chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscles aches; fatigue; headache; injection site became sore; injection site became sore, red; injection site became sore, red, and hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On 31st October 2020, the patient experienced muscle pain, fatigue and headache. On 5th November 2020, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved. On 7th November 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, muscle pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received blood thinner concomitantly. The patient received Shingrix in left arm. The patient stated that later that day her injection site became sore, red, and hot.  She also developed muscle aches and fatigue that both had improved but were still on going.  The patient also developed a headache on and resolved.  She stated she had COVID testing and results were pending. The reporter consented to follow up.
EMPLOYEE HAD AN ALLERGIC REACTION POST VACCINATION. EMPLOYEE STATED THAT HER EYES WERE SWOLLEN AND WENT TO E.R. AROUND 7PM ON 02/22/27 AND WAS GIVEN ALLERGY MEDICATION AND WAS REALEASED.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. Dosage regimen, route of administration, lot number and expiry date were not reported. It was reported that the patient had "titers of less than 10" for Hepatitis B (Hepatitis B surface antibody negative). It was reported that it could not be ruled out if the patient had RECOMBIVAX HB prior to the titers or another company's Hepatitis B vaccine. The outcome of hepatitis b surface antibody negative was unknown. Causality assessment was not provided by the reporter. No product quality complaint (PQC) was involved. Additional information has been requested.
Approximately 10 minutes after vaccination injected, patient reported local reaction to left deltoid injection site.  It appeared red and swollen.  An ice pack was applied and 25 mg diphenhydramine PO was given.  There was no shortness of breath or other symptoms noted.  Remained alert & oriented x 3 and patient was able to go home a short time later after symptoms improved.
pt had only 2 pox on body. rash lasted one day.  no rx drugs given. no complications
Chest pain began evening after 3rd dose - initially right sided then left sided then bilateral and substernal constant pressure sensation. Following day, chest pain evolved to sharp pain that was intermittent. No changes with position, inspiration on exertion.
Moderna COVID-19 vaccine EUA  after the second dose in March 24 is when I had the symptoms. starting at about 10 am on March 25 a Fever of over 101 that lasted until Saturday the 27.  March 25 temp 101.8. March 26- temp of 101.4. March 27- temp of 99.5. March 28- temp of 98.9.   Other symptoms experienced were an extremely sore left arm, headache, nausea, tiredness, loss of appetite, chills and alternating sweating. All the symptoms lasted until Saturday, March 27th until about 9 am.
Redness in the injection spot; Injection spot not the right place; A spontaneous report was received from a nurse concerning a 31-years old female patient, who was also a physician, who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced product administered at inappropriate injection site and injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were provided.   The patient received her first of two planned doses of mRNA-1273 vaccine (batch number 039K20-2A) on 28 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced product administered at inappropriate injection site when the shot was given below her deltoid.  On 29 Dec 2020, the patient noticed redness at the injection site.  Treatment information was provided.  Action taken in response to the events were not reported.  The outcome of the event, injection site erythema, was not resolved. The outcome of the event, product administered at inappropriate injection site, was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 31 year-old female, who experienced a non-serious expected event of injection site erythema and product administered at inappropriate site. The event of injection site erythema occurred 1 day after first dose of mRNA-1273, lot # 039K20-2A. No treatment was administered for injection site erythema. Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. There was no reported AE associated with the case of product administered at inappropriate site.
myocarditis-heart muscle inflammation; syncopal episode; This is a spontaneous report from a contactable nurse. A male patient in his 40's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number was not reported), via an unspecified route of administration on 20Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. HCP reported that the patient received the Pfizer Covid-19 vaccine on 20Aug2021, had a syncopal episode on 21Aug2021, and on 23Aug2021 his cardiac enzymes were elevated and was diagnosed with myocarditis-heart muscle inflammation. HCP is asking if there were any incidences with stroke after a delay of time after the administration of the Pfizer Covid-19 vaccine? The outcome of the events was unknown.   The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Patient indicated she had involuntary facial muscle movement on left side, tingling in the facial area, some swelling of lips/tongue. Slight nausea and a tin taste in mouth. Blurry vision.  She did contact her physician by phone.
Severe cough, nausea; 14NOV91 chest pounds today; too ill to get out of bed, sore throat; fever 101;
About 10 mins after getting the vaccine i began feeling light headed dizzy nauseous and warm. It got pretty bad. I said something to the nurses who took my bp. My bp was very elevated. At one point I had to use the bathroom but I needed assistance due to the dizziness. I left work about 2 hrs after the vaccine but i do not remember the drive home.  i came home and went to bed The next morning I woke up and felt fine. I also felt fine on saturday. On sunday I woke up with a severe migraine I could not get out of bed i was nauseous. light and sound bothered me. This lasted until Friday morning, on Monday I went to work with the migraine and worked 3.5 hrs. I came home and went back to bed. I went to work Tues as well and stayed all day. Wed morning I was extremely dizzy to the point where I could not stand with out feeling dizzy. I called in sick to work. I did a virtual visit with Dr. He told me I needed to go to the ER bc I had the Migraine for too long and nothing was working.  I went to the ER on Wed and was released. Thurs night. The Dr. kept me out of work for the rest of the week On Friday I was fine for a week and a half I was okay. Then the Next  week I was down with another migraine, this happened on and off until may. In may I had one migraine that was mild compared to the others this year. So i felt this migraine was more typical to my usual migraines. the other migraines were on my left side which is unusual. The migraines are gone now and I do still get headaches but not migraines like the latter. I had 5 visits to the emergency room. My doctor has also advised that these migraines were due to the vaccine.
Resident was identified as needing bivalent booster on 12/16/2022 and received the bivalent booster on 12/16/2022.  Later discovered the resident received bivalent booster on 09/30/2022.  No adverse effects reported.
Initial unsolicited report received from a non- healthcare professional (Medical Assistant) on 20 October 2016. This case involves a 13-month-old female patient who was vaccinated with a second dose Fluzone Qiv 0.25ml (batch number: UT5583UA, expiration date: 30 June 2017, dose and route of administration were not reported), in the left thigh on 18 October 2016. It was reported that patient had diarrhea after first dose (previous) of flu vaccine vaccinated on 07 March 2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 18 October 2016, same day following the vaccination, the patient had diarrhea. Relevant diagnostic tests or laboratory data was reported as none. Patient's corrective treatment was not reported. On an unknown date patient recovered from the event. List of documents held by sender: none.
Started with itching underarms about 10:30 AM 8/15/11. Woke am 8/16/11 with rash that started on inner thighs and spread to stomach, back of knees & underarms. Had two doses of BENADRYL at home. Given Hydroxyzine prescription at office visit. Had no difficulty with breathing or swallowing.
Patient was administered flu vaccination on 10/7/08 as well as pneumovax.  Flu shot was given in L arm, Pneumovax in the R arm at approximately 2PM.  Later that evening, the patient noted significant swelling and redness about her R upper arm, without accompanying fever or chills.  She sought care in the ER and was given a prescription for keflex for cellulitis and prednisone x 4 days.  Followup visit in the office with me on 10/8/08 showed improvement in redness, still with significant swelling, distal R extremity was neurovascularly intact.  No sign of lymphangitis.  I advised the patient to fill her prescription for keflex and prednisone, and to call if worsening signs or symptoms.
I started feeling achy. My right armpit started getting really sore and the lymph node started to swell. This was the same side as my vaccine. I got to the point when the achieving started to get worse. About 4 hours later the lymph nodes started to swell on my right shoulder and the back of my neck just below and behind the ear. I decided to go to the ER and they advice I should use a warm compress on the lymph nodes. I had trouble find a position to sleep because the lymph node under my arm would be compressed and start to hurt. I was taking ibuprofen to help with inflammation. By 04/15/2022 I could move again and I was feeling much better. I also took a COVID test just to make sure it wasn't from a breakthrough COVID case. Test came back negative. I did visit my primary care physician on, but because the swelling had gone down she wasn't concerned.
lou gehrig's disease; Nervous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) in a 61-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) (seriousness criterion medically significant) and NERVOUSNESS (Nervous). At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) and NERVOUSNESS (Nervous) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Caller stated the vaccine attacked on the patient's Central Nervous System. No treatment information was reported. Company comment This spontaneous case concerns a 61-year-old male with no reported medical history who experienced the unexpected, serious (medically significant) event of Amyotrophic lateral sclerosis which occurred after receiving mRNA-1273 vaccination. Latency cannot be calculated since the exact event onset date and vaccination date are unknown. Patient age and gender can be considered as risk factors. Additionally, the patient experienced non-serious event of nervousness. It was reported that the vaccine has attacked patient's central nervous system however further details on the clinical course, risk factors, etiologic and diagnostic work up, concurrent diseases, concomitant medications and event treatment were not provided. Outcome of event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737864, US-MODERNATX, INC.-MOD-2023-737856 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For Bother case (Same Reporter) US-MODERNATX, INC.-MOD-2023-737864:2nd sister case US-MODERNATX, INC.-MOD-2023-737856:1st sister
The next day significant breathing difficulty gradually reducing as muscular aches, nasal and chest congestion set in.  Followed within 24 hours by a system rash all over the body.
I developed a cold sore on my bottom right lip.  I am just treating it with over the counter cream.  This sore developed on monday 3/29/21 which was 4 days after my vaccine.
SKIN BREAKDOWN AND RIGHT BREAST IMPLANT EXPOSED; SURGERY TO REMOVE THE RIGHT BREAST IMPLANT; AREA OF ECCHYMOSIS OVER THE RIGHT BREAST; MULTIPLE BRUISES THROUGH OUT BODY; This spontaneous report received from a pharmacist concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included right breast cancer, right breast removal, removal of TE (tissue expander) with right breast implant, TE (implant), lymphoedema, primary genetic predisposition, and secondary Lyme disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unknow date in APR-2021 (reported as about 3 weeks ago from the date of reporting) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (reported as sometime after receiving the Janssen COVID 19 vaccination), the patient developed multiple bruises though out her body, an area of ecchymosis over the right breast that evolved into skin breakdown and the right breast implant was exposed to this (skin breakdown). The patient was hospitalized on 11-MAY-2021, and she had to have surgery to remove the right breast implant, and the status post washout of redundant skin removal including nipple areola complex. The patient's health care profession was considering Heparin for her post operation for DVT (Deep vein thrombosis) prevention but was concerned about doing that based on the CDC (Centers for Disease Control and Prevention) information.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the multiple bruises through out body, area of ecchymosis over the right breast, skin breakdown and right breast implant exposed and surgery to remove the right breast implant was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0.20210523197-COVID-19 VACCINE AD26.COV2.S Skin breakdown and right breast implant exposed, surgery to remove the right breast implant, area of ecchymosis over the right breast, multiple bruises through out body. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
left paraclavicular lymphadenopathy; This is a spontaneous report from a contactable nurse (patient) reported that a 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 14Jan2021 14:30 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscularly on the left arm on 23Dec2020 10:45 for Covid-19 immunization. It was reported that approximately 72 hours (17Jan2021) after second dose, the patient developed left paraclavicular lymphadenopathy. No treatment received was reported for the reported event. The outcome of the event was not recovered.
vaccine exposure during pregnancy; wrong vaccine administered; This spontaneous prospective pregnancy report concerning a 30 year old female patient who was reporting on herself. The patient's historical vaccines included completed series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) when she was around 18 or 19 year old. The patient had no medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On the morning of 27-JUL-2020, the patient went to her physician's office to get vaccinated with Rho(D) immune globulin (RHOGAM) however her Doctor's office contacted her later in the afternoon to notify the patient they had inadvertently vaccinated her with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) instead of the Rho(D) immune globulin (RHOGAM) shot she was intended to receive. Patient said she was concerned that she was administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot in error because she was 6 weeks pregnant at the reporting time.   On an unknown date, the patient became pregnant with last menstrual period (LMP) of 15-JUN-2020, and estimated date of delivery (EDD) of 22-MAR-2021. The pregnancy outcome was pending.
23JUL PM high temp 105R;23JUL during day seemed to have temp didn't take-didn't seem ill;
9/25: (LEFT) Arm red, swollen and hot to touch, became red and swollen from shoulder below elbow by 9/26. 9/27 patient states arm swelling as if water around elbow.
Patient was given vaccine and 30 minutes later reported chest pain.  EMS was called and patient was given 325mg aspirin.
This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting RECOMBIVAX HB (lot number J010335, expiry date 17-DEC-2015). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the unspecified number of patients were administered RECOMBIVAX HB (dose unspecified). Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadryl it subsided, it did come back several days again.  Otherwise 24 hours after the shot exprienced, slight fever, chills, muscle aches, headache, head sinus pressure, joint pain, diarrhea and nausea. Also several days later arm still hurts. 3 days after had shooting pain in injection arm, leaving me to not use my left arm. 4th day much better.
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 08-FEB-2007 was vaccinated IM with a first dose of Gardasil and on 17-APR-2007 was vaccinated IM in the left deltoid a second dose of Gardasil lot #655849/0263U. Concomitant therapy included Adderall Tablets and thyroid medication (therapy unspecified). A few days after receiving the second injection, the patient developed tenderness, soreness, erythema, swelling. warmth, burning and pruritus in the injection site area of her left arm. She also developed a red bruise on her chest, medical attention was sought. Patient had not recovered. Additional information has been requested.
Beginning around 11/12-11/15/21 developed increasing Leg and back pain, leg weakness, loss of balance, loss of deep tendon reflexes, right foot drop, saddle numbness and difficulty urinating . Seen at local clinic 11/29 /21 then ER 12/1/21. Admitted to hospital on 12/1/21. Scans , LP, and blood work done. IV steroids and pain meds given. Discharged 12/4/21.
swollen, painful lymph nodes in base of neck and under arm all on left side of body.
My son broke out in intense hives on and off for 2 weeks about a week after receiving the vaccine. He has never experienced hives before. These hives would come and go at alarming rates and pop up in new places head to toe with multiple areas affected at same time.
Received MMR 6/3/10, 6/4/10 temp up to 103 and 6/5/10, 6/6/10, 6/7/10 no temp or rash. 6/8/10 hives both lower extremities, swelling up both lower extremities, ankles and knee. Give 12day tapering dose of steroids, XYZAL.
Within 5 minutes of receiving shot, felt a tightness in my chest. Felt extremely dizzy, so much so that I needed to sit down.   I started having throbbing in my left temple and felt a wave of nausea.  After a few more minutes, those symptoms started to dissipate, but then I started to have intense ringing in my ears.  Still had the tightness in my chest and felt like i could not take a deep breath.  Waited at the pharmacy for 15 minutes them headed home.  By the time I got home, my arms, legs, hands and feet were numb and tingling.  I took benadryl and Tylenol to combat any reaction but I felt really crappy.  Slept in and off for the last 24 hours. The tightness in my chest has let up some, but my arms, legs, hands and feet are still numb and tingling.  I am extremely dizzy and unstable when walking.  I am nauseous. I have a headache. I am smelling things that no one else is smelling.