chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing.  Another resident on the same hall was COVID positive on 1/11/21.  Results of the PCR test were obtained on 1/16/21.  He appeared asymptomatic at that time. Given his COVID positive status, all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21, he had the onset of acute respiratory failure and was transported to the hospital. Per notes, he was put on BiPAP for several hours, but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers, he had DNR/DNI orders.  The hospital physician spoke with his brother and the decision was made to  move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related, but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination.
Patient reported malaise and shortness of breath; onset approximately three to four days after receiving immunization.  She followed up with her primary care physician who prescribed ADVAIR.  The doctor did not feel that symptoms were related to the vaccine, but patient is still concerned that it is.  Reported to us 10/11/09.
CHills, myalgias, headache all started around 11pm last night. Also had a "few drinks" last evening. Chief complaint today: headache, aches. Denies vomiting, nausea and diarrhea. Temp 99.2, BP: 108/92, Pulse: 68
Pt received immunizations on 9/12/11. Called clinic on 10/11/11 reporting arm as still tender & use of arm. Appt scheduled for 10/12/11. Eval on 10/12/11 showed not redness, swelling, or warmth, normal ROM, but tender to palpation.
Case number PHEH2013US019893 is an initial spontaneous report received from a nurse on 20 SEP 2013. This report refers to an unspecified age and gender patient. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12097) reconstituted with sterile water intramuscularly on an unspecified date. The patient did not receive the Men C Y W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error.
I got an eczema rash on my neck 3 weeks after the vaccine out of nowhere. I had eczema as a kid and sometimes get allergic skin reactions to topicals but this was unprompted by a lotion/creme etc. I have received "flare ups" of eczema each month since having the vaccine but they are decreasing in severity each time and go away after a month with the use of a topical steroid. I understand eczema is an immune response and that the vaccine may have awakened a dormant condition. I am not overly concerned but I wanted to write the report since I did seek medical attention for it and am receiving treatment with steroid.
The patient states the injection site became reddened and with a hard lump under the surface. The erythema area was reported as softball size.
c/o dizziness and increased heart rate.  Assessed by attending and hospital MD present.  HR went from 138 to 80 beats per min in 3 minutes.  Able to walk to reclining chair from straight back chair without incident.
pt recv vax & sx of chest pain lt arm & leg pain & weakness began 8NOV:seen by MD in ER 11NOV secondary concerns about poss MI;no tx given;c/o lt arm pain, weakness & dec function of lt hand;
Per registry this resident already received a 2-dose series of Moderna on 1/5/2021 and 2/2/2021. We administered 1 dose of Pfizer on 4/21/2021 under the assumption this would be the resident's first dose of the COVID-19 vaccine.
pt recv vax;devel painful rash along w/ malaise;no tx given;MD indicated event probably not serious;
6 days p/vax 1st pox lesion followed by typical chicken pox rash of >100 lesions & fever of 101-illness lasted 1wk; tx w/Acyclovir-would have required MD visit x/pt is a MD & self treated
Pain at site of injection. Tinnitus - still present. Extreme fatigue requiring bedrest. Nausea. Myalgias - still present.
This case was reported by a physician and described the occurrence of meningoencephalitis in a 11-year-old patient who received BEXSERO. The patient's past medical history included asplenia and spherocytosis. Concurrent medical conditions included headache. Concomitant products included FLUVIRIN. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced meningoencephalitis (serious criteria hospitalization and GSK medically significant) and streptococcal pharyngitis. On an unknown date, the outcome of the meningoencephalitis and streptococcal pharyngitis were unknown. It was unknown if the reporter considered the meningoencephalitis and streptococcal pharyngitis to be related to BEXSERO. Additional details were provided as follows: In July 2014, the patient had undergone splenectomy. The patient had headache prior to vaccination with BEXSERO. The patient experienced aseptic meningoencephalitis and Group A strep pharyngitis. The patient was receiving not any penicillin prophylaxis at the time of reporting. Follow up information was received on 6th April 2016: It was concluded that the symptoms experienced by the patient were very unlikely related to BEXSERO and that the patient should receive the 2nd dose of the vaccine.
Breakthrough case admission after 3 vaccines ; Moderna 1/27/21 Lot# 032H20A;  Moderna 1028/21 Lot# 076C21A;  Moderna 4/28/22 Lot# 048L21A
Severe headache, nausea, vomiting. CSF studies with WBC 972, Lymphs 89%, Glucose 44, Protein 120. Concerning for bacterial vs viral meningitis. Work up in progress.
SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 61-year-old female. The patient's weight was 180 pounds, and height was 61 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04ZAZ1A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain. This report was non-serious.
pain  in arm on the 21st injection  welted up, was red, hot and painful pain in armpit icky feeling swollen arm
A grey cap Pfizer vaccine was opened and punctured on 6/24/22. This same vial was used to vaccinate this individual on 6/27/22, past the 12 hour limit on grey caps after puncturing.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. No adverse effects were reported.
Body aches, worse than the first; Fatigue; Headache; Very sore arm; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, fatigue, headache and pain in arm. On an unknown date, the outcome of the general body pain, fatigue, headache and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, fatigue, headache and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060165   Additional Information: GSK Receipt Date: 4-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose Shingrix vaccine and experienced body aches, fatigue, headache, and a very sore arm. The patient thought this was the normal reaction though. The pharmacist warned her that the second shot would be worse than the first. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060165:Same reporter.
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 08/11/21. Patient was hospitalized from 08/19/21 - 09/12/21. Below is copied from discharge (death) summary:    Patient is a 62 y.o. male with PMH significant for HLD, morbid obesity, DMII, schizophrenia, and anxiety/depression who presents for shortness of breath 2/2 to COVID. Initially admitted on 8/19/21. Patient had increasing O2 requirements with multiples desaturations on HFNC, and subsequently admitted on 8/31 for acute hypoxic respiratory failure/worsening O2 requirements 2/2 COVID PNA. Pt intubated on 8/31. Episodes of Paroxysmal A-fib, lopressor started and amiodarone started on 9/1. HDS during episodes. Bedside echo demonstrated reduced EF. Formal echo on 9/1 was normal LVEF 65%. Fever spiked  8/31 empiric abx (Vanc and Cefepime and flagyl) started. Blood, urine, and respiratory cultures ordered.  Initiated prone ventilation with improving oxygenation. Continue solumedrol, floloan, and statin. DVT ppx. No Toci given duration of illness. Afib with RVR but his cardiac function is wnl so this likely driven by his sepsis and hypoxia. Continue Amio. Strep/Staph bacteremia, however, may be contamination and unable to speciate staph so given his clinical picture, will treat and continue Cefepime. D/c Vanc. D/c Cefepime. Switched to Ancef given MSSA pneumonia. Repeat blood cultures negative. Strep viridans 1/2 blood cultures. Weaning Solumdrol. Tolerating prone ventilation. Procal remains negative but up trending WBC so will send fungal cultures. US lower extremity negative for DVT. US UE negative. Diuresing with Lasix 60 mg IV x2. Robitussin-codeine started for cough. Fevers persistent and WBC slowly downtrending.  D/c Diamox given mild worsening of acidosis. NPH 25 bid with SSI. CXR concerning for progression to fibrotic covid.  S/p Ancef for MSSA pneumonia. Progressive  Hemodynamic instability 9/11 requiring pressors with levophed and vasopressin. Repeat blood cultures 9/10, 1/2 with gram positive rods. Started on vanc/zosyn/caspofungin for broad coverage on 9/11. Called at 10:00PM for lost pulses. Pulse check without pulse. ACLS inititated as patient was full code at the time. Patient received 2x Epi/Bicarb, IVF bolus, and 3 rounds of CPR with PEA. At 3rd pulse check, patient with ROSC. Epi gtt initiated alongside Levo/Vaso/IVF. Pulse Ox with persisent desaturation depsite max FiO2/PEEP. Bedside US without signs of PNX or RV enlargement/strain. ECG without RV strain. CXR without signs of PNX; persistent b/l infiltrates consistent with active COVID. Called significant other, pt made DNR. Bicarb and epi gtt added. Pt's pulse lost again. Time of death 10:17.
This spontaneous report as received from a physician assistant refers to a 71 years old female patient who "four years ago" in approximately August 2008, was vaccinated with a 0.65 ml dose of ZOSTAVAX (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that four years after receiving ZOSTAVAX on 21-AUG-2012, the patient developed shingles-like symptoms. The patient had a mild rash. The physician assistant was "pretty sure" that it was shingles. There were two dermatomes present and somewhat resembled a bug-bite. Unspecified antivirals were given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for the patient had a mild rash, the physician assistant was pretty sure that it was shingles and there were 2 dermatomes present and somewhat resemble a bug-bite was unknown for ZOSTAVAX. Additional information has been requested.
Patient was scheduled to recieve her 2nd primary covid vaccine. She was given a bivalent covid booster on accident. Doctor and patient were both notified of the error.
First day 8/20: upper arm pain Second day 8/21: sharp intense pain between scapula and sternum area, radiating left chest and shoulder pain that was not relieved by Tylenol and ibuprofen, had very sensitive skin/allodynia anything that touched skin felt like needles including just wearing clothes,  feeling very fatigue and weak
This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with combined KINRIX. Previous and/or concurrent vaccination included live MMR II (strain not specified), manufacturer unspecified given on the same unspecified date as KINRIX, MMR and VARIVAX; manufacturer unspecified given on the same unspecified date as KINRIX. On an unspecified date the subject received 1st dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site). A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected. All of the children were within the four to six years age range. She stated that she gave KINRIX on one arm and MMR vaccine and VARIVAX on the other arm. Please see A0780868A, A0780876A, A0780877A, A0780878A, A0780879A and A0780880A for the six additional cases reported by the nurse. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Following a dog bite, the hospital suggested I receive a tetanus shot.  Within a day of the tetanus/diptheria vaccine, I developed severe chills to the bone, fever, nausea, mental confusion, aches in my joints...in general would have chosen death over living in that condition.  It lasted for about 6 weeks.
36 hours after receiving vaccine, patient felt alternating tingling sensation in his upper and lower extremeties.  As of 3/5/2021, which is when I evaluated him, his symptoms were still present and unchanged.  His reflexes and strength were normal.
Swelling of lips and face. Started where I had rubbed Aquaphor Healing Ointment on the nose the night of the Vaccine shot. Some of the ointment got on the right lip and face during the night. Next morning swelling of right upper lip and right ride of face. During the day left side of face swelled up. Trip to  ER for IV of Benadryl, Pepcid, and Steroid.
Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; This is a spontaneous report from a contactable consumer (patient) via a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that within a few minutes after receiving the vaccine, the left side of her face and tongue got numb like it was treated with Novocaine. Her medical doctor (MD) told her to pre-treat her second dose (scheduled for 31Mar2021) with Tylenol and Benadryl. On 12Mar2021, the patient reported that she received the first COVID vaccine on 10Mar2021 and 25 minutes after, her left side of face and tongue got numb and tingly. It is almost back to 100% now of feeling normal. Her healthcare professional (HCP) said to take Benadryl before the second COVID vaccine. She is making sure that this will be ok to do. The outcome of the events was recovered on 12Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient reports that she had earache, headache, and tongue felt funny after the second dose.  (also had reaction to first dose but did not tell anyone until my last visit with her in April 2019).  she wanted me to report this.
swelling in throat, inflammed mucus membranes (no trouble breathing); red, sore & swollen eyes;
I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t think much of it. As I was standing up I notice all of the following-  headaches, body pain, fever, low energy (although this one went away fast). I also felt like puking most of the day. I woke up at 7am and After work I took a nap. I woke up at 7pm feeling a lot better.  I still had some minor headache but it went away with Advil.
Patient's reaction(s) noted during COVID vaccine observation period: felt lightheaded, dizzy, and like she was going to pass out.  This lasted only a couple minutes before she felt better.   Actions Taken: VS taken, BP 132/76, pulse 80, RR 18 and O2 99% .     Disposition: Patient declined ED visit.   Feelings noted to only last a couple minutes before she felt better.
Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily; Headaches; Pressure around The Heart; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart). At the time of the report, EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Lot number: FE3592), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FE3592 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical Course: Received covid treatment.  No follow-up attempts are possible. No further information is expected.
Elevated heart rate (over 140 bpm), Significant chest pain, Jaw pain, Nausea All occurred from approximately 11:00 PM to around 5:00 AM. After taking ibuprofen, heart rate stabilized and symptoms were reduced.
Vomiting - about 3 times. Inconsolable crying - mom reports 3 episodes of crying. Gas that resulted in baby turning blue. Will not take pacifier or breastfeed at all.
Sore throat, swollen throat, Eye infection, severe ear infection, mid high to high fever, chills, hearing loss (degree YTBD), loss of taste, loss of smell, Patient still recovering
He developed a rash on his body/ It's on his legs, back, arms and it itches horribly; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Received first two vaccines for COVID). Past adverse reactions to the above products included No adverse reaction with COVID-19 vaccine.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly). At the time of the report, RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly) had not resolved.            No concomitant medication information was reported.  On 27-Dec-2021, the patient received the Moderna booster shot.   The patient developed a rash on the body that was still present for an entire year later. The patient was still suffering from this rash.  The patient had consulted with physicians and nobody knew how to treat this condition. It cost the patient a lot of money.  No treatment medications were reported.
States he received the Zostavax vaccine at the pharmacy on 3/25/08.  States he had shingles when he was vaccinated and "should have never received the vaccine".  Had an outbreak of shingles on the right chest and right back.  Outbreak is improving now, and patient now has an order for gabapentin to help with the pain.  Also received acyclovir 800 mg q4h following the immunization. Patient denied having any other immunizations in the month prior to receiving Zostavax.
At about 3.58 pm  patient was given a  moderna covid vaccine. A few minutes after the vaccinations  pt started to develop a rash around his neck he also started complaining of shortness of breath . All these happened in a spun of about 5 minutes. He was offered assistance in the form of water but pt declined . Patient felt okay and rejected as calling 911 and also an epipen shot. He indicated that he hears those shots are crazy and flat out refused. He decided to have his wife drive him to the ER. I called later to check up on him but his wife  said he was fine and that they were almost at the ER. Will follow up tomorrow
Tingling in both feet. Twitchy muscles in both legs. Painful breathing in diaphragm area. Took her to the ER, where she was examined and released.  We were told to watch her over the next couple of weeks and seek medical attention if the symptoms returned.