chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt experienced clinical varicella. Pt has approximately 3 dozen lesions and is afebrile. It was reported that the pt was not seen in the physician's office; however, unspecified medical attention was sought. Additional information has been requested.
Could taste the injection in the back of my throat and nasal cavities soon after the injection. Neck felt swollen as I was getting in my car to leave Mild headache early evening and into the following day Developed Itchy Rash by bedtime: upper chest and back and base of neck - which is the reason that I am submitting this form. The rash is still itchy. Have used OTC allergy meds and calamine spray
PATIENT DEVELOPED ATYPICAL CHEST PAIN AND EFFORT INTOLERANCE.   EXTENSIVE PULMONARY EVALUATION INCLUDING BRONCHOSCOPY WAS NOT REVEALING.  CARDIAC MRI 7/27/2022 POSITIVE FOR LGE AND MILD LV AND MODERATE RV DYSFUNCITON. MILD PERICARDIAL EFFUSION.   JUL 2022 CTNI, GAL-2, BNP, ST2, ALL WNL ON 5/22/22.  DIAGNOSIS IS COVID-19  VACCINED-INDUCED MYO-PERICARDITIS.
within 2 days of injection, patient developed a large area of erythema and tenderness extending from shoulder to fleural crease of the elbow. Patient needed admission and iv clindamycin. She had fever to 102.6 at the time of admission. she remained in the hospital for almost 48 hours. 12/27/06- records received and reviewed for DOS 12/7-12/8/06 DC DX:cellulitis  right arm swollen red. temp 39
I had a normal pregnancy but at the week 12 I started with a mild bleeding and after the 3rd day I had a miscarriage. The bleeding started on Wednesday 12.09-and lasted till 12-14-09.
2/22/2023 I started with a mild sore throat. By the next morning my arms and hands were aching. I also had a bad headache and was fatigued. I also had severe chills with around 102-degree temperature. I took an at home COVID test which was positive. I took acetaminophen. On 2/23/23 I called my doctor and was prescribed PAXLOVID which I began taking that day. I took this for five days. Around the third day, 2/25/23 I began improving. On 3/14/23 I went back to the doctor because I was still having a lot of residual symptoms. I was prescribed doxycycline, FLONASE nasal spray and an albuterol inhaler. I am feeling great now.
Day after 2nd COVDI 19 vaccine patient presented with painful supracalvicular lymphadenopathy x2. Also had mild intermittent tingling in right arm.
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Blood pressure high.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication used were Beta Blocker For HBP and another medicine for Mitral valve prolapse  No treatment details were reported.
Diabetic foot ulcer. Unsure why tested in the ED. Asymptomatic
In error, the patient was given 2 flu vaccines this flu season: on 9/22/22.
Massive headache and arm pain at injection site; Massive headache and arm pain at injection site; This is a spontaneous report from a contactable physician (wife of the patient).  This Physician reported similar events for two patients. This is the first of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  After receiving COVID-19 Vaccine, it was reported that the husband had a massive headache and pain at the injection site. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021047955 same reporter, drug, different patient and similar event
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 57.07  for dose administered on 13-Feb-2021 and 57.17 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34,37 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-April-2021. Product moved to clinic on  20-Mar-2021 .  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Gradual development of hypertension, myocarditis or pericarditis (chest pain). Hypertension increased to very high (180/120) over time (approximately 1 month)
Patient came in for 2nd half of 1 year old vaccines, already completed MMR and Hep A. He was due for his varicella and prevnar. However, it had been only 27 days since the administration of the other live vaccine (MMR) and the recommends 28 days between live vaccinations. Thus, the varicella that was administrated was invalid and the patient will flag for needing an additional dose. Patient's mother was notified of event and understanding of this information. No treatment or medical intervention was needed.
COVID Breakthrough. Patient became hypoxic on 11/22/21 and was brought to the ED by EMS. She was tested positive for COVID and put on 15L of Oxygen.
Patient stated The day after receiving the vaccine she felt dizzy and nausea. She tried to let it pass but it only became worse. On 11/04/209, she then developed a red rash on The same arm as the vaccine.
ED to Hosp-Admission Discharged   9/13/2021 - 9/17/2021  Last attending o Treatment team COPD exacerbation  Medical Problems Hospital Problems        POA    * (Principal) COPD exacerbation Yes         Depression Yes        Benign essential hypertension Yes        Adrenal insufficiency  Yes      Pulmonary embolism related to COVID-19 infection COVID-19 infection. Presenting Problem/History of Present Illness/Reason for Admission COPD exacerbation  [J44.1] COVID-19 [U07.1] COPD exacerbation Adrenal insufficiency Smoker Pulmonary embolism associated with Covid   Hospital Course   Patient was admitted on 13 September I saw her i
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Pain in arm after injection up to 3 days. Enlarged left and right lymph nodes.
Pt noted with temperature of 105 degrees 3-4 hours after the vaccinations. He vomited, chills stated.
she developed a lump in her lymph node under her right armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8732) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she developed a lump in her lymph node under her right armpit". Clinical course: Within 24 hours after receiving what was her second Pfizer Covid-19 shot, she developed a lump in her lymph node under her right armpit. This was also the same arm that she was injected. The patient did not experience this with her first COVID-19 shot. She was on no concomitant medications and has no underlying conditions.  No follow-up attempts are possible. No further information is expected.
A bit below the injection site, developed a deep ache, followed by swelling and redness. Over the course of the evening I watched the redness and swelling actually crawl down my arm to my elbow. The whole of my upper arm was hot, swollen, red and tender by bedtime. Following day (yesterday) I went back to the Drs. office and he prescribed Cephalexin antibiotic, 500mg 4X daily for a Dx of Cellulitis. Also cold compresses and Ibuprofen for discomfort. Today, my arm is swollen beyond the elbow, halfway down my forearm. It is still tender, painful at times, red, hot and swollen. I got light headed this morning when I went out I felt lightheaded and have been feeling "weak" all day.
fatigue, headache, muscle pain, joint pain, chills, nausea. And weakness and dizziness. All started 15-20 hours after injection. Weakness and dizziness comes and gos. Still have other symptoms.
GUILLAIN BARRE SYNDROME/ AIDP; HEADACHE; This spontaneous report received from a patient concerned a 50 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 03-APR-2022 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2022 (a few days after the vaccination), the patient first experienced some headaches. On an unspecified date (currently), the patient suffered from a guillain barre syndrome. The patient experienced arm and face numbness (symptoms of acute inflammatory demyelinating polyneuropathy (AIDP) and was just diagnosed with acute inflammatory demyelinating polyneuropathy (AIDP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome/ aidp, and the outcome of headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220525640 -Covid-19 vaccine ad26.cov2.s -GUILLAIN BARRE SYNDROME. This event(s) is labeled per authority and is therefore considered potentially related.
Information has been received from a registered nurse (R.N.) concerning a 23 week old patient who on 30-JUL-2010, was vaccinated with a first dose of ROTATEQ, oral (dose and lot number not reported). On 10-NOV-2010, the patient received a second dose of ROTATEQ, oral (dose and lot number not reported). On 10-JAN-2012, the patient received a third dose of ROTATEQ, oral (dose and lot number not reported). No known adverse effect. Follow-up information has been received from a registered nurse (R.N.) concerning a 23 week old male patient, birth weight 6 pounds 13 ounces, with 1 sibling, with recurrent upper respiratory infections, possible asthma, recurrent otitis media and left serous otitis at time of vaccination, with no adverse events following prior vaccination, who 10-JAN-2012, at 11:30 AM, was vaccinated with a third dose of ROTATEQ (lot number 1303AA), oral, (dose not reported). Concomitant therapy included his fourth dose of PENTACEL and his fourth dose of PREVNAR 13. No adverse event reported. The patient did not seek medical attention. There were no lab diagnostic studies performed. Additional information has been requested.
Moderna COVID 19 vaccine EUA  Admitted inpatient for CHF exacerbation
she started feeling bad and had to stay in bed initially; dry mouth; stuffy nose (can't breathe through nose); headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details include vicks, dry mouth spray.
About 12 hrs later, strong headache, chills, sweating, vomiting, body ache. Next day mild headache and tiredness.  Sore arm around injection site
Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PEGVISOMANT (SOMAVERT) for Acromegaly.    The patient's past medical history included Liver disorder in October 2021, Kidney dysfunction in October 2021, Gallbladder stone in October 2021, Dark urine in October 2021 and Hospitalization (Hospitalized for 5 days in October 2021 for liver and kidney function issues, dark tea colored urine (all now resolved)) in October 2021. Concurrent medical conditions included Joint pain since October 2021.   On 01-Mar-2019, the patient started PEGVISOMANT (SOMAVERT) (Oral) 30 milligram. On 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient had stopped co-suspect for a while, during all of October 2021, due to liver and kidney function issues, dark tea colored urine and gall stones stuck in bile duct. All resolved now, was hospitalized for 5 days during this in October 2021. Currently reported joint pain and controlled IgF values since. After taking first dose with Moderna COVID vaccine, had an anaphylactic reaction and was taken to the emergency room. Unsure if was admitted or not.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  CC: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine. Patient visited the emergency department due to her anaphylactic reaction. Further details on the medical history, hospitalization details, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine. Patient visited the emergency department due to her anaphylactic reaction. Further details on the medical history, hospitalization details, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
Diarrhea  at 11:35 PM on 3/3/21. 100.2 fever at 1:30 PM on 3/4/21. Fever ended at  8:00 PM on 3/4/21
6 cm x 6 cm area of induration and redness with wheels/scratches on right lateral thigh
Fever 103, shakes, chills, profound weakness, loss of appetite, high blood sugar
Really tired; Her arm hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site). At the time of the report, FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment details was not provided.
No additional AE reported; Customer called to report that PROQUAD and V ARlV AX were inadvertently administered to a 12-month old female consumer; This spontaneous report was received from a consumer referring to a 12 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
second dose has not yet been given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2022 received, first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: second dose has not yet been given).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter stated that a patient received his first dose of Shingrix at another facility a year ago. The second dose of Shingrix had not yet been given, which led to incomplete course of vaccination. The reporter consented to follow up.
My glands swollen on the left side. I went to see the doctor and when I was there the CDC sent documentation referring to the symptom. My doctor tested me for cancer which was negative. In May I went to see a surgeon for pain, I was diagnosed with an issue related to my gall bladder; an EKG was ordered. Electrodes were not good so I was sent to the cardiologist and after a few months I was cleared by the cardiologist.
The patient states that she starting developing hives (and did take photographs of hives that were generalized, erythematous) and had then intermittently. She was given Prednisone and developed dyspnea and throat-closing sensation and was seen in ED, requiring Epinephrine, Decadron, and Benadryl. She was discharged on Famotidine, Zyrtec, and Hydroxyzine.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 30-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the posterior left upper arm, lot # was unknown inadvertently instead of VARIVAX (Merck). No adverse reaction reported. The patient did not sought medical attention. Additional information has been requested.