chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine, dizziness, triggered PMDD symptoms of major depression and hopelessness for 10 days
Patient called on 2/11/2021 reporting fever and swollen left arm. On 2/11/2021 I, assessed patient's arm and the left deltoid and the muscle was tender, warm and there was firm baseball size swelling. Patients temp was 100.4. She reported that she didn't feel well and had a wet cough. I recommended Tylenol for temp and arm pain and encouraged an ice pack to her arm 15 minutes every hour for reduce swelling. Spoke with patient on 2/12/2021. She reports she called her Doctor and he prescribed her an antibiotic and she states she is feeling better and the swelling in her arm has gone down.
have them, got both shingles vaccines/Suspected Vaccination failure; have them; I'm miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and feeling miserable were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.  Addition details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles right now at the time of reporting for the 2nd time, and he/she got both Shingles vaccines. The patient was miserable. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
The nurse reports the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies, or concomitant medications were not reported.  On 13-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (product storage error) (lot number S027462, which has been verified to be valid, expiration date reported and validated as 02-MAR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent, lot number T003594 and expiration date 07-JUL-2022. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (°F) to 14 °F for 16 hours 17 minutes, 15 °F to 46 °F (16.7 °F) for 1 hour 21 minutes, as recorded by a data logger. There was no previous temperature excursion.
high-dose vaccine was given to pt who is only 64 years old (not yet 65)
Continuous headache since first dose .; This is a spontaneous report from a contactable nurse (patient). A 53-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 22Dec2020 13:30 in right arm (at the age of 53-years-old) at SINGLE DOSE ,  second dose via an unspecified route of administration on 12Jan2021 16:30 in right arm (at the age of 53-years-old) at SINGLE DOSE for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing.  The patient did not have any allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a hospital. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Dec2020, the patient experienced continuous headache since first dose. The patient did not receive treatment for the continuous headache since first dose. Outcome of the event continuous headache since first dose was not recovered.
Mother of patient noticed redness, edema, and pain on right upper arm after he got home from school on 8/16/17, approximately 3:30-4:00pm. Mom gave patient TYLENOL for pain in arm. Patient says it hurts to move his arm, but pain is not as bad as yesterday. No fever noted at home, but mom stated that patient felt warm last night. No fever today. On exam today, Right upper arm (deltoid site) with 12cm x 12cm site of induration, redness, edema. Area warm to touch and tender to palpation.
After 2nd shot, began having respiratory problems, weakness, fatigue, swelling and pain in hands and arms, weight loss, skin on hands thickened and cracked. Treated for arthritis but no improvement. Sent to a Rheumatologist in July 1999 who dx'd as Autoimmune connective tissue disorder and he is treating it with Prednisone and Methotrexate and is still under treatment. Consulted my Internist about taking 3rd shot; once I took the 3rd shot, conditioned worsened; slow improvement now but activities are still limited by condition and still have all symptoms. Pt returned for her regularly scheduled visit today. She has an undifferentiated connective tissue disease manifest by evidence of inflammtory myopathy with anti-Smith antibody. This is most likely a lupus variant. She is doing remarkably well with the combination of low dose methotrexate and prednisone. Her prednisone has been tapered to 3 mg daily. Her methotrexate has been tapered to 10 mg every other Monday in rotation with folic acid. She has instructions to further reduce the prednisone over the coming months. She has now completed four years of Fosamax therapy for her bone mineral density abnormalities. She states that the DEXA performed after approxiametly 1 1/2 years of therapy showed improvement in bone mineral density. I believe she is due for another one now. This would serve as the baseline for a comparison DEXA to be performed three years from now to be sure that her calcium supplementation and exercise is adequate to mantain bone density off Fosamax. I am planning to see her back in about four months unless questions or problems arise. Pt is a 61 year old with a history suggestive of an evolving autoimmune inflammatory connective tissue disorder. Her symptoms were probably manifest as much as five years ago, but have blossomed more prominently in the last eight months. She has several symptoms and signs which render an overlap appearance to her disease. A definitive diagnosis cannot yet be made, but certain that her differential diagnostic list can be shortened significantly once some additional lab is obtained.
Patient reported hives, mouth sores and rash started approximately 1 week after vaccination date.  Symptoms still present. Patient notified MD.
EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud's syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Patient had vasovagal syncope shortly after receiving a Moderna (0.25ml) booster shot.....she woke up before EMS arrived and had vomiting and dizziness....EMS arrived and took the patient to the hospital for further evaluation
swollen (area at the injection site); Vccination site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red). The patient was treated with PARACETAMOL (PANADOL) at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
My four year old daughter was incorrectly given the adult Pfizer Covid 19 vaccine, instead of her 3 toddler dose.
FEVER; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 subject experienced fever, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reporter This report was non-serious.
Can not administer the whole product into the skin, completely depress the plunger; it stops with either 0.2ml or 0.3ml remaining, no AE; Can not administer the whole product into the skin, completely depress the plunger; feel pressure when they press down, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number lot UJ237AB via unknown route in an 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 is an actual medication error case due to vaccine underdose. It was reported that when they drew up the 0.5ml dose and the assistant practice manager attempted to inject into a staff member and the plunger stopped with 0.2 ml remaining in the syringe. It is also a case of syringe issue as it was reported that the nurse is not able to completely depress the plunger; it stops with either 0.2ml or 0.3ml remaining. Can not administer the whole product into the skin,  feel pressure when they press down.  At the time of reporting, no adverse event was reported.  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.
profound weakness; malaise; fever; This case was reported by a physician via call center representative and described the occurrence of weakness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October or November 2017).   In March 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness, malaise and fever. On an unknown date, the outcome of the weakness, malaise and fever were unknown.   It was unknown if the reporter considered the weakness, malaise and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A physician reported that he received the 1st dose of Shingrix sometime around October or November 2017 and the 2nd dose around March 2018. After receiving the 2nd dose he experienced fever, malaise, and profound weakness. The reporter consented to follow up.
pulmonary embolism; shortness of breath; she is a little bit overweight her weight is 25 lbs; thyroid problem; an intense shoulder pain just right above the injection site; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included blood clotting for which was patient was treated. The patient's concomitant medications were not reported. The patient previously took rivaroxaban (XARELTO) from 01Jun2020 to 16Mar2021. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Mar2021 for covid-19 immunisation and experienced sore in the arm and fatigue. The patient got the second dose last 19Apr2021 and after 4 days (23Apr2021) she had an intense shoulder pain just right above the injection site. The patient was treated for blood clotting. After getting the second dose, the patient said that the 2 clots on her knee broke and right now, she has pulmonary embolism. She also had shortness of breath. On the other hand, her doctor told her that there is no new blood clot. The patient added that she is a little bit overweight her weight is "25 lbs" (as reported) and has a thyroid problem. Her hematologist advised her to be placed back on Xarelto and now on bed rest for a few days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Presented to ED due to rectal bleeding and was tested for COVID-19 prior to admission to hospital. Patient was asymptomatic for COVID-19.  Received Pfizer BioNTech vaccine on 1/26/21 and 2/16/21.
Onset of sx several hrs p/administration; mom reports pt had low grade temp for 24 hrs w/APAP, high pitched cry off & on for 5 hrs; Also swelling of DTP site;
The pt had Pfizer  #2 vaccines on 5/30/2021  and 6/23/2021  Had Moderna   booster" on 3/31/2022, developed left arm and left chest pain on the next day , progressively worse  EKG findings c/w with  pericarditis , started on  Naproxen
Almost immediately post vax the pt experienced swelling and redness at the injection site and broke out in a single hive. The hive resolved and the swelling/redness dissipated slightly upon observation. The pt recovered. No further information is available.
total body ache, extreme pain in lt arm where shot was given-entire arm, severe tiredness, headache (more painful on lt side) & eye pain on lt side;pt states still extra tired cont to have h/a & eye pain;
Arm pain started first,  then fever developed. For 2 days it was 2 degrees higher than normal. At that time I had chills and aching, along with fatigue. Now, several days later, te mpis still about a half degree higher than normal,  and I still have some muscle aches and fatigue, although not as severe.
Fever, swelling of right cheek, bilateral otitis media.  12/26/2007 MR received for ER visit 9/14/2007 for c/o fever and swelling of R cheek x 2 days. DX: R cheek cellulitis.  L otitis media. L inguinal hernia. On PE R cheek noted to be warm, swollen, and tender. D/C on abx.
Pt had flu vax on 11/11/99. On 11/18/99, she had dizziness which became gradually significant w/progression to ataxia, weakness of lwr extremities & ptosis. Pt admitted to hosp dx w/Guillaine-Barre' Syndrome and tx w/plasmaphoresis. 60 day follow-up dated 09/27/00 provided no additional data. Discharge summary states principal dx to be GBS (Miller-Fisher varient), opthalmoplegia with ptosis and the secondary dx to be ataxia, hypertension and diabetes
Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Back pain". Additional information: Patient was in a lot of back pain for two days, no other symptom at all, everything was fine. Patient was a healthy person.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red rash that has gotten bigger and hot to the touch; itches and hurts to touch; arm is sore
Pt. in observation area at 9:07 reported swelling of sides/tip of tongue. Stated also occurred with 1st dose,  no other sx reported. Medical consult requested, evaluated by MD. VS taken no SOB/stridor, 180/77, HR 67, 02 98% RA. Zyrtec 10 mg PO administered at 09:35. Patient monitored until 10:15 am.  09:40 pt reports tongue feels "thinner" and "it's helping". 09:53- "more normal". 10:00 am- "Pretty good". 10:15 am- pt. escorted to tram, reports "much better".
Significant right axillary lymphadenopathy, swelling and bruising along right lateral breast
patient report pain, no edema, erythema, difficult to elevate arm since the injection given, only pain has been the only complaint, short course of prednisone given with out any result, no improvement no worsening, will send MRI deltoid area, since inspection is normal
Lost vision in left eye on Thursday evening (03/11/2021) around 7:00 pm.  My condition was not improved when I awoke the next morning (03/12/2021).
Patient was fully vaccinated at the time of first dose of Pfizer. Patient was vaccinated with Moderna on 0317/21 and 04/14/21. Patient attested on consent form that this was her first dose of the COVID-19 vaccine.
Patient was on the last day of her cycle and had spotting.  After the vaccine that day, she started having heavy flow.  This very heavy flow continued for 2 weeks.  She is still having spotting.
psoriasis flare; This spontaneous case was reported by a health care professional and describes the occurrence of PSORIASIS (psoriasis flare) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA AC) for Psoriasis.    No Medical History information was reported.   In August 2018, the patient started ADALIMUMAB (HUMIRA AC) (unknown route) 40 milligram. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PSORIASIS (psoriasis flare). At the time of the report, PSORIASIS (psoriasis flare) had not resolved.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
After a booster shot on the Left arm I was in muscle pain, swelling, bruise redness lasted over 2 weeks than I couldn't lift my left arm having intense pain and swelling under arm....I made an appointment on 1/13 with chiropractic Dr. he took X-ray of my RT, LT shoulders begun to treatment of 12 week of therapy twice of week. After 6 week of completions my left arm/shoulder still in pain no improved full  motions..that point Dr. informed me his treatments will not going to work, he recommended to see Orthopedic specialist to take an MRI.  I made an appointment on 3/1 with Dr. clinic and PA ordered a Steroid shot injections on LT arm.  Current conditions are still the same.