chrisvoncsefalvay/vaers-outcomes huggingface dataset:
every dose made her very sick; This is a spontaneous report received from a contactable reporter (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "very sick"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "very sick"; Bnt162b2 (DOSE 3), for Covid-19 immunization, reaction(s): "very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her very sick".  Additional information: The reporter was an Optometrist. It was reported that the patient was considering taking Paxlovid. She explained that she had taken four doses of the Pfizer COVID-19 Vaccine and the original primary series and two booster doses and that every dose made her very sick and each one made more sick then the one before. She suspects that this reaction was caused by gluten or an egg-derived ingredient. In order to take Paxlovid, she wanted to make sure that this medication does not contain any gluten. She described to be already very sick from COVID. She also said that she took a third booster dose (last dose) from Moderna, and that vaccine did not make her sick at all. So, the patient was trying to find a Moderna Bivalent booster to take, and she did find where they are. The patient just didn't have time to get the booster before she came down with COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201206645 Same patient/drug/event, different dose;US-PFIZER INC-202201210013 Same patient/drug/event, different dose;US-PFIZER INC-202201210014 Same patient/drug/event, different dose;
Patient had significant redness and some swelling/tenderness (not with movement but to the touch) the day following the vaccine. I spoke to her two and three days after vaccination and she was having some improvement in symptoms and has not sought medical treatment.
Patient came to the pharmacy today (12/06/2018) and reported the pain that she got from the vaccinations. The patient said after she got the flu and PNEUMOVAX 23 shots, she got a lot pain on her left arms on that day. She said there were no rash or swelling on the sites of vaccination. She called her family doctor, and the doctor did not give her any medications, just recommended her to exercise on her left arms.The pain get better now but she wonder why the pain last so long.
Severe headache/fever. Headache lasted 6 hrs. Low-grade fever for 4 days.
developed painful outbreak of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (Pt) of unknown age. Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On or around 26-SEP-2017, the Pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as recommended by his primary physician for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, on an unspecified date in 2017 (reported as within a week after vaccination), the Pt developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the Pt's symptoms had resulted in physical limitations not presenting prior to the use of the vaccine. As a result, Pt sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered the event of herpes zoster to be disabling.
pt states arthritic pain both elbows-present;pain in forearms to elbow;awaken from sleep;loss of strength lasting to present;
I contracted COVID-19 on 06/19/2022 with symptoms of sore throat, congestion, and cough. I was prescribed Paxlovid on 06/22/2022. I was ill for 6 to 7 days before my symptoms resolved. I am fully recovered with no lingering symptoms.
rash across chest area et lt arm c/o thrist, denies h/a, resp & GI sx;
Progressive over 3 days: Throat irritation, throat burning, difficulty breathing, puffy/swollen eye.
No additional AEs were reported; Pharmacist reported that a patient was given an expired MMR II vaccine on 05/20/2022.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 1 dose, lot # t003384, expiration date: 28-JAN-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (expired product administered).
Fever up to 103.7, cough, vomiting. Patient had H1N1 vaccine 11/10/09 ~ 3:45pm, fever started 11/11/09 ~ 12noon. Then developed cough that evening.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED
Pt has red area (circle in shape) not at the injection site but underneath the injection site. Pt says does not itch and not swollen or hard to touch. Pt says she has been on Benadryl so that may be why spot is not itching. Patient says only painful when lying on that arm.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Pt developed a red-bluish bruise around the injection site area. Also has some yellowing and swelling.
Fever 100.2; PT awakened by mom at noon, went shopping; while returning home, began gagging; then gasping for air, became cyanotic; recovered when moved from car seat; now on apnea monitor; MD advised no Pertussis;
I got the shoot on the 8th of last month and I'm still very ill; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to the company on 03-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got the shoot on the 8th of last month and I'm still very ill) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got the shoot on the 8th of last month and I'm still very ill). At the time of the report, ILLNESS (I got the shoot on the 8th of last month and I'm still very ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant product use was not provided.
Redness, minor swelling and induration, itchiness surrounding injection site lasting 4 days (so far).
mom states had high pitched cry w/1st, 2nd, & 3rd, very irritable, restless, & wouldn't sleep; only told the MD p/recvd vax inAM & by 2PM devl high shrill cry gave APAP every 4 hrs; high shrill cry lasted for 1st day; 2nd day OK;
pt recv vax 3JUN96 & 22JAN98 pt devel 8 to 10 little shingles on lt arm;
patient given Pfizer 5-11  yr Pfizer even though was 14 yrs; did receive appropriate second dose  Pfizer for age 1/21/22
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's medical history and current conditions were not provided. On 23-JAN-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number and expiration date were not reported), 0.5 ml, intramuscular. No concomitant medications were reported. No adverse events were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Breakthrough case admission after 2 vaccines' Pfizer 1/6/22 Lot# 33130BA;  Pfizer 2/10/22 Lot# FJ6369
Pt Rec'd DTaP (RA) & Varicella(SQLA) & PPD. routine physical on 10/01/02. Pt returned to clinic on 10/03/02 for PPD reading. Mom  RN at this time that pt's left arm was swollen. Arm was very swollen and warm to touch. Appt scheduled immediately with physician, who saw pt and advised mom to monitor.
Bruising developed 11/6/21.  Seen in clinic 11/8/21 - platelets 18,000.  Dx with ITP.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (Merck) inadvertently instead of a dose of ZOSTAVAX. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Swelling right thigh with erythema 10 x 14cm. Cellulitis.
patient had severe arm pain could not lift arm till Monday 10-14-2019 also reported neck and shoulder pain I suggested Ibuprofen every 8 hours and add Acetaminophen 1000mg if Ibuprofen does not handle the pain and also suggested ice on and off every 20 minutes when she can.  Spoke to patient today 10-15-2019 and she stated all back to normal. no pain.
Inj given in pre-deployment line on Sat 1 May 10.  Site red, hot and hard after 24 hrs.  Spread to 4" X 7" by 3 May 10.  Placed on KEFLEX (500 mg, 2 X day for 10 days).  Extremely sore, red, hot & itchy.
I had the shot at 6:15PM and waited 15 minutes. I felt fine, 10 minutes later I started feeling my throat swell. I had a hard time swallowing and I could feel it getting a little worse right away and then I took 2 small sips of water and got home abd was afraid to eat or drink in fear of choking. This lasted from onset to finish 40 minutes and then I could feel it go away. I was very tired and went to bed. No other symptoms that night 24hrs later 6:20PM had teeth chattering chills and felt feverish 97 temp went to bed wrapped up and 2 hrs later felt fine.
Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, finger numbness. Benadryl was given at 1046.u
A report has been received from a Health professional concerning a 5 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIS QUADRIVALENT started on 17-Dec-2013. The patient was administered expired FLUMIST which started on 17-Dec-2013. The outcome od the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout body, stomach tightness and sweaty
Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date; Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 days beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 24-JAN-2022. The vial did not undergone any temperature excursions. The Pharmacist does not know which dose this patient received the invalid dose on and wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022.  No Concomitant information was reported. No Treatment information was reported.  The Pharmacist did not have any other adverse events or side effects to report.
patient exhibited anxiety and was passed out for a few minutes. called 911 for paramedics to come in. No adverse effects was reported or examined by paramedics. his vitals were checked and everything was normal
Pt had rash develop 4 days after immunization, mild to face and peri vaginal area. Mom requested form to be completed.
Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
MUSCLE WEAKNESS IN VICINITY OF INJECTION; MUSCLE SLIGHTLY PAINFUL; BRAIN FOG; TIRED; BRUISED FEELING AT THE SITE OF INJECTION; GHOST HEADACHE/SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced bruised feeling at the site of injection. On 10-MAR-2021, the subject experienced ghost headache/slight headache. On 11-MAR-2021, the subject experienced brain fog. On 11-MAR-2021, the subject experienced tired. On 15-MAR-2021, the subject experienced muscle weakness in vicinity of injection. On 15-MAR-2021, the subject experienced muscle slightly painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, and tired on 12-MAR-2021, bruised feeling at the site of injection on 14-MAR-2021, and ghost headache/slight headache on 11-MAR-2021, and had not recovered from muscle weakness in vicinity of injection, and muscle slightly painful. This report was non-serious.
Breakthrough case admission after two vaccines Pfizer 12/16/21 Lot# 33130BA;  Pfizer 1/6/22 Lot# 33130BA
"3 to 6 days, post vax of MMR II, complained of extreme exhaustion and migratory myalgias, mostly back, buttock, jaw and chest" X 7-9 days. Aches lasted a few hours. Declined to return to Employee Health. Employee went to another place and started feeling better by 11/2/00; no follow-up planned.
T99.5 pt recv vax approx 950AM; bandaid applied to both sites; lt deltoid appeared inflamed 3/4" hive appeared above inj site; MD examined ice applied; mom stayed for 20mins no other distress noted called mom 1PM pt OK
Pt began itching (R) arm where the MENVEO vaccines was administered, shortly after swelling and redness developed. Pt was seen in ER where they advised ibuprofen, ice and BENADRYL. Spoke with mom 7-16-12 and reinforced ER advice.
Patient commited suicide 05/18/22 (self inflicted gunshot wound). Family all had COVID19 Oct 2021, and patient never recovered from fatigue and lack of motivation. Wife thinks his symptoms (fatigue) got worse after Pfizer-BioNTech COVID-19 Vaccine 03/30/2022 & 04/22/2022.  Wife says his underlying restless leg syndrome got worse with more sleep disturbance.  Seen in PCP office 4/25/22 with overwhelming sense of fatigue. Little motivation to do anything. Said everything in his life "feels like a chore".  Actively treated long-term for depression, followed by psychiatrist.  Actively treated long-term for restless leg syndrome, requiring low dose Methadone with better success than any other RLS medicine, Rx by neuro.
A report has been received from a Health Professional concerning a patient born on 30-Mar-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Jan-2013. The reporter stated that they had accidentally administered expired FLUMIST to patients. The outcome of the event of ADMINISTERING EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 31-Jan-2013 from consumer. The reporter's details updated. Corrected reported 08-Jan-2013. Patient was added as an additional reporter. Event onset date was updated.
Information has been received on 05/23/2001 from a registered nurse concerning four patients between the ages of 15 and 18 months of age who about three weeks ago on approximately 05/01/2001 were vaccinated with one dose of MMR II (lot 637431/0026L). Seven to eighteen days later, the four patients reported to the emergency room, one with a high fever and the four also developed a generalized rash. It was also reported that one other pt, vaccinated from the same lot developed a low grade fever (WAES01072621). It was reported that all of the children are "doing fine now" and were recovered. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose) and VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose). On an unknown date, the patient experienced VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).). At the time of the report, ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose) and VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).) outcome was unknown. No concomitant medication was provided.No treatment medication was provided. Patient stated that her last shot was in ??-AUG-2021 and she had a COVID arm (Left arm injection Site). And wants to know whether she can get booster shot in her left arm or in opposite arm.
A burning/itching rash and blisters started on 1/30/21. It completely covered her backside/buttocks.  She was prescribed Acyclovir 800mg on 2/2/21.  The rash has subsided however, because of the location of the blisters, they still haven't completely healed.
I had side effects immediately after my first Pfizer dose on July 2, 2021  My head started pounding right after I got the vaccine. After 5 min my neck hurts so bad that I couldn?t move it. But the worst side effects happened After 3 days from my first vaccine shot I started with Vertigo/Ringing in the ear/Tinnitus.  And leaving me  deaf from my left ear now.  My ear examination on August 2, 2021 showed that I?m 100% deaf from my left ear. I can?t no hear nothing on that side now. As now, August 11, 2021 I have been on medicine for vertigo, and steroids to see if I can get my ear function again. I have been spending money on doctors and exam out of packet because I don?t have any kind of health insurance. So as you can se now. I really need help with this. Please reach out to me if you can help.
patient was very ill for two weeks after the flu shot, never had another and never got the flu, It has been like 40 years; Initial information was receive on 07-Oct-2020 regarding an unsolicited valid non-serious case from the consumer/non-health care professional.  This case involved an unknown age female patient who was very ill for two weeks after the flu shot, never had another and never got the flu, it has been like 40 years (illness), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was very ill for two weeks after the flu shot, never had another and never got the flu, it has been like 40 years (illness), (latency: unknown) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown at the time of reporting.  There will be no information available on the batch number for this case.
swollen/painful left arm pit swollen/painful left side of arm pit/side of chest left shoulder and collar bone hurt (not injection site)
in the night awoke very diaphoretic states clothes wet, attempted to get up and got very lightheaded and fell back in the bed , legs very weak unable to walk and headache
Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004961: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1705USA004967: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1705USA004960: US-009507513-1705USA004962.
Error was discovered when vaccines were to be entered into the computer system.  Menactra vaccine (MCV4) was given instead of PCV13 vaccine. Mom was contacted and states the baby was fine and no adverse effects were noted.