chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe gum recession in mouth; severe gum and tooth pain; severe gum and tooth pain; difficulty opening mouth; severe pain in left ear; severe pain in left hear and left side of face; shingles-like events on left side of face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown, Expiry date not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (age at vaccination was 28 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy, osteoporosis, and gluten sensitivity. The facility where the most recent COVID-19 vaccine was administered was a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: Unknown, Expiry date not reported), arm left, on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced severe gum recession in mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe gum and tooth pain on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, difficulty opening mouth on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left ear on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, severe pain in left hear and left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date, and shingles-like events on left side of face on 12Apr2021 15:00 with outcome of recovered with sequelae on an unspecified date. Therapeutic measures were taken as a result of the events included dental service, antibiotics, and antivirals. The events were reported as serious, disabling by the health authority.  No follow-up attempts are possible. No further information is expected.
First evening (7:00 PM): aches all over as well as injection site, chills, loss of appetite, lethargy Second day:  aches all over as well as injection site, chills, fever (99.8) in the evening, lethargy, loose stool Third day:  Aches all over , fever lower, chills, lethargy, loose stools Forth day:  Aches all over, chills, general tiredness, low appetite
This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) 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. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second 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 WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) 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 WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.). No concomitant information was reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2023-716914 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-716914:same reporter.
This spontaneous report was received from a Registered Nurse regarding 2 unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in February 2015, the patient was vaccinated with 2 doses of improperly stored VARIVAX (Merck) (dose strength, route and lot number was unkonwn). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED VACCINE THAT WAS DATED WITH END OF USE DATE OF NOV 30, 2021 AND PATIENT WAS ADMINISTERED THE VACCINE BOOSTER ON DEC 1, 2021.  PATIENT HAD NO ISSUES AT THE TIME OF VACCINE, DURING APPT OR OBSERVATION TIME IN OFFICE.  NO ISSUES WERE NOTED FROM THE PATIENT.
Patient with single J+J COVID vaccination 08/12/2021 who admitted to hospital with positive COVID test.  Provider discharge note below:  "90 YO male with h/o dementia, HTN, DM2, HFpEF, who was initially admitted with acute multifocal stroke in setting of COVID-19 infection. He was quite debilitated on admission with generalized weakness, inability to eat, left gaze preference and expressive aphasia. MRI brain showed multiple small acute infarcts in the frontal lobes, parietal lobes, and in the left temporal occipital lobe. TTE and U/S Carotids unremarkable.  He was started on aspirin per stroke protocol. A couple days into his hospitalization he enrolled in hospice due to failure to improve and severe persistent neurologic deficits.  Due to COVID-19 infection, his hospitalization was prolonged while waiting for bed availability and clearance of COVID.  Surprisingly, during this time he had significant improvement in mental status and will returned nearly to baseline.  Given the dramatic improvement in mental status and he was unenrolled from hospice enrolled in hospice.    After revoking hospice, he was noted to not have completed a full stroke workup. He subsequently had CTA head/neck which was negative for atherosclerotic disease. Telemetry had been discontinued when he enrolled in hospice, and he refused for it to be replaced.  He also refused any repeat labs.  Discussed TEE with him and his wife and they deferred at this time.  I was able to discuss his case with a neurologist.  Given multifocal embolic appearing stroke the strongest suspicion is for either hypercoagulability due to COVID-19 infection or paroxysmal atrial fibrillation that was not captured during the hospitalization.  Discussed risks and benefits of anticoagulation with patient and his wife.  They are amenable to starting anticoagulation with Eliquis.  Will order Zio patch monitor on discharge for further evaluation of atrial fibrillation.  If this is negative for atrial fibrillation would consider stopping Eliquis in treating with anti-platelet therapy alone.  He will follow-up with neurology on discharge for further evaluation.  Discharged to SNF in good condition. "
This spontaneous report was received from a licensed practical nurse refers to a 17 year old patient, gender unspecified. On 18-MAR-2013 the patient was inadvertently vaccinated with 1 milliliter (ml) VAQTA (lot#, expiration date not reported) intramuscularly. No adverse effects reported. Additional information has been requested.
CHILLS; LOW GRADE FEVER; EXTREMELY FATIGUED; SORE ARM; DELAYED OF MENSTRUAL CYCLE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 100 pounds, and height was 61 inches. The patient's concurrent conditions included hypothyroidism, seasonal allergies, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride.  On 08-APR-2021, the subject experienced delayed of menstrual cycle. On 08-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced extremely fatigued.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and low grade fever, and extremely fatigued on 10-APR-2021, and had not recovered from delayed of menstrual cycle. This report was non-serious.
pain/soreness at the injection site; hardness of the left arm at the injection site; red rash on her right breast,  tiny red rash in her right shoulder; irritation in her bra area; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix (intramuscular) and the 4th dose of COVID 19 BOOSTER (intramuscular). In April 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site induration, red rash and skin irritation. The patient was treated with hydrocortisone (Hydrocortisone Cream). In April 2022, the outcome of the injection site pain and injection site induration were recovered/resolved. On an unknown date, the outcome of the red rash and skin irritation were not recovered/not resolved.   The reporter considered the injection site pain and injection site induration to be related to Shingrix. It was unknown if the reporter considered the red rash and skin irritation to be related to Shingrix.     Additional Information: GSK receipt date: 22-Apr-2022 Reporter's comment:The patient self reported this case. On 22nd April 2022, the patient contacted GlaxoSmithKline response center. She had Shingrix shot and a Covid booster shot on the same day in left arm.  She did not remember the day she got the immunizations but she thinks it was late last week.  She did not had the paperwork nearby to check for the date of administration or the lot number/expiration date.  She provided information regarding which pharmacy she had the shots at since they would had that data on file.  She reported that she could felt them being administered (going in) into the muscle.  She experienced pain/soreness and hardness of the left arm at the injection site. These local events had resolved. She started to felt a little irritation in her bra area. She took a shower and noticed a red rash on her right breast. This rash has not yet resolved.  In April 2022, she had been applied hydrocortisone cream and had made an appointment to see her OB/GYN doctor.  She also had a tiny red rash in front of her right shoulder that looks like it could be a (bug) bite. This tiny red rash on her right shoulder had not yet resolved. She was not sure if this rash was due to Shingrix or not but she regrets getting Shingrix and the Covid-19 booster on the same day. Consented to follow up.
Beyond the 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported. It was reported that dose was drawn up on 30Nov2021 and the dose was administered on 01Dec2021
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not reported.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received a vaccine past the beyond used by date. Treatment medication was not reported.  This case contains information for the 31st of 190 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
herpes zoster, 2-3 dermatomes, rt thoracic area;hx of uncomplicated varicella @ 2wk of age p/household exposure, maternal hx of childhood varicella;had negative IgM & IgG titers JUL95;zoster currently active;
Local reaction right thigh with erythema and induration developed nine days after immunizations.  Also with low grade temp. (99.9)
Red circle around injection site. Itchy and about the size of a baseball. Recommended benadryl cream application and oral claritin for a few days. If reaction gets worse, patient is to go to urgent care.
7 days after patient had her first shot she started developing a rash that has involved 85% of her body.
NEARLY DIED; NEARLY BLIND; HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 prophylactic vaccination. No concomitant medications were reported. The batch numbers were not reported. The Company was unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced nearly died, nearly blind, and heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nearly died, heart issues and nearly blind was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
pt states that her lymph nodes swelled, she states 2 lymph nodes were swollen and caused swelling from her shoulder to elbow.  She also states she had a fever of 102 degrees that lasted for 2 days. she received her shot Friday around 5:15pm and had fever the next day during the day. She said the Saturday night the swelling occurred causing her to go to the emergency room for treatment. They treated her and she is recovered now but was advised by the emergency room that this was a systematic reaction and to have the pharmacy report it to vaers
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
Case number PHEH2016US026177, is an initial spontaneous report received from a consumer on 10 Oct 2016. This report refers to a 59-year-old female patient. Past medical history included throat swelling/thickening throat, itching and seizure like phenomena on COMPAZINE. Concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 04 Oct 2016. On 05 Oct 2016, the patient experienced thickening of throat, itching and pre seizure symptoms/ seizure like phenomena. The patient was treated with BENADRYL. The physician gave the patient steroids (unspecified) and PEPCID. It was reported that, patient felt well (reported as on 7th, date unspecified). The patient stated that, he had similar reactions to COMPAZINE. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non-serious by the consumer. The causality of the events was not reported. The case was lost to follow up at initial.
This is a spontaneous report from contactable physician via Pfizer Sales Representative. An 18-years-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose in left arm for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe pain in left arm and neck stiffness on an unspecified date after receiving meningococcal group b rlp2086. Event outcome was unknown.
I received my first Pfizer booster for COVID-19 on 8/26/2021. On 7/20/2022, I began to have symptoms similar to those of a mild environmental allergy. I just had a slight cough, a postnasal drip, and a bit of a sniffle. On 7/21/2022 at around 3 AM, I had increased coughing. I was getting ready to go to work at 6 AM, and I decided to take a home test for COVID-19, and the result was positive, though with a very faint line. Later that day, I called my doctor's office and requested a prescription for Paxlovid. I picked up the Paxlovid at around 4 PM that afternoon, and shortly before that, I began to have a deep cough accompanied by a fever of 101, chills, and shaking throughout my entire body. I also began having some shortness of breath. I began the Paxlovid that evening and went to bed. The deep cough lasted for about 48 hours. I felt weak and tired for about 5 days. I had some heart palpitations, but I suspect they were caused by the Paxlovid rather than by the virus. I took another home test on 7/27/2022 and 7/28/2022, and they both yielded negative results. On 7/29/2022, I returned to work. I immediately felt weak and had shortness of breath. I was supposed to work 12 hours that day, but I ended up working only 8 hours. During my time at work, I had to pause and rest a lot. On 7/30/2022, I felt fine and worked my usual 12 hours. On 7/31/2022, I went to work to fill in for someone for 4 hours. At about 11 AM, I went back home. At around 1 PM, I started having a scratchy throat, so I retested myself, and the result was positive. By that night and for the following four days until 8/4/2022, I had a minor cough. My main symptoms were shortness of breath and extreme weakness and fatigue. I was barely able to walk from my bed to the bathroom. I tested myself every day up until 8/8/2022, and the results were consistently positive. I did not get a negative result until 8/10/2022. I retested again on the morning of 8/12/2022, and the result was negative. It was on that day that I again returned to work. At the time of this writing, I still have some weakness and shortness of breath. I'm normally a very active person, but I haven't been able to walk more than a block without stopping to catch my breath and rest. I have returned to work, however. I work part-time, so it doesn't demand too much out of me.
This spontaneous case reported by an other healthcare professional, describes the occurrence of product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion). At the time of the report, product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Syncope, flushing/dizziness, sweating, BP 92/50 (pulse 77). F/u pulse 116/56, O2 sat 99%.
Patient vaccinated on 8/7/2019.  Returned to clinic on 8/8/19 with redness and swelling at site of varicella vaccine administration.
been sick for a week now; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case from a consumer via media.  This case involves patient of unknown demography  who had been sick for a week now (illness), after receiving  INFLUENZA VACCINE.  Patient had flu shot every year.  The patient's other past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number  and expiration date not reported )via unknown route in unknown administration site for prophylactic vaccination.  It was reported that the patient knew that it doesn't stop the flu from happening but people don't get it as bad ,however because of the stress on account of the Virus last year and on an unknown date, the patient was sick for a week now (illness, non serious) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event sickness.  There will be no information on the batch  number for this case.
violently ill for 4 days, nausea, diarrhea, headache/fever, chills, aches and pains, sweats, extreme fatigue, dizziness, trouble breathing, unable to take deep breath, unable to eat