chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body ache; Fatigue; Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced fever, body ache, fatigue, nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fever, body ache, fatigue, nausea and vomiting were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/5/21 patient noticed spotting  and urine in underwear, patient has not had period for over 3 years.    By 11/8/21- Patient had pretty heavy bleeding similar to having a period.  She also had abdominal pain on her sides.  As of 11/11/21 patient states she still has her period.  She will see her md next week.
5 days after the injection, I started having intense itching at the injection site. 7 days after injection, I have an itchy, red, hot circle rash around the injection site.
15cm x 10cm erythema around injection site/5cm x 5cm induration around inj site/L thigh. Minimal tenderness.
No additional AEs reported; 5 year old patient was administered GARDASIL 9; This spontaneous report was received from a physician and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-OCT-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). No additional adverse events were reported.
Per the report, the patient was due for this year's flu vaccine. Consent was obtained from the parent and the form was signed. I drew up the Fluzone vaccine and upon entry to the room, obtained the patient's name and date of birth and verified the vaccine. When I went to enter the administered vaccine to our EMR, I observed that a flu vaccine was administered on 11/8/2022 but was not documented in system. However, signed consent for that date was present in the patient's EHR. I informed the provider and my immediate supervisors. I spoke with RN from our Immunizations Department...who advised that the patient was at risk to develop a high fever and that ibuprofen was recommended to be used every 6-8 hours, at least three times. I informed the parent of the error and how it occurred. The patient was kept for approximately 30 minutes after the vaccine and showed no noticeable signs of a reaction. Patient was alert, oriented, had a good demeanor, was breathing and playing well and skin appeared within normal limits. I relayed the recommmendations for ibuprofen use for the next 24 hours, parent demonstrated understanding. I called and followed up with parent on 12/8/22 who stated that she did not use ibuprofen since the patient did not develop a fever and the injection site looked fine, the patient was also playing and acting well.
After the injection the patient grabbed her arm and when she was asked if she was ok she didn't respond and seemed slouched down. It didn't seem like she passed out but she was slouching and not responding. She seemed like she was having convulsion that lasted less than 5 seconds. Then she calmed down and her breathing was fine. I got her to respond to me that she was awake and ok. She responded with head nods. She seemed to come to a little more after a minute and she said she was fine but I wanted to call 911. I called the paramedics. During the wait she seemed to get better, we gave her water and she was slowing starting to move around more. We asked her about any under lying issues or any problems with any vaccine before. She said no to everything. The paramedics came and took all of her vitals and she was cleared that everything was ok. She called her boyfriend and we asked him to come by to help her and give her a ride home and assist. He got here and she still didn't feel totally better. After a few more minutes I took her blood pressure and it was 87/55 and her pulse was around 60. We called 911 again because she stated she wasn't feeling well again. The paramedics came back and she had a 89/41 blood pressure with a pulse of 40. They indicated that she may be having a cardiac issue so they took her to the ER.
Case number PHEH2015US021921, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 38-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157003) intramuscularly on 19 Oct 2015. On the same day after vaccination, the patient experienced immediate local reactions to heat, swelling and itching at the injection site. On 20 Oct 2015, the patient experienced chest tightness, shortness of breath, dizziness, headache, hot flash, the patient's heart felt heavy and feet were tingly. The patient took BENADRYL. On 21 Oct 2015, the patient blood pressure went up and she went to emergency room after the patient spoke to a nurse. The patient blood pressure was through the roof and it set the alarm off on the machine. On 22 Oct 2015, the patient was pretty much tired and anything the patient did left the patient winded. The patient used Albuterol inhaler to help with tightness. On 23 Oct 2015, the patient had to leave work due to dizziness that lasted for hours. Itching, swelling and redness went away on 24 Oct 2015. The site flared up on 26 Oct 2015. It was reported that over the weekend the patient was still winded and fatigued and outcome of other events was unknown. Seriousness of the events and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Fever of 102.4, Tylenol 100mg reduces fever to 99.8. Fever returns when Tylenol wears off approximately 4 hours. Body aches, weakness
Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid; Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: diagnosed with Covid-19, after being vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that she received the Pfizer Covid 19 vaccine primary series and a booster. She was presently taking Paxlovid, and she wanted to know if she could get a Flu vaccine and the Pfizer Bivalent Covid booster and if she can have a glass of wine while she was taking Paxlovid. She also wanted to know how long she should wait after completing her Paxlovid course before she gets a Flu shot, and the Pfizer Bivalent Covid booster vaccine. Patient declined to complete a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Transverse Myelitis.  11/23 and 12/01/09 Medical records and discharge summary recieved for DOS 10/12-10/18.  Final DX:  Acute disseminated encephalomyelitis, most likely s/to flu vaccine.  Hypertension uncontrolled.  GERD, Dyslipidemia.  Myalgias s/to statins, improved.  D/C to home.  C/O diplopia, balance problems, burning skin. Muscle weakness and pain. Tachycardia, hypertension. Reflexes 2/4 bil proximal and distal. MRI + acute demyelinating encephalomyolitis probably s/to vaccine. IV steroid tx, immediate improvement.  ICD9 Codes:  760.79, 789.02, 784.0, 368.8, 780.4, 401.9, 305.1, 401.9, 728.87, 784.0, 434.91, 066.0
2MAY95 t101.4 ax, vomiting, whining; 7MAY95 lt message @ #; 12MAY95 NA @ # letter sent; 21JUN95 contacted MD ofc pt seen 2MAY95 w/t102 & ear pain; dx early lt OM w/probable vax rxn;
slight itching and small bump onright arm.; small bump on right arm; discomfort with small knot in lower right abdomen; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA vaccine; Lot number; En6208) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and type 2 diabetes. The patient had a history of allergy to shellfish and PAC (perennial allergic conjunctivitis). Concomitant medications received within two weeks of vaccination included valsartan (MANUFACTURER UNKNOWN) and metformin hydrochloride (MANUFACTURER UNKNOWN) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 16:00, the patient had experienced slight itching and small bump on right arm. She had noticed discomfort with a small knot in lower right abdomen on Wednesday. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight itching and small bump on right arm, discomfort with small knot in lower right abdomen were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
No symptoms other than possible Abdominal Aortic Aneurysms, not in age group, race, or factors that would cause this event.
Two full doses of 0.03 ml of Pfizer boosters given on in left arm and one in the right right arm on the dame day by volunteer RN. She had though she had given first injection as a 1/2 dose so administer a second dose also thinking she had given another 1/2 dose. At the end of the Clinic  she was checking her paperwork and realized she had given a second full dose and reported the error. Today when mother of patient contacted she reported only a temperature of 99.5 as the only symptom.  the ARNP contacted Mom and discussed the potential side effects.
Heart palpitations; increased heart rate; SOB; chest pain; throat closing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 12:00 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "Heart palpitations"; HEART RATE INCREASED (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "increased heart rate"; DYSPNOEA (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "SOB"; CHEST PAIN (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "chest pain"; THROAT TIGHTNESS (medically significant) with onset 19Nov2021 12:30, outcome "recovered with sequelae", described as "throat closing". The events "heart palpitations", "increased heart rate", "sob", "chest pain" and "throat closing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (19Nov2021) increased. Therapeutic measures were taken as a result of palpitations, heart rate increased, dyspnoea, chest pain, throat tightness. The patient received treatment with Epi pen, iv fluid, fantomide, Benadryl and prednisone.  Clinical course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: Heart palpitations, increased heart rate, SOB, chest pain, throat closing. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. It was reported that Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I noted on November 2, 2023, that I gave the patient the wrong vaccine.  He was supposed to receive MCV4 (Menveo) instead of Bexsero since he was only 14 years old.  I called the patient down to the health center from class, on November 3, 2023,  and asked him about any possible reactions from his vaccines he received a week earlier.  He stated that only had sore arms but did have a small bruise on his right arm, however, he did receive 2 other vaccines in that same arm, in the same vicinity as the Men B, that same day.  I explained to him what happened and that I would be calling his parents to inform them also.  I was unable to reach his parents so will try again on Monday, November 6, 2023.  I spoke with the patient's mom later in the evening and explained to her the error that was made and let her know that she may get some follow up calls about this.  Explained to her that she shouldn't notice any problems at this point, being 1 week after the vaccine but if she did she could contact her son's dr. office or our office with any questions.  Just a note that mom does not speak the language.
Patient experienced a slight fever relieved with medications, swelling and redness at the site, and soreness at the site of injection
Six days after I received the vaccine, I experienced blurred vision and loud tinnitus. I felt weak and shaky, my whole body just felt like it was shaking. I was having inflammation zingers. I felt like my body was inflamed and bad brain fog. Two days after that I started having pain in my left leg below my calf muscle and behind my knee. Whenever the knee pain started happening, I started to get worried, the pain started on 4/14/21 in my left leg. On 4/16/21, I still felt shaky, weak legs, headache over my ears, and felt borderline nauseated and felt like I was going to pass out. On 4/21/21, I experienced tinnitus through the roof. I went to doctor on 4/26/21 and she ordered a D-dimer test. The test came back elevated. I then had an ultrasound done on 4/27/21 at Radiology. The US came back negative for blood clots. I had another appointment with on 4/30/21, she determined the lymph nodes in my legs were inflamed and that was causing the leg pain. The leg pain still comes and goes. I have experienced numbness in my toes. Another MD feels that it may be the beginning of neuropathy, but I have not had that checked out yet. I am waiting to have an upcoming surgery to have the metal in my neck removed to see if that helps resolve the issues. The vaccine may have triggered an inflammation response to the metal in my body since I have an allergy to metal. ( I have metal in my neck from a surgery a couple years ago, I have a known metal allergy but was not told when surgery was done that metal was placed in my neck. )
shot has your arm sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: shot has your arm sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he or she got it, but that shot had the arm sore, and the patient did good with shots, but guessed it was better than shingles. Follow-up was not possible, as no contact details were available.
site black & blue w/extreme redness & swelling;almost to elbow-hot to touch;sx persist w/continuing severity;
Experienced a little bit dizzy in the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Experienced a little bit dizzy in the morning".  Additional information: Patient reported that her 2nd dose was scheduled on 16Mar2021, however as she was experiencing dizziness for couple of days now so she couldn't come for vaccination. She wanted to know if she could still get the 2nd shot even if it's in a later date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I contracted COVID-19. I was out of the country at a conference around 10/01/2022 and that is where I believe I contracted the virus. I developed a sore throat, headache, fatigue, and runny nose. On 10/07/2022, I received a prescription of Paxlovid. I took the full course of Paxlovid and remained positive until 10/14/2022.
Pt developed malaise x 3 days. He was more achy at the end of the day. He had red, rash-like papules on upper body and trunk.
DIARRHEA; BAD HANGOVER; BREATHING RAPIDLY; SHORTNESS OF BREATH; NOT HUNGRY; FEELS FULL; TIREDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced bad hangover. On 11-MAR-2021, the subject experienced breathing rapidly. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced not hungry. On 11-MAR-2021, the subject experienced feels full. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, tiredness, bad hangover, breathing rapidly, shortness of breath, feels full, and not hungry. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
I am having rashes in my upper torso. Itchy but thankfully not overly painful. I took pictures. They appear to go away, and then flare up. Not sure why
Patient states she had her first Moderna COVID-19 vaccine on 18 March, 2021. She started to have experience back spasms and involuntary muscle movement in her legs the following day. Caller is due to have her second vaccine on Saturday 17 April 2021 but her PMD wants her see a Neurologist before doing so. Symptoms have subsided, but her legs are weak, has difficulty standing for long periods of time.
Patient came in and stated that last month she was vaccinated (8/16/19) after 24 hrs her arm started swelling up. After 3 days not getting better she went to urgent care and was advised to go to E.R. Patient was experiencing adverse reaction (face is swelling and tongue; rapid heart beat) she was discharge on the same day. She is feeling better now.
Mom reports fever 102.8 R 27DEC91, treated w/APAP; 28DEC91 t99 pt was active in AM sz occurred suddenly in afternoon mom called ambulance; t reported 104.7 ax; pt taken to ER;
Information has been received on 01-NOV-2016 from an immunization official/coordinator who reported that improperly stored doses of ROTATEQ (lot# K022992, expiration date 30-JUN-2016), VAQTA (lot# L007559, expiration date 01-JUN-2017), GARDASIL 9 (lot# K005881, expiration date 14-JAN-2017) and RECOMBIVAX HB (lot# J013394, expiration date 25-AUG-2016) were administered to unspecified patients on an unspecified date. Temperature was 31.8 Fahrenheit for a time frame of 170 minutes. There was no previous temperature excursion. Call was because of a data logger. No adverse effects reported. No further information provided. Additional information has been requested.