chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 40 year old female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. The pt's medical history included joint pain. Concurrent conditions and medications were not reported. The pt  received injections of LYMErix on 7/23/99, on 9/2/99 and 10/31/00 "according to the client." Confirmation from the vaccine provider was supplied for only the 7/23/99 dose. Upon follow-up received 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain in her hips, knees and ankles and severe fatigue." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. On 9/3/03, the pt's attorney alleged that the pt "suffered joint pain, which was more severe and longer lasting beginning 10/17/00 according to the client." Treatment and outcome of the alleged event was not reported. The following info was provided via the pt's medical records, which did not confirm vaccination dates nor provide additional info regarding reported adverse events. Medical history included knee injury, congenital hip dysplasia, and Lyme disease. Following the reported onset of exacerbation of joint pain, the pt experienced left flank lipoma, cough, sinusitis, and hypoglycemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. On 15Sept04, the pt's attorney alleged that the pt experienced pronounced joint pain of the hips, knees, and ankles, fatigue, short term memory loss, poor concentration, gait disturbance, and a loss of stamina. Time to onset, treatment, and outcome were not reported. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Fever, Chills, Muscle pain, Severe Joint Pain even now 3 months later.
could not lift or rotate arm/5th person to complain about this; could not lift or rotate arm/5th person to complain about this; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "could not lift or rotate arm/5th person to complain about this".  Additional information: Caller wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from (with held) and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well. Will fax on her behalf.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER_INC-202101619553
Suspected vaccination failure/Has taken the vaccine for years, got shingles; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter stated that you can still get them with the vaccine. The patient was 84 years old and had taken the vaccines for years and got shingles about 4 months ago. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Vaccine administered 2021-02-26. Blister cluster formed on right eyebrow near temple on 2021-02-27. Lymph node swelling/tenderness and further inflammation of blister site noted on 2021-02-28. Teledoc called on 2021-03-01, Bactrim DS and Mupirocin 2% ointment for diagnosis of impetigo. In-person appointment with Dr  on 2021-03-03 for second opinion. Resulting diagnosis is shingles outbreak near right eye.
Injection was not given in the deltoid but higher near the shoulder. Compared to 1st dose this one burned. Told my husband it was too high(I am a retired CMA). The following Monday my arm started to hurt. By Wednesday I could not move my arm. I felt as I if I had bursitis in the shoulder. It has been more than 3 weeks and I am still having pain.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Lot number: FH8028), in left arm and on 11Apr2022 as dose 2, single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: LEVOTHYROXINE, start date: Oct2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (25Jun2022) Negative, notes: COVID symptoms returned 2 days after initial 10-day course of quarantine and testing negative; (27Jun2022) Positive, notes: Retesting 2 days later was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: COVID symptoms returned 2 days after initial 10-day course of quarantine and testing negative. Retesting 2 days later was positive.  No follow-up attempts are possible. No further information is expected.
Pt reports redness, hives, burning, and pain to anterior arm, joint, and axilla. Benadryl, Prednisone.
27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/ source case
Mom called Monday 5/5/03 to say son has a rash on trunk and it is spreading: she was on her way to see their MD. I called back today (5/6/03) and Mom on cell phone in car, taking her children to "the Zoo". States he is still "covered" with spots. MD states "probably from his shots" but not certain. Tx 2 days no spots appeared, but severe ear infection.
Pt. reported pain and range of mobility limitations. 3 weeks post vaccination referred to clinic for eval.
Daycare notified mom that child had 102 fever. Mom picked him up from daycare that afternoon. That evening he had a brief episode of twitching that resolved quickly. Mom placed him in a bath and he became glassy-eyed, body stiffened, and unresponsive. He was immediately brought to ER, episode lasted approximately 45 minutes.
pt recv vax 6MAY76 & 28MAR77 & 1SEP96 lab eval revealed rubella titer <10.0 (not immune), rubeola titer <10.0 (not immune) & mumps titer 0.17 (no antibody);pt recv 3rd dose 4OCT96;
This spontaneous report as received from a pharmacist via company representative refers to a diabetic female of unknown age. The patient was not pregnant. About one and a half year ago, in an approximately April 2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX for prevention of shingles (dose and lot number not reported). On an unknown date, after administration of ZOSTAVAX, the patient experienced tingling sensation throughout her entire body. It was unknown if the patient sought medical attention. No treatment was given for the patient's event. The outcome of tingling sensation throughout her entire body was unknown. Relatedness between ZOSTAVAX and the patient's event was not reported. Additional information is not expected.
DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.)  for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for atypical chest pain, AF, Diastolic heart failure, coronary arteriosclerosis, hx of angioplasty, Atrial flutter, carotid artery occlusion, essential HTN, tobacco use, t2dm, cancer of esophagus, , CAD,PVD, non-hodgkins lymphoma. Went to ER 3/26 for Chest pain. Was also inpatient 3/14-3/19 for pneumonia. In ER found to have afib with rvr. Was discharged 4/1. 2nd Pfizer dose received 4/1. Deceased 4/11 with no cause of death listed.
Hot vaccination area; Itchy vaccination area; Little swollen vaccination area; Red vaccination area; A spontaneous report was received from a consumer, concerning herself, an 84-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hot, itchy, little swollen and red at vaccination area.  The patient's medical history provided by the reporter included diabetes and hypertension. Concomitant medications reported included pressure pills, diabetes pills and liquid removal pills.  On 05-Jan-2021, approximately 7 days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine (lot# unknown) intramuscularly in the right arm (dominant arm) for prophylaxis of COVID-19 infection.   The patient reported that, she did not present with any reactions after the shot of vaccine on 05-Jan-2021. But, however, on 12-Jan-2021 at 08:00 PM, the patient developed itchy, red, hot, and a little swollen at vaccination area, which were most annoying. Reporter also stated that these symptoms were continued except for itchy and was less swollen. Treatment for the event included acetaminophen and icepack application.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, hot vaccination area and red vaccination area were considered unknown. The outcome of the event, little swollen vaccination area was considered resolving at the time of this report. The outcome of the event, itchy vaccination area was considered resolved on an unspecified date in Jan-2021.; Reporter's Comments: A spontaneous report concerns an 84-year-old, female patient, who experienced hot, itchy, little swollen and red at vaccination area. The events occurred 7 days after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Treatment provided included acetaminophen and icepack application and outcome is unknown.  Based on the information provided, which indicates a temporal association and local reactions at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site itchy, injection site redness and swelling are consistent with the known safety profile of mRNA-1273 vaccine.
My sugar jump up to 144 when it always been 70-100; 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 BLOOD GLUCOSE INCREASED (My sugar jump up to 144 when it always been 70-100) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (My sugar jump up to 144 when it always been 70-100). At the time of the report, BLOOD GLUCOSE INCREASED (My sugar jump up to 144 when it always been 70-100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details provided.   Reporter did not allow further contact
After getting my shot in the morning, in the evening I had significant in my left breast and a large swollen mass in the lower part of my left armpit. It feels like the lymph nodes are swollen and extremely tender. When I try to bring my left arm down close to my left side it feels like it pinches and hurts. The armpit swelling is so uncomfortable that it hurts to move or use my left arm. The whole area hurts to touch and was tender for 3 days. There where I got the vaccine was extremely tender and ached when I moved my arm. I got a weird nerve pain like lightning bolts spasming shooting down my arm towards my finger tips in both my arms. On the first night it was worse on the right side. I had all over body aches and fatigue and still have an ongoing headache. The headache is similar to sinus pain but none of my sinus pain remedies have worked. I haven't had a fever and no loss of taste or smell. Other than the swelling and shooting arm pain. My reaction is similar to how I reacted to the first 2 vaccines. I am most concerned about the under arm and breast swelling since its the lymph nodes and after my 2nd dose of the vaccine I had abnormal mammogram.
Pt is a wiggler with vaccines and upon administration of the shot, patient moved and vaccine did not get injected. Upon further examination, injection site was indurated, red, puffy and warm with 5 raised areas. Over the next 10 minutes this transitioned into one massive hive with redness and swelling.
Tired all weekend, headache lasted until Jan 31st, Fever: 99 early morning on Jan 29th to 101.2 in the afternoon to 102.4 early evening to 99 on Jan 30th in the morning to 97.8 Jan 30th in the evening. Achy, nausea Jan 29 and Jan 30, Injection site hurt until Jan 31.
Headache, body ache, body chills, fever 100.6, very sore arm, nausea, numbness is finger tips and feet
Chills. Fever. Sleep 18 hrs. Extreme headache 48 hrs Mild vomiting. Swelling on injection arm from shoulder to almost elbow. Swelling is hot, defined like a welt and hard 3 days after injection
Patient states after receiving second dose of Pfizer in primary vaccination series starting the second day, on March 18, 2022 he has continued to experience severe arthritic type symptoms concentrated mainly from his hips down to his feet. This has caused uncontrollable pain rendering him not able to do normal day to day chores or enjoy any quality of life.
Called clinic today with 3 days of swelling, tenderness and redness at injection site on left deltoid. Patient asked to come in and be seen, treated for localized cellulitis/possible reaction. Noted raised erythematous area with streaking and induration the size of a quarter at site of injection. Patient beleives it is where Tdap was given but she cannot be sure. No fevers or s/s of systemic illness.
911 was called today 1/19/2016 for the minor patient. Minor had a reaction due to the vaccines. Minor jerked back and her visions went blank for a few seconds after the vaccines were inserted. Visually minor looked really pale. Vaccines were stopped as soon as we saw that minor jerked back and 911 was called. When we asked minor how she was feeling she replied with "What's up?". Minor doesn't recall anything besides seeing all black.
itching rash allover the body; Painful rash allover the body; Red rash allover the body; Pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both legs), RASH PRURITIC (itching rash allover the body), RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in both legs). On 19-Jan-2021, the patient experienced RASH PRURITIC (itching rash allover the body), RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body). The patient was treated with SALICYLIC ACID (CREAM 91) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in both legs) outcome was unknown, RASH PRURITIC (itching rash allover the body) was resolving and RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications have not been provided.  Treatment included topical cream.
He woke up with chest pain in the upper right quadrant at midnight and then it intensified when he was breathing deep breaths. They woke him up when he was sleeping and did not go away. Then, it continued through the next day and we asked our doctor if we needed to keep an eye on him because of all the reporting and stuff about the heart problems. They did a triage consult visit to see if it could be an adverse event from the vaccine. The course of action was to take 2 ibuprofen every 4 hours and use ice and heat to see if the pain improved to rule out musculoskeletal situations because that was what they thought it was. We did that for 2 days and then the pain moved to his back upper right quadrant and we noticed a rash all over his abdomen and we were not sure where he got that. Based on the fact that the pain moved the doctor was more confident that it was not an adverse event.
this patient's adult caregiver received an accidental exposure in an unspecified eye to a partial unspecified volume of the vaccine during the administration event; patient's caregiver has not reported any symptoms after the accidental exposure to the vaccine.; This spontaneous report was received from a licensed practical nurse, referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient received an accidental exposure in an unspecified eye to a partial unspecified volume of the vaccine during the administration event (accidental exposure to product). The nurse stated that the patient's eye was irrigated/flushed with water after the exposure. The nurse reported that the patient had not reported any symptoms after the accidental exposure to the vaccine.
After 8 hr of vaccination pt. had chills, fever (100 degrees) for about 4-5 hours. When he took Advil he went to bed, Today (next day of vaccination) he is feeling ok.
I received my vaccine that afternoon, I had a sore arm, I woke up the next day, on my left thigh I had a small blister and skin growth. It was the size of a dime. It was the exact same thing that happened with my first dose. The doctor froze the area and removed the skin from the area. When I got my booster shot nothing happen at all.
Swollen Lymph Nords; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246, via an unspecified route of administration at left arm on 08Jan2021 12:00 at single dose for COVID-19 immunization. Facility type vaccine was at military base. The patient medical history was not reported. Concomitant drugs was none. No other vaccine in four weeks or other medications in two weeks. The patient experienced swollen lymph nodes on 09Jan2021 15:00. No treatment received, no COVID prior vaccination and COVID was not tested post vaccination. The outcome of the event was unknown.
11 hours after the vaccine I had strong flu like symptoms; vomiting, achy, fever, chills, headache. Symptoms began to subside 15 hours later and were not present after 24 hrs.