chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; rash looks like little red dots, it itches and it covers the following areas of her body; Anal pruritus; itches on her ears; rash also covers around her left eye; her left eye is swollen; redness under the right eye; her body was aching; fever; redness at the injection site; irritated bump at the injection site; felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th October 2019, refer case US2020046892). Concurrent medical conditions included rheumatoid arthritis.   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, less than a day after receiving Shingrix, the patient experienced itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital. In March 2020, the patient experienced influenza like illness, general body pain, fever, injection site erythema and injection site swelling. The patient was treated with certolizumab (Cimzia) and methotrexate. On an unknown date, the outcome of the influenza like illness, general body pain, fever, injection site erythema and injection site swelling were resolved with sequelae and the outcome of the itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital were recovering/resolving.   It was unknown if the reporter considered the influenza like illness, itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling, erythema periorbital, general body pain, fever, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after 2nd dose started having a rash looks like little red dots, it itches and it covers the following areas of her body: around the neck, on the chest, down the right arm, on the top of the left arm, down her left leg, on her belly, on her anus, on her ears (both).  The rash also covers around her left eye and that her left eye is swollen. The patient also had redness under the right eye but no rash. The patient also felt like she had the flu and her body was aching and she had a fever of 100.7 degree F and also had redness at the injection site, and an irritated bump at the injection site. The patient consented to follow up.
Heaviness in the left arm, pain, under arm pain  (elbow to underarm, then lymnodes swollen and sorenes - lasted for for almost 2 weeks.
Having like the hive rash all over her entire body and in the trunk; Having like the hive rash all over her entire body and in the trunk; it makes her hands itch; Little blackness on her knee cap; Cold; Stuffy nose; This is a spontaneous report from a contactable consumer or other non-health care professional (parent) reporting for her daughter. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered in left arm on an unspecified date in Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received other vaccines prior to the COVID vaccine. Historical vaccine included that on an unspecified date in 2021 patient previously took Hepatitis B Booster and another unspecified meningitis booster for immunization. Reporter stated that actually 2 weeks prior to that day, I read and waited for 2 weeks and she had her full physical and they gave her Hepatitis B Booster and there is new Meningitis, I think it is B and also her Meningitis booster (Unspecified Medications). So, she ended up having three that day and then it was told that she was fine to get a shot. Reporter stated that her daughters got their first vaccine on Friday and then yesterday and today and she kind of done her own research to the 'local three hours department of zero health'. She reported has been having like the hive rash all over her entire body and in the trunk. It is coming and going, she can feel it coming and then it be there for couple of hours and then it goes away and it is weird, they are all over her body, they are all over and then it makes her hands itch. Reporter stated that she got her shot on Friday at about 11 o' clock am and on saturday afternoon or evening, she had maybe a little blackness on her knee cap and then yesterday about mid-day, that would have been on sunday, that is kind of when like it is all over her back, all over her stomach, over her butt, her torso like all over her body, her face and everything, just totally broke out and then it kind of went away and then it came back again, she could feel it, it was like, so that when it was. Reporter further stated that on saturday, it was just like on her kneecap and then sunday, yesterday, it was kind of all over her body. For second shot due date reporter stated that she believes its in three weeks on 13Aug. Other medical conditions: Reporter stated that she has got like a cold and stuffy nose and is almost kind of stuffed up. Reporter stated that I don't know if this is fine or is there any stuff in her throat or I don't know but her breathing is fine'. Patient did not receive any treatment for her events. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
increased sleepiness; low grade temp; sore arm; blood pressure slightly elevated; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 19Mar2021 (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1 (Manufacturer unknown)), for COVID-19 immunisation. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "increased sleepiness"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovering", described as "low grade temp"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "sore arm"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure slightly elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported low white blood count and neutrophil count - to be repeated next week, had covid vaccine dose 2 on 04Apr2021 with increased sleepiness, low grade temp and sore arm the next day but better now, blood pressure slightly elevated and being monitored. No change in medications. Patient saw MD yesterday and aware. Patient was taking Ibrance for 21 days on, 7 off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a breakthrough case of Covid only experienced a sore arm from the injection with mild fatigue. First date testing positive I experienced a fever of 100.1 for two days. I also had a sore throat for 2 days, had congestion.
Patient said she felt very "achy" and "sore". She also had a fever. As of today, 9/12/18 she said the fever is gone but she doesn't feel 100% better. She took THERAFLU on Tuesday 9/11/18 for fever and aches.
worst reaction; temp went up to 101.8; weak; eyes were bothering me; light would bother them too; just like the COVID over again; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (worst reaction), BODY TEMPERATURE INCREASED (temp went up to 101.8), ASTHENIA (weak), ABNORMAL SENSATION IN EYE (eyes were bothering me) and PHOTOPHOBIA (light would bother them too) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ADVERSE REACTION (worst reaction), BODY TEMPERATURE INCREASED (temp went up to 101.8), ASTHENIA (weak), ABNORMAL SENSATION IN EYE (eyes were bothering me), PHOTOPHOBIA (light would bother them too) and COVID-19 (just like the COVID over again). At the time of the report, ADVERSE REACTION (worst reaction), BODY TEMPERATURE INCREASED (temp went up to 101.8), ASTHENIA (weak), ABNORMAL SENSATION IN EYE (eyes were bothering me), PHOTOPHOBIA (light would bother them too) and COVID-19 (just like the COVID over again) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 09-Mar-2021, Body temperature: 101.8 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Patient states that a few days after receiving the injection in her left arm, she developed swollen lymph nodes in her neck and under her jaw.  She then had some swelling along her collar bone.
On the evening that the baby received IZ's, baby had choking type episode. The baby became pale, white lips and gums; eyes rolled back in head. Slight shivers often but no twitching. Father gave mouth to mouth breathing. Did not go to ER. Pt was seen in office on 1/14/00. Spoke with doctor on 1/12/00.
7:00 extreme dizziness, impaired motor skills;8:00 above sx plus resp problems-throat closing;9:00 listless behavior, swelling;10:00 tx @ hosp ER for allerg rxn;cont to take DPH q 4hr for 1 wk p/shot so pt could breathe;
sore arm-no big deal; gotten violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "recovered", described as "gotten violent chills".  Additional Information: She's had 5 previous Covid vaccines, and all of them have been from Pfizer. With the five previous vaccinations, she felt all of them go into her arm muscle. She has managed to get the vaccines and boosters, and managed to never get Covid and she doesn't want to start now. Usually she feels it go into her muscle and she gets a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   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-202300322047 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322049 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322046 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322048 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300318101 Same reporter, Patient / Different AE, Vaccine Dose;
achy legs from previous dose; She reports headache from her previous two doses; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (achy legs from previous dose) and HEADACHE (She reports headache from her previous two doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Migraine. Concurrent medical conditions included Hypertension. Concomitant products included GABAPENTIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy legs from previous dose) and HEADACHE (She reports headache from her previous two doses). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy legs from previous dose) and HEADACHE (She reports headache from her previous two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Blood pressure medication.   This case was linked to MOD-2021-406263 (Patient Link).
Pharmacy I was advised to drink 16oz of water 1hr before the shot which I noticed prevented the headache this time. And the arm at the injection site got sore for a few hours but nothing else was associated.
Mild daily headaches, swollen neck lymph nodes, and moderate chest pain mostly on the right side of the chest. Unable to sleep as the lymph nodes cause me to wake up and feel as though I am unable to breath. Have been hesitant to go in to doctor just because this should be keeping me out of the hospital.
STARTED 2 WEEKS FROM 1ST VACCINATION - LUMP AND PUFFY ON UPPER BEND OF LEFT ARM REPORTED AT TIME OF 2ND VACCINATION 08/17/2021.  SHE SAW A NP AND WAS TOLD TO SELF-MONITOR.  CALLED 8/26/21 11:55 A.M. LEFT ARM IS JUST PUFFY, NOT HARD ANYMORE.
Pimple in right thigh area a week ago. Last night more red. Tender today. Due to location likely MMR or Varivax location - in SQ location. Given 10 days of Keflex to treat for cellulitis beginning 1/12/2016.
Pt was having generalized fatigue and nausea and vomiting.  She is admitted due to COVID pneumonia, DKA, and increased hypoxia.
Injection site is not painful, but it is warm, very red (described as angry looking by wife), and extremely itchy. Pharmacist has not seen the arm/injection site.
two DVTs after getting three shots/Blood clots; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (two DVTs after getting three shots/Blood clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient developed two DVT's after getting three shots. Blood clots where patient never had any problems with this in life.  Treatment information was not reported. Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced unexpected serious (medically significant) AESI of Deep vein thrombosis (reported as TWO DVTS AFTER GETTING THREE SHOTS/BLOOD CLOTS) which occurred in context of receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact vaccination date unknown and exact event onset date unknown. The patient reported developing two DVTs after getting three of Moderna shots. In addition, the patient informed that has never had any problems with blood clots in the past. Details regarding exact vaccination date, events onset date, clinical symptoms, concomitant medications and concurrent diseases, accompanying circumstances and/or risk factors, etiologic and diagnostic work up and treatment details are not available in the report. Event's outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744997 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2023: Live follow-up received, and Quality Complaint number added. On 10-Oct-2023: Live follow-up received and reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744997:Same reporter
Received only the liquid portion; Received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 28-DEC-2022. Reporter's Comment: Nurse reported unknown patient received only the liquid portion of Menveo at an unknown date.  No additional adverse event details available per HCP. HCP gave consent for safety team follow up. Consented to follow up.
Swelling in left neck with tenderness. Also, tingling  in the left Arm with mild fatigue and tremors in the arm
Flare of auto immune-AS; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 49 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Patient was not a smoker/former smoker" (unspecified if ongoing); "Heart Disease: SVT" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing); "Immunosuppressive disorder/Immunocompromised" (unspecified if ongoing), notes: Medication Cimzia positive Imuran; "Autoimmune conditions -AS-uveitis-HLA- B27" (unspecified if ongoing); "Autoimmune conditions -AS-uveitis-HLA- B27" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; IMURAN [AZATHIOPRINE SODIUM] taken for immunodeficiency, ankylosing spondylitis, uveitis; CIMZIA taken for immunodeficiency, ankylosing spondylitis, uveitis; PROTONIX [OMEPRAZOLE]; TOPROL XL. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot number: EK9231, Route: Intramuscular), administration date: 11Feb2021, for COVID-19 immunisation; BNT162b2 (Dose 2, Single, Batch/Lot number: EN6206, Route: Intramuscular), administration date: 04Mar2021, for COVID-19 immunisation; BNT162b2 (Dose 3 (Booster), Single, Batch/Lot number: FC3181, Route: Intramuscular), administration date: 25Aug2021, for COVID-19 immunisation; BNT162b2 (Dose 4 (Booster), Single, Batch/Lot number: FJ6369, Route: Intramuscular), administration date: 05Apr2022, for COVID-19 immunisation. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Flare of auto immune-AS".; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event spondylitis ankylosing aggravated  is related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.  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.,Linked Report(s) : US-PFIZER INC-202300081585 Same patient, same product, different event (LOE);
Low grade fever; pain at injection site; fatigue; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 24Dec2020 09:30 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history provided as none and there were no known allergies. The patient was not allergies to medications, food, or other products. There was no other vaccine received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient did not diagnose with COVID-19 prior vaccination and since the vaccination, the patient did not have test for COVID-19. The patient experienced low grade fever, pain at injection site, fatigue on 24Dec2020 14:00. No treatment received for the adverse events. The outcome of the events was recovered in Dec2020.  Information on the Lot/Batch Number has been requested.
Narrative: Patient tested positive for Covid-19 and was hospitalized on 11/23/2021 despite the full vaccination of J&J on 8/30/2021. No booster received.
pt had ectopic pregnancy dx on 3/4/21, seen in er and  surgery performed on 3/6/21
Small stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Small stroke) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Small stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Small stroke) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time. No follow up is possible.   This case was linked to MOD21-068562, MOD21-068587, MOD21-068589, MOD21-072303, MOD21-072304 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible. MOD21-068562:same reporter MOD21-068587:same reporter MOD21-068589:same reporter MOD21-072303:same reporter MOD21-072304:same reporter