chrisvoncsefalvay/vaers-outcomes huggingface dataset:
57y.o. with PMH of anxiety disorder, BPH, bipolar disorder, chronic back pain, radiation induced neuropathy s/p spinal stimulator, depression, dyslipidemia, GIB, GERD, IBS, rectal cancer, OSA, panic attacks, Type II DM, Parkinson's Disease, seizure disorder, and TIA presented for elective Right THA (Total hip arthroplasty). Patient with known progressive, severe R hip pain.  He was evaluated as an outpatient and diagnosed with advanced arthritis of the R hip.  Non-operative treatments including activity modification, weight loss, anti-inflammatory use, and PT failed to provide long-term benefit.  He underwent RTHA on 9/26/22 with Dr.    His post operatively he had right surgical site thigh pain and swelling of the right thigh and
Noticed redness/puffiness around area of shot right thigh on 11/01/2001 by parents. Shot given 10/26/2001 at HD. No other symptoms. Area of redness 2.25 inches by 2 inches.
Injection site is warm to touch; Big red patch in the area surrounding the injection site; Knot at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PAIN (Soreness at injection site). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included massaging.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
headache; feel a pressure around the head; anxiety; feel like I will lose control of my limbs; started to develop a high blood pressure; fever; This is a spontaneous report from Pfizer-sponsored program. A contactable healthcare professional (patient himself) reported that a male patient of an unspecified age (Age: 27; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient stated "I received the second dose on 08Jan2021. After receiving the vaccine, I had a headache which is still there. I feel a pressure around the head which gives me anxiety. I feel like I will lose control of my limbs. I recently started to develop a high blood pressure and fever." Onset dates for events were unspecified. The patient went to the emergency room. Outcome of the events was unknown.       .  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient reported she had one red, itchy area appear on her arm around injection site the day after vaccine was administered. The next day, she noticed another spot. A third spot showed up today (6 days after vaccine administration). She describes the spots as red and itchy about the size of silver half-dollar coin. No other signs or symptoms of allergic reaction noted. Pharmacist instructed patient to use hydrocortisone locally to reduce redness and itching.
Pt. states Lt. upper arm swollen, painful from Lt. shoulder down to elbow, moderate headache, nausea, denies vomiting, symptoms already resolved except for left arm still sore.
After covid vaccine 2/23/21 started blurred vision and lightheadedness.  No itching rash.  Provided juice crackers and monitored x 1 hour.  Next day,  hives and swollen at home.  Face swollen   Took Benadryl and that relieved those symptoms Called in sick..  Also had body aches and chills lasted x a few hours .  2/25 and 2/26  went to work  and was fatigued but okay.    Daughter got sick on  2/26  she is asthmatic PND, seasonal allergies and is testing  later today.  Employee is getting evaluated today at Urgent care.    Today 3/2 ee has sore throat and runny nose now is going for testing today.
Pt. complained of feeling dizzy within 5 min of receiving flu vaccine. Pt was asked to sit and given water. When asked if he felt short of breath he replied no, but within 15 more min. he complained of chest pain and tightness. 911 was called at this point, firemen and paramedics arrived quickly and began evaluating.
Headache, achy feeling like the flu, tender on bottoms of feet, sore arm at injection site.
redness at the vaccination site; Temperature is high at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (The patient stated "fell kind of dizzy".), CHILLS (Chills) and MYALGIA (Body ache) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (The patient stated "fell kind of dizzy".), CHILLS (Chills) and MYALGIA (Body ache). At the time of the report, DIZZINESS (The patient stated "fell kind of dizzy".), CHILLS (Chills) and MYALGIA (Body ache) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.
Severe frontal headache impairing vision, entire head itching profusely radiating down to R shoulder at site of injection.
Eye virus prob herpes. Multiple lesions around left eye. Conjunctivitis. Initially diagnosed as allergic issue. Then after Dr visit, localized pain, swollen lymph nodes, for herpes sores around orbital lobe, headaches, multiple tingling Locations around mouth and scalp.
DID NOT FEEL RIGHT; PATIENT WAS OFF HUMIRA FOR TWO MONTHS; SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS; SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (DID NOT FEEL RIGHT), INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Herpes zoster immunization: Shingles Vaccine (Side effects were fever and chills). Past adverse reactions to the above products included Fever with Shingles Vaccine. Concomitant products included ADALIMUMAB (HUMIRA) for Plaque psoriasis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (DID NOT FEEL RIGHT), INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS). At the time of the report, FEELING ABNORMAL (DID NOT FEEL RIGHT), CHILLS (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) and PYREXIA (SHINGLES VACCINE SIDE EFFECTS WERE FEVER AND CHILLS) outcome was unknown and INTENTIONAL PRODUCT MISUSE (PATIENT WAS OFF HUMIRA FOR TWO MONTHS) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported stopping Humira (ADALIMUMAB) for two months because she received the Shingles Vaccine but it was not reported if she stopped Humira before or after receiving the shingles vaccine.  No treatment information was provided by the reporter.  RA Report: 21K-163-3972737-00
This case was reported by a pharmacist via call center representative and described the occurrence of dry mouth in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dry mouth and swallowing difficult. On an unknown date, the outcome of the dry mouth and swallowing difficult were unknown. It was unknown if the reporter considered the dry mouth and swallowing difficult to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The reporter also said that the employee health nurse at her facility felt that they were having more reactions to the vaccine than normal. The reported said that he reported one reaction that was felt to be serious and requiring a visit to the emergency room. The patient experienced dry and cotton mouth and difficulty swallowing. No further details available about the statement more reactions to the vaccine than normal. This case was linked with the case US2018GSK169505, reported by the same reporter.
This study case was received from the investigator on 27 August 2012. A male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 04 December 2009 an elevated Troponin, central laboratory level of 0.15 ng/ml (also with a reported date of 11 December 2009). The subject had a rapid Troponin I level on 04 December 2009 that was within normal limits (negative). On study day 22, the subject had a visit for back pain. No other reported visit, no chest x-ray, no echo and no labs. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered an other important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
While administering needle got disconnected; While administering needle got disconnected; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected). At the time of the report, DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt complained of initial soreness and a 3 inch wheal of redness around injection site. Then next day a larger 4 inch red area developed about an inch away from other red area.
This case was reported by a healthcare professional and described the occurrence of gastrointestinal problems in  a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included possible drug allergy to DIFLUCAN. Concurrent vaccination included Haemophilus influenza type b vaccine;manufacturer unspecified given on 3 February 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 3 February 2010. Concurrent medications included ZANTAC. On 3 February 2010 th subject received 1st dose of ROTARIX. On 11 November 2010, 9 months after vaccination with ROTARIX, the subject experienced gastrointestinal problems and diarrhea. The healthcare professional reported that the subject was first seen for diarrhea problems on 11 November 2010 and had follow-up visits afterwards. At the time of reporting the events were unresolved. The vaccination course with ROTARIX was discontinued. The healthcare professional considered the events were unrelated to vaccination with ROTARIX. The healthcare professional reported that the vaccine was ROTARIX, however the lot number provided (1208Y) is not a legitimate GlaxoSmithKline lot number. Follow-up information received via the reporter on 05 August 2011 indicated that the gastrointestinal problems had nothing to do with ROTARIX treatment. The reporter noted that she planned to return follow-up paperwork stating no further contact. Follow-up information received via the reporter on 15 August 2011 indicated that the events of gastrointestinal problems and diarrhea had nothing to do with ROTARIX vaccination; therefore, no additional information was provided.
Patient became sweaty, pale and very dizzy.  We measured her BP and it seemed very low but later after 10 minutes it went back up again. We called 911 and medics came to take her to the hospital.
This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical or concomitant drugs were not reported. On 25-MAR-2019, the patient was vaccinated with a dose of M-M-R II 0.5 mL, intramuscularly, lot # R019391, expiration date 05-JUL-2020, for prophylaxis; the vaccine was diluted in sterile diluent (lot # and expiration date not reported).
Pt said that when he received his first SHINGRIX shot, employee hit his bone & his arm was "vibrating" for a little while after he received the shot.
severe reaction; pain/ Painful; This case was reported by a consumer and described the occurrence of adverse reaction in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2019, the patient received Shingrix. On 29th June 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction and pain. On an unknown date, the outcome of the adverse reaction and pain were not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction and pain to be related to Shingrix.  Additional details were provided as follows: The patient had a severe reaction since receiving vaccination and it was so painful. The reporter asked how long does a shingle vaccine side effect last.
1-2 minutes, post vax, and walking around, pt fell to the floor. BP 132/84; P 100; R 24. Laceration to tongue and lower lip and about 1" laceration above right ear. Has a history of seizures. Sweating profusely and ice was applied to lip and ear. Pt did lose consciousness of 1-2 minutes.
Partial numbness/tingling sensation in left arm; Partial numbness left half of face; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 18:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, narcolepsy, and sleep apnea. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both from unknown dates and for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 19:00 the patient experienced partial numbness/tingling sensation in left arm and left half of face beginning within 20 minutes of injection, and subsiding after about 2 hours. The patient seemed to retain full muscle control throughout this time. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events partial numbness/tingling sensation in left arm and partial numbness left half of face were recovered on 31Mar2021.   No follow-up attempts are needed. No further information is expected.
Started with achy body the next day around 7am, then cold chills(couldn't get warm for nothing) and headache then fever of 101.7.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-OCt-2013 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # H010515, exp. 13-FEB-2014) intramuscular in her arm. On 31-OCT-2013, the patient developed redness and slight swelling on the inside of the arm in which PNEUMOVAX 23 was administered. The pharmacist stated that the redness and slight swelling extended from just below the site of injection to the wrist. The patient sought medical attention - visited the pharmacist. The outcome of redness and slight swelling on the inside of the arm was reported as not recovered/not resolved. The relatedness between redness and slight swelling on the inside of the arm and PNEUMOVAX 23 was not reported. Additional information has been requested.
High Fever (104), Tinnitus, Felt like floating, Skin sensitive (pain) to touch things, Nausea, waited it out, lasted 24 hours after onset. Most intense first 12 hours after onset. 4 hours previous to onset began to sense swelling and tingling internally -- like anaphylaxis
Information has been received on 05-NOV-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On or about 06-AUG-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown), as recommended for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster related injuries. Upon information and belief, on or about August 2013, health care providers recommended, prescribed, and/or administered the ZOSTAVAX to the patient for the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. In 2015, the patient was treated at a hospital for shingles or herpes zoster and other zoster-related injuries. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician concerning a 29 year old female who on 14-MAY-2009 was vaccinated with VARIVAX (Oka/Merck) (manufacturer unknown) (dose route and lot no. not reported). Concomitant therapy included RECOMBIVAX HB (unspecified) (dose route and lot no. not reported) and DTaP (dose route and lot no. not reported). On 03-JUN-2009 the patient found out she was pregnant, she conducted a home urinary pregnancy test, patient's LMP was on 01-MAY-2009. The physician reported that on 05-JUN-2009 (three days after patient's finding) she decided to have an elective termination of her pregnancy at another practice. The patient would have a follow up visit with them on 26-JUN-2009. Upon internal review abortion was considered to be an other important medical event. No further information is available.
Injection site reaction that has spread beyond an inch of the injection location; A spontaneous report was received from a nurse concerning a, 33-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site reaction that has spread beyond an inch of the injection location.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On the afternoon of 22 Dec 2020, less than 24 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unspecified date in Dec 2020, less than 24 hours after receiving the injection, the patient experienced an injection site reaction that had spread beyond an inch of the injection location. No treatment for the event was received, but she was advised to ice the area.    The outcome of the event, injection site reaction that has spread beyond an inch of the injection location, was considered not resolved.     Action taken with mRNA-1273 in response to the event was not reported.  The reporter assessed the event, injection site reaction that has spread beyond an inch of the injection location, as related to study drug.; Reporter's Comments: This case concerns a 33-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed event of injection site reaction. The event was considered possibly related to the vaccine due to the known safety profile and the temporal relationship with onset within 24 hours of dosing.
vertigo the evening she received the injection.  She states she has a "spinning" sensation when rolling over in bed or when she turns her head from side to side or if she looks up or down.  She also had nausea associated with the vertigo.