chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 2 doses of Engerix-B, 2nd dose given 9MAR91; One day later on 10MAR91 pt exp rash over arms, legs, chest & abdomen; Then devel swelling of hands, knees, shoulders & ankles w/pain in these joints along w/low fever; Taken to ER;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 02:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 280 pounds, and height was 65 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 08-APR-2021, and tiredness on 07-APR-2021. This report was non-serious.
Patient vomited, had a low grade fever, chills, headache, flu-like symptoms, and muscle pains from head to toe. Symptoms caused her to seek medical attention.
Information has been received from a nurse practitioner concerning a 19 year old female with a history of seasonal sinus headache and seasonal allergy who on 08-Jan-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot #655165/1425F).  On 12-Mar-2007 the patient was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #655165/1425F).  On 17-Jul-2007 the patient was vaccinated IM with the third dose of Gardasil (lot #654272/0319U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), ethinyl estradiol/norethindrone acetate (ESTROSTEP) and iron (unspecified).  In August 2007 after administration of her third dose of Gardasil, the patient developed migraines.  The patient also experienced a tingling sensation in her extremities, particularly her hands.  The patient fainted twice since her symptoms started.  An MRI and EKG were performed yielding normal results.  Iron levels (Fe) showed low results.  The patient's status was reported as not recovered.  Migraines, tingling sensation in her extremities and fainting were considered to be disabling.  Additional information has been requested.
Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 10ARP90, 8MAY90, 15OCT90 & on 19OCT90 exp inject site swelling, induration, pain radiating to back of arm & down; pt exp pain, redness & edema, tenderness of site; 2 nodes devel & persisted w/o inc in size;
Reporting 2 1/2 hours after initial symptoms, facial hives, facial swelling, lymph node swelling. Tired, but alert enough to fill this out.  Puffy is the best feeling to describe it.  Right arm very sore, hand tingly.  Will report if anything gets worse. Thank You.
Myalgia; chest pain; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath). At the time of the report, MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Within 5 minutes of receiving Tdap vaccine, patient reported lightheadedness and nausea. Denied pain, trouble breathing, or rash. Patient appeared diaphoretic and pale. VSS. Rapid response was called and transferred to urgent care. IV epi (0.3 ml), IV dexamethasone (8 mg), 1 L NS, and oral benadryl given. Symptoms resolved and patient was discharged.
8 days after the vaccine I have itching and redness and tenderness at the sight that started out of nowhere.
Left side (where the shot was given,)  went completely numb for 12 hours or so about 3 hours after 2nd dose was administered.
Patient received the Pfizer monovalent vaccine noted above instead of receiving the Pfizer bivalent vaccine booster.  NO adverse reactions. Pt notified of vaccine error, denies any side effects/adverse effects.
Complained of rash over entire body, sore throat on 08/13/2003.  Patient complained of itching only on face and arms.
Awoke this a.m. w/ redness, swelling & induration of skin over the left deltoid.
itching; pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (pain) and PRURITUS (itching) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Pain.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (pain). On 23-Feb-2021, the patient experienced PRURITUS (itching). On 25-Feb-2021, PRURITUS (itching) had resolved. At the time of the report, PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included : steroid cream  No concomitant medications were reported
Patient came in with painful rash on R side of forehead on 3/24/21 exam and symptoms consistent with zoster. Treated and rash resolved but has persistent pain
Sudden global joint pains, bone pain, rashes, rapid / unintentional excessive weight loss, sudden bilateral kidney lesions, severe spinal degeneration and deformities ( scoliosis, lordosis, kyphosis), sleep disturbances, night sweats, inability to move finger joints, hair loss
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Mar2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: foods: pineapple, carrots, apples; "vegetable allergy" (unspecified if ongoing), notes: foods: pineapple, carrots, apples. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: Feb2018; RED YEAST RICE, start date: Feb2019; KIRKLAND SIGNATURE FISH OIL, start date: Feb2019; NIACIN, start date: Feb2019; D3 50, start date: Feb2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient was treated with anti viral drugs (Lot number# GC9461) as a treatment for Covid-19 from 24Jun2022 to an unknown date in May2022. It was reported that the patient received other medications in two weeks of vaccine administration. Patient was taking Natures bounty (Zinc- 50mg) (Lot # 523179-03) from 24Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine administered at 0906am patient was instructed to wait 30min off to side due to history of allergies. no history of anaphylaxis.   checked on patient about 10 min after dosage administration of 2nd Covid vaccine. no prior anaphylaxis or allergy to 1st covid vaccine. She reported feeling dizziness. had patient recline and consume water. offered granola bar.  -vitals stable- BP 124/93 HR 54 O2 96% RA. lungs clear, HR regular rhythm no murmurs.  -patient with shaking of left hand and continued dizziness. started to report tongue numbness. no SOB, CP or difficulty breathing.  -medications: 0.5ml diphenhydramine 50mg/ml was administered into L arm.  -prior to administration patient reported feeling better, dizziness had improved.  -patient continued to improved dizziness, resolved, no further tongue tingling and tremor resolved -I suspect patient experienced dizziness post vaccination with a component of anxiety. with history of allergies administration of IM benadryl was discussed and administered without further side effect.   patient was stable and drove home at 0950am.
Information has been received from a female consumer who in 1995 thinks she was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3.  She reports that she was tested for antibodies "against MMR viruses" and the test showed she had low antibodies or no antibodies, the reporter was uncertain.  The consumer reported that her immunization records show she received MMR in 1978 and measles + rubella in 1989.  The consumer reported that her physician wants to get revaccinated because she is interested in becoming pregnant.  There was no product quality complaint.  Additional information has been requested.
Reported that 2 days after MMR on 3/17/09 she developed tremors to arms and legs.  She also stated vomiting and weight loss.
This case was reported by a physician via sales representative and described the occurrence of nerve hit during vaccine injection in a 67-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; left arm given on 18 January 2010.  Concurrent medications included Blood pressure medication (Unknown blood pressure medication).  On 18 January 2010 at 11:45 the subject received booster dose of BOOSTRIX (unknown, right deltoid).  At an unspecified time after vaccination with BOOSTRIX, the subject experienced nerve hit during vaccine injection, possible hematoma, tingling sensation, burning sensation and nerve irritation.  On an unspecified date the subject returned to the physician office reporting tingling and burning sensations around the front part of the arm in which the BOOSTRIX was given.  The physician suggested that the subject might have a small hematoma or general nerve irritation from the BOOSTRIX needle.  The subject also received HAVRIX the same day, but in the left arm.  The subject has since sought the medical advice of a neurologist who suggested that the person who administered the vaccine may have hit a nerve; however, "the medical assistant stated that she did not aspirate blood, which one would expect if a nerve had been hit".  At the time of reporting the outcome of the nerve hit during vaccine injection, possible hematoma, tingling sensation, burning sensation and nerve irritation was unspecified.
Patient received multiple vaccines. Reported redness and hive like bumps at MMR and varicella injection sites. Patient given diphenhydramine 6.25 mg by mouth once following the reaction. Family sent with prescriptions for acetaminophen 80 mg by mouth every 6 hours as needed and ibuprofen 80 mg by mouth every 8 hours as needed.
Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration date 06/24/2021). Caregiver of Client asked EMT and EMT to check her blood pressure and her injection site. At 1754, RN responded to this event. At 1754, vital signs are blood pressure 163/84, heart rate 70, oxygen saturation 99%. Client reports she was anxious. RN answered all concerning questions in regards to COVID vaccine. Client reported to have a thyroid disorder, hypertension, high cholesterol. Client reports in taking Levothyroxine, Aspirin, Cilostazol, Amlodipine, Hydrochlorothiazide, Atorvastatin, Lantoprost. RN educated Client about ED precautions and common adverse effects of the COVID vaccine. At 1800, vital signs are blood pressure 162/80, heart rate 72, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, no dizziness, no blurred vision, no headache, no nausea. At 1810, vital signs are blood pressure 160/79, heart rate 72, oxygen saturation 98%. Client reports no new symptoms and that all concerns have been addressed. Client is talking to staff and caregiver. At 1830, Client stood up with no complaints. Client walked out of facility with a steady gait using her cane accompanied by caregiver.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Stated she watched the nurse administer vaccine and said she passes out very easily with blood draws and other health issues. She was sitting and fainted, but didn't fall to the floor as she had her boyfriend with her and he was able to hold her up. 911 was called. She came to, and was flushed. We gave her a bottle of water and sat her on the floor at her request. EMS arrived and took over care.
The next day swelling is still there, along with redness; The next day swelling is still there, along with redness, warmness to touch; itchiness; First day was swelling/ palm is swollen; tenderness/Whole left arm feels tender, and palm is swollen and tender.; This is a spontaneous report from a non-contactable consumer, the patient,  via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 7533), via an unspecified route of administration, in the left arm on 01Apr2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.  Medical history included COVID-19 prior to vaccination from an unknown date to an unknown date. The patient had no allergies to food, medication or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within two weeks of vaccination.  The patient did not receive any other vaccines within four weeks prior of the vaccination. On 02Apr2021, the patient experienced swelling and tenderness. On 03Apr2021,the next day swelling was still there, along with redness, warmness to the touch, and itchiness. The whole left arm felt tender, and palm was swollen and tender. The patient did not receive any treatment for the events. The clinical outcomes of swelling, tenderness, warmth, redness and itchiness was recovering.   No follow-up attempts are possible. No further information is expected.
Hospitalized with GI bleed probably due to cirrhosis and continuing to drink heavily, was COVID + on screening for inpatient ETOH treatment was quarantining in hotel when GI bleed started.
pt recv vax 31MAR97 & 7APR97 pt devel a total 15 lesions on wrist & ear;
Comvax (Hep B and Hib) and PCV given "IM" one inch apart R LT. Erythema of right leg and face occurred approximately five minutes after immunizations. Immediately taken to physician.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Lot# not reported)(dose, frequency and route unspecified by the reported). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient received a dose of improperly stored VARIVAX on 07-APR-2014. No adverse event reported. Additional information is not expected.
PATIENT WAS BROUGHT IN ON 10/7/21 FOR 1 YEAR VACCINATIONS. I ASSISTED THE ADMINISTERING NURSE TO PULL VACCINES AS HE WAS UNFAMILIAR WITH OUR PROTOCOL. I PULLED THE COMBINATION (PENTACEL) AND IN ERROR PULLED AN EXTRA HIB VACCINE INSTEAD OF HEPB. I DID NOT NOTICE THE ERROR WHEN DOUBLE CHECKING THE VACCINES AGAINST THE RECOMMENDATIONS LIST. THE NURSE THEN DREW UP THE VACCINES AND ADMINISTERED TO THE PATIENT. HE DID NOT HAVE ACCESS SO I ENTERED THEM INTO THE SYSTEM ON 10/8/21 AND IT WAS AT THIS TIME THAT I NOTICED THE ERROR. I CONTACTED THE MOTHER AND LEFT A VOICEMAIL, I ALSO HELD THE INFORMATION TO THE ATTENDING PHYSICIAN, AS IT WAS LATER IN THE DAY FRIDAY. DR. WAS ABLE TO REACH THE PATIENTS MOTHER AFTER HOURS AND HIS DOCUMENTATION IS AS FOLLOWS:   "I spoke with the patient's mother this evening and she stated since last night patient has had increased fussiness, fevers with Tmax of 103 F last night, treating with alternating Tylenol and Motrin, Temperature when on the phone today is 98.1; last dose of Advil/Tylenol given 1 hour ago; only drinking water and juice today, not eating at all today.  Patient is having increased runny nose, loose stools, more fatigued and very fussy, sleeping more during the day.  Mother reports patient's leg is very swollen from injections, pt. walking "funny" per mother but no headaches/seizures/convulsions or NV reported."  ON 10/11/21 THE MOTHER CALLED TO MAKE NOTE OF ISSUES/MISTREATMENT WHEN AT THE ER OVER THE WEEKEND. I ATTEMPTED TO CONTACT THE MOTHER TO FOLLOWUP AND AGAIN RECEIVED A VOICEMAIL, ONE OF OUR CLINIC SUPERVISORS WAS ABLE TO MAKE CONTACT AND TAKE NOTE OF HER COMPLAINT.  FOLLOWUP APPOINTMENT SCHEDULED FOR 10/12/21 WAS NOT KEPT AND, TO MY KNOWLEDGE, AT THIS TIME THERE HAS BEEN NO FURTHER CONTACT WITH THE MOTHER OF THE PAITENT.
In approximately 18 hours following the flu vaccine, my left arm ached at the site of the injection. It has now been two months since the injection, and my arm at the site of the injection still aches several times each day. I am a true believer in vaccines and have always had a flu shot. This is the first time I had the senior dose.
GUILLAIN BARRE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced guillain barre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220652101-covid-19 vaccine ad26.cov2.s -guillain barre. This event(s) is labeled per agency and is therefore considered potentially related.
Patient reports heart palpitations after vaccine. Unsure if it was after the 1st dose (4/12/21) or the 2nd dose (5/10/21).
Five minutes after vaccination patient complained of scratchy throat and difficulty breathing with lots of coughing at the throat.  Patient took 2 inhalations with her Proventil inhaler.  However, this did not stop the issue.  Rash spreading across face and chest started as well.  Patient was given 2 doses of Benadryl.  This did not stop coughing or rash.  911 was called and patient was taken to Hospital for further observation
Complete loss of strength, totally flaccid, paresthesia weakness, no grip, no limb mobility, unable to keep eyelids open, unresponsive to sternal rub. BP 144/61 P-77 T: 98.6 R-20 O2 Sat 94%, BS 99, pupils 2/reactive, asthenia. No tx, sx resolved.
pt recv vax 2OCT96 & NOV96 pt exp an unexplained rash;the rash was dx as severe atopic dermatitis which was treated w/hydrocortisone;
Patient received injection of Tetanus 0.5mg IM Right Deltoid. On 10/13/10 reported redness from site of injection to elbow that covered the whole diameter of the upper arm.
body pain; Bone pain; This case was reported by a pharmacist via patient support programs and described the occurrence of general body pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hmg coa reductase inhibitors (nos) (Statins).   On 15th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain and bone pain. On an unknown date, the outcome of the general body pain and bone pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and bone pain to be related to Shingrix.  Additional details were provided as follows: The patient reported body pain all over and in bones for 3 days. The pain subsided after 3 days and did not return.