chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
30 min after vaccine pt returned - Hot, nauseated, pale, sweating, shaky. Pt was seated given cool cloth for head, and BTL of water. After 30 min pt's color returned, sweating stopped, shakiness stopped, nausea subsided. Pt requested to go home.
Redness (5cm in diameter), itching, warmth, and tenderness beginning 6 days after receipt of vaccine.
Fever, chills, headache, body ache, achy. Jaw pain (don?t know if that related or not)
Left arm (elbow) swelling after injection of MMR (24) hrs after injection redness and swelling. Benadryl given today 10-3-07.
pt recvd vax & exp arthritis-like pain & arthralgia; tx w/ ibuprophen & seroconverted & recovered;
Inner left arm: hives over bicep area over 36 hours. Inner right arm: Shingles developed rapidly next morning.
Hospitalized (9.30.21);  COVID-19 positive (9.30.21);  fully vaccinated  Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 9/30/2021 Discharge Date: 10/02/2021 PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 76 year old male with history of NICM, SSS s/p PPM, A-Fib/Flutter s/p Watchman, prior DVT, HTN, HLD, T2DM with chronic neuropathy, alcohol use with hepatic steatosis, pancreatic insufficiency, COPD, OSA, depression and RLS who presented to the ER with generalized weakness. Patient reported normally performing ADLs with occasional assistance from family, however lately had been so weak he had difficulty standing and ambulating. He denied subjective fevers/chills, however noted to have fever by EMS. In the ER, he was febrile, not hypoxic, and tested positive for COVID 19. CXR was negative for infiltrate. He was admitted under observation for further monitoring.    Patient qualified for monoclonal antibody infusion which was given. He did not qualify for Remdesivir or Decadron with negative CXR and no hypoxia. Patient worked with PT/OT who did not identify any needs for him at home. The following day, patient felt much better. He denied shortness of breath, fever. He continued to have fatigue, but overall improved. He was ambulated multiple times by PT and found to not be hypoxic/needing home O2. He was discharged to home in improving condition on 10/3/21.
After Flu Mist was administered on 10/3/14 I felt nauseated, threw up, I felt it was related to anxiety and panic that I often experience with medical procedures.  Then on 10/8 I felt painful electric like shocks in left lower tooth area that escalated over the course of a few days.  I saw a dentist and endodontist on 10/9/14.  On 10/10/14 I was diagnosed with trigeminal neuralgia by my primary care doctor in consultation with a neurologist and treatment was initiated.  A neurologist confirmed the diagnosis on 10/14/14 after an appointment. Seizure medications initiated on 10/10 (Tegretol), Baclofen on 10/11 in the Emergency Department, Tegretol discontinued on 10/14/14 and Trileptal initiated and Baclofen discontinued.  Symptoms continue at this time, medication treatment and monitoring are ongoing to control symptoms.  I am currently on medical leave from work.
Fever (not documented), nausea, Diarrhea, sore joints - resolved late Friday night (12-03-2004).  Denies adverse effect after Hepatitis B #1.
Had fever and chills and body aches. Hurt to walk in my feet and my hands were so cold they were numb. Felt nauseous but never threw up Lips are swollen ( have lip filler volbella) and continue to swell after 36 hrs.  Fever broke after 36 hours and feel better now.
16May - tested positive; 16May - tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "16May - tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) positive; (25May2022) negative; (28May2022) positive, notes: Minor symptoms start again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site swelling which inflamed to the size of grapefruit; Redness at the injection site; Inflamed Swelling; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and inflammatory swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had injection site swelling which inflamed to the size of grapefruit. The reporter agreed to follow-up with GlaxoSmithKline.
Information has been received from a physician concerning a 22 week old (pre-term at 32 weeks) male with no other medical history and no drug allergies who on 24-JUL-2007 and 24-SEP-2007 was vaccinated PO with his first and second dose of RotaTeq (lot# 656184/0558U and 656846/0940U). There was no concomitant medication. On 20-OCT-2007 the patient experienced diarrhea and "gastroinitis." The physician performed a "stool test" that confirmed results of rotavirus. Subsequently, the patient recovered. There was no product quality complaint. It was noted that the physician will give the patient the third dose of RotaTeq which will be due next week. Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow-up information from the reporting physician and medical records indicated that on 19-NOV-2007 the patient was vaccinated PO with his third dose of ROTATEQ (lot# 657666/1391U). On 20-OCT-2007 stool cultures were performed which revealed a negative result for C. difficile toxin A/B and a positive result for rotavirus. Lab results for campyobacter were pending at the time of this report. The patient was diagnosed with gastroenteritis rotavirus. Additional information has been requested.
Severe redness and swelling in upper arm, which covered most of the upper arm. Blood underneath skin (I believe) moved into underside of arm. Area covered with redness was most of the upper arm except directly underneath. Flu-like symptoms, body aches, low-grade fever, chills, headache, nausea, loss of appetite, lethargy. No treatment except self-treatment with Tylenol.
Patient developed a rash at site of injection approximately 3 inches wide and 4 inches long in size. Patient did not have or express any symptoms like itching or fever. Patient self treated with hydro- cortisone cream topically and benadryl 25mg orally. Duration of rash is still present but less than on 1/5/2021.
Low grade fever (100.3 max) at 8 pm on 2/23; body aches, chills.  Fever was normal in morning and day of 2/24. On 2/24 at 6 pm low grade fever again reaching 100.4 max and temperature was normal in morning 12/25. No medication was used to lower low grade fever. Was unable to return to work due to having low grade fever at night. Contacted doctor's office at the request of my employer. Doctors' office requested me to complete this report.
Information has been received from a pharmacist concerning a 66 year old female with hypertension, and allergies to tetracycline, penicillin and sulfonamide who on 27-Aug-2007 was vaccinated with Zostavax by subcutaneous injection in a pharmacy.  Concomitant therapy included sertraline HC1, estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) and hydrochlorothiazide (manufacturer not specified).  On 29-Aug-2007 the patient developed a rash.  The patient went to the pharmacy but had not contacted her physician.  The rash consisted of red, slightly raised, itchy, tender to touch lesions on the patient's right torso.  The patient's treatment and outcome were not reported.  Additional information has been requested.
Red raised area around injection site. Reminded me of a mosquito bite. Red, warm, itchy.
Phone call from vaccine recipient, reports 30 min, approx. after immunization, had headache, nausea, vomiting, no fever, still feeling ill today - has had flu vax before with (-) problems - he to consult with dr.
2/9/22 pt to ED with c/o CP, SOB, weakness, lethargy, cough, nausea, dry heaves; given Decadron, ABX in ED; rapid COVID test negative but PCR was positive; CT chest showed findings comparable to COVID pneumonia; Vapotherm; declining O2 saturations; transferred to ICU; intubated; sedated; became hypotensive; PEA; multiple rounds of CPR, shock and medications without success; pt passed away in the hospital
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV at inappropriate age. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date (reported as today), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1810 via unknown route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been receive from a registered nurse concerning of himself a 27 year old male with sulfonamide allergy who in 1983 was vaccinated with a dose of MMR II and now had negative mumps titer. On 19-FEB-2009 the reporter received a second dose of MMR II. Follow up information has been received from a physician concerning a 27 year old male patient who on 09-AUG-1982 was vaccinated with the first dose of MMR II (Lot not reported) and on 15-JUL-1995 with the second dose of MMR II (lot not reported). Now the patient had negative mumps titer. Additional information is not expected.
Numbness in hands and feet Swelling in legs & feet Weakness in hands & feet requiring strong mental concentration to make them work I communicated via message with my doctor, as I was on vacation Spent 2 weeks like that, then slow improving .. feet swelling remained for over a month
Shortness of breath; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 13Aug2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received epinephrine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 15Aug2021 at 09:30, the patient experienced persistent shortness of breath at hour 49 that lasted for 10 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of breath was resolved on 15Aug2021 at 19:30 after a duration of 10 hours.  No follow-up attempts are possible. No further information is expected.
received Tubersol injection by accident instead of the ordered influenza vaccine / no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA296272.  This case involves Adult male patient who received vaccine TUBERCULIN TEST [TUBERSOL] instead of INFLUENZA VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that received Tubersol injection by accident instead of the ordered influenza vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
A-Fib; This is a spontaneous report from a contactable consumer. A non-pregnant 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 17Feb2021 at 13:15 (Batch/Lot Number: EL9Z67) as a single dose for COVID-19 immunization.  The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included age-related macular degeneration (AMD) from an unknown date and unknown if ongoing, heart arrhythmias (undiagnosed heart arrhythmias 1-2/month) from an unknown date and unknown if ongoing, allergy to antibiotic from an unknown date and unknown if ongoing ("a few other antibiotics"), penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported; also reported: List of any other medications the patient received within 2 weeks of vaccination: Yes. The patient previously received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Jan2021 (lot number=EN5318, administration time=13:30, vaccine location=Left arm, dose number=1). On 03Mar2021, the patient experienced a-fib (atrial fibrillation) (medically significant). The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The clinical course was reported as follows: The patient did not know if it was connected, but prior to vaccination, the patient "had undiagnosed heart arrhythmias 1-2/month." Two weeks after the second vaccination, the patient began having daily or every other day intense tachycardia and arrhythmias, now diagnosed as A-Fib. Therapeutic measures were taken as a result of a-fib, which included apixaban (ELIQUIS) and diltiazem. The clinical outcome of the event was not recovered. Since the vaccination, the patient was not tested for COVID post vaccination.
Fever above 103 for four hours with high of 103.8. Whole body extreme shivering for two hours with uncontrollable limb jerking. Severe headache for 10 hours. Muscle tightness in random and varying areas continuous beginning 5.5 hours after shot. Onset of first symptoms commenced 5.5 hours after shot.
Pt describes moderate myalgia 8pm night of vaccination, around 2am pt reports of sever myalgia and present was red/swollen in and around injection site. It has spread to cover the bicep and tricep as of 9am on 6/20/20.
Swelling and redness to area 2 days after vaccine.  Warm soaks, Tylenol.
Localized redness and swelling to injection site approximately 7.5 cm x approximately 12 cm (R) deltoid.
Several months later unknown relation: got sick and lost voice. Sore throat and trouble breathing upon exhale. Needed inhaler every two hours consistently coughing with pressure.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 29-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 13 in the literature article. On an unknown date, 8 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included pruritus, angioedema with serious criteria of GSK medically significant, cough, swelling, generalized urticaria, rash and shortness of breath. The subject was treated with antihistamine, H2 blocker and steroid (unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included pruritus (recovered/resolved), angioedema (recovered/resolved), cough (recovered/resolved), swelling (recovered/resolved), generalized urticaria (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, pruritus, angioedema, cough, swelling, generalized urticaria, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 29-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). The following day, 8 hours after the vaccination, the patient developed angioedema, lips, uvula and mouth swelling, generalized urticaria, pruritus, rash, shortness of breath and cough. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral H2-blocker and oral steroids. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
high-pitched cry w/hoarseness 6d;low grade fever & fussiness 3d;
1st day - deltoid "hard lump" which subsided. Sometime into day 2-3 a rash began along backside of injected arm, spread around arm, under deltoid area of vaccine & down to elbow.
I got the Pfizer covid vaccine I am experiencing mild to moderate chest pain getting elevated sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 25Oct2021 16:00, outcome "not recovered", described as "I got the Pfizer covid vaccine I am experiencing mild to moderate chest pain getting elevated sometimes". Therapeutic measures were not taken as a result of chest pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Reported Event: From the time patient got the Pfizer covid vaccine patient had experienced mild to moderate chest pain which was getting elevated sometimes. Pt never had chest pains before in life. Reaction: Allergy. Known allergies: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 01Nov2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
pain around her pancreas; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain around her pancreas) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pancreatic mass.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (pain around her pancreas). At the time of the report, ABDOMINAL PAIN UPPER (pain around her pancreas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's second vaccine dose is scheduled on 07-May-2021. No concomitant medications were reported. Treatment information was not provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
- Erythematous rash on 4 extremities, neck & face approx 4 hrs after immunization given -> treated with prednisone, 40mg PO daily x 4 days. - Petechiae (B) lower legs & feet.