chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had developed welts on her leg and a rash broke out/she has welts on the side of her thigh; Had developed welts on her leg and a rash broke out; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Other Products, Patient History, and Investigation Assessment Not Provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date as single dose COVID-19 immunization. It was reported that DSU agent mentioned caller had developed welts on her leg and a rash broke out on an unspecified date. Caller had some questions regarding the side effects associated with the vaccine. It was reported that she had the Pfizer injection this past Monday, it was her second injection. It was reported that Today she had welts on the side of her thigh and a little rash broke out. She doesn't know if it would be a side effect of the injection. She wants to know if its related. Reporter seriousness for events Unspecified. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Mother described injection site of DTaP - left deltoid red area about size of quarter, has center that looks as if it has pus in it. Had some drainage, itches and is warm to touch. Child has elevated temp. 6/11/03: Call PMD again; saw NP at MD's office. Was given Motrin and Benadryl. No infection, only local allergic reaction.
Swelling, induration 40mm X 40mm, redness 5cm X 5cm and warmth.
Arm/muscle pain; Arm/muscle pain; Exhaustion lasting two days; This is a spontaneous report from a non-contactable nurse (patient herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (arm right), on 17Dec2020 at 06:00, at a single dose, for COVID-19 immunization. Relevant medical history included depression, anxiety, exercise endured asthma, migraines, and allergies to estrogen supplements. Concomitant medications included sertraline hydrochloride (ZOLOFT), galcanezumab (EMGALITY), clarithromycin (CLARITIN), and norethindrone. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced exhaustion lasting two days, and arm/muscle pain. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient showed a negative post vaccination nasal swab result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given PNEUMOVAX on 6/17/2013. Had reaction next day. Redness and swelling below left deltoid. 6-18-2013 physician saw patient. Return to clinic for spreading of redness, increasing pain or swelling, fever. Recommend ice and elevation of arm.
we already had the COVID; we already had the COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we already had the COVID".  Clinical course: Reported inefficacy after COVID vaccine. Probably, because they already had the COVID in May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200020676 same drug/event, different patient;
soreness of the arm; heavy arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant details were not provided.
Bodily muscle aches and spasms, dizziness, headache, brain fog, fatigue, nausea, and erratic temperature (hot and cold).
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
On March 4th, the day after the vaccination I woke up at 6:30 AM with aches and pains all over.  After walking the dog and eating some cereal I began to experience chills.  I measured my body temperature - fluctuating  up to 102 degrees F.
Patient c/o tingling itchy throat caused patient to cough a little bit. Patient denied chest pain or SOB. Patient also reported that she has schizophrenia and did not take medications because she did not want it to interfere with the vaccine. Nurse practitioner on site did patient assessment and vitals. No EMS was needed. BP: 139/84 HR: 79
Found obituary through web search. Patient passed away on 25Apr2021.; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer. A 64-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown number dose, single dose for immunisation (Pneumococcal Pneumonia). Medical history included asthma and diabetes. The patient's concomitant medications were not reported. Found obituary through web search. Patient passed away on 25Apr2021. Cause of death is unknown. The patient died on 25Apr2021. It was unknown if an autopsy was performed.  Amendment: This follow-up report is being submitted to amend previously reported information: formulation of product has been changed.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Patient passed away on 25Apr2021.
Pneumonia; muscles aches; neck pain; shoulder pain; have soreness in my shoulder, in my neck and in my arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, lung cancer, back disorder, from an unknown date and unknown if ongoing. Concomitant medication(s) included formoterol fumarate, glycopyrronium bromide (BEVESPI AEROSPHERE) taken for chronic obstructive pulmonary disease, start and stop date were not reported; salbutamol sulfate (PROAIR HFA) taken for chronic obstructive pulmonary disease, start and stop date were not reported. On an unspecified date patient experienced pneumonia, muscles aches- myalgia, neck pain, shoulder pain- arthralgia, pain in my arm- pain in extremity. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, x-ray with result unknown.  Patient has been taking treatment for back problem with Hydrocodone or Vicodin. The outcome of Pneumonia, myalgia was unknown, Neck pain was recovered and arthralgia, pain in arm was not recovered.  Information about lot/batch no has been requested.
Hives; Rash; SOB; Wheezing; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives"; RASH (non-serious), outcome "not recovered"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; WHEEZING (non-serious), outcome "unknown".  Additional information: Hives, sob and wheezing 45 min after vaccine, rash ongoing 2 weeks after vaccine; Event took place after use of product.  The information on the batch/lot number for (Comirnaty) has been requested and will be submitted if and when received.
Patient reports shoulder pain since receipt of first SARS COV2 vaccine on 1/29/2021. About 4 weeks after receipt of second dose pain became significantly worse . Evaluated by NP on date 3/22/2021 who reported in her note: "Left upper arm below the injection site with hematoma, site warmer than the right arm, no redness."
They received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They received an expired dose) 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 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They received an expired dose) had resolved. Not Provided          No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
The pt developed fever (105.5 deg F) 18 hrs after receiving DTaP and hib vaccinations.
I received my flu shot in the morning, around 1:30 p.m. I began to feel extremely tired. Around 2:30 p.m. I had a feeling of being disoriented where I felt like the room became fuzzy.  My boss went and got me a glass of water. I was slightly worried about driving home, so I stayed at work until about 4:30. I did have more pain in my arm than usual from the flu shot. I went home and went to bed early and was feeling better by the next day. Patient did not require any further treatment for this as she felt better within 24 hours.
Dyspnea (Hx of asthma, takes inhaler, oral albuterol, Flovent). Physician diagnosed as RAD. 7/27/06 Received medical records from hospital which reveal patient admitted 11/9/04 on day of vax with chief complaint of SOB, productive cough, chest tightness, HA & leg swelling.  PMH: asthma x 10 years, OA, RA, irregular heart beat, back pain, c-spine fusion, hypothyroidism & gout.  Patient continues to smoke approx 1ppd cigarettes.  Stated that on day of vax did not use her nebs & SOB became progressively worse.  Exam revealed coarse rales & exp wheezing with decreased air movement.  There was 2+ pitting edema of bilateral lower extremities. Dx: acute exacerbation asthma, possible CHF, possible COPD, possible URI, shronic back pain, HTN, irregular heart beat & tobacco abuse.  Progressed well & was d/c home on steroids.  Final dx: acute reactive airway disease/ss
Severity of tinnitus increased from 1 to 5 on scale of 1-10 accompanied by "brain fog". Brain fog dissipated over next 48 hours, tinnitus has remained at 5.
Resident received vaccine at 0840. At 0842 patient started complaining of chest tightness. Moments later, she started complaining of pain in neck and forehead. Vital signs immediately taken. BP 90/38 P60 Resp 18 SP02 96%. Moments later SPO2 dropped to 89%. Resident placed on 2L nasal cannula and SPO2 increased to 97%. Previous pain persisted. Resident started complaining of new pain in left hip and lower back. Patient was given nitroglycerin sublingual. At 1003 patient taken off 02 and at 1015 patient given albuterol updraft.  Also at 1015 patient began complaining of shooting pain in left eye and temple. At 1030 50 mg IM benadryl given. -
This spontaneous report as received from a pharmacist via company representative refers to a approximately 70 year old female patient. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J011826 dose 1, .65 ml, subcutaneous injection. No concomitant medication was reported. On an unspecified date in 2014 the patient experienced bruising at the injection site (medically significant), swelling from the elbow to the lymph nodes of the patient's neck (medically significant). Physician was contacted to sought medical attention. It was reported that patient was seen by unspecified physician a few days later approximately in 2014 who gave a prednisone injection. The outcome of were reported as resolving. The relatedness between the ZOSTAVAX and event was not reported. Upon internal review the event swelling from the elbow to the lymph nodes of the patient's neck and bruising at the injection site was considered medically significant. Additional information has been requested.
pt recvd vax & devel small rash on stomach-vomit-could not hold anything down, low grade temp rash spread over entire body;
BODY ACHES; SORE THROAT; FELT WARM BUT NOT FEVERISH; OCCASIONAL DRIP FROM NOSE; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced body aches. On 02-AUG-2021, the subject experienced sore throat. On 02-AUG-2021, the subject experienced felt warm but not feverish. On 02-AUG-2021, the subject experienced occasional drip from nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore throat, felt warm but not feverish, and occasional drip from nose. This report was non-serious.
Patient states she tolerated the injection fine, then that evening went to a fitness class.  After the fitness class she was doing her usual stretching where she laid on the floor, crossed her arms across her body at the elbows and held the pose to stretch her back. She states she always does this stretch after her class.  When she released her stretch she immediately felt pain in the arm she had her injection in.  Pain that shot down to her wrist and then up to and through her shoulder, neck, and to her head.  She continued to feel this pain all night, it was not relieved by OTC NSAIDS and it kept her from sleeping.  She called the pharmacy the next day as her arm was still hurting, to the extent that she said she "couldn't do anything with it".  She states she has never had any adverse reaction to any other vaccine.  She is not one of our regular patients, but she did include on her VAR she had received a "regular flu shot" in the past 4 to 8 weeks.  It sounded like she went to a vigorous fitness class, but she said this was her normal class, and normal amount of physical exertion. she called to ask if she should contact her physician, and was told she could and should if the pain did not resolve with self-treatment, but it is unknown at this time whether she has sought out treatment.
Pt had satellite lesions 1/2 an inch to the left and right of the original vaccination site.  All three lesion were healing well with scabbing.  Pt woke up this morning 01 Sep 09 with scattered red bumps across his chest.  Pt was seen by Dr.  She Dx the pt with a reactive rash from the smallpox vaccine.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date of 2008 (administered between the dates of March 2008 and September 2008) the patients were vaccinated with GARDASIL, injection, (dose, frequency and lot# were not provided) which was invalid dose because the vaccine was stored incorrectly during that period of time. The outcome, action taken and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
Night of vaccine, some aching of joints and fatigue. Next day, hives and swelling on back of neck and all over head, throughout next day after shot and that evening itchy swelling lips. Took Benadryl and itchiness calmed down Next day forehead, lips, itching and swelling of  hands and wrists, took more Benadryl Next Day still having swelling of wrists and cracking of skin on wrists Congestion and phelgm
This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 61-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) due to dialysis. Concurrent medical conditions included dialysis and hypertension. Concurrent medications included Unknown. On an unspecified date in July 2010 the subject received 1st dose of ENGERIX B (unknown route, unknown arm). One week after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B.
On December 18th, 2022 I woke up with a stuffy runny nose, sneezing, coughing, no appetite, and headache. I was really tired and felt blah. Not anything too bad right away. Within two days I felt so horrible it was scary because I am asthmatic. I was having trouble breathing. I have a pulse oximeter to monitor my oxygen. I was coughing, body pain, restlessness, and tired. I didn't have fever. I had diarrhea, stomach upset. I felt so horrible and went to the emergency room. On day four I was able to get PAXLOVID from my doctor and began to feel better. I finished the medication on  December 26th, 2022 and began to feel much better. Today I feel icky and I have nasally, congestion, and coughing. When I went to the hospital the emergency room doctor told me not to take it because it was going to make me feel worse so I went to my PCP the next day who did prescribe me the PAXLOVID.
I have pain in my upper back radiating up the right side of my neck and down my right arm.; I have pain in my upper back radiating up the right side of my neck and down my right arm.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown (Not available/not provided to reporter at the time of report completion)) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:15 (Age at Vaccination: 38-year-old) as dose 1, single for covid-19 immunization at workplace clinic. The patient took no other vaccine in four weeks, had not covid prior vaccination and was not covid tested post vaccination. Medical history included obese and overweight. The patients known allergy was codeine Patient took other medications (unspecified) in two weeks. On 28Feb2021 at 03:00, the patient stated that she had pain in her upper back radiating up the right side of her neck and down her right arm. It was unknown if the treatment for adverse events was taken by the patient. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a medical assistant referring to a 68 year old female patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On 15-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date: 06-APR-2020, dose and frequency were unknown) intramuscularly in the left arm for prophylaxis. On 16-OCT-2018 the patient experienced redness and swelling which extended from the left inner arm to the elbow and the injection site area was hot to touch. The patient notified physician's office of reaction on 16-OCT-2018 and was told to observe the reaction site area and to call back if symptoms worsened. No treatment was given for the events. No lab diagnostics or studies were performed for the events. The outcome of the events was recovered. The causality assessment was not provided by the reporter.
11/20/11 Reports twitching & numbness of lip on (R) side. 11/21/11 (R) eye burning, irritated & numbness. 11/22/11 (R) side face numb & eye & lip drooping. Went to ER. Started on anti-viral med and steroids, eye drops. Allergy to eye drops. 11/20/11 Follow up with optometrist for cornea scratch 12/5/11. Numbness & drooping lasted for 2 weeks. 12/9/11 (R) eye still being treated at this time.
Initial extreme muscle soreness, headache and fatigue with dizzy/vertigo upon standing for approximately 2 days. Muscle soreness and fatigue subsided upon day 3 with intermittent headaches and dizzy spells continuing.