chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine. Rec'd Pfizer-BioNTech COVID Vaccines on 2/9/2021 and 3/2/2021. Admitted to Hospital for N/V w/recent COVID/PNA (7/18/22), now w/post COVID PNA, c/b hypoxic resp fail, admitted to ICU w/HF O2. Increased WOB, cont'd to desaturate, less responsive, intubated 8/8. Transferred 2/2 concern for CMV reactivation. P/F ratio <300 tx'd per ARDS recommendations including lung protective ventilation, permissive hypercapnia, proning, paralyzed, conservative strategy of fluid management & Medduri protocol. Started on Baracitinib for COVID-19.  BPs cont to fall despite multiple therapies. Transitioned to DNR-COT. Tx'd w/meropenem, vanc, ganciclovir,  cresemba, baricitinib and decadron. Exp. 8/18/22
Information has been received from a registered nurse concerning a patient who was vaccinated, at 1 year of age, with a dose of varicella virus vaccine live (Oka/Merck). It was reported the patient developed shingles between the ages of 1 and 4. Subsequently, the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
My eyes, cheeks, and tongue swelled up about 45 minutes after getting vaccinated. I took Benadryl and Pepcid an hour before getting vaccinated to try to prevent an allergic reaction but my face still swelled. I took Benadryl and steroids for the next week to reduce the swelling.
arm turned red with slight swelling; arm turned red; hot to the touch; injection site developed a knot that grew; Initial information was received on 12-Jan-2021 regarding an unsolicited valid non-serious from a physician via other health care professional.  This case involves a 03-Year-old female patient whose arm turned red with slight swelling (vaccination site swelling), arm turned red (vaccination site erythema), hot to the touch (vaccination site warmth) and injection site developed a knot that grew (vaccination site mass), while being received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On 07-Jan-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients arm turned red with slight swelling (vaccination site swelling), arm turned red (vaccination site erythema), hot to the touch (vaccination site warmth) and injection site developed a knot that grew (vaccination site mass).  No laboratory data was reported.  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
This case was reported by a physician and described the occurrence of unconscious in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included MENACTRA. On 14th July 2016, the patient received BEXSERO. On 14th July 2016, immediately after receiving BEXSERO, the patient experienced unconscious (serious criteria GSK medically significant), screaming, pallor, fainting and dizziness. On an unknown date, the outcome of the unconscious, screaming and pallor were unknown and the outcome of the fainting and dizziness were recovered/resolved. The reporter considered the unconscious, screaming, pallor and fainting to be probably related to BEXSERO. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm and MENACTRA in the right arm. Immediately after the vaccination, the patient experienced fainting. The patient had weird screaming noise, become ashened and had unconsciousness. The patient wake up after a couple of seconds and the patient kept for observation for additional 20 to 30 minutes. The patient was also dizzy. The physician think it was BEXSERO due to temporal association and the patient had MENACTRA before. The reporter did not have territory ID. There were no seriousness associated with the reported event. This case is linked with US2017GSK024125, as reported by the same reporter.
patient stated that he developed a fever peaking at 102.6 F the night of vaccine administration and the fever resolved within 2 days. He also developed arm soreness (extending past the injection site down his left arm) and had difficulty lifting his arm for 3-4 days afterwards.  All adverse reactions have since fully resolved by time of patient reporting reaction to pharmacy
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In February 2010, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On 29-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Dr.: Mother and Father returned with the patient about 20 minutes after the immunizations noting swelling and redness of the left thigh. This was the location of the Varicella and MMR immunization. The child was evaluated and did have an area of swelling and erythema measuring about 2 inch in diameter. Ice was placed and 1/4 cc of Benadryl at 12.5 mg/5cc was given. Ice was applied. Patient was monitored for another 25 minutes. The area of swelling decreased, vitals was stable, respirations were normal. Patient was discharged in good condition. Our office will call mother/father back later today to check the status. Benadryl advised tonight at the same dose as above. Ibuprofen dosed based on weight recommended for any fever pain. Parents understood, all questions were answered. Dr. also evaluated the patient. Please check on patient this afternoon.
reports mild adverse reactions to the 2nd shot of the Pfizer covid vaccine but nothing out of the ordinary. Temperature of 100.; This is a spontaneous report from a contactable consumer (reporting for herself). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reports mild adverse reactions to the 2nd shot of the Pfizer covid vaccine but nothing out of the ordinary. Temperature of 100. Informed that deaths have not been associated with the covid vaccine as per what are the risks document. Callers son in law says her chances of getting covid, now that she is fully vaccinated, are smaller than the chances of her being hit by lightning. How rare will it be to get covid if fully vaccinated questioned. Caller very concerned about deaths from Vaccine and wanted information about deaths. Outcome of the event was unknown.
I had chest pain on my left side which it was throbbing. It wasn't consistent and it was across my left side. Shortness of breath, I decided to go the ER in the afternoon and had an EKG to make sure nothing was wrong with my heart, Doctor said he believed I was having muscle cramping and I was sent home.
Pharmacist administered shingles vaccine too high on the shoulder and patient has been experiencing numbness down the right arm for the past two days.
Pt. stated he had received many other previous flu shots to date without incident. Pt. was advised to remain in vicinity for 15 minutes post-administration. Pt stood to leave 2 minutes post-administration and fainted. Another customer prevented a complete fall. Pt. sat in chair provided and appeared non-lucid with possible apnea. He regained cognitive capacity within 10 seconds. Pharmacist monitored until paramedic dispatch arrived. Pt. left as paramedics were approaching and refused treatment. Telephoned pt at home at 1:04 P.M. He reported that his "head is still a little fuzzy" and his "arm hurts". He said he did not wait for paramedics and was feeling fine otherwise. Thanked us for follow-up call. 1/4/11
LARGE RED WELTS ON LEFT CHEST, SHOULDER AND LEFT SIDE OF NECK. DR. DIAGNOSED AS SHINGLES WHEN SEEN AGAIN ON FRI. (11/23/2012) PRESCRIBED ANTI VIRALS, VICODIN, IBUPROFEN, GABAPENTIN.
Information has been received from a pharmacist concerning a female who on 19-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL, subcutaneously (LOT # 659268/0158X). On 21-APR-2008 the patient developed two vesicular lesions over on her ribs. No other symptoms were noted. The patient contacted the pharmacist. No further information was available.
Information has been received from a medical assistant reported a nurse from a hospital concerning a patient who on "yesterday morning" (06-Jul-2011), was vaccinated with ROTATEQ (lot number, dose, route not reported). "Last night" (06-Jul-2011), the patient had a seizure and was hospitalized. Rotavirus was found in stool sample. The patient had hypernatremia. At the time of reporting, the outcome was unknown. All telephone attempts to obtain follow information have been unsuccessful. Additional information had been requested.
PATIENT WAS GIVEN MODERNA VACCINE BEFORE IT WAS DETERMINED HE WAS 17 AND 10 MONTHS
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection.   Physical Exam:  Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally  Skin: no injection site erythema or swelling. No rash.  No lip/tongue swelling or narrowing of oropharynx.   Plan:  Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance.  She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
Prevnar # 2 dose, 1 Week of Irritability, crying, 3 weeks of poor gait with noted leg dose administered in; collapsing not supporting full weight (4 other immunizations given on the same day? Which given in the same leg). Prevnar dose # 3, 3 day history of gait control leg collapsing under fall at Nml gait and 3 days post immunization.
Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock;  Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified patients were vaccinated with an improperly stored GARDASIL (dose and route of administration not reported; lot # K011562 and expiration date on 08-APR-2017). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Physician asked by medical assistant  to assess patient as she reports itching.  Patient states she notices some mild itching, 10-15 minutes after receiving 2nd dose of Pfizer COVID-19 vaccine. No throat swelling or difficulty breathing, otherwise feeling well.  BP checked manually at 112/74.  Patient received 50mg PO benadryl (patient reports she tolerates without drowsiness), and observed x 15 min after receiving benadryl.
Left thigh about 4 in flat, Erythema warm to touch, Rash. Advice to apply cool compress, return to clinic if symptoms get worse.
Dizziness lasting for 5-10 minutes was given lots of oral liquids & laid flat on bed; vital signs were stable; kept under observation for 45 minutes.
fever, chills, joint & muscle aches, coughing, sneezing;lasted approx 1wk;
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with ROTATEQ on 13-AUG-2012 that expired 04-MAY-2012. The patient was not experiencing any known symptoms. Additional information has been requested.
Patient had moderna vaccine #1 given on 4/8/21 at Public health; moderna dose #2 was given at Public Health on 4/22/221; moderna booster dose given 2/7/22 at Pharmacy; Patient thought she had to return for dose #2 two weeks after dose #1.   she went back to public health and received her 2nd dose. She said the facility did not check her card so she was totally unaware it was too early.
Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Es1685, expiry date not reported), via an unspecified route of administration on 22Dec2020 at 09:30 AM at single dose for Covid-19 immunization. There were no medical history and no concomitant medications, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines with 4 weeks prior to COVID vaccine nor any other medications within 2 weeks of vaccination. On 01Jan2021, the patient has a cold and headache, she was sent for Covid test 1/5 loss smell/ taste 1/3. The patient did not receive treatment for the events. The patient underwent lab test on 06Jan2021 which included nasal swab: pending result.  Outcome of the events was recovered. The reporter assessed the events as non-serious.  Information on Lot/Batch has been requested.
I felt a tingly itchy sensation about 5 minutes after the initial dose at 8 AM. I started to feel a little lightheaded and anxious. Around 10 AM I noticed hives appearing on my upper chest to under my chin on the right side of my neck. The right side of my jaw where the hives appeared feels slightly tight. It is now 10:50 AM and I'm starting to feel itchy again.
GBS related symptoms.  Beginning 2 days after the vaccine, experienced fatigue, chills, diarrhea, lump and swelling at site of injection, severe pain in the back shoulder blade area, right arm from shoulder down, numbness and tingling in fingers of right hand.    Reported symptoms to an urgent care center 1 week after the vaccine and was advised to take motrin and tylenol for the pain.   After another week, completed a telehealth visit with a physcian who prescribed indomethacin in addition to continued motrin and tylenol.   No changes in condition.
Systemic: Lymph Node Swelling-Medium, Additional Details: Patient is stating that between his armpit and chest on his body is swollen and sensitive.  It is not painful.  It is sensitive when he raises his arm. I asked him where shot was given and he showed me over his clothes.  It looked like it was given in the appropriate spot from what he showed me.  I asked him if he thought it was given in an unusual spot and he stated that he did not think so.
Pt not acting right x 1 hr; then had shallow breathing & went limp; hospitlized 20JUL92-22JUL92;
Numbness in (L) arm that began 1 day after vaccination. Advised pt to consult physician, he said he would 1stt see how it progressed. Spoke to pt on 10/11/15 a.m - said he has much improved and would monitor. He had not seen a doctor.
Progressive numbness from eyelid to nose to face to entire body, beginning 3 days after vaccination.
patient inadvertently given fluad (high dose) flu vaccine at age of 63, not indicated for this age. No reported adverse effects at this time
Patient came to pharmacy and said that she had received the pneumovax vaccine at our pharmacy and after getting it, complained of soreness, pain, hot, and red. Patient had told this information to the doctor who told patient to come into pharmacy and have pharmacy complete VAERS form.
My symptoms became more frequent and more and it would take my breath away. That continued until late January when I first went to the doctor and then they put a Zio Patch on me to monitor my heart rate for 2 weeks and then I had to send that back and it took 4 weeks to get results and they called me and referred me to cardiology. Then I saw the doctor and that was a month after symptoms worsened which was almost the end of April, and by that it had eased off and it had gotten better and he wanted me to do a scan and an echocardiogram and they both showed that they were fine. As summer went on it really went away and it was really gone by the summer.
Significant swelling, erythema, warmth, pain at vaccination site and about 15cm diameter surrounding. Continued soft tissue swelling for >1 month.
Patient reported lump in arm at injection site. She described it being rock-like. She became extremely tired, experienced flu-like symptoms, fever, profuse urination and diarrhea. Patient also fell while sitting on the toilet.
redness, swelling spreading to below the knee, warm to touch.  Prescribed prednisolone and benadryl.
Civatte; hives; red spots and it was itchy; red spots and it was itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on February 1st and broke out into hives on 01Feb2021. She had red spots and it was itchy. She was getting mixed reactions from different doctors about getting the second dose. She was prescribed Civatte from the dermatologist and the prednisone from her primary doctor. After 5 days of prednisone, she would have some spots that would show up every now and then. The patient asked if she should get the second dose. The outcome of events was unknown.  Information about batch/lot number has been requested.
This spontaneous case, initially received on 13-Sep-2018 was reported by other health professional and concerns a 25-year-old adult female patient. The patient's medical history and concomitant medications were unknown. On 12-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195250, expiry date: 30-Jun-2018). On 12-Sep-2018, 11 months after vaccination, the patient developed flu (considered as vaccination failure). On an unspecified date, the patient visited physician and was tested positive for influenza B strain. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAI reference number was 1033366. At the time of this report, the patient had recovered from the event flu without any problems and was back to work. The reporter assessed this case as non-serious. Non-significant follow up received from Quality Assurance Department on 20-Sep-2018: The QAI reference number (1033366) was added in additional information tab. The narrative was amended accordingly. Follow up received from the reporter on 27-Sep-2018: The outcome of the event flu was changed from not reported to recovered. The patient's medical history and concomitant medications were unavailable (reported as refused). The narrative was amended accordingly.
Symptoms and Electromyelogram results consistent with Guillain-Barre Syndrome. Medical records state decreased reflexes, asthenia, otosis, ataxia. msv
Patient received Moderna COVID vaccine on 1/4/22 and 2/1/22. On 1/3/23, patient tested positive for COVID. On 1/7/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia secondary to COVID19 infection, lactic acidosis and severe metabolic acidosis with increased anion gap, and AKI with hyperkalemia. As of today (1/13/23), patient is still admitted in the med/surg unit.
Police reported to us that patient was found dead in her home the day after flu vaccine was administered. We had no communication w/ pt after office visit 10/4.
Medication Administration Error - Patient was administered second dose of pediatric Pfizer vaccine as drawn from the vial without dilution. Patient's mother notified by staff at clinic when vaccine dose discrepancy was discovered. Mother informed no cause for concern other than increased redness at injection site and to monitor patient for any severe reaction. Mother commented that patient had a temperature of 99-100 after the vaccination; no further adverse reactions were reported. This event was reviewed with all medical assistants in the clinic and banding of the vaccine with the diluent vials occurred to prevent recurrence.
Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX.  On 31-AUG-2006 the patient experienced injection site pain and slight fever.  The reporter felt that the causal relationship between the patient's injection site pain and slight fever and therapy with PNEUMOVAX vaccine was unknown.  The reporter considered the patient's injection site pain and slight fever as non-serious.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Headache Joint pains, body aches, fatigue and swollen glands on left arm. Redness and pain at inj. site Narrative:  Other Relevant History:
Information has been received from a healthcare worker referring to a 13 year old female patient. On 23-DEC-2014 the patient was vaccinated with a dose of GARDASIL which was post non-supported excursion (lot # K005083, expire date 04-NOV-106, 0.5 ml) intramuscularly. No adverse effects were noted. This is one of several cases reported by the same reporter. Additional information has been requested.