chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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.  An adult patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Other medical history: Diabetes type 2; "asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Pt recvd vax & devel soreness, swelling & heat @ the inject site which limited ROM; react lasted several days;
Patient reports that his arm was sore immediately upon receiving the vaccine at 9:40 am on Nov, 2. States that he rubbed the area all morning and afternoon to try to ease the soreness. By evening of 11/02/20 a visible knot the size of a nickel had formed on the back of the left arm. He reported having chills that had went away by the next morning. Today, 11/04/20 he said that the arm is still sore and it is warm to touch 6 inches around the area.
rec'd herpes zoster vaccine 9/18/09, on 9/25/09, dev'd rash on both  arms from wrist to axillary region, the rash has since progressed to lower abdomen, left waist & mid-back--she was not on chemo nor rec'ing steroids or any type immunosuppressives at time of vaccine--she had chickenpox as a child & outbreak shingles during former chemo--the rash is nonprurutic & she denies sob, wheezing or any resp difficulty--she is having difficulty describing rash characteristic; she does not remember prodrome or any blisters nor is any of the rash area scabbing or crustey--no other new Rx's--in view of extent of rash
The day after I got the shot, when I went to get out of bed in the morning, I felt like I was going to pass out, so I waited. I got to the bathroom, sat down on the toilet and had some diarrhea and then I started to burn up, freeze and shake all at the same time. I've never had that happen before. I didn't know what was happening to me and I got scared. When I tried to stand up, I couldn't. My legs had no muscle strength. So I sat on the toilet for about 20 minutes, burning up, freezing, and shaking, all at the same time. Then I was finally able to get up. I put a wet wash cloth on my forehead and laid down in bed cause I was still burning up, freezing and shaking. After an hour or more I finally stopped shaking, freezing and burning up. I called the pharmacy and told the pharmacist what happened. She said I probably had a reaction to the shot and to call my Dr. I called the Dr. and they were out to lunch, so I called later at 2. I told the gal what happened and she said she would tell my Dr. and get back to me. They finally called back after 5 and said I should take some Tylenol. By that time I was feeling better, but I tool some Tylenol anyway. The next day, I was feeling almost back to normal. That was so scary for me since I was home alone and didn't know what the heck was happening to me!
brain fog.memory issues.difficulty remembering where things were and also memory loss academically while studying for exams.Exercise, vitamin B,amphetamine,methyphenidate and neuriva
pt reportedly received pertussis vax @ 6mos of age & exp hypotonia which lasted for several months; date of vax & event is unk; however, event probably occurred several yrs ago;
Case number PHEH2016US029282, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to an elderly old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly following temperature excursion at 52 Fahrenheit for 01 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error (incorrect product storage).
Red, indurated warm area around injection site at Left upper arm.  Itanxkx, no fever.  Treated for presumed cellulitis with Augmentin.
Numbness and soreness in arm Tuesday - extremely bothersome at night-pt took some pain meds she had at home- wednesday- spoke to pharmacist- told me it was much improved- looked up s/e information b/c soreness is typical but was alarmed by "numbness". told pt to contact md.
Case number PHEH2014US024276, is an initial spontaneous report received from a nurse on 02 Dec 2014, and with a follow up report received from nurse on 21 Jan 2015. This report refers to a 53 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 12 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree for 1 hour and 15 minutes. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided. Follow up report received from nurse on 21 Jan 2015. Updated site of vaccination.
No immediate reaction.  On 6/11/2022 I was admitted to the hospital for an ischemic infarction in the brain.  I know that there was a study of patients (2020/2021) >65YO (approx 3,000,000 patients) where ?17,000 patients suffered ischemic infarctions.  I don't know for sure if this was related, but these patients had the event within one month of a vaccination. I wanted to report this adverse event in case other patients are having the same problem and it needs to be tracked.
The patient started feeling anxious when she got out of her car to come up to the clinic.  After she received her vaccination, she started to feel anxious, felt like her heart was going fast, and sat down.  We checked her blood pressure and HR which were normal.
Chonic dry cough and throat thickness/clearing associated with shortness of breath and chest tightness are the worst symptoms that have continued and worsened since the initial dose in January. I also have experienced multiple episodes where things get really bad and I have palpitations pre-syncope with tunnel vision, hot flashes, numbers/tingling starting in hands/feet and travel upwards.. I have extreme fatigue and general feeling of unwell. Also a chronic facial rash and an intermittent vesicular and red oral/throat rash
reddened area w/yellow center-wheals/hives on buttocks around diaper area & on arms & trunk; pt observed-2 hrs later & sx lessened considerabily & pt sent home;
I had vaginal bleeding for three days. I was worried and saw a doctor and they found I had Ovarian Cancer was the adverse event and treatment was chemotherapy.
Pt felt nauseous immediately after vaccination was given. Pt stood up to walk to observation area and stated wanting to throw up. Pt was laid down and v/s were initiated at 1815. BP was 100/80. Pt threw up after 10 min. V/s improved and were within normal limits at 1835. BP improved to 110/80.  Pt was in stable condition and left the vaccination site at 1851.
Felt throat is closing; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Felt throat is closing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced THROAT TIGHTNESS (Felt throat is closing). At the time of the report, THROAT TIGHTNESS (Felt throat is closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Pt was given Dtap/IPV at his 11 yo check up instead of Tdap BOOSTRIX.
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/17/21 (031L20A) Moderna Dose 2 3/17/21 (031A21A) Pfizer Dose 3 11/10/21 (FF2589) COVID Positive 1/18/22  1/18/22: Patient is in poor health and resides in a nursing home for the past year due to declining health and according to the daughter-in-law the patient was running out of her house and up and down the street to neighbors had bring her back home and the patient was a danger to self.  Patient has been tested positive for COVID at the nursing home and today the pain as an it band heart block along with the UTI hyperkalemia chronic renal failure. Patient's eye post states that she does not want anything other than comfort cares and being fitted for a pacemaker seeing a cardia stir not in her wishes.  He is soft tissue also SIRS a lot of skin breakdown with severe fungal infection underneath the left breast and shoulder on the bottom .  1/21/22: Patient is a 84-year-old female who was admitted to the hospital on January 18th with UTI and confusion.  She was treated with Rocephin.  She gradually improved but she is still confused.  After discussion with family a decision for hospice was made.  She was discharged to assisted living with hospice services.  I prescribed Keflex upon discharge.  She was in a stable condition when she left the facility.
Both leg & foot severe pain, swelling, burning. My right foot dropped. Both legs have black blotches. I have been ill since October, 2009 and have not been able to work. I currently use a walker.
RHEUMATOID ARTHIRTIS; This is a spontaneous report received from a Pfizer program. A contactable other healthcare professional reported that a 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) (at the age of 62 years old) as 2nd dose, single for COVID-19 immunisation; and tofacitinib citrate (XELJANZ XR), oral from Aug2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history included sinus infection. Concomitant medications were not reported. Tofacitinib citrate was placed on hold per MD order, 1 week prior and 1 week after both COVID-19 vaccines were administered. The patient previously received the first dose of BNT162B2 on unknown date for COVID-19 immunisation. After receiving the second dose of COVID-19 vaccine on 04Feb2021, the patient experienced pain and swelling in lower back, knees, and soles of feet on an unspecified date in 2021. The patient experienced rheumatoid arthritis (aggravated) on unspecified date in 2021. The patient was prescribed prednisone to help with inflammation. The pain now is "not as severe and tolerable". MD was aware. Patient was able to manage symptoms at home with rest and heating pad. MD was aware. The action taken in response to the tofacitinib citrate was dose not changed. The outcome of the event rheumatoid arthritis aggravated was recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: A contributory role of the reported aggravation of rheumatoid arthritis, for which it is detailed that 'the patient experienced pain and swelling in lower back, knees, and soles of feet', as signs and symptoms, cannot be completely excluded for Covid-19 immunization. The event is assessed as unrelated to tofacitinib. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recvd vax; inject site rxn characterized by erythema, induration, hot to the touch;
pt recvd vax 23JUN93 & 2 wks following vax devel a rash over upper body, neck & face; No further details were provided;
Patient, never having previously used the pharmacy, contacted the pharmacy on the evening of 10/18/2020 with the complaint of having had shoulder pain over the last two weeks after having received a flu vaccine on Tuesday 10/06/2020. Patient stated that she has gotten the flu vaccine before and never had any problems. She also stated she knows that if the vaccine isn't given in the correct location, that it could cause an injury. She says that the day after receiving the vaccine, her arm became red and swollen until that Friday 10/09/2020 and that since then, the redness and swelling has resolved, but she has had progressively worsening pain since then. She says that the pain is present both with and without movement but is most notable in the sitting position. Patient was advised by pharmacist to seek medical attention if deemed necessary. On Tuesday 10/20/2020 patient contacted the pharmacy to update that she is beginning to feel a lump in the area where the vaccine was administered and that she has scheduled an appointment with an orthopedic doctor for Wednesday 10/21/2020. She will follow up with the pharmacy on any pertient details or results of the appointment.  The immunizing pharmacist has undergone injection technique training and completed a quality care check on vaccine administration. Upon watching surveillance footage of the time the patient presented for the vaccine, the camera angle does not allow full visibility to the entire event to determine if the vaccine was administered in the right location of the deltoid. However, it was noted that the patient was wearing a short sleeve shirt and therefore most likely rolled the sleeve up above her shoulder to expose the entire deltoid muscle. Typically, shoulder injury related to vaccine administration is more likely if the patient is wearing a long sleeve shirt that they aren't able to fully roll up above the shoulder or if they are pulling their shirt down at the neckline because in both instances, the deltoid muscle is not fully exposed. This was not the case with this patient. After having received the vaccine, the patient can clearly be seen walking away unremarkably, never holding her arm or appearing to be in any distress or discomfort from being immunized.
Felt like I had covid again within an hour. Lasted almost 5 days. Arm got swollen and red on  3 day at vaccination site. It was about 3 inch circle that was hot and swollen and very painful.
Seriousness Criteria: Other-Medically Significant. Initial report was received 10 December 2008 from a health care professional. A 9-year-old male patient had received an injection of FLUZONE SV 2007-2008, lot number U2449AA on an unspecified date last year and moments after vaccination, he passed out. Specific details were not reported for the event; however, the patient had experienced a subsequent event where they passed out following receipt of FLUZONE SV (captured in case 2008-03954). The subsequent events lasted less than five minutes and the patient became alert and oriented with no deficits noted by the physician. The patient recovered from the events. This event had been received as a cluster report. The patient experienced a subsequent event which was captured in case 2008-03954. Documents held by sender: None
Pfizer-BioNTech COVID-19 Vaccine EUA  I noticed swelling of a lymph node above my left collar bone 7 days after receiving my first vaccine dose. It's now 16 days after my first dose, and the swelling persists. I am scheduled to get the second dose on 4/23.
pt recv vax; ran T; was fussy and cried constantly for over 3 hr; would not eat; pt seen by FMD who recommended no further pertussis vax;
Pt started the Moderna vaccine with his first dose and was vaccinated for the second dose with Pfizer Covid-19 vaccine.
Extremely bad headache: include upper arms and neck. Taking Ibuprofen : lots. Shot area swollen and painful: ice.  Follow up on 06/28/04 states: "Headache, immediately after, Motrin, now Bextra, joint pain, knees, week after, still ongoing. Lot # different from original: FAV083."
he has been having cycles of not feeling well; feeling fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient  reported that he received his first vaccine dose on 07Mar2021 for covid-19 immunization and did fine. He received his second vaccine dose on 25Mar2021 and ever since he has been having cycles of not feeling well. Caller reported a few days of feeling fatigue and not feeling well and then the symptoms resolved but a week later they come back. He was not feeling well for a couple days and then was ok, then about a week later he felt unwell and fatigue was setting in. It was like a cycle. Last week he wasn't feeling well and has been feeling well the last 3 days. It had been a month of feeling unwell and well cycle. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433973 same reporter/drug, similar event, different patient
2 days after receiving vaccination red spot appeared 3 in x 7 in size, warm to touch.
severe localized inject site and regional arm pain, distal hand discomfort and decreased ROM, dry mouth, dizziness
Pt. states that after receiving the 2nd dose of Phizer 02/02/2022, started experiencing symptoms that evening of fever (102.0), nausea, vomiting (self-treating Zofran), high heart rate, dehydration, chills, and tachycardia. Symptoms lasting 4 total days before subsiding. (Previous Covid + 08/11/2021 - Hospitalized to Hospital Diagnosed with Arrhythmia ) No noted Primary visit/communications.
slight nasal congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJI685), intramuscularly in left arm on 22Dec2020 13:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. The patient experienced slight nasal congestion (non-serious) on 22Dec2020 14:30 with outcome of recovering. No treatment received for the event.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 17032, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
PT WAS GIVEN ZOSTAVAX SQ TO LEFT ARM ON 7/8 BY TODAY PT HAS DEVELOPED REDDENED AREA SYMETRICAL IN NATURE AROUND INJECTION SITE. DARKER RED IN CENTER  MEASURES 2.2 X 2CM WITH LIGHTER RED RING AROUND. MEASURED TOTAL AREA  9CM X 8.5 CM HARDENED AREA IN CENTER AND WARM TO TOUCH THROUGHOUT. C/O PAIN TO SITE. OTHER SYMPTOMS ALSO INCLUDE HA,MUSCLE ACHE, AND JOINT PAINS. TX BY PA-C BENEDRYL 25MG Q4HRS PRN, TYLENOL PRN, COOL COMPRESS.
no other AEs reported; administration of a dose of PROQU AD to a 25 year old patient; This spontaneous report was received from a physician and refers to a 25-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 26-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHa)) (PROQUAD) 1 injection (lot # T021643, expiration date 21-DEC-2021) (exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate age at vaccine administration). No adverse event was reported.
Patient described weakness, dizziness and a feeling of anxiety/shortness of breath within a few minutes of the vaccine. After several more minutes these subsided and he left the pharmacy (he didn't want medical treatment).
Lump at injection site, swelling, redness, itching, sore (all localized to injection site).
Could not hardly move (L) arm - had to ice. Several hours - inj site black, blue, pink.
Thurs (next day) - quarter size area bright red, pain, extreme pain at ZOSTAVAX site. Friday - Area bigger - still painful and swollen. - Temperature - normal / severe headache. Pt feeling better on 10/11/14.
The evening of my Moderna booster shot, I began to vomit uncontrollably, with chills, headache, nauseated. This lasted for about 24 hours. I did not take any medications. Once I felt better, I was left extremely fatigued without the ability to go to work. The following week, when the fatigue subsided  on 1/12/22, I woke up and could barely open my eyes. They were swollen and itchy and I had hives all over my body. I contacted my PCP and was told to stop my thyroid medication and to take Claritin and Pepcid and he also prescribed 5 days of Prednisone. I followed the regimen, but it did not offer much relief. Today is 2/3/22 and I still experience hives, burning, and itching on random parts of my body at random times. I have since stopped taking any medications and have just learned to "live" with it.  I am scheduled to see an allergist in March.  As an example, I have been sitting at a table and my mom will say what's happening to your face? Hives will just begin to grow suddenly be itchy for about an hour and then disappear from my face and then it's my thighs or back or arms, etc.
Immediately after injection, the patient began bleeding at the injection site. I applied pressure with a cotton ball and within minutes, the bleeding had stopped but a small hematoma formed under the skin. It was a raised bump, about the diameter of a quarter and was purple under the skin where you could tell blood was pooling. The patient waited about 10 minutes and was feeling fine so I told her she could leave and I will follow up the next day to make sure it was looking better. I instructed her to contact the pharmacy or her MD if it appeared to be getting worse.