chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in 1 month later and said she is still experiencing pain in her left arm. She said that her arm feels weak and when she lifts her arm up (like to put on a shirt) she has a sharp pain in her arm. She said she also has pain when she lifts her arms in front of her. The pain has slowly decreased over time, but she is still experiencing pain. She said she typically gets her flu shot and has not experienced this before. Usually her arm does not hurt the next day unless she pushed on the area, but this one has been much more painful.
1st week after 2nd pfizer shot experienced reported side effects: headache, sore arm, extreme fatigue, muscle, joint pain. On 9/3 awoke to cold symptoms (runny nose, sore throat, congestions, headache). Developed head pressure, hoarseness, sore throat, scratchy throat, felt lumps in front neck, very difficult swallowing, lump and soreness under right ear. Symptoms continued from 9/3-9/27. The extreme fatigue, muscle, joint, and nerve pain continues at an elevated level above the normal pain I experience due chronic health issues.
LEFT ARM/SHOULDER VERY SORE WITH LIMITED MOBILITY ESPECIALLY DURING THE NIGHT AND THE MORNING.  UNABLE TO RAISE ARM ABOVE CHEST LEVEL OR LIFT OBJECTS >1 POUND.  11/8/2010 HS CALL TO PATIENT-BETTER SOME DAYS, PAIN RETURNS AND LASTS FOR A FEW DAYS IN THE SHOULDER.  TYLENOL AND HEAT HELP PAIN.
Patient experienced flu-like symptoms, headaches, extremity pain, and burning eyes.  Patient said the symptoms start the night after receiving the vaccine.
Injection site pain 14 hours after with body aches; 28 hours after fevers 102 sever body aches rigors; Injection site pain 14 hours after with body aches; 28 hours after fevers 102 sever body aches rigors; This is a spontaneous report from a contactable physician (patient himself).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, as first single dose on 18Dec2020 (at 12:45) for COVID-19 immunisation. Relevant medical history included acid reflux and allergy to cats. Relevant concomitant medications included omeprazole (PROTONIX). 14 hours after vaccination, the patient had injection site pain with body aches. 28 hours after vaccination, he had fevers 102, sever body aches and rigors. However, it was reported that onset of the events was on 19Dec2020 at 17:00. The patient did not have loss of smell, SOB, dyspnea, loss of taste or diarrhea. The patient did not perform COVID test prior or after vaccination. No treatments were given for the events. The patient was recovering from the events.  Information on the lot/batch number has been requested.
this patient was given his booster dose, and then it was noted that he had received an infusion only 6 weeks prior, so he wasn't eligilbe for a booster at this time.
Pt has a PMH of CHF, aortic stenosis, stage III CKD, type II DM, and came to the hospital with complaints of shortness of breath, and intermittent chest discomfort.  He was found to be COVID positive and admitted for acute on chronic systolic and diastolic heart failure.
Patient received his 1st Shingrix dose on 11/30/19 at 2:58pm. Later that evening, he began to not feel well. He reported severe stomach pains, sweating and then passed out as he was trying to walk across a room in his house. 911 was called and he was taken to Hospital emergency room. The patient said he was counseled by the pharmacist about possible flu-like symptoms following his immunization and mentioned the immunization to the ER doctor. It was then determined that he was experiencing an adverse reaction to the Shingrix and was advised not to get his 2nd dose.
He had a fever for 4 days after the shots , followed by diarrhea and a runny nose. About the 7th or 8th day after his shots I noticed a rash that started on his face / scalp that made it's way down his body and got so severe he had almost no white skin visible. It was confirmed by his pediatrician that it was vaccine strain measles.
Pt is a 29-year-old male received a total of four anthrax immunizations between Nov 1999 and May 2000.   In February 2000 he was told he had high normal limits of his blood pressure, and increase in his cholesterol. He reports that both were normal before his trip to the desert. In May of 2002 he noticed periods of erratic behavior and forgetfulness. States he is normally a very passive person and was now experiencing aggression, rage and problem with his temper.  He states he felt better last October when he knew what was going on with him. Currently states he has more control and that he is not getting aggravated as often. In July 02 he developed a chronic cough with pneumonia like symptoms. Diagnosed with pneumonia, given medication and cough cleared. No cough now. In August 02 he noticed blood in his stools. Now episodes are sporadic and not associated with any factors. States he has an episode once every 3 months and it lasts only 2-3 days.  Noticed since the summer of 2002 periods of dizziness he states his MD's have no opinion. Pt states when he walks the floor drops. Distorted view when he walks. Complains of dizziness when he stands for prolonged periods of time. Has at least one episode a week and that it last 1-2 sec. He states it is not associated with any position change. He has no vision changes and no interference with activities. States his doctor is aware and for now he should not worry.  April 03 he went to his doctor for acid reflux and diagnosed later that month with glomerulonephritis. States reflux is now resolved. He states he gets headaches 3 times weekly since the year 2000 but now headaches are almost daily. Headaches last approximately 2 hours but when he takes Aspirin they only last 30 min. States he has occasional photosensitivity and no nausea. He is able to continue working through his headaches. He did mention headaches to his doctor who told him not to worry about them. Patient reports that his blood pressure is still high. Pt also reports periods of chest pain described as a constant sharp pressure in upper left chest with strenuous activity. Is associated with shortness of breath. States pain lasts a couple of minutes and when he takes a couple of deep breaths and rest, it eases.  Noticed in February 2000 and saw MD. EKG was normal. Pain still occurs with strenuous activity. He did mention it again to his doctor but not his nephrologists.   Update: 14 Feb 05 Patient reports that he is doing better. He states that his kidney function has stabilized and he does not require transplant or dialysis. He reports that his cholesterol is also under control and since his kidney function test has stabilized his headaches and chest pain has decreased. He states that he is working full time with no problems performing his duties.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: according to patient, vaccine was administered by standing pharmacist. Vaccine was given too far forward and to the front of shoulder as opposed to in the deltoid
1st night 01.25.20,   Fever 101.  now .low grade all day.  Dizzy,  Body Aches.   Feeling of ?stabbing?  Pins and needles in fingers and toes, felt like fainting, blacking out during this time.  Loss of taste today, 01.27.21.
Redness and warmness, redness 16cm x 17cm up and down arm and around arm.
for several hours during the night I kept feeling like electrical shocks in my body in my different body parts; had no cold symptoms but today and during the night I woke up and my mouth was really dry; I was breathing through my mouth and when I closed my mouth it's like like oh, I can't breathe from my nose and it was very strange.; tried like pulling my nose I didn't feel like I didn't feel congested. I didn't feel pressuring my nose; but it was weird and it was scaring her; but it was weird and it was scaring her; fever; headache; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0187, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 22May2021 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 64 years). The patient medical history included blood pressure high. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 64 years). It was reported that, the other treatment medications included for high blood pressure she was taking medications. On an unspecified date, the patient experienced for several hours during the night she kept feeling like electrical shocks in her body in her different body parts (That was very strange, it happened In her ankle, in her abdomen and then at the base of her spine and then it felt like it radiated up towards her neck and her spine), It happened like you know off and on over a period of like four hours but she does not had that sensation since but it was weird and it was scaring her, had no cold symptoms but today and during the night she woke up and her mouth was really dry, she was breathing through her mouth and when she closed her mouth it was like oh, she cannot breathe from her nose and it was very strange, tried like pulling her nose she did not feel like she did not feel congested. She did not feel pressuring her nose, fever, and headache. It was reported that, no, after four hours Saturday night she has not experienced anything else other than fever and headache. The outcome of the events fever and headache was unknown and for the remaining events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Information has been received regarding a case in litigation as reported in a newspaper article that the author's normal 4 year old daughter was transformed into a seizure-stricken, neurologically impaired child with no ability to walk, talk or feed herself. Subsequent tests revealed an inordinate level of lead and mercury in her body, "clearly the result of the MMR II. She had "undergone eight years of therapy and faces a lifetime of more. "Seizure-stricken" and "neurological impaired" were considered to be disabling. No further information is available.
Proquad and Varivax were administered at the same time; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 02-JUN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) at the same time, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). The reporter requested information on potential side effects when these vaccines are given concomitantly. The outcome, action taken and causality assessment were not provided.
Vaccine given at 4 PM. At 6:45 hives noted in diaper area, on chest and back. Called ER. Physician prescribed 25 mg Benadryl and close observation of airway. Ears, face with hives, nose swelling noted. By 10:30 hives were fading. Next morning had few spots. Pt has been seeing allergy specialist; specific allergies not pinpointed due to young age.
Pt. reports body aches and headache the day after the vaccine. She developed a rash on the anterior surface of her LFA. The area was round and approximately 4 cm. in radius. Pt. reports that the rash was pink and itched. No spread of the rash from the time it was first noticed. She was seen in the office again on 3/12/19. At that time the rash was observable. The skin looked dry and the area was no longer pink. The rash area was more of an opaque color and the skin was flaky.
Unspecified reaction to COVID [coronavirus disease] vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine) in a 62-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 27-Jan-2022, the patient started TREPROSTINIL SODIUM (unknown route) 54 microgram four times per day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine). At the time of the report, IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       NDA number was reported as 022387.  Patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 27 Jan 2022 for secondary pulmonary arterial hypertension. The current dose was reported as up to 54 µg (up to 9 breaths), four times a day (QID) via inhalation (IH) route. On 18 May 2022, 3 months, and 22 days after initiating Tyvaso, the patient was seen in the emergency department regarding an unspecified reaction to COVID. The reporter's causality for the event of immunization reaction was considered as possibly related to COVID-19 vaccine. It was reported Treprostinil sodium dose up to 54 µg, qid, Inhalation, with expiry date 31/08/2023. No treatment medications were reported.
Information has been received from a physician concerning a 24 month old patient who on 23-JUL-2009 was vaccinated with the first dose of MMR II.  There was no concomitant medication.  On 02-AUG-2009 the patient experienced fever of 102.4 degree, spots on belly and truck that were red and raised and fatigue after vaccination.  At the report time the patient had not recovered.  Follow-up information was received from the physician concerning the 24 month old male patient with scoliosis.  On 23-JUL-2009 the patient was vaccinated subcutaneously with the first dose of MMR II (lot # 660315/0146X) in his left side.  On 03-AUG-2009 (previously reported as 02-AUG-2009) the patient experienced high fever with maculopapular rash.  At the time of the report, the patient had recovered.  No further information is available.
This case was reported by a physician and described the occurrence of generalized malaise in an unspecified number of adult subject of unspecified gender who was vaccinated with influenza virus vaccine (FLUARIX, GlaxoSmithKline) for prophylaxis. It was reported that an unspecified number of subjects experienced malaise following previous vaccinations. On an unspecified date the subject received 1st dose of FLUARIX (1 ml, unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced generalized malaise. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLUARIX. Per the source document, the physician noted that he has noticed malaise in approximately one out of three adult subjects. He was making a broad observation and specific details regarding the number of subjects, time of administration or other details were not provided. The physician noted that the subjects then refuse to obtain subsequent FLUARIX vaccinations in later years due to the malaise. It was reported that an unspecified number of subjects experienced malaise following previous influenza injections and following previous vaccinations.
HIGH FEVER, DIZZINESS, SORE THROAT, PALE/GREY SKIN, NAUSEA, VOMITING.
ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient was registered with DOB 8/15/2009 actual DOB 9/15/2009 patient is only 11  and vaccine not approved for under 12
Developed shingles, painful rash on mid back and abdomen. Treated by MD and recovered gradually over the following month.
devel swelling, redness, induration approx 2nd day p/vax & pain w/movement;pt said area extended above & below inj;6/25/99 redness 35mm x 20mm & induration 50mm x 35 1/2mm;seen by PMD 6/26/99;tx w/cephalexin;
Child was inadvertently given Infant Pfizer, dose #2, and it should have been Moderna, dose #2. Parent was informed of vaccine error and child is doing fine, no problems.
Moderna booster was given to patient on 8/8/2022, but it was not approved for under 18 years old. Patient's parents and doctor were informed. Patient's mother said patient vomited the same night and fever the next day.  He is fine afterwards.
Patient developed flushing and itching of the face and neck 15 minutes after her 2nd COVID-19 vaccine.  No reaction to first vaccine. Treated with diphenhydramine 50mg PO and symptoms resolved within another 15 minutes.
Headache, Fever, Chills for 48hrs. Headache, Fatigue additional 24hrs.
Initial report received from a health care professional on 09 December 2010. A 31-year-old female patient received on 03 December 2010 a left arm subcutaneous injection of YF VAX, lot number UF797AA. The patient received on 18 November 2010 an injection of Hepatitis A vaccine, lot number not reported. The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medication was reported as birth control pills. On 09 December 2010, the patient reported feeling faint and dizzy and the left injection site had an area of redness. Today (date not provided), the patient had no fainting or loss of consciousness (LOC). The patient was to have a physician evaluation. The outcome was reported as unknown. Follow-up information was received 10 January 2011 from a health care professional who reviewed the case and had no additional information to provide at the time of the report. Documents held by sender: None.
large round circle on arm, very red with fever. Two days later still quarter size reaction on arm.
3 Hours after injection left arm swollen from shoulder to elbow.  2 days after injection arm still swollen and rash on 20 percent of left arm
Patient received PPSV23 on 8/7/18. The evening of the vaccine patient report swelling, pain, redness and hardened tissue below insertion site, mid upper arm. Co-workers marked the redness this morning. Redness continues to remain within the marked border. Patient notes swelling has decreased significantly overnight. Pain started on the medial side of the upper arm and is spreading underneath and to the lateral side. Marked area is red, warm and hard. Home cares; ice, elevate, TYLENOL/ibuprofen, compression.
Stomach pain; Diarrhea; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and PYREXIA (Little fever) outcome was unknown.            no treatment medications were reported concomitants medications were not reported  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-059927, MOD-2021-052899 (Patient Link).
ABDOMINAL PAIN, MORE INTENSE IN THE LOWER LEFT SIDE. RASH ALL OVER THE BODY MORE INTENSE IN HANDS AND HEAD.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer and concerned a male of unspecified age of unknown race and ethnicity. 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: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had developed a Covid infection where he had a fever of 103 and extreme fatigue (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, and COVID-19 virus test (NR: not provided) positive (still testing positive). It was reported that, patient was feeling much better now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211008860-covid-19 vaccine ad26.cov2. s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, Myalgia, Fever, NauseaVomiting, Palpitations, Abdominal cramps, upper back cramps Narrative:
0.8mL of diluent was mixed in pfizer vial instead of 1.8mL, and given to the patient
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 50 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix in winter 2000 and summer 2000 "according to the client." This represents an inappropriate schedule of drug administration, as the administration of LYMErix does not adhere to the recommended 0, 1, and 12 month schedule. On 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, fatigue, tingling, and headaches." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his 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. 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.
A woke during the night vomiting, severe lower abdominal pain . Diagnosed at the ED with  Mesenteric Adenitis