chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My heart was fluttering and pounding in ways it never had before. I felt it in my neck and chest.; My heart was fluttering and pounding in ways it never had before. I felt it in my neck and chest.; Very strange sensation and scary; Patient received bnt162b2 dose 1 and dose 2 on 10Jun2021 for covid-19 immunization.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Jun2021 (Batch/Lot Number: EW0175) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 (Batch/Lot Number: EW0180) as dose 2, single (both doses at the age of 58-year-old) for covid-19 immunization. Medical history included hypothyroid, cardiac flutter (It happened once when I was driving and I had to stop the car), palpitations (It happened once when I was driving, and I had to stop the car). Known allergies were reported as no. Concomitant medications included levothyroxine 75 mcg daily. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested post vaccination. The patient reported that on 03Jul2021, her heart was fluttering and pounding in ways it never had before. She felt it in her neck and chest. Very strange sensation and scary. It happened once when she was driving, and she had to stop the car. These symptoms occurred randomly day and night for about 10 days. The patient went to see her healthcare provider and had an EKG done, results were normal. Seriousness criteria: results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect was reported as no. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date of 2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for adverse event. Device date was provided as 28Jul2021. The outcome of events cardiac flutter, heart pounding and feeling abnormal was recovered on an unspecified date of 2021.   Follow-up attempts are completed. No further information is expected.
After receiving the vax, the pt returned to waiting room. He sat down in there and reported feeling sick to his stomach the his body stiffened and his eye rolled back. He was lowered to the floor near the waiting room. Mother reported the child was unresponsive for several seconds. The skin was warm, moist and pale in color.
Headache, NauseaVomiting, Chills Narrative:  Other Relevant History:
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-JAN-2015 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Patient developed left leg pain 5 days after the vaccine, with tightness behind the knee, and then soon developed swelling. As pain improved he did not seek attention until today, 4/14/2021 and was found to have a severe large fully extensive and occlusive femoral DVT L leg.
Patient felt lightheaded, dizzy and faint. We sat her down, then laid her down. After 30 minutes, she walked to her daughter's car and went home. I called her at about 6:30 and her husband said she was doing great.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; BUPROPION. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms plus Positive test; Negative, notes: Had tested negative on home antigen for 2 days before rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
first dose: 12/23/2020 - generalized body ache, headache, low grade fever, chills for 3 days until 12/26/2020 2nd dose: 01/20/2020 - low grade fever and chills
arm was a little sore; breaking out in hives; itching and little blotches on her skin; itching and little blotches on her skin; This is a spontaneous report from a contactable consumer.  This 68-year-old female consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown),  on Mar2021 at single dose for COVID-19 immunization. medical history included she is allergic to pollen. She felt all right after vaccination. Her arm was a little sore.  However, since unknown date in Mar2021, she's been "breaking out in hives". She has "bumps on her arm and neck". She stated she feels all right but noticed she's "itching and little blotches on her skin, around her neck and some on her thighs". She took Benadryl. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 13-OCT-2014 the patient was vaccinated with RECOMBIVAX HB lot # H014029, which was expired on 07-SEP-2014. No adverse effects reported. No further information. Additional information has been requested.
Patient received his flu shot and received a bandaid. Upon turning around to place needle in sharps container, the patient leaned out of chair onto the floor. Nurse immediately went to his side and laid platient flat . Less than 1 minute passed and the patient was awake, alert, and asking what happened, trying to get up but patient has told to remain lying down. Patient laid on floor approximately 10 minutes, then he was allowed to sit up for 5 mins. PAtient reported feeling "normal and  okay". Father was offered an ambulance but declined. Mother was called and declined ambulance as well.
This spontaneous report as received from a registered nurse refers to a 9 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Severe joint pain, exacerbated rib injury, lower back pain, fatigue, fogginess, muscle aches, cold
Covid19 Pfizer-BioNTech for age 5years to <12 years vaccine was not diluted and the entire contents of vial was administered IM. 10 X the recommended dose. Initial symptoms were pain/swelling/warmth at injection site, headache, low grade fever, general body aches. Symptoms worsened to fever of 103F, continued headache, body aches. Went to the ER late 9-30-22. Labs and imaging done.
Quarter sized bump at injection site, hot to the touch, sensitive and painful to the touch, redness around area, itching at and around area
Headache, injection site pain, tiredness, chills, fever, injection site redness, vomit, arm pain
Hepatitis A given 05/02/02.  On 05/03 c/o chest pain with difficulty breathing. Went to ER. Dx normal x-ray and EKG. Dx as possible reaction to Hep A with probable Ischemia. Referred to cardiologist.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed tinnitus (got tinnitus in left ear), with outcome of not recovered. The event evaluated at a physician office visit. Additional information: The patient stated she developed tinnitus in her left ear from Pfizer COVID-19 shot. She went to her neurologist/doctors. They said this was not the first time they had heard of it. She wanted to know if there is anything they can do about it. It was driving her nuts. She was told someone was trying to come up with something for it. She developed tinnitus after her first shot. She got second shot because she thought it would go away. She did not know what tinnitus was and did not know it was permanent. She did not know if this was a common occurrence. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt recv vax on 2/23/99;2 1/2 hr post vax pt exp difficulty breathing, stomach cramps, swollen tonsils, dizzy; dx=tonsillitis, bronchitis; tx=antibiotics
At the injection site and it's a bit warm; At the injection site and it's a bit warm and hard; Big red circle on my arm at the injection site; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site warmth). The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: Not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced big red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration) was not reported.; Reporter's Comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the events reported and the product use cannot be excluded. Injection site redness and Injection site induration are consistent with the known safety profile of the vaccine
Patient reports feeling pain upon administration of pneumonia shot and feeling like it did not go into the muscle.  The next day, patient called the pharmacy and stated that her arm was painful, red and swollen. Asked pt if shot was given too high on the shoulder and she responded no. The area where the shot was given was not painful, but lower on her arm, including on the inside of her arm was very red and slightly swollen. States it is painful to the touch. I told her to use Tylenol and ibuprofen to help decrease pain and ice to help with the swelling, but to call back or see the doctor if it got worse. She called me again today (2 days after shot was given) explaining that her arm was not getting any better. As the painful area was not near the injection site and had not improved from the day before, I advise her to be seen by a doctor. She was seen in urgent care later that day and given a prescription for Bactrim DS 1 bid x 10 days for cellulitis. Doctor was not sure if the shot could have aggravated something or it was unrelated. Pt wanted me to report the reaction
-redness at area of injection, MD determined cellulitis, treated with antibiotics. -rash
5 minutes after vaccination - eyes rolled back, lost consciousness, which returned upon being laid down vs stable - lips were blue, but color returned when laid down.  Doctor stated it probably wasn't allergic, but was a veso response.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Information has been received from a physician concerning nine patients in their late fifties, early sixties and their twenties who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X or 665300/1314Y). Concomitant therapy administered on the same patient visit included a dose of influenza virus vaccine (manufacturer unspecified). After administration of PNEUMOVAX 23, the patients had severe adverse effects including malaise, pain, fever, induration, severe tenderness upon touch and erythema. Symptoms lasted for more than one week. All but two patient's had a normal CBC count. It was also reported that one patient had a blood cell count of 18,700. The physician cultured nasal area in all of the patients and did not find anything remarkable. The physician requested a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up telephone information was received from a health care professional who could not supply the following information: patient name, date of birth, date of vaccination, dose number, dates of events and recovery status. A standard lot check investigation for lot# 662905/1162X has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check investigation for lot# 665300/1314Y has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
An 8 year old male received an injection of Pnu-Imune 23 and meningococcal vaccines, each in different arms, on 2/18/00 and subsequently, developed chills, nausea and an injection site reaction at the Pnu-Imune 23 administration site characterized by a 1 3/4" X 1 1/2" area of erythema and pain. He was treated with acetaminophen and cortisone cream. His temperature was 99F.. Additional information received on 10/30/00, indicated that the pt was seen by a physician and recovered.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 17 years. It was also confirmed that on 07-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1709USA005737: US-009507513-1708USA001768: US-009507513-1709USA005735: US-009507513-1709USA005740.
10FEB97 fever started & v once;started dec in appetite;fever lasted till Wednesday;12FEB97 rash started on torso & moved up to neck;very irritable-crying during the noc;eye started looking like hadn't slept, no appetite;didn't drink fluids;
vaccine was stored in the refridgerator instead of the freezer  from receipt 2/27/23
Woke up with a few bumps on arms that I thought were bug bites. Throughout the day she developed bumps that covered her whole body. Some were as large as 5 inches in diameter. By noon her face was swelling and body was covered in raised red itchy bumps. I called Dr. and she said it was due to the MMR vaccine and I needed to give her Benadryl every 6 hours until the symptoms go away.   My poor daughter has been very drowsy and not able to participate in normal activities because of this. I am fearful that she will have long term damage because of this vaccine.
Left arm began swelling, warm to touch and red at injection site. Recheck on 2/28 - swelling and redness have completely resolved. No pain.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a Physician Assistant and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received vaccine, waited 15min in observation room then once he went to his vehicle he states he had to come back in because he felt numbness on right side of face and body.
Narrative: No other information regarding death in chart. Pt expired within 42 days of covid vaccination
Child received MMR 8-4-11. On 8/21/11 mother noticed approximately 5 areas of small, flat red areas of rash on the abdomen, back & forehead. Had a low grade temp. & headache. Today the child has 3 more areas on her face. Mother has been giving MOTRIN. Child c/o not feeling good.
Information has been received from a consumer concerning her 15 year old daughter who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL. The patient has been getting dizzy "almost every single day" when she stands up, she sits down then this happens, and when the dizziness goes away her face feels flushed and she gets a headache. Prior to getting the vaccination, she would feel dizzy sometimes when she got out of bed in the morning shortly before her menstrual cycle. She will not be getting the rest of the series. Additional information has been requested.
Moderna COVID-19 VACCINE EUA  Redness, swelling (hardness), and itchiness at site of injection. This reaction started 7 days after the shot and lasted about 5 days.
I have a complicated pregnancy. I was hospitalized on 01-19-2021 at about 10pm.  I had repeated bleeding episodes. At the hospital they diagnosed me with chronic placental abruption.  I delivered my baby by emergency C-section.   I also had left arm soreness  at the injection site.
2/10: fatigue, fever, decreased appetite. Tylenol 2/11: mental status wax/wane, lethargic 2/13 @ 0900: unresponsive to sternal rub, increased WOB, tachycardic, febrile D5 1/2 NS IV bolus, Rocephin Transferred to Hospital 2/13
30JUL fever & lethargy; 31JUL hives all over face lasted about 4 hrs;
Pt. had small pox vaccine approx two weeks ago and presented to the ER with chest pain and ekg changes, increased troponin and acute mi per ekg. Was transferred for cardiac cath, and was diagnosed with myocarditis.  8/31/07  Reviewed hospital medical records which reveal patient experienced flu like symptoms, sore throat & general body aches.  Then developed substernal chest pain which radiated to neck, jaw & back w/associated diaphoresis & SOB.  Treated at outlying ER & transferred to higher level of care for emergent cardiac catheterization.  Admitted 7/25-7/27/07.  Remained hemodynamically stable & was d/c to home w/military f/u. FINAL DX: Myocarditis; recent smallpox vax; anteroapical hypokinesis by echocardiogram.
feeling urgency for bowl movement; blurry vision; feeling like going to throw up; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL TENESMUS (feeling urgency for bowl movement), VISION BLURRED (blurry vision) and NAUSEA (feeling like going to throw up) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included ROSUVASTATIN CALCIUM (IBSTATIN) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RECTAL TENESMUS (feeling urgency for bowl movement), VISION BLURRED (blurry vision) and NAUSEA (feeling like going to throw up). At the time of the report, RECTAL TENESMUS (feeling urgency for bowl movement), VISION BLURRED (blurry vision) and NAUSEA (feeling like going to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included antiseizure for vertigo and allergy medication 125 mg. Treatment medications included antacid and diphenhydramine. The patient received diphenhydramine on 01-Feb-2021 and 02-Feb-2021.