chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that something didn't feel quite right when she received the shot, that her arm felt weird and the shot hurt a lot.  She said that her arm stayed warm and she noticed over the next few days that a hard spot was forming where the vaccine was given and has progressively gotten larger and warmer.  She believes she has been running a fever off and on, and she has radiating pain across her back  down to her kidney area.  I was able to palpate a warm hard area on her right arm that was about 1.5 inches in diameter.  She states that ibuprofen or aleve help with the pain, but that her cleaning job in environmental services, chores like mopping cause worsening of her symptoms and even cause her arm/shoulder to freeze up.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 13-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Headache, Myalgia, Arthralgia, Fever, altered sense of smell Narrative:
At 15 month well-child visit, physician ordered PREVNAR (pneumococcal vaccine) #4.  The patient was given Meningococcal instead.  No reported adverse events/effects.
10x10 cm area of redness (R) upper arm. No discharge or pus. Vaccine reaction DTaP. Advised ATARAX 10/5 1 tsp q 8 hours PRN.
patient had biopsies and the result was granuloma annulare possibly caused by vaccines.; initial fatigue for a couple of days; patient had shingles, patient thought to be caused by body's immune response to the shot. The rash from shingles never went away it has now spread over about 30% of body.; This is a spontaneous report from a contactable nurse (patient). A patient of an unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not provided), via an unspecified route of administration in an unspecified anatomical location on an unknown date, as single dose for COVID-19 immunization. The patient's medication history and concomitant medication were not reported. Patient was among the first nurses to receive the COVID vaccine in December/January. Other than the initial fatigue for a couple of days, patient had none of the bad side effects. On an unknown date in Feb2021, patient had shingles, patient thought to be caused by body's immune response to the shot. The rash from shingles never went away it has now spread over about 30% of body. Recently patient had biopsies on an unknown date and the result was granuloma annulare and possibly caused by vaccines. The patient underwent lab tests and procedures which included: biopsies: granuloma annulare and possibly caused by vaccines on an unknown date. Outcome of the event shingles was not resolved and outcome for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event Shingles, Granuloma annulare and the suspect drug BNT162B2 cannot be excluded. 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.
I received the seasonal flu vaccine, I don't know what particular name it has.  My symptoms started that night and went through the next day. They included: fever, great fatigue, headache, and a little diarhhea.
She presented to the pharmacy with swelling and severe pain at the injection site.; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; She presented to the pharmacy with swelling and severe pain at the injection site.; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included psoriasis. The patient's medical history, concomitant medications, and historical drugs were not reported.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, intramuscularly in the right deltoid with lot # T021485, and expiration date 15-MAR-2022 for prophylaxis.   On 10-OCT-2020, the patient presented to the pharmacy with swelling and severe pain at the injection site. The pain radiated down her arm (pain in extremity) and up to her neck and was described as her "arm was on fire"(feeling abnormal ). She went to her primary care physician and received unknown care, and the last contact the pharmacist had with the patient was on 10-OCT-2020.   At the time of the report, the outcome of injection site swelling and injection site pain was reported as not resolved. The outcome of pain in extremity, feeling abnormal and neck pain was unknown. The reporter did not mention the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Breakthrough case admission after third dose;   Moderna 3/7/21 Lot# 023M20A;  Moderna 4/8/21 Lot# 018V21A;  Moderna 11/4/21 Lot# 077C21B
Local redness swelling and faint trunkal rash, fever. Treatment- Tylenol, Benadryl, Cool Compress.
This spontaneous report as received from a pharmacist refers to a 82 year old patient with penicillin allergy. On 20-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014809, expiration date: 20-FEB-2015) 0.65 ml, once, subcutaneous. No concomitant medications were reported. The patient stated that on an unknown date in October 2014, after vaccination, he had a stiff neck and it hurt to hold his neck up or move the neck in any way. On an unknown date in October 2014 the patient sought medical attention and contacted unspecified pharmacist. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported.
10-31-05 Pt presents to clinic small bruise noted at injection site L delt. Bruising noted below deltoid area. Pt report delt. was very "sore" on evening of injection. No problems at time of injection. Reports redness, swelling and itching of entire deltoid area when pt awoken 10/29/05 am. Began to reduce on 10/30/05. 10/3/05 MD ordered Benadryl.
I got a delayed (9 days later) itchy rash over my body, along with heat that builds up, like my ears would suddenly get very hot, or around my mouth, or my lips start to swell up. This is in addition to a fairly persistent heartburn (I very rarely have heartburn and wasn?t sure it was related but a post-booster support group has confirmed experiencing similar symptoms  that not only include the rash, but also the heartburn). The rash and itch is spread out and will come and go from one area to the next. When I say everywhere, I mean all the way from my scalp to the bottom of my feet, including but not limited to- face, hands, and itchy ear canals. Additionally I?ve experienced some wheezing (which is undoubtedly the scariest symptom).  I am taking Benadryl which helps with itch, calamine lotion for external relief, using Cetaphil in the shower, and I took Pepcid yesterday for the heartburn but it didn?t do anything, so I will be trying Peptobysmol next. I went to Urgent care, but that was to report the rash, and I am confident I was misdiagnosed (the diagnosis does not even begin to explain any of the other symptoms, including the hot ears and wheezing). I will be seeing a dermatologist tomorrow.
Red rash appeared at injection site 8 days after injection.  The area is also warm to touch, but not painful.
I haven't had my periods from almost 10 years; all of the sudden I started vaginal bleeding; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Jul2021 09:15 as dose number unknown single for COVID-19 immunization. Patient stated, she just wanted to know that the whole sheet of information that she was given to from the pharmacy that she got the shot today this morning 10Jul2021 at 9:15 and she came home she had not had her periods from almost 10 years and all of the sudden she started vaginal bleeding. Patient stated, the name of the product was the Pfizer shot which she got this morning, the COVID, (confirmed as Pfizer Covid 19 vaccine). The outcome of the event was unknown.   Information about lot/batch number has been requested.
Daughter called and reported that patient did not sleep well.  Chills, redness of upper arm and Headache.
On 2-24-21 was at Dr. Office visit and BP up, was 166/86.  Felt Fine.  Dr. was Ok with it.  On 3-5-21 BP shot up in evening to 143/74, Felt chest pressure, light headed. Didn't feel good. Tired all day. Nausea, Headache. Joints in knees and ankles been hurting. Took special BP pill Indapamide that I had been off and helped to relieve symptoms. Only take it twice a week, when on it before. Every day since then BP comes down to 120/66 after taking regular dosage of BP pills. on 3-9-21 started feeling better. Still on Indapamide.  On 3-10-21 at 5:09 PM BP 143.74 before evening BP pills. Heart has felt like beating fast for several hours this afternoon.
Initial non-serious report received from the vaccine provider in the United States on 18 July 2007. A ten-week-old male with no known pre-existing medical conditions or allergies was vaccinated with ActHIB, Daptacel, IPOL, Hepatitis B (trade name and manufacturer not reported) and Prevnar (manufactured by Wyeth) on 10 July 2007. Lot numbers and routes/sites of administration were not provided for any of these vaccines. The reporter indicated that the patient's parent called stating that the baby cried inconsolably for two hours. The baby had gone home and slept for three hours, then woke up with inconsolable crying for two hours. The baby fed well and was irritable afterwards. There was no known illness at the time of vaccination. Tylenol was given and the patient recovered. No additional information was provided at the time of this report. Follow-up information received on 01 October 2007 from a health care professional. In response to a query requesting lot numbers and routes and sites of administration of the previously reported vaccinations, the reporter provided the following information. The subject had received a right thigh, intramuscular injection of IPOL, lot number Y1032 (not a valid sanofi pasteur lot number); a left thigh, intramuscular injection of Daptacel, lot number C2552AA; a left thigh, intramuscular injection of ActHIB, lot number UFOU98AB (not a valid sanofi pasteur lot number); and a right thigh, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B53981E. The patient had experienced an episode of inconsolable crying followed by three hours of sleep. He was able to eat but was irritable and cried when the vaccination site was touched.
R arm cellulitis at site of Dtap and right axillary reactive adenopathy.
I had no major adverse effects immediately after the last booster shot/vaccine. It was my fourth one. However 2 months later, I contracted the most recent strain of Covid-19 on July 20, 2022, and started having symptoms on that date. My Covid test was positive on July 22, 2022. My Covid symptoms were severe, as I have asthma related issues. My symptoms included extreme fatigue, fever, body aches, chills, sore throat, nasal congestion, sporadic headaches, brain fog, lots of phlegm, cough, difficulty breathing, and low oxygen level (it got down to 81). I also lost my sense of smell and taste, which has not yet recovered. Because of the oxygen level, my doctor could not prescribe Paxlovid, but he ordered an Antibody Infusion, which I received on July 23, 2022. My initial symptoms were very intense, and although I improved over time, I continued to have brain fog, extreme exhaustion, cough, and a low grade fever for 3+ weeks. I still have brain fog and days where I cough a lot, and I am so exhausted, that I cannot go about my daily routine. Although a bit improved, I am still unable to smell or taste very much (I previously had a keen palate and sense of smell).
Left arm pain - worse when arm is lifred in the air or rotated. Saw my doctor 12/15/15 was given a steroid pack/pain patch.
This spontaneous report as received from a 61 year old male patient with no known drug reaction/allergies, and no other pertinent medical history, refers to himself. On 20-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. On 27-JUL-2013, a week after receiving the ZOSTAVAX vaccine, the patient notice lesion on right leg, ankle to knee, inner leg, and on both arms with red spots. He reported it was very itchy and then turned into blotches. The patient did not seek medical attention. No lab diagnostic tests were performed. He had been treating with topical ointment like for poison ivy which he thought he had originally until he read about ZOSTAVAX vaccine online. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
Approx 24 hrs p/vax had 1 sz; Mom did not take temp thinks pt had fever;
My right eye started twitching, like a tic. It continued day and night. Gradually it tapered off and was gone 1 month later
began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.
evening of 8.21 developed maculopapular raised rash to cheeks bilaterally, hot to the touch, appearance like slapped cheeks of Fifths Disease (no known exposure to this virus); evolved to rash on medial thighs bilaterally, also raised in places 8.22 woke up with raised rash on thighs, bilaterally but in more ventral; given diphenhydramine 8.23 no sxs 8.24 slight runny nose, no rash 8.25 runny nose AM; PM developed spotted rash on trunk looking like measles, traveled up to neck, face (blotchy in this location); gave diphenhydramine
I received the Vaccine 10/17/16 I would have been 2 weeks pregnant at that time. My due date would have been July 20th 2017. I had my miscarriage on 11/07/2016 I had a severe sharp pains and some spotting on that day. I had my complete miscarriage on the 11th.
A small itchy bump appeared under his left breast on day 2. At the same time developed rash over legs and thighs.  Treated with eczema cream and saw a dermatologist.  Since then, rash has covered his torso, legs, thighs. Dermatologist thought it was due to Exforge. Primary Care Provider thinks it is due to the Zostavax.
Rec'd vaccine @ 9:00 am (H1N1); 12:00 N started with burning at injection site, eyes red/watering, nauseated, chills, called HD to report. Nasal congestion; requested she call 2/25/10 to report back.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, 4 days after receiving SHINGRIX, the patient experienced weakness, headache and tiredness. On an unknown date, the outcome of the weakness, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the weakness, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide any demographics. The patient received 2nd dose of SHINGRIX on 10th August 2018 and reported that about four days later she experienced feeling weak, tired and headache and that those symptoms were still persisting at the time of reporting.
The edema began after he received his 3rd COVID vaccine today. It started at roughly 3pm. He then presented to the ED. At roughly 530pm,
back pain,; she couldn't sleep; she couldn't lay on her left side; she lost her balance and sat down; fell down; neck started to hurt / she had a dull ache all of the time; left side hurt really bad / side pain; pain - into her rib cage on the left side / hurt to the touch / ribs felt like they were broken; uncomfortable on the left side of her chest; she felt miserable / she felt crummy; didn't want to do anything with fatigue; joint pain / her wrist is really bad; eyeballs hurt /both of her eyes hurt so bad / eye pain; she had a headache / had a headache above her eye; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 22nd April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced eye pain, headache and joint pain. On 18th August 2020, the patient experienced feeling abnormal and fatigue. On 19th August 2020, the patient experienced chest discomfort. On 22nd August 2020, the patient experienced rib pain and pain localized. On 24th August 2020, the patient experienced neck pain. On 26th August 2020, the patient experienced loss of balance and fall. On 28th August 2020, the patient experienced sleeplessness and mobility decreased. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen, meloxicam (Mobic) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the feeling abnormal, eye pain, pain localized, joint pain and back pain were not recovered/not resolved and the outcome of the fatigue, chest discomfort, rib pain, neck pain, headache, sleeplessness, mobility decreased, loss of balance and fall were unknown.   It was unknown if the reporter considered the feeling abnormal, fatigue, chest discomfort, rib pain, neck pain, eye pain, headache, pain localized, sleeplessness, mobility decreased, loss of balance, fall, joint pain and back pain to be related to Shingrix.
Hospitalization: Admitted 8/14/22, discharged 8/22/22 Presentation to the ED: Shortness of breath. elevated white blood cell count.  COVID-19 + date: 08/14/22  Treatment: Patient was admitted from the ED to the ICU. He had a productive cough. Patient was treated for lung cancer, COPD, and cardiovascular problems. He was prescribed vancomycin, but was not given COVID prophalyxis.  Discharge: deceased on 08/22/2022.