chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on trunk times approx 3 days. Fever to 99.1 on Wednesday (1/18/06).
Had H1N1 shot this morning. Mother called 6 hrs later reporting vomiting. Nurse stated he had red eyes this morning. Mother denied that he was sick. Said he had "allergies". Temp taken was normal.
Right acute otitis media, fever, fussiness and vomiting, hours after procedure/immunization.
On 11/2/07 in early afternoon felt fatigued, flushed, developed headache, had severe chills, skin hurt to touch.  Took Tylenol that evening, continued Tylenol on regular basis.  Symptoms continued until PID appt on 11/5/07.  Started taking ibuprofen BID that evening 11/9/07 feeling some better, no HA, no chills, still feels fatigued.  Plans to follow up with MD next week if not feeling 100%.
Should & neck pain starting 10/19/2018. Pt also experienced whole body pain for at least a week starting 10/19/18, but has since isolated to shoulder and neck. Patient reports 10/10 pain today (10/30/18). Pt visited the hospital 10/25/18 with pain, was prescribed tramadol 50mg.
BODYACHES; CONGESTION; HEAVY CHEST; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bodyaches, congestion, heavy chest, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, bodyaches, congestion and heavy chest was not reported. This report was non-serious.
Patient states the day after the injection her arm began to hurt. She continues to have pain at rest and with movement of arm despite being 4 weeks out from her injection date.
Approximately 5 minutes after receiving the vaccine, the patient stated that his right eye was swollen shut. The patient denied itching, shortness of breath. The right eye was not edematous and no erythema noted. The eye just appeared to be squinted shut. The patient's vitals were monitored for 30 minutes and he was given Benadryl 25mg by mouth at 10:20 am. At 10:40, his eye was completely opened. The patient denied any shortness of breath, itching, or difficulty swallowing. He was dismissed from the clinic alert, oriented, and ambulatory without difficulty.
Breakthrough infection with COVID-19; Breakthrough infection with COVID-19; This is a spontaneous report from a non-contactable consumer or other no-health care professional. An adult female (non-pregnant at the time of vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 24Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported/Lot Number: EP9655) via an unspecified route of administration, administered in Arm Left on 14Apr2021 as dose 2, single for covid-19 immunization at Workplace clinic. The patient had medical history of Rheumatoid arthritis from an un-known date and unknown if ongoing. Concomitant medication included other medications the patient received within 2 weeks of vaccination as adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination patient had been tested for COVID-19. On 08Sep2021, the patient had breakthrough infection with COVID-19 along with vaccination failure. Timeframe between vaccination and starting of symptoms was 5 months 15 days. On 22Dec2020, the patient under-went lab tests and procedures which included Sars-cov-2 test Covid-19 with Nasal swab results negative, on 31Jul2021 patient had Nasal swab with Antigen Covid-19 results negative, on 06Aug2021 patient had Nasal swab with Antigen Covid-19 results negative, on 31Aug2021 patient had Covid-19 with Nasal swab results negative and on 07Sep2021, Covid-19 with Nasal swab results Positive. Patient did not receive any treatment for the event caused. Outcome of the events was recovering.
This infant had a local reaction at the left deltoid site of DTaP # 4. She had swelling, redness, and itching that started on 05/09/01 at 1:00 PM. She was seen by a doctor on 05/09/01 at 5:00 PM. Not cellulitis. Home treatment with Benadryl PO and Ice to the site.
Documented vaccines were exact duplications of vaccinations that patient received at medical center prior to admission to medical center where duplicate vaccines were given prior to discharge. Influenza vaccination given on 09/25/2015 and PREVNAR 13 given on 06/25/14 at medical center. Patient is not known to have suffered any adverse reactions to duplicate vaccination with both influenza and PREVNAR 13.
momentarily vision loss; This is a spontaneous report from a contactable female consumer. A 65-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8728) via an unspecified route of administration, in left arm on 31Mar2021 11:00 (at the age of 65-years-old) as single dose for COVID-19 immunization. Vaccine was not administered at Facility. Facility type was Department of Health. Medical history included bone loss diagnosed more than 3 years ago from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamins nos (Multivitaminum) taken for routine health maintenance from an unspecified start date and ongoing; calcium taken for bone loss from an unspecified start date and ongoing; vitamin d [vitamin d nos] taken for routine health maintenance from an unspecified start date and ongoing taking it for years. Also patient stated she started on her own because reading and recommendation vitamin D was so critical. This is vitamin D3 and she does not know if sun can provide. She has been taking it only about a year. Patient asked about a question on her vaccination questionnaire. She said it asked about every getting vaccines on a base, why was that question there. Caller stated this happened early in the afternoon and she was in the kitchen and was standing near island she was working up right. She was not bent over. All of sudden she looked up and maybe for a minute or two lost her vision. It was not too long, but long enough it certainly caught her attention. Caller stated when she was looking down at whatever she was doing on the counter she looked up and her line of sight was in the great room but she could not see anything and thought oh my gosh what happened. Patient reported that she and her husband both received their first doses of the PFIZER-BIONTECH mRNA COVID-19 vaccine on 31Mar2021. She reported that they've both experienced visual disturbances since then, with no prior history of vision impairment. She stated her husband was nearby and he was like what do you mean and she could not even see a foot in front of her. Reported that by the time she went through a conversation her vision had come back and she has not experienced it since. Her episode occurred on Friday (02Apr2021), during the day while at her kitchen island. She was unable to see, but it resolved quickly. Her husband's episode occurred last night 05Apr2021. She reported that her husband (67 y/o, male) woke up from being asleep, asked if the TV was on (which was because he could hear it, but could not see it). His symptoms have also resolved. Patient explained her husband and she both, on different days experienced vision disruption. Momentarily, but they experienced it different day. They both had the general feeling that something was a little different but nothing severe and worrisome until the vision thing. Event blindness transient was considered serious (medically significant) based list. No treatment for the events was given. Outcome of the event was recovered on 02Apr2021 for female patient. Follow up attempts are completed. No further information is expected.
Bone pain in the pelvis and hips; Resting heart rate between 135-145 bpm for ten hours; Fever of 101 degrees; This is a spontaneous report received from a non-contactable consumer, the patient. A 46-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 13Mar2021 at 11:30 (at the age of 46-years-old) as single dose for COVID-19 immunisation. Medical history included acute myeloid leukaemia (AML), stem cell transplant, graft versus host disease (GVHD), Graves' disease and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included sirolimus (MANUFACTURER UNKNOWN), sulfamethoxazole; trimethoprim (BACTRIM DS), valaciclovir (VALTREX) and levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indications from unspecified dates. The patient previously received penicillin (MANUFACTURER UNKNOWN), levofloxacin (LEVOQUIN), and vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 14Mar2021 at 01:30, 14 hours after the vaccination the patient experienced significant bone pain in the pelvis and hips which caused a resting heart rate between 135 to 145 beats per minute (BPM) for ten hours due to pain and fever of 101 degrees. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures included intake of paracetamol (TYLENOL) during the same time frame. The patient did not receive any treatment for the event resting heart rate between 135 to 145 beats per minute (BPM). The clinical outcomes of the events bone pain in the pelvis and hips, heart rate between 135 to 145 BPM for ten hours and fever of 101 degrees were recovered on unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
The patient received 0.1ml  Ipol intradermally rather than 0.1ml of Tubersol, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Medical Information (Reference number- 00457650) and transmitted to Sanofi on 02-Feb-2021.  This case involves an 18 year old female patient who received 0.1 ml dose of suspect IPV (VERO) lot number not reported via intradermal route in unknown administration site for prophylactic vaccination on an unknown date instead of getting tested with TUBERCULIN TEST [TUBERSOL] (Wrong product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of an actual medication error due to wrong product administered (latency same day).  The nurse reported that an employee was undergoing pre-employment health screening, but did not receive the Tubersol 0.1ml for tuberculin sensitivity testing.   At the time of report, no adverse event was reported.  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.
The Rph from the pharmacy, was the immunizer that administered Covid vaccine for the health facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Very vivid short nightmares  Will fall asleep for 10 to 15 minutes then I can't get back to sleep.
Patient was given the pediatric dose .25ml of COVID 19 bivalent vaccine, not the adult dose of .50ml
Patient erroneously was given FLUARIX instead of BOOSTRIX. No additional adverse events were reported.
Sensitivity to cold and hot, sensitivity to touch on hands; Tingling in face and arms, spread to whole body; Tingling in face and arms, spread to whole body; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm (at the age of 56-year-old) on 11Mar2021 09:00 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing slight tingling in hands, known allergies: Penicillin and Tetracycline. Concomitant medications included lisinopril; atorvastatin; zinc; vitamin b complex. The patient experienced Tingling in face and arms, spread to whole body; Sensitivity to cold and hot, sensitivity to touch on hands and arms on 11Mar2021 09:00. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
HEADACHED, NAUSEA, BODYACHE. FATIGE, SORE ARM.
12 hours after shot - fever - lasted 12+ hours (took tylenol to treat) 6 hours after shot - headache - lasted 12 hours starting few hours after shot - soreness in arm - lasted over 24 hours
Patient received second dose of Jynneos monkeypox vaccine 7 days before second dose was due. No immediate adverse outcome while in vaccination clinic.
Underage before the 5/12 approval for Pfizer vaccine  Suspected falsification of DOB ? unable to contact guardian DOB was recently changed in system to 01/22/XXXX, was previously 01/22/XXXX
Rash next day on trunk red blotchy - still had rash somewhat 2 week + later.
CERVARIX was given to a male patient, while it should be given to the female patients only.
Woke on Day 8 w/4"x5" red, hot band 2" below injection site.  Itchy but did not scratch it.  Almost gone on Jan. 25 (today).  Husband had same Lot# and experience,  although much less red.  Had taken 5-hr. nap on day after vaccine, 8 days prior. Those are only two "events." I have photos.
Information has been received from a registered nurse on 03-SEP-2010. The 43 year-old male was vaccinated with a pre-filled syringe of AFLURIA 0.5 ml IM on 02-SEP-2009 (lot number 05649111A, expiration date: 10-JUN-2010). There was no pertinent medical history or history of drug reactions/allergies. Concomitant medication was unspecified by reporter. On about 28-SEP-2009 (the last week of Sep-2009), he experienced hives with big splotches from his shoulders to knees. His hives continued and did not completely clear. His hives would subside then continue "again". Many allergies were ruled out by the allergist. The patient received the H1N1 vaccine 20-JAN-2010 with no adverse symptoms noted. There was no change in his hives. The event outcome was not yet recovered. Additional information has been requested. The case was originally reported to Merck & Co., Inc. (case#: 1009USA00266). The case was not considered to be serious. The company considered events possible to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 1 time. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) was 16,33, 0.555555556 and R. This is one of several reports received from the same source. Additional information has been requested.
Information regarding Prevnar was received from a healthcare professional regarding a 4-month-old male patient who experienced pneumococcal sepsis and drug ineffective. At 4 months of age, the patient received the second dose on an unspecified date. One week after receiving the second dose of Prevnar (date not specified), the patient was hospitalized and diagnosed with pneumococcal sepsis in Jun-2006. Laboratory tests were performed; however, the results were not available. The reporter indicated that the infant is currently hospitalized and "in bad shape." No additional information was available at the time of this report.
Joint pain; Muscle pain; Heart racing; Extreme thirst; Feeling of excessive dehydration; body, skin, eyes, feel dry; body, skin, eyes, feel dry; feeling of decreased urination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 31Aug2021 (Lot number: EW0169) at the age of 50 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: THIRST (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Extreme thirst"; PALPITATIONS (non-serious) with onset Sep2021, outcome "not recovered", described as "Heart racing"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain"; DEHYDRATION (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Feeling of excessive dehydration"; DRY SKIN (non-serious), DRY EYE (non-serious) all with onset 31Aug2021, outcome "unknown" and all described as "body, skin, eyes, feel dry"; URINE OUTPUT DECREASED (non-serious) with onset 31Aug2021, outcome "unknown", described as "feeling of decreased urination". The events "extreme thirst" and "feeling of excessive dehydration" were evaluated at the physician office visit.  Additional information: Patient did not receive any other vaccines within four weeks prior to the suspect administration. Patient had received one allergy shot but no vaccine.  No follow-up attempts are possible. No further information is expected.
Called pt. on 11-2-15 client stated the afternoon after getting her injection her arm swelled, became reddened, tender and warm. She reports the redness et swelling spread and tenderness increased so she saw her healthcare provider. She was dx with cellulitis and given 1 gm ROCEPHIN IM, KENALOG IM and prescribed BACTRIM DS BID et prednisone 20 mg BID. As of 11-2-15 most symptoms have resolved and she reports her arm is not tender anymore and just slightly reddened.
Child found in AM of 3/26 in the process of a grand mal seizure and taken to ER. He was admitted for overnight stay. He had 6 more seizures since 3/26/99, the last one on 4/11/2000.
Arm injected in swelled from shoulder to fingers, tingling, numbness.; Intense joint aches and extreme fatigue; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Lightheaded and short of breath all within 30 minutes.; Lightheaded and short of breath all within 30 minutes.; After an hour an a half a fever spiked; Intense joint aches and extreme fatigue.; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported)  via an unspecified route of administration on 26Mar2021 at 09:30 (at the age of 26-years-old, Non-pregnant) as dose 1, single for covid-19 immunisation. Medical history was none. The patient had no known allergies. There were no concomitant medications. Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Mar2021 at 10:00, the patient experienced arm injected in swelled from shoulder to fingers, tingling, numbness, intense joint aches and extreme fatigue, lightheaded and short of breath all within 30 minutes, after an hour and a half a fever spiked. Treatment was provided with Tylenol and antihistamine. Facility where the most recent COVID-19 vaccine was administered was a hospital. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered on an unspecified day in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I thought it was sort of coincidental, had appointment with my cardiologist. I got my first shot in January and second in February and about a couple of weeks before the booster started to have changes in my heart rhythm, rapid heart rate and skip beats. I do not know if my symptoms were caused by the vaccine.   An EKG was also performed.  I also have a pacemaker and I thought it was the pacemaker that was causing my problems, they adjusted it. I am still getting a rapid heart rate. I also had no pain or fever. I did not have these cardiac changes before the vaccine.
COVID symptoms after first vaccine/had COVID tested and it was positive; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; could not get out of bed; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; This is a spontaneous report received from a contactable consumer. A 85-year-old female patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 2 days after her first dose on 25Feb2021, the patient started with COVID symptoms, very weak, achy, and could not get out of bed and was hospitalized, and it was unsure if patient had COVID when she got the vaccine. On 01Mar2021 her mother tested positive for Covid. Patient experienced. The patient was scheduled to have her second dose on 16Mar2021. But patient tested positive again on 16Mar2021 and did not receive her second Pfizer Covid vaccine. Outcome of events was not reported.  Additional information has been requested.; Sender's Comments: Linked Report(s) : PFIZER-2021347468 same reporter/ product, different patient
Started as really cold feet and feeling tired. Laid down and watched TV. Head felt like it was on fire, and also felt nauseous. Felt extreme chills and laid under blankets with heating pad, and still felt chills. Fever went up to 101F. Experienced non-stop coughing