chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I passed out/minor seizure?  Was transported to the ER and given fluids. All test results came back OK and I was released.  Nothing like this has ever happened in my life.
No additional adverse effects reported; Pneumovax 23 was loaded into the database on 14-FEB-2020 at 1239 and was administered to this patient on 16-FEB-2020 at 1231. The vaccine was at room temperature; This spontaneous report was received from a pharmacy technician, and refers to a 80 year old patient of unknown gender. Information about the patient's medical history, concomitant medications and drug reactions or allergies was not provided. The patient was currently hospitalized for an unknown reason     On 14-FEB-2020 at 12:39 pm, the dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S028602 with an expiration date in 28-JUN-2021), was loaded into the database and was left at room temperature of 69 degrees Fahrenheit until 16-FEB-2020 at 12:31 (72 hours), when the patient was vaccinated via intramuscular (strength, dose and frequency were not provided), for prophylaxis. The patient received the vaccination right before discharge and was no longer in the hospital. It was also reported that there was no previous temperature excursion and that the digital data logger was not involved. No additional adverse effects were reported.  This is one of two reports received from the same reporter regarding different patients.; Sender's Comments:  US-009507513-2002USA007244:
At first Tired  arm itchy.  10 days after 1st Moderna  shot arm was burning itchy hot and  small red blotches. Headaches joint aches.  Got random  pin prick feelings in arms and legs redness got larger each dayContinued for 9 days finally started to get less red less symptoms  April 1 felt much better arm is still discolored
Approximately 2 hours after receiving vaccine, employee had tightening of throat, swelling eyes, lips, tongue, and tingling of gums and mouth. Was home -> went to ED.
10/4/21 pt transferred from ER for a higher level of care; went to ER on 10/3/21 with dyspnea and altered mental state; found to be positive for COVID; hypoxic (O2 sats 80% on RA); placed on O2; elevated glucose; transferred to Facility; quickly became BiPAP dependent, but still hypoxemic; pt transitioned to comfort care, and passed away in the hospital
10 minutes after receiving vaccines, patient's face started swelling and hives on back.  vomiting started.  patient seen in ER, oral steroid and benadryl given.  symptoms improved.
It was reported that a patient received a DTP (Diphtheria-Tetanus-Pertussis) vaccination for prophylaxis (dose and date of vaccination unknown). The patient developed a rash, redness and swelling after the shot. Further information is requested. From additional correspondence received on 10/31/00, it was reported, "this was not reported by anyone from this office. We do not see children under 10 and do not even stock DTP in our office." No further information is expected, this case is closed.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA274340 and 2018SA274344 (Same reporter). This case involves an 8 years old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (second patient). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (reported as The 3 children were administered Daptacel, but were greater than 6 years old). It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by sender: none.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687, 2018SA281692 (Same reporter). This case involves a three months-old (also reported as 4 months old) female patient who received a dose of PENTACEL, lot C5507AA, expiry date- 05-Sep-2019 via unknown route in the left thigh on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of actual medication error due to incorrect product storage. It was reported that the vaccine was given after temperature was at 30 F for 4 hours: below freezing. No adverse event was experienced. 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 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. List of documents held by sender: None.
I had my vaccination on 09/23/2022. On 02/04/2023 I started to experience headache and a light cough. It progressed to a fever with chills. I tested COVID-19 Positive on 02/05/2023. I was prescribed Paxlovid when I had a fever of 103.  I tested COVID-19 Negative on 02/11/2023.  I presently feel well on 03/27/2023.
Patient has localized redness on left arm. Patient had initial itching then redness. Not itching at this time. Just has hot red area. BENADRYL 25 mg 3 x day HC 1% cr. 4 x day.
Immunization given 4/12 next day had large red area on left leg IPV and DTap.
Patient returned to pharmacy after vaccination to question if we had given her the wrong paperwork or vaccine. Upon review, it was discovered that the patient had intended to request first COVID-19 vaccination, but had received flu vaccination. She did not note any side effects at that time and proceeded with COVID-19 first dose.
pt recv vax JAN98 & devel sterile abscess @ the inj site;MD reported that it was like a marble under the skin;
Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire body lasting  3 days
I had my 2nd Dose of Pfizer on 03/25/2021 and on 06/03/2021, I noticed blisters on my forehead and in my scalp. I was diagnosed with shingles through a video doctor.  I went to urgent care because my eye was swollen. My treatment were: Acyclovir, Prednisone, Doxycycline- oral medication . Erythromycin ointment for my eye. Prednisolone drops for my right eye. Pain medication Gabapentin. I have not recovered from my AE because I still have blurriness and pink in my eye  but it's clearing up,
Infection on same arm as injection. Pt had vaccine on 9-3-09. She reported an infection on 12-15-09.
Rash over neck/face, chest. SOB. vomiting and throat tightness. 19 yo female presents by private vehicle for evaluation of allergic reaction. Pt reports 1hr of progressively increasing: (+) rash over neck/face chest (-) facial swelling (-) tongue swelling (-) dysphonia (-) difficulty swallowing (+) SOB (-) wheezing (+) vomiting x 1 (+) throat tightness. She received her Tdap and meningitis vaccine today and symptoms started within 1-2 hours of receiving these. The patient reports no prior hx of similar problem. No other new foods, medications or exposures. EPIPEN IM given. BENADRYL 50 mg IM, ZANTAC 300 mg by mouth and prednisone 60 mg by mouth given. She is observed in the emergency department for approximately two hours, resolution of symptoms noted and she feels ready to go home. They verbalize understanding of discharge instructions as well as return precautions.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Fatigue, localized pain, chills, swollen glands, Narrative:
A large red, hot and swollen rash on my left arm. Was tender to touch and almost pulsing.
Body aches, fever (40.0 C), shakes, sweating, waking with hallucinations of people she knew.
pt recv vax 19JUN95 & 02JAN96 pt devel full blown chickenpox;pt recovered & no other complications were noted;no further details were provided;
Swellenband painful   lymph nodes behind ears. Fever rash over 100%of body . Started day two after vaccine it is now day 7post vaccine rash getting worse
bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered.  Information on the lot/batch number has been requested.
sun and light hurts his head; worst headache/migraine right above his eyes and back of head; worst headache/migraine right above his eyes and back of head; This is a spontaneous report from a contactable consumer, the patient. This 44-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0176, Expiry Date: 31Aug2021) via unspecified route in the right arm (right shoulder) on 08Jul2021 at 12:00-12:30PM (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included headaches, allergic to penicillin, and wife contracted COVID (ongoing). His parents have diabetes, but he doesn't. There were no vaccinations received within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient reported that he has been having the worst headache ever since he received his first shot. The headache began the second day after his first shot (10Jul2021). He clarifies they are like migraines, it's been the same headache for weeks. It's right above his eyes and the back of his head. He made an appointment with a neurologist in a few weeks. He has never experienced headaches like this before. He doesn't wear glasses, contacts, anything like that. His job is so tedious and dangerous, he has been put on almost like a 'work idol' basically to lessen his responsibility due to the headaches. It was scaring him. He clarifies he has experienced headaches before, but he has never experienced a headache at this magnitude before. The headache is continuous, it's all day today (12Aug2021). He wakes up with it and goes to sleep with it. It's lasted for weeks. The headaches are so bad he has to stay in the house all day, it's just like the sun and light hurts his head and makes it so much worse, he just stays in a room. He confirms the headaches have worsened. Now, it's more like a thumping headache. The events did not require a visit to the ER or physician's office. The patient stated he has been wanting to go, but the reason he couldn't is because after he took the first vaccine, his wife contracted COVID. She works in the healthcare field and had to take the vaccine, but ended up catching COVID after taking the vaccine. So, he (patient) had to quarantine for 2 weeks after that. The outcome of the events was not recovered.  The patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Aug2021 at 14:23 (Lot: EW0182, Expiry: Aug2021) in the left arm as a single dose for COVID-19 immunization.  Follow-up attempts are completed. No further information is expected.
Patient reports a gradual onset of edema and erythema, first to the vaccine site, then spreading to the entire arm. She reports the site was warm to the touch with some burning and itching present. Patient's temperature was 100 degrees Farenheidt throughout the reaction. She was out of town during the time of reaction, but she did call her doctor and took Benadryl and Tylenol, which she said did not seem to help. Patient reports gradual recovery, and now there is redness around the vaccination site, about 3 inches in diameter.
Local symptoms- Pain -discomfort, redness, swelling. General symptoms- fatigue, shaky nervous Narrative:
Myalgia, Fever, NauseaVomiting & GastricBleeding Narrative:
Hormonal Imbalance. Frequent bleeding every month in between periods lasting from ovulation through period. Periods now coming twice a month. Heavier periods. Mood swings. Linea nigra appeared (not pregnant).
Sudden tightening of throat, coughing, urgency to throw up (did not) repeatedly, difficulty getting air, could not speak, looked for allergy relief medicine, took 3-4 Hyland's seasonal allergy relief chewable. The meds reversesed the reaction enough to call a friend to go to hospital, voice broken and raspy, while focussing on breathing. To hospital about 1:05, still having difficulty breathing. They did not administer meds, did ekg, normal. Itchy chest, tightness in head at temples, clearing throat,  Symptoms continued to subside, left hospital about 2:23. Was told to contact my pcp if need.
3/30 - Vaccine around 11am. Started feeling shortness of breath, sensation of throat tightening and a flat hive with red outline appeared on my neck around 2:30. Subjectively felt feverish, only 99.6 with chills. Around 3, hands turned purple, lips turned white and I felt like I was going to pass out. Took some Benadryl and saw improvement within 20 minutes. Husband monitored for a few hours afterwards, still felt a little off but didn't get worse and saw gradual improvement, started being itchy all over. 3/31 - Extremely tired, sore arm, puffy face, extremely itchy. About a 4x4 inch patch of itchiness moves all around from my scalp, to ribs, to back of knees, etc. and stays itchy for about a minute or two, then moves. Very odd sensation. 4/1 - Still very tired, arm is achy but not sore, face is less puffy but throat still feels slightly tight. Not itchy. Seems to be on the way out.
LEFT ARM NEUROPATHY PAIN AND SWELLING; UNABLE TO MOVE ARM BACKWARDS AFTER GETTING THE VACCINE
According to staff present, patient was found nonresponsive. Nurse Practitioner and RN entered room too assess resident.  He was slow to respond, but appropriate.  He was very warm to touch. Temp was 100.4, BP taken manually 158/78. Spo2 95% on room air.  received 1st dose of vaccine yesterday  12/29/2020 at approximately 1230 pm.Chest X-ray and STAT labs were ordered. After a few minutes pt was awake and alert and oriented to person, place, and time and back to his baseline.  Resident was given acetaminophen for fever.
This spontaneous report was received from a pharmacist via company representative and refers to a 75 year old female patient. There was no information about concomitant medications, concurrent conditions and medical history provided. On 05-JUN-2015, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route of administration not provided) in the left deltoid. Approximately in June 2015, the patient experienced a "shingles-like rash" on the right side of her face. She sought medical attention and visited the pharmacist and her primary care physician, however no treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with an improperly stored dose of MMR II (dose, route and lot# were not reported). No symptoms were reported. This is one of several cases reported by the same reporter. Additional information has been requested.
extremely Stiff muscles and joints. Fatigue. stuffy nose. Mild headache.
Pt recvd 1st dose of Engerix-B & 3-4 days later devel blurred vision; pt seen by ophthalmologist; several days p/onset blurred vision persisted but was diminished;
Wheezy and tight chest within the hour Severe headache started around 6:30 pm lasting 5 days diminished to mild but persistent headache that continued daily - never stopped Body aches day 2 through day 5 Fever day 2 through day 5 Fatigue 6:30 pm day of persisted daily - never stopped Vertigo same evening as injection persisted daily x 5 days - daily intermittent bouts since Cough started strong day two through day 5 - then continued - never stopped
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 (also reported as 12Oct2022) as dose 1, single (Lot number: HG4659), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient has no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Pain at injection site, swelling at injection site, redness at injection site, warmth at injection site.
Tendinitis, mobility issues, pain. All started about 5-6 hours after injection. Currently has been over two weeks and still very painful. Can?t move arm in certain positions.
patient describes feeling 'warm and tingling' over entire body starting several minutes after vaccination and lasting several hours. no loss of consciousness, no fever, no weakness, no dizziness
Headache, Myalgia, Diarrhea & Nausea Vomiting Narrative:
Severe pain in both shoulders. Some days it was so bad I could not function. As of today I've been taking between 600 and 800 mg Ibuprofen with some relief. So when it started I figured it was a side affect of the vaccine but when it didn't stop I call the hospital and they suggested the Ibuprofen. If I started a fever they wanted me to come in. No fever.
Client reported hx of anaphylaxis to flu vaccine. Vaccine administered with client in supine position on a cot. EMS present. Approx 3-5 minutes post 1st dose Pfizer vaccine client reported feeling pressure in her chest, tiredness, vertigo, itching in her throat. vitals WNL. Client reported symptoms worsening. EMS present entire time. On-site medic called. Decision to call for Medic, Benadryl given by EMS team 50mg, PO, at 12:00. Decision to transfer client to ED.
102 degree fever; rash under arms and in groin area; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received BNT162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 15:00 (Lot number: Er8737) at the age of 32 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "some GI issues" (unspecified if ongoing). Concomitant medication(s) included: LEVAQUIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Vaccine Administration Time: 04:30 PM), administration date: 30Apr2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fj1611, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 09Apr2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 15:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "102 degree fever"; RASH (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "rash under arms and in groin area". The events "102 degree fever" and "rash under arms and in groin area" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, rash.  Additional Information: The patient did not have other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient did not test post vaccination. The patient did not have known food allergies that have resulted in a rash. It was also mentioned that the patient had 102 degree fever for 12 hours the 1st day after vaccine, and experience rash under arms and in groin area 2nd and 3rd day after vaccine. The patient used Antihistamine as treatment for AE .  No follow-up attempts are possible. No further information is expected.
felt achey; felt bad no energy; felt bad no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 11:50 (Lot number: EN6203) at the age of 83 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Influenza (Route: Left arm, Lot number: 274571), administration date: 26Aug2020, when the patient was 83 years old, for Immunization; Prevnar 13 (Date: 08Jul2006, Date: 12Apr2003), administration date: 08Jul2006; Tdap, administration date: 08Jul2016; Bnt162b2 (Dose: 01, Time: 9:50 am, lot number: EI8982, anatomical location: arm left), administration date: 12Feb2021, when the patient was 83 years old, for Covid-19 immunization, reaction(s): "Peripheral swelling", "Side of face was swollen", "felt bad", "Lymphadenopathy", "Fatigue", "Wheezing", "Cough", "Aches", "Pain", "Asthenia". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "unknown", described as "felt achey"; ASTHENIA (non-serious), MOOD ALTERED (non-serious) all with onset 05Mar2021, outcome "unknown" and all described as "felt bad no energy". The events "felt achey", "felt bad no energy" and "felt bad no energy" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Right thigh erythema and swelling. Site where Pediarix and Hep A given.