chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: ER8736) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE, SINGLE), when the patient was 73 years old, for Covid-19 immunization, reaction(s): " first one was fine". The following information was reported: FATIGUE (non-serious), ILLNESS (non-serious), STRESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed".  Additional information:Patient had his Pfizer second shot on Wednesday but the first one was fine, she didn't feel anything on the site (vaccination center) but after the second one had a very bad time, she was fatigue, tired and got up and feel the same way again. he just took an Aspirin (treatment) is this anything else he can do Patient added, patient 73 Years old but she never been sick, she take care of her husband and it's very stressful but she don't know what is wrong with her because the first one was fine." Patient said that she was fine till the first morning as woke up and after this second dose, felt this worst that she felt today and just stayed in bed and didn't "make dinner or nothing" (not clarified)."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021532129 same reporter/drug/event different patient
RED SPOT ON INJECTION SITE; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 150 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included non smoker, wine-one glass with dinner, and short term memory stroke, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on right arm with 2" length of needle on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included apixaban for due to stroke. On 14-MAR-2021, the subject experienced red spot on injection site. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red spot on injection site on 15-MAR-2021. This report was non-serious.
skin felt like it was burning; pins and needles; fever of 99.6; aches and pains; patient received vaccine via subcutaneous route with no adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a 66-year-old female patient who stated skin felt like it was burning, pins and needles, fever of 99.6 and aches and pains and patient received vaccine via subcutaneous route with no adverse event  after receiving influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rivaroxaban (Xarelto); verapamil; and paracetamol (Tylenol).  On 03-Oct-2023, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine, prefilled syringe (strength, lot, expiry date: unknown) via subcutaneous route in left arm for Prophylactic Vaccination (immunization). Information on batch number was requested and patient received vaccine via subcutaneous route with no adverse event (incorrect route of product administration) (latency: same day)  On 03-Oct-2023 the patient had events of skin felt like it was burning (skin burning sensation), pins and needles (paraesthesia), fever of 99.6 (pyrexia) and aches and pains (pain) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  It was reported, Received 65+ shot at Pharmacy at 11:00 AM. Was fine all day. At 7:00 PM, took xarelto 15 mg and verapamil 240 mg. Within 1/2 hour, my skin felt like it was burning with pins and needles. I developed a fever of 99.6 with Tylenol in my system. I had severe aches and pains .  Relevant laboratory test results included: Body temperature - On 03-Oct-2023: 99.6 UNK  Action taken with quadrivalent recombinant influenza vaccine (Flublok Qiv) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome:  Unknown for the event patient received vaccine via subcutaneous route with no adverse event and Recovering / Resolving for all other events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Immunization provided to patient.  After 5 minutes patient became light headed and had a syncope event. upon coming to Vomiting occurred.  Layed patient down and placed cold pack on back of neck.  Water provided. BP taken found to be stable.  Vital were normal. Within 5 minutes of sitting patient back to pre vaccine status.
I got a ringing in my ear. I was diagnosed with Tinnitus on April 9th. They did a hearing test and ruled out any other problems with my ears. There wasn't anything that could be done about it. I took vitamin supplements online, I took them for about 3 months. It doesn't feel like they helped, but it did help improve from one COVID-19 shot to the second vaccine. Its a constant ringing, and high pitch sound. I was told by my doctor that there's nothing that can be done about it. I thought it was related to my antibiotic but it didn't seem to be that. It was getting any better from the first dose reaction.
felt uncomfortable for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of discomfort in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt uncomfortable for a couple of days after the first dose of Shingrix. The reporter did not consent to follow up. This case has been linked to cases US2019228120 and US2019228122 reported by the same reporter.
Patient came in on 11-6-22 to another location to report adverse advent. Patient states arm swollen, red, over about 3 days reach 3cm in diameter. Patient reports fevers, chills, about the 3rd day starting to go down after taking tylenol, but as of 11-6-22 still red and swollen. Patient did not report to ER.
Symptoms started in the evening on same day of vaccine: Temp max 100.6; 1 episode of vomitting; Chills
After being administered the vaccine, I began to itch.  Within the first 3-days, I developed hives including swelling, rashes, wheals, and severe itching.  I also had heart pain and palpitations.  The severity of symptoms became worse not better over time.  I developed large blisters on my hands and feet and continued to have hives, rashes, swelling, itching and heart issues since being vaccinated.  I sought medical care at an urgent care center and at my primary provider.  I was prescribed an initial 7-day prednisone packet, plus Benadryl and Pepcid AC.  The symptoms lessened but returned after 2-days without prednisone.  Since then, I have been prescribed 2 more packets of methylprednisolone, Benadryl and Pepcid AC.  Each time I finish with the prednisone component, the symptoms start to worsen again.  I have been reacting to the Pfizer vaccine 24/7 for 93-days.
Pt's husband called and reports: a day or 2 later after PCV13 injection pt developed a red, ring redness to the injection site, warm to the touch, denies fever but now has developed sore rash around it.
I had a sore throat, a cough and neck pain. I contacted the doctor and had a telehealth visit. The nurse inquired about my profession and advised me to have a COVID-19 test at the urgent care and they did the swab for COVID-19. They called me the next day and told me I was positive. I was prescribed pills for the cough. I am still currently going thru the symptoms. I still have the cough and sore throat. I was advised to contact my healthcare provider again if I was still symptomatic after June 23rd.
2 month old male presents with c/o fever low grade and sleeping a lot with shots, eating well, voids a little down, but other wise doing fine.
TOOK TWO DOSES IN A ROW; This spontaneous case report (PVX2019-2005) was received from a consumer on 02-Aug-2019. It described a female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took first two doses in a row. The doses were taken on 01-Aug-2019 and 02-Aug-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
p/vax pt exp soreness @ the inj site which subsided;pt started to devel a rash w/approx 10 bumps that resembled insect bites w/surround red area that have been coming & going;malaise;scattered papules;dx Ehlers-Danlos synd;
Pt recvd pneumovax 23 approx 1989; Later devel positive streptococcus pneumonia culture;
Patient was waiting the 15 minutes for observation after vaccine was administered and after about 5 minutes patient slid out of chair and had a syncopal episode with extreme redness around throat area, elevated heart rate and blood pressure, extreme shakiness. And could not clearly describe her symptoms. Patient stated she just wanted to go to sleep. Patient was monitored and epi pen was administered to patient by provider. EMS was called and patient transported to ER.
I have a patient who had muscle disease following the vaccine; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced have a patient who had muscle disease following the vaccine on an unspecified date. Reporter (Rheumatologist) stated, I was calling to see what's the process is for may be reporting, what I think it could may be associated with the Covid vaccine. I am a Rheumatologist and I have a patient who had muscle disease following the vaccine. I was just curious about reporting over the phone. Rheumatologist stated That's why I am calling I don't know how much information you need. I don't want to go through this long list of questions. I think I didn't gave her the vaccine somebody else did I only give she just came to me after that. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call. The outcome of event was unknown.  Information about lot/batch number has been requested.
Patient's wife developed shingles immediately following injection of o.patient.  Patient's wife has had lymphoma of thyroid about 5 years ago.eular doctor She was taken to emergency room on Saturday October 27, 2007 about 11 AM and was treated by Dr.  Her regular doctor is MD.
Broke out in large itchy hives around my waist, buttocks and leg.  Took Benadryl to relieve symptoms.  As of yet has not resolved.
Pt received vaccinations for trip overseas. Didn't feel well next 2 days. Fever to 99.2 F. OK now but swollen lump under chin per mother. Parent requested VAERS.
Slight fever - red neck 1st day 4" long 1" wide red swollen welt at inj. site lasting 3 days. Hot to touch, no itching.
Tinnuitis. Started Apr 7, 2021, about 1 week after 2nd vaccine dose.  Rt>Lt ear. Increased Sinus Pressure.  ER Apr 8/9.  CAT Scan positive for congested sinuses.  Placed on Amoxicillin for 7 days + Pseudofed bid.  No real relief.  Saw Primary DR.  Apr 13, 2021.  Removed ear was rt ear-this helped a bit. Told to stop pseudfed and start Mucinex and continue with Amoxicillin for e additional days (total 10 days). Minimal relief. Still have buzzing in my ears.  Plan to see an ENT DR.  Will call4/19/2021. Unable to sleep!!!
Patient with pain, redness, induration 3-5 cm, warmth, elevated body temperature, and itching at site of injection > 8 days
After getting Hep B vaccine #2 at 1100, pt reports he developed headache, feeling hot/cold and redness of face, neck, arms, hands at 1300 with 2 episodes of mild lightheadedness. When seen at Employee Health at 1510, his symptoms of redness were fading, his headache was 4/10 with ALEVE at 1330 and he was not experiencing other symptoms; email from pt next AM states he recovered.
history of her and her husband being slightly immunocompromised; history of her and her husband being slightly immunocompromised; felt heat at the injection site; felt mild, warm tingling sensation at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd Dose, Caller states that after the second dose of vaccine, she felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu.), for Covid-19 immunization, reaction(s): "tiredness", "cold", "Nausea"; Bnt162b2 (1st Dose, Caller states the second vaccine had stronger effects than the first one.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "history of her and her husband being slightly immunocompromised"; FEELING HOT (non-serious), outcome "unknown", described as "felt heat at the injection site"; INJECTION SITE PARAESTHESIA (non-serious), outcome "unknown", described as "felt mild, warm tingling sensation at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101706095 same reporter/drug/AE with different patient
Patient presented to ED with chest tightness on 4/20/21  54YO male with PMH significant for CAD s/p PCI to RCA x2 (2003, 2005), chronic HBV, GI bleed, H. pylori gastritis presented to the hospital with chest tightness. Patient had just finished working out for about 45 minutes when he noted tightness across his lower chest/epigastric region. Found to be in V tach upon arrival and underwent electrical cardioversion with relief of symptoms. Patient was aspirin loaded and started on heparin and lidocaine drips. He underwent cardiac cath which did not show any hemodynamically significant stenosis. Also underwent cardiac MRI which demonstrated a non-viable transmural infarct of the inferior wall. Etiology of VT was thought to be scar mediated from prior MI. Patient underwent uncomplicated ICD placement and was started on metoprolol. ICD interrogation POD 1 was unremarkable. Patient discharged in stable condition with close follow up with PCP, Cardiology, and EP. Patient with unchanged coronaries and unchanged ejection fraction. Patient received Covid-19 Pfizer vaccine IM on 3/27 (left deltioid - LOT ER8733) and 4/17 (left deltioid - LOT EW0170).
I received my first Covid vaccine on Saturday, February 27. I began to experience severe pain in my torso on Sunday, March 1. Initially there was no rash just a line of pain around my torso on the right side. I sought medical attention on Wednesday, March 3. I was diagnosed as having shingles. The doctor has prescribed  prednisone 20 mg twice daily for three days then every day for four days and Famciclovir 500 mg tablets one tablet three times a day for seven days. I am concerned about proceeding with the second dose.
A 10 year old patient came in for Pediatric Pfizer booster. Was administered with .3ml Pediatric Pfizer that was not reconstituted with the diluent.  No adverse reaction was observed.
In bed day after shot due to reaction; two days later heart attack coronary artery blocked ; may or may not be related; possibly due to stress from shot?
Stomach ache, diarrhea, confusion, body pain began the evening after she was vaccinated. Followed then on 2/11/2012 with the appearance of 4 spots on her back that the husband noticed. On 2/13/12 she was diagnosed by her family doctor as having Shingles.
High fever the next day, highest was 101.5, lowest was 100.8.  Severe body aches, felt like the flu.  2nd day, lower grade fever 100.8 highest, only pain was injection site, very hot to the touch but flu like symptoms were gone.
Pt's husband called pharmacy about 7:30pm to report wife was clammy, sweaty & felt like fainting. She was lying down but felt sick, had rapid heart rate & felt like something was "stuck in throat". She now felt very cold & had chills. I advised pt go to ER where she was diagnosed with anaphylaxis due to flu shot. I advised pt talk to me about any future flu shots since chance of anaphylaxis was high. If she does decide to receive another flu shot she should have in MD office. I spoke to pt 10/8/11 in am. She said she felt much better.
Starting about a month after Pfizer vaccines and lasting a couple of months I started to experience frequent PVCs or feeling of heart skipping a beat. This has since resolved but for a period was happening quite frequently. Had never felt this prior to vaccination.
Headache first.  Then progressed to loss of appetite, nausea, tiredness.
Fever of 100.4, flu like symptoms, lymphadenopathy of right axillary.
Information has been received from a registered nurse concerning a white 15 month old female with no known drug allergies who on 02/23/01 at 10:00 AM was vaccinated with MMRII (Lot 537382/1509K)SC in the left arm. concomitant vaccinations on the same day included the first dose of Streptococcus pneumoniae vaccine (Prevnar) (Lot # 473-332) IM in the left thigh  and the fourth dose of diptheria toxoid(+) haemophilusBconjugate vaccine (+) pertussis vaccine(+) tetanus toxoids (TriHibit) Lot # UA554AA and UO341AA) IM in the right thigh. On 03/23/02, within 15 minutes of the injection with MMRII, the patient developed a 1 cm hive with an area of red plaque with a central white wheel. She had no other hive lesions develop. The child was given diphenhyramine (Benadryl) 3/4 tsp and ice. She was observed in the clinic for an additional 30 minutes without further reaction. The mother was given instructions to give diphenhyramine same dose every 6 hours while awake on 03/23/01 and then discontinue. The patient recovered from the event. The patient's sister (WAES#01033060) had a similar experience. No further details were provided.
MMR Booster - Runny Stools the next day - Followed 2 days later by fever of 102 and up for 4 days- on the 4th day complained of pain in legs and couldn't walk - could only walk on tip toes.
Pt vaccinated w/first 2 dose of vax w/o adverse experience; following 3rd dose developed temp of 101F, malaise & h/a; pt had malaria, condition was not related to Hep B Vax;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.33 No concomitant medications were reported. On 17-Feb-2021 at 09:00 A.M., the temperature recorded was 22 degree Fahrenheit and vial was initially moved to the fridge on 11-Feb-2021 and beyond use date was 13-Mar-2021. Product moved to clinic on 17-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Severe body aches for two days. Frequent urination, fever up to 102 for one day, lingering low grade fever and body aches, anxiety, hunger,  headache, cough, shooting pains in my neck and hip joint, emotional distress(mainly crying), elevated heart rate
Nurse mixed vaccine vial with 0.3 mL diluent instead of 1.3 mL. CMA administered one dose from vial. Rest of vial was discarded.  Patient was observed for 30 min. Parent was informed by provider by phone. Patient stable at discharge . Parent will be contacted today (6/30/22) for follow up by nurse. Per notes no symptoms, bruising at injection site 6/30/22.