chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she had a S/E of right arm pain from upper arm down her arm which lasted 5 days, It was hard for her to lift her right arm over her shoulder. This started at night on 1-15-08 and was worse in the arm 1-16-08, she also had dizziness X2 days. Ice and Tylenol helped the arm pain.
Injection site became red, warm, egg size raised area, site area reaction for 7 days Body aches, headache, lasting 4 days
Had severe muscle soreness in lower body for approximately 24 hours after both shots.  Had right hip pain for approximately 2 weeks after both shots.  Experienced severe ringing in right ear with almost total hearing loss starting 5/7/2021 in the morning.
First dose children's Pfizer COVID on 1/15/22. Tested positive for COVID on 1/26/22 then had 2nd covid vaccine morning of 2/5/22. That night started with fever up to 40.4C & complaints of stabbing on and off headache, taking tylenol and ibuprofen with some relief; then started with vomiting  on 2/6/22, multiple times, last time early morning on 2/8 & then came to pediatrician's office. Treated with Benadryl &  Maalox   On 2/10 returned to provider with new rash in mouth, continued cough, headache, fatigue, sore throat, chills, unable to eat or drink.
Got shots, went home acting normally, at 5 pm went to get her out of car seat after a drive and noticed emesis and was not acting right, was limp, blue, purple color and gasping as if respiratory distress and eyes rolling back. 911 called and about 30 minutes later was still not acting normally, by 30 minutes when EMTs arrived breathing was easier. Taken to Hospital.
Two weeks after flu-pneumonia shots I got flu like symptoms and skin rash. Gradually the rash on my legs turns in vasulitis and foot drop. In December of last year I contracted unusual and extremely severe skin rash and flu like symptoms, just two weeks after my flu-pneumonia shots. One week later, I got typical flu like symptoms, with joint pain, fevers with temperatures over a 100 deg. F. This condition went on for five weeks. I spent five days in a local hospital. I was treated with antibiotic Augmentum and eventually my temperatures came down to normal by 1/20. However, the rash which started before the flu gradually spread all over my body. It was of very unusual character, extremely irritating burning and itching to a point where I was not able to sleep. Eventually the rash spread all over my body. The dermatologist ordered a biopsy, which was done and came back negative, so no pathogen was found responsible and that condition was diagnosed as eczema. A variety of cortisone ointments were prescribed with little or no healing effect. In early February, I noticed swelling on my ankles and some strange pinching sensation when I pressed with my finger the soft tissue. MD, who was subtitling for my primer physician did not make any conclusion and simply said it is common for older people. Later the same month, I again went to see my primer physician MD and I was started on ointments Triamcinolone Acenonide cream 0.025%. This was the first cream which started to reduce the rash and itching. However, the rash persisted to stay on both legs. Under the skin patches of very painful strips developed along the tibia bone. In late May 2002 this condition worsened even more and then started a pinching and stabbing sensation. Also both legs and ankles got more swollen and the swelling gradually has spread further up to the knee. The reddish spots were inflamed and sensitive to touch and it started to appear around the front leg bone and some dark blue spots occurred on the right leg. This condition was getting worse and w...The medical records state thrombophilebitis, and edema of leg.
About 12 hours after receiving the vaccine the resident developed temperature 101 F, headaches, vomiting and fatigue. Responded to Tylenol 1gm PO. Resident instructed to leave shift and go home to rest about 12 hours after that she was improved .
Patient received a dose of Twinrix that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Twinrix and Twinrix 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: 09-AUG-2022 Reporter's Comments: The radiology technician reported that a patient received a dose of Twinrix that had expired on 7th August 2022, which led to expired vaccine used. The reporter consented to follow up.
Information has been received from a licensed practical nurse concerning a 50 year old white female homemaker with hypertension, diabetes mellitus type 2, and rheumatic heard disease, who on the morning of Oct 05 2004 was vaccinated intramuscularly into the left deltoid muscle with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M. That same day, the patient developed a sore shoulder, and the area of injection was red, swollen, and sore for two days, it was reported that the patient was unable to sleep on her left side for two nights because her shoulder hurt. in two days, the patient recovered. Unspecified medical attention was sought. The nurse also reported 2 other patients who has similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) (WAES0410USA00811, WAES0411USA01576). Additional information has been requested.
Patient experienced hypotension/blood pressure was 80/50/the hypotension lasted all day; This case was reported by a other health professional via sales rep and described the occurrence of hypotension in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced hypotension. On an unknown date, the outcome of the hypotension was recovered/resolved.   It was unknown if the reporter considered the hypotension to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comment: The reporter stated that, a patient experienced hypotension after her Shingrix.  The patient was also a physician in the reporter's office.  She received Shingrix at an unknown pharmacy in the afternoon (date unknown).  The next morning when she woke up her blood pressure was 80/50 mmHg.  The hypotension lasted all day and the patient had to be taken home. She had since recovered and her normal blood pressure is 120/80 mmHg. The reporter did not know batch number and expiration date.  The reporter did not know the office fax or email number. The reporter consented to follow up.
Patient presented to the ED on 3/20/2021 and was subsequently admitted. dmb
Around noon became very tired. Then chills started & a slight fever. Between 9 -10 pm same day it all went away. Felt myself again.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Most painful vaccine ever received.  Over 6 months later I still feel a dull ache at the injection site.  The pain is minor but persistent.   It is simply not normal to continue to have injection site discomfort 1/2 year later.  I am a health care provider, a dentist.  One of my patients, another health care provider and I discussed my infection site discomfort and he too, months post injection is also having injection site discomfort.  This is not normal!  Additionally, I usually get one minor cold sore a year that Valtrex and Abreva manages well.  Before the Covid-19 vaccine the cold sore would fully resolve in 2 weeks.  I had a recurring cold sore start on July 7th, 2021 that was treated as before with Valtrex and Abreva.  The lesion blistered 2 times larger than ever before, and the sensation of the cold sore for the first time extended to the chin.  It is now one day less than 7 weeks later and I still have slight swelling where the cold sore blister was and I still feel the prodromal sensation one gets just before the cold sore presents.  I am concerned that the Vaccine has somehow changed my immune response to the recurring viral infection.
Pt stated dizzy asked ambulance to be called.  While waiting for ambulance pt continued to experience dizziness and reported feeling hot and numb in left arm.  Pt asked if he had eaten and was offered water and lollipops.  Paramedics arrived and took pt to hospital.
Came in Saturday 10/25/14 with headache and red/warm swollen arm. Pt sent to ER. Diagnosed with cellulitis and sent home with antibiotic.
Parents report symptoms experienced, patient was not evaluated in office since symptoms had resolved by the next morning. About 24 hours after the vaccine the patient developed a fever that lasted for about 12 hours (though would temporarily come down with the use of tylenol or ibuprofen). When she was febrile she experienced disorientation, potential hallucinations after her nap, and had "sleep paralysis" during a nightmare she experienced in the middle of the night (described as having her eyes open and speaking/screaming out but unable to see parents, was terrified). By the next morning fever had resolved as did the disorientation and hallucinations.
Pt recvd 3 doses of Hep B vax 1NOV90, 17JAN91, 23MAY91 & 1st dose was w/Recombivax, 2nd & 3rd w/Engerix-B; Reporter indicated that pt was a non-responder;
I received a call around 7 pm that night (6 hours after vaccination) that they had improperly dosed my child. They had not diluted the pediatric dose. They still have not communicated to me exactly how much was given. Around 11 pm he began projectile vomiting and has ran a 106.7 fever. He has thrown up 8 times since last night and isn?t keeping anything down.
High fever 103.8 102.4, headache, dizziness, fatigue, lethargic for 5 days, difficulty breathing & coughing.
Pain in arm and shoulder, 48 hours Fever of 100.8, overnight, 24 hours Chills, overnight, 24 hours Swollen/painful lymph node on left side only, 48 hours
fever of 103.6 began 7/27/99 & then;erythema multiforme rash began macular 7/27/99 most impressive target lesions notable by 7/30/99 w/expanding rash legs then covered buttocks/lower back, arms some of face 7 post neck;ecchymosis;
Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection.  Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
Hospital Course Covid pneumonitis with hypoxia-much improved, oxygenating well off oxygen for several days cxr no acute pulmonary process, CTA showed no PE and no acute disease in the chest. IV azithromycin has been stopped 2 days now. s/p iv solumedrol x 1 day, now on po prednisone 60mg from 12/30/21 to 1/3/2022, prn albuterol neb tessalon prn cough. Steroid, albuterol inhaler, tessalon prescribed upon discharge.  continue incentive spirometry, pulmonology and ID inputs appreciated. currently no indication for remdesivir. encourage ambulation as tolerated Elevate ddimer likely due to infection-vq scan showed low probability for PE, CTA negative for PE, Bilateral LE's venous doppler showed no dvt's. on eliquis for anticoagulation Chestpain-pleurisy related EKG with aflutter rvr, tele paroxysmal afib-now in nsr, cardiology increased eliquis, will monitor  Acute kidney injury due to volume contract, poor po intake-resolved. encourage po intake. monitor labs, resume acei/arb/nsaids cautiously Nausea-resolved, zofran given for antiemetic prn and zofran is prescribed upon discharge Generalized weakness and physical deconditioning with history of lumbar stenosis and radiculopathy status post L2-S1 fusion-PT/OT following, up as tolerated History of recurrent DVT and IVC filter. on Eliquis. Bilateral LE's venous doppler showed no dvt's Hypertension-bp stable, continue amlodipinne, continue lopressor. hold ace/arb for now as he's recovering from aki BPH-continue on proscar Kidney Stones. Monitor for recurrence. Hyperlipidemia. continue on lipitor. GERD-iv famotidine, change to po pantoprazole upon discharge Elevated fasting blood sugar. Monitor Hx R TKA.  Dispo: cleared by all to go home. Follow up in 2 weeks with Dr. and with specialists per requests
w/in 24hr of vax pt devel a fever of 103;pt recovered p/2 days;
after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Numerous patients have received doses of the Moderna covid-19 vaccine after the published expiration date between 28OCT2021 and 14DEC2021. They thought that the expiration date on this vaccine had been extended, however it had not.  No temperature excursions. No concomitant medications were reported.
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves possibly 15 patients (age range of patients is 35y to 64y) under 65 years of age who received FLUZONE HIGH DOSE (lot UJ039AB and Exp. Date 15-May-2019) in time range of October to November 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration and overdose. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 documents held by sender: none.
On 3/17, headache, chills, and body pain; chills; body pain; This is a spontaneous report from a non-contactable reporter.  A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced on 17mar2021, headache, chills, and body pain. Took acetaminophen with relief. On 18Mar2021, the events were completely resolved .  No follow-up attempts are possible.inormation about batch/lot number has been requested. No further information is expected.
Received flu shot on 10/1, morning of 10/2 started to get redness at injection site, inching,  and hives. Red spot was about 5 in by 4 in oval. Hives inside red area. Took 12.5 mg of Benadryl and it cleared up within about an hour1.
Sore arm at injection site; light fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 17:00 as dose 4 (booster), single (Lot number: 11185) at the age of 37 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 as unk, single (Batch/Lot number: unknown), in left arm for influenza. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; OMEPRAZOLE; ATORVASTATIN. Vaccination history included: BNT162b2 (DOSE:3), administration date: 24Nov2021, for Covid-19 immunization, reaction(s): "myalgia", "Vaccination site pain", "general fatigue", "Immunization"; BNT162b2 (DOSE;2), administration date: 05May2021, for COVID-19 immunization; BNT162b2 (DOSE;1), administration date: 09Apr2021, for Covid-19 immunization, reaction(s): "vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Sep2022 at 07:00, outcome "recovering", described as "Sore arm at injection site"; FATIGUE (non-serious) with onset 14Sep2022 at 07:00, outcome "recovering", described as "light fatigue". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: Patient not had covid prior vaccination, covid not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Awoke to find baby not breathing and skin cool to touch. Called 911. Administered CPR until EMS arrived. They took over and transported her to the hospital ER.
Developed "mRNA Vaccine Arm" or "COVID Arm."  7 days after receiving the 1st dose, my arm became itchy near the injection site. Shortly thereafter, the area turned bright pink and started to swell.  Over the first 3 days, I treated it with ice and acetaminophen.  For days 2-5, I also treated it with an antihistamine (Benadryl).  Every day, the swelling and redness (shade) went down, and the area of the redness increased.  All symptoms has disappeared by Day 8.
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
Sudden hearing lost on right ear after 3 days of first shot. And no recover as of now.
Sudden onset of Tinnitus (varying severity throughout the day and has lasted for over a week - ongoing problem) Dizziness the night of vaccine (subsided by morning) Severe arm pain with swollen lump (subsided in 4 days)
Cough; Great amount of mucus; Super weak; Chills; Fever went up to 102°F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BRONCHIAL SECRETION RETENTION (Great amount of mucus), ASTHENIA (Super weak), CHILLS (Chills) and PYREXIA (Fever went up to 102°F) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever went up to 102°F). On 03-Aug-2021, the patient experienced ASTHENIA (Super weak). On 04-Aug-2021, the patient experienced COUGH (Cough) and BRONCHIAL SECRETION RETENTION (Great amount of mucus). The patient was treated with DICLOFENAC (DICLO [DICLOFENAC]) ongoing from 02-Aug-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, COUGH (Cough), BRONCHIAL SECRETION RETENTION (Great amount of mucus), ASTHENIA (Super weak), CHILLS (Chills) and PYREXIA (Fever went up to 102°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Had vaccine on 5/26/20.  vaccine Quadracel on (L)  upper arm. Had mild swelling  erythema & fever 101.5 F that  day. Rash until 5/28/20.
Pt was given vaccine, stated it hurt and started to move her arm.  She then got dizzy, light headed, and had shallow breathing.  We laid her down, elevated her legs and put ice packs on her chest and head.  She started to feel better.  We did this and slowly sat her up and stood her up.  Pausing a couple of minutes at each step.  Pt said she was feeling better by the end.