chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm had a red spot; Really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued). At the time of the report, INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
A nurse reported that the mother of a 4 month old female called to report that her daughter who received Prevnar, HIB, DPT and IPV vaccines on 8/7/00, sounded hoarse, "like trying to clear her throat", 1 1/2 hours, post vax. She also developed a cough and "funny" wheeze. The pt was prescribed diphenhydramine. She recovered. On the date this report was received, the pt was seen by the physician and was described as "doing fine". The reporter questioned whether this event was an allergic reaction.
On 01/02/2023, I started with a scratchy throat. It got sore as the day went on. I have a history of strep throat, so I wanted to stay on top of my symptoms. I went to a local urgent clinic on 01/03/2023, where they did a Strep test and a COVID-19 test. The Strep test was negative, but the COVID-19 test was positive. They administered DECADRON in the office. They offered a round of PAXLOVID, but at the time I wasn't feeling too badly. However, my symptoms continued to get worse, so I called my primary doctor who prescribed a Z-PAK.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 19-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012584: US-009507513-1811USA012586.
Aches and Pains; Dizziness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and PAIN (Aches and Pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headaches) and PAIN (Aches and Pains). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            Med Info Agent:  AE submitted via chatbot Patient stated that he received the second dose Moderna shot on 19May2021. Patient is still experiencing dizziness, headaches and aches and pains. Patient stated that these side effects would last only 2 to 3 days.  Patient wanted to know what he should do   Reporter did not allow further contact
Patient had Moderna Vaccines on 1/4/2021 and 2/1/2021.  No reactions developed after both vaccinations.  Patient came into the ED on 7/15/2021 with complaints increasing dyspnea and a cough that started 9 days ago. She tested positive for COVID 19 and was admitted to ICU for hypoxemic respiratory failure on BIPAP.  She is now on heated high flow NC at 100% FIO2 40L oxygen.  Patient was started on ceftriaxone, doxycycline and remdesivir.  7.23.21 - patient is still admitted at the time of this form submission.
Mucositis with ulcers to tongue, inside cheeks, roof of mouth, inner and outer lips,  body aches, cervical lymphadenopathy, ongoing fatigue (still present). On 9/4 developed pain to left side of scalp that is sharp when touched.
Pt. came in for a TB skin test read and was complaining of itching and redness to the area. Pt. had itching, redness with a measurement of 50 x 35 and warmth to Varicella injection site. Pt. also received Hep A and Meningo on the same day. WHNP-BC looked at site and recommended BENADRYL and Hydrocortisone.
After my 3rd vaccine I began to experience ear ringing. 24/7 in both ears.  I was seen by my primary care doctor, pharmacy, and the university.   It has been 24/7 non stop with no relief.  Hearing eval indicated loss in the left ear.  The condition is debilitating
Headache; pain in left arm; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 27Jan2021 11:15 AM at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included PROBIOTIC and colecalciferol (VITAMIN D). The patient have not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 12:00 PM, the patient experienced headache and pain in left arm. The patient did not receive treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was recovered on an unspecified date in 2021.
Patient requested 3 vaccines on 01/02/2017, HAVRIX, BOOSTRIX and PREVNAR. Patient was unable to use both arms for vaccines b/c patient had a mastectomy (or some other issue). Pt. suffered severe cellulitis in her arm. Redness, swelling, inflammation.
The pt scored Apgars of 8 and 9 at birth and breathed room air. Within 48 hours of vaccination, he developed apnea/bradycardia. He is now autistic spectrum.
Information has been received from a RN concerning an 8 yr old female with no known medical conditions or allergies who on 22Nov99 was vaccinated SC with a first dose of varicella virus vaccine live (lot631073/0450J). There was no known illness at the time of vaccination. On 03May05, the pt presented with a varicella rash. Unspecified medical attention was sought and she was treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) baths. At the time of the report, the pt was recovering.  A product quality complaint was not involved. Follow up information was received from the RN who reported that on 01May05, there were no complications and the pt was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. The pt's rash was described as circular, raised, red, itchy and spreading on the head, face, back, right lower extremities, both arms, and neck. No diagnostic lab tests were performed. The pt was seen at the physician's office on 03May05 and was determined to be recovered. No further information is expected.
tips of toes of right foot developed lesions, slightly swollen, red/dark red and painful to touch or any pressure.  Painful small bumps below skin on balls of both big toes.  Also exacerbation of mild putative Raynaud's syndrome (first symptoms in middle age); for first time, fingertips and feet began turning blue/purple when inactive or chilled even slightly.  First thought it was from ill-fitting footwear.  Sought medical help when did not seem to be healing.  Telemedicine visit w. Dr.  3-9-21, he advised rest, conservative care, avoid wearing closed-toe footwear.  Did not resolve.  Office visit with Dr.  on 3-26-21.  He prescribed Triamcinolone .1% cream, continue to limit walking and closed-toe shoes.  He also ordered blood and urine tests for possible systemic pathologies.  See below.
fever, pain, malaise, nausea, t101.9, treatment fluids, rest;
54 y/o F with pmhx of PCOs c/o chest tightness, lightheadedness, dizziness, and left arm numbness and tingling about 10 minutes after receiving her booster dose of the Pfizer COVID vaccine. Patient received Moderna as her first two shots in the series. She states that she began to feel the chest tightness first and then immediately felt like her heart was racing with palpitations. She then states that she was having lightheadedness and feeling extremely dizzy. She laid down in the cot and states that she still had chest tightness. She was given oral hydrations and fluids to drink but nothing was improving the chest tightness. Vitals were stable, though, she self attested that her blood pressure was high considering her baseline is usually normal. She was observed for an additional 35 minutes and states that the chest tightness improved but did not go away.   Vitals:  1515  BP: 132/85 ; HR: 82 bpm ; SpO2: 100% 15:30  BP: 144/82 ; HR: 78 bpm ; SpO2: 100% 16:00 BP: 136/79 ; HR: 71 bpm ; SpO2: 100%   PE: General: NAD HEENT: NC/AT, EOMI, PERRLA, airway patent, no trismus  Lungs: CTA B/L, no wheezing, rales or rhonchi  Heart: Clear s1 and s2, no murmurs, gallops or rubs  Abdomen: soft, non-tender, BS x 4  Patient was advised to go to the Hospital
About 12 hours after my shot I started getting pain under my left arm but I thought it was connected to my pain from my injection site so I ignored it. It got worse overnight. By the next morning I could barely move my arm because my axillary lymph nodes were so swollen (and still are at this moment) that I had pain all the way to my fingers. I haven?t been able to do much functioning and when I force myself it?s extremely painful. It?s still very swollen and now it?s very itchy but my pain in my hands is gone. I saw online it could take several weeks to go away so I haven?t contacted my doctor. I took naproxen a few times and it hasn?t helped at all for the pain or swelling. If it?s still very bad next week I?ll contact my doctor then. I know I take a lot of meds and have a lot of health problems but I?ve been ill my whole life and I 100% guarantee you it?s from the covid shot and not due to my health or some pill I take. And I wouldn?t take my time filling out this form neither. 2 of my kids got the same shot the same times I did and they are doing okay.  I am very nauseated too but I don?t know if it?s from the severe constant pain or the shot or both but that is manageable.
Patient started feeling dizzy with nausea . We applied cold compress on her face, neck and wrist and elevated her feet, checked her BP and HR, she had normal BP but her heart rate was slightly elevated. Gave her some cold water and observed her for any other symptoms or worsening of symptoms. She started feeling better after about 10 or 15 minutes, her BP and HR were normal, and she said she is feeling ok to drive home.
Patient fainted. No anaphylactic reaction. Moved patient from chair to floor to lie on back.
Pt developed a vesicular papular rash in various stages of evolution, typical of varicella, plus pruritus. No fever and no known infection exposures. This vaccination was given in 1998.
pt recvd vax & exp erythema; induration; pain at inject site followed by bullous lesion approx 1/2 cm; myalgias; somnolence; conjunctival inject;
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with the second dose of the Gardasil on an unspecified date. Subsequently, the patient experienced " a really fast heartbeat". The patient sought unspecified medical attention. At the time of the report, the patient had recovered from the increased heartbeat. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additonal information is not expected.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a second dose of LIQUID PEDVAXHIB (lot # N008080 with expiration date of 02-DEC-2019; strength, dose, route and anatomical location were not provided), for prophylaxis, 6 weeks after receiving the first dose. No adverse effects reported.
Excessive swelling in left thigh. Edema noted from left groin to left calf. Erythema and redness extends from injection site circumferentially around thigh. Severe pain noted in left thigh, child refuses to bear weight on affected extremity or bend leg at the knee.
Fine rash first appeared on back & chest, spreading to neck, arms & thighs. Body aches, joint pain, low grade fever, minor sore throat, ear ache, sneezing, some h/a and some stomach upset.
Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.
6 days after vaccines child was febrile, with hive like rash, the next day bruising in the central part of each hive; child uncomfortable and cranky x 3 days after injections all resolved.
Lack of appetite, Achy, Stiff, mild headache and tired entire body. No fever, No nausea, No vomiting.
Severe muscle pain in both legs; Thighs feel heavy; fatigued; tender to the touch; deep muscle pain and cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:45 (Lot number: FF2590) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN9581, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 12Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 22Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Severe muscle pain in both legs"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Thighs feel heavy"; FATIGUE (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "fatigued"; TENDERNESS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "tender to the touch"; MUSCLE SPASMS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "deep muscle pain and cramps". The events "severe muscle pain in both legs", "thighs feel heavy", "fatigued", "tender to the touch" and "deep muscle pain and cramps" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of myalgia, limb discomfort, fatigue, tenderness, muscle spasms.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Severe muscle pain in both legs. Thighs feel heavy, fatigued, tender to the touch, deep muscle pain and cramps. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient has no known allergies.   No follow-up attempts are possible. No further information is expected.
Patient presented to ER on 11/5/21 and was admitted.  On arrival the patient was soiled and sitting in the same location he last saw her and her mail was piled up in the mailbox.  Patient is unsure when she last moved, however claims she is mobile and eating and drinking without any difficulty. He notes the patient has had a gradual decline in her mental status over the last couple months and feel like she has become more confused over the last week, however is unable to give a specific example.  The patient denies any complaints.  Her brother states that she does have history of lower extremity edema however today her legs look worse than normal.  He reports patient stop taking all of her home medications approximately 6 months ago. ROS limited due to patient mental status, she denies any fever, chills, nausea or vomiting, decreased appetite, gait problems, back pain, lightheadedness or dizziness.    In the emergency department routine labs were obtained.  BUN 35, creatinine 1.7 (which appears to be at her baseline).  Magnesium 1.5, ammonia 16, glucose 121, troponin negative, BNP is elevated at 1300, ABG within normal limits, WBC elevated at 17.85.  Lactic 1.07, CRP 96, procal 1.73.  Urine drug screen negative.  Urinalysis indicative of possible UTI with 51-150 wbc's, negative nitrates, 3+ WBC esterase.  Urine cultures and blood cultures x2 were obtained currently pending. Placed on ceftriaxone for UTI and found to have a DVT so placed on heparin drip.
Patient presented for a well child exam.  Patient was given a Proquad vaccination.  Patient was 14 years old at time of vaccination.  Patient should have received MMRII and Varivax instead of Proquad.  No adverse reactions noted.
Pt presented to the hospital on 2/14/22 COVID + and SOB.  Reported SpO2 in the 80's for past few days, temp 101.2 with chills.   ED workup significant for tachypnea max 24, hypoxia 89% on room air, elevated troponin 25 (at baseline) and elevated BNP 2482 (at baseline), elevated AST 71, elevated ALT 43, positive COVID-19.  Discharged back to ALF 2/16/22 Pfizer 1/26/21, 9/30/21
-pronounced local reaction to L deltoid - immediate hard bruise to site and then itching and redness extending over L shoulder and down upper arm, no systemic efforts bruise next a.m.
The patient's husband visited the pharmacy and stated the patient was having trouble moving/raising her arm due to soreness. He also presented a picture of a near-circular bruise approximately an 1.5 inches in diameter light brown in color in the center of the left deltoid.
After a few minutes of vaccination, pt broke out with a rash around the wrist. Pt complained it was itchy & had chills. Pt took BENADRYL & ADVIL. Symptoms subsided after 1.5 hrs.
Swelling and taut skin around injection site approx 5-6 inches from top to bottom. Motrin and cool packs to site.
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 13:00 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization, received in the Public Health Clinic/Veterans Administration facility. The patient received the first dose on 29Jan2021 at 01:00 for covid-19 immunization. The patient did not receive other vaccines in four weeks. Medical history included kidney transplant from 2016, ongoing hypertension, ongoing high cholesterol. The patient had no COVID prior to vaccination. The patient was not COVID tested post vaccination. Concomitant medications included anti-rejection medication, hypertension and high cholesterol medications; all ongoing. The patient experienced mild bells palsy on 13Mar2021 at 10:00. Event resulted in physician's office visit. The patient received treatment for the event which included Anti viral medication- acyclovir 800mg. Outcome of the event was recovering, almost recovered at the time of report.
Mild hives; red itchy rash on neck, front and back. No treatment. Began 2 days after booster and has continued for 2+ weeks. No other changes in diet, lotion, etc.
A patient was given ActHib in the left thigh when 4 weeks old instead of the intended vaccine which was hepatitis B, no AE; A patient was given ActHib in the left thigh when 4 weeks old instead of the intended vaccine which was hepatitis B, no AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 weeks old female patient received vaccines HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI965AAA, expiry date: 13-Mar-2020, via unknown route in the left thigh) instead HEPATITIS B VACCINE, on 09-Sep-2019. It was reported that ACT-HIB was the first time administered to the patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   At the time of reporting the patient had no adverse event.  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 document held by sender: none.
I felt achy like when we get the flu; I was cold but it rest the next day too; night I got up with the worst chill; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient just calling to tell what side effects were, patient did not have adverse side effects, just had side effects but it was on 9th. Consumer stated had the Vaccine on Monday, 09Aug. That night everything was well but that night patient got got up with the worst chill, no fever but had chill and had cold but it rest the next day too, patient was cold and felt achy like when we get the flu. The outcome for the events was reported as unknown at the time of this report.  Information on Lot/Batch number has been requested.  Follow-up (31Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
5:00am  Woke up dizzy, couldn't stay awake, nausea, headache, fever, chills, left arm was real sore and hot,  It felt like getting COVID again (Nov.)  except for the cough and I had taste.  I didn't feel better until 4:00 pm that day.
Rash all over face, skin was hot, extreme fatigue, headache, muscles weak, brain fog, malaise, stomach cramps