chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had no energy; was tired; she noticed it was harder to move; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of loss of energy in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced loss of energy (Verbatim: had no energy), tiredness (Verbatim: was tired) and mobility decreased (Verbatim: she noticed it was harder to move).  The outcome of the loss of energy, tiredness and mobility decreased were not reported.   It was unknown if the reporter considered the loss of energy, tiredness and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the loss of energy, tiredness and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-Sept-2023 The patient received 2nd dose of Shingle vaccine and felt like crap. The patient was also tired, had no energy and noticed that it was harder to move.
Tiredness/fatigue; Sleepiness; Diarrhea; Joint pain; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose number unknown, single (Lot number: FN2908) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness/fatigue"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepiness"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Consumer reported, that he was basically trying to figure out how long these side effects last. He had the COVID shot the Lot# FN2908 on the 26th of July that was Tuesday. Queried for how long these side effects last. Consumer stated, that well it was just on the side effects listed its mentioned to report the side effects and report them to the Pfizer account. Reporter stated that he got the shot on Tuesday, 4 days ago and tiredness, sleepiness, fatigue, diarrhea, joint pain, fever. Reporter stated that patient had no Medical history and not had received any other medication and had not undergone any laboratory test.
The patient was inadvertently given the Pfizer vaccine for his second dose when he received Moderna vaccine for his first dose. First dose of Moderna was given on 4/7/2021 and the second dose of Pfizer was given on 5/12/21. Pt reports no side effects from the vaccine. The pt was examined by his primary care doctor on the same day of the second dose.
This case was reported by a consumer and described the occurrence of joint pain in an 84-year-old female subject who was vaccinated with Influenza quadrivalent vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included lymphoma "10 years ago", "severe" osteoarthritis and "very, very" weal immune system. On 2 October 2013 the subject received unspecified dose of Influenza quadrivalent vaccine (unknown). On 2 October 2013, within hours of vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced joint pain and less than a week (between 02 October and 06 October) after vaccination with Influenza quadrivalent vaccine, the subject experienced did not feel well and low grade fever. The subject reported that she "was not ill from any disease that I know of the day I took the vaccine. However, since then have had severe pain in all my joints, especially neck, back and hands. Could I be having a reaction from the flu shot? I had a brief low grade temp the night after taking the shot also. I took the shot on October 2nd, and still do not feel well (06 October)." At the time of reporting the events were unresolved except the outcome for low grade fever was resolved.
Pt received FLUMIST and per mom ("a couple hours after he developed a tic in which he blinks his eyes more or less constantly and makes a throat clearing noise").
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. No information regarding the patient's concurrent conditions and medical history were reported. On unspecified dates, the patient were vaccinated with doses of improperly stored ROTATEQ, oral (unknown strength and lot#). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
No adverse effects were reported; TE with PNEUMOVAX 23 PFS; This spontaneous report was received from a consumer and refers to a 77-year-old patient of unknown gender.. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 03-MAR-2023, the patient was vaccinated  with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023 (product storage error). No additional adverse event (AE).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002750: US-009507513-2304USA002667: US-009507513-2304USA002694: US-009507513-2304USA002746:
patient was dizzy, sweaty, skin color pale.  He wanted to lie down and not would not respond to calls or touches.  After about a minute he became responsive with normal skin color.  Vital signs normal a
Congestive Heart Failure; fluid on lungs; He was found to have fluid on the heart; Shortness of breath; Stroke; A spontaneous report was received from a family member concerning reporter's husband who was also a 86-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke/cerebrovascular accident, congestive heart failure/cardiac failure congestive, he was found to have fluid on lungs and hear /pulmonary oedema and pericardial effusion and shortness of breath/dyspnoea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) on 23 Jan 2021. On 20 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient had a stroke. The patient consulted with general practitioner on 22 Feb 2021 who ordered a magnetic resonance imaging (MRI). Patient started to develop shortness of breath on 22 Feb 2021. The MRI on 24 Feb 2021 confirmed that the patient had suffered a stroke. On 05 Mar 2021 the patient went to the emergency room with shortness of breath. The patient was diagnosed to have fluid on the heart and lungs and with congestive heart failure. Treatment for the events included Clopidogrel and aspirin.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) and NO ADVERSE EVENT (no adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, 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 06-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023).    No concomitant medications were reported. Vial size was reported as 2.5 mL.Vial was initially stored in the refrigerator on 10-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
APPROXIMATELY 4 DAYS AFTER GETTING THE FIRST SHOT OF THE COVID-19 VACCINE, MS. THREATT EXPERIENCED NAUSEA, BODY ACHES, VOMITING (FOR FOUR DAYS), AND A CHANGE IN TASTE BUDS. SHE SAYS SHE NO LONGER CAN DRINK ANYTHING BUT WATER AND CLEAR LIQUIDS AND THAT FOOD SUCH AS MEAT AND BREAD ARE NO LONGER ABLE TO BE EATEN.
I tested positive for COVID-19 on 12/22/2021. I didn't have symptoms at the time, but I knew that I had been exposed and decided to test. Later on, I developed loss of taste and smell. I was not prescribed medications for this health event. I also did not take any over-the-counter medications.  I had these symptoms for about a month and a half. I still have altered smell and taste. Everything smells and taste kind of like onions. I have also developed high blood pressure and I am pre-diabetic. That does not run in my family or anything, so it is kind of strange to me.
first dose in 2018, has not received their 2nd dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was requesting guidance regarding the second dose or if the patient should restart the series. The reporter did not consent to follow up.
Erythema, edema and pain at DTAP site left thigh.  Treatment with Rophatexin 25 mg 1 tsp three times daily for 7 days.
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patient was inadvertently vaccinated with 4 doses of ZOSTAVAX injection (dose, route, frequency, lot # and dates of vaccination were not provided). It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. No adverse effect was reported. Additional information has been requested.
Information has been received on 08/12/2002 from a licensed practical nurse concerning a female who was vaccinated with two doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  It was reported that the patient still does not show immunity to mumps."  The patient sought unspecified medical attention.  Additional information has been requested.
Tingling in legs after receiving shot. Initial pulse 45, after 2min heart rate 60. Laid down, feet elevated, felt better after resting.
Chills, sweats and all over body pain about 10 hours after injection.  Was greatly improved by taking ibuprofen, but I still felt tired and had a headache for about 20 hours.  Axillary lymph node became swollen and tender a few hours after injection.
extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly.  Feeling of overall pain and discomfort. exhaustion.
Patient received his first Pfizer COVID vaccine on 09Feb2021.  Patient then received his first Ilumya shot, which is a SunPharma product, on 26Feb2021; Big red, warm splotches up and down sides; Big red, warm splotches up and down sides; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; tildrakizumab asmn (ILUMYA), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via an unspecified route of administration from 09Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriasis. Medical history included psoriasis. Concomitant medications included steroids (did not know the specific name of steroid that was prescribed), fluid pills. Reportedly, reporter was calling to report a potential adverse event with the Pfizer COVID Vaccine as a patient received our covid vaccine and their product as well that was an injection. Reporter stated that the patient was transferred to her from their (manufacturing company) Drug Safety Department, and this was the information they provided to her. Patient received his first Pfizer COVID vaccine on 09Feb2021. Patient then received his first ILUMYA shot ( product), on 26Feb2021. After patient got his ILUMYA shot, patient broke out with big red, warm splotches up and down his sides on unspecified date in 2021. Reportedly, assessed as other medically important condition. He had no issues with his first ILUMYA shot or first covid shot but since getting both, he was not sure if there might be some interaction. On 09Apr2021, he got the second ILUMYA shot. Reporter states that ILUMYA was for psoriasis and states that the patient told her that his psoriasis was better. The outcome of events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events " Skin disorder" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
first injection Aug 19, 2018 / Get second injection now, three years later?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 19th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by the patient for himself or herself. The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked about dose schedule and questioned if the patient should get second injection now, three years later or start over with two-injection regimen. The reporter consented to follow up.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the second of three reports. A male patient of an unspecified age (reported as above 65, unit unknown) received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced oval shaped red patch with red dot under injection site. The outcome of events was unknown. Information regarding the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018223259 same reporter, suspect drug and event/ different patient;US-PFIZER INC-2018225880 same reporter, suspect drug and event/ different patient.
13jan90 pt vax Hepta B. pt developed pharyngitis,malaise,dizziness,rhinitis,dysuria,loss of appetite,increased nasal congestion,arthralgia, and orthostatic hypotension.  Pt treated w/ tylenol and prednisone. pt recovered.
Lip tingling  within an hour of vaccination.  Woke up in the morning around 5:30am.  Upper lip was extremely swollen and bottom lip was moderately swollen.  Swelling was also present on left side of face from chin to left eye.  Medical Director was notified, MD and she advised to immediately take Benadryl and Zyrtec.  Medication taken at approximately 8am. The symptoms began to alleviate within the hour after taking the medication.
6 hrs after injection arm pain 10/10, arm went limp, associated swelling next day pain reduced to 2/10.
Telephone call at 3:30 PM 6/17/03 stating since 8:00 AM on arising she has felt "real dizzy". Dizziness increases with turning her head. She is able to walk without losing balance, but walks slowly. Also complained of sore arm at site of injection. Complained of some shakiness.
Dolor en el medio del craneo muy fuerte boca seca fiebre constante, dolor de  oído  diarreas
Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from Department of Health and Human Services until 05-01-2023, sent via e-mail to my supervisor, and then forwarded to me on 05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Had already received earlier dose of Pfizer mRNA vaccine. Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 06/07/2023 and tolerated well.
Started with a headache 5 hours after the vaccine. Got worse and worse and got dizziness, weakness, fever (got worse and worse up to 103), and nausea.
Break through bleeding; bleeding in between periods; Biopsied and found mRNA in the cervical tissue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001181 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Break through bleeding; bleeding in between periods"; CERVIX DISORDER (non-serious), outcome "unknown", described as "Biopsied and found mRNA in the cervical tissue". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
67M with dementia, HTN, HLD, DM2, subarchnoid hemorrhage due to ruptured right middle cerebal artery distribution aneurysm s/p craniotomy complicated by encephalomalacia, seizure disorder and hydrocephalus s/p ventriculoperitoneal shunt 2010, vaccinated w/ Moderna 3/18, seen in ED for seizure 8/4, tested covid + (asymptomatic), presented on 8/13 with generalized weakness, found on the floor at home   Methylpredniolone 125 BID, iNO (8/13-8/15) Decadron 10mg BID (8/16- Completed 5 days remdesivir today (8/14-8/18)   FiO2 35L, 90%    Covid pneumonia/acute respiratory failure - received tocilizumab in ED. Admitted to ICU and treated with methylpredniolone 125 BID, iNO (8/13-8/15) and HFNC. FiO2 req is variable. He is more alert today -cont HFNC and wean as tolerated -cont decadron 10mg  BID 8/16- -cont to trend inflammatory markers