chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two hours later, her fillers were swollen; A spontaneous report (United States) was received from a (Consumer) concerning a  75 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced two hours later, her fillers were swollen/ Swelling face. The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, approximately same prior to the onset of the events, the patient received their unknown of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and left site for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced Swelling face just two hours after the vaccination.  Laboratory details not provided. Treatment details were reported as Benadryl. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported to be Recovered/Resolved.; 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.
received her first dose / on 12/12/2019  / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 2nd and 3rd dose of Shingrix refer linked cases US2020AMR248212 and US2020247551 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020247551:3rd dose US-GLAXOSMITHKLINE-US2020AMR248212:2nd dose
This spontaneous report as received from registered nurse refers to 4 months old patient (gender not reported). Nurse reported that an expired dose of ROTATEQ lot# 0210AE (exp. date 29-SEP-2013) (route and dose not reported). went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several report from the same source (MARRS# 1310USA004161, 1310USA006562). Additional information has been requested.
Moderna (lot # 029L20A) Left side  Patient presented to HRH ED two days after receiving Moderna COVID-19 vaccine dose #2 at HRH vaccine clinic with palpitations, chills, and headache since vaccination. Home blood pressure = 154/82 mmHg. Diagnosed with atrial fibrillation, PACs, and PVCs. Discharged to home stable with holter monitor and follow-up with cardiology.
Pt had chest pain 2 days after vaccination. She did have pericarditis and a pericardial effusion develop. She was hospitalized for a few nights and treated with prednisone, ibuprofen and colchicine.
Pt given vaccine. Within 10min reported feeling dizzy and that her heart was racing. Stayed in pharmacy waiting area for about an hour before ems was called at pts request. Lost to follow up.
First day chills started in afternoon.  Second day, chills, headache and nausea all day.
Left side of face would go numb from top of head to chin. Left side of face drooping Left eye swollen, watery, blurry Left eye ball quivers when having an attack of the above
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 29-JAN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Vomiting, trembling, headache, weakness, tiredness and unusual swelling at injection site.
beginning 1-20, started to experience mild itching at injection site. itch increased 1-21. today, site is extremely itchy, mildly swelled with an approx 2" area of inflammation @ site and pinhole where injection was given is visible. Area hot to touch and painful
I started getting edema in my feet and ankles. I am not for sure if it is due to the vaccine. I went to my doctor and I do have further testing with an Hepatology and Endocrinologist. The swelling comes and goes. This still persists even yesterday.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: still testing positive; Positive, notes: initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Problems started on April 7 (vaccination was March 30).  I woke up and my eyes were almost swollen shut, all the fingers on both hands were very swollen (so badly that the rings that are usually comfortably loose were wedged on) and some had painful red areas, both feet were puffed up, a big red rash on one ankle and the underside of both big toes was firey red and intensely ichy.  My right arm, the shoulder area felt like a torn rotator cuff (believe me I know what that feels like), but wasn't, and my right wrist felt like it was sprained.  My spine was burning.  I took Benadryl immediatly and used a topical prescription steroid (Triamcinolone) cream.  Everything responded to the Benadryl and the steroid.  I've been taking Benadryl since the 7th.  If I try to back off it, symptoms come roaring back. I still have joint pain (in joints that have never bothered me), but oddly not in my neck which has been a problem for years.  Also oddly my left arm has barely any issues.  I have rashes where I've never had them before, and a few scaly areas turned bright red and are starting to calm down after using the steroid cream.  The right arm  sometimes feels better with use throughout the day, after I've had Benadryl, but in the evening it starts getting worse, until more Benadryl.   And I've been adding fiorinal or Baclofen.   I was hoping I could ignore this and it would all go away.  But it was best to see my doctor.  I saw her on Wednesday, April 20.  She prescribed Triamcinolone (what I had on hand was out of date since I only rarely used it), Diclofenac, Baclofen (what I had was out of date) and told me no second COVID vaccine until at least 3 weeks after I have no symptoms.  Prescriptions were delayed at the pharmacy (Trimacinlone still isn't ready!!!) until today, April 23.  Symptoms are still pretty unpleasant.  My spine feels like it is burning.  The rash on my right ankle is less red but it is burning. Multiple joints are burning that have never burned before.
Right and left feet had went numb; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date reported, Solution for injection), via an unspecified route of administration, administered on an unspecified date, as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a right and left feet had went numb. Within the original report the caller mentioned that when her daughter was sitting in the chair after the COVID vaccine that her right and left feet had went numb. She said that this same side effect also happened to her friend (withheld). The event accessed as a non serious. The outcome of event is unknown.  Probed if caller wanted to complete a safety report for the individual mentioned and she declined and said that she cannot speak on their behalf.   Information about lot/batch number is requested.
screaming spell lasting over 3 1/2 hrs; could not comfort pt afebrile;
No additional adverse effects; PNEUMOVAX23 was inadvertantly administered insteas of Prevenar13; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.    On 24-JUN-2020 the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, route of administration anatomical location, lot # and expiration date were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (lot # and expiration date were not reported) for prophylaxis. No additional adverse effects reported.
Shoulder/arm throbs and will have numbness/tingling down entire arm into hands. Limited range of motion and increased weakness in that arm.
HAD THREE ARTERY BYPASS IN TWO WEEKS; This spontaneous report received from a patient (health care professional (registered nurse)) via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: For years, the patient had not been sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered (dose 1) on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The patient had annual physical and all was well. On an unspecified date the patient had three artery bypass in two weeks. Reporter stated " Johnson & Johnson way too much writing. I had checked all the companies as husband was insisting I take vaccine. I chose j&j as seeing made felt the best as know most doctors very smart ( I'm an RN). Oh well. Had just had annual physical. All was well. Had not been sick in years. In two weeks had three artery bypass ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had three artery bypass in two weeks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221212440 - had three artery bypass in two weeks. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sharp pain in right arm since Tdap administered. Decreased ROM and pain with range of motion. Treatment evaluated in Health Department 10/10/11. Ice to (R) arm. ALEVE 2 BID. No redness, swelling, warmth, numbness, tingling, nausea associated with symptoms.
On 11/12/2014 I had extreme pain and swelling around injection site. The next day the pain was from my neck and shoulder all the way down to my elbow and the injection site had little red bumps surrounding the area. I had extreme fatigue and flu like symptoms including nausea, dizziness and fever which got up to 102.4 for 2 day following.
Pt recv vax on 4/12/99; 4 1/2 hr post vax pt exp rt arm pain, fever (102), unable to move rt arm; dx=local rxn to vax; tx=Hydrocortisone cream, Anaprox
wasn't able to get my second dose until 5/25; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25). On 25-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wasn't able to get my second dose until 5/25) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Two days post vax, this pt reported having a wheal of 2 inches and erythema 6-8 inches at injection site.
2-3 Minutes after receiving the vaccine, the patient was seated in the waiting area for his 15 minute wait time.  We heard a crash and the yell of his wife and 3 children.  Found the patient laying on his back on the ground.  Patient was breathing, but non responsive to tapping and shouting.  911 was called.  Patient regained consciousness after about 15-30  seconds.  He complained of being hot, thirsty, having to go to the bathroom and feeling out of it. He appeared pale.  We did record a BP of 95/57.  He remained conscious until EMT's arrived.  He was attended to and taken to the ER by emergency personal.
Severe soreness in left arm 1-2hours after vaccination.  Grandma (who is his guardian) states she rubbed him down with some muscle rub.  When he woke this am he felt as though is was difficult to move his arm without great pain.  I instructed them to give tylenol or advil whatever her normally takes for pain, and to put a cool moist cloth on redness at vaccination area.  I encouraged him to move arm around more if possible and if symptoms increased or felt he should be seen to call his PCP.
Patient received Zostavax on 5/26/15 with no side effects at time of administration. Patient returned to pharmacy on 6/5 complaining of fever blister that appeared on 6/4. He feels it was caused by vaccine because this is his first fever blister. Patient was advised to contact physician if any further symptoms developed and OTC product was recommended as well as lifestyle modification to avoid further irritation.
3rd shot received tuesday, 28jan03, 2nd shot received friday 10jan03.  On wed 29jan noted swelling, redness, pain, itching below elbow.  Extent of redness now 15".  No LAD, no loss of use of arm.  No systemic symptoms.,
Patient was given 2nd Moderna shot and walked to register a minute later.  While at the register, he stopped talking and went flat back hitting the back of his head.  He was twitching slightly on the ground while unconscious for no more than 30 seconds.  911 was called, the AED was being retrieved and management on-site was notified.  The patient quickly regained consciousness as RPH was assessing for anaphylaxis protocol.  He was responsive, aware and coherent but groggy and repeatedly rubbed the back of his head.  At this point store manager stayed with patient while waiting on EMS.  Blood pressure was normal but low per EMS.  Patient did admit to recreational marijuana use prior to shot.  He denied further medical assistance.
Severe radiating/pulsing pain in both knee joints. The pain woke me from sleep, and repositioning did not provide any relief. Weakness and tightness when attempting to stand/walk. Unable to stand from a seated position without using hands to pull up. Episode lasted about 5 hours, pain has gone from severe to mild as of the time of writing this.
He received the shot in an afternoon clinic and that night he woke up around 1:30 am screaming and holding his head.  He was saying everything is spinning, I don't know what is wrong.  Called 911 and they came and evaluated client.  Mom took temperature and the temp was 103.  EMS evaluated client and did not find anything.  October 10th client developed a cold and then went and was put on amoxicillin.  Rash started on his face a week after that and rash has spread on his face.  Rash is only on the right side of his face.  Finished the course of amoxicillin.  Has appointment with dermatologist on Thursday.
Fever of 100.9 F after the 1st dose; Headache after the 1st dose; Chills after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Food allergy.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 13-May-2021, PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Cognitive impairment, lower brain function, confusion, memory impairment and other impairments related to overall brain function.
A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 28-Oct-2013. The patient experienced tested positive for flu A which started on 16-Dec-2013. The outcome of the event of tested positive for flu A is unknown. The report was considered to be non-serious.
pain; nausea; Each time I get pancreatitis/diagnosed with pancreatitis 3 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Each time I get pancreatitis/diagnosed with pancreatitis 3 days after first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache and Immunocompromised. Concomitant products included AMITRIPTYLINE for Headache, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), FOLIC ACID, VITAMIN D3, DENOSUMAB (PROLIA) and RITUXIMAB (RITUXAN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PANCREATITIS (Each time I get pancreatitis/diagnosed with pancreatitis 3 days after first dose) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) and NAUSEA (nausea). At the time of the report, PANCREATITIS (Each time I get pancreatitis/diagnosed with pancreatitis 3 days after first dose), PAIN (pain) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) pancreatitis.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Pain medication and Nausea medication  Company comment- This spontaneous case concerns a 71-year-old female patient whose immunocompromised,  who experienced serious unexpected event of pancreatitis. The event occurred approximately 3 days after the first dose of the Moderna COVID-19 vaccine and the event reoccurred after the second and the third dose. Rechallenge was positive since the event reoccurred after every dose administered.  The benefit-risk relationship of product is not affected by this report   This case was linked to MOD-2021-395624, MOD-2021-395640, MOD-2021-395624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Significant Follow-up information received: updated events and outcome of events; Sender's Comments: This spontaneous case concerns a 71-year-old female patient who's immunocompromised, who experienced serious unexpected event of pancreatitis. The event occurred approximately 3 days after the first dose of the Moderna COVID-19 vaccine and the event reoccurred after the second and the third dose. Rechallenge was positive since the event reoccurred after every dose administered.  The benefit-risk relationship of product is not affected by this report
Approximately 1 month after my 1st booster shot (Dose 3) I contracted COVID and had the following symptoms:  Minor flu like symptoms, Sinus Infection (That lasted for months).I took Dayquil and Nyquil for treatment and it took me around 5 months to recover from my sinus infection, post covid.
Patient states that her right knee down to her foot has swollen. She states that her foot is so swollen that she can barely wear a shoe.
Case number PHEH2013US021614 is an initial spontaneous report from nurse received on 16 Oct 2013, with a follow-up received on 13 Nov 2013. This case refers to 02-year-old female patient. She received FLUVIRIN (batch number: 1307801), 2.55 cc intramuscularly instead of 0.5 ml, into thigh on 14 Oct 2013 at 6:30 pm. No adverse reaction was reported following medication errors. She was revaccinated with flu vaccine (manufacturer and batch number unknown) on an unspecified date. Follow-up was received on 13 Nov 2013. Patient demographics, vaccination date, vaccination site and time and revaccination information were updated.
Patient presented to office with complaints of fever, redness, swelling, and pain of L arm starting on 04/10/2018. Fever lasting 48-72 hours and two quarter size red areas to L arm that was mildly tender which she reported had improved at the time of office visit. Patient was instructed to take Ibuprofen 800mg three times a day as needed along with applying ice to the area for 20 minutes as minutes.