chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had an reaction to FLUZONE QUADRIVALENT; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown demographics patient who experienced reaction (adverse reaction) to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiration date unknown] via unknown route for prophylactic vaccination.  On an unknown date, (unknown latency) the patient experienced a non-serious reaction (adverse reaction) to INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests included no lab data.  Final diagnosis was adverse reaction.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
swollen leg (rt thigh) w/o fever area warm, few bumps;DPH recommended;rash surrounds both immunizations sites;
Uncontrollable screaming and crying.  Fussy. Decreased appetite, refusing to sleep.  Temperature 99.9F. Seen at office 4 days after vaccine administration.  Soon at or 8-9 days after vaccine administration with persistent unconsolable crying.
With in 12 hours of the vaccine I woke up with 101 fever, chills, all over pain and nausea with  vomiting  a few times.  Large amount of  arm swelling and erythema about 5inches wide and 6 inches long.  L had was tingly and painful. Nauseated most of the next day and feverish  on and off all day as well  ranging from  99.0 to 101.2 . L arm remains red, tender and itchy and it is 1/3/2021. Was unable to work 12/31/2020.   treatment included. ibuprofen, Tylenol, Aleve, ice, and rest
Headache onset 4 hours after vaccine  Nausea and vomiting onset 10 hours after vaccine
This spontaneous report as received from a physician refers to an approximately 79 year old male patient (the physician himself is the patient). No information about medical history, drug reactions and allergies was specified. Physician reports that he administered a dose of ZOSTAVAX (lot #, dose, route not reported) about 5 years ago that was exposed to temperature outside of the proper storage range. No concomitant medications were reported. Physician states he experienced an episode of shingles about 4 years ago. Physician states that "the bout of shingles was very mild" and "went away on its own after a only a few days" (recovered). There was no product quality complaint. No treatment was given, no lab diagnostics were done. Patient did not seek medical attention. The causality of the event episode of shingles was unknown. This is one of the two reports received from the same reporter (MARRS # 1410USA004305). Additional information has been requested.
Eczema; Developed a measles like rash throughout his body covering chest, arm leg and groin area; I feel itchy, rash is overwhelming; Measles like rash; Rash covering my body; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and RASH (Rash covering my body) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included SIMVASTATIN, COLECALCIFEROL (VITAMIN D3), LEVOCETIRIZINE, ALPRAZOLAM, ATENOLOL and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash), RASH (Rash covering my body) and HEADACHE (Headaches). At the time of the report, ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and HEADACHE (Headaches) outcome was unknown and RASH (Rash covering my body) had not resolved.            Other medications include  Probiotic.  No treatments were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Patient Date of birth and Outcome of an event rash was updated.
Not received the 2nd dose; Uncontrollable shaken; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tremor in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In FEB-2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor (Verbatim: Uncontrollable shaken). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Not received the 2nd dose). The outcome of the tremor was resolved (duration 1 hr) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the tremor to be related to Shingrix.     It was unknown if the company considered the tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAR-2023 and 31-MAR-2023 The reporter states that the patient visited pharmacy today (day of reporting) and reported that after he received Shingrix vaccine and had uncontrollable shaken. HCP (healthcare professional) reported that patient had not received the 2nd dose until additional information was gathered due to initial AE (adverse events) reaction of uncontrollable shaking, pharmacist did not provide any information for the patient's reaction augmented. The reporter did not consent to follow-up.  Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was identified as duplicate of US2023048514. Case US2023048514 was deleted, and all the future correspondence will be added in the present case which stands as case of record for this subject.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. In approximately 2014 (exact dates not reported) unspecified number of patients were vaccinated with (Merck) VARIVAX, (subdermal, dose, anatomical location, lot#, expiration date not reported) that had been improperly exposed to -9 Celsius degrees since 01-MAY-2014. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
vaccines were used in error as diluent/no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who only received diluent portion of received vaccines VARICELLA VACCINE, MMR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without active constituent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to Active ingredient not added to diluent.  It was reported that there was no adverse event noted.  Information on the batch number was requested.  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 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.
Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  The patient took allergy medications for the events.   This case was linked to MOD-2021-279502 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: The follow up document was received and had  significant information, that is the patient provided her email address.
Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies). On 18-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that patient had had anti-SARS-CoV-2 monoclonal antibodies treatment on 23-Nov-2021.
Vaccine was administered after at room temperature for 3 hours, which is outside the guidelines.  patient notified, feeling fine, told to contact us otherwise.
Arm got real sore by evening.  During the night I came down with the chills, extreme headache and body aches all over.  Some nausia,  had a mild earache and sore throat along with fever. Had a little bit of an appitite.    Earlier today (11:30 AM) I took two dayquil which took approx 1-1/2 hours b4 body aches, etc subsided a bit.  Felt ok for a couple of hours.  Its now 5:00PM and I'm feeling at my worst.
Information has been received from a nurse concerning a female who on 21-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660717/0224X). On approximately 21-OCT-2008, after receiving PNEUMOVAX vaccine, the patient experienced a fever, as well as redness and swelling at the injection site. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The patient had completed two courses of unspecified antibiotics but had not fully recovered at the time of this report. The patient visited the office for medical attention. This is one of several reports from the same source. Additional information has been requested.
Tested positive to Covid three day after getting the booster shot.  Was down sick for two weeks.   This same thing happen with my first round of shots.  Still having issues from having covid in 2021 and now more issues since having it in 2022.  Still having follow up visits with pcp.
3/30-  Resident was sent to ER was found to have acute CVA, R vertebral occlusion, carotid stenosis, 17mm lung mass suspicious  for malignancy, family opted for palliative and or Hospice. 4/03-re-admitted to the facility. 4/14 Admitted to Hopsice. Resident deceased on   4/16.
Hospitalized (10.25.21 - currently still admitted);  COVID-19 positive (10.25.21); fully vaccinated HISTORIES: 10.25.21 - at admission HISTORY OF PRESENT ILLNESS:  a 64 y.o. female who presents today with hypersomnolence, confusional state and generalized weakness of 4 days onset per the husband. Patient is very somnolent and when she wakes up does not answer any of my questions. Her husband is in the room who gave me all the information and answered my questions. Patient has h/o Morbid obesity(bed and wheelchair bound), diastolic chf not very adherent to her diet, oxygen therapy, CPAP at times medications per the husband. She has had few admissions this year because of CHF exacerbation, generalized weakness. Apparently patient was getting more and more weak in the last 4 days. She has been more somnolent and at times confused in the last day. He denied any fevers, chills, cough, worsening shortness of breath. However he did mention that patient has been gaining weight of several pounds and her edema has been getting  Worse. She did not have chest pain. Given the inactivity the effect of exertion cannot be quantified. She has been able to do her ADLs with more effort. She is not very compliant with her diet, fluid restriction, oxygen per husband. She is supposed to be on 3L oxygen at home for her CHF and should be on cpap for OSA but apparently she does not wear it. She apparently takes her medications on time but some times non adherent. She is tested positive for covid 19 in the ER. She is started on decadran. Her cxr does not show pna. She is on 4L/min oxygen now.( At home she is supposed to be on 3L/min per husband.) Patient also has bilateral venous eczema and follows with wound care clinic. She is recently started on bactrim for her left toe cellulitis 10.31.21 (transferred to ICU)  HPI: 64 year old vaccinated female with super morbid obesity (BMI 48), HFpEF, CKD III, WHO group 2 and 3 PH, untreated OSA, mild COPD, DM, Hypothyroid, mostly bed bound, multiple psych meds, developed COVID-19 pneumonia, admitted and diagnosed on 10/25/21. Accelerated to requiring HFNC morning of 10/30/21 and became hypoxic and encephalopathic 10/31/21 leading to ICU admission and subsequent intubation.  Currently still intubated
I experienced pain in my arm pit area approximately 8 hours after receiving my 2nd dose of the Pfizer vaccination. As I was taking my clothes off, I felt the swelling in my lower arm pit and pain in the upper armpit. I immediately went to the mirror and could visibly see an enlarged mass in the lower arm pit area same side in which I received the shot.  Also feeling swollen in neck and shoulder area but this is not visible.
Patient presented to hospital with GI bleed and underwent several colonoscopies. Diverticulosis identified. Pt had reaction to anesthetic and need to intubated. Pt was discharged to HCF
NAUSEA; FEVER; SWEATING; PAIN/INJECTION SITE PAIN; SWELLING/INJECTION SITE SWELLING; HIVES; BODY ACHES; EXHAUSTION; REDNESS/INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 42 year old female. 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 15:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced pain/injection site pain. On 03-APR-2021, the subject experienced swelling/injection site swelling. On 03-APR-2021, the subject experienced hives. On 03-APR-2021, the subject experienced exhaustion. On 03-APR-2021, the subject experienced redness/injection site redness. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9, 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and exhaustion on 05-APR-2021, sweating on 04-APR-2021, and hives on 03-APR-2021, was recovering from fever, and pain/injection site pain, and had not recovered from nausea, redness/injection site redness, and swelling/injection site swelling. This report was non-serious.
Flushed; Vomiting; Nausea; Redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FLUSHING (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Flushed"; VOMITING (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Vomiting"; NAUSEA (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Nausea"; ERYTHEMA (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Redness".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: I believe there were a couple of follow-ups sent to this throughout the week linked to the reference number. I am not sure the vaccine received, but I am 99% sure vaccinated.  Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt recvd vax 1130AM & on 18FEB95 about 3PM on the same day started day fever, poor appetite & slept more than usual; seen by MD on 20FEB t101.9; PE nl x/mild runny nose;
fatigue; a fast heartbeat that went away shorted after it started; flat headache; redness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a fast heartbeat that went away shorted after it started), HEADACHE (flat headache), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (fatigue) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Seafood allergy). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Allergy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced HEART RATE INCREASED (a fast heartbeat that went away shorted after it started), HEADACHE (flat headache), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). On 10-Jan-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 09-Jan-2021, HEART RATE INCREASED (a fast heartbeat that went away shorted after it started) had resolved. On 12-Jan-2021, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (flat headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement.  Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work.  Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm.  Slept in 2 hrs increments all night.  Saturday sipped fluids
Brain fog; feeling of sluggishness; annoyingly mild headache; Mildly sore left arm where injection was; Body felt warmer than usual when went to bed; This is a spontaneous report from a non-contactable consumer (patient herself). A 35-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1686), via an unspecified route of administration in left arm on 14Jan2021 at 17:45 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. No allergies to medications, food, or other products/known allergies. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D); Patient received both drugs within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration in left arm on 24Dec2020 at 09:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization and experienced sorest left arm where the injection was and very mild swelling of the area. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 14Jan2021 2nd dose. Later that night had a mildly sore left arm where injection was. Body felt warmer than usual when went to bed. Next morning, 15Jan2021, woke up with a brain fog, feeling of sluggishness. Mid-day, 15Jan2021 around noon, started having an annoyingly mild headache. Same night my body felt warmer than usual again. Next morning 16Jan2021 woke up feeling great and all symptoms resolved. Did not take any medications except for nature made Vitamin C and D. No treatment medications were received for the adverse events. On 22Jan2021, the patient underwent lab tests and procedures which included nasal swab: Negative, RT-PCR COVID-19 test: Negative. The events were considered as non-serious by the consumer. The outcome of the events was recovered on 16Jan2021.