chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Visible swelling noted; redness about 2 inches x 1 inch oval; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Left deltoid tightening felt immediately; Could not sleep on left side; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 09:15 (Lot number: EW0185) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CELEXA [CELECOXIB]; VITAMIN B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL1284,, prev dose dose number=1, prev dose vaccine location: Left Arm), administration date: 30Dec2020, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL9262,, prev dose dose number=2, prev dose vaccine location: Left Arm), administration date: 20Jan2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 01Oct2021 09:15, outcome "recovering", described as "Left deltoid tightening felt immediately"; SWELLING (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "Visible swelling noted"; ERYTHEMA (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "redness about 2 inches x 1 inch oval"; HEADACHE (non-serious), MYALGIA (non-serious), BACK PAIN (non-serious) all with onset 01Oct2021 09:15, outcome "recovering" and all described as "Headache day after injection with myalgias esp hips and lower back"; INSOMNIA (non-serious) with onset 01Oct2021, outcome "recovering", described as "Could not sleep on left side". Therapeutic measures were not taken as a result of muscle tightness, swelling, erythema, insomnia. Therapeutic measures were taken as a result of headache, myalgia, back pain.  Additional information: Left deltoid tightening felt immediately which was dissipated over the next few hours and then increased over the following 12-18 hours.  Patient could not lift elbow above shoulder level. Visible swelling noted 2 days after followed by redness about 2 inches x 1 inch oval. Headache day after injection with myalgias esp hips and lower back which was resolved with Aleve 400 mg. Headache improved 48h after injection.  No follow-up attempts are possible. No further information is expected.
Significant hair loss including eyebrows and eyelashes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 10:30 (Lot number: EW0150) at the age of 48 years as dose 1, single and administered in arm left, administration date 24Sep2021 09:15 (Lot number: 30130BA) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID taken for thyroiditis, start date: 2017 (ongoing). The following information was reported: ALOPECIA (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Significant hair loss including eyebrows and eyelashes.". Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. Significant hair loss including eyebrow and eyelashes soon after first and second covid vaccine it has been over a month and the hair loss, brow and lashes continues no other reason for this other than vaccine it is the only thing done differently. No follow-up attempts are possible. No further information is expected.
Diaphoresis pale, dizzy. Placed in supine position, BP 86/54. Cool compress. Improvement in 5 mins. BP 110/ 60 after 25 minutes.
Pt received vaccine 3/3/2021. Pt began with congestion and shortness of breath 03/17/2021. Pt admitted to hospital 3/23/2021 with DVT and PE. Pt was fully ambulatory and no recent procedures prior to this
Presented to observation area with emt  15 mn post vaccination presented with hives, facial swelling     Initial evaluation:  VS: 138/90, 138. 99%  HEENT: moderate facial edema, hives noted on developing on anterior chest wall.  Lung:clear  CV tachcardic  Benadyrl 50 mn IM given 1303  Pt began to develop severe edema now extending into her ears, hives extending down chest and to bilateral arms. Moderated edema to oropharynx noted.  Vs: 135/86, 145, 100%  Epi pen injected at 1311. ALS ambulanced called.  13:17 Vs: 109/68, 138, 97%   post epi pen noted reduction in edema.  Dr called Doc box   13:20: edema noted to be returning and increasing. About to give second epi pen and als crew arrived. ALS crew stated will give epi in truck. Care transfered
pt noticed rash on feet evening of 14APR96 AM of 15APR96 pinpoint rash over entire body w/itching;no fever;to MD 15APR96; AM of 16APR96 rash more severe but feeling good;attended school
joint aches; wrists, elbows & ankles & sharp pain w/movement; no erythema or swelling; began 2 wks p/vax;
The day (2/27/2021) I got the first dose of the Moderna Vaccine my left ear started feeling congested/clogged. I thought it would go away. Months later my left ear was still feeling congested; It started hurting and I would intermittently hear "swooshing" sounds, as if I had wind or water in my ear. I went to the doctor months later (9/2021) and was told I had a chronic ear infection and was prescribed 2 weeks of antibiotics. My ear continues to feel clogged w/ water sounds and I will need to go seek care from a ear specialist for further evaluation.
Suddenly stopped speaking after a lifetime of echolalic speech.   Also stopped laughing or smiling.  Originally appeared in pain, dark circles under eyes, seemed to be off balance.  Almost seemed as if part of his face didn't have muscle tone any longer.
At 4:05pm, patient fainted 5 minutes after vaccine administration and came to within 10 seconds but fell onto floor. 911 was called immediately by pharmacy staff. EMT arrived within 10 minutes. Patient was alert while waiting for first responders to arrive. First responders took over at 4:15pm. Patient was advised to seek medical attention after leaving store, but was not escorted to ER by first responders. Patient walked out himself, and went to see his doctor at  hospital at 5pm.
On the night of November 11th my left arm was swollen, very hot and very red.  It was also very painful.  I took advil and benedryl and iced the arm.  The next day it wasn't as red but was still painful.  I continued with ice, tylenol and benedryl.   I did not seek medical attention.
Since I was vaccinated I have been feeling more tired and I'm short of breath when exercising. I did not think it was serious until today 9/14/2021 when my chest hurt, my ears buzzed, I had tachycardia and almost fainted, I had to call my wife to pick me up because I felt like I was losing consciousness, I did not call 911 because I don't have insurance or money to pay for a doctor.
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of oral ROTATEQ (dose and frequency were not reported) lot # M044396 with expiration date of 19-JUN-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the ROTATEQ was between 9 °C and 25 °C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004409: US-009507513-1706USA006312: US-009507513-1706USA006314:
Developed fever 104 F, redness and swelling of left arm. Symptoms improved in 24 hrs of antibiotic and BENADRYL.
Small amount of the vaccine ran down his left arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Small amount of the vaccine ran down his left arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced UNDERDOSE (Small amount of the vaccine ran down his left arm). On 31-Mar-2021, UNDERDOSE (Small amount of the vaccine ran down his left arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.
I have pictures with times and dates as well.  8/12/21, 4:15pm, 8 mins after 2nd vaccine she complained of pins and needles in fingers. 100 fever by 10pm. 14th to 15th fever 100-101. body sore, tired. 15th overnight to 16th at 1:45 am had a hard time getting air in lungs. said felt like someone standing on sternum. skin red 103.8 fever even rotating Tylenol and Advil every 4 hours. 16th called Dr told to go to ER. got there around noon.  EKG, chest xray, covid test, CBC and more neg or normal still 101 fever at ER. whites of eyes red they said she was just dehydrated. tried to send us home but she started breathing funny before we could leave. I went back to room and she got IV fluids then sent home. Next morning back to dr. she ran test and sent us to ER. Smalls 103.8 fever again, no iching, but joint pain, body aches, high fever, skin sensitivity, sore throat, cough, nausea, throwing up, red splotchy skin, whites of eyes red, knees and elbows red and hot, warmer that the arms and legs skin, red circles on skin around eyes, chest pains, hard to get air in, brain-fog and dehydration. next day swollen ankles and fingers (still pins and needles in fingers, did not stop). ran so many test. gave Doxycycline, she broke out in hives and swelled up again, found out slightly allergic to it but it was helping so they continued with it but gave her Benadryl 30 mins before to help with swelling and hives. I have waited a month to submit to see if anything else will happen. She still has brain-fog, tired, and crying because she feels overwhelmed at school. She is unable to keep up and has more trouble than normal staying focused. WE had to add another anxiety med Fluoxetine 20 mg started taking it today. I have pictures of everything.
After the first dose at noon 1/16/2021 mountain time, I began to have a fever in the evening, starting from 101 F,  then it went up to 104 F at midnight, feel chill and body aches, bad headache. I never had such high temperature in my lifetime.  I took ibuprofen and it seems the fever went away in the next early morning 1/17. However, my temperature went up again 101.3 F at noon 1/17 and it went up to 103 F at night 1/17. I consulted the doctor and took Tylenol. 1/18 the fever was way but still headache, body aches and feel very weak.
I DID NOT HAVE AN ADVERSE EVENT. THE EVENT OCCURED FROM BEING INJECTED INTO THE WRONG AREA. CAUSING PAIN, ITCHING, REDNESS. THE FOLLOWING DAY NOT LIMITED ROM AND SHARP SHOOTING PAINS UP AND DOWN MY ARM. TODAY I STILL HAVE LIMITED ROM WITH EXTREME PAIN
Extreme eczema covering entire body including eyelids, dry scaling skin (permanent as it's been 10 weeks), fever of 103 last 5 days, extreme discomfort and itching especially around ears and face, hives, rash covering most of body.
Within minutes of receiving the vaccination she reported feeling lightheaded  and racing heart. She reported feeling "hot and cold".  She did not loose consciousness. VS were WNL. She was observed in a private observation area for approx. 30 minutes and felt fine to leave.
After her 4 month well check over 1 week the infant gradually decreased cooing and babbling, wasn't responding to being called by her name, would just stare looking up and around but not making eye contact and was much less interactive. After 5 days, she started grabbing things again, would look at mom and got loud/noisy again.
administered only the DTaP-IPV portion of Pentacel to patient/No AE; Initial information was received on 14-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 month old female patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; ROTAVIRUS VACCINE; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On an unknown date, the patient received third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ057AAA, expiry date - 07-Nov-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique. A medical assistant who administered only the DTaP-IPV portion of Pentacel.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 10/19 he got immunization on left leg (PCV, DTAP, HIB) and per mom it was red and warm the next day. It cleared up over time, Never had fever, However there is a small hard lump under the skin, No other concern, Per mom he had a similar reaction on another pervious and had gone to ER. This time no clinical visit was done.
Lab work showing acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The consumer reported same events for himself and his brother. This case is for his brother.   A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose :1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PANCREATITIS ACUTE (medically significant), outcome "unknown", described as "Lab work showing acute pancreatitis". The event "lab work showing acute pancreatitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: acute pancreatitis; computerised tomogram: unknown result.  Additional information: The caller stated his brother was having the same symptoms that the caller had.  His brother's lab work was showing acute pancreatitis.  Caller states his brother was advised by the doctor to go to the Emergency Room as soon as possible for a CT Scan. The caller stated his brother had his second dose of the Covid Vaccine 3 weeks ago and was now on his way to the emergency room with pancreatitis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721024 Same reporter, same drug, same event, different patient
The patient is a 74-year-old female who presented to hospital with COVID-19 and exhibited shortness of breath.  The patient has acute respiratory failure also and was treated with IV steroids.  The patient improved throughout stay.  She did have elevated troponins and was started on heparin drip, but this was deemed to be demand ischemia.
I began to have lower back pain in 2003 that worsened following AVA vaccinations during deployment.  I've also experience joint pain in fingers, knees, shoulders, loss of night vision, dizziness, headaches, shortness of breath, fatigue, and some short term memory loss.  Knee problem began after injury twisting knee w/torn MCL, patellofemoral syndrome and chronic hx of lower back pain.
Started feeling itching in throat, lips and heaviness in chest 2 mins after shot. Known egg allergy with hives and itchy throat. Gave benadryl 50mg Im at 1151. HR 135 Respiratory rate 20 O2 100% BP 135/90. After 5 mins 1156 HR 105 BP 120/80, feeling a little better. 1211 Bp 130/90 HR 120s , still feeling tingling in hands, mild nausea. no rash.
Multiple contusions on bilateral legs, buttocks ~3 days after vaccine. Resolved over next week. No other associated symptoms.
Severe allergic reaction, brain damage, fussiness, and nasal allergic rhinitis, asthma, eye conjunctivitis allergy.
At 10 weeks pregnant, I received the first dose of Moderna vaccine. 5 days after the vaccine, I had numbness in hands and feet and weakness in legs. After 10 days, I was unable to walk and had numbness and pain all over my body. I went to the emergency room, where they did blood work, spinal tap, and scans to diagnose me with Guillain-Barre Syndrome. I was hospitalized and received IVIG treatments for 5 days. I was discharged - still unable to walk without strong dependence on a walker, still in extreme pain and unable to use my hands or arms. I did in-home physical and occupational therapy for a few weeks, then did outpatient physical and occupational therapy for 3 months. I gave birth to my daughter on 2/22/2022 and I continue to have no feeling in most of my body and trouble with walking, balance, fine motor skills, and pain. I struggle immensely with day to day tasks (dressing and bathing my baby, opening bottles/lids/cans, reaching for items, using stairs, picking things up, etc.). I have seen neurologists, specialists, chiropractors, acupuncturists, massage therapists, etc. I will be starting a second dose of IVIG in coming weeks.
Began getting errythemia and induration of the left deltoid on 10/1/2018. It continued to spread. When seen in the office it covered just posterior of the left shoulder to proximal of the left elbow. It was hot to the touch and the client said it was spreading. She had not tried anything for relief. Referred to Urgent Care.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017, dose and route not reported). The doses of vaccine were improperly stored at 34 degrees Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JAN-2010, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-JUN-2016, the patient was treated by a physician at a community hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient complained of feeling nausea and warm "flushed" apprx 15 mins post vaccine.  VS HR 74, RR 17, O2 95, 100/60, wheeled patient outside for fresh air.  Patient improved. Left walking to car with family members.
I got fever,  severe pain in the body from the tip of the head to the toes, without exception. All this for 4 days. In this same period snot and gag, throat felt a bit clogged and I did force myself to breathe the first day.   Headache, tiredness, a little diarrhea only for 2 days.
Initial report received from a consumer on 20 OCTOBER 2014. A 62 year old female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose FLUZONE QIV (batch number and expiry date was not reported) in the left deltoid on 16-OCT-2014. On 17-OCT-2014, one day after vaccination the patient's redness, warmth and swollen area 2 inches below the injection site. There was a rash on back and "tummy". She went to the orthopedic doctor who saw the rash. She is going to her personal doctor today. The patient has pain when she moves the arm. Symptoms eased some, but have not become worse. Pain is still present 3 weeks after vaccination. The patient's illness at the time of vaccination, pre-existing allergies, birth defects and medical conditions was unknown. Corrective treatment and laboratory data were not reported. At the time of this report the patient was not recovered. List of documents held by sender: none.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The nurse called to report an expired dose of Bexsero was administered to a patient. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Headache several hours after injection with mild shortness of breath. I felt warm but did not seem to have an elevated temperature. Sore muscles and tired.