chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I didn't really have any symptoms at first. I had a headache but that maybe from the congestion and I also have coughing. I thought these were flu like symptoms and then I tested and found out I had COVID-19. I was having some clogging in my ears. I had some flushing episodes at night. I called my doctor once I got the results, and I was sent over a script for PAXLOVID. I am also having issues with my nose with drainage.
Around 1540, while in observation, client notified of rash and itchy skin at vaccination site. EMS attended the client and released him.
low level fatigue for a day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (low level fatigue for a day) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2022, the patient received fifth 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 FATIGUE (low level fatigue for a day). At the time of the report, FATIGUE (low level fatigue for a day) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.   Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711664 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711664:Monovalent case
Dtap vaccine administered on 02/25. Morning of 02/26 at 0700 mother noticed normal knot and swelling of site. Morning of 02/27 child woke with whole left lateral thigh swollen, hard and hot to touch.
Received Moderna Vaccine on 01/06/2021. Reported 5 days after injection 1/11/2021 noted redness, swelling, itching at injection site along with lymphadenopathy axillary, left side, breast left side and chest left side along with fever 100.3F to 100.4 F. Reported right axillary lymphadenopathy as well but not as severe as left side. Reports called PCP on 1/14/2021 and was advised to f/u with medical evaluation 1/15/2021 went to ER where was diagnosed with lymphadenopathy and small P.E. Reported given topical Benadryl cream for itching of injection site. Reports site was fine until day 5. Reports today still has large lymph node swellling on left axillary, breast area. Denies itching of site today. Denies fever today.  Reports today, history of P.E. 4 years ago and lymph node swelling over 25 years ago after receiving a flu vaccine. Denies any vaccine since then until 1/6/2021 COVID-19 vaccine (Moderna).  Was seen in E.R. and discharged home with only topical Benadryl cream.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored GARDASIL 9 lot number L019297, expiration date 18-AUG-2017; lot number L043213, expiration date 28-AUG-2017 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 30.49F for 48 hours (the worst case scenario) at least 5 times. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 13 week old (reported as "14 weeks of age") female and her twin sister (WAES# 0802USA01046) who on 19-NOV-2007 was vaccinated with her first dose of Rotateq. The patient was not experiencing any known symptoms. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
CELLULITIS SHOULDER TO ELBOW, GENERALIZED ACHES, PAIN, DIZZINESS, WEAKNESS, FEVER.
w/in 7 minutes p/immun devel hive on head-disappeared in aobut 5 min; got 2 hives & red raised rash on abd went to ER-hives came & went -had shot in ER told to use DPH;
Side Effects:  Headache, nausea, dizziness, body aches and stiffness, low energy, fever and chills.  Dizziness and weakness was noticeable 18 hours after the injection.  The most intense side effects occurred from 21-31 hours after the injection.  All symptoms were clear 40 hours after the injection.
The skin on my back got extremely sensitive to everything.; Skin sensitivity on my back - felt like Ihad been badly sunburned. There was no visibleredness or swelling but everything thattouched my back stung.; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 1045 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6198) via an unspecified route of administration in the left arm on 27Feb2021 at 1045 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 2100, the patient reported that she had skin sensitivity on her back which felt like badly sunburned, the skin on back got extremely sensitive to everything. There was no visible redness or swelling, but everything that touched her back stung. It was reported that no treatment was taken for the events experienced. The clinical outcome of the event skin sensitivity which felt like badly sunburned and everything that touched her back stung was resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat, difficulty swallowing, trouble staying awake, gassy
?Janssen COVID-19 Vaccine EUA? Adverse events included chills, muscle pain, fever, headache, nausea
This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than an hour after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site itching. On 9th October 2018, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by physician for himself. On the day of reporting, the patient received the flu vaccination on left deltoid. Within an hour after receiving Flu vaccine, the patient experienced itching at the injection. Once the patient removed the band aid from the injection site, the itching resolved. The patient knows it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183712, reported by same reporter.
Left arm swelling size of a softball from the shoulder down to the elbow.  Redness, no fever, but had flu like symptoms - body aches and malaise.  Missed 2 days of work.  Seen by MD.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B. TREATMENT:  PT COUNSELING.  DOSE #2 22Jan90 PT EXP SIMILAR PAIN AT SOI.
Tongue had blisters on edges and tip and swollen. Reports of it feeling scalded.
Rashes, Itching, Red Induration, Tingling, Joint swollen ( Lt hand) and pain.
Loose stool; Severe body aches; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool), MYALGIA (Severe body aches), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05TK20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIARRHOEA (Loose stool), MYALGIA (Severe body aches), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Loose stool), MYALGIA (Severe body aches), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
I started waking up every day with a migraine. For awhile, I thought I was just having a difficult migraine period. But when it didn't stop, I talked to my doctor and they ordered an MRI. And then they ordered a more specific MRI with contrast. It was sent to Neurologist. He changed my migraine medication. They couldn't find anything else  wrong so just gave me a new med and it is: Ubrelvy . It helped me better than Maxalt but it still didn't help enough and migraines still were occurring.  ENT - Looked at the MRI and said there was swelling in my nasal mucous = and he thought that was the cause of the migraine - especially because I'm getting them in the morning after lying down all night. So he gave me Afrin to spray in the nose and Flonase to spray twice a day for two weeks and he also told me to take Zyrtec Antihistamine. I have been doing this for almost two weeks. I was migraine-free for about a week. I have an appt to go back and see the doctor on Monday. Today, unfortunately, I woke up with a migraine again. I don't know if it is because of changing weather or something else. I will take Ubrelvy today since I have a migraine again - it is to be used when I have the migraines.  Note: Also, I had what they thought was Tonsillitis (but it wasn't) - in early May and then I got sort of a red bump on the side of my lip and it was painful.  I went to Urgent Care - at the Medical Foundation.  My doctor thought it was Shingles. I was given Anti-viral medication and it went away. I am vaccinated against this so it was a mild case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Hypersomnia" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: red food dye" (unspecified if ongoing); "Known allergies: horse hair" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLUCOPHAGE XR, start date: 27Mar2023; AMOXICILLIN, start date: 30May2023, stop date: 08Jun2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovered" (Jun2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) Negative, notes: tested negative on day 7 after starting the prescription. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After finishing the paxlovid, I tested negative on day 7 after starting the prescription. Two days later I started to feel a little sick again and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300216472 same patient, different drug/AE.;
Bilateral pain and swelling at location of Preauricular Lymph Nodes (below right and left temple and jaw joint, pain location where lower ear attaches to side of face, with swelling from temple area down to rear of lower  jawline). Onset at about 4-5 days after injection.
Fatigued; Cough; No sense of smell; Loss of taste; Covid test positive; Fever; Chills; Headache; body ache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COUGH (Cough), ANOSMIA (No sense of smell), AGEUSIA (Loss of taste), COVID-19 (Covid test positive) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced COUGH (Cough), ANOSMIA (No sense of smell), AGEUSIA (Loss of taste), COVID-19 (Covid test positive), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (body ache). On 17-Jan-2021, the patient experienced FATIGUE (Fatigued). On 17-Jan-2021, COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (body ache) had resolved. At the time of the report, ANOSMIA (No sense of smell), AGEUSIA (Loss of taste), COVID-19 (Covid test positive) and FATIGUE (Fatigued) outcome was unknown.        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 were not reported by the reporter. Treatment included Advair inhalation and cough pill.
Given monoclonal antibody infusion 3 days prior to admission.  Now with covid PNA and admitted to the hospital.  On room air right now dexamethasone started,
Pt recv vax on 10/23/98; on same day pt exp pain & numbness of  vax site, pain in left hip &leg, dizzy, left side pain & numbness, headache, neck & shoulder pain, diarrhea, tired x 10dy
#2 imms due today - mother reported infant cried most of the day with #1 set - a slight elevation in temperature but not recorded. Resolved by night. #2 set given with plan to follow-up 6/22. TC 6/22 - mother reports infant cried for 4 hours and when he awoke next day cried most of morning. No other symptoms reported.
Information has been received from a registered nurse concerning a 20 year old female who on 29-AUG-2007 at 4:45 PM was vaccinated in the left deltoid with the third dose of Gardasil (lot # 658556/1060U). On 29-AUG-2007, in the evening, the patient developed a temperature of 102 degrees, and experienced a backache and headache. It was reported that the patient was unable to go to work the next day on 30-AUG-2007 due to fatigue. The patient's physician was notified on 29-AUG-2007 and advised rest and TYLENOL. The patient was to call if symptoms persisted. There were no further problems reported. The patient subsequently recovered from the fever, backache, headache and fatigue on 30-AUG-2007. Additional information is not expected.
Information has been received from a physician concerning a 75 year old male with a history of shingles several years ago who on 06-NOV-2006 was vaccinated in the left deltoid with a 0.65 ml dose of Zostavax. Concomitant therapy included hydrochlorothiazide (manufacturer unknown). Subsequently on 26-APR-2006 the patient developed ocular shingles which has affected his vision. He has not driven for one and half months plus he cannot see well. He was being treated with valacyclovir hydrochloride (VALTREX), pregabalin (LYRICA), "TRI-FLUOR" eye drops and Prednisone. The patient has had some improvement and was recovering. Ocular shingles was considered to be disabling by the physician. Additional information has been requested.
experience chest pain and tightness.  He had some dyspnea.  This occurred for the next week or so with the patient.  He suspected it may be a myocarditis event.  The pain is no longer present in
I experienced shingles after my vaccine. I took steroids that were prescribed. My shingles have gone away.
Fussy 18h after vaccine - 5d (so far); intermittent; uncomfortable and not truly high pitched.
Patient was admitted with high ostomy output resulting in dehydration and AKI. Pt was treated with IVF and AKI resolved. He was started on fiber supplement and imodium for ostomy output which slowed and he was able to maintain fluid balance on oral fluids alone. ED visit to hospital admission within 6 weeks of receiving he COVID vaccine.
Systemic: Sweating, Light Headed, Dizziness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient felt dizzy, light headed, profusely sweating.  Requested to lay down, then laid on the floor, small blanket under head.  SBP 90 over palpable, respirations 16, pulse 60, Temp 98.4.  Denied itching, shortness of breath, swelling of throat or difficulty swallowing.  911 notified, examined by EMS.  Patient refused transfer to ED by EMS, father stated he would transfer to ED/Urgent Care.  Patient stated she felt better, but agreed to go for further evaluation.
Fever 101.5, body aches, chills, 24 hours followed by swelling of injection site. Site is hot to touch with large rash. Very sore.
TOOK THE LAST DOSE OF VIVOTIF LATE; This spontaneous case report (PVX2019-2782) was received from a consumer on 12-Nov-2019. It described a female consumer who "took the last dose of Vivotif late" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif according to the schedule. The doses were taken on 03-Nov-2019, 05-Nov-2019, and 07-Nov-2019, respectively. Then, she took her last dose on 12-Nov-2019.   Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took the last dose of Vivotif late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the last dose of Vivotif late" was considered as not applicable.
A non-serious spontaneous report of sore throat, fever of 102 F, low appetite and didn't seem to feel well has been received from a non-healthcare professional concerning a 46-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 15-Nov-2010 in the evening. After receiving FLUMIST, the patient had low appetite and didn't seem to feel well. On 16-Nov-2010, the patient complained of a sore throat and on 18-Nov-2010 had fever of 102 F. The outcome of all the events was unknown.
Severe dizziness and nausea appeared suddenly three (3) days after getting the first vaccine; Severe dizziness and nausea appeared suddenly three (3) days after getting the first vaccine; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 10Apr2021 at 17:00, 3 days after getting the first vaccine, the patient suddenly experienced severe dizziness and nausea. The symptoms lasted for over 11 days and were still going at the time of this report. Dizziness was less severe at day 11 but was still there. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified nausea and dizziness medications. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent SARS-CoV-2 RNA, QL, RT PCR test and the result was found to be negative. The clinical outcome of the events severe dizziness and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia, penicillin allergy, and allergy to sulphates. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 12-MAR-2021, and had not recovered from chills. This report was non-serious.
pt recv vax 6JUN95 & 7JUN95 pt exp very stiff & sharp pains in neck;the pain was so bad that could not lift head from the pillow;pain lasted for 3 days;also exp joint pain in neck