chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Engerix-B instead of Heplisav-B for Dose 2; Initial Report Received on 27-Oct-2020  A pharmacy manager in the US (UT) reported that a 22-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization but was administered Engerix-B for the second dose.   No medical history was reported.   No concomitant medications were reported.  On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in Texas.   On 19-Oct-2020, more than 1 month later, the patient went to a pharmacy in Utah for her second dose. The patient did not notify that HEPLISAV-B was given for the first dose and received Engerix-B (hepatitis B vaccine) intramuscularly in the right deltoid.   At the time of report, the patient did not report any reactions to the vaccine.  No additional information was reported.   The reporter stated that the report was submitted through an internal system that reports to the Vaccine Adverse Event Reporting System (VAERS).  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient said she had fever, body aches, sore arm and was sick for 5 days. Told patient Pharmacist will report to Vaers.
April 2 vaccine - injection shot location pain Day 2 - flu like symptoms Severe body aches, fever, terrible sinus pressure, fluid in ears. Slept all day Took Advil, aspirin, Benadryl, corcidin.  Day 3- reduced by 1/3 still weak and tired Day 4- reduced still. Mostly sinus pressure, vertigo, aches, fatigue  Day 5 woke up with some sinus, tired, vertigo Day 6 woke up with some sinus still tired, vertigo but was relatively better. About 12 noon heart started racing felt very lightheaded and dizzy. Felt like I was going to pass out. After about an hour or so it started to subside and I felt very drained and tired.  still feeling unwell.  Loss of apetite
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Strong chemical taste in mouth that will not go away with food, drink or gum. Other medication in 2 weeks: No. Product: COVID 19 Treatment, Brand: Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
experienced standard flu like symptoms for both injections.   I have currently at three months later ;  I have lost muscle strength and range of motion in my left shoulder and left elbow.   A   Sharp stabbing pain when I raise my arm, in the shoulder joint,  loss of the use of my left arm , due to pain when using arm.  Feeling fatigue and a desire to be active/ my upper part of my body wants to lay down and go to sleep.  the lower half wants to go out dancing ....Pain in shoulder L side ;  pain in elbow L side..... loss of range of motion and strength.
Rash/hives which started in right arm, spread to both arms, chest, then back, legs. Swollen fingers.
Wife have had a reaction, the rash; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. It was stated, "I have a married couple on the other line. He took the Covid-19 vaccine, the wife have had a reaction, the rash, but the husband had no reaction." The reporter stated, "Correct, she had a rash 4 days after (Jan2021). We had the vaccine on Wednesday and the rash appeared on Sunday." Therapeutic measures (Prednisone) were taken as a result of wife have had a reaction, the rash (rash). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
got COVID; rash on my arm; She had the rash for a few days after the last booster. It was itchy.; COVID arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (COVID arm), COVID-19 (got COVID), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE REACTION (COVID arm), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.). On 25-Jul-2022, the patient experienced COVID-19 (got COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.) had resolved and COVID-19 (got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2022, SARS-CoV-2 test: Positive.         Patient had no allergies.  She had preliminary shots and 2 boosters, She was wondering how it was different from the vaccines. She has gotten COVID arm, rash on her arm after all 4 shots. She had the rash for a few days after the last booster. It was itchy. She was not hardly sick.  Patient received Flu vaccine on 09-Sep-2022.  The AE did not cause patient to seek medical care.   This case was linked to MOD-2022-670562, MOD-2022-670500 (Patient Link).
This spontaneous report as received from a other health professional refers to a 12 years old male patient with lithium allergy, headaches, unspecified hearing loss, allergic rhinitis, eczema and ADHD. The patient was vaccinated with lot # (670048/0963AA) dose 2 GARDASIL, right deltoid on 04-JAN-2012 at 05:47 PM. No other co-suspects were reported. Concomitant medications included: FLUMIST. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
5/5/21 6:00 pm:  Headache, Foggy, Extreme Exhaustion    Treatment:  Took 2 Bayer Aspirin;  5/6/21 morning:  Headache, Foggy, Chills, General Body Aches, Extreme Exhaustion;  afternoon:  Headache, Foggy, Chills, General Body Aches, Joint pain, Extreme Exhaustion        Treatment:  Took 2 Bayer Aspirin every 2 hours, took warm bath, took nap 5/7/21 morning:  Headache, Foggy, Chills, General Body Aches, Joint pain, Extreme Exhaustion afternoon:  Headache, Foggy, Chills, General Body Aches, Joint pain, Extreme Exhaustion, nausea, runny nose; painful rash on torso, back, lower arms, and legs   Treatment:  Bayer Aspirin every 2 hours, warm baths, naps, 1/2 benadryl, emetrol See Page 2
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They first tested positive for COVID-19 on 10/16/2021; a second test on 10/16/2021 was negative. They had a symptom onset date of 10/18/2021 and also tested positive of this day. They experienced complications of pneumonia and died on 10/28/2021. I see no indication they were hospitalized related to this illness. They were a resident of a nursing home.
Dizziness; headache; big red circle under injection site/rash, and then clarified that it is a big, red circle; big red circle under injection site/rash, and then clarified that it is a big, red circle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Lot number: EP1533) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EN6205), administration date: 13Mar2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 09Apr2021, outcome "recovering" and all described as "big red circle under injection site/rash, and then clarified that it is a big, red circle"; DIZZINESS (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 23Apr2021, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site rash, dizziness, headache.  No follow-up attempts are possible. No further information is expected.
Eyes, itchy, swollen.  10 minutes post vaccination. Skin flushed, sweaty. BENADRYL given. Child sent home with mom
Had heat sensation, flushed feeling, nausea and dizziness after flu shot (same day): 2nd day increased chest pain and throat tightness and severe bilateral arms. Chest pain lasted almost a week.
Red raised area on RD approx 40mm in size temp 98 (Twin #2).
Sore throat, weakness, tired, cough, stuffy nose, aches, symptoms would come & go for about 2 full weeks
fever, pain, swelling, redness at site, extreme irritability, refusal to  BF
Pt didn't feel well, then head dropped w/wheezing, muscle contractions; pt was arching back, legs & arms contracted lasting 2 min, jerked, felt like was asleep & wanted to awaken but couldn't; BP 140/82; pt c/o weakness & sore back muscle;
Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbness; skin feels sunburned but no skin findings; lower abdominal burning sensation; This is a spontaneous report from a contactable physician. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 11Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies: shellfish. Historical vaccine included 1st dose of BNT162B2 (lot number=59267-1000-1 Lot EJ1685) via intramuscular on left arm on 21Dec2020 for COVID-19 immunization. Concomitant medications included semaglutide (OZEMPIC), atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and enalapril, all taken for an unspecified indication, start and stop date were not reported. Patient developed unilateral neuropathic pain in one thigh, progressing to both thighs. Patient also had posterior arm numbness, skin feels sunburned but no skin findings, also now with lower abdominal burning sensation. The events onset on 22Jan2021. Patient received treatment for the events included prednisone. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94).  10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at  10:34am - Temperature: 37 degrees Celsius.  10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale.   10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90.  Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
Eye spasms/eye twitching in right eye for about two months and up to 12-20 times per day for 1-2 minutes at each occurrence  (I think injection was in left arm, but am not positive).
pt admitted to hospital for intractable CA pain; tested positive for COVID; altered mental status secondary to sepsis from COVID pneumonia; treated with dexamethasone, empiric antibiotics; DNR; pt became hypotensive and his condition deteriorated; pt died in the hosp
developed symptoms on 10/05/2021 of coughing, SOB,fatigue, headache, congestion, loss of smell/taste. ADmitted to hospital on 10/09 and diagnosed with COVID Pneumonia
Left arm is just starting to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm is just starting to hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, High cholesterol and Kidney stone (started an unknown antibiotic for a pre-planned kidney stone procedure.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm is just starting to hurt). At the time of the report, PAIN IN EXTREMITY (Left arm is just starting to hurt) outcome was unknown.            No treatment information was provided. Concomitant medications included unspecified blood pressure medication, an unspecified statin to treat high cholesterol and unknown antibiotic for pre-planned outpatient kidney stone procedure on 12 Feb 2021.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-030996 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Since receiving the shot I had a bump at the injection site. However, yesterday I started noticing that the bump was larger. Today I noticed that it's hot to touch and more like a welt that's larger than quarter size.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 21-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H010661, expiry date 02-FEB-2014, (dose and route not reported). The patient experienced no adverse event. This report is linked to MARRS # 1403USA012633 (Same reporter link). Additional information has been requested.
Patient had never received a flu shot before. Gave in L arm. While pt. was waiting after, about 5 min later his wife alerted us he was having a reaction. Pt. was unresponsive, eyes rolling back, slumped in chair and raspy breathing. Unable to answer to his name or questions. Pt. started coughing and looked like he was going to vomit. 911 was called. Gave 1 0.3 mg Epi Pen in R leg. Pt. came back around, fully alert. He had no memory of the event. EMT's arrived and took pt to hospital.
A physician reported that a 7 month old male received his 3rd dose of Prevnar along with Tripedia, Comvax, and Recombivax-HB vaccines on 01/07/2002. On 01/31/2002, the infant was seen by a physician for fever, vomiting and irritability. A blood culture was positive for streptococcus pneumoniae, serotype 19F. A CBC was performed; however, results were not reported. The infant received unspecified treatment. Streptococcal septicemia is considered medically important.
It started whenever I would get up from being in a sedentary position; every joint in my body ached. It took time for me to get up and I had to tread slowly until everything loosened up to be fully mobile. When I would go for walks, my shoulders would begin to hurt to where I would have to tuck my arms in so it wouldn't hurt. I couldn't reach for anything, and I had trouble sleeping. Even though I was on Botox treatment for migraines, I started waking up with headaches. My jaw would be painful to eat or take a bite of food to chew. The pain was mainly in the shoulders and arm and neck. This all began the first week of post-vaccination. I went to my PCP who completed bloodwork and indicated my autoimmune markers were out of range and referred me to a rheumatologist. Prior to that, I did have 2 other autoimmune conditions, so I was advised to see one to investigate whether it was from my past conditions or new developing ones. In December, I contacted my neurologist because of the constant headaches and migraines and was put on a steroid antibiotics for 5 days that helped drastically improve the muscle stiffness. I saw my rheumatologist on 01/25/2022 who mentioned because of the steroid improving my condition, she diagnosed me with PMR and GCA and I was put on a higher dose of steroids for the next 30 days and for another bloodwork appointment to see my PMR and GCA numbers during the course of the steroid intake.
Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to. Concomitant therapy included multi-dose vaccines containing Thimersol beginning in or about September, 1997 up through and including 1997. It is alleged that at a result of the vaccine containing Thimersol, the patient sustained severe and permanent personal injuries, including being diagnosed with severe autism and other neurological disorders. It is also alleged that the patient sustained further neurological insult from other vaccines. Including MMRII which  does not contain Thimersol but caused further neurological insult and exacerbated the neurological disorders from the prior Thimersol exposure. Upon internal review, autism, neurological disorders, exacerbation of neurological  disorders and permanent personal injuries were considered to be other medical events. Additional information has been requested.
Headache, nausea, red, swollen, warm inj site, throat itchiness, weakness, pale, L upper arm.
Muscle aches and pain in neck and shoulders on 3/5/21. Felt better 3/6-3/8. Muscle aches and pain in neck and shoulders and eczema flare up started on 3/9/21. Muscle aches and eczema continued throughout the week. Worsened on 3/10 and had a mild headache for 3 days straight from 3/10-3/12. Pain and eczema flare was at its peak on 3/11. Still had a mild headache. Muscle aches, eczema and headache continued to be bothersome on 3/12, but not as bad as it was on 3/11. 3/13 - Still achy neck and shoulders, eczema is less flaky.
redness, swelling, pain arm/ax;sweats & fatigue;MD dx serum sickness rxn to Td
This spontaneous report as received from a other health professional refers to a 20 year old female patient with allergy to penicillin, sulfonamide, AUGMENTIN, BIAXIN and doxycycline. The patient did not take any concomitant medications and had no pertinent medical history. On 02-AUG-2017, the patient was vaccinated with M-M-R II lot # M042846, expiration date 21-OCT-2018 (dose, route of administration and anatomical location were not reported) reconstituted with sterile diluent (manufacturer unknown) lot# M046371, expiration date 06-JUL-2019 (dose, route and anatomical location were not reported) for immunization for college. Other suspect therapies included tuberculin purified protein derivative ("PPD test") in her right arm. On 02-AUG-2017 (reported as "within a few hours of leaving the office"), the patient's arm became red and warm to touch, and "got worse over the next 2 days". On 04-AUG-2017, the patient was seen by the physician and her right arm was "red and warm to touch" during the visit. She was prescribed clindamycin for the events. Follow up call was made to the patient on 08-AUG-2017 and the patient reported, that she "was doing fine". The relatedness between the events and the suspect therapies was not reported. Additional information has been requested.
Pt vax w/ 2nd hepta B; One month later devel bilateral capsulitis.  Tx w/ anti-inflammatory therapy, possibly Voltaren.  MD felt that reaction was due to profession not vax.
Started feeling warm at the injection site within 2 hours of the vaccine injection. Warm and numb feeling spreading into my left shoulder bone, left cheek, jaw, up to my eye brow. Feeling as if left side of my face is swollen but it?s not swollen when looking in the mirror. Pressure in left ear - as if I was diving and got water in my ear, or as if I just got off the airplane with altitude changes. On and off ear ache still present 10 days after injection, in both ears......
Incorrect dose of vaccine given. Patient 10 years old was given 12+ vaccine at 0.2ml volume
Patient is a 12 year old male who received his second dose of the Pfizer COVID19 vaccine on 11/29 at 3:33 PM. Patient was incorrectly given the Pfizer COVID19 vaccine for age 5-11 instead of the Pfizer COVID19 vaccine for age 12 and up. Per agency guidelines, there is no need to repeat the dose; however, a repeat dose of the Pfizer COVID19 for age 12+ can be administered 21 days after the dose given in error. Will follow-up by advising patient's parents to consult with patient's pediatrician to see if a repeat dose is needed.