chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US Support. A 78-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EL9267, Expiry date: was not reported) via an unspecified route of administration on 23Feb2021(at the age of 77-year-old) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EN6208, Expiry date: was not reported) via an unspecified route of administration on 16Mar2021 11:00 as dose 2, single for covid-19 immunization. Medical history included Lung problems from an unknown date and unknown if ongoing Verbatim: Lung problems, Blood pressure high from an unknown date and unknown if ongoing Verbatim: Blood pressure high, Diabetes from an unknown date and unknown if ongoing Verbatim: Diabetes , asthma from an unknown date and unknown if ongoing Verbatim: Asthma , severe bronchitis from 2000 to an unknown date he was getting severe bronchitis twice a year , pneumonia from an unknown date and unknown if ongoing He was in Oregon and he went to his Pulmonologist's office twice within 6 months with Pneumonia , immunocompromised from an unknown date and unknown if ongoing He states because he is immunocompromised, Temperature is up, Wheezing, Cough, breathing meter goes lower than 300. The patient's concomitant medications were not reported. The patient previously took flu, Pneumonia shot, cortisone inhalant for asthma, prednisone for cough, Azithromycin for Temperature is up, Prednisone for wheezing. Additional Vaccines Administered on Same Date of the Pfizer Suspect and AE(s) following prior vaccinations was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter stated that he already got the first and second dose of the Pfizer Covid Vaccine back in February and March. Reporter stated he was immunocompromised and has low immunity in any viruses. Reporter was advised to get the booster shot or the third dose of the Pfizer vaccine. After he got the second dose the vaccine or in between the doses, he experienced fever and pain. He also mentioned her lung problems and that he had blood pressure and diabetes. Basically, the reporter wanted to know was it good to take the third dose or the booster shot or was it better to get the Moderna Vaccine for the the third shot. Reporter also clarified the fever and pain (on 2021) occurred after the first dose and after the second dose for a couple of days and then it was all gone. On an unspecified date the patient underwent lab tests and procedures which included body temperature: up as his temperature is up, investigation: lower than 300 as breathing meter goes lower than 300. The patient did not visit to Emergency Room or Physician Office. The clinical outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
pt c/o sore lt arm (joint pain), had a rash from below vax site to elbow; cried all evening & c/o aching, hurting all over but exp in lt shoulder area; c/o aching lt shoulder & legs knees; whelps, rash from below inject site to elbow on arm
At 24 hours after the shot, exhausted and ?loopy.? Then, intestinal pains for 36 hours.
About day after administration patient had tingling in (L) arm from neck down to fingers. Patient started ibuprofen but has had little relief. Pain still present but slowly resolving.
the evening p/vaxs pt started running 105 fever & jerking; went to ER; no infection noted in ears or throat;
I have had continued issues with taste and smell. Many foods taste like chemicals and the outside air smells like chemicals. Many smells from cooking food is terrible as well.
COVID 19 Treatment; COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 030A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 021B21A), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 006D21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Non-radiographic Axial Spondylarthropothy" (unspecified if ongoing); "Pain" (unspecified if ongoing), notes: Maintenance med for pain; "Back pain" (unspecified if ongoing), notes: Back pain medication. Concomitant medication(s) included: ENALAPRIL MALEATE taken for hypertension, start date: Jan2022; HYDROCODONE/ACETAMINOPHEN taken for pain, start date: Jan2022; VOLTAREN [DICLOFENAC DIETHYLAMINE] taken for back pain, start date: Jan2015; MAGNESIUM OXIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Apr2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive; (19Aug2022) Negative, notes: rapid test; (22Aug2022) Positive; (31Aug2022) Negative, notes: Rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID symptoms started on 13Aug and then tested positive on 14Aug2022. Started first round of paxlovid same day on 14Aug2022. Took the entire five doses with final dose on 19Aug2022 in the a.m. Felt better and tested negative with rapid test on 19Aug2022. Rebound occurred and tested again on 22Aug2022 and was positive.  No follow-up attempts are possible. No further information is expected.
Tinnitus in left ear. As if went to a loud rock concert the night before. Steady and not waning for 2 days.
I had a one-sided headache made several trips to the doctor. My doctor stated he has seen many patients experiencing the same symptoms. I started having body joint pain and felt off balance month after. I had to go see my eye doctor due to my vision getting blurred. For a couple of months had insomnia, finally went away. My toes on each foot were trying to draw under and had to massage my feet. I always had a sharp memory can't remember like I use to. I'm still problems staying awake it scares me especially while driving.
A 14 day old infant was erroneously administered ActHIB today, 18May2022 on the right thigh; Initial information received  on 18-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 14 days old male patient who was erroneously administered acthib today,18may2022 on the right thigh while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for immunisation; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix) for Immunisation.  On 18-May-2022, the patient received a  0.5 ml dose of suspect HIB (PRP/T) Vaccine (batch lot :UJ614AB)(Expiry date :12-Mar-2023)(unknown strength and formulation) via unknown route in the right thigh for immunization.  On 18-May-2022 (latency : same day) the patient developed a non-serious event of  a 14 day old infant was erroneously administered acthib today, 18may2022 on the right thigh (product administered to patient of inappropriate age) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  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 guidelines. 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.
hospitalized 10/10/21; symptom onset 10/4/21 and include fever, rigors, cough, wheezing, shortness of breath, chest pain, headache, fatigue, diarrhea, loss of taste/smell, and difficulty breathing
Patient passed away unrelated to covid vaccination Narrative: The patient received his first dose of Pfizer vaccine on 1/20. Patient was on hospice and passed away at his home with family on 1/26. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Upon waking, very lightheaded and had to sit down to shower. Took blood pressure, 93/66 HR 91. Arrhythmia- could not tell if atrial or ventricular in nature.  Had missed beats  with fast and slow rate.  Upon getting to work, temp  99 increased to 100.6 throughout day.  Arrhythmia lasted for a 24 hour period with the majority in the AM and no regularity.  Long and short runs of arrhythmias.  Unable to work.  Body aches. 9pm night of 25th, BP 75/57 HR 102 after going upstairs.  Taken 20 min later after resting, 101/57, HR 87.  Next day- no arrhythmia but increased HR and difficulty with standing and movement.  No appetite for 2 days.
rash over arm and chest; itching; red crackle spot; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, itchy rash and red rash. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the itchy rash was not recovered/not resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the rash, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced itching, red crackle spot, rash all over the arm and chest after the 1st dose of Shingrix. The reporter asked can receive the second dose.  No further information provided. The reporter consent to follow up. This case has been linked with case US2020176170, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176170:same reporter
Patient developed brief faintng spell, eye twitching, arm jerking within 5-15 minutes of administration of vaccine.  BP before administration 109/65; after fainting 97/58; after 15 minutes of resting 112/78.
This spontaneous report was received from a nurse practitioner and refers to a 28 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-SEP-2017, the patient was vaccinated with a ZOSTAVAX 19400 PFU, lot # N013278, expiry date 26-JUL-2018 (dose and routed of administration were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT). The reporter stated that administration was due to human error (also reported as given instead of VARIVAX). No adverse effect was reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Paralyzed from the waist down for a few minutes and fell down; Feels disoriented; Sometimes can't even stand up; A spontaneous report () was received from a physician concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included poly vitamins.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, approximately a few hours post vaccination, the patient experienced paralysis from the waist down for approximately 15 minutes which made her fall down. This event occurred two times. The patient stated she felt disoriented and could not stand up.   Treatment information was not provided.  The outcome of the events, was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a health professional concerning a 46 year old male who on 22-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (lot#654018/0904F). In August 2007, the patient experienced Bells Palsy. The timing of the onset of the Bells Palsy was unknown. The patient did not return to the office to complete the series. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Shot given 6/1/10. On 6/2/10 large, raised, hard lump which was hot to the touch.
Left arm had a welt about 3 cm wide 7cm long. Hot to the touch.
I had a stuffy nose that eventually led to a cough. On Tuesday night I threw up, I couldn't sleep, I had chills, sweating. On Wednesday, I was blowing my nose constantly, I had to fly home, could not get my ears to pop open, I did not go work on Thursday. I took a home COVID-19 test that came back positive. I was taking over the medication, everything seemed to be going away, then the cough came back with a vengeance. I was coughing so hard it was giving me a headache. I tried talking to my doctor, but he was running late, I talked to his nurse who suggested I try Mucinex DM. I took two full bottles. I am still coughing because of a lingering tickle in my throat.
sick; pain in shoulder; the place where they did injection is little bit swollen and feel pain; the place where they did injection is little bit swollen and feel pain; pain was getting stronger; fever; not feeling well; This is a spontaneous report received from a contactable consumer (patient) via a Medical Information Team. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0179) via an unspecified route of administration on 04Jun2021 as 2nd, dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0172) received three weeks ago, on an unspecified date for COVID-19 immunization and experienced little bit pain. It was reported that, the patient received the Pfizer Covid vaccine second dose yesterday (04Jun2021) and today (05Jun2021) he felt sick and pain in shoulder. The place where they did injection was little bit swollen and feel pain in Jun2021. Before he received three weeks was okay was no problem, but this time it was kind of bothering him, the pain was getting stronger and fever in Jun2021. The patient was not feeling well in Jun2021, and he do not want to be bothered and was not feeling well right now. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 33 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 11-SEP-2013, the patient was vaccinated with M-M-R II, dose 1, lot # J003791, expiration date: 28-MAR-2015, 0.5 ml, subcutaneous, reason for therapy: non-immune to rubella. Other suspect therapies included AFLURIA (dose, route and lot number were not reported). Concomitant medication was not reported. On 01-OCT-2013, the patient reported for dose of AFLURIA and second dose of M-M-R II. After AFLURIA was administered, the patient stated she may had been pregnant and may had been approximately 3 weeks pregnant at the time of initial M-M-R II on 11-SEP-2013. The patient became pregnant with LMP of 21-AUG-2013 and EDD of 28-MAY-2014. To date, the patient had not received second dose of M-M-R II, nor had she gone to her doctor to confirm suspected pregnancy. It was reported that no treatment was given. The outcome of the event was unknown. Additional information has been requested.
Child displayed slight fever and uncomfort, the days after the 12 months vaccines were administered. Then, he underwent a febrile seizure on Sunday morning. No other symptoms showed except for fever during these days. He finally was fever-free on Tuesday, May 12th.
At time of injection: injection seemed to be a larger than normal amount of fluid compared to other vaccines that I have received (eg flu) and took 5-8 seconds to complete. It took the health care worker two "pushes" to get all of the fluid in. I take a mAb every 8 weeks and it felt like more significantly more fluid than in my regular mAb injections.  t+1hour: I felt tingling in my lips and a bit fatigued, soreness at injection site. t+1 day: Significant headache (relieved with tylenol) and fatigued, soreness in injection arm. t+2 days: significant headache, fatigue, nausea, vomiting, fever, no appetite. t+3 days: significant headache, fatigue, nausea, fever, chills, no appetite. t+4 days: fatigue, nausea, chills, no appetite. t+5 days: fatigue, nausea, chills, no appetite. Lymph node soreness began, unable to sleep on side. t+6 days: fatigue, nausea, chills, no appetite. Lymph node soreness. t+7 days: headache, fatigue, nausea, no appetite. Lymph node soreness. t+8 days: headache, fatigue, nausea, no appetite. Lymph node soreness. t+9 days ? t+14 days (today): headache, mild soreness in left arm, fatigue, limited appetite.
Pt. states that after receiving the 1st dose of Influenza High-Dose 10/25/2021, started experiencing symptoms that night of dizziness, chills, headache. Symptoms still continuing slowly subsiding. No noted Primary visit/communications.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
on 11/23/2021 had a mini-stroke (12 days after 2nd covid vaccination. This is the 1st mini-stroke I have ever had. arms and legs weren't moving right, speech slurred, mouth on one side was drooping.
This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Six hours after I received the second dose of the Covid vaccine from Moderna I experienced Covid like symptoms. I had tested positive for Covid 75 days prior to the vaccine, and my symptoms were similar or worse than when I had Covid. I had severe body aches, fever of 101F, headache, fatigue and confusion  starting on 16 April. The fever and body aches subsided the morning of 19 April. I continued to have severe fatigue and headaches through 22 April. Starting the morning of 19 April small bumps begin to appear behind my ears mostly on the left side. On the morning of 21 April a rash appeared on the left side of my neck, it began to spread down my arm and up my face, unilaterally. It began to blister, itch and burning pain. The rash clearly followed dermatomes. By evening the rash spread into red bumps all over my body, bilaterally upper and lower extremities. Rash was not reactive to Benadryl. I went to the ER and was immediately admitted to the hospital with a dx of Shingles. My left eye and left ear were beginning to swell shut, with an increasing headache. Please note the afternoon of 20 April I did have Dysport injections to my upper forehead. I have had these injections several times before without any prior reaction.  Also, severe Covid like symptoms were experienced with the first dose of the vaccine.
Developed hives on 10/24. Started cetirizine 10/25 and may need to take prednisone.
Uncontrollable screaming/crying more than three hours. Parent called 911. Afebrile positive erythema/edema/tender DTaP site
Red, raised rash on both upper thighs.  "Pimple like" appearance. Afebrile.  No treatment given.
Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked out. he doesnt remember being brought over to the observation room. He was encouraged to drink fluids, patient stated he was feeling better and reported no further tunnel vision, he was escorted out with his son accompanying him. vital signs @ 1024 HR 62, BO 98/60 RR 18, pulse ox 96%, at 1027, HR 81, BO 111/65, RR 18 and pulse ox 95% on RA, at 1044 HR 62, BP 111/ 69, RR 18 and Pox 97%. He was released at 1045 by himself to the exit of the facility.