chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pulmonary-renal syndrome; Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis; This is a literature report for the following literature source(s):.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "stage 3b chronic kidney disease" (ongoing); "cough" (unspecified if ongoing); "hemoptysis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY RENAL SYNDROME (hospitalization, medically significant, life threatening), outcome "unknown", described as "pulmonary-renal syndrome"; VASCULITIS (hospitalization, life threatening), outcome "unknown", described as "Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antineutrophil cytoplasmic antibody: positive; Antineutrophil cytoplasmic antibody (0.0-0.9): Greater than 8; negative; Biopsy kidney: focal necrotizing and crescentic glomerulonephriti, notes: focal necrotizing and crescentic glomerulonephritis and pauci-immune type MPO-ANCA seropositivity; Blood creatinine (normal low range 1.73): 4.56 mg/dl, notes: Baseline 1.73; Blood pressure measurement: 83/30 mmHg; Computerised tomogram thorax: patchy ground-glass and confluent airspace opaciti, notes: patchy ground-glass and confluent airspace opacities in both lungs; Haemoglobin: 9.1 g/dl; examination: he had pitting edema on the, notes: he had pitting edema on the lower extremities and scattered rhonchi and crackles on both lungs; Oxygen saturation: 77 %, notes: on ambient air; Protein urine: positive; Respiratory rate: 36; improved; Urine analysis: 21-50 red blood cells, and positive for protein; White blood cell count: 13.7. Therapeutic measures were taken as a result of pulmonary renal syndrome, vasculitis.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine given: 10/9/17 6:30pm - PT fine at time of vaccination. Next day patient had to ice site of PNEUMOVAX 23 injection on left arm. Patient stated she needed to be wheeled out of work to her car. Was shaking, week, heart rate of 109, fever of 101, experiencing muscle pain and weakness x 3 days. Reached out today 10/13 to patent no response as to resolution of symptoms.
Pt admitted with weakness and abdominal pain.  COVID positive on 10/28/2021. Pt has also been experienced worsening confusion. Chest x-ray showed left upper lung opacity.  Of note patient presented to the ED on 10/16 after suffering a mechanical fall from a nursing home. D-dimer 1935.   DVT prophylaxis with Lovenox 40 mg daily.  GI prophylaxis with PO Protonix.  Symptoms \ improved and discharged to rehab.
Extreme sweating and discomfort, muscle pain. Nausea and headache day after vaccination. Arm sore during day of vaccination, adverse effects worsened overnight causing loss of sleep
Left shoulder hurt really badly; Felt sluggish; Felt feverish; Had no energy; Like he had the flu; drug dose administration intervell; Circumstance or information capable of leading to medication error; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th July 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the shoulder pain, sluggishness and fever were recovered/resolved and the outcome of the loss of energy, influenza-like symptoms, drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On 13th July 2020, the patient received 1st dose of Shingrix in left deltoid. After receiving the 1st Shingrix vaccine, his left shoulder hurt really badly, he felt sluggish, had no energy, and felt feverish like he had the flu. Customer reports that he is just getting back on his feet and started feeling better three days after Shingrix dose.  The health care professional scheduled the 2nd dose on 17th August 2020, which was less than two months after first dose the patient was not yet received, which led ted shortening of schedule and circumstance or information capable of leading to medication error. The reporter stated he read the package insert and wants to know if that scheduled date is appropriate. Informed customer that second Shingrix dose should be administered 2 to 6 months after the first dose and not sooner. The reporter did not consent to follow up.
Jan 20, 1 week after 1st vaccine, rash on left neck, blisters in mouth and extreme fatigue. Spent I day in bed sleeping. Feb 12, 14 hours after second vaccine, severe chills, body aches, dizzy, whole body hurt-skin hurt. Severe rash on left arm, shoulder to elbow. Felt a little better on Feb 13, but slept most of the day. Body aches continued and head felt "fuzzy" for next few days. Rasj resolved after 2 weeks. Mostly resolved, but body aches and difficulty concentrating continue until today.
Pt fainted for a few seconds. Called 911 and paramedics came to assess pt. they took her to hospital. Pt was fully aware and answering paramedic's questions after the spell.
Large, warm knot right deltoid area of injection. Medrol dose pack, cool-warm compresses.
Onset of mouth tingling, throat dryness and tightness - vital signs taken observation for 1 hour post MD evaluation.
On 10/13/00, the pt experienced a fever and seizure. Admitted to the hospital.
"I" developed a rash on the 4th day and then hives. The hives woke me up at 2am on 4/27.; "I" developed a rash on the 4th day; "I" experienced chills and aches for 3.5 to 4 days; "I" experienced chills and aches for 3.5 to 4 days; Soreness in left "my" armpit; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The medical history included moles removed, benign thyroid nodule and half of thyroid removed. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included levothyroxine sodium (UNITHROID), ascorbic acid (VITAMIN C), multivitamin(unspecified), sambucus nigra fruit (ELDERBERRY) and vitamin d nos (VITAMIN D); all for an unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced chills and aches for 3.5 to 4 days, including soreness in left armpit. On 26Apr2021, the 4th day the patient developed a rash. On 27Apr2021 at 02:00, the hives woke the patient up. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives included treatment with diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC). Since, the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and aches were resolved on unknown date in Apr2021, while the clinical outcome of the event soreness in left armpit was unknown at the time of this report. The clinical outcome of the events rash and hives were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to the case 1404USA014432 and 1404USA014696 (same reporter link). Additional information is not expected.
inject site surrounded by red hard area measuring 3" x 2 1/2", tender to touch;
Tachycardia, jittering. After taking antihistamine, symptoms lessened. Continued for two more days, continual use of antihistamines and resolved completely after 4 days
elevated blood pressure; dizzy; light-headed and crummy; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for an unspecified indication. Medical history included neoplasm malignant from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination she had been treated for cancer and blood pressure issues. On 27Jan2021 the patient experienced elevated blood pressure, dizzy, light-headed and crummy. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 08Feb2021.The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Varicella vaccine given 01/30/2002 at 12 month check up. Diagnosed with post vaccine. Varicella 12/02/04 age 3 years.
Swelling and pain in arm and shoulder, severe pain in lower back,collar bone pain across chest
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Fatigue). On 04-Feb-2021, FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-067099 (Patient Link).
high fever (even while taking Tylenol),  severe chills, coughing, sore throat, migraine, and fatigue started hours after receiving vaccine and lasted 2 days
Pt had had bleeding more than the average. Also had bruising. Other than that everything feels fine.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 08-JAN-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # K026531, expiry date: unspecified). On 08-MAR-2016, the patient received their second dose of vaccine (lot # K024553, expiry date: unspecified) at a greater than recommended interval (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
11 hours after vaccine, fever to 102.8, chills, tachycardia, mild headache, body aches and fatigue. Low grade temps, body ache and fatigue lasted approximately 18 hours.
Itchy Sensation - All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Sensation - All Over Body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Itchy Sensation - All Over Body). The patient was treated with HYDROXYZINE at an unspecified dose and frequency. On 25-Feb-2021, PRURITUS (Itchy Sensation - All Over Body) had 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.
pt was given an expired vaccine due to local vaccine coordinator having incorrect manufactures expiration date listed on site
Moderna COVID-19 Vaccine EAU  04-16-21  2:00 A.M.  Chills. Body ache.  Extreme headache. Pain in the left side/middle part of my back that was radiating around toward my belly button.  04-16-21  10:00 A.M.  I still had the body aches as well as a headache.  It was just difficult for me to find the energy to even get out of bed. The pain in my back was still intense, so much that it had become difficult for me to even walk. And I had become very nauseated. I was extremely tired. Still dealing with a headache. 04-18-21 Feeling fine. Dealing with a stuffy nose
Approximately four weeks after receiving the shot I came down with symptoms related to Shingles and was diagnosed with such five days later.  Unsure if there is causation but I thought it was worth reporting because other than receiving the covid vaccine I have had no changes or health issues or anything else that would indicate a change in my immunity status that could have resulted in this onset.  I am a bit on the young side to be experiencing Shingles so thought it was worth reporting.
After my Moderna vaccine I experienced flu like symptoms then those went away. On 01-13-2021, my left arm got itchy and formed giant hives and also my left arm swelled up.  I took topical steroids and Benadryl and two different kinds of anti-histamines.  About 5 days later my hives got worse and I went to the ER saw Dr.  My tongue and throat swelled up and I also had a dry cough for eight weeks. I was put on to use an inhaler. I had multiple lab draws. I had weird itchy bump to my left arm, and I've had extreme fatigue for about ten weeks now and have ended up on a higher dose of steroids.
Bell's palsy, viral polyneuropathy; paralized; SN hearing loss; rt facial paralysis; last vax MAR92; onset 26JUL92; patch rt eye; artificial tears; lacrilube ointment; facial massage;
Patient was given DTaP instead of Tdap. Patient did not have any adverse reactions to the DTaP, she was just given the wrong vaccine.
Injection site red, warm to touch, rash. Had difficulty moving right arm. Temperature was 101.0 F, and patient had vomiting. Patient was seen at emergency room, given tylenol and something for vomiting.
tender enlargement of the lymph node on the neck; regular tenderness or arm pain; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j2A) for COVID-19 vaccination.     Historical condition of the patient is not mentioned and concomitant list is provided.  Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and FLUOXETINE HYDROCHLORIDE (PROZAC).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (regular tenderness or arm pain). On 19-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck). At the time of the report, VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) to be possibly related.    Concomitant drugs are vitamin-D and prozac
Systemic: Slight swelling of lip and numbness of tongue-Mild, Additional Details: Patient complained of slight swelling of the lips and numbness of tongue. Symptoms resolved once patient was at home.
About 10 minutes after vaccine patient reported shew as dizzy and felt nauseous. Her blood pressure at the time was 104/60, hr 76 and regular, SPo2 was 98% on RA. she was assisted to lay down. Her blood pressure and vitals were checked again and were 90/60, HR 78, SPo2 95% on RA. She complained of chest pain. EMS was called. they arrived at about 145pm and transported her to Hospital per the patient's request. She remained conscious, alert and responsive through the episode.
Extreme leg pain - aching; stabbing pain. Patient was afraid she had a blood clot. Chills, fever, achey body. Symptoms resolved within 48 hours. Patient did not seek treatment. She walked a lot.
1-22-13 received influenza vaccine. 2-11-13 patient developed myalgias, cough, diarrhea. 5-13-13 diagnosed facial shingles.
sore arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (in April 2018) and nerve pain (from shingles outbreak in April 2018).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient's arm was sore the next day, but it resolved and he had no other adverse event. For tolerances of 2nd dose of Shingrix, refer linked case US2019AMR201604.
hand closed into fist, shoulder issues, something running back in forth over left breast, left lung lower pressure, -put on 2 medications, ahortness of breath
Diarrhea several times a day; Fever; Exhausted; Sick feeling; Muscles hurting; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Jun2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL IR); all were for an unknown indication from an unknown date and unknown if ongoing. On 15Jun2021, the patient experienced diarrhea several times a day, fever, exhausted, sick feeling and muscles hurting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea several times a day, fever, exhausted, sick feeling and muscles hurting was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; expired on 1/6/2021; This spontaneous report was received from an unspecified reporter referring to an 18-month-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # T001419, expiration date was 06-JAN-2021, strength and route were not provided) 0.5 milliliter for prophylaxis which was expired on 06-JAN-2021 (expired product administered). No other adverse events were identified.
Patient received immunizations on 2/8/18. She presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away the same day, presumably from Influenza B.
Patient came in and received a 3rd dose of Pfizer's Covid 19 vaccine, They reported no previous doses.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable Physician. A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) 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: "Chronic Hep B" (unspecified if ongoing). There were no concomitant medications.Patient did not have other medication in 2weeks. Patient has no known allergies. 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. Patient received Paxlovid as covid treatment from 23Jun2022 to 28Jun2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.