chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; very tired; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the first dose of the Pfizer covid 19 vaccine the last Friday in December. Patient reported that she had a bad reaction reporting chills, fever and very tired on unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested
Received vaccine on 4/16 and developed itching back for 2 days. On 4/17 ankles swelled.  On 4/17 developed varicella like like lesions of her lower extremities and upper chest.
Very sore arm; metallic taste in mouth; nauseous; intense chills; This is a spontaneous report from a non-contactable consumer (the patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 9809), via an unspecified route of administration, administered in left arm on 08Feb2021 12:30 (at the age of 42-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications included rabeprazole taken for an unspecified indication, start and stop date were not reported; telmisartan taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient has not been tested for COVID. On 08Feb2021 15:00, the patient experienced very sore arm, metallic taste in mouth, nauseous. On an unspecified date in Feb2021, the patient experienced intense chills. It was reported that on day 1 the adverse events are very sore arm, metallic taste in mouth, nauseous. On night 1 after vaccination, he had sore arm. On Day 2 of vaccination, very mild sore arm. On night 2 of vaccination, very sore arm, intense chills. The patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
she still feels having shortness of breath; tachycardia; Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose; The same thing happened next night exactly same way; The same thing happened next night exactly same way; and chest pain.; 4 days later (04Sep2021), she woke up with gasping the breath; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia), CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included West Nile virus meningoencephalitis in May 2021. Concurrent medical conditions included Herpetic whitlow (she has for over 20 years seems to have triggered after 1st dose).    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath). On 05-Sep-2021, the patient experienced DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way). On an unknown date, the patient experienced DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia) and CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose). At the time of the report, DYSPNOEA (she still feels having shortness of breath) and TACHYCARDIA (tachycardia) had not resolved, CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) outcome was unknown and CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath) 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.   No Concomitant medications were reported. No Treatment information was reported. It was reported that first episode of chest and gasping was resolved within 10 minutes after patient sat up on her bed.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929 , Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787 US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
FACIAL SWELLING, RASH, ITICHING OF EYES & FACE.  STARTED 3 DAYS AFTER INJECTION. METHYLPREDNISOLONE 4MG TABLETS GIVEN.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 3 (booster), single (Lot number: FI9893) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Lot number: 012L20A), in left arm and on 22Oct2021 as dose 2, single (Lot number: 046C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obese" (unspecified if ongoing); "pulmonary embolism" (unspecified if ongoing); "infarction" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN & HCTZ, start date: 01Jan2020. Past drug history included: Vicodin, reaction(s): "known allergies;  Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound starting the day after stopping Paxlovid; Positive, notes: Still testing positive 20 days after initial positive test with continuing cold type symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID 19 Treatment with Paxlovid , treatment start date: 11Jul2022, treatment stop date: 15Jul2022.It was also reported that  rebound starting the day after stopping Paxlovid. Still testing positive 20 days after initial positive test with continuing cold type symptoms.
Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21
Red blotches on arm. Red circle where injection bandage was, blotches down around inside of arm to approx 6 inches below the injection site. Very warm to the touch. Upper arm is very sore, and noticed the red blotches 24 hrs after injection. Still very present 48 hours after injection.  Monitoring the reaction at home. Also experience migraine-like headache, dizziness, and fatigue with dose 2.
multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Extremely dry eye and dry mouth for multiple months after the vaccine. Dry eye so bad I woke up in night to put more drops in. I had to begin taking Restasis for dry eye.   I experienced chills, body aches, weakness, fatigue, confusion, anxiety, and a fever of 103 degrees F for the next day and elevated temperature (100 degrees F) for 10 days following the second dose.
Information has been received from a physician concerning a 16 year old female with an unspecified drug allergy who on 09-MAY-2007 was vaccinated IM with the first dose of Gardasil. Within an hour, the patient experienced shortness of breath and possibly hives. The physician sent the patient to the ER. Additional information has been requested.
Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Didn't feel so good; Coughing; Pulmonary issues; Felt crappy; Flu like symptoms; Arm pain; Fatigue; This is a spontaneous report from a contactable physician (patient himself). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm, on 12Mar2021 02:30 (age at vaccination: 54-years) as dose 1, single for covid-19 immunisation. Patients medical history included ulcerative colitis (He was also on an immunosuppressive medication for his ulcerative colitis) from an unspecified date and unknown if ongoing, and positive for SARs-COV-2 since an unspecified date in Dec2020 (It was early December when he was sick. He went to the local hospital) unknown if ongoing. Concomitant medications were not reported. Patient received dose last Friday, and "didnt feel so good." Positive for SARs-COV-2 in early December, takes immunosuppressive medication on an unspecified date. He was not hypoxic or anything and he was never admitted. After getting it he did feel better. However, his lungs were not doing real good. At that time he was also on an immunosuppressive medication for his ulcerative colitis. He mentioned his pulmonary symptoms with the cough, and shortness of breath lasted and continued to persist for a month so he was started on a steroid inhaler. He was also started on Decadron when he received the monoclonal antibodies. He was told he could not get the COVID Vaccine until three months after receiving the antibodies. He received the Pfizer COVID Vaccine on Friday 12Mar2021. There was no emergency room visit or physicians office visit due to the adverse events. After getting the vaccine he felt crappy for several days afterwards. He is wondering if he had to get the second dose of the COVID Vaccine. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Day one PM: went to bed itchy on legs. Day 2: Woke up and was itchy all over, especially scalp and ears. Continued to get worse throughout day until rubbed skin raw. Went to urgent care, steroid shot and started coarse of steroids day three AM. Chest was tight and prescribed inhaler. Would need to use multiple times a day and several through night. Day 6: Went back to urgent care. Highest dose of steroids. Didn?t help. Day 7 went to allergist, gave me different dose of allergy medicine and to take acid controller to help with itching. Helped slightly. Continued to be itchy through steroids and was not only on highest dose but longest period possible. Skin reacts to just about anything it touches.  While not itchy, uncomfortable she still happens to this day almost 2 months later. Allergist is convinced it is a result of the vaccine. Breathing is better but I had significant trouble for first 10 days.
Severe flu symptoms, chills, nausea, joint pain that kept me in bed for a day.  Very sore arm.  Lymph nodes under shot arm swollen almost golf ball size ..2 big balls and a few smaller ones.  They have went down but not completely as of today...almost 2 weeks later.
Patient was given second dose of Moderna after having been given a Pfizer vaccine for her first shot.
2 hours after the application of the HepA vaccine, pt developed low-grade fever, splitting headache, loss of appetite and dizziness. Pt had difficulty standing due to the dizziness. It has been 1 week since the vaccine, pt is still not feeling well and running low-grade fevers.
Redness & swelling at site of both injections approximately 2 1/2 weeks post injection. No fever-diameter of swelling-3 cm of firmness. Pt instructed to take ibuprofen & apply ice packs if no better or sxs worsen notify MD.
Patient should have received pediatric dose and was administer adult dose. The patient didn't have an adverse reaction and no treatment was needed.
30 minutes post Covid vaccine #1 patient experienced facial "tightness and numbness"; patient stated that sensation felt as if she was wearing a tight mask; sensation lasted 30 to 60 minutes; symptoms returned one day later and also lasted 30 to 60 minutes;  no symptoms since then;
Fever for 2 days. Rash on leg and face intermittently from time of injection, lasted 3 days.
At 15 minutes post administration he started to feel his lips tingle. Patient was observed for an additional 5 minutes and at 20 minutes did feel like his tongue was swelling. Initial dose of Epi was given immediately. Patient was then transported to the hospital ER. While in transit he did require an additional dose of Epi. Once in the ER he was treated with steroids and Benadryl and was discharged later that same day.
Rash maculopapular on 01/05/2006, no fever, mild fussiness.
Pharmacist stated vaccine would go in back of arm subcutaneous and stated that since it is only injected in the skin layer it would be painful that evening. Vaccine given back of arm, about 1/2 way between shoulder and elbow. Had moderate pain that evening, some redness, site hot to touch. Next 3 days, fever up to 101.5, extreme fatique, swelling around site, redness growing to 6x3 in. Day 6-8 more redness, pain still present, fatigue, no fever. Still painful and red with signifcant oval "bump" under skin today. Pharmacy advised to go to dr. on Mon if not better.
Rapid onset cough, sneezing, difficulty breathing, congestion, runny nose, diarrhea, exhaustion, tightness in chest
I had my booster on Nov 8 2021 which was my 3rd dose of Moderna. On November 19th shortly after waking up I started experiencing severe itching. My head itched like crazy as if I had lice and then the itching started moving all around my body - my palms,, my neck, armpits, elbow, legs, ears,  The itching was not everywhere at once but multiple places at at time. I finally took an anti histamine that night and have had to take one every day since. I think (hope) my symptoms are finally subsiding today Dec 2 2021 because I have not had the anti histamine in over 36 hours and I am not severely itchy. The anti histamine worked perfectly and relieved all symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 at 10:45 as dose number unknown, single (Lot number: FK9895) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any other medication in 2 weeks. Patient received Paxlovid from 18May2022 to 23May2022 for the treatment of COVID-19.   This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in a Regulatory Authority.   Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9895. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Rash, fussiness and mild diarrhea started 7/17/13.
27yoF without hx of anaphylaxis had acute N/V and shakiness about 10mins after 1st dose of Pfizer vaccine was administered. Vitals 118/74, HR 80s, RR 22. Was speaking fine throughout, w/o any SOB/wheezing or chest pain. Sx were resolved after 10 mins. Had extended monitoring x30 minutes and remained at baseline and was allowed to leave vaccine blitz site. Instructed that 2nd vaccine should be given in Clinic.