chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Patient started to c/o throat hurting within 10 mins administering VARIVAX and MMR vacc then started to cough and wheeze. Eyes puffy and lips swelling.
4 days p/recvd 1st dose of Engerix-B & exp double vision & weak detached feeling while driving;
Began feeling cold , got the chills, Went to bed around 11:00pm, awoke to use restroom was very dizzy and stumbled in to wall. Got back to bed awoke in the morning around 8am very weak and tired had a very bad headache, took some aspirin, IB porphin was feeling better that afternoon around 4pm
diarrhea; nausea; fever; felt sick; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in 2020 in left arm and experienced chills and flu like symptoms. For the tolerance of 1st dose, refer linked case US2021008406).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced diarrhea, nausea, fever and feeling unwell. On an unknown date, the outcome of the diarrhea, nausea, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the diarrhea, nausea, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. In 2020, the patient received both the doses of Shingrix in his left arm.    After receiving Shingrix, the patient experienced diarrhea, nausea, fever and he felt sick like he should be in bed.   The reporter consented to follow up.  This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008962:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter US-GLAXOSMITHKLINE-US2021008406:same patient, 1st dose
Positive COVID test on 26Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE. The following information was reported: COVID-19 (non-serious) with onset 25Sep2023 at 05:30, outcome "recovering", described as "Positive COVID test on 26Sep2023". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Other medications in two weeks: Finasteride 1 mg. AE treatment: Over the counter cold/flu medications If covid prior vaccination: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003207 is a spontaneous case report initially received on 15-Sep-2022 from a nurse via Bavarian Nordic and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose or site of administration, administered intramuscularly (explicitly coded as 'incorrect route of product administration'). After the vaccination, the patient was observed for approximately 20 minutes and no adverse event occurred.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from Company on 15-Sep-2022 included Company ID and indication for Jynneos, and is blended in the case narrative.  This case is linked with the case US-BN-2022-003208 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.
fever 102 F, congestion, sore throat, chills, shortness of breath, and body aches starting 12/25/21.
Redness, swelling and increased temperature to right anterior thigh (7cm X 6cm area), slightly tender, afebrile, no limp. Advil (per parent) unsure of dose at time.
Shingles; Developed rash around mastectomy site; blisters around mastectomy site; Nausea; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters around mastectomy site), HERPES ZOSTER (Shingles), RASH (Developed rash around mastectomy site) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea). On 23-Feb-2021, the patient experienced BLISTER (blisters around mastectomy site) and RASH (Developed rash around mastectomy site). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, BLISTER (blisters around mastectomy site), RASH (Developed rash around mastectomy site) and NAUSEA (Nausea) had resolved and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Event  was added (herpes zoster) and Event outcome was added as recovered
Flushed skin to face, chest and abdomen area  Itchy feet hand knees face with hives. Swollen lips and tongue
Diarrhea; This is a spontaneous report from a contactable male Pharmacist (patient). A male patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: unknown, Expiry date: Not provided), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient had diarrhea for the last two days. He had the shot nine days ago. He wants to know if this is a listed side effect. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
generalized itching that started in her left hand then spread to the rest of her body. Itchy ears, throat, eyes. Slight coughing and runny nose
Pt. presents to ED on 05/29/2021 stating that she received her 2nd Covid vaccine on 05/05/2021 and she feels like she is having a reaction to her 2nd covid shot. Pt. reports having shooting left arm pain and left leg pain with movement. Pt. reports that her 1st Covid vaccine made her feel the same way.  ED physician reports that pt. admitted to not taking basically any of her regular medications due to not having, ran out, or quit taking because she did not tolerate the side effects of her medications. Pt. presents with significant left lower leg edema, reports putting on 60 + pounds in the past 2 years, and reports she quit her HCTZ because it hurts to bad to get up and pee.
Altered taste in mouth: initially sour, followed by bitter, salty, metallic, soapy . Tongue felt swollen
Herpes simplex 1; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES SIMPLEX (Herpes simplex 1) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN and METFORMIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES SIMPLEX (Herpes simplex 1). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing from 14-Feb-2021 at a dose of 1 dosage form. At the time of the report, HERPES SIMPLEX (Herpes simplex 1) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included Glycoside NOS.  As per follow up, patient states not being diagnosed with Herpes Simplex and no more information.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant information added-Event Outcome updated.
Received expired vaccine beyond manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033A21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Dose details: Half dose Patient have received half dose of MODERNA COVID-19 vaccine No concomitant information were reported by the reporter.
Patient experienced extremely swollen lips. They began to swell on the right side of the top lip and continued to move across until it reached the middle of the left side. Shortly after the swelling of the top lip began, the lower lip began to swell.  It continued until the entire left lower lip was extremely swollen. This all took place beginning around 10 am on Wed (the day after the Tuesday afternoon injection) and continued to get larger as the day went on.
Deep tissue soreness that travels down left arm and to other muscles in body starting 18-20 hours after injection.  Soreness started to dissipate in grade around Day 4.  Left arm deltoid still sore to touch today, Day 6.  Fatigue also present Days 1-4.
Ear ringing; Ear pressure; Sinus pressure; Slightly dizzy; This spontaneous case was received on 13-Oct-2023 from other non-health professional (consumer) via Company (reference number SEQW23-03360) and concerned a 77-year-old, female patient.   The patient's past medical history included some allergies. The patient's concomitant medications included unspecified allergy medicine.   On 12-Oct-2023, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as she takes flu shot every year, as reported. The batch number reported was 370270.   On the same date, after receiving Fluad Quadrivalent, the patient experienced ear pressure and ringing, sinus pressure and felt slightly dizzy. The patient started taking Flonase (fluticasone propionate) and loratadine.  At the time of initial reporting, the patient had not recovered from the events. As it was reported that she still had ringing and some pressure and that symptoms were still ongoing  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 77-year-old patient was vaccinated with Fluad Quadrivalent vaccine. On the same day after receiving the suspect vaccine, the patient experienced tinnitus, ear discomfort, paranasal sinus discomfort and dizziness.  Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to chronological plausibility.; Sender's Comments: A 77-year-old patient was vaccinated with Fluad Quadrivalent vaccine. On the same day after receiving the suspect vaccine, the patient experienced tinnitus, ear discomfort, paranasal sinus discomfort and dizziness.  Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to chronological plausibility.
Her oncologist postponed the second dose; earache; bumps behind ears; severe sore throat feeling like two balls inside her throat; Injection site pain; Vaccination site bump and swelling; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earache), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Vaccination site bump and swelling), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PHENYTOIN SODIUM (DILANTIN D.A.) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE SWELLING (Vaccination site bump and swelling). On 24-Mar-2021, the patient experienced EAR PAIN (earache), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat). On an unknown date, the patient experienced OFF LABEL USE (Her oncologist postponed the second dose). On 26-Mar-2021, EAR PAIN (earache), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Vaccination site bump and swelling), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat) had resolved. At the time of the report, OFF LABEL USE (Her oncologist postponed the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include Benadryl cream for itching Ibuprofen for earache at ER Other Concomitant Medication was Zonosimide and radiotherapy( for Cancer).
I have known I have had arthritis for several years but is it is spreading  more, I don't  if it is because of my age or not but at  the time of my last booster it became so hard it was difficult to walk or be on my feet period.
Patient developed maculopapular rash with itchiness after 7 days of vaccinations.
Did not get second dose; Edema in right foot; Generalized arthralgia/every joint in bodyis painful and difficult; Cannot floss teeth/cannot pour coffee from carafe/cannot drive car; Muscle soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get second dose), OEDEMA (Edema in right foot), MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car), MYALGIA (Muscle soreness in left arm) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 399043L20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, LOSARTAN, FISH OIL, COLECALCIFEROL (VITAMIN D 3) and COENZYME Q10 [UBIDECARENONE] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car) and MYALGIA (Muscle soreness in left arm). On 13-Feb-2021, the patient experienced OEDEMA (Edema in right foot) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 13-Feb-2021, MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car) and MYALGIA (Muscle soreness in left arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose) had resolved and OEDEMA (Edema in right foot) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Percuman was reported.; Sender'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.
Really sick; belly burning; watery diarrhea; dizzy; scared; don't normally get sick; intestinal distress; felt weak; a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy) and FEAR (scared) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous). At the time of the report, ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications include Tried to treat with a homeopathic remedy for intestinal distress with some relief.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021 contains significant information- Patient demographics, event, second dose details.
approx 40min p/vax given mom & pt were in lab pt cheeks became flushed & scattered hives appeared on pt trunk, legs, & diaper area;no acute resp distress, afeb;sx resolved p/ DPH;
I26.99 ACUTE PULMONARY EMBOLISM 4/9/2023 DM 2 W RENAL MANIFESTATION
Received vaccines (listed below) 2/10/14. 2/11/14 - 103 fever, c/o pain, soreness bilateral thighs. Seen in office 2/11/14. No erythema, bruising or rash on exam. Uncooperative with movement of legs due to pain - (L) leg discomfort at SLR and hip flexion. 2/13/14 seen in office with very faint, erythematous rash to (L) thigh, no fever.
Pt. experienced itchiness, rash, swollen face, chest tightness, swollen hands, headache.   Took Benadryl to relieve the itchiness.  continued to have tightness in the chest.  Still experiencing these side effects 24 hours later.
Severe Flu-like symptoms. Fever, Chills, Joint Pain, Vomiting, Headache and Mental Disorientation.
On the day I received the shot I ran five miles before I got the injection. The next morning I did a vigorous physical workout for two hours. During the workout I felt a little tired and weak. Later that day I began to feel worse. I felt tired, weak, feverish, and a little dizzy. I felt so tired, weak, feverish, and uncomfortable that I spent most of the afternoon amd night in bed. The next day I was able to run a few miles, but at a slower pace than normal. During the day I continued to feel weak and tired. The next couple of days I also felt weak and tired. In addition, I experienced diarrhea for a few days.
fatigue, body aches, headache, nausea taking advil 600 mg every BID
PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.
Swelling and redness from elbow to top of shoulder-felt warm to patient. Over weekend had fever, chills, body aches.
Twelve hours post vax the pt experienced a fever of 102, became lethargic, achy and slept poorly. The next day the pts fever rose to 103.
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme  tiredness that sleep did not help.  Also, hot flashes during night. took Tylenol.   Second day,  pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder.  It had spread and was now a light pink.  A small amount of dizziness.