chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Dizziness; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (COMIRNATY), on 21Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diagnosed with a long time ago, doesn't remember when diagnosed with. The patient's concomitant medications were not reported. Vaccination history included: covid-19 vaccine (DOSE 3 BOOSTER, lot: FH8020, NDC: unknown , expiration: unknown , route of administration: right deltoid), administration date: 09Nov2021, for Covid-19 Immunization; covid-19 vaccine (DOSE 2, SINGLE, lot: ENK1810, NDC: unknown , Expiration: unknown , Route of administration: left deltoid), administration date: 19Feb2021, for Covid-19 Immunization; covid-19 vaccine (DOSE 1 ,SINGLE, lot: EN9581, NDC: unknown , Expiration: Unknown, route of administration: right deltoid), administration date: 29Jan2001, for Covid-19 immunization. The following information was reported: DIZZINESS (medically significant) with onset 21Oct2022, outcome "not recovered"; HEADACHE (medically significant) with onset 21Oct2022, outcome "not recovered". Clinical course: Patient received the Comirnaty booster dose a week ago last Friday, 21Oct2022. She has had a headache and dizziness since. Stated that it is kind of strange because the dizziness is worse at night. Especially when she lays down flat on back.; Sender's Comments: Based on the available information, the reported serious events cannot be excluded for the suspect drug BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
antibodies "at the 140 level, below the expected level of 160 or above."; a rash of 12 dots; This spontaneous report was received from a patient's mother and refers to a female patient of unknown age. No information regarding the her pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneous, (dose, lot # and expiration date were not reported) for vaccination.  On the same date, she experienced rash of 12 dots at an unspecified location, which resolved on an unknown date in approximately 2019, provided as "shortly after the vaccine was given".  On 06-DEC-2019, reported as eleven weeks after the dose, the patient had varicella titers test drawn, showing antibodies at the 140 level, below the expected level of 160 or above (units not provided). On an unknown date patient sought medical attention and contacted a physician. The outcome of the event of antibodies at the 140 level was reported as recovered (date unspecified). The relatedness between the events and the suspect vaccine was not provided.
Had varivax on 7/7/00. On 9/9/02 developed red, fluid-filled rash. Seen by MD and diagnosed with Chicken Pox.
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Vaccines given in am of 8/21/07 Swelling and redness within 2 hrs of receiving DTaP and HIB in (L) thigh.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # L033343 expiration date: 13-SEP-2017), the vaccines were exposed to 68.7 °F for 5 hours; also the vaccine with lot # L040458  expiration date: 04-FEB-2018 was exposed to 54.4 °F for 5 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010217: US-009507513-1612USA010219: US-009507513-1612USA010220.
I experienced COVID after my vaccine. On 09/02/2022 I tested positive for COVID.  I was extremely exhausted with body aches and chills but no fever. I also had severe headaches and a cough that lasted about three weeks.  I got COVID from my son. I took an at home COVID test which resulted positive.  I did do a tele-health medicine and a month follow up later and saw my doctor and was told to be careful. I have no symptoms today.  Once school went back, I feel the cases went up in my opinion.
Patient reports that she noticed tenderness to the interior aspect of her thigh and calf on Saturday after receiving Janssen vaccination in clinic 4/8/2021. Per patient areas of tenderness now present as "greenish- colored" bruising of unknown origin.Patient denies fever, chills, abdominal pain, or headaches but did take Ibuprofen on Friday for mild body aches with relief.   Vital signs performed: Yes.    Patient denies any new headaches, history of migraines which she reported to take Naratriptan as needed. Denies blurry vision. Denies trauma to the affected area. Patient reported cramping left leg friday night.  2 yellow-green bruises (roughly the size of a quarter) were found. 1 on R. lower leg and 1 located on R. inner thigh.   Pt evaluated by MD. Will f/u with patient tomorrow via phone.
Vaccination complication; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination complication) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced VACCINATION COMPLICATION (Vaccination complication). At the time of the report, VACCINATION COMPLICATION (Vaccination complication) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is reporting an interaction with their Warfarin medication after receiving the Moderna COVID-19 shot (did not indicate if 1st or 2nd).   Reporter did not allow further contact
Information was received on 13-JUL-2017 from a registered nurse regarding an unspecified number of patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA, M-M-R II, GARDASIL 9, RECOMBIVAX HB, ROTATEQ and VARIVAX (dose, route, site of administration and lot numbers not reported). It was not known if sterile diluent used to reconstitute M-M-R II and VARIVAX was improperly stored, at the time of the call. No adverse effects were reported. No further information was provided. Temperature: Unknown by reporter at time of call. Time frame: Unknown by reporter at time of call. Previous temperature excursion? Unknown by reporter. Was call because of a data logger? Yes. On the same day the nurse called back to provide lot #s and expiration dates. VAQTA (lot # N012324, exp 05-APR-2018), M-M-R II (lot # M047302, exp 30-NOV-2018; lot # N002337, exp 20-JAN-2019 and lot # M039914, exp 26-SEP-2018), GARDASIL 9 (lot #N003703, exp 29-OCT-2019; lot # L037554, exp 25-DEC-2017), RECOMBIVAX HB (lot #N006321, exp 08-NOV-2019; lot # N009802, exp 19-DEC-2019), ROTATEQ (lot # N009948, exp 21-OCT-2018 and lot # N003396, exp 03-NOV-2018), VARIVAX no lot #'s provided. Additional information has been requested.
Fever for 2 days  Left Arm muscle pain radiating into the arm pit for 4 days  Sick to stomach for 1 day  General feeling of being unwell for 2 days
Began with rash on 4/27/10, has > 30 papules on body, given script for acyclovir and mom to do BENADRYL also.
Heavy and extended menstruation. My period lasted for  approximately 45 straight days after my 2nd vaccine. It also lasted slightly longer after my first shot (2 weeks vs my average 5-6 days), but I didn?t think anything of because it wasn?t super heavy, just slightly abnormal.
Localized pain, redness, and swelling at the injection site covering a 2x3 inch area of skin. Did not start until the next morning (1/15/21) and got progressively worse through that day/night. Pain started to subside Sunday morning (01/17/21) but site was still red and slightly swollen. Site is now pink in color and lessened in size (01/19/21) but still tender.
On 9/10/2010 patient reported numbness secondary to pain after flu shot; numbness occurred on (L) arm at injection site for 4-5 days.
This spontaneous report was received from a Licensed Practical Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date in 2014, the patient was vaccinated with GARDASIL 9, then on an unspecified date in 2016, the patient was vaccinated with 2 doses of GARDASIL (interchange of vaccine products) (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.  She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out." Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12  repeat at 16:30 BP=139/100, P=99 pulse OX 100%  She then C/O chills later. Paramedics were called and transferred in to ED. She takes AMLODIPINE 5 MG DAILY FOR  HTN. She has family HX of HTN.  Negative for headache, + palpitations, + presyncope, + shortness of breath, slight difficulty brathing. She did not experience any loss of consciousness. Never had any chest pain,  angioedema, rash, pruritus, throat swelling, hoarse voice. The patient has had no recent illnesses, fevers, chills, nausea, vomiting, diarrhea, or flu-like illnesses. She has had no cough, rhinorrhea, or congestion. She denies any recent vaginal bleeding, or abdominal pain. Denies any history of cardiac disease, or history of arrhythmias. Denies any history of prolonged immobility, recent travels, or history of clots.   In ED: 36 year old  female presents with dizziness and presyncopal like symptoms approximately 15 minutes after receiving the Medina vaccine at this hospital the patient who is mildly tachycardic mildly hypertensive but otherwise normal and stable vital signs and is overall nontoxic appearing.  Of note the patient's oxygen saturation was 97% while I was in the room and not the 2% that is documented here.   EKG notable for a rate of 87 normal axis normal sinus rhythm T-wave inversion in V1 otherwise no evidence of Brugada interval abnormality or evidence of electrolyte abnormality that would require further workup at this time.  Patient counseled to follow up with her primary care.  Patient given EpiPen given her EpiPen has expired.  Patient requested to go back to work I feel this is fair given patient will be on campus and can return to the emergency department should she develop any further symptoms.   Patient states her symptoms have completely resolved and she has normal vital signs currently heart rate in the 80s blood pressure 138 systolic feeling well and requesting to be discharged.
Blood in the urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA), SALBUTAMOL (ALBUTEROL HFA) and PRAVASTATIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the urine). The patient was treated with NITROFURANTOIN at an unspecified dose and frequency. At the time of the report, BLOOD URINE PRESENT (Blood in the urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to healthcare professional for urine analysis.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-MAY-2014, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Frequent heart palpitations developed in the days following the vaccination.  No history of ANY medical issues, patient in excellent health.  Now experiences heart palpitations regularly throughout the day, with no improvement one week later.
Patient did not actually have any Adverse effects, situation is when we tried to bill the patient's vaccine, we found she already had a profile in our system for the year of 2009, called the pharmacy that gave her the flu shot in September 2020 and they confirmed that consent form marked year of 2009. I then proceed to call the mother and she confirmed at least twice that the daughter was born in 2008 and that she thinks she wrote the year wrong last year for the flu shot. However, in the evening when we tried to bill the insurance it also stated the year of 2008 was invalid DOB.
6p - body aches and chills 100.9 8pm - 101.8  ibuprofen 600mg taken 12a woke up drenched in sweat body aches severe next day no fever but severe body aches still  shortness of breath is worse tightness in chest is back Wednesday 8p diarrhea
Event #1: Left arm and chest pain following second injection for two weeks. Admitted to emergency care for left arm and chest pain. Arm and chest pain continued for over two weeks and did not get better. Left arm pain would shoot down towards hand. Did not go away within a week.  Event #2: Continuing, non-stop arthritis in hands, knees, feet, and arm joints. This includes aching and creaking joints. No arthritis symptoms before Covid injections. Two nurses recommended I visit urgent care after I described the above symptoms. I entered urgent care on Oct. 19. The chest and arm pain has gone away but the arthritis has not.
Via phone call on 3/24/21 - She states that approximately 10 minutes after getting her vaccine she started having itching in her throat and an "extreme Migraine". She was given Benadryl. The muscles in her throat seized up and she could not swallow and the itching in her throat became "severe". She was given an Epipen and was sent to Emergency Department via rescue.  She states she was treated in the Emergency Department and discharged to home 5 to 6 hours later with prescription for Prednisone which she took for 3 days. In addition to the Prednisone, she took Benadryl for 4 days. She is going to follow up with her Primary Care Physician next week.  States since receiving the vaccine she still has no energy and pressure behind her nose - "like someone is pushing or holding pressure behind her nose."
24 hrs post immunization pt. reported back to clinic with dyspnea & throat tightness was assessed by HCP at clinic. HCP referred pt. to an urgent care for possible rxn to SEPTRA or Immunizations and anxiety.
Left thigh redness/swelling/tenderness 10cm/12cm no streaking, no fever.
pt recvd vax 20MAY93 & 1JUN93 pt exp clinical rubella w/rash, fever, sore throat & lt knee pain;seen by MD 11AUG93 & 27SEP93 for cont joint pain, swelling & malaise;16FEB95 lab eval revealed pos EBV serology, EBV IgG capsid antibody was 758
Nauseated, extreme fatigue and low grade fever of 100.1.  Site of injection is very sore.
pt c/o macular red rash severe pain lt arm distal to vax;2d p/vax;
Upper female lip swell to maximum capacity. Did not report to work on Tuesday, October 12, 2021. Treated with ice packs and Tylenol every four hours until swelling subsided.
Side effects: Mini-stroke, strange frontal headache since April 20, 2021 (does not respond to normal medication), low oxygen (drops like a stone when I exercise and will have to move to sea level; now sleep with oxygen at the Lake, 6500 ft El, else O2 at 84-90%. Health-History: Prostate removed June 17, 2008 due to cancer.  Radiation in November and December 2014 due to reoccurrence of the prostate cancer.  Born with somewhat week lungs, but OK to ski any mountain up to 10,000 ft until that vaccination side effect occurrence, a biker/kayaker/hiker (live in city and hiked up the mountain in summer-time, 5 days a week and in winter, skiing almost daily if possible).
AFTER FIRST HEPATITIS B VACCINE HAD FATIGUE AND RIGHT ARM SORE. 13 DAYS AFTER SECOND VACCINE HAD RIGHT SHOULDER AND NECK PAIN,EXTREME FATIGUE, HEADACHE, WEAKNESS, TREMOR, VISION DIFFICULTY, SWALLOWING PROBLEMS, JOINT PAIN MORNING STIFFNESS, FACIAL NUMBNESS, MEMORY LOSS, DIFFICULTY CONCENTRATING, BURNING FOOT PAIN, FREQUENT NIGHT URINATION, DRY EYES/MOUTH. 60 Day follow up: Chronic fatigue, joint pain, stiffness, chest pain, rib cage tender, lack of concentration, forgetfulness, irritable bowel/bladder, numbness hands/feet, sensitive to heat, odors, noises, bright lights and touch. Dry eyes, skin and mouth. Out of work going on 8 months. Per the follow up report-Patient states, "I have worked hard all my life as a Navy diver and then as supervisor for County Jailed inmates. I am not a quitter and have a very positive attitude. I take each day as it comes. I have seen 4 Rheumatologists, an immunologist, an Neurologist, an Neurosurgeon and my MD. All suspect that the Hepatitis B vaccine I received due to working with inmates was the cause of the fibromyalgia. The pain and fatigue are very severe. While in the Navy as a Diver, were subjected to extreme pain and fatigue. Everyday I experience muscle stiffness, weakness, spasms, twitches, cramps, pain widespread, overall weakness, tender points, exercise intolerance, Paradoxical breathing, Parethesia, malaise, breast pain and tenderness, headache, facial jaw pain, impaired coordination, lack of hand/eye coordination, dropping things unexpectedly, bumping into things, night sweats, fingernails split and break easily. There are no 1/2 moon on the lower part of my nails and vertical ridges on them, dry eyes and mouth, tinnitus, dizzines, difficulty swallowing, nausea, diarrhea, sensitive skin, blurred vision, hypersensitivity, ultra sensitive skin, heat, odors, bright lights, sound, orders, loss of short term memory, inability to concentrate, absentmindedness, impaired thinking, easily distracted, inablitly to comprehend written or spoken words, decision making problems, calculation difficulties. Thank you for your time and consideration.
Temperature of 103; Had severe body aches; Weakness; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient in her 60's received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for preventative for Covid 19. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient experienced temperature of 103, had severe body aches, and weakness on an unspecified date which lasted for two days and then recovered on an unspecified date.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Received immunizations on 3/21/03 afternoon-on 3/21/03 pm-L arm itching, red, warm to touch, and swollen-MD aware-child encourage to use compress for swelling and Tylenol for discomfort.