy gave the immunization too high on the arm, causing possible frozen shoulder, pain, and swellling.   I apologized for the harm caused and asked if I could follow up.  I will be contacting the patient every couple of days to make sure the problem doesn't get worse.
pt recvd vax 6MAR92 & 17AMR92 pt devel inc pain in shoulder of vaxed arm (day of onset unk) & restricted shoulder movement; orthopedist dx frozen shoulder; pt undergoing physical therapy;
Localized induration, diffuse erythema (approx 4cm diameter), bordering erythematous ring approx 6cm in diameter, mild pain/pruritis.
Pnucn20  gave me swelling, pain, and redness to left are to the area of sight within a short time. Several hours later I began having abdominal cramping with nausea, vomiting, diarrhea, chills, and fever that lasted several hours.
Non response and posturing after tetanus shot, lasting 45-60 seconds, without memory, with fatigue.
This spontaneous report as received from a 86 year old female consumer reporting on herself. On 15-APR-2013 the patient was vaccinated with ZOSTAVAX (Lot # not provided) 1 time vaccine, subcutaneous (dose not reported). No other co suspects were reported. Concomitant therapies included hydrochlorothiazide, lisinopril+hydrochlorothiazide and levothyroxine sodium. The patient reported that on 29-APR-2013, the patient experienced a rash under her arm on the opposite side the vaccine was given on . The patient reported the rash was on her right elbow to wrist and now on the left arm and stomach. The patient described the rash as itchy, red and welts. The patient did not seek medical attention. Treatment was not given for the events. The outcome of the patient had a rash under her arm on the opposite side and the rash as itchy and welts was unknown. Additional information is not expected.
an expired dose of Fluzone High-Dose Quadrivalent was administered with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 72 years old female patient who had an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 27-Oct-2022, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ731AA and expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for Influenza, Immunization.  On 27-Oct-2022 the patient developed a non-serious event of an expired dose of fluzone high-dose quadrivalent was administered with no reported adverse event (expired product administered) (Latency: same day). Reporter was requesting efficacy and the need to re-administer.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
At 2:00 approx while in school he reported nausea and feeling hot and weak; at 5:30 I observed patient to go white, diaphoretic, clammy, c/o of trouble breathing (though visibly breathing), headache, nausea, low grade fever 99.4 lasted all weekend. Cold sx next day. Missed school on Monday.
passed out on the floor; fainted; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who fainted and passed out on the floor.  The patient's medical history was not provided. Concomitant medications included a blood pressure pill and a thyroid pill.  On 23 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The details of the administration of the first dose were not provided. On 24-Feb-2021, after being awake for 30 minutes, the patient passed out on the floor and fainted.    Treatment information was unknown.  Action taken with study drug was not applicable as the patient had already received both scheduled doses.  The outcome of the events, fainting and passed out on the floor, was resolved on 24 Feb 2021.; Reporter'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.
Moderna COVID?19 Vaccine EUA April 20th 1. Diarrhea beginning one hour after vaccine which lasted 4-5 hours 2. Severe arm pain including underarm 3. Extreme fatigue 4. brain fog, dizziness April 21st 1. had severe chills for 4-5 hours without fever (4am-9am) 2. Body aches similar to the flu, especially around the neck area 3. Swollen neck lymphnodes 4.. Started running fever  in the early afternoon which gradually reached  100.7 at around 3  or 4pm.  (My normal body temp is 97.3) I took tylenol for the fever and advil for the pain 5. Fever reduced to 99.4 but did not go away until 3rd day 6. headaches 2nd and 3rd day after vaccine  By Friday April 23, 2021 (4th day) slmost all symptoms gone.  Remaining side effect is neck pain, stiffness, and tenderness.
received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021.  Presented to the ED on 1/24/2021 with the same symptoms; COVID-19 test came back +.  Per ED physician, "On repeat evaluation she is resting comfortably in the room.  O2 saturation remains in the low 90s on room air.  Vital signs otherwise stable.  Her Abbott Covid test was positive.  CBC does show leukopenia otherwise unremarkable.  BMP shows mildly elevated creatinine, no other significant abnormalities.  Chest x-ray unremarkable.  Patient was ambulated with pulse oximeter and O2 saturation dropped into the mid 80s.  Recommended she be admitted and she agrees.  Case discussed with hospitalist who agrees to meet the patient.  We will give her Decadron here". Admitted to the RCU where she received ceftriaxone and azithromycin for bacterial pneumonia.  Transferred to healthcare facility on 2/1/2021.
Lymph nodes in armpit on affected side started swelling, as well as neck and now chest lymph nodes are swollen
eye muscle twitching for 1 day right side head scalp & around right ear pain ( occipital neuralgia) for 4days on going continuously till today 01/11/2021
Severe right deltoid pain and swelling with vomiting x 1 and low grade fever. After 48 hours patient felt much better.
Mother and pt in clinic. C/O "fever last night". C/O blister-like lesion on R arm. Currently Afebrile today (6/7/07). Observed 2 lesions on R arm, currently not blistered. Lesions are not on injection sight. Lesions are where the sticky part of the bandaid would have been. Instructed to keep clean and if worsens go to PMD for follow-up.
rash on my thighs and arms/rash moves to another area; blisters hands, fingers, toes, feet, knees, and elbows; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (blisters hands, fingers, toes, feet, knees, and elbows) and RASH (rash on my thighs and arms/rash moves to another area) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced BLISTER (blisters hands, fingers, toes, feet, knees, and elbows). On an unknown date, the patient experienced RASH (rash on my thighs and arms/rash moves to another area). At the time of the report, BLISTER (blisters hands, fingers, toes, feet, knees, and elbows) and RASH (rash on my thighs and arms/rash moves to another area) outcome was unknown.        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 concomitant medication details was reported. The patient saw his HCP on 06Jul2021. Doctor prescribed him an anti-fungal medication, but he has not used it.
During the holidays, I had a stocked up head, blowing my nose constantly, low-grade fever, constant sneezing, and sort of a cough. I did develop a little headache after with slight lethargic/fatigue. I took a COVID-19 rapid antigen test on 12/31/2022 since my husband had tested positive days before. My test came back positive. I contacted my doctor who prescribed me Paxlovid 5-day prescription after having to wait to be off my heart medication for 24 hours. Since then, I'm doing better with slight shortness of breath periodically.
[COVID-19 Vaccine, Pfizer] treatment under Emergency Use Authorization(EUA): Patient presented to outside hospital with petechial rash around injection site and within mouth. COVID Vaccine was administered 1/22. For 2 days following the vaccine she felt extreme fatigue and headaches. By Monday 01/25/2021 her symptoms had improved but then developed a diffuse rash and sores on her gums. Evaluation in the outside ED showed a platelet count of 2,000. Patient was transferred to our hospital for increased level of care, hematology consult, and platelet transfusion. Thrombocytopenia likely sec immune mediated destruction vs infection vs medications vs unlikely MDS or marrow infiltrative process.
Patient with right-sided facial twitching ~2weeks after 1st Moderna vaccine, no other neuro symptoms or fevers. Also received 2nd vaccine yesterday. Referred to neuro.
Muscle ache, headache, nausea, chills, pain at site of injection.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 02-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient. The patient did not have any known allergies. On 04-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J003808, expiry date: 03-JUL-2014, in left deltoid for routine vaccination. On 05-DEC-2013, 2 days after onset of therapy the patient experienced redness, swelling, and tenderness at her injections site. The outcome of redness, swelling, and tenderness at her injections site today was reported as not recovered/not resolved. Causality was not provided. Additional information has been requested.
18-24 hours post vaccination, had fatigue, malaise, nausea, "wierd feeling in head."
1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
Info has been received on 6/11/02 from a registered nurse w/a history of endometriosis and NDKA who "11 yrs ago" received a series of Hep B vax recombinant. Subsequently the PT had a titer that was negative. On 3/5/02 the PT was vax'd w/a booster dose of Hep B vax recombinant. Concomitant therapy on 3/5/02 included tramadol HCl (Ultram), valdecoxib (Bextra) and carisodropol (Soma). The nurse had a titer in Apr. 02 that indicated the presence of antibodies. The PT also has labs drawn on 5/29/02 and had an "elevated SGOT 52 (nl 1-50) and SGPT 76 (nl 1-50)." It was noted that the PT also received a dose of MMRII at the end of March 02, "because of a negative rubella titer." Add'l info has been requested.
I spiked a fever; shivering chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 12 hrs after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had no side effects after the first dose. The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. About 12 hours spiked, the patient experienced fever and shivering chills.  The patient asked how long do the side effects usually last.
Monday morning inc temp, given APAP temp dec then at noon had a sx; stated temp back up; bathed pt w/cool cloth; mom stated temp 100 & some;
WORST CHILLS; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On an unspecified date, the subject experienced worst chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worst chills. This report was non-serious.
LMP 18 Jun, vaccinated 11 July. Pos preg test 18 July. Did have vag bleeding in late July/Aug dx with subchorionic hemorrhage. Doing well in Oct. On 04 Nov fetal demise noted on ultrasound.   Symptoms: SECONDARY AMENORRHEA(N911).