chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Practical Nurse concerning a 24 year old female employee in the office who on 01-OCT-2007 was vaccinated subcutaneous with a first dose of pneumococcal 23v polysaccharide vaccine lot #657525/0554U. On 01-OCT-2007, after the injection the patient developed immediate itching and redness at the injection site. She still had the red area at the injection site. No other information to report. The patient was recovering. Additional information has been requested.
Extreme exhaustion, mental cloudiness, chills and hot flashes, diaphoresis, temp spikes,  99.5. normal temp is 97.6 to 98.0
I have a itchy golf ball size swollen lymph node under the arm pit of the are I got my vaccine. 1st dose
Patient received shingrix vaccine on 8/4/19.  2 weeks later patient developed blistery weeping rash over both arms, stomach, thighs and back. Rash lasted over 2 weeks and was very itchy.
Few hours after receiving dose, extreme pain from shoulder to hand w/ numbness and tingling. Inability to sleep. Took Ibuprofen which helped with pain. Following day numbness subsided, pain continued in arm. inability to sleep. by 3rd day noted swelling/ warmth to puncture site and red bruising. Contacted MD. as unable to lift arm up. fourth day continue to have bruising, swelling, pain and now added itching to site
Immediate burning and pain when administered.  Bruising and severe pain to date. Needle inserted too high and with force causing severe pain, weakness and limited mobility. I?ve had x-rays, mri, cortisone injection, taken orally ibuprofen 600mg, medrol dosepak, tramadol HCL 50 mg, and I am now taking Meloxicam 15mg   Pain , weakness and limited mobility has not improved. Scheduled for physical therapy as well.  This has all been under the care of an orthopedic surgeon. MD
Had about a 3 inch circumference red spot at the area of injection; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had about a 3 inch circumference red spot at the area of injection (noticed last evening) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Started Prednisone 50 mg x 2d, Phen 40 mg x 2d etc (in tapering fashion) on 10/31.  Left leg pain and rash.  Started 11/1 or 11/2, seen on 11/5 had typical Zoster rash.  Distribution left leg.
Skin bumps that feel like chicken pocks on my lets; burning sensation in my arm pits.; Especially painfully after taking a shower; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 11Apr2021 at 13:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications included cyanocobalamin B12 (MANUFACTURER UNKNOWN) and MULTIVITAMIN from unknown dates and unknown if ongoing for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 21Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 the patient experienced skin bumps that feel like chicken pox on the legs, burning sensation in the arm pits and especially painful after taking a shower. Therapeutic measures were not taken as a result of events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events skin bumps that feel like chicken pox on the legs, burning sensation in the arm pits, especially painful after taking a shower was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Have a one inch by three inch RED, raised rash on injection site. Also had headache evening of vaccination. Used ibuprofen and cortisone cream for relief.
The evening of the vaccination, the patient stated "my arm started feeling sore, but it wasn't swollen." The next morning, the area below the vaccine site was swollen all around arm in a circle. Later that evening, patient stated, "I noticed a rash around area with redness, even to the back of my arm. My arm felt itchy under my clothing." 10/30/05 in am, patient stated "my arm was extremely red all over and felt warm to the touch. Pain was felt upon movement. Yellow discoloration noticed at that time."
Patient states she has had arm pain since the event and believes it was injected into vein.  She states she can not lift her arm to even brush her hair and has had intense pain going down her arm and into her armpit since the shot.  She sought medical treatment at an Urgent Care and was given oral steroid dose that did not help.  It is now 3 weeks later and she is exasperated with her continuing pain and inability to move her arm.  I phoned her Dr. and they said they would contact patient to decide how to proceed.  As of tonight 7pm 6/21/23 Dr. has not contacted her.
Covid19 breakthrough.  1st vaccine received on 02/26/2021.  77 y/o PMH HTN, HLD, Glaucoma, ESRD on HD, DJD, Goiter, Hypothyroidism, Aortic stenosis, Orthostatic Hypotension, HTN presents to ED after dialysis.  Pt states had been having SOB, cough and dizziness that worsened after dialysis.  Pt found to be in Afib with RVR, CXR- multifocal PNA. T-101.  Treated with IV ABX.
" Patient experienced fever, chills, neck pain radiating to head, mild weakness and dizziness.  Patient denies any emergent concern at this time. Urgent care visit scheduled"
Patient came in for second dose of Moderna. Registration checked him on the system, which showed he only had one dose of Moderna (WebIZ: 5377664). Second dose was given and after his observation period, on the way out, he told registration that it was his fourth dose of the vaccine and showed them a picture of his Pfizer card. No adverse events were noted during time of observation. WebIZ was searched using his birthday and he had both Pfizer vaccinations under the name (WebIZ: 3791774). Both IDs on WebIZ have same birthday and address on file, just different first name.
always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9895, Expiration Date: 31May2022), in arm for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: caller had to go to a dentist appointment and because caller had hip replacement caller usually takes 4 antibiotics., had to take amoxicillin due to history of a hip replacement. Vaccination history included: Bnt162b2 (1st dose: Says Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN5318 , Expiration date: 31May2021 , NDC number: Unknown), for Covid-19 immunization, reaction(s): "always get a sore arm where I get the shot"; Bnt162b2 (2nd dose: Says Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN6203 , Expiration date: 30Jun2021 , NDC number: Unknown), for Covid-19 immunization, reaction(s): "always get a sore arm where I get the shot"; Bnt162b2 (3rd dose: Booster 1 , Lot number: FF2588. , Handwritten on card without a sticker because caller went to a different hospital for this dose. , Expiration date: 28Sep2021 caller believes. , NDC number: Unknown), for Covid-19 immunization, reaction(s): "always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "always get a sore arm where I get the shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter called Pfizer before because she had to go to a dentist appointment and because caller had hip replacement and she usually takes 4 antibiotics, no specific product names provided, prior to the visit, and that would have been Monday and she had the vaccine on Friday so called Pfizer to get information. Called dentist and dentist said caller could skip the antibiotics this time because the visit would be an easier reason caller was going, would be okay without taking the antibiotics. She was calling before because wanted to know if there was an interaction with taking the antibiotics so close to getting the vaccine, she did not take the antibiotics, made decision after talking to dentist that it was okay to not take the antibiotic. She clarified and confirmed this dose was caller's 5th dose total and clarified and confirmed that the Pfizer bivalent vaccine was the Pfizer BioNTech COVID-19 bivalent vaccine, but caller always has the arm pain, always happens that way, not a new experience for her. Confirmed that her 4 prior doses were all the Pfizer BioNTech COVID-19 vaccine. Upon follow-up of 01Dec2022, it was stated that she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot."
Expected adverse reactions after approximately 24 hours including lethargy, body aches, fever (100.1), chills, and headache. The headaches are continuing 4 days post vaccine, although, not as severe. They do respond to Tylenol. My doctor said this should be reported due to the longevity of the symptoms.
Patient's right arm became swollen and red around injection site and down towards elbow. She started with cold symptoms the day after vaccine.  Her arm became inflammed and red 2 days later. On Saturday, 11/12/22, pt called the pharmacy and I advised she take her temperature and see MD or go to urgent care. Patient did go to urgent care that evening and they marked her arm and advised pt to go to ER if it got any bigger.  They also gave pt Keflex to take for 7 days. And while pt was there, she did have a fever with cold symptoms so they tested her for Covid. She was postive for that as well.
Narrative: Patient presented to ED on 4/8/21 after complaints of developing a fever, body aches, and a rash the day after receiving the first dose of the Jansen COVID vaccine the day prior. He stated that his fever was 104F at home; however, it was reported as 99F en route with EMS. Patient tested negative for COVID-19. A chest x-ray was performed and no acute abnormalities were noted. Patient was not treated with any medication and was stable upon discharge home.
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon). At the time of the report, VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Initial information has been received from a nurse practitioner concerning a 19 year old, female, who reportedly developed a rash with Ceclor, whose reported weight was 175 pounds (lbs) and whose reported height was 66 and 1/2 inches (in), who had no illness at the time of vaccination, who on 15-DEC-2006 was vaccinated intramuscularly, into the arm with her first dose of Gardasil, (lot # 653978/0955F), (WAES # 0701USA00254). On 28-DEC-2006 (also reported as 28-DEC-2007), the patient was vaccinated into the left arm with hepatitis A virus vaccine inactivated (Lot # AHAUB1Y1AA), (manufacturer unknown). It was reported that on 01-JAN-2007, the patient developed hives and rash on chest. At the time of report it was unknown if the patient recovered. Additional information has been requested.
Patient c/o generalized body aches, fever, HA, decreased appetite and fatigue.  Patient stated he feels better today than yesterday.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients may have received improperly stored doses of ROTATEQ orally, lot # L010126, expiration date 22-JAN-2017 (dose was not reported). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion at 34 degrees Fahrenheit for 75 hours. Data logger was involved. There were no previous temperature excursions reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to walk in clinic on 1/15/2019 and it is documented that she has had pain in her left arm, was reddened, had blistering and weeping from the lesions. Treated with BACTROBAN ointment by walk in clinic staff.
slight increase in pain in large joints and ankles; slight increase in pain in feet; This is a spontaneous report from a contactable other health professional via a Pfizer-sponsored program. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included tendonitis and pain in fingers relieved with steroid injections. The patient's concomitant medications were not reported. It was reported that patient missed his one dose of medication on the day of COVID vaccine. On an unspecified date, the patient experienced adverse event of slight increase in pain in large joints, ankles, and feet. Therapeutic measures were taken because of slight increase in pain in large joints, ankles, and feet. The outcome of the events was recovered/resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hot to the touch; red; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (hot to the touch) had not resolved and VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.   Reporter did not allow further contact
Patient received vaccine, stood up to leave to lobby for observation period, turned back and said he felt light headed, this RN advised that he needed to sit down but before we could find a seat, patient wobbled then fell backwards, striking his head on an upright support.
This case was reported by a consumer via call center representative and described the occurrence of passed out in a 56-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole (Prilosec). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain. On 2nd May 2018, the patient experienced passed out (serious criteria GSK medically significant), nausea, blood pressure decreased, sweating and fever. On an unknown date, the outcome of the passed out, general body pain, nausea, blood pressure decreased, sweating and fever were recovered/resolved. The reporter considered the passed out, general body pain, nausea, blood pressure decreased, sweating and fever to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included supplements. The patient received SHINGIRX on right arm. The patient experienced mild body aches began in evening on the day of vaccination and became more severe on next day. On 2nd May 2018, the patient felt nauseous but did not vomit. The patient was passed out on bathroom floor (while feeling nauseous). The patient was thinking passing out might have been related to decreased blood pressure. The patient moved to her bed where she experienced incredible body sweats for the remainder of the day. The patient did not take her temperature but felt that she might have had a fever.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient (age not reported) who received a dose of vaccine TENIVAC instead of ADACEL (lot number not reported) via unknown route in the deltoid on 03-Dec-2018 or 04-Dec-2018 (reporter was unsure). It was reported that the purpose of receiving ADACEL was to receive the pertussis component to protect newborn grandchild. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
8 Days after injection, developed a itchy, warm, red rash around the injection site. Internet stated it was a known side-effect called "Covid Arm".  Rash lasted about 5 to 7 days.  Applied Cortaid.  Did not seek medical attention.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician (site not specified), for a vesicular outbreak, which was diagnosed as shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Additional information has been requested.
NEPHROTIC SYNDROME; SWELLING; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included minimal change disease, diagnosed in 2009 and was in remission since 2015. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, soon after vaccination, the patient experienced swelling. Approximately 4 weeks later, patient experienced nephrotic syndrome with 5 grams of protein in urine. The patient believed that vaccine triggered the relapse. On 12-APR-2021, patient visited the nephrologist who agreed that vaccine might have been the cause of relapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nephrotic syndrome and swelling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210422260-covid-19 vaccine ad26.cov2. s-nephrotic syndrome. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Chief Complaint ; Right ICA occlusion; History of Present Illness; Patient is an 80-year-old white male with a past medical history of HTN and gout brought to the ICU after undergoing R ICA angioplasty & stent placement with the NeuroIR team on 7/22/2021. The patient was admitted by the Stroke Service on 7/20/2021 after transfer from an OSH where he had presented earlier that day for aphasia and dysphagia. Of note, the patient was found to be COVID-positive at the OSH before his transfer to this facility for a higher level of care. The patient was diagnosed with R cerebral infarction (mechanism: atherothromboembolic) and found to have severe stenosis of the R ICA. He was started on dexamethasone and remdesivir on 7/20 by the stroke team.