chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling unwell; Slept for 13 hours; Felt like she was beaten with a stick, Aching, whole body aching , body ache; Cant get her breathe; Dizzy; Havent gotten better; So weak; Feeling tired, Fatigued, Cant be up more than 10 minutes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe) and DIZZINESS (Dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCODONE for Pain, INSULIN LISPRO (HUMALOG), LOSARTAN, DULOXETINE, LEVOTHYROXINE, GABAPENTIN, VITAMIN D3, VITAMIN B12 NOS, SIMVASTATIN, HYDROCHLOROTHIAZIDE and FLUOCINONIDE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow up received: Reporter's address was updated, Con-meds and treatment medication updated. On 12-Jul-2021: Non significant FU_Received
I received the Moderna Bivalent booster for COVID-19 on 11/21/2022 at about 1 PM. At about 4 AM on 11/22/2022, I woke up with hives on my lower abdomen. I then started itching on the upper right side of my chest. When I got up, I noticed a rash in that area, as well. The rash then spread throughout the day on both of my hips, both of my thighs, both of my flanks, my entire right arm. Later in the evening, I felt my scalp and the back of my neck itch, and I began scratching those areas. I took ZYRTEC that day, followed by BENADRYL. I didn't really have any results from the medicines. On the morning of 11/23/2022, I woke up and saw welts on my neck. Hives then appeared on my face later in morning, with my right eye becoming swollen and crusted over. The areas where the rash has appeared are mildly tender to the touch at times. I had a telehealth appointment with a doctor on 11/23/2022. I was prescribed steroids and ATARAX. The doctor also told me to continue taking ZYRTEC and BENADRYL. I began taking the steroids on 11/24/2022. I felt better most of the day afterwards. However, I did break out a little on my right arm, left flank, and left axillary area, and I had itching in those areas. I also had a breakout of itchy, burning hives on my face and neck that evening, mainly on the right lower mandible and the right posterior neck. I took BENADRYL and ZYRTEC that night. I woke up the morning of 11/25/2022, and the hives on the right lower jaw, right posterior neck, and right arm are worse; they feel like they are on fire and they look like welts. I also noticed new rashes on both legs and thighs, but they are not as severe as the ones that appeared earlier on other parts of my body. I took BENADRYL, ZYRTEC, and the morning dose of steroids. I have not yet taken the ATARAX, as it makes me sleepy. I also put on a topical steroid and topical BENADRYL cream. I have also applied ice to the rashes. None of these things have really helped. I have also taken PEPCID in the hope that it will bring some relief during this phone conversation, but I have yet to see the outcome. I have begun to see improvements in the areas of breakouts, but I am now seeing new breakouts in different areas as those improve. I am scheduled to see an allergist on 12/5/2022 if these symptoms do not improve.
Approximately one week after second injection, my shoulders became very painful and range of motion was severely restricted. Pain extended down both arms and into wrists.
Patient stated she received her vaccine around 9:50 am and started having symptoms of fever, body aches, HA, chills and nausea around 3:50 pm that afternoon.  States fever went as high as 106 degrees.  She took tylenol initially for symptoms.  As fever continued to increase she called her PCP who told her to take tylenol and motrin at the same time and if temperature did not drop below 103 to report to her local hospital.  States her temperature decreased to 102 the next morning on 3/6/21 and then all symptoms resided by afternoon on the 6th.
pt recv vax 28APR98 & 1MAY98 pt exp a localized rxn;from follow-up  of 26MAY98 it was reported that pt recovered from this experience;
Patient was vaccinated last week for the first dose of the primary series, we vaccinated them again this week. He received two doses of the vaccine within a week.
Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an adult patient who received an exposed vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via unknown route. This is a case of actual medication error due to product storage error due to a temperature excursion where Adacel was recommended to be discarded. No AE information was provided.  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 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.
She was running a 102 plus fever starting on the 29th for about 3 days and vomited on the morning of the 30th. Obvious Malaise, irritable, refused to eat.  4 weeks later she was irritable again with a high fever and was diagnosed with hand foot and mouth, though the only symptom was fever and ulcers in the back of throat. Since then for the past 11 months patient has developed cyclical fevers in which she will have 105 fevers for 5 to 7 days that result in a tonsillitis throat, but negative strep test and any other bacterial test.  During the fevers she refuses to eat, sometimes vomit and has complained of abdominal pain, but no diarrhea.  Her pediatrician is considering that she may have Pfapa.  The fevers have been shut down this month with 3 28 mg doses of prednisolone, but we expect it to return next month.
Very mild pain at injection area; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6198) via an unspecified route of administration in the left arm on 17Mar2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal stenosis, arthritis and penicillin allergy from an unknown date. Concomitant medications included buprenorphine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN) and bisoprolol (MANUFACTURER UNKNOWN) for an unknown indication and since an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 14:00, patient experienced very mild pain at injection area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The outcome of the event very mild pain at injection area was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Tinnitus - immediately after vaccine, no treatment, has improved minimally Purple Sparkles in vision - later in the evening on the same day of the vaccine, improved after 3 months but came back 2 months later as bad as initially Blind spot - In right eye. Occurred within a week of the vaccine, diagnosed as Neuroretinitis, fluid/swelling improved but blind spot is still present (more opaque) currently and imaging shows inflammatory cells are still present Flashes, floaters and halos around lights - in both eyes. Occurred within 2 weeks of the vaccine and got progressively worse. Retina images are normal, doctors believe its neurological Purple delayed afterimages - Began in September 2021, retina imaging is unremarkable so doctor's believe it is neurological Hypertension - Had pre hypertension in the past which was under control with 25mg Losartan (as needed), did not need to take medication majority of the time. Stage 2 resistant hypertension began within a week of the vaccine. I have taken 5 different medications (at high doses and in combinations) and still get high readings, spiking up to hypertension crisis (203/105) while on high doses of medication. Brain fog - Began immediately after the vaccine, no diagnosis or treatment Migraine - Debilitating migraine for 5 days beginning immediately after the vaccine. Excruciating pain and nausea and was unable to leave bed. No medication (Tylenol or Excedrin) worked went away after 5 days.
76 yo female with pmh of Group 1 PAH-CTD, ILD, SLE/CREST variant of scleroderma, chronic hypoxic respiratory failure (4L), CAD s/p CABG, chronic diastolic heart failure, and CKD who presented for shortness of breath and hypoxia. She was lying in bed and woke up short of breath. She was reportedly tachycardic, tachypneic in the 30s, and O2 sats in the low 80s on CPAP so she was transitioned to HHFNC, given vanc, cefepime, and 2.5L NS and transferred to ICU. EMS reported a fever of 101.1. Of note she had a Lexiscan stress test with perfusion imaging done on 12/6/21 per pulm htn, with LVEF 64% without evidence of provoked ischemia    Please note: Patient received first dose Pfizer vaccine on 2/23/2021 Lot # EL9265 and the second dose on 3/16/2021 Lot # EN6205
9:30 7/3/12 Patient was told to lay down after HPV. Patient was sitting down and fainted. Within minutes patient was alert. Dr was called. B/P WNL.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: ACUTE FLACCID MYELITIS (medically significant), outcome "unknown", described as "acute flaccid myelitis"; ACUTE RESPIRATORY FAILURE (medically significant), ACUTE HEPATIC FAILURE (medically significant), outcome "unknown" and all described as "acute respiratory failure and liver". The lot number for bnt162b2 was not provided and will be requested during follow up.
drop or so of liquid at injection site/ a little bit blood mixed in too; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77-year-old female patient who experienced drop or so of liquid at injection site and a little bit blood mixed in too (vaccination site haemorrhage), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided. List concomitant or no other vaccines was reported as none.   On 05-Sep-2020 (Saturday), the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [prefilled syringe, lot number and expiry date not reported] via an intramuscular route at the left deltoid for prophylactic vaccination.  On the same day, after vaccination patient observed a drop or 2 or a little liquid an inch below the injection site which was all the way down to her elbow and to her fingertips.  It was reported that, a little bit blood mixed in too with the drop or so of liquid at injection site (vaccination site haemorrhage).   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for vaccination site haemorrhage.
Booster; Not felling well at all; Difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (2nd Dose), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "Not felling well at all"; DYSPNOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Difficulty breathing".  Additional information:  Reporter stated, "My husband and I had a booster shot yesterday and he was not felling well at all. He was having a lot of, he did not have chest pain but difficulty breathing." If taken the Pfizer Covid-19 vaccine booster shot: Reporter stated, "It was Pfizer the booster, we got our two shots back in Apr2021."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case description: This 45 year old female was vaccinated with an i.m. typhoid vaccine in FEB 84, APR 92 and April 95. After vaccination with oral typhoid vaccine Vivotif Berna (typhoid vaccine live oral Ty21a) in FEB 1999 the patient developed an anaphylactic reaction. The patient recovered completely. On 30 APR 1999 the patient was vaccinated with Typhoid IV (Manufacturer Merieux), the vaccine was given by progressive challenge and the patient developed throat tightening and generalized itching 0.02 sec after 1:100 diluted vaccination. This case was reported by FDA; VAERS No.: 121896. (While preparing a publication on typoid vaccines FDA realized that this cse has not yet been reported to Berna Biotech)
Patient came back to get his second Pfizer covid-19 shot and said that 10 days after getting his first shot he developed pleurisy which he was treated outpatient for with ibuprofen. He spoke with a nurse that wanted him to get his second shot to complete the series and for him to return if he has these symptoms again. They were unsure if it was related to the vaccine or not.
About 2 weeks after I received my Covid vaccine  I experienced a sharp pain in my chest. I wasn't on going so I didn't worry about it but another week after that I began to feel palpitations and decided to go to the emergency room at Hospital. I was given an EKG and an X -Ray of my chest. They didn't notice any abnormalities so they told me to follow up with my physician. My doctor made an appointment for me to have a stress test. I was on the treadmill for 6 minutes and my blood pressure dropped so low that Dr. called an ambulance to take me to the hospital.  I was there from the 27th to the 30th of May taking test.  I  also had a cardiac cath test which came back inconclusive. Another symptom that now is troubling me is vertigo
Breakthrough case admission after three vaccines Pfizer 3/24/21 Lot# ER8727;  Pfizer 4/14/21 Lot# EW0158;  Pfizer 10/24/21 Lot# FC3181
Pateint received dose 1 of COVID 19 Pfizer vaccine on 5/19/2021. Appointment for 2nd dose was made on incorrect day and patient received 2nd dose on 06/01/2021. Earliest dose should have been 06/05/2021. Patient's mother  was notified and told of error on 6/01/2021 by telephone. Patient vaccine record had an appointment on wriiten backside for 6/9/2021. Mother will closely moniter the patient for any adverse affects.
Subsequent to receiving vax, the pt experienced a red rash across the chest, swollen throat, headache and fatigue. The rash resolved in one week. The other symptoms resolved in three days. As of 08/14/2000, the outcome of the event is resolved.
Patient contracted COVID after being fully vaccinated cough, chills, diarrhea, loss of taste, loss of smell, sore throat.
cough; mucus; back pain; This is a spontaneous report from a contactable other hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on unspecified date of Aug2021 (at the age of 70 year) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Palbociclib (IBRANCE, Tablet 125 mg) (cyclic (125 mg tablet once per day for 21 days on, 7 days off)) taken for Breast cancer from 30Apr2021 (to stop date 06Sep2021 and restarted on Sep2021) to an unspecified stop date. Patient reports Ibrance had been on hold since 06Sep2021 due to symptoms from covid vaccine. On unspecified date of 2021 the patient received the vaccine four weeks ago and had been experiencing cough, mucus, back pain, after the start of Ibrance. Patient will be following MD recommendations on future restart date for Ibrance. Patient was treated with antibiotics. The outcome of the events was recovering.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
pt recvd flu vax 6OCT95 & 10 days p/vax exp redness & swelling & warmth @ site-went to neck & shoulder (soreness);c/o lt arm, shoulder, back pain cont-pt feels sick;?abscess;pos influenza synd by flu shot;neuropathy, tingling, weak, dx UTI
Mother stated pt left arm had a base ball size red bump after about 8 hrs and worsened after 20 hours. Pt taken to ER and was told Pt had an infection.
Vaccine was given on 7/10/2017. Patient reports redness ans mild swelling 1-2 inches below injection site later in the day. 7/11/2017, area was raised and painful. 7/12/2017 she is seen in clinic, area of erythema and mild swelling  to left upper arm starting 2 inches from injection site measuring 16cmx 22cm.  TX: ice, NSAID, Benadryl.
Approximately 6-8 hours, post Menactra, experienced myalgias and fatigue and fever of maximum 101.5F. Symptoms all resolved with Tylenol and did not return.
His head doesn't feel right, like he's in the twilight zone; Slight rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face). At the time of the report, FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Narrative:  Patient received pneumonia 23 vaccination on 4/21/21 and presented to the ED with right upper arm pain, redness, swelling that occurred for 3 days after receiving PNA shot. Pt was evaluated in the ED and it was stated that the rash was cellulitis and most likely unrelated to the vaccination. Pt minor redness initially may have been from the vaccine.
This patient received a COVID-19  vaccine that was a day past it's refrigeration time. Refrigeration time was up on the 17th of July.  But was not removed from the fridge and it was used on the 18th of July to vaccinate this patient.  Patient as of now has not reported an adverse event due to this vaccine.
4/13/22:  Intense itching (multiple body parts: arms, torso front/back, groin, ankles, palms of hands, bottom of feet, inner ears, and scalp). Red Rash, Welts, Swollen lip (only half left side) + raised welt on Tongue, Slightly swollen throat 4/14/22 Went to ER:  Given Benadryl shot (which offered no relief.) ER performed no tests. 4/17/22 Post care:  Healthcare provider offered no other testing.  Treatment plan consisted only of treating the symptoms with Prednisone (high dose). I deferred due to contraindication with my history of heart arrhythmia. Requested tests, bloodwork, so I could assess, then make decision for this Rx, they offered NO blood tests.  They did not refer me Allergy/Immunology.
Information has been received from a medical assistant concerning a 10 year old male patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) in his arm. Concomitant therapy included BENADRYL. Shortly after vaccination, the patient developed a red mark at the injection site which became softball size. Unspecified medical attention was sought. No further injection was given and he was treated with BENADRYL that made the reaction go away. At the time of this report, the patient had recovered from a red mark at the injection site. Additional information has been requested.
Pt had flushing and pt stated that she had chest pain.  Pt was provided oxygen to ease breathing.  EMS was called.
40mm induration and erythema, hot to touch, pain and temperature 99 degrees.
has severe pain in her arm and feels that she can no longer more,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "has severe pain in her arm and feels that she can no longer more,".  Additional information: My mother was vaccinated with her vaccine against covid, and it has been 7 months since the second dose. Lately my mother has severe pain in her arm and feels that she can no longer more, the pain you feel in your arm is very intense and I need your prompt help, please.  The lot number for bnt162b2 was not provided and will be requested during follow up.