chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is swelling; fever; it is hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is swelling"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING HOT (non-serious), outcome "unknown", described as "it is hot". Additional Information: NDC number of COVID vaccine: Not Provided. Reason for no lot number: of COVID vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of COVID vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided. Investigation Assessment: Not Provided. It was reported that, Caller said that she calling because she didn't know who to call really, yesterday she took the shot, clarified to the COVID vaccine, and when she came home she got stung in the same arm by a wasp and now her arm is swelling. It feels like it has a fever in, it is hot. When caller was informed that it is recommended for her to follow up with her primary care provider she purposefully ended the conversation and then disconnected the call. Unable to obtain further details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she is positive for blood in her stool; left hip/back/kidney pain; left hip/back/kidney pain; left hip/back/kidney pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020 (reported on 05Jan2021 as 'a week ago Monday'). After getting the vaccine (2-3 days after getting the vaccine) she started to have some events happen that she was not sure were side effects from the vaccine. She mentioned she started to experience blood in her stool - following a test at her doctor's she was positive for blood in her stool. Also, the left side of her lower back and hip started hurting. She was experiencing left hip/back/kidney pain, as reported. She took hydrochlorothiazide. The outcome of the events was unknown. She wanted to know if this had anything to do with the vaccine and if this could be a side effect. These events did not start happening until after she got the vaccine.   Information on the lot/Batch number has been requested.
Due to clients extensive history of allergies, client was placed in 30 minutes post vaccine observation by EMS.  It was there client started experiencing " tingling and scratchy throat." Client's VS were taken at 1148 and as follows: BP 144/103, Pulse 85, O2 Sat 100%-EMS took over care and continued to monitor patient.  At 1159 BP has increased to 158/95. At 1200  50 mg Benadryl IM was given in RDM.  At 1204 BP had decreased to 148/86. EMS made the call to transport the client to Hospital for further evaluation and treatment.
Minimal exertion and I had a hard time breathing. I had to correct by sitting down and control my breathing to catch my breath. When I told my doctor he said it will be fine and prescribed Albuterol. Saw a cardiologist and had ECG, Stress test(nuclear), MRI, blood work, uranalysis, ect. Basically the whole gambit and found it all to normal. Still struggle sometimes when exerting myself.
UTI and then diagnosed with HSV-1 after outbreak occurred around my genitals. I developed what I thought was just a UTI on Thursday and was prescribed the medication to treat that. For the next few days I was sore, had body aches, and chills. On Sunday I noticed the outbreak on my labia and went into Urgent Care to diagnose it. I haven't been aware of any HSV-1 in my system, but somehow I ended up getting HSV-1 all around my genitals. On Sunday i was prescribed Valacyclovir. I was in intense pain when using the restroom for both urinating and bowel movements. I went to my primary care doctor on Monday to have a second opinion and found the same answers. I missed work for two days due to the pain I was in and my inability to walk. I then had to work from home the rest of the week. My partner has been tested and does not have HSV-1 or 2.
Reports 24 hrs after vaccination that pt. developed hives (mostly on stomach), rash, itching and headache. Consulted PMD, took BENADRYL p.o. and sx subsided. Then 48 hrs after vaccination pt developed the same sx, took BENADRYL p.o. and sx subsided. No diff. breathing reported. Pt was never evaluated in person by a physician. No further sx.
Developed red rash on arms and legs beginning on 10/26 (3 days after vaccines given)-presented to office 10/17/05 with erythema multiforme minor (no mucosal involvement)-no fever.
Patient came to clinic for well visit and catch up vaccines as he was behind. He was to get three shots. Kenrix was chosen because it combined two of three vaccines needed which would result in two shots rather than three.  Kenrix and Hib vaccines were given at the same time. Patient tolerated the shots well. Mom was given VIS and encouraged to treat with tylenol as needed, and left clinic. It was then discovered that the Kenrix vaccine is for 4 - 6 year olds. Three seperate attempts were made to contact mom to assess the patient's condition without success. A message was left for her to call back but did not get a return call.  PA was also notified. Clinic was contacted with a return email stating that if the time intervals parameters were met, the doses could be considered valid.
General discomfort: fever, aches. Also, on 3/10/2021, ten days after receiving the 2nd dose, I had recurring fever and aches for another 8 hours
Severe left knee pain and stiffness without trauma.  No redness or swelling.  Feeling of heat on anterior of both lower extremities.   Associated with chills and moderate fatigue.
Injection Site sorenes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Mar2021 17:00 (Batch/Lot number: unknown) at the age of 49 years 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: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021, outcome "recovering", described as "Injection Site soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was also reported that the vaccine was given on Monday 22Mar2020.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11 day post vaccine developed had severe vertigo attack with nausea. The severe vertigo/nausea took approximately 12-15 hours to subside, followed by dizziness and feeling of being "off balance". Symptoms persisted, was prescribed meclizine 2 weeks later by primary care with no improvement noted. Evaluated 2 weeks after that by ENT who diagnosed vestibular neuritis. Symptoms persisted, one month later diagnosed with secondary BPPV. Was started on PT June 2021 with some improvement. Had a second opinion with another ENT, confirming diagnosis. Feeling of being "off balance" is always there, will have random episodes of vertigo, triggered by positional movements. Vertigo episodes are more frequent over the past 2 weeks.
Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines; Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 16Feb2021 as dose 2, single (Lot number: EL9265), on 18Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698), all unknown for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing), notes: had HIV for 32 years; "Mild kidney disease" (unspecified if ongoing), notes: Diagnosed a long time ago, but it's stable. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines". The event "treatment of covid-19/positive for covid-19 after receiving 5 pfizer covid-19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: 101; Renal function test: kidney function was improving; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clincal course: His viral load was suppressed. He stated that he was good with suppressing things in his body. This was his first time having COVID in 3 years. He had 5 COVID-19 Vaccines and the latest one, the bivalent. Had very mild COVID-19 symptoms. Initially tested positive Saturday evening. Sunday he only had an elevated temperature of 101. Since then, has had no temperature. He started Paxlovid on 19Mar2023 after testing positive the first day. All 5 vaccine was administered in the morning, around 9AM. Was told to not take his simvastatin with Paxlovid because of a potential interaction. He stopped taking Simvastatin for the 5 days he took Paxlovid. The doctor checked all of his other medications and those were ok to take with Paxlovid. He went to the urgent care with a mask on and explained he took a home test that was positive for COVID-19. He was not retested for COVID-19 at the urgent care. At that time, he didn't have a fever, had no symptoms but a little scratchy throat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130658 same reporter/patient, different product/AE;
moderate chills, body aches, sweats, fever measured at 100.7F: occurred about 12 hours after injection and lasted 8-10 hours
PCR positive; PCR positive; cough; congestion; allergies last week; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247), on 22Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. It was unknown if patient received any other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2022, outcome "unknown", described as "allergies last week"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "PCR positive"; NASAL CONGESTION (non-serious) with onset 27Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 27Apr2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive, notes: Covid test type post vaccination was Nasal Swab. Patient experienced allergies last week then cough and congestion on 27Apr2022 mild sx but PCR positive on 27Apr2022. It was unknown if patient had COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination. COVID-19 test type post vaccination was Nasal Swab and COVID-19 test name post vaccination was PCR. The test was performed on 27Apr2022 with result as positive.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
she had developed what she believes is a blood clot in her leg; This is a spontaneous report from a contactable other healthcare professional (nurse) via medical information team. The contactable consumer reported for her mother that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) intramuscularly on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took her first dose of bnt162b2, on an unspecified date for covid-19 immunisation. The patient's mother received the second dose of the covid vaccine yesterday morning. When the caller saw her mother last night, she had developed what she believes is a blood clot in her leg on an unknown date. The reporter would like to know whether a blood clot is a possible side effect from the covid vaccine. The patient did not receive any type of treatment for the adverse event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Thrombosis leg   due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this elderly patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including venous doppler of lower extremities and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
REDNESS, SWELLING, HOT, PRURITUS ON THE INJECTION SITE.
child in foster care; pt lying on the floor eve of 13SEP95 started to gurgle; foster mom picked up & pt ceased to breath; no fever, excessive crying, etc from immunizations
pain, swelling, warmth @ site w/o abscess; tx APAP, warm compresses;
patient reports numbness of the injection site. Upon performing exercise, patient was able to move her right arm. Ice pack was placed on the site for 15 minutes. patient was fine. and was able to drive home
-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch   18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs  -General fatigue  All symptoms subsided after 48 hrs
Mild chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced mild chest pain. that didn't last long. The patient had been taking ibuprofen which dulls the pain somewhat. The patient received treatment of ibuprofen. The outcome of the event was recovered on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine was expired. Pfizer stated that if it was given before 10/19/22 It was ok, patient does not need to be re vaccinated.  No treatment needed. Patient is fine.
Two days after receiving my shot I started to get pain in my arm. Almost felt like when you have arthritis and it?s going to rain out and your bones are bothering you. The pain started to get worse and worse very quickly. To the point I had to take Tylenol. Then the next morning, my armpit was extremely swollen and hurt to the touch. Hurt to even put deodorant on. And the pain in my arm continued. It was extremely uncomfortable and the swelling and pain went on till yesterday, Saturday October 9th. Which was 5 days after my covid vaccine. Today, October 10th is the first day I do not have any swelling or pain. Four other co-workers of mine had the exact same reaction but just never reported it. Theirs started on day 2 as well. However mine lasted 2 days longer than theirs did and I was in more pain than theirs. However I am a smoker so that could be the reason. Tylenol is what I took for pain every day.
Baby to see pediatrician for bloody stools x 2 and fever 8-22-08. Dx hematochezia, R/O intussusception. Admitted to hospital and dx'd with positive intussusception on 8/22/08.  9/10/2008 ER rec received from CDC for DOS 8/22/08 with D/C DX:  Intussusception.  Infant presented with fever, decreased po intake and bloody/mucousy stool.  Frank blood in diaper at PCP office. To ER to r/o IS. Barium enema used to confirm and reduce IS of the large bowel in the RLQ.
Developed a rash at the injection site a day and a half after receiving injection.  Approx 4" x 3".  Red, firm and warm to the touch.
temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; patient received Pentacel after a temperature excursion occurred, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)] after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5ml total dose (0.5 ml 4X) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation, route: unknown) (lot number: UJ666AAA and expiry date: 04-May-2023) in unknown administration site for Immunization.  On 23-Sep-2022, non-serious events reported, temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) and patient received pentacel after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, a temperature excursion that occurred on 23SEP2022 and was reported on 26SEP2022. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients? Individual patient information was not available at this time. This situation is reported as a medication error due to vaccines being administered post-excursion.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both 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.
This spontaneous report was received from a healthcare worker refers to a 22 year old female patient. No medical history was reported. The healthcare worker reported that the patient was in office on 19-JUN-2013, to receive the third dose of GARDASIL (lot#, expiry not reported). On 12-JUN-2012, the patient received dose 1 of GARDASIL (lot #, expiry not reported) and on 17-AUG-2012, patient received the second dose of GARDASIL 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Head feels very heavy; Dizzy on standing; Sleeping on and off; feels sick; head feels very heavy, head is pounding; Body feels achy; slight nausea; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick) and HEADACHE (head feels very heavy, head is pounding) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001AZ1A and 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired). At the time of the report, HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired) had not resolved.            Concomitant product use was not provided. No treatment information was provided.
Throat/tongue felt fat, dizzy, speech changed 20min after shit. Taken to ER for stroke protocol, 3 day hospital stay. No stroke. Speech still not good, Numbness/tingling/dizzy throughput whole body all day long like waves. Some confusion