chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included "thyroid," high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), intramuscular in left deltoid in Jan2021 (reported as 06Jan2021 or 07Jan2021 at 11:30) at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received the first dose of bnt162b2 on 16Dec2020 at around 19:30, intramuscular injection in left deltoid. A day after vaccination, since an unspecified date in Jan2021, the patient's lymph nodes were swollen for 3 weeks at the time of report. The swelling went down some but was still very noticeable. Outcome of the event was recovering. Event did not require a visit to emergency room or physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.
Shot area is red, hard, hot to touch, itches.  Redness extends for about 4 inches.
Severe shoulder pain and loss of  left arm mobility following covid vaccination. Administration of vaccine was very superior and slightly posterior on left arm.  Shoulder pain increasing 24hrs after administration. Prednisone prescribed for 5 days with moderate improvement. Shoulder inflammation/pain returned 3 days after finishing prednisone taper. Left hand becoming discolored (bluish/purple in color) when arm down by side. Ultrasound of the shoulder performed on  1-18-21 with normal findings. Blood work-up (for possible underlying autoimmune disease) and x-ray performed on 1-21-21(results pending). Another round of prednisone prescribed on 1-21-21. Shoulder pain/ discomfort still present 3 weeks post vaccination.
Client received HPV (R) arm on 1-15-19. Return to clinic 2-11-19 stating right arm "burning" and discomfort for approximately 2 weeks.
Call from mom 30MAR92; report pt had redness & swelling on face approx 5 mins post vax; 1 noc had profuse sweating; temp not measured; did not feel hot; foul order to breath; has not wanted to eat x/liquids for past 6 days; Urine output dec
PSORIASIS FLARE UP; WEARING OFF EFFECT; HEADACHE; OFF-LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis.  The patient received 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination and dose was not reported, 1 total administered on an unspecified date and month in 2021 for prophylactic vaccination (which was off label use and inappropriate schedule of vaccine administration). The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis flare up, itch for two or three days before injection with humira, headache and wearing off effect (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from psoriasis flare up, and wearing off effect, and the outcome of headache, off-label use and inappropriate schedule of vaccine administered was not reported. The patient received moderna covid-19 vaccine (dose number in series 2), (form of administration not reported, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No adverse events were reported following administration of moderna covid-19 vaccine (dose number in series 2). This report was non-serious.
Patient stated her period came 10 days early.  Earlier in this report I stated that it happened on the same day and time as the vaccine.  I do not actually know when she had her period, other than that it was 10 days early.  I did tell her that stress / anxiety can cause changes to your menstrual cycle, and it was probably from that.
patient reports no known drug allergies.  patient called on 8/3/09 to report the following effects following vaccination: raises whelps & itching at the admin site, also generalized aching and dizziness.
Headache fatigue Narrative:  headache, fatigue; self recovered in 48 hours
Patient administered Pfizer vaccine, waited 30 minutes for monitoring without incident.  Patient drove away. Patient returned 10 minutes later with complaints of ?a peppery taste in her mouth and my upper lip is itchy.?  Patient reports not drinking water this morning but did eat some gummy bears and drank some coffee.
16hrs-rash inflammation soreness at injection site, very sore joints and muscles, lucid and vivid dreams 32hrs-headache and diarrhea  56hrs-continued diarrhea None after 72hrs
Patient has swelling in both hands and some red patches on his legs.  No reaction at injection site, just swelling in hands and states no new meds or changes.
This spontaneous report as received from a physician refers to 2 patients of unknown age. Patient's medical history and concurrent condition was not reported. On 19-SEP-2014 the patient's were vaccinated with PNEUMOVAX23 prefilled syringe (dose and frequency unknown). Patient's concomitant medication was not reported. On an unknown date the patient experienced fever and chills. When doctor used the first 2 out of a 10 pack box, both patients broke out in fever and chills. The doctor does not want to use the other eight. The outcome of the event was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Patient states injection was painful upon administration and pain has worsened over time to include her whole arm with shooting pain down arm.
CHIEF COMPLAINT:   pt states that she is feeling weak SOB and had a syncopial episode   HISTORY OF PRESENT ILLNESS:     94 years old female with past medical history of hypertension, hyperlipidemia, hypothyroidism, coronary artery disease, patient presents to the ER with near syncope, she is awake and alert able to answer questions oriented to x2 person on place poor historian.  She was found to have left lower lobe pneumonia mildly tachypneic and short of breath in the ER.  She was afebrile.
Overly tired, cold, some shivers and a headache at the end  Took A Tylenol Cold & Head caplet in the afternoon and the symptoms started to ease up.  Felt normal at 3 am the next day except for the raging headache but that went away by 5 am.
Pt was given H1N1 vaccine intranasal instead of intramuscular administration no symptoms of flu noted as of 12/16/09. Thinking that this is protocol no MD order in place.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occurred and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Severe Body Aches, Fever little over 100 degrees F, Chills.    Started about 9 hours after injection - lasted 7-8 hours.    Arm pain but that was no big deal.
BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS  MOSTLY INSTEP AND CALVES; MIGRAINE TYPE HEADACHE LIKE STEAK  THROUGH THE HEAD; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine type headache like steak through the head. On 06-APR-2021, the subject experienced cramps in calves/leg cramps mostly instep and calves. On 06-APR-2021 03:00, the subject experienced bone ache. On 06-APR-2021 03:00, the subject experienced body aches. On 06-APR-2021 03:00, the subject experienced very high fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, and very high fever on 06-APR-2021, and migraine type headache like steak through the head, cramps in calves/leg cramps mostly instep and calves, and body aches on 07-APR-2021. This report was non-serious.
Hair loss started 4 days after 1st vaccine, had chicken pox type lesions when had active positive covid and lesions reappeared after vaccine.
Pt left health care facility and became unresponsive for approx 10 min. 911 was called, paramedics arrived, pt became responsive after cold cloth was applied.  Pt returned to health care facility soon after and patient was examined by physician and was found to be normal
temp of 100.4, chills, diarrhea, muscle aches, runny nose--symptoms resolved 1/20, also had a covid exposure so will get tested in 5-7 days post exposure
Since injection in Oct. 2012 in deltoid muscle, have had deep muscle ache at exact site. Over several months, this progressed to shoulder pain, stiffness and severe decreased mobility. This has never gotten better. Taking meloxicam for (shoulder bursitis).
Upper left arm swollen and extremely red, low grade fever and nausea at first.  After day 2, the fever and nausea subsided but on day 4, the redness has spread to the underside of my upper left arm, is swollen and hot to the touch.   I have been taking ibuprofen for pain as well as icing the area constantly and using Aloe Vera with lidocaine.
Frequent headaches episodes, generalized muscular pain, generalized weakness, hypothyroidism, anxiety disorder, shoulders, knees and ankle joints pain, hearing loss. I received 4 anthrax vaccines in a 40 days period.
I received the Moderna vaccine at Pharmacy ( on 4/9/2021 at 8:15 am), and  I noticed that my injection site was starting to become sore at night on 4/17/2021. The next afternoon (4/18/2021 around 3:00 pm) I started feeling stiff w/ some body aches.  By 8:00pm I had a mild fever (95.5 degrees) and noticed a pink area around the injection site.  It was not bumpy or itchy, just a little swollen and pink (about 3" tall and 2 1/2" wide).  The fever and body aches were gone by the time I woke up the next day (4/19/2021), but the pink area lasted until 4/21/2021.  I also had moderate headaches starting around 8pm on 2/19 and 2/21.  The reaction seemed completely cleared by the morning of 4/22/2021.
Hives 4 days after first dose that was self-limiting and resolved with Benadryl, reported at time of 2nd dose
A lot of fatigue; Three days of pain in the place of the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Three days of pain in the place of the vaccine) and fatigue (Verbatim: A lot of fatigue). The outcome of the injection site pain was resolved (duration 3 days) and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient just got 2nd vaccine and had three days of pain at the injection site and lots of fatigue but it was over now (in recent time). And based on the experience, the patient stated it was worth getting the vaccine, supposedly it protects you for approximately 5 years. Follow-up not possible as no contact details provided.
Information has been received from a registered nurse concerning a male dialysis patient with a long medical history who had completed a hepatitis B virus vaccine series in the past who on 2/13/03, 5/18/04, 6/18/04 was vaccinated IM with a 0.5ml dialysis formulation booster doses of hepatitis B virus vaccine. Concomitant medications were noted, however, the list was unknown. It was noted that since he was a dialysis patient, he got his antibody titer drawn regularly. The patient had surgery and received a blood transfusion. On 7/8/04, he was given an additional dose of hepatitis B virus vaccine. When his antibody levels were tested after that, he came back positive for hepatitis B infection. The infection progressed, renal failure occurred, and the patient expired. There was no product quality complaint involved. The reporter indicated that hepatitis B virus vaccine was not the cause of any adverse experiences. Additional information has been requested.
Feeling of burning up from the inside out of body. No Fever. Dizzy, light headed,especially when standing. Headache. nauseated
Shortly after administering vaccine Tdap (Boostrix) at around 4:30 P.M patient felt ok, but was stating she felt a little dizzy. She was monitored for a few minutes and when she walked up front she felt dizzy again and fainted. She was worked up by MD with stable blood pressure and sugar levels. She was taken to hospital for further check up. followed up with patients parents on 3-3-2020 at 8:40 A.M and was told she was home doing well. Patient was worked up and found tooth infection and is being treated for infection all other exams were normal per conversation.
Diagnosed with Type 1 diabetes in Sept 2004, classic symptoms of polyuria, polydipsia, acidosis,  fatigue and weight loss. Brief hospitalization for IVF's and insulin initiation. Family history of diabetes. 8/3/06-medical records included with VAERS report.  Chief Complaint on visit of 6/20-06: " I was told you were doing research on people who got diabetes after getting the vaccines." HX Present illness: Patient interested in filing a VAERS report regarding the onset of his Type 1 diabetes following receipt of multiple vaccines.  After vaccines of MMR, IPV, TD, Hep A and Hep B on 5/2/05 complained of "feeling sick" (body aches, fatigue) within 2-3 day period. No local reactions to Typhoid and Influenza vaccines on 5/19/05. Smallpox on 6/13/05 and denies any significantly increased redness, streaking or swollen axillary lymph nodes. C/O pruritus at small pox vaccine site. In August 2005 began to experience increase in drinking water and frequency of urination, weight loss of 5 pounds. Increase intake "lots of sugar in his diet to regain weight." Constipation for 2 weeks, back pain, numbness and tingling in legs, felt like "feet wouldn't move." Fatigue, continued weight loss, breath "fruity", seen in ER blood glucose >300, admitted for ketoacidosis, hospitalized for 7 days.  Family HX: type 1 diabetes and type 2 diabetes. Consulting MD: no fevers or chills, positive for weight loss and anorexia. No blurry vision, no nausea, vomiting or abdominal pain. Positive for polydipsia and polyuria. Positive for nocturia, no dysuria. Positive for musculoskeletal pain in his legs and back. All other pertinent review of systems are negative.  DX: Diabetes Mellitus Type I with symptom onset approximately 3-4 months following multiple vaccinations.  No additional records requested. krk
No pain and minimal if any soreness in left arm. The morning after I had three fleeting bouts of recognizeable depression- like a dark cloud that very suddenly came on and departed within minutes. First two about an hour apart the third I was walking an hour or so later and a sudden feeling of depression came again. I laughed at it the third time as it was such an odd and unusual feeling while enjoying outside, this too was fleeting. No more symptoms other than some tiredness over the next week .
she tested positive after taking the Pfizer Covid 19 vaccine; She tested positive after taking the Pfizer Covid 19 vaccine; 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 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have the hearing problem" (unspecified if ongoing), notes: Consumer stated, I have the hearing problem. I can't really hear you. I have put on hearing aid; "hearing aid" (unspecified if ongoing), notes: Consumer stated, I have the hearing problem. I can't really hear you. I have put on hearing aid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she tested positive after taking the Pfizer Covid 19 vaccine"; COVID-19 (medically significant), outcome "unknown", described as "She tested positive after taking the Pfizer Covid 19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The caller is she tested positive after taking the Pfizer Covid 19 vaccine and also she was prescribed to take Paxlovid since she tested positive for Covid so, she already took the dose. So, she started taking the Paxlovid around 2:30 the afternoon so, she also have the question about the product." I had three vaccines full doses and I had one booster and I stayed home 2 years and only now I went out little bit and so, I am shocked that I have covid and because I am 74 year old and I was authorized to take this drug and I received it just now and I decided there is time limit when you take it. I took it this afternoon at 2:30. I was not going to wait till tomorrow morning. It is a simple question as I don't want to double up and it's for 5 days it means I continue taking this weird hours but I want to know when should I take my next dose should I wait till morning or should I wake up 2:30 in the morning or what.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed swelling, redness and warmth to touch at injection site the following evening Wednesday 9/26/18. Irritable, and is walking stiff-legged. Seen in Urgent Care and are treating with TYLENOL and BENADRYL. Still determining what next step in care will be.
pt recv vax & 7 days post vax pt exp sz;5mo later pt exp a severe sz & was hosp;the parents now allege that child devel mental retardation since the occurrence of the second sz;
Caller states she thinks the person giving the injection put the darn thing through her bone.; Caller reports that with the first shot she got a really sore arm.; This is a spontaneous report from a contactable nurse (patient herself). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL8982), via an unspecified route of administration, administered in arm on an unspecified date (age at vaccination was 80 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced patient states, she thinks the person giving the injection put the darn thing through her bone and she reports that with the first shot she got a really sore arm. She thought it was to be expected but it feels like the person who administered the vaccine was a poor shot giver. The outcome of events were unknown.   No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On 10-MAR-2017, the patient went to the pharmacy for a dose of ZOSTAVAX. Reportedly, the patient had an active case of shingles at that time, which started from an unspecified date. The patient's outcome and the causality assessment between ZOSTAVAX and herpes zoster were not provided. Additional information has been requested.