chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A parent reported that her 24 month old son received an injection of Prevnar on 5/9/01. On 5/10/01, at approx. 02:00 AM, he awoke with "severe" stomach cramps. At 09:00 AM, he developed a temperature of 103F and was given Tylenol. At 11:00 AM, he experienced lethargy and a seizure. Between 13:00 PM and 13:15 PM, he experienced 2 additional seizures. The reporter described the seizures as "jerks". The child's physician was notified and indicated that these were febrile seizures. The child was seen by the physician and blood work allegedly showed "low" iron and "low" RBC's. The child was hospitalized on 5/11/01; his mother indicated that her son was dx'd with "erythroblastemia". He received a transfusion and later released to home. On 5/14/01, the mother reported that her son developed "severe" diarrhea. No further information was available at the date of this report. F/U info received from the physician on 10/16/01, provided office and hospital medical records. On 5/10/01, the physician noted that the child was very fussy and lethargic and had a fever of 101.4F. During the exam, while the mother was holding the child, he experienced 3 separate episodes where his body jerked about 3 times each, followed by some crying. During these episodes, the child remained awake and did not lose consciousness. The physician noted that the child was pale and referred the child to the ER for a hematologic evaluation. The physician suspected a viral illness, possible febrile seizures and severe anemia. The following day, the child was transferred to a hospital. A primary dx of severe anemia, probable transient erythroblastopenia of childhood (TEC) was made. Associated dxs included fever and convulsions. He was transfused with 1 pedipak of packed RBC's and if well tolerated, 3 additional pedipaks were planned. The child was discharged to home and scheduled to return to the center within 7 to 10 days for a repeat CBC.
Pain & swelling in his arm significant enough for him to have difficulty moving it. The pain started the night of the vaccine & had been an issue for 24 hours at the time of notification
Patient with syncope event 5 minutes post vaccination. Patient falling forward out of chair and hit forehead. Immediately aroused and neurologically appropriate. Placed in recumbent position, given juice and water. Sat up about 10 minutes later and hypotensive requiring being placed in recumbent position for another 10 minutes. Escorted to ED.
This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included stent placement, and concurrent conditions included diabetic. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced swelling of left ankle. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of left ankle. This report was non-serious.
Injection site is greenish at the top and reddish around it; Injection site is reddish; Injection site is sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site is greenish at the top and reddish around it) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site is greenish at the top and reddish around it). At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site is greenish at the top and reddish around it) outcome was unknown.            Treatment medication included use of Amica cream to alleviate the symptoms.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain  and vaccination site erythema are consistent with the known safety profile of the vaccine.
PT reports 5 severe migraines within the last three weeks since receiving her COVID vaccine. She states the first one occurred 3 days after the shot. She states she has had migraines occasionally in her life but never this often. PT is in the ER for a TIA on 2-14-22.
Immediate light headedness. Took blood pressure after 15 minute wait. 3 times. First two were very high. I sent the results but they did not arrive? the third, after deep breathing through the first two, was normal. I went to work for 5 hours and felt fine. A bit weak but okay. I went home, drank some wine and took a nap until about 7:30 pm. When I woke my left arm was hurting. I felt very weak. I made a sling  for the arm and went back to bed. I slept for almost three days. I had to take 3 days off work and am still very weak and the arm is guarded and it hurts to use it as I normally would.  I called the pharmacy and they said it would get better with use. It has not yet. I see the doctor for allergy on Monday the 28th. The first shot, I did suffer pain in the arm but not unbearable and not weakening.  Today I actually had blurry vision, that was when I called the doctor.
Patient stated that when he got home a few hours later during that night, he felt very uneasy on one side of the body, he felt digestive problems, not feeling well, and not being able to eat. After that night, in the morning he felt fine again.
Vaccine was given in the left arm. A brown  bruise appeared on the right upper arm. the next day. No pain or discomfort.
Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10:40 & She started to have tingling in her hands about 15 mins after.  I took her blood pressure at 11:00am because she was getting dizzy/lightheaded.  It was 135/85 & her pulse was 85 so I believe she was getting more anxious. At 11:05 she stated that she was having trouble breathing, so I confirmed with her several times that she was having trouble breathing & gave EpiPen in left leg 0.3mg then called 911. She felt like she was breathing easier but was going to pass out so had her lay on her back with feet elevated until paramedics arrived.
Swelling/redness/rash around injections site.  Mild pain and stiffness in left upper arm
I had burning feet at night- so hot; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left am on 20Apr2021 at 01:00 PM as 2nd dose, single for COVID-19 immunization. It was reported that patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left am on 20Apr2021 at 01:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 06:00 PM, patient had burning feet at night- so hot that patient had to pit ice packs around them for two nights in a row after the 2nd dose. No fever. Patient was not pregnant at time of vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The outcome of the event was recovered.  Information on the lot/batch number has been requested
I've had a low grad consistent 99 fever since receiving the booster and have been bleeding (mensuration) since that day as well. My regular cycle completed 4 days prior to getting the shot.
The patient's wife called to report that her husband received his flu vaccine with no adverse reactions for the first two days.  Starting on day three, the patient was experiencing pain in his bicep that has gotten worse over time.  Today, he was having trouble raising his arm due to the pain.  The patient has used ice, heat, ibuprofen, and lidocaine to help with only temporary relief.  I recommended the patient may want to have a physician consulted if it continues to worsen.
I started having a sore throat on Wednesday before I tested positive, followed by an extremely runny nose, extremely tired. I took an Ihealth test that came back positive, called in a prescription for PAXLOVID, I am feeling better just still tired.
Itching, redness and warmth on the injection site; Itching, redness and warmth on the injection site; Itching, redness and warmth on the injection site; This spontaneous case was received on 10-Nov-2022 from other healthcare professional (consumer/nurse) via Communications (reference number SEQW22-05668) and concerned a 65-years-old, female patient.  The patient had no relevant medical history. The patient's concomitant medication included Zoloft (sertraline hydrochloride), calcium and vitamin e, all used for unreported indication.   On 07-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0,5 ml, route of administration and anatomical location: not reported), for influenza prophylaxis. The batch number was not reported.  On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site.  The outcome of events vaccination site warmth, vaccination site erythema and vaccination site pruritus was unknown.  The reporter assessed case as non-serious.  Company comment: A 65-year-old male patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site. Causality is assessed as possibly related, based on anatomical and chronological plausibility.; Sender's Comments: A 65-year-old male patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site. Causality is assessed as possibly related, based on anatomical and chronological plausibility.
Pt recv booster vax & 11 days later to MD w/cellulitis @ inj site (right deltoid). Pt allergic to Penicillin & Motrin tx w/Keflex & Benadryl. Cellulitis resolved.
potential Covid-19 breakthrough case/covid test date=17Dec2021, covid test result=Positive; potential Covid-19 breakthrough case/covid test date=17Dec2021, covid test result=Positive; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 23 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 09:00 (Lot number: EW0217) at the age of 23 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 21Apr2021 12:00 (Lot number: EW0161) as dose 2, single, and intramuscular, administered in arm left, administration date 31Mar2021 12:00 (Lot number: GR8734) as dose 1, single for covid-19 immunisation; influenza vaccine AFLURIA QUADRIVALENT, administered in arm right, administration date 27Oct2021 (Lot number: P100354282) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported IMMUNISATION (medically significant) with onset 27Oct2021 09:00, outcome unknown; VACCINATION FAILURE (medically significant) with onset 17Dec2021 12:00, outcome unknown, COVID-19 (medically significant) with onset 17Dec2021 12:00, outcome not recovered. The event potential covid-19 breakthrough case/covid test date=17dec2021, covid test result=positive, and potential covid-19 breakthrough case/covid test date=17dec2021, covid test result=positive was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (17Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. No allergies was reported.  No follow-up attempts are possible. No further information is expected.
My baby was sitting in her high chair when she stopped breathing and her eyes rolled back into her head and her body went limp. This lasted about 60 seconds. I rushed her to the infirmary in case she had another. When they did some tests on her that diagnosed her with Pneumonia and I saw on the brochure doctor gave me it can happen to some children even though rare.
Fever, redness & swelling at vaccination point.  Baby slept for 2 days, would wake up screaming several times and inconsolable, lack of appetite and could not wake him to feed.  This was completely out of character for my baby.
Pain, swelling, bruising at injection site, fever , no appetite, feeling very sick, sent home from school by nurse  the following day Jan 7, 2020.  Pain and Swollen arm still present above injection site day 4. Swelling, pain present for 7 days.  7 days purple bruising at injection site.
Fever 102, edema allover my body( specially left arm, left shoulder, left breast, under my left armpit), body aches, severe joints pain, headache, weakness, fatigue, pain and heaviness in my left arm with numbness and tingling, memory loss.
There were several times that I had to be off work because I was experiencing fatigue and flu like symptoms. In July 09, 2021 I had to leave work early and go to the ER with a fib and rapid ventricular response. They did x-rays, blood work, CT scan. Since then I have been seeing the cardiologist and they have made more tests. They said I have super low injection fraction in right ventricular and left bundle blockage and they said I might have had a heart attack and I told them I was feeling fine until that day. Since then I have been staying home. They gave me some heart medications.
have the same shoulder pain that I experienced with the first two vaccine, very similar; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jan2021 (Lot number: FE3594) at the age of 42 years as dose 2, single and administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Verbatim: Type 1 diabetes. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "have the same shoulder pain that I experienced with the first two vaccine, very similar".  Additional information: Consumer was informed about Pfizer. Consumer was informed about Information department. Consumer was provided with Information department contact information. When probed if patient has received the Pfizer COVID-19 Booster Shot: Consumer stated, "Correct." Consumer stated, "I have the Lot number." Consumer stated, "I would not be surprised. It is definitely noticeable shoulder pain so it lead me to believe that I got something." Laboratory tests were none. Investigation Assessment: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The date of booster (3rd dose) was given before the 6 months period apart from the second dose, as 2nd dose given on 6/4/21 and 3rd dose given on 11/12/21. Patient did not show any adverse events at the time or during 15 minute monitoring period.
presented to clinic on 03/11/2020 with c/o swelling, pain & tenderness of the upper left arm / axillary - Pt was seen on 09mar2020 for a smallpox "take check" with normal results. Pt states the site continued to get more red & swollen over the past 2 days - pt states he has not taken anything for the pain & swelling. Increased redness around smallpox site with increased swelling in left axillary compared to initial "Take Check" on 09mar2020. Pt also states he feels pulsating upon rest. Pt denied chest pain & difficulty breathing Pt showed facial grimacing upon palpation of left axillary area. Provider notified.
Patient described a clear liquid coming out from under the Inject-Safe Barrier Bandage, after exiting out of the store (after shopping in the store as well). The liquid created a stain of approx 5 inches on her sweater. She did not report it immediately and went home. Overnight, she developed pain, swelling, bruising around the injection site (she described it as black and blue) and some more clear liquid oozed out. She called her MD and the nurse advised her to call the pharmacy. As of now, no other symptoms developed. The patient is monitoring and she will report to ER or Urgent Care if symptoms get worse. Patient states she has received this vaccine last year with no side effect, other than being a bit tired for the following 1-2 days. This time she said she only felt a bit tired for the first part of today.
had the vaccine, still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
It hurts to sleep on that arm; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received crizotinib (XALKORI) at 250 mg, with frequency, route of administration, therapy dates and indication unspecified; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was hurting to sleep on the arm. The action taken in response to the event for crizotinib was unknown. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Zoster (shingles) rash on right arm (same arm where she got the vaccine seven months earlier. Patient is otherwise asymptomatic and is expected to recover.
On 10/9/2012 a 48 year old female was administered an inactivated influenza vaccine (Multiple dose vials, Novartis (FLUVIRIN), Lot# 1205901, Exp - 06/30/2013) in occupational health. Per pt report, roughly 45 minutes to an hour after the administration she experienced pruritus from her ears to her throat and a rash on her back. She returned to occupational health and was given 50mg of diphenhydramine which resolved her pruritus. She had an influenza vaccine administered in the previous year, 2011, without adverse effect. She was directed to not receive an influenza vaccine again this year in 2013.
I had only a sore arm until about 14 hours second shot.  Became chilly, achy, and fever 100.6.  It was like one second I was fine and next it hit me all at once.   I drank a lot of fluids, mainly Pedialyte and chicken soup.   My temp hovered between 100.5 and 101.6 most of the day.   Around 7PM, it went to 102.4 and I took one 500 mg Tylenol.   That brought it down to the mid 100?s.  I took another 500mg Tylenol at midnight.    This morning, about 24 hours after my 2nd shot, I still have a slight temp of 99.4 but no aches.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 29-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
itching more and more all over her hands, eyes, ears, everything/few spots on her body; Been cold; Short of breath; Blood pressure up; itching more and more all over her hands, eyes, ears, everything/few spots on her body; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The Patient did not received other products. Caller received the first Pfizer COVID vaccine on 24Mar2021. Caller asks could it be related to the vaccine. On unspecified date, A week ago she started itching more and more all over her hands, eyes, ears, everything. It is only a few spots on her body. Caller asks could it be related to the vaccine. She has been cold, and shortness of breath. She got real short of breath a couple nights ago, and her blood pressure was up. She had to take her blood pressure medicine to get it down. She did not stop itching and had another spell last night. She got her breathing under control. States it is like she was itching on the inside. She has not change her laundry detergent and she is not on any new medication. Caller says maybe it is an allergy to some pollen or could it be the shot. She asks could it be affecting me after three weeks of taking it.Could this possibly be from vaccine. She do not want to take the second one if it is from the vaccine. She called her doctor and if they call back she may go see him. The outcome for the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Tennitis. Started in left ear pulsing different frequencies now a constant high pitch ringing. Seems to be getting louder over time. Right ear started ringing Aswell now but not as loud as right.
1045 - c/o dizziness. Laid on floor with feet elevated. Pale, skin warm, dry. BP 78/50, p-72. A & O, speaking banana/coffee this am. 1048 - 84/58 - sitting up 1050 - BP 90/64, P-60.
As the influenza shot was placed in arm, left arm and hand went numb. My hand remained numb and tingled for an hour and a half, then my left arm started improving. Still has numbness on forearm and base of palm. Large egg shaped lump around injection site.